Fdd Leaders Handbook

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LEADERS HAND BOOK Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Rajesh Bhatkal Ambuj Kumar Ajanta Sengupta E Mujahid Mathen Mathew Nirav Mistry PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

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FOREWORD

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o master the sitar. To travel around the world. To write a book. These are just a few of the dreams and goals that feature in this very special handbook. Featuring ordinary people who have achieved extraordinary results in their chosen areas of expertise. Touching all of our lives, without us even knowing them. Who are they? Why did they choose to be 'lab rats'? What are their dreams? Who motivates them? What keeps them going, day after day, year after year, decade after decade, chasing an elusive idea?

Fanning a spark into a flame, into a fire?

Express Pharma is honoured to present the first edition of the FDD Leaders Handbook, an endeavour to recognise and celebrate the achievements of some of the leading formulation development and drug delivery (FDD) researchers in India.

This very first volume focuses on FDD professionals currently employed in Indian pharmaceutical companies. We know that we have taken only a first small step to shine a light on these achievers, the achievements they value the most, their dreams and ambitions, the role models. More importantly, we have tried to go beyond the lab coat to the person, both at work and at play.

With the support from our Presenting Partner, Ideal Cures, led by founder Suresh Pareek, we hope to add to this roll of honour at regular intervals in the future.

We seek your blessings as we embark on this journey to partner the FDD segment to greater heights. Do write back with your suggestions on how we can take this effort to the next level.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com www.expresspharmaonline.com

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CONTENTS

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Dr Himadri Sen

Dr Shirish Kulkarni

Sukhjeet Singh

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Ramesh Jhawar

Arun Kumar Pandey

Rajesh Kshirsagar

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Dr Milind Biyani

Ravinder Kodipyaka

Srikant V Pimple

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Vinod Kumar Arora

Dr Vijaysinh Vanvirsinh Chauhan

Jaya Abraham

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Dr Girish Kumar Jain

Makarand Avachat

Ulhas Dhuppad

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Pramod Pimplikar

Dr Jayant Karajgi

Dr Krishna Murthy Bhavanasi

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Seetaraju Gembali

Sushrut Kulkarni

Dr Sunil B Roy www.expresspharmaonline.com

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Dr Goutam Muhuri

Sarabjit Singh

Dr. (Ms.) Monika Srivastav

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Dr Pankaj Kumar Khapra

PVS Narasimham

Hitesh Kumar Maheshwari

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Pratibha Omray

Krishnakant Gandhi

Dr J Suryakumar

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Dr Veerababu Taduri

Dr Pavan Bhat

Dr Prafulla S Chaudhari

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Dr Prakash Shetiya

Sunil Tiwari

Dr Deepak Gondaliya

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Chandrashekhar Kandi

Dr Rakesh Bhasin

Dr Amit Biswas

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Jagdish C Koshti

Sandhya Shenoy

Ashish Gogia

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Kamal S Mehta

Nagaprasad Vishnubhotla

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✦Education: M.S. Pharma, Ph.D. ✦Designation: Chairman, SteerLife India ✦Experience: Involved closely with the pharma industry for over four decades ✦Specialities: Extensive and in-depth experience in pharma product development and technology, both generic medicines and drug delivery systems, with deep insight into global quality and regulatory affairs. inspirational leadership to transform Indian pharma R&D to take up challenges in converting concepts to product in the regulated global market ✦Number of patents filed: More than 50 patents ✦Awards: ■ Lifetime Achievement Award 2016

by IPA, Pune Branch ■ State Honour as Research Scientist of the Decade at 5th Annual Pharma Summit & Awards 2012 organised by a bi-monthly magazine, Pharmaleaders ■ Distinguished Scientist Award from American Association of Indian Pharmaceutical Scientists (AAiPS, San Diego, US 2007) ■ Research Scientist Award by Pharma Business and Technology (2004)

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FDD LEADERS HAND BOOK

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DD needs the ability to connect the dots, from designing and developing the product to scaling up and commercialisation

MEMORABLE INCIDENCES AS A SCIENTIST ◗ Being instrumental in out-licensing a drug deliverybased pharma product deal for the first time from India to a big multinational pharma company in July 1999 ◗ Fronting the implementation of more efficient processes such as rapid mixer granulator, fluid bed dryer and aqueous film coating in perforated pan during the early days of solid orals processing in the Indian pharma industry ◗ Working closely with Dr Gerhard Gergely, a pioneer in the field of effervescent technology for topo granulation process and its applications

LEADERSHIP IN PHARMA R&D ◗ Great team building ability to for achieve long term goals.

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◗ Leadership is not only about leading from the front, but also involves developing young scientists to take on leadership roles for the future. I have been able to provide guidance to many who are leading the pharma industry.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD Important intellectual ingredients comprise attention to details, at both micro and macro levels, i.e., deeper understanding of ingredients’ composition. It involves process on one hand while it is about developing the understanding to use them effectively to create a highperforming, desirable, end product, on the other hand. FDD needs the ability to connect the dots, from designing and

developing the product to scaling up and commercialisation.

LIFE GOALS AT 70 ◗ Changing the way we make and take medicines. This goal includes changing from batch to a truly continuous and integrated process in pharma industry. ◗ Providing an option to sip medication rather than swallowing it, in case of paediatrics and geriatrics as well as the adult population ◗ Contributing to make India a global hub for innovative technologies for drug delivery and manufacturing

WORDS OF INSPIRATION These lessons can stand in good stead in the pharma industry: ◗ The best preparation for tomorrow is doing the best today ◗ Be decisive and take your destiny in your own hands ◗ Key attributes to success: Passion, Patience, Perseverance, Persistence & Innovation.

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✦Education: PhD (Pharmaceutics) MBA (Operations & Marketing) ✦Designation: President, Ajanta Pharma ✦Experience: More than 45 years ✦Specialities: Experienced in all functions of pharma operations ✦Number of patents filed: Couple of patents issued

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t is the mindset of progressive organisations that bring novel and disruptive products to serve the global community

LEARNINGS AS A SCIENTIST There were several occasions where I could resolve multiple, unanswered findings with the help of science and it further led to major financial gains. To recount a few examples: On one occasion, when multiple batches were failing to meet dissolution specs, on careful investigation it was observed that the dissolution media had marginal solubility for the analyse. Just slight enhancement of the solubility parameter, resolved the problem for ever. On another occasion, a vendor developed an expensive process in terms of inputs, but the lengthy process could be reduced from seven days to few hours and input cost by 50 per cent based on the scientific understanding of the product and process. There are several such life examples which awarded the organisation based on better understanding of science underneath the problem.

Therefore, it is the mindset of progressive and innovative organisations which bring to the world, novel and disruptive technologies and products to serve the global community.

LEADERSHIP IN PHARMA R&D Leadership role is the same in all industries whether it is technology, pharma, biotech, manufacturing or infrastructure. www.expresspharmaonline.com

Similarly, the challenges are same in other functional areas such as finance, operation, marketing, quality and regulatory to name some. In a leadership role, it is important to keep morale of the operating staff high throughout business cycles, be they good or bad. Like all other curriculums in different industries, Pharma R&D is not immune to business cycles.

There are additional challenges because of multiple variables when it comes to pharma R&D. Therefore, it puts additional burden on people in the leadership role. In my view, one must be analytical, understanding, willing to take ownership, and should stay updated to play a leading role.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD In the generic pharma industry, there is a need to understand the entire landscape of the product life cycle and design the path forward.

The challenge starts from product selection and ends with the completion of the product life cycle. Then, you face challenges dealing with intellectual property,

ingredient sourcing, composition, process technology, quality and regulatory landscape, analytical challenges, competition, post marketing surveillance and many others. Therefore, an individual heading R&D and FDD must be fully familiar with the entire life cycle of the product.

LIFE GOALS AT 70 I do not envision myself sitting idle or whiling away time in casual activities in my retirement years.

If I reach there and I am forced to choose limited things in my seventies, then I will like to continue to serve the industry and the profession with the knowledge I accumulated in my life. Of course, there will be other leisure activities such as travelling and spending quality time with family .

WORDS OF INSPIRATION The world is progressing at lightning speed and there are multiple challenges for the next generation in this ever-changing environment. Therefore, stay updated and stay vigilant. You cannot be complacent and need to equip yourself with new tools and skills frequently. Pharma is an applied science; therefore, you need to be aware of innovation in related industries as well. All it takes is hard work and staying motivated.

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✦Education: B.Pharm., M.Pharm., Ph.D (Tech), PGD in patents ✦Designation: Director-R&D, Aspire Advisors Pvt. Ltd ✦Experience: 40 years in formulations development ✦Specialities: 505(b)(2) type innovations in formulations, NDDS, Liquid filled hard capsules, generics, patented extracts ✦Number of patents filed: 19 ✦Publications: 28 ✦Awards: The company award for patenting and commercialising the product from the concept stage at Ajanta Pharma

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ailure can be a step towards success.

Never stop learning and working

MEMORABLE INCIDENCES AS A SCIENTIST One of the most important moments was when the first US product patent was granted and based on it, the product was

successfully launched in India.

Facing US FDA auditors for PDR review was another significant moment. Another important incidence was attending the 505(b)(2) pre-NDA meeting with US FDA team of 18 experts.

Another important milestone was the approval of the first ANDA and site by US FDA. Still another incidence was when the product was selected for ANDA and licensed out for the US market.

LEADERSHIP IN PHARMA R&D It means leading by example for innovations, spearheading different R&D initiatives, and successful commercialisation of patented products. Keeping updated with latest technologies.

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INTELLECTUALINGREDIENTS FOR SUCCESS IN FDD ◗ Deep and thorough thinking of different options. ◗Thinking out of box. ◗ Good understanding of patents and Quality by Design (QbD).

LIFE GOALS AT 70 ◗ Developing novel product using liquid filled hard capsules for enhancing bio-availability.

505(b)(2) type NDA ◗ Enabling institute-industry collaborations

WORDS OF INSPIRATION ◗ Innovate, innovate, innovate! ◗ Keep improving continuously. ◗ Failure can be a step towards success. Never stop learning and working.

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✦Education: M. Pharm; DBM ✦Designation: Principal Advisor, Institute of Good Manufacturing Practices India and Medicines of Patent Pool ✦Experience: Over 39 years ✦Specialities: Generics, Differentiated, NDDS/NCE Dosage Forms Development ✦Number of patents filed: Authored/co-authored over 100 patents in the area of NCE/Differentiated products/NDDS/Generics ✦Awards Felicitated by former President of India, Dr APJ Abdul Kalam, for development and launch of first NCE, an anti-malarial, from India

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he harder/smarter you work, the more you will feel satisfied when the goal is achieved.

DEFINING INCIDENCES AS A SCIENTIST There were several incidences in my professional journey spanning 39 years, but I would like to share three such incidences.

First one is of Synriam - First NCE (anti-malarial fixed dose combination) launched by an Indian company. In 2002, my team and I were assigned the responsibility to develop the formulation, post an interview by a University Professor. We were working with Medicines of Malaria, Geneva team. We had to face several challenges and roadblocks but finally, when the product was launched on Malaria Day, after working for around 10 years, we all were very happy.

The second one was during development of Ciprofloxacin once-a-day formulation. We were asked by Head R&D whether we will be able to develop this formulation and we agreed as in

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the past we had worked on such products. However, when we started developing our first pilot PK study, results were not satisfactory. But, after working for three to four months, we did our second PK study and results were on expected lines. We were very happy and thereafter work continued.

The third one was during the filing of Voglibose tablets for the Japan market, as the first Indian company to file India manufactured product in Japan.

This was done in collaboration with NPI, Japan. As it was the first product, understanding Japan’s regulatory requirements, Japan team’s perspective about the issue, gaining insights into their way of thinking etc. were challenging.

Once filing was done, we all celebrated.

LEADERSHIP IN PHARMA R&D Don't be afraid of what could go

wrong and think about what could go right as experimenting will give you learnings, be it failure or success. Always believe in yourself and your inner strength. There is a saying that a bird sitting on a tree is never afraid of the branch breaking because her trust is not on the branch but on her wings.

The harder/smarter you work, the more you will feel satisfied when the goal is achieved.

Learning/training should be a way of life

LIFE GOALS AT 70 ◗ Join an NGO and guide the team for the benefit of society. ◗ Sharing knowledge by delivering lectures in my area of expertise. ◗ Spend time with loved ones

WORD OF INSPIRATION There are huge opportunities for growth. However, due to changing regulatory, quality and compliance scenario there are challenges to meet expectations and we will be able to address this with the help of skilled manpower, changing our mindset, signing up for refresher courses on quality/cGMP, benchmarking, data integrity etc.

Let us be optimistic and have positive thinking as most of the things have been accomplished by people like you and me who kept trying when there is little or no hope.

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✦Education: M. Pharm, Ph.D ✦Designation: President- R&D, Alkem Laboratories ✦Experience: 23+years Industrial and about 7 years academic ✦Specialities: Extensive experience in formulation development especially NDDS products ✦Number of patents filed: More than 650 patents internationally ✦Achievements: 10 Papers published in national and international journals Filed more than 200 ANDAs with US FDA

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eadership is defined in managing change and taking informed but quick decisions, especially in tricky situations

DEFINING INCIDENCES AS A SCIENTIST There are many moments as scientist.

However, I would like to mention the following: ◗ In 1997-1998 while developing Cipro OD, a floating tablet was to be developed. I still remember when first time a big tablet floated in the beaker.

Further improvements and developments lead to a product which was ultimately licensed to Bayer US. ◗ Approval of generic version of Claritin D24 hour ( Loratadine + Pseudoephedrine ER tablet). This was the first US approval for an NDDS product in Sep 2004 from Ranbaxy. ◗ Approval of generic version of Toprol XL ( metoprolol Succinate XR Tablet) in July 2010. This was a technological breakthrough and only second generic of Toprol XL.

LEADERSHIP IN PHARMA R&D Like any other industry, leaders in pharma R&D need to have strategic perspective. The leader should under-

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stand the viewpoint of higher management and effectively analyse complex problems. Leaders should quickly master new technical and business knowledge as well as encourage team members to learn new techniques and implement them in R&D. Leadership is defined in managing change and taking informed but quick decisions, especially in tricky situations. A leader has to show compassion and sensitivity, genuine interest in others and sensitivity to employee needs, putting people at ease. Warmth and a good sense of humour are prerequisites in a leader. Respect for differences; balance between work and personal life priorities is very important. A leader must also be aware of his own strengths and weaknesses and be willing to improve.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD Indian pharma industry is basically a generic industry. Formulation development requires dealing with IPR in India and highly regulated countries. Therefore, a basic knowledge of interpretation of patents is becoming an increasingly necessary

requirement. Combining this knowledge with basic knowledge of pharma development and pharma chemistry plays a decisive role in formulation development. Knowledge about human physiology helps in designing formulation which helps in development of bioequivalent products. Lot of new excipients or older excipients with modifications are being launched by excipient manufacturers. A constant interaction and judicious use helps in developing formulation development.

LIFE GOALS AT 70 The goals in life changes with time, However, I would like ◗ To live a stress free, happy and healthy life at 70. ◗ To contribute something to the society's wellbeing. ◗ If needed, share my knowledge with fellow pharmacists.

WORDS OF INSPIRATION There is a quote of Anne Frank, “Everyone has inside them a piece of good news. The good news is you don’t know how great you can be! How much you can love! What you can accomplish! And what your potential is” I feel it is very true. Therefore, it is very important to have faith in self. It is one’s biggest weapon in attaining whatever one wants to achieve. Do best for your organisation. Learn from your mistakes and have a positive attitude.

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✦Education: M,Pharm, PGDPM ✦Designation: Managing Director, Shalina Laboratories Pvt Ltd ✦Experience: 32 years ✦Specialities: Pioneering production techniques, Improving R&D, M&As, process improvement and commercial operations

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see a bright future for Indian pharma industry and it will lead the world in the healthcare industry by 2025

LEADERSHIP IN PHARMA R&D Critical leadership competencies for pharma R&D are: Strategic perspective: Understanding the goals and approach of business needs. An ability to analyse problems and solutions.

Effective decision maker: Quick thinker and proactively act in difficult situations.

Catalyst for change management: Adopt strategies to support the change in organisation and motivate people to change.

Leading employees from front: Attract, nurture, motivate and bring improvement among employees.

Conflict management: Resolve conflicts amicably without hurting employees and ensure fair play.

Group management: Bring the team members together and use the strength of employees to achieve the organisation’s goal.

Considerate and benevolent

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approach: Demonstrate confidence in the employees and empathise on various issues with colleagues.

Individual strengths/weakness: Understand one’s strengths and weaknesses and mould himself to maximise stregths and mitigate weaknesses.

Talent and career management: Use effective career management tactics including mentoring, professional relationships and feedback channels.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD To succeed as a pharma scientist it requires a deep love for science and drug development.

You need to be highly observant since you will be dealing with research data and samples. If you are not used to noticing subtle changes in the results of your experiment, you could arrive at wrong conclusions. Critical

thinking and analysis are also very important in this profession. Since you will be working with fellow scientists and explaining the results of your research to nontechnical personnel like the business team of the drug development firm you are working for, excellent oral and written communication skills are a must.

LIFE GOALS AT 70 ◗ To be part of an education institute and nurture future generation of pharmacists. ◗ To form a forum which will deal with social problems like women education/water conservation. ◗ To stay healthy so that I will be able to contribute to the above goals.

WORDS OF INSPIRATION Generally it is a complaint that pharma companies place profits over people. The pharma industry would be glad of the opportunity to reorient their research towards medicines that are truly needed, provided such research is financially sustainable. Indian pharma industry is doing very well in spite of shrinking margins and investing in formulation development and drug delivery. I see a bright future for Indian pharma industry and it will lead the world in the healthcare industry by 2025.

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✦Education: Masters in Pharmacy & Post Graduation Marketing Management and Production Management ✦Designation: Managing Director, GSR Pharma ✦Experience: 28 years ✦Specialities: Patent challenging formulation development, Analytical development, RA, Setting up new R&D centers ✦Number of patents filed: 3 ✦Awards: 3

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he best intellectual ingredient for formulation R&D is innovative thinking and good development strategy

MEMORABLE INCIDENTS AS A SCIENTIST There have been several such incidents over the years.

For a formulation scientist, the best moment is seeing their product successfully developed and launched in the market. My first product was sustained release cough syrup, launched way back in 1990, one of the first liquid products in sustained release dosage form.

While I was working with Ranbaxy, the first Indian company to enter the US market, a memorable moment was when an Abbreviated New Drug Application (ANDA) was successfully submitted with the US FDA. Being selected by the Foreign Ministry of Health, based on scientific capabilities and industrial experience to train Jordanian FDA people on industrial perspective was a very memorable and proud moment for me.

For any formulation development scientist the goal is to achieve a stable, bioequivalent product developed in stipulated time. The success of 25 products in one year was a great achievement.

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each stage of development gave me great pleasure and a sense of scientific satisfaction.

LEADERSHIP IN PHARMA R&D Development of a quality pharma product in a differentiated manner, with a cost-effective process, is not one man’s role. It always needs team work. A good leader always ensures team spirit while inspiring them to achieve set targets in an innovative way, within the time frame. It is necessary to credit each scientist for their achievements/ contributions throughout the project.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD The best intellectual ingredient for formulation R&D is innovative thinking and good development strategy.

Formulation scientists should be able to anticipate the problems/troubleshoot during scale up, commercialisation and product launch.

Thorough knowledge of

different regulatory guidelines will help in designing suitable development strategies to finalise robust formula and process of any pharma product.

Develop and generate all the scientific data on worst case scenarios to tackle any future complications and troubleshoot issues that would arise during production.

It is important to learn from the failures of an experiment through root cause analysis and thereby redesign the experiment for a successful formula.

LIFE GOALS AT 70 ◗ Try to bridge the gap between pharma academics and industrial practices by sharing knowledge and experiences with students coming out of college and help the universities in designing the new syllabus accordingly. ◗ Set up own R&D centre to develop innovative products. ◗ Getting into entrepreneurship and creating employment for at least 1000 people in India.

WORDS OF INSPIRATION ◗ Learn from failures, never get scared. ◗ Share the credit of success with team members. ◗ Be transparent and honest. Have an open mind towards learning. ◗ Be passionate about what you do.

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✦Education: B.Pharm. (India), M.S. (Canada), Ph. D. (US) ✦Designation: Senior VP, R&D Sun Pharma. India ✦Experience: 27 years ✦Specialities: NDDS, VAG, F2F Para IV, Preformulation, Formulation Development, Tech Transfer, CMC, IND, NDA, ANDA, 505(b)(2) NDA, Clinical studies, BA-BE studies ✦Number of patents filed: 55 ✦Awards: ■ India (2009): Outstanding Pharmacist Award ■ USA (1994-2006): Creative Thinking Award (GPC Biotech Inc., 2005) Special Recognition Award (Monsanto, 1998) Outstanding Graduate Student Award (Auburn Uni. 1996) ■ Canada (91-93): Parke-Davis Pharmacy Research Award, (Dalhousie Uni. 1992) Novopharm Graduate Research Award (Dalhousie Uni. 1993) CPhA Graduate Research Award (Dalhousie Uni. 1993)

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eadership is not about a title, role or a designation.It is all about their impact, influence and ability to inspire others and guiding them on to a path to places where they themselves have never been

DEFINING MOMENTS AS A SCIENTIST In early 90s, when I was working on my Ph.D, I did get an opportunity to visit Memorial Sloan Kettering Cancer Centre in New York City. The scene in the paediatric ward was the greatest paradox I ever seen in my life. These young children with excruciating pain were looking forward to days when they would be free from the disease and pain because their doctor has given them “Magic Medicine”. Some were looking forward to playing with their bikes or baseball with their friends, a few of them were making plans to visit Disney Land. Some were hoping that Santa Claus would bring them a big present. The optimism in their voice and face was phenomenal even when the death threat was just lurking around. This made me realise how precious life is and how important it is to be able to live a healthy life. Their belief in the medicine and their struggle to get on with their lives made me more determined to work on novel medicines and drug delivery systems to ameliorate human suffering.

LEADERSHIP MANTRA Leaders in Pharma R&D is defined by their vision and their ability to translate that vision into reality.

Leadership is not about a title, role or a designation. It is all about the impact, influence and ability to inspire others and guiding them onto a path, where they themselves have never been. A good leader is able to harness power www.expresspharmaonline.com

within the people by unlocking their potential and empowers them by providing appropriate training, tools, resources and guidance to do extraordinary things.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD To be successful in the formulation development and drug delivery area, one needs to have a great mix of scientific abilities and capabilities. A

sound knowledge of human physiology coupled with an in depth understanding of physicochemical properties of materials and drugs certainly help to design dosage form for its optimum delivery and desired efficacy. In FDD, failure is an integral part of journey towards success. Each failure enhances knowledge about endeavours undertaken. One should have ability to think outside the box, imagine, innovate and create, and not be afraid of failures.

LIFE GOALS AT 70 ◗ Write a book on Pharma Industries in India ◗ Build a high-school and a solar farm in my ancestral village ◗ Able to gain mastery over playing a sitar

WORDS OF INSPIRATION Pharmaceuticals is a noble profession and we are the noble warriors in the fight against the human suffering due to diseases and sicknesses. Although sometimes there can be a mismatch between what science knows, and what business does, it’s our duty as a scientist and science-based industry, to innovate, develop and manufacture reliable and quality medicines with an affordable price, so that our customerthe patient can lead a quality life. It will be the greatest achievement for the mankind, when one doesn’t have to choose between paying for food versus paying for medicines.

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✦Education: M. Pharm ✦Designation: Sr Vice President, Alkem Laboratories ✦Experience: 20 years ✦Specialities: Formulation development of oral solids, liquids, semi-solids, powders etc dosage forms including controlled release products, non-infringing formulations, complex generics, VAGs and other innovative products for US, other regulated markets and India ✦Number of patents filed: 08 ✦Awards: ■ Guest of honour awarded by Baba Sahib Ambedekar University, Aurangabad (March 2017) ■ Honoured as expert speaker organised by BITS Pilani on International Conference on Drug Delivery Systems (February 2017).

■ Chairperson for various scientific governing bodies, elected for post graduate of pharmacy colleges.

■ Member of Health Food Dietary Supplement Association (HADSA) ■ Member of Protein Foods and Nutrition Development Association of India.

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s we work for humankind, it's our moral responsibility to produce world class medicines.They should be of the super drug quality, yet be cost effective to make it affordable to the consumer

MEMORABLE INCIDENCES AS A SCIENTIST I started my professional journey as a production scientist in pharma companies. The challenges during the assignments were to organise the work and get maximum output by improving the process and introducing new technologies.

Then, my dream was to be involved in research work and discover a new and innovative process apart from the existing ones.

I faced several challenges during production. However, resolving them with timely and appropriate inputs paid off and helped me gain more knowledge and insights. Being flexible and always trying to expose myself to as many types of research techniques as possible during that period was of real help in furthering my interest in research.

At the end of the day, my hard work has shown fruitful results.

LEADERSHIP IN PHARMA R&D R&D is the backbone of any organisation and an R&D leader should possess the following skills: ◗ Skill to drive innovative research /strategic thinking ◗ Passion for work ◗ Ability to build collaborative relationships www.expresspharmaonline.com

◗ Strategic perspective ◗ Willingness to take initiative ◗ Proficiency in change management ◗ Decisiveness Driving innovative ideas/strategic thinking is the first and foremost quality for any R&D leader. This will always lead to the evolution of an organisation and set a benchmarks for others.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD Following are the intellectual ingredients for success in FDD: ◗ Ambition ◗ Vision ◗ Execution ◗ Determination ◗ Timing ◗ Customer satisfaction ◗ Employee orientation

LIFE GOALS AT 70 One goal isn’t good enough. Some goals take longer to achieve than others – and if you spend years working toward only one objective, you’re likely to get discour-

aged when it doesn’t happen right away.

But when you have a long list of goals you’d like to achieve, you have more to strive for, and more opportunities to check those goals off your list. And the rush you feel every time you check one of those goals off the list will inspire you to accomplish even more of them. My three life goals at 70 are: ◗ Setting up a new venture for new drug discovery ◗ Working to bridging the gap between industry & institution ◗ Setting up an NGO for rare diseases (cancer patients)

WORDS OF INSPIRATION As we work for mankind, it's our moral responsibility to produce world class medicines. They should be of the super drug quality, yet be cost effective to make it affordable to the consumer.

Similarly, during R&D work for any new dosage form, new chemical entities with different diversions must be evaluated and R&D leaders must involve themselves in this area. I am insisting on this because, in my view, a lot of work is going on in this area but the outcomes have not been very significant. So, my request to pharma industries is to make this area a prime focus with an aim create a better tomorrow for our next generation.

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✦Education: M Pharm ✦Designation: Senior Director, Head of PSAI Formulations, DRL ✦Experience: 23+ years ✦Specialities: Formulation development, Project Management, Technical operations ✦Number of patents filed: 14 ✦Awards: ■ Received R&D excellence award for fastest development of oral solid product ■ Received Chairman Excellence Award for new business initiative ■ Received certificate of excellence in intellectual property management

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he fundamental aspects that are critical for sucess in FDD- your ability to understand business dynamics, assess the need on ongoing basis and provide technical solutions within a timeframe

DEFINING MOMENTS/ INCIDENCES AS A SCIENTIST Impact and significance of medicines for patients is well recognised. Being able to positively contribute to the society with development of quality and affordable products is a very satisfying experience. Having led teams to deliver some very complex products in soft gels, ODTs, MUPS, controlled release products, every product that reaches patients and serves their needs is a cherished experience. It gives immense satisfaction that many of my formulations have

reached patients worldwide. I take pride in being one of the first generation scientist from India who understood patents and leveraged the knowledge for developing affordable and innovative medicines for global markets.

LEADERSHIP IN PHARMA R&D Leadership in R&D is driven by in depth understanding of science and management -science of product and management of people. Each of these is important and needs continuous nourishment. A successful leader has to ensure right percolation of organisational vision and motivate people around him/her to actively contribute to that vision. The key aspects of leadership in pharma R&D - your accessibility and connectivity with people at lowest level, being transparent, establishing trust with seniors, subordinates, peers and cross

functional teams, ability to mentor and coach people to develop and build long term career for themselves.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD The fundamental aspects that are critical for success in FDD - your ability to understand business dynamics, assess the needs on ongoing basis and provide technical solutions within a timeframe. Of course, this require continuous upgradationof skill sets, competency and technical knowledge. Other key ingredients are creativity, analytical thinking, curiosity and reasoning ability.

LIFE GOALS AT 70 ◗ I would believe life goals would be achieved when you: ◗ Improve connectivity and strengthen social life ◗ Leverage experience and knowledge for the benefit of upcoming generations ◗ Lead a peaceful life

WORDS OF INSPIRATION Dream big and achieve big. Be passionate about what you do. Be clear in your thinking and execute your plan with confidence. Involve people and get the best out of them. Care for society and people. www.expresspharmaonline.com

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✦Education: M. Pharm, PhD ✦Designation: Sr Vice President – Research and Development (Formulation Finish Products), Intas Pharma ✦Experience: 24 years ✦Specialities: Excellent data analysis skill for decision making, timely deliverables and team building ✦Number of patents filed: 5

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o become successful, one should always focus on learning, irrespective of experience or age

DEFINING MOMENTS AS A SCIENTIST In the pharma industry, it is a wellknown fact that opting for a career in formulation development is a daring dream. I started my career as a scientist in this field, two decades ago. Recollecting and recounting golden memories of being a scientist is a great pleasure. During the initial days of my career, my senior told me to do a trial on paracetamol to develop tablets. I was told to start the trial in the presence of three or four seniors. By the end of the trial, everyone was laughing at the cake/heavy dough mass of powder, I had created. A very embarrassing incident, but a learning experience as well.

LEADERSHIP IN PHARMA R&D Globalisation comes with its own set of challenges. These span across multiple levels in pharmaceutical organisations from marketing to regulatory.

Healthcare reforms, changes in technology, evolving government policies and rising consumer expectation are factors which require strong leadership qualities in R&D heads along the following lines: ◗ Broad perspective: Understand the viewpoint of higher management and effectively analyse complex problems to www.expresspharmaonline.com

provide strategic solutions. ◗ Decisiveness: It is the ability to take timely and appropriate actions in varying situations. ◗ Adaptability: Adopt change for constant growth and to enhance company’s initiatives. Overcome resistance to change through effective strategies. ◗ Proactiveness: Always be ready to take initiative and capitalise on opportunity. ◗ Be patient and demonstrate self-control in difficult situations. ◗ Always try to be a bridge between colleagues and top management .

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD In the current times, R&D leaders in formulation development have to deal with a lot of challenges like changing regulatory scenario, government policies and pressures from top management to meet commercial targets, while creating and sustaining a robust and successful formulation development and drug delivery system within their organisations.

Scientists should always emphasise on a science/technology-based approach to ensure safe and effective development of medicines for patients. Selfawareness and continuous interaction with seniors and management helps to understand and enhance the outcomes of their endeavours. Encourage team members to share experiences.

Work at creating collaborative relationships between co-workers and external parties. Always challenge yourself and evaluate your work independently, as well as through seniors and peers.

LIFE GOALS AT 70 1. To serve the society and ensure healthier lives.

2. Keep learning constantly.

3. To be recognised among the best formulation scientists in the industry.

WORDS OF INSPIRATION Performance, attitude and leadership during difficult situations is key to success. One should always focus on learning, irrespective of experience or age.

Always believe in hard work and be ready to capitalise on opportunities. However, it is also important to strike a balance between personal life and work life.

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✦Education: M. Pharm ✦Designation: Senior VP, Pharma Research, Lupin ✦Experience: 29 years ✦Specialities: Involved in leading a diverse group of formulators, analysts and bio-pharmaceutists. Engaged in design, development and filing of generic and novel products for multiple geographies like the US, Europe, Japan, Latin America, Australia and India. Broad area of expertise is in the development of solid and liquid orals, ophthalmics, complex injectables and topical products. Developed products for domestic market to complex generics and 505 b(2) NDA products for advanced markets. Filed over 150 ANDAs/generic products for advanced markets and 180 products for other markets.. ✦Number of patents filed: Co-authored more than 20 patent applications and published five scientific papers in the national and international Journals ✦Awards: ■ Gold Medal for being the University topper in M. Pharm.

■ Awarded 1st prize twice for national level of essay competition held by BV Patel Educational trust.

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he first and foremost trait that defines leadership in pharma R&D would be the highest level of integrity and ability to lead by example

DEFINING MOMENTS/ INCIDENCES AS A SCIENTIST In 1989, as a young scientist with just a year into my professional career at Lupin’s R&D, I was called by the then R&D Head and was asked to stop working on all the projects and was given a challenge to develop Lupin’s first extended release product.

Accepting that challenge and successfully completing the assignment was a stepping stone towards being the formulation scientist that I am today. It was an enriching learning experience which offered me with an opportunity to create a niche for myself in the organisation.

And exactly 25 years later and again at Lupin with a team of 150+ scientists working with me when the MD of Lupin threw the challenge at me to develop the generic of a most complex MUPS-based ER tablet product for the US market. I realised that there is never an age for proving yourself. Accepting such challenges and overcoming them is perhaps the only way of remaining relevant.

LEADERSHIP IN PHARMA R&D In today’s world, the first and foremost trait that defines leadership in pharma R&D would be the highest level of integrity and ability to lead by example. www.expresspharmaonline.com

The current breed of scientists are technically much more updated and tech-savvy, but also very impatient. So, the ability of the leader to value talent, be pragmatic, be inclusive, be humble and to listen and value opinions/ideas coming from even the junior scientists in the team will decide how successful he/she is in leadership roles. A leader’s ability to strategise around technology, product, talent, cost and time would define the organisation’s growth trajectory.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD In today’s pharma world, nothing can substitute technical competency required at top levels. Therefore, the ability to understand, assimilate and adapt to the most recent technological advancements is a key ingredient for success. Also, one is required to be a keen observer with critical analytical reasoning skills, coupled with good understanding of fundamentals of physical

pharmaceutics and biopharmaceutics and lateral thinking ability. It is essential to be strategic in intent and introspect to look for the solutions to the problem in most neutral manner. Lacking any of the above traits one should be able to identify and nurture the best of talent at every level.

LIFE GOALS AT 70 ◗ To be useful to pharma professionals and students for scientific and professional advice ◗ Maintaining good health through self-discipline ◗ Develop a sustainable hobby for retired life

WORDS OF INSPIRATION To me a leader is not one who forces others to make him stronger, rather I prefer to be someone who is willing to give his strength to others so that they may have the ability to stand on their own and get noticed. I usually do not sermon my team on how to do things but tell them what to do and they often surprise me with their results.

In R&D, one's strength is tested at times of failure and someone who maintains his calm and can think rationally will inspire and come out successful.

To me leadership and learning are indispensable to each other!!

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✦Education: M Pharm, PhD, MBA (University Gold Medallist, B Pharm and M Pharm both) ✦Designation: Chief Scientific Officer, Wockhardt Ltd ✦Experience: 25 years (12 years at leadership position as Head/President R&D). Almost entire experience is for US & EU markets, besides Japan, India ✦Industry Excellence: More than 400 ANDAs and hundreds of EU submissions, besides ROW and India ✦Specialities: Complex generic development in sterile space, suppository development, soft gel development, end to end knowledge across all aspects of drug development from API to formulation to analytical to clinical/ BE to IP to packaging to regulatory and techno commercial research mindset. ✦Number of patents filed: 25 + ✦Awards: More than five major awards at various forums and University Gold Medalist for B Pharm as well as for M pharm.

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ou cannot soft pedal your way to success.And having achieved success, it is more difficult to sustain and manage it; so keep working harder!

MEMORABLE INCIDENTS AS A SCIENTIST Filing and approval for 180-days which was an exclusive product with sole exclusivity, beating two other competitors by barely a few days/weeks. The reference product was yet to be launched in the US market. We proactively developed the product and even kept two to three exhibit batches ready with different formulations.

As soon as the innovator was launched, it was procured, characterised and the appropriate exhibit batch was dosed within days. The bio study was completed by dedicating all the resources of the CRO and filing was made in time to become the exclusive first filer.

Filing more than 50 ANDAs of sterile products in an otherwise dormant facility to fill the business gap. A ` 250 crore sterile facility with eight lines was existing and almost completely underutilised with barely any commercial products. More than 50 sterile ANDAs were developed and filed from this facility in a matter of three years.

LEADERSHIP IN PHARMA R&D Leadership in pharma R&D is all about technical competency coupled with effective people utilisation. An R&D leader has to have excellent domain knowledge. www.expresspharmaonline.com

On top of it, he/she should have people management skills and interpersonal management skills.

R&D is a unique function wherein diverse and completely different skills like formulation, analytical, packaging, bioequivalence and regulatory etc., have to work in isolation in their respective expertise areas, but at the same time be in tandem to create a unique product – the Dossier! The leader has to ensure that all these moving parts work independently, but come together at the right moments.

Secondly, the crux of any leadership is relentless 'execution'. Most well-made plans will fail if not executed efficiently.

An R&D leader, having strategised and planned, has to constantly oversee and execute till the job is done.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD ◗ Ability to see what everyone has seen but to think what nobody has thought. ◗ Ability to observe critically, be it data or process, analyse it and proceed accordingly. ◗ Ability to acquire understanding of allied fields of formulation, viz analytical, packaging, manufacturing and BA/BE. ◗ Being hands on! More the formulator stands in the process area, the more he will learn. ◗ There should be a burning desire to succeed, grow and learn

LIFE GOALS AT 70 ◗ Keep working for the pharma industry, may be as an advisor. ◗ Be content with what I have avhieved in my past 69 years ◗ Spend time with my wife and my grandchildren.

WORDS OF INSPIRATION ◗ You cannot soft pedal your way to success. Having achieved success, it is difficult to sustain and manage it; so keep working harder. ◗ Be sincere and honest in whatever you do. ◗ Take care of your health and family. ◗ Believe in yourself and don’t ever let go of God – you never know when you will need him. And you will need him for sure!

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✦Education: Masters in Pharmaceutical Sciences ✦Designation: Senior VP & Head Pharmaceutical Technology Center, Zydus Cadila Ltd ✦Experience: 22 years ✦Specialities: End-to-end product development to commercial launch for global markets in various technology platforms ✦Number of patents filed: About 150 across formulation technologies ✦Awards ■ Best Development Team Award at Sandoz

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he leaders need to demonstrate innovation, cost leadership and technical vigilance in lieu of growing technological advances in formulation, analytical and regulatory sciences

MEMORABLE INCIDENCES AS A SCIENTIST One was when my team got the 'Best Team award for development of modified release formulation' during my tenure at Sandoz as team leader. As a scientist, there are many instances during product development when technical hypothesis based on in-vitro data evaluation, appropriate understanding of pharmacokinetics of drug substance and drug product

proves correct and gives defining direction to the product development.

LEADERSHIP IN PHARMA R&D The current global market scenario alongwith the everchanging regulatory landscape across the globe poses a tough challenge to leadership in pharma R&D. The leaders need to demonstrate innovation, cost leadership and technical vigilance in lieu of growing technological advances in formulation, analytical and regulatory sciences.

This has changed the dynamics in product development, regulatory review cycle and later commercialisation of products.

INTELLECTUALINGREDIENTS FOR SUCCESS IN FDD Keep pace with technological

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advancements, regulatory science advancements and keeping team motivated during difficult times. In this era of information age, data analytics remains critical aspect for the success in FDD. Lastly, building strong focused team and creating subject matter experts based on individual strengths helps to keep momentum in technology development.

LIFE GOALS AT 70 â—— Fitness and healthy lifestyle â—— Mentor future leaders

WORDS OF INSPIRATION Leaders should always remain composed in difficult times, solving problems effectively.

Operate with a strong result focus, seek different perspectives, confront brutal facts but never lose focus.

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✦Education: Ph.D. (Pharmaceutics), M Pharm (Pharmaceutics) and PG Diploma in Marketing and Sales Management ✦Designation: Senior VP – Pharma Research, Panacea Biotec Ltd ✦Experience: 24 years ✦Specialities: Experience in developing generic as well as innovative formulations, Handled varied parenteral dosage forms for ICH markets and Good understanding of regulatory and IP requirements of ICH markets ✦Number of patents filed: 23 patents ✦Recognitions: Member of professional organizations like AAPS, ACS and EUFEPS Member of Board of Studies of Pharmaceutical Sciences and Drug Research, Panjab University, Chandigarh and Punjabi University, Patiala, Punjab, India Member of Local project Advisory Committee (LPAC) of National Institute of Pharmaceutical Education and Research (NIPER) Mohali, creating a database of resources available in the field of tuberculosis under a DST sponsored project.

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ndian pharma industry is indebted to its leaders whose vision and hard work has put the country at an enviable position in the global arena

DEFINING MOMENTS AS A SCIENTIST The life of an R&D scientist is full of adventure. Each new day brings new challenges as well as sudden, sometimes serendipitous solutions. The immense joy of finding a solution to a nagging problem can only be felt and appreciated by a scientist.

While working on a microemulsion based soft gelatin capsule formulation we were stuck with the problem of capsules becoming too soft and losing their shape within no time. We had tried every additive known to us and also all process variations.

Nothing seemed to work. On one fine day, an excipient supplier came to meet us and introduced us to a new grade of gelatin. A small trial and we knew we have achieved success.

My first major success as a scientist was the launch of Cyclosporin Capsules which are used for organ transplant. Our company was the first Indian company to launch this technically complex product in the domestic market.

Another defining moment was when I was invited to Japan to deliver a lecture on an innovative Anti-TB formulation of Rifampicin, Isoniazid, Pyrazinamide and Ethambutol which had been developed by our www.expresspharmaonline.com

group. It was my first lecture in an international conference.

Another instance was the opportunity to lead the team responsible for formulating vaccine and biological products.

The efforts of more than seven years by our group led to the recent launch of a hexavalent vaccine (EASYSIX) to protect children against six dreaded diseases. It is world’s first fully liquid, ready to use, patented, hexavalent vaccine.

LEADERSHIP IN PHARMA R&D A leader should inspire others to dream more, learn more, do more and become more. Indian pharma industry is indebted to its leaders whose vision and hard work has put the country at an enviable position in the global arena.

A successful R&D leader has to be a role model who can inspire the teammates to give their best. An R&D leader knows that a good, motivated team is most important for success. A leader should be ready to face challenges and own failures. The leader has to keep

abreast of latest knowledge in the ever-changing world of pharma.

A leader must plan things beforehand and be ready with Plan B to ensure success. Good performance is the result of better planning, enthusiasm and timely execution of the plans. A leader must also have an optimistic approach, a willingness to explore opportunities.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD To lead pharma R&D, the leader has to have a well-rounded knowledge of related fields. A scientist in FDD must work with the end in mind. Drug delivery technology needs to be designed with the end user i.e. the patient in focus. We need to understand the overall profile and co-morbidities of the patient to be successful. Another important factor is right pricing and value proposition being offered.

LIFE GOALS AT 70 ◗ Post retirement from active leadership role, be a teacher in a pharmacy college to pass on the knowledge gained to younger generation of budding scientists. ◗ Travel throughout India to learn more about our people and cultures ◗ Enjoy quality time with family and friends Express Pharma

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✦Education: M Pharm ✦Designation: Chief Technical Officer, Microlabs ✦Experience: 25 ✦Specialities: Novel Drug Delivery Systems ✦Number of patents filed: 43 ✦Awards: 4

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e should focus our intellect on innovation and make India the super power of pharma world

DEFINING MOMENTS AS A SCIENTIST The defining moment for any scientist is when, his developed technology-based innovation is patentable and it brings him national and international recognition. In my career, as a development scientist, there have been many such defining moments, I would like to share one of the projects which established me as a reputed scientist in the pharmaceutical field. The development of a challenging modified release formulation for one of the epileptic drugs Levetiracetam. It was unique and challenging for product development in terms of size, process ability and intellectual property rights. The composition was selected scientifically and strategically to develop the novel formulation which could be patented. The product has successfully passed the comparative pharmacokinetic profile in healthy human volunteers and the process was scalable and reproducible. The formulation is patented and the technology was out-licensed to the innovator company.

LEADERSHIP IN PHARMA R&D Leadership qualities are essential to drive innovation in R&D. They include a combination of www.expresspharmaonline.com

creativity, science, development, coaching, leading and business acumen to target the safety, efficacy, quality and cost of the product. The Leader should have the ability to generate ideas, develop and test these new ideas and should use creative problem solving techniques. The research which is undertaken should have the commercial applicability and be used in betterment of the health of the patients.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD The scientist in formulation drug development is owner of the product from initiation to delivery to the market. Process development and scale up

challenges should be well understood to target simplified, scalable, controlled and reproducible processes. During product and process development, it should start with quality target profile, identify critical quality and process attributes to link them with critical quality attributes of product with help of control strategy. Use of statistical tools in design of experiments during development is a key for success in quality product development.

LIFE GOALS AT 70 ◗ Guiding young budding scientist in the field of pharma. ◗ Write a book on the gurus I met in my life ◗ Travel around the world to places untapped.

WORDS OF INSPIRATION We are blessed to be in the pharma industry where in we can improve the human life and serve the mankind by providing medicines.

We need to innovate continuously, to keep ourselves motivated to innovate. Innovation should not be treated as special achievement but should be a part of the routine business process. We have one of the best talents in the pharma field across the world. We should focus our intellect on innovation and make India the super power of pharma world.

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✦Education: D. Pharm /B. Pharm/ MS Pharm tech/PG Diploma in patent law ✦Designation: Head Formulation development ✦Experience: 29 years ✦Specialities: Solid dosage forms IR/ER Injectable Liquid / Lyo Para IV submission. First to file submissions Complex generics, QbD ✦Number of patents filed: More than 7 ✦Awards: 2

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uccess is never final and failure is never fatal, it is courage that counts

DEFINING INCIDENCES AS A SCIENTIST When I started my R&D journey way back in 1988, very few companies realised, focussed and paid enormous attention to R&D. I was fortunate enough to initiate my career with researchbased companies like Wochardt, followed by Crosland’s Ranbaxy, Emcure, Microlabs, FDC etc. I experienced a lot of changes pre and post GATT/TRIPS. India’s domestic pharma companies have experienced a significant increase in R&D. As far as the development work is concerned, I just cannot forget the development of VOLINI gel at Crosland’s which was much appreciated by the top management. Apart from this, the formulation development of various chiral molecules at Emcure Pharmaceuticals was a challenging and memorable experience of my life. I had received best performance and meritorious performance awards for consecutive two years at Wochardt Pharma.

LEADERSHIP IN PHARMA R&D R&D leadership teams need to engage and coordinate with other team members to deal with the complexity of this new competitive landscape. I believe that the industry requires www.expresspharmaonline.com

leaders who can deal with ambiguity, anticipate and respond to environmental changes, and bring greater impact by going beyond incremental change.R&D leaders need to have a collaborative mind, proactiveness, agility and should be smartest to quickly address challenges. They need to remain flexible and efficient regarding potential opportunities within and beyond their environment.

R&D leaders need to focus on retaining and developing talent for tomorrow. An important hallmark of successful organisation is how they manage their leadership talent pipeline.

Create a workplace that supports the desires, needs and aspirations of people and ensure clarity of career path and fairness of compensation and rewards. External awareness, customer orientation, relationship building skills and a clear vision for the future are some other qualities of a good R&D leader.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD We need to be well conversant and updated with countryspecific regulatory guidelines.

Cost competitiveness is one of the key factors to run the business and increase the profitability of the organisation.

Formulation scientist should pay attention on the cost of API, excipients and packaging materials at the initial stage only. Always develop one or more vendors for all the materials so that more options will be available for commercial needs. Science and business should go hand in hand.

Success is never final and failure is never fatal, it is courage that counts.

Smart work saves a lot of time and allows you to be more organised. It is important to inculcate the habit of reading.

LIFE GOALS AT 70 ◗ To work towards bridging the innovation gap between academia and industry. ◗ To work on self-medication awareness among patients. ◗ Conduct patient health awareness programmes. ◗ To work on the harmonisation on academic syllabus between the Indian states and between countries.

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✦Education: M Pharm, PG Diploma in Patent Laws, MDP, Strategy & Finance, PhD thesis under submission ✦Designation: Head – Formulation /Biopharmaceutics/ Reverse Engineering Analytics, IPR Landscaping and Strategy design, Packaging, Torrent Pharma ✦Experience: 23 years ✦Specialities: Strong scientific background and experience in pharma development of NCE, NDDS, generics and super-generics from lab to commercial scale; proven track record of development programmes and successful products in various dosage forms; expertise in strategic evaluation of disease prevalence, identifying unmet clinical needs, understanding PK-PD and bridging the gap through innovative drug delivery systems to improve patient adherence to therapy ✦Number of patents filed: More than 50 patents in various projects and different countries ✦Awards: ■ Le Alpilles Diploma award for Scientific Achievements with highest score by the Gattefosse foundation ■ Presentation of scientific work in World Pharma Congress/World Drug Delivery Conference/Biodegradable Polymers

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eaders should have the vision to optimise R&D portfolio and maximise RoI

DEFINING INCIDENTS AS A SCIENTIST Every scientist would dream of Eureka moments in their life. I have had the opportunity to experience many such adrenaline gushing moments from getting a pseudo plastic material granulation right to launching first transdermal patch in the country.

The essence of scientific achievements reflects in offering patient-centric solutions to bridge the gap in current therapy. This is reflected on some of the projects I have ideated on like combination in MDIs to offer solutions form management of COPD, converting many IR projects to CR once a day solid orals, changing an oral molecule into intranasal drug delivery for pain management or modifying the crystal structure to create long acting injectables, designing platform technologies where in the drug can be modelled and used into the platform based on physicochemical and biopharma properties, creating cocrystal with permeation enhancers to improving bioavailability and dose reduction.

Some of the work is reflected in the IP filings which has many international citations. For one of the first in India launches it was immensely gratifying to scale out from 300 gms to 1,000 kg high shear granulator. This year we www.expresspharmaonline.com

have been able to achieve 100 per cent pivotal BE success which is a record breaking milestone in the Indian industry. We have delivered the project for the Indian market in close to five months timelines and complex F2F project in less than nine months.

Differentiated dosage forms are key to contribution to the top line and bottom lines in any organisation and I have had the experience of launching more 300 project so far.

LEADERSHIP IN PHARMA R&D Leadership role in pharma R& D requires self-discipline, open mindedness, curiosity and quest to change lives of ailing millions.

Innovation can only thrive when every individual in the team is empowered with skills and freedom to explore his or her scientific inquiry. One needs the courage to accept any failure and stand up once again to find workable solutions. One also needs to nurture resilience,

patience and perseverance to go through the long drawn regulatory approval processes. Leaders should have the vision to optimise R&D portfolio and maximise RoI to be sustainable in the long run.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD ◗ High EQ combined with high IQ, adaptability quotient, calculated risk taking ability, good listening skill is a must. ◗ One needs to inculcate a habit of reading to keep oneself updated on the scientific progress and regulatory requirements. ◗ Should be able to lead diverse skilled scientists from technologists, process engineers, statistician etc. ◗ Tangential thinking

LIFE GOALS AT 70 ◗ Be a part of disruptive innovation to change the way diseases are treated ◗ Be an integral part of team to let wider access to Biosimilars or Biobetters. ◗ Use simulations/modelling to convert current manufacturing processes to continuous processes with real time release. This will lead to uninterrupted supply of medicines across the globe ◗ Preventive medicine to tackle oncology Express Pharma

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✦Education: M. Pharm ✦Designation: Executive Vice President (CMC); Glenmark Pharmaceuticals Ltd. ✦Experience: 26 years ✦Specialities: Formulation development (all dosage forms; generic and novel) ✦Number of patents filed:30

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here are many incidences where we can crack the problem and succeed in a given time frame

DEFINING /INCIDENCES AS A SCIENTIST I’m a strong believer of perseverance. Being in R&D and working on novel or non-infringing ideas, we quite often land up in situations where it seems that there is a dead end. In this situation, I take some time to start thinking afresh on the problem.

It’s always possible to overcome tough situations through out of box thinking. Our new education system train us to select between the options which some time kill out of box thinking process. There are many incidences where we can crack the problem and succeed in a given time frame.

LEADERSHIP IN PHARMA R&D Leadership is the ability of an individual to set and achieve challenging goals by careful maneuvering of whole team efforts. A leader is the one who takes swift and decisive action, outperforms the competition, and inspires others to perform well.

Leadership provides direction for a team.

In R&D, it is always a game of uncertainty and is also time bound. Hence, R&D leadership always need to be aware of capabilities of individuals working in his or her organisation. R&D leader need to embrace the situation and persuade the team www.expresspharmaonline.com

for next attempt. Often successful leaders know they aren't always going to make the right decision.

Effective leadership includes strong character, honesty, integrity, trustworthiness and ethics. Leaders act in line with how they speak, and earn the right to be responsible for others’ success in the company. Leaders speak with and listen to staff members, respond to questions and concerns, and are empathetic.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD In R&D, to succeed, one needs to have good understanding of the subject matter and willingness to take challenges. One should decide a career path based on their own capabilities. One needs to dedicate

quality time in resolving the problems and should never give up in any situation. There is a famous quote by Albert Einstein, he said “It's not that I'm so smart, it's just that I stay with problems longer.”

One has to be very sincere in their work to succeed in R&D. There is no quick success story but it is definitive, one has to have patience for that.

LIFE GOALS AT 70 My life goal is very simple. I want to be counted as a person who has made some positive impact on the society. In my 70s, I wish to dedicate my time on conservation of nature and do some work in primary schools to inculcate values in our younger generation.

One area which often interests me is the field of renewable energy.

There is an urgent need for the country to work in that direction.

WORDS OF INSPIRATION Pharma fraternity has evolved a long way and we are part of that noble profession. Challenges keep coming in life but that gives us opportunity to learn. No matter how much the world tries to hold you back, always continue with the belief that what you want to achieve is possible. Believing you can become successful is the most important step in actually achieving it.

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✦Education: M Pharm, Ph.D ✦Designation: GM-FR&D, Natco Pharma ✦Experience: 18+ years ✦Specialities: IR tablets, capsules syrups, MR/ER/DR tablets and capsules, ODTs and liquid and lyophilised injectables and technologies like solid dispersion, HME and SDD, nanotechnology and lyophilisation ✦Number of patents filed: More than 13 patent publications in novel dosage forms for various molecules ✦Awards: ■ Silver Jubilee Award from Andhra University ■ VC Graduate fellowship from USM for academic excellence

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trong fundamentals,detailed analysis of the problem and relentless patience are prerequisites for success in FDD

DEFINING MOMENTS/INCIDENCES AS A SCIENTIST

INTELLECTUALINGREDIENTS FOR SUCCESS IN FDD

Have struggled years to get bio success of many complex products and able to file ANDA/Dossier of them. There were many learnings during this journey.

Strong fundamentals, detailed analysis of the problem and relentless patience are prerequisites for success in FDD. One should also have a never give up attitude.

LEADERSHIP IN PHARMA R&D

LIFE GOALS AT 70

Having micro details of every aspect and requirements in a dynamic regulatory environment is paramount. A leader should also motivate the team and get it prepared for the future.

◗ Farming ◗ Leading a healthy life ◗ Mentoring the young generation

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WORDS OF INSPIRATION Starve your deviation and feed your focus

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✦Education: Ph.D (Pharmaceutical Sciences), MBA ✦Designation: Director and CEO, Ascent Innovative Medicines ✦Experience: 36 years ✦Specialities: Pharmaceutical R&D, Regulatory, Manufacturing ✦Number of patents filed: 40

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eadership should be focussed on the ultimate goal – caring for the patient

DEFINING INCIDENCES AS A SCIENTIST In the 1980s, the pharma industry was heading towards globalisation and all India-based pharma companies were shifting their strategies for development and export to regulated markets of the world. The pharma industry wanted rugged systems to produce consistent batch to batch quality products, to produce uniform batches and minimise batch to batch variation. Prior to the 1980s the focus was on formulation drug development and less focus was given on transfer of technology, process control, leading to repeated batch failures, difficulty in ensuring quality of the final product.

I pioneered the concept of process development and control was brought into Indian pharma to achieve these objectives. By establishing the group of process development and laboratory for smooth and efficient technology transfer, leading to defect free production, a very first in India for an Indian pharma company. This was taken as an example and adopted by the Indian pharma industry.

Transdermal technology is a complex technology. Although India has been manufacturing patches since ages, this technology in India was very www.expresspharmaonline.com

primitive much until a decade ago.

I established the technology development group which revolutionised the transdermal technology scenario in our country. I also introduced concepts and science which could compete with the technology available globally which in turn led to the creation of first Indian pharma’s first R&D transdermal patch facility in India that launched products in the highly regulated markets of the world.

LEADERSHIP IN PHARMA R&D Mantra for pharma R&D leadership in today’s world should be ethical, becoming a good teacher, a mentor to the teams they lead, and lead by example.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD Indian scientists working outside

India have proven themselves in a big way. Many leading science and technology centres across the world have Indian scientists in key leadership positions who are bringing great innovative products and technology, to benefit their organisations globally. They are continuing to impact their societies with their innovation. Patents worldwide on many key technologies and products in the pharma world are ample testimony to our Indian enterprise and technical brilliance. But such innovation is still not being seen locally. How to address this gap is the key.

For success, the following key qualities are essential - Knowledge of all types of dosage forms, manufacture, process, how to commercialise product from bench level to commercial level and above all, requiring great perseverance and skill in handling failure and coming out of it.

LIFE GOALS AT 70 ◗ Remain healthy and active and be a good human being as well as a good citizen of the country.

WORDS OF INSPIRATION Leadership should be focussed on the ultimate goal – caring for the patient. Core principles always should be remaining ethical to self.

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✦Education: B. Pharm, M. Pharm and Ph.D. in Pharmacy ✦Designation: President, R&D – Formulation, IPCA Laboratories Ltd ✦Experience: Over 25 years ✦Specialities: Unique combination of business and technical skill. Founder of American Pharma Solutions, LLC in the US to provide CMC related to due diligence and technical support to investment firms and start-up pharma companies ✦Number of patents filed: 20+ ✦Awards: ■ UGC Research Fellowship ■ United Nations Industrial Development Organization Fellowship ■ Rohm Pharma Research Grant, University of Manitoba (Canada) ■ Post-Doctoral Research Fellowship etc

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ision and on timely execution based on best science and technology

DEFINING INCIDENCES AS A SCIENTIST Development and commercialisation of first generic anticancer drug (Capacetabine) for the US market during my tenure at Teva Pharmaceuticals (USA). I was blessed to bring affordable generic version of anticancer drug to millions of needy patients all over the world.

based on best science, technology and integrity.

INTELLECTUALINGREDIENTS FOR SUCCESS IN FDD Think differently, think positive.

LIFE GOALS AT 70 ◗ Work for humanitarian causes ◗ Travel to all the safe countries in the world ◗ Search for spirituality

LEADERSHIP IN PHARMAR&D

WORDS OFINSPIRATION

Vision and on timely execution

Follow your passion

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✦Education: M. Pharm, Ph.D ✦Designation: VP – Formulation Development, Alembic Research Centre, Vadodara ✦Specialities: NCE and generic product development and drug delivery

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eadership should focus both on present needs of the organisation as well as have vision on emerging trends in the area of therapeutic agents and delivery systems

DEFINING INCIDENCES AS A SCIENTIST Achieved quite a few milestones to meet organisational goals for development of formulations of complex NCEs, which were perceived very challenging by my peers. My team and I could achieve the goals, gave some kind of satisfaction, however, am still awaiting for my dream moment.

Scientific pursuit continues and I am yet to achieve my 'Eureka' moments.

LEADERSHIP IN PHARMA R&D Leadership should focus both on present needs of the organisation as well as have vision on emerging trends in the area of therapeutic agents and delivery systems. The organisational needs are quite often focussed on – earliest launch in market, cost effectiveness that means, shortest time for development of a product with high quality and trouble free manufacturing process as per the current regulations. Quite often it’s a big challenge for any team. Team with different scientific skill sets, as required for different phases of product development, is required to handle complexity of the development, leveraged with technological options, is key for success. Collaboration and support from cross functional www.expresspharmaonline.com

teams and effective project management is a must for creating a common goal across the teams responsible for success of any product from development until commercial manufacturing.

Leaders should demonstrate high level of integrity, transparency and thrive for scientific excellence. Ensure that team imbibes these principles over the years.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD Deep understanding of physicochemical aspects of drug substance, Pharmacokinetic of drugs, intended therapeutic goal, understanding of formulation excipients and likely impact on pharmacokinetics of drug substance, understanding delivery system and its in-vivo behaviour. It’s equally important to understand and anticipate the

effect of manufacturing process on performance of dosage form while developing it from lab scale to commercial scale manufacturing. Selection of packaging components for maintaining the quality throughout the shelf life and choices we make keeping in mind the economics of business and affordability.

LIFE GOALS AT 70 ◗ Build an organisation focussed on development of a nonconventional drug delivery platforms, which can offer better safety and ease of administration at affordable costs. ◗ Sense of having lead professional and personal life with high level of integrity. ◗ Physical and mental fitness to serve family and society.

WORDS OF INSPIRATION Life is a journey which has to be lived in totality. We are unique and therefore it’s normal to have unique objectives/ purpose/ achievements/ capabilities of life and not mirroring them to satisfy the current social mind set. One should be ready to recalibrate own path as often as needed without any regrets as every success or failure is just a lesson learned in this journey. Never give up!

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✦Education: M. Pharm ✦Designation: Technical Director, Khandelwal Labs Ltd, Mumbai ✦Experience: 29 Years (Pharma R & D and Techno-commercial) ✦Specialities: Dosage form development, oncocare products, technomarketing, IPR ✦Number of patents filed: 192 (Granted 50, US – 04, Europe – 01, Other Countries – 14, Indian – 36 and rest under various stages) ✦Awards ■ Illustrious Alumni Award 2016, University of Saugar

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he shortest route to success and accomplishing a task or project is the systematic and scientific approach

MEMORABLE INCIDENCES AS A SCIENTIST Every product and technology is a challenge and its application to evolve an effective, innovative and cost-effective product is a real experience. Developing nano silver gel has been a lifetime experience, starting from the scratch and taking it to get US patent status and commercialising it to success.

The oncocare formulations are a challenge by itself. I am proud to state that most of the products which are available in the Indian market have been originally developed at our end by me and later by my team.

Though FDC formulations are a taboo these days in view of renewed scrutiny, I say with pride that I had successfully developed and commercialised dozens of therapeutically rational effective and medically authenticated combos, which have undoubtedly made the cost of treatment affordable without compromising on compliance. Oncocare and cytotoxic products registration globally has been a big challenge and the up-gradation of R&D and manufacturing facility has also been a big task and achievement.

LEADERSHIP IN PHARMA R&D Leadership is fundamentally a well known phrase, 'Lead from the www.expresspharmaonline.com

front' and support/criticise your co-workers for their contribution or failures. Leadership in pharma R&D revolves around two major attributes: knowledge and execution. Doing it yourself and sharing knowledge, encouraging your team-mates to ideate is equally important.

Reading, updating on the international scenario of medicines, technology, delivery systems, drug substances /drug products and excipients (functional and non-functional) are key factors.

It is important to learn from the technicians and operators and reading through the operating manuals of the instruments and machines.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD First and foremost is a proper educational background from institutes where the emphasis is on learning and doing it yourself.

No work or discipline which is applicable to my performance and task is less important. If need

arises, be ready to do a plumber’s or mechanic’s job to understand the intricacies of the system.

Be a hands on leader. Don’t be casual in your approach, learn to record and analyse each and every aspect / observation during the course of experimentation.

Avoid repetition and wasting resources. Apply time tested, intelligent designs for your experiments and don’t term your efforts as trials. Follow the ICH guidelines in word and spirit.

LIFE GOALS AT 70 ◗ Continue to be young and energetic to contribute to science and the profession. ◗ Work towards alleviating suffering of the patients by way of providing affordable medical support. ◗ Make a contribution which is acknowledged as an innovation in the field of FDD.

WORDS OF INSPIRATION The shortest route to success and accomplishing a task or a project is taking a systematic and scientific approach. Learning, reading, updating and sharing knowledge is the best way to resolve most complicated situations. 'Team work' and 'Doing it right for the first time' matter since these, if successfuly followed, will assure all-round growth .

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✦Education: M. Pharmacy.; Ph.D. (Tech., Pursuing at Charotar University of Science and Technology, Changa.Gujarat) ✦Designation: Vice President –R&D (Formulations) ✦Experience: 32 years in FDD and 1 year in teaching ✦Specialities: Major focus on solid dosage form development including extended I R and enteric coated dosage forms, parenteral SVPs and LVPs , parenteral emulsions and DPI ✦Number of patents filed: About 40

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eadership in pharma is about driving innovation and thereby success

DEFINING INCIDENCES AS A SCIENTIST There are several such incidences but these were some of the memorable ones: In 2012, there were tense moments when we, at Alembic, were trying to fileDesvenlafaxine ANDA and Desvenlafaxine E.R.Tablet NDA, as ‘first FTF’ and ‘First NDA and 505(b) (2) application’. At the same time, it was also filled with hope and anticipation that it might be the first successful attempt from an Indian generic company.

There were happy moments when we successfully filed and received FDA permissions for a large number of products. Some of these products were patented: such as Tadalafil Tablets,

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Fesoterodine E.R. Tablets, Asenapine sublingual Tablets, Febuxostat Tablets etc., These products fared very well during CMC reviews by FDA as well.

Thus, there were several such incidences.

LEADERSHIP IN PHARMA R&D Leadership in pharma is about driving innovation and thereby success. Spearheading innovation automatically defines leadership in pharma R&D.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD

LIFE GOALS AT 70 Until we reach 60 years of age, in applied research, we will have to focus on organisational growth rather than achieving personal goals. But, between 60 to 70 years of age, if I get a good platform, I want to be associated with mega projects headed by WHO or Indian government or FDA for the 'Eradication of communicable diseases through suitable drug delivery systems'

WORDS OF INSPIRATION We should stick to knowledge and merit, not politics.

We need several intellectual ingredients to achieve success in FDD, but the foremost is basic knowledge about innovative drug delivery systems.

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✦Education: M Pharm, PhD ✦Designation: Associate Vice President, Formulation R&D, Hetero Labs, Hyderabad ✦Experience: 18 ✦Specialities: Expert in pharma formulations ✦Number of patents filed: About 20

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ake every chance which comes in life, because some opportunities come only once

DEFINING INCIDENCES AS A SCIENTIST: Pursued and honored Doctorate of Philosophy in Pharmaceutical science during lot of professional and personal commitments.

LEADERSHIP IN PHARMA R&D ◗ Recognising the problems, issues and opportunities. ◗ Implementing problem solving strategies ◗ Willing to make tough decisions ◗ Confidently expressing ideas and opinions

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD Determination and constant never give up approach in mind.

LIFE GOALS AT 70 ◗ To have an incredible 75th birthday party with my B Pharm/M pharm classmates. ◗ To have a Europe trip with my lovely wife. ◗ To be recognised as a one of the contributor for the pharma field.

WORDS OF INSPIRATION Take every chance which comes in life, because some opportunities come only once.

When you decide to give- up just think on why you held it for so many days. www.expresspharmaonline.com

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✦Education: M Pharm from University of Pune, 1997 ✦Designation: VP, R&D Formulations, Aurobindo Pharma Limited ✦Experience: 19 years ✦Specialities: Upper hand in Designing and Development of Novel Drug Delivery Systems in Oral Control Release System (OCRS). Handled many difficult to develop generic products eg. MUPS technology / OROS technology & FTF’s ✦Number of patents filed: 16 patents

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ffective leadership in pharma R&D domain should have a proper blend of technical and management skills

DEFINING MOMENTS/ INCIDENCES AS A SCIENTIST I feel the period in which I started my career I was fortunate enough to be a part of the journey

wherein the Indian pharma industry witnessed exponential growth. Yet, as compared to today’s world, we had very limited access to the electronic world , for us learning was through less talking and more reading and listening. My first memorable moment was getting my first patent published under the guidance of Dr Himadri Sen who was driving the developmental team. Secondly getting an opportunity to drive the developmental team at Aurobindo for working on difficult to develop generics and FTF’s and successfully demonstrating the role. I am thankful to my mentors from whom I was able to learn directly or indirectly.

LEADERSHIP IN PHARMA R&D In my opinion, effective leadership in pharma R&D domain should have a proper blend of technical and management skills. In addition to this, a leader should be highly motivational and also need to involve all the team in addressing the challenges faced which will make them feel empowered for getting better solution for any problem. As a leader, equal importance need to be given for productivity and morale and newer ideas need to be respected and appreciated.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD Passion for your work and remaining updated are the required intellectual ingredients for success in this field

LIFE GOALS AT 70 I want to maintain a balance of good health , happy relationships and strong finances.

WORDS OF INSPIRATION 'I can and I will' attitude will bring the best out of you. Also it will bring success to your team.

I always give the credit of my successful professional journey to my family who were always standing firm with me during the journey. www.expresspharmaonline.com

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✦Education: M.Pharm ✦Designation: Director-R&D ✦Experience: 32 years ✦Specialities: Oral dosage form development like tablets, dispersible tablets, mouth dissolving tablets, controlled released tablets, bilayered tablets, liquid dosage form, suspension form etc. technology transfer, product quality evaluation ✦Number of patents filed: Nil ✦Awards: ■ IDMA Excellence Award

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ou are never too old to set another goal or to dream a new dream

LEARNING EXPERIENCES AS A SCIENTIST I started my career as a scientist from Lupin Laboratories, Aurangabad, wherein I acquired the knowledge of product development including tablets, liquid and capsule dosage forms as well as about documentation i.e. BMR/MFR etc.

In 1987, I joined IPCA Laboratories, wherein I got opportunities to develop dosage forms of various therapeutic categories. Technology, transfer and documentation for new manufacturing units was challenging, which I learnt to handle successfully.

As a scientist, there are various incidences while developing a product. Some of them are as given below: There were challenges in formulating chloroquine

phosphate liquid as a palatable liquid as it is bitter in taste. We were successful in doing so and its monograph was included in IP. Another instance was when, under the guidance of Dr Noor, we optimised the pellets coating technology. After that, it was developed and commercialised successfully.

We developed the Nefedipine SR Tablets for the first time and launched it. While commercial production, there was a teething problems w.r.t. dissolution profile. We worked on it for almost five days continuously to resolve the problem.

We have reformulated several products for quality improvement and cost reduction.

These have been real learning experiences.

Handling a team of 38 scientists and developing

products as per the priority of organisation have helped me grow as well.

LEADERSHIP IN PHARMA R&D ◗ Strategic perspective ◗ Building collaborative relationship ◗ Taking initiative ◗ Participative management ◗ Decisiveness

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD ◗ Summary of the development strategy ◗Target product profile ◗Market assessment ◗ Regulatory strategy ◗Manufacturing strategy ◗Lifecycle management plan ◗ Back-up and follow-up compounds

LIFE GOALS AT 70 ◗ Health and wellness ◗ Work ◗ Finance

WORDS OF INSPIRATION ◗ You are never too old to set another goal or to dream a new dream ◗ I cannot change the direction of the wind; but I can adjust the sails to reach my destination ◗ Nothing is impossible, the word itself says I’m possible ◗ Quality is not an act, it is a habit www.expresspharmaonline.com

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✦Education: M. Pharm from BITS Pilani ✦Designation: Senior VP – R&D Formulations, Jubilant Generics Limited, Noida ✦Experience: 23 years ✦Specialities: Experience in designing complex formulations. Demonstrated project management skills.

Established team building and leadership skills. Good problem solving and troubleshooting skills ✦Number of patents filed: 50 novel inventions corresponds to 95 patent applications in various jurisdictions ✦Awards: ■ Recipient of 'Bhamashah Award' for securing first rank in the Rajasthan State in B. Pharm.

■ Recipient of 'National Merit Certificate,' awarded by Ministry of Human Resources & Development (Department of Education) under National Scholarship Scheme in the year 1987.

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uccess is a single word but it is a combination of hard work, team work, attitude and belief

DEFINING INCIDENCES AS A SCIENTIST I got the opportunity to work on critical products during various phases of my career, right from development to commercialisation for key markets, and thereby helping the organisation to build a strong portfolio.

Development of formulation with novel approaches like coating of drug on core tablets, taste masking of extremely bitter drug in granules for oral suspension, exposure to advanced equipment and technologies and, interaction/ working with people of different nationalities have been few of the defining moments of my career in the early stages.

Various such opportunities provided me exposure on humerous fronts, like technological and regulatory advancements, interaction with internal and external functions across organisational geography etc. and thereby helped me in

establishing myself as a crucial team member.

LEADERSHIP IN PHARMA R&D Pharma leadership needs active involvement in various stages of the business. It involves conceptualisation, feasibility, execution and commercialisation. Critical competencies include, but are not limited to, strategic perspectives, building collaborative relationships, leading teams, decisiveness and problem solving ability, career management and change management. A proactive approach is a must to meet the targets while managing dynamic regulatory, compliance expectations and technological advancements. A leader should have control of the situation and the vision to anticipate problem areas. The objective should be to give quality medicines to patients at minimum costs.

INTELLECTUAL INGREDIENTS

FOR SUCCESS IN FDD Success is a single word but it is a combination of hard work, team work, attitude and belief. To be successful, one must go down to the bottom of every problem and situation. Superficial understanding may give you momentary pleasure but may not help you in the long run. One of the most important ingredients that all successful people have in common is passion for life and a passion to pursue their interests.

It becomes a motivating force that makes success happen.

Successful people have minds like sponges, they keep absorbing more and more knowledge about their passions. They never assume that they know everything and they keep on learning. Be flexible and adapt with the dynamic environment.

LIFE GOALS AT 70 ◗ To be fit and healthy and spend quality time with family and friends ◗ To be able to contribute/provide my services for improvement of pharmacy education/pharma industry ◗ Write a book on learnings

WORDS OF INSPIRATION Never give up! Perseverance is the key to success. www.expresspharmaonline.com

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✦Education: M Pharm. Currently pursuing PhD at Free University of Berlin, Germany ✦Designation: Sr Vice President, Cipla ✦Experience: 22 years ✦Specialities: Novel drug delivery, complex technologies, nanotechnology formulation development, process engineering, injectable, oral, nasal and topical formulations. Expertise both in generic and NDA applications with regulated markets ✦Number of patents filed: More than 25 patent applications have been filed. 8 publications and presentations at reputed conferences ✦Awards ■ Innovation of the Year Award 2011 ■ Nanotechnology of the Year Award 2011

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e should use knowledge and skills to provide the best and most useful, patient-friendly dosage forms, especially for chronic diseases, such that the suffering is minimised

MOMENTS/INCIDENCES AS A SCIENTIST I have had the opportunity to work and lead the development of technology based nanodelivery systems till commercialisation. I developed and commercialised the first prescription-based effervescent product in India way back in the year 2000. Similarly, I was instrumental in developing country’s first mouth dissolving technology-based product, buccal adhesive dosage form, and many more. A very recent achievement has been the successful commercialisation of India’s first generic version of indigenously developed and manufactured albumin bound nano particle dosage form of Paclitaxel. This was recognised

as innovation of year award for the year 2011.

LEADERSHIP IN PHARMA R&D Pharma R&D is a knowledgebased industry, hence a strong command on science and its interface with technology and application to business needs is the hallmark of strong leadership skills. Application of pharmaceutical science and know-how to develop complex and innovation-based formulations that can lead to improvement in quality of life of the patient defines leadership of today and the future.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD To be current in science and engineering, along with

technological advancements happening around the world.

Application of new and novel tools to develop and commercialise robust and patient-friendly products.

Developing QbD-based processes are the stepping stones of success, hence sound knowledge of quality systems in pharmaceuticals would undoubtedly lead to success.

LIFE GOALS AT 70 ◗ Travel the world. ◗ To be able to disseminate the knowledge I would have gained over the years to next generations. ◗ To compile and publish my journey in the Indian Pharmaceutical industry.

WORDS OF INSPIRATION Pharmaceuticals is a profession that is next to practicing medicine. I feel that we should use our knowledge and skills to provide the best and most useful, patient-friendly dosage forms, especially for chronic diseases, such that the suffering is minimised. As pharmaceutical technologists, we have the skill to innovate what may be clinically most relevant, hence, we need to use this skill and partner with care givers for a better society. www.expresspharmaonline.com

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✦Education: M.Pharm ✦Designation: Head of Department F&D, Mankind Pharma ✦Experience: Around 22 years ✦Speciality: Worked on several technologies and dosage forms like oral films, ophthalmics (gels, suspensions, liquids, nanoemulsions) parenterals, nano emulsions, nano technologies apart from solid orals, liquid orals and topicals as well as worked for various markets like US, ROW and domestic ✦Number of patents filed: 7 ✦Awards: Won best team award twice in DRL

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o problem exists in this universe without a solution

DEFINING MOMENTS/ INCIDENCES AS A SCIENTIST Achieving success in any complex problem while working on alternate solutions

due to IP constraints are delightful moments which provide more satisfaction than receiving an award.

LEADERSHIP IN PHARMA R&D The ability to identify and enable creative scientists, to cultivate new scientific insights, to identify sources for innovation, to nurture and navigate promising ideas for better quality outcomes, to reinforce an environment of top quality science, and to keep the brightest minds engaged day in and day out.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD ◗ Knowledge of technology, ingredients and process. ◗ Independence – being able to work without close supervision, managing time and projects ◗ Critical thinking – being able to evaluate work, making judgements about the value of information and drawing conclusions from data. ◗ Problem solving – devising strategies to work towards a solution

LIFE GOALS AT 70 ◗ Interpretation of Vedas from a scientific perspective

WORDS OF INSPIRATION ◗ No problem exists in this universe without a solution.

Shraddhavan labhate jnana. www.expresspharmaonline.com

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✦Education: M Pharm (UDPS Nagpur University) ✦Designation: Director, Product delivery team, Dr Reddy’s Laboratories ✦Experience: Overall 19 years of FDD ✦Specialities: Oral Solids, FDCs, Modified release oral dosage forms, Sachets, Liquid orals and Characterization based products ✦Number of patents filed: About 20 ✦Awards: ■ Effective People Manager award at DRL, ■ Various team awards at DRL. ■ Special recognition award at Alembic for one of 505b2 application (in licensing deal with MNC)

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nderstanding beyond R&D specifically in portfolio, quality and production drives the leadership

DEFINING MOMENTS/ INCIDENCES AS A SCIENTIST ◗ Launch of first own developed products in India, the US, the EU, RU, AU, CA and many other markets. ◗ Achieving technical breakthrough like bio or mitigating IP challenges, filings and approvals. ◗ Taking product for global development, filing and launch. ◗ Above all, reaching patients to solve unmet needs will bring in more proud moments.

LEADERSHIP IN PHARMA R&D In pharma, it is important to understand the complete cycle of development, which starts with product selection process till its launch. In my opinion: ◗ End-to-end visibility of product life cycle gives 3600 learnings and driving skills ◗ Understanding beyond R&D, specifically in portfolio, quality and production drives the leadership.

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◗ Managing micro and macro issues. ◗ Global development vision, early to market thinking gives advantages over conventional US lead development process.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD It can be divided in two areas, core technical and other valued services.

Core technical includes: ◗ Understanding patients' unmet needs, helps to develop the right product. ◗ Ability to leverage own and others knowledge, brings direction to development. ◗ Art of questioning, defining problem statement and need, helps to review the development process. ◗ Connecting the dots across all functions give significant value addition in project risk management. ◗ Other than core technical competencies, there are various

core areas which drive the successes like, companies internal processes, internal reward processes, efficient support functions, cost of development, drives success in FDD. We need to focus on three P’s. They are product, people and processes.

LIFE GOALS AT 70 ◗ Improving reach of medicine to patient. ◗ Knowledge sharing on the professional front. ◗ Guiding and focusing on young talent.

WORDS OF INSPIRATION What we are sowing today will bear fruits in future. There are no shortcuts to development.

Shortcuts are negatively impacting end objectives across industry, which cannot be limited to data integrity.

The Indian pharma industry is at a transformation phase. It is a very crucial moment for all FDD scientists to be part of this transformation. Become the reason for change, drive change, sustain change and bring about change in your growth. Hope and patience will achieve more than force. At Dr Reddy’s, we relentlessly pursue excellence in science and speed, because good health can’t wait.

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✦Education: B. Pharm, Ph.D., MBA ✦Designation: Executive VP of Technical Operation, Natco Pharma ✦Experience: 20+ years ✦Specialities: R&D, First-To-File products, non-infringing formulations, portfolio identification and management ✦Number of patents filed: 5 ✦Awards: ■ 2000, 2001: Honoured Member, Strathmore’s Who’s Who, Millennium Edition,Westbury, NY ■ 2000: MBA Marketing Seminar Award,West Virginia University ■ 1999-00: Marquis Who's Who in America, Science and Engineering, New Providence, NJ ■ 1997-98: International Who’s Who of Professionals,Jacksonville, NC ■ 1992: The University of Iowa, Graduate College Scholarship ■ 1991: The University of Iowa, College of Pharmacy Merit Scholarship ■ 1988: The Bombay College of Pharmacy Gold Medal and Merit Scholarship for securing highest marks in Bombay University Examination

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eadership in pharma R&D is the ability to not compromise quality in development over speed

MEMORABLE MOMENTS AS A SCIENTIST ◗ During my PhD research, the ability to understand the physiological impact of lower respiratory tract diseases on drug

delivery ◗ As a young industry scientist, the first transdermal patch and the first oral tablet that I developed. ◗ Developing multiple noninfringing formulations, first-tofile products amongst a patent minefield laid out by the brand companies. ◗ Being part of core team involved in the largest pharma acquisition in India by a US company (Mylan acquiring Matrix) and being involved in the trans-border integration activities. ◗ As Global External R&D Head, being responsible for company’s entry into hormonal products, controlled substances and sterile ophthalmic products.

LEADERSHIP IN PHARMA R&D ◗ Ability to not compromise quality in development over speed. ◗ Being able to connect experiences from various setbacks and use that to improve the quality of products in future development. ◗ Provide continuous training to less experienced team members. ◗ Being able to balance completing priorities and deadlines and to develop products within the design space, ability to identify critical parameters which influence critical quality attributes of the final product.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD ◗ Knowledge of regulatory requirements of different products and markets. ◗ Good knowledge of pharmaceutics, controlled release, pharmacokinetics, chemical kinetics and pharmaceutical engineering along with IP, compliance and quality.

LIFE GOALS AT 70 ◗ Spend more time with family and friends and travel the world. ◗ Still be actively engaged with the pharma industry in a mentoring role. ◗ Provide any voluntary services to help the fraternity and society. www.expresspharmaonline.com

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✦Education: M Pharm ✦Designation: Senior VP, Hetero Drugs ✦Experience: 24 years ✦Specialities: Pharmaceutical product development, validation, engineering and manufacturing expert ✦Number of patents filed: 3

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he best things in life come from passion, persistence and hard work

MEMORABLE MOMENTS AS A SCIENTIST For me, science is application of common sense backed by strong knowledge to achieve targets.

Hence, I enjoy being a scientist.

There are many moments/incidences which have occurred to me or my colleagues which have inspired and defined my path. So, it is very challenging to pick up one such defining moment. However, brain storming sessions/discussions with my fellow scientists to resolve challenges have led to many such moments.

logical conclusion. Identifying and leveraging the capabilities of individuals in his team to achieve the best out of each member is what defines leadership in pharma R&D. In today’s fast changing regulatory and product development requirements, it is necessary for a good leader to be up-to-date and well informed.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD

LIFE GOALS AT 70 ◗ I should be fit enough to work for minimum eight hours in a day. ◗ Spending time with my family and friends. ◗ Visiting different places in the world before it is too late.

WORDS OF INSPIRATION Life is a struggle, whatever you are struggling with. The best things in life come from passion, persistence and hard work.

◗ Strong scientific knowledge. ◗ Application of knowledge and experience ◗ Awareness of the current requirements for FDD.

LEADERSHIP IN PHARMA R&D Leadership in pharma R&D is all about leading the scientific and regulatory challenges to its

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✦Education: M Pharm; PhD; MBA ✦Designation: Senior VP & Head – F&D, Cadila Pharma ✦Experience: 22 years ✦Specialities: Novel drug delivery system (NDDS), New drug application (NDA), Complex generics development and Para IV filings ✦Number of patents filed: 8 ✦Awards: ■ Received recognition during International Conference on Novel Formulation strategies 2017, Selectbio, HITEC City Hyderabad ■ Received recognition during Innogen Summit India 2016, Mumbai for contribution towards NDDS ■ Received recognition during Global Drug Formulation Summit- 2015, CPHI conferences, Mumbai, for contribution towards critical stability issues and resolution ■ Received excellence in Innovation award for Innovative Product Development from Head of Integrated Product Development Organisation in Dr Reddy’s Laboratories

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f we collaborate in the right spirit with top academic institutes, we can accelerate the drug development programme

DEFINING MOMENTS/ INCIDENCES AS A SCIENTIST A few years back, I was given the challenge of developing a block buster molecule which was being researched on for the past eight years with no success. There were all types of challenges in this product ranging from stability to bio variability. Moreover, the product was protected by all kind of patents. Team members were afraid of handling such a high bio variable and unstable molecule.

Motivating team members was a key challenge apart from handling complexities of the molecule.

However, we were able to develop a stable, cost effective and bioequivalent product in around a year's time. Though this product was designed to be patent non infringing, a big MNC sued us and I had to represent my company for this litigation. I was able to defend our formulation during my deposition with the big MNCs attorney team in the US. My deposition went off very well and I was able to convince them that we are not infringing any of their valid patent. The product got approved by the US FDA and apart from providing affordable product to patients, also generated great returns for the organisation. My team and I got an award from the CEO of the organisation and this was a special moment for me. www.expresspharmaonline.com

LEADERSHIP IN PHARMA R&D The most important aspect of leadership in pharma R&D is how to handle failures and temporary setbacks in complex molecules development. Solutions to problems are found when the leader connects all the dots to make a turnaround and achieve success.

A real leader will set the right direction by motivating the team members and analysing the sets of data available.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD Understanding the basics of science related to human physiology, chemistry and novel drug delivery system are essential components required to succeed in formulation development.

Without understanding how a drug will behave in the body with different biological environments, it is virtually impossible to develop an innovative drug. Strong knowledge of chemistry is also essential to understand compatibility of active drug

substance with different excipients. Application of quality by design principles like design of experiment and programme management are essential to deliver successful quality products in a time-bound manner.

LIFE GOALS AT 70 ◗ To write series of books on drug development and discovery programme with real case studies that will act as a guiding tool for young scientists. ◗ Mentoring of young scientists to turn them into great leaders of tomorrow. ◗ To establish drug delivery platforms which can be used to develop cost-effective drugs that can reach every person in the society.

WORDS OF INSPIRATION We may not have the best resources in the world to work on drug development programmes, but we have the right aptitude, talent and desire to research for the best class of drugs. Now, the time has come to deliver new innovative drugs by using whatever resources we have. It may be academia-industry partnership or more collaborative work. If we collaborate in the right spirit with top academic institutes, we can accelerate the drug development programme.

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✦Education: M. Pharm ✦Designation: AVP – R&D Formulation, FDC Ltd ✦Experience: 24 years in R&D Formulation ✦Specialities: Development of noninfringing Para 4 and high value first to file products. Conventional and modified release solid oral dosage forms and ophthalmics for the US and European market. Formulation of specialised dosage forms like peptides and lyophilised products.

Planning of projects, allocation of resources, budgeting, product scaleup, technology transfer, process validation, trouble shooting and cost saving activities. Knowledge of patents and regulatory requirements ✦Number of patents filed: 7 ✦Awards: ■ Total Quality Management Champion (TQM) at Ipca Laboratories ■ Winner of the Colorcon Innovation forum award 2016

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leader in pharma is one who can win the trust of the team, take it into confidence and propel it into action

MEMORABLE INCIDENCES OF YOUR CAREER A few incidents which have been responsible in bringing out the best in me: At the very beginning of my career, formulation development was mostly for the domestic and rest of the world (ROW) market. I recall this incident, during one of the project meetings, my superior who also was a very senior person highly appreciated my efforts in meticulous planning and execution of the trial batches. He also made a special mention of my documentation skills with reference to the exhaustive process details captured in the lab note books, making it easy for anyone to reproduce the trails taken by me.

Must say… this could be my first brush with QBD. Another incident, much later in my career. I was to travel outstation for the manufacture of pre-clinical batches of a peptide product. It was an important product for the organisation.

After completion of the batch, I was treated to a surprise lavish dinner by my HOD who was also accompanying me. Later, I got to know, that our Technical Director who was also Member, Board of Directors had told my HOD to ensure that I do not miss www.expresspharmaonline.com

on my birthday celebrations. I was touched by humility and the very kind gesture of this great man.

You may be high up the ladder of success, but you still are a human.

LEADERSHIP IN PHARMA R&D A leader in pharma is one who can win the trust of the team, take it into confidence and propel into action. Percolate the vision of the organisation, set clear goals and provide an environment conducive to thinking out of the box. Create a team that is fearless to admit mistakes, quick to learn from them and wise to never repeat the same. Have the ability to mitigate risks by doing extensive and robust ground work. Keep

abreast of the changes happening in the current dynamic situation. Willing to take tough decisions when required. Empower the team members, delegate responsibilities and create future leaders.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD Inquisitiveness, logical reasoning and a never ending zeal to experiment. Ability and humility to accept failure. Ability to transform data to information and knowledge to wisdom. Work hard, work smart. Develop competence which reflects in confidence and attitude leading to progress. Update knowledge base to make informed decisions.

LIFE GOALS AT 70 ◗ Reaching healthy 70 ◗ Having an impromptu dance session with my grandchildren ◗ Working towards a greater cause alongwith my son in the healthcare system

WORDS OF INSPIRATION These are borrowed…but I love and live by these lines. I can’t help sharing them.

Everybody is different.

Everybody has different styles.

Just do it the best way you know how.

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✦Education: M Pharm (Pharmaceutics) ✦Designation: President R & D, Aurobindo Pharma ✦Experience: 25 Years ✦Specialities: Solid dosage forms IR/ER, Injectable Liquid / Lyo, Para IV submission, First to file submissions, Complex generics, QBD ✦Number of patents filed: More than 50 ✦Awards: 2

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ne has to strive consistently and continuously to ensure quality-based product development in R&D which effectively employs innovation in product and process

DEFINING MOMENTS/ INCIDENCES AS A SCIENTIST As a scientist, I was involved in the development of various complex generics. Developing difficult products became a passion for me.

In this journey, some technologies, concepts got patented. Many difficult products got commercialised successfully. In the initial days of my career, I worked at Dr Reddy's Laboratories, Cipla and Ranbaxy where pharma industry was in the early phase of the generic medicines business. Scientists were identified by the product they were working on. I received a

high level of appreciation in all companies I worked and this was a source of satisfaction and motivation for me.

LEADERSHIP IN PHARMA R &D One has to strive consistently and continuously to ensure qualitybased product development in R&D which effectively employs innovation in product and process.

Successful leaders in pharma R&D focus on product composition/process, stability, analytical challenges, clinical challenges and regulatory requirements of product along with standard documentation

practices. The ultimate aim is to achieve commercially feasible simple, cost-effective product.

Further, understanding viewpoint of higher management, effectively analysing complex problems, settling problems internally and externally, taking initiative to seize opportunities is important. Should have the capability to lead an operation from its inception through to completion.

LIFE GOALS AT 70 ◗Providing a good number of innovative cost-effective drug products. ◗Becoming a good pharma leader in ◗Being a mentor.

WORDS OF INSPIRATION Knowledge will never go waste.

Keep reading multiple things related to your product. Read – Experiment—Read – this will give you maximum success, maximum satisfaction. A formulation scientist who does physical observations, analyse data, relate with theory, and take decision are most successful in their career.

Small observations will make big differences. Quality, formulation, analytical, clinical, regulatory and manufacturing teams need to work hand-in-hand throughout life cycle of product. Work fearlessly, confidently, enjoy it! www.expresspharmaonline.com

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✦Education: Master of Pharmacy (Quality Assurance), Ph. D. (Pharmaceutical Tech.) ✦Designation: Deputy General Manager, USV Mumbai ✦Experience: 21 Years in R&D formulation development in various organisations ✦Specialities: Development of various dosage forms ranging from solid orals, injectables, solutions and suspensions. Intensely worked on biosimilars for global markets ✦Number of patents filed: 4 (2 granted and 2 pending)

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here is a need to create awareness in order to recognise the ongoing trends in global R&D scenario

DEFINING MOMENTS/ INCIDENCES AS A SCIENTIST In Alkem Laboratories, from where I started my career in R&D, I got an opportunity to work on a product for taste masking. The drug was extremely bitter in taste and had to be formulated as a paediatric suspension. The expectation from the organisation was tremendous. The taste masking was achieved using wax substance and simultaneously

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passing all the other physical and chemical parameters of the product. Those were the initial days in R&D. Completion gave a great sense of satisfaction and motivation as a scientist.

LEADERSHIP IN PHARMA R&D Leadership in pharma R&D is developing competencies. There is a need to create awareness in order to recognise the ongoing trends in global scenario.

Leaders should be able to visualise the expectations of internal and external customers.

They should have useful networks and business relationships. They need to share the responsibility and finally should be decisive in nature, which will help them to make timely decisions to continue with the project or terminate from company’s perspective.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD The knowledge of the subject and constant upgradation is the key for success in FDD. The ability of a person, to adopt positive changes like technology, automation, outsourcing the elaborate task will take a long way. Share knowledge, give opportunity to young people.

LIFE GOALS AT 70 ◗ Develop effective medicines and ensure that they are within the reach of every individual. ◗ Enjoying life. ◗ Be the best mother to my two children. ◗ Live life as it comes.

WORDS OF INSPIRATION I don’t know if my life and struggle is an inspiration to anybody, but hardwork with intelligence and honesty will take anyone a long way and towards success. Do things yourself as it will be the best learning and experience. Get ego and pride of degrees out of your mind, grab knowledge and learn from the experience of others that will save time for better things in life.

Respect the work of every individual. Acceptance of ignorance is better than embarrassment later.

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✦Education: M. Pharm. (Masters in Pharmaceutical Sciences) ✦Designation: Executive Vice President and Head - R&D (Formulation and Analytical Research), Macleods Pharmaceuticals ✦Experience: 18 years ✦Specialities: Formulation Development, NDDS, Analytical Research, Regulatory Affairs, Para IV and IPR ✦Number of patents filed: 8 (including applications) ✦Awards: Received multiple awards for outstanding performance and achievements at Macleods and Intas

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ne should have passion and a lot of positive energy to be successful in research and development

DEFINING INCIDENCES AS A SCIENTIST ◗ Post GATT era and overcoming the patent challenges. ◗ Filing Para IV products with US FDA and getting 180 day exclusivity. ◗ Developing multiple NDDS based products and launching the same.

LEADERSHIP IN PHARMA R&D Formulation development and drug delivery is a very vast field comprising different dosage forms with different drug release mechanisms which are dependent on several attributes. In such a scenario, scientists have different strengths, capabilities and weaknesses. Leadership is the ability to identify the strengths and weaknesses of each team member and optimally utilise their strengths to develop products and motivate them to overcome the weaknesses.

Leadership is the ability to bridge the gap between the expectations of the management and the team of scientists to ensure that targets for product developments are met within the stipulated time frame and in an efficient and organised manner. Leadership www.expresspharmaonline.com

is the ability to remain updated about the latest scientific and technological trends and ensure that the team does the same to suggest new development ideas to the top management.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD Characterisation of the drug substance and thorough, indepth knowledge of the excipients are two vital ingredients required to start any formulation development.

Characterisation of the reference product is essential to have a benchmark for our development. Next comes the

knowledge of the equipment. It is very essential to know the use of the equipment and their critical parameters which can have an impact on the quality of the product. And lastly, but a very important ingredient, is the development of an accurate and robust analytical methodology to test the finished product because the results of the analysis is very vital in taking critical decisions about formulations.

LIFE GOALS AT 70 ◗ To be the head of a researchdriven organisation. ◗ To have filed and launched first-of-a-kind product in India and other markets. ◗ To have filed and launched multiple first-of-a-kind products in India and other markets.

WORDS OF INSPIRATION Apart from qualification and competence, research requires a lot of patience, going into details, data cracking and interpretation along with good planning. Therefore, one should have passion and a lot of positive energy to be successful in research and development.

Passion and positivity provides patience and longevity which eventually leads to success.

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✦Education: M Pharm, Ph.D, PDF (USA) ✦Designation: Senior VP (Tech Operations & Pharma Research), Orchid Pharma Ltd ✦Experience: 25 years in various industries ✦Specialities: Biopharmaceutics & Pharmacokinetics, Novel Drug Delivery Systems & Complex Generics ✦Number of patents filed: 17 ✦Awards: GP Nair Award and 4 Gold Medals of IPA & Kakatiya University

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e need to ensure that work pressure does not turn into stress and use every ounce of our talent to be successful

MEMORABLE MOMENTS IN LIFE A scientist, working with the uncertainties of science, experiences such moments often and he/she should consider every such moment as important. As a scientist we are not sure when that defining moment would embrace you professionally.

Some of the defining moments in my life as a scientist were getting a Ph.D degree, important novel drug delivery projects being successful and getting positive outcomes and filing several complex, generic products.

LEADERSHIP IN PHARMA R&D The pharma industry in general, and pharma research in particular, is a multifarious and evolving landscape. More so, in times when companies are trying to cut down on R&D expenditure and shrinking product pipelines.

Leadership in pharma research is expected to be accustomed to these challenges and uncertainties.

Leaders in pharma R&D need to give a new direction or vision for success to the company and he/she should spearhead the team in the new direction. A leader is defined by his ability to manage changes in technology, regulatory requirements and customer expectations. www.expresspharmaonline.com

Decisiveness with good analytical skills and quickness in managing these changes are also very significant qualities. In addition, maintaining personal rapport with the team members is an important leadership quality.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD Intellectual ingredients required for success in formulation development and drug delivery are innovation, product costing and timing of development.

In addition, we also need to have complete clarity on the following: Target product profile, regulatory strategy, intellectual property, manufacturing

strategy and life cycle management. Sometimes discussion with the regulatory agencies will give better clarity with respect to regulatory strategy.

LIFE GOALS AT 70 ◗ To be physically and mentally active ◗ To have great satisfaction of having contributed to the wellbeing of the society ◗ To have satisfaction at having made many friends, both professionally and personally, and maintaining good relations with all the family members

WORDS OF INSPIRATION One should be sincere, honest, dedicated, and thereby an asset to the organisation wherever they are working. We need to ensure that work pressure does not turn into stress and use every ounce of our talent to be successful.

When we are unable to change a situation, we need to change ourselves and adapt to the situation. We should have faith in ourselves to deliver.

“Knowing others is intelligence; knowing yourself is true wisdom. Mastering others is strength; mastering yourself is true power.” – Lao Tzu – Tao Te Ching.

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✦Education: M Pharm, Ph.D (Tech) ✦Designation: Head- F&D (Pharma), The Himalaya Drug Company ✦Experience: 22 yrs ✦Specialities: Formulation development, analytical development, technology transfer, good knowledge about Microsoft Excel Programming ✦Number of patents filed: 1

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any things can be done by adopting an alternative and a simpler approach

INTERESTING EXPERIENCES AS A SCIENTIST During my association with The Himalaya Drug Company, Bangalore, we introduced a concept of Quality by Design (QbD). The topic is quite difficult to understand. I prepared a simple presentation covering each and every concept of QbD including DOE and risk assessment. Each concept was explained with lot of reasoning and examples. I also explained its practical implementation during product development.

I always feel that many things can be done by adopting an alternative and a simpler approach. During my association with Janssen Cilag Mumbai, we had a practice of completing investigations related to OOS, OOT within a short time. I noticed that, after completion of analysis, it takes a day or two to complete calculations. Meanwhile, the analyst has to hold all the glass apparatus, HPLC equipment and solutions till he/she completes the calculations, so that, investigations can be performed if required. Due to this, the productivity was reduced.

I implemented my knowledge of Microsoft excel programming and devised a programme which can import the chromatographic data from HPLC directly into the www.expresspharmaonline.com

excel sheet. Calculations were done within a few minutes after completion of analysis. This led to effective utilisation of resources and increase in productivity. My team was very happy with this new approach.

LEADERSHIP IN PHARMA R&D ◗ Willingness to make tough decisions. ◗ Being a good listener. ◗ Identifying capabilities, motivating others to provide new ideas and to perform at their best. ◗ Team building, aligning and influencing other stakeholders to achieve assigned goals. ◗ Recognising problems, issues and opportunities. ◗ Strategic thinking. ◗ Implementing problem-solving strategies.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD ◗ Good knowledge of formulation and stability aspects of various dosage forms.

◗ Good communication skills, presentation skills. ◗ Good knowledge of local regulatory guidelines and guidelines related to filling of ANDA, new drug and CTD. ◗ Good knowledge of production processes and tech transfer activities. ◗ Good knowledge of patents for developing non-infringing strategies. ◗ Good analytical skills, for conclusive interpretation of situations and route cause analysis. ◗ Good training capability. ◗ Awareness about clinical trials. ◗ Awareness of new excipients and new formulation technologies. ◗ Daily check on guidelines, patents and formulations.

LIFE GOALS AT 70 ◗ To be a mentor and advisor. ◗ To maintain good health. ◗ To participate in a marathon.

WORDS OF INSPIRATION ◗ Never underestimate your capabilities. ◗ Put in your best efforts while working. ◗ Be determined and work smart to achieve it. ◗ Never reinvent a wheel. ◗ Make your own strategy to tackle difficult situations. ◗ Appreciate good work.

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✦Education: M. Pharm., Ph. D, MBA ✦Designation: Sr. Director – Operations and Tech Services, R&D, Emcure Pharma ✦Experience: Around 20 years ✦Specialities: Designing complex formulation, great leadership, team building ✦Number of patents filed: Total 12 patents filed national and internationally ✦Awards ■ Gold medallist in B. Pharmacy from Saurashtra University ■ Awarded with best research paper by IDMA ■ Awarded The Great Manager Awards under category of ‘Individual Credibility’ in the list of Hunt for Great Managers 2016 by Time Ascent and People Business

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fficient leaders identify scientists with great potential for breakthrough insights and encourage them to strengthen their core areas of expertise

DEFINING MOMENTS AS A SCIENTIST The moment when I started research and development in the industry, was a very significant one as I had dreamt making novel drugs which will be cost effective and efficient. However, when I look back, the journey was memorable but not a bed of roses. It started from a small town where even basic necessities were hard to come by. I personally feel that one should never concentrate on miserable past moments but take them as lessons and make them a ladder of success. That's the way to feel happy and also spread happiness among others.

LEADERSHIP IN PHARMA R&D Innovation distinguishes between a leader and follower. Efficient leaders identify scientists who have great potential for breakthrough insights and encourage them to strengthen their core areas of expertise. They show decisiveness and dedication in their actions. Leaders anticipate problems and deal with them in a principled manner. Some of the prominent qualities of leaders are a strategic perspective, composure, willingness to take tough and bold decisions and persistence. Leaders should examine problems through multiple lenses and ensure that www.expresspharmaonline.com

their scientists understand different perspectives. Such leaders use informal channels to understand the strengths of their people and what motivates them.

Leadership and learning are indispensable from each other.

Leaders should empower their team with honesty and transparency.

organisational skills, persistence, discipline, hard work and humour are some important qualities to make a leap from gaining knowledge from others’ discoveries to make inventions on our own. One must involve in constant reading and keep himself updated. Lastly, dream as they transform into thoughts, and thoughts result in action.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD

LIFE GOALS AT 70

Research is hardly easy. I believe there is a special set of traits that will equip a researcher to successfully solve the problems.

Curiosity, creativity, determination, sound judgment, a well-drawn project roadmap, hope and positivity, acceptance of failures, out-of-the-box thinking, good communication skills, great

◗ Strive and engage myself in activities to enable socioeconomic upliftment of the society. ◗ To lead a healthy, happy life and spend quality time with family and friends. ◗ Working with prominent research institutes to create future scientists with leadership qualities.

WORDS OF INSPIRATION “Thinking is the capital, enterprise is the way and hard work is the solution.” If we start believing in our goals, our dreams will become reality and results will begin to follow. One must start developing that conviction in ourselves, discarding things that hold us back and throwing away inertia, the mindset of defeat. As we speak to people, give them something to feel, to remember and to do. Thus, our ability to lead others will go to the new level.

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✦Education: Ph.D and Masters in Polymer Science from Case Western Reserve University, Ohio, USA; and a Bachelor of Technology in Chemical Engineering from Indian Institute of Technology, Bombay ✦Designation: Executive VP Integrated Product Development (IPDO), Dr Reddy’s Laboratories Ltd. ✦Experience: 28 years ✦Speciality: Academic and industrial research, product development, technical service and management of research and technology in the areas of pharmaceuticals, engineering polymers and plastics, high performance fibers and coatings, and alternate energy technologies ✦Number of patents filed: 6 ✦Awards ■ Research Fellowship Award by the Max Planck Institute for Polymer Science (Germany) ■ JFWTC Leadership Award for Driving Innovation by GE Plastics (US) ■ UICT Diamond Jubilee Visiting Fellowship Award by the Indian Plastics Institute ■ Adjunct Professorship: Centre for Research in Nanotechology & Science, IIT-Bombay

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very failed experiment is an opportunity to learn what you do not know

DEFINING MOMENTS After my Ph.D., I spent nine years as a scientist at Dupont’s Central R&D Centre in Delaware,US, also called the Experimental Station.

This is where polymers such as Nylon, Teflon and Lycra were invented. I had the opportunity to interact with Stephanie Kwolek, inventor of Kevlar, which is used to make bullet-proof clothing. One of my mentors in Dupont introduced me to Pharmaceuticals – he was an expert in X-ray Crystallography, which is used to understand how drugs interact with receptors in the body. My approach to R&D was shaped by my experience at Dupont. I learnt that there is no substitute for scientific rigour coupled with long hours of experimentation and analysis. Every failed experiment is an opportunity to learn what you do not know. Look out for mentors who can help you make the right career decisions, and enable you to unleash your full potential.

understanding of the critical quality attributes of the final product. ◗ Leverage the cumulative knowledge of others through analysis of their publications and patents, to supplement our own work. ◗Co-optimise formulation and process parameters together using design of experiments, understand and control sources of variation for developing robust, manufacturable products.

LIFE GOALS AT 70 ◗ Contribute significantly as an expert consultant, to increase

the global relevance Indian pharma. ◗ Align with an academic/research institution to help groom the next generation of Science & Technology leaders. ◗ Enable the differently-abled lead a quality life while contributing to society.

WORDS OF INSPIRATION ◗ Aspire for the best, for yourself, your family, your team, your country! ◗ Prioritise! Use the 80/20 rule. and get the job done! ◗ Don’t take life too seriously – have fun!

LEADERSHIP IN PHARMA R&D Make a difference to millions of patients worldwide by developing innovative and affordable medicines.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD ◗ Be thorough in your www.expresspharmaonline.com

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✦Education: M Pharm (Delhi University) ✦Designation: Executive VP, R&D, Medreich Ltd ✦Experience: 23 Years ✦Specialities: Oral Solid, Injectables, Novel Drug Delivery System ✦Number of patents filed: About 10

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reate novel, innovative products to improve Indian pharma industry’s market share globally

DEFINING INCIDENCES AS A SCIENTIST ◗ Wearing a lab coat, learning SOPs, reading guidelines, journals and usage of internationally sourced raw materials on state-of-the-art R&D miniature model machine in R&D labs for trial purposes linked to US and EU generic development in the late 90s were proud moments for me. ◗ Developing first time in the world and first time in India, as well as patent challenging, novel alternative formulation development for Paragraph IV & 505 (b)2 US filings, approvals and commercialisation gave me scientific exposure of the formulation development cycle. ◗ Learning to be more systematic and improve execution informulation development cycle (in less time and higher complexity) for new product developments to achieve customer delight and reliability.

LEADERSHIP IN PHARMA R&D Typically, leadership would be defined as inspiring and motivating people and to drive them to achieve a common objective and vision. However, pharma R&D is complex and challenging. It involves a wide array of functional needs and has seen revolutionary changes in www.expresspharmaonline.com

technology and the regulatory landscape in an unforeseen way.

So, while one may demonstrate exemplary leadership role in one’s own functional area, they may underperform when it comes to a broad functional leadership role in pharma R&D. The reason is the very narrow functional orientation one has been exposed to. So, for leadership in pharma R&D, one needs excellence, not only in soft skills but also in their ability to widen their functional horizon.

You need to be aware of all other functional areas involved in pharma R&D and adapt to the changing landscape, as an individual and as an organisation.

INTELLECTUAL INGREDIENTS FOR SUCCESS IN FDD The most important ingredient is critical thinking. One needs to analyse, evaluate and interpret the pertinent information gathered during developmental

phase to arrive at larger conclusions relevant for the commercialisation phase. It is important to recognise a problem early and provide a solution to the same before it starts pinching. Reason out the known facts first before attempting to discover new information or concepts. Core critical thinking skills include observation, interpretation, analysis, inference, evaluation, explanation, and metacognition.

LIFE GOALS AT 70 ◗ Maintain good health and be free from illness. ◗ Reach out to extended family and friends. ◗ Sharing life’s experiences and learnings to build future leaders.

WORDS OF INSPIRATION ◗ Update skills and knowledge by reading and conducting experiments. ◗ Interact and share knowledge, and experiences with cross functional team members. ◗ Challenge current knowledge facts or gaps/regulatory barriers with scientific evidences and rational arguments. ◗ Create novel, innovative products to improve Indian pharma industry’s market share globally.

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