FDD LEADERS HANDBOOK
PRESENTS
F D D L E A D E R S H A N D B O O K
2018
Edit.qxd
6/7/2018
4:22 PM
Page 5
FDD CONCLAVE 2018 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, Swati Rana New Delhi Prathiba Raju DESIGN
National Design Editor Bivash Barua Asst. Art Director Pravin Temble Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma Digital Team Viraj Mehta (Head of Internet ) Dhaval Das (Web Developer) Photo Editor Sandeep Patil MARKETING Rajesh Bhatkal Ambuj Kumar Ajanta Sengupta E Mujahid Nirav Mistry PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Santosh Lokare CIRCULATION Circulation Team Mohan Varadkar
FOREWORD FDD LEADERS, TAKE A BOW!
T
aking forward the tradition started in the first edition of the Formulation Development and Drug Delivery (FDD) Conclave in June 2017, we set out to put together the second edition of the Conclave as well as the accompanying FDD Leaders Handbook. The Leaders featured in this Handbook are the minds and hands that have shaped and are shaping FDD research in India as well as abroad. Some are at senior leadership levels in the industry while others are steadily rising up the ranks but already showing great promise. This year, riding on the success of the first edition, we cast our net wider and reached out to a more diverse selection of professionals within the FDD fraternity. To add depth to the content, we asked for more information, through a form asking for information on each professional's educational background, current designation, years of experience in the pharma sector, the areas of specialisation, number of patents filed, as well as awards/accolades received. We decided to add a different dimension to each profile. So besides these hard facts, we asked each professional to share with us their success mantras, as well as some lessons they have learnt in the course of their life's journey as an FDD scientist. We rounded off this section with their personal vision of the Future of FDD. We hope this section will be inspirational and serve a hook for fresh talent considering a career in FDD research. Clued into the headwinds impacting FDD research, this section also has gems of wisdom on how the sector could evolve in the future and what the fraternity needs to do to prepare for these influences. And because a person is more than just his profession, we asked for some interesting facets about their personality beyond the profession. So for example, we have marathon runner and fitness freak Arjun Singh Dasoondi, Sr Manager Business Sustaining & Technology Transfer, Amway India who also is a voracious reader with a personal library of more than 500 books on topics ranging from pharma, ayurveda, nutritional supplements as well as self-help, management and mythology. We have a cycling enthusiast like Nitin Deshmukh, GM, Glenmark Pharmaceuticals. Dr Sumedha Nadkar, Site Head and Senior Director, Perrigo India Consumer Health Care give back to society by mentoring women and being involved with CSR activities especially related to the environment and women empowerment. She is in fact presently studying psychology and counselling to further help these endeavours. So here you have it: in alphabetical order, our second compilation of FDD Leaders. We hope we will be able to discover and feature many more such deserving talented FDD professionals in our third edition.
VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com Express Pharma
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 5
Content.qxd
6/7/2018
4:54 PM
Page 6
CONTENTS 10
16
22
28
DR AMIT MUKHARYA
ANIL KUMAR R
DHANANJAY SAPRE
HEMANT B NARKHEDE
AMNEAL PHARMACEUTICALS
STRIDES SHASUN
CHARAK PHARMACEUTICALS
LAURUS LABS
12
18
24
30
DR ASHOK OMRAY
ARJUN SINGH DASOONDI
ELAYARAJA NATARAJAN
I. SRINIVAS
ADVISOR TO THE PHARMA INDUSTRY
AMWAY
RUBICON RESEARCH
NEUHEIT PHARMA
14
20
26
32
ANANDARUP DATTA
DR BIJAY KUMAR PADHI
GANESH N PHADTARE
JATIN GAJJAR
BLISS GVS PHARMA
UNICHEM LABORATORIES
GSK
AMNEAL PHARMACEUTICALS
6 | FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018
Express Pharma
Content.qxd
6/7/2018
4:54 PM
Page 7
CONTENT 34
40
46
INDOCO REMEDIES
XYLOPIA LABS
CADILA PHARMA
DR KAVITA INAMDAR
DR MANISH CHAWLA
DR NARENDRA SONI
52
DR PACKIARAJ JEYACHANDRAN PAR FORMULATIONS
36
42
48
54
KISHOR DEO
DR MANUTOSH ACHARYA
NITIN DESHMUKH
DR PRAVEEN KHULLAR
BIOLOGICAL E
OMNIACTIVE HEALTH TECHNOLOGIES
GLENMARK PHARMA
GROUP SANOFI
38
44
50
56
MUNISH TALWAR
PANKAJ SMANDPE
PREETI P RAUT
LUPIN
MICRO LABS
CIPLA
MANJURAHAMAD S MOMIN JOHNSON & JOHNSON
Express Pharma
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 7
Content.qxd
6/7/2018
4:55 PM
Page 8
CONTENT 58
66
74
82
DR PUSHPALATHA HB
DR RAHUL S DABRE
DR SRINIVAS ARUTLA
DR VALLABH PANSURIYA
THE HIMALAYA DRUG COMPANY
ALEMBIC PHARMACEUTICALS
APOTEX
J B CHEM ICALS & PHARMACEUTICALS
60
68
76
84
DR RAVEENDRA PAI
DR SUMEDHA NADKAR
GLENMARK PHARMACEUTICALS
PERRIGO INDIA CONSUMER HEALTH CARE
DR VENKATARAMANA NAIDU
DR RAJAN VERMA ABBOTT HEALTHCARE INDIA
62
DR RAJESH SIRWANI SHALINA LABORATORIES
70
78
DR RAVIRAJ PILLAI
SUBHRANGSU SENGUPTA
ABBOTT INDIA
INTAS PHARMA
IPCA LABORATORIES
64
DR RATNAKAR P MEHENDRE ALKEM LABORATORIES
8 | FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018
72
80
SAPNA RAMESH
DR TG CHANDRASHEKHAR
INDOCO REMEDIES
KUSUM GROUP OF COMPANIES
Express Pharma
Ad.qxd
6/7/2018
4:29 PM
Page 9
Amit Mukharya- FDD handbook_OK SD.qxd
6/7/2018
11:47 AM
Page 10
EDUCATION M Pharm, Ph D
EXPERIENCE IN PHARMA 24 years
DESIGNATION VP R&D, Amneal Pharmaceuticals
NUMBER OF PATENTS FILED More than 20
SPECIALITIES Pharmaceutical Formulation Development and Technology Transfer (Generic Medicines & Drug Delivery Systems)
AWARDS/ACCOLADES Acknowledged for development and commercialisation of Polycap (5 in 1 cardiac pill) in domestic and some international markets
Dr Amit Mukharya
Amit Mukharya- FDD handbook_OK SD.qxd
6/7/2018
11:47 AM
SUCCESS MANTRA
Page 11
There is no elevator for success; one has to take the steps of hard work, dedication and determination
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He is the inventor of Polycap (5 in 1 cardiac pill), a first-of-its-kind product, for domestic and international markets
FUTURE OF FDD
Express Pharma
• Prime motto for formulation development should be quality focussed cost effective commercialisation • Streamlining communication and the development process in order to achieve timelines • As a mentor show a big picture to the team and guide through the process with a sense of ownership
One of the major requirements would be to identify and develop new uses for existing drugs. Secondly, it would involve monitoring new molecules and their profiles for promising lines of research, technology and techniques. Lastly, manage the drug development interface with clarity about product opportunity in the challenging pharma industry by focusing on projects with real potential
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 11
Ashok Omray_OK SD.qxd
6/7/2018
1:50 PM
Page 12
EDUCATION M. Pharm., Ph. D.
DESIGNATION Advisor to the pharma industry
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 39 Years
30
SPECIALITIES Pharma Product Development (Formulation and Analytical) & Technology Transfer (Generic Product and Drug Delivery Systems), Packaging Development and Regulatory Affairs
AWARDS/ACCOLADES
Dr Ashok Omray
• Life time achievement and most illustrious alumni of University of Saugar • Invited guest speaker and panellist in various Indian and international forums • Associated with various universities as expert and research collaborator • Member of NBA, Govt. of India for accreditation of Pharmacy courses
Ashok Omray_OK SD.qxd
6/7/2018
1:51 PM
Page 13
SUCCESS MANTRA
Start with a conviction that the task will be achieved successfully. Detailing of failures will lead to success. The objective has to be excellence
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He is a socio-economic analyst and a great believer in the freedom of expression
FUTURE OF FDD
Express Pharma
• Mediocrity and a lackadaisical attitude is dangerous and can be disastrous • Use your imagination and knowledge but don’t sidetrack the norms, ethics and compliance • Use science and technology for best results, we are in an ethical profession and ad-hoc adjustments should be avoided
The demand for drugs is not going to diminish, and hence there is a great future for the industry.Therefore, innovation and technology upgradation for better development and and usage of safe drug molecules, improved lifecycle management and new indications are the need of the hour. Focus will be on quality generics, whether it is in India or global markets. So, quality, quantity, compliance and affordability must not be compromised. Somehow, new molecules have not stayed for long in the last three decades and the development of biotechnology-based biocompatible, biodegradable, targeted devices, functional at cell level and repair-oriented drugs will be the future areas of growth
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 13
Anandarup Datta, Bliss GVS_OK SD.qxd
6/7/2018
11:56 AM
Page 14
EDUCATION M. Pharm., MBA
DESIGNATION Associate VP & Head R&D, Bliss GVS Pharma
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA Over 20 years
11
SPECIALITIES Pharma Product Development (Formulation and Analytical) & Technology Transfer (Generic Product and Drug Delivery Systems), Packaging Development and Regulatory Affairs
AWARDS/ACCOLADES
Anandarup Datta
• Outstanding Formulation Scientist 2008 at Dr Reddy’s with stocks award • Best Leader award 2012 at Amneal Pharmaceuticals • Best Innovative R&D Leader 2013 at Amneal Pharmaceuticals • Stocks from various organisations as an accomplishment
Anandarup Datta, Bliss GVS_OK SD.qxd
6/7/2018
11:57 AM
SUCCESS MANTRA
Page 15
Quick decisions will help to find the right developmental pathway faster and to meet desired timelines
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He was instrumental in successfully setting up R&D operations for two organisations to serve target-driven, regulated markets
FUTURE OF FDD
Express Pharma
• FDD is like managing a family, one needs to take 360° care by paying attention to all hurdles at both, micro and macro level, to achieve quality targets on time • One should be mature enough in his steps during development with a transformational leadership approach to triumph as a team • There is nothing called failure, it’s learning for success in future
Product developmental needs are shifting towards perfection with a QbD approach. The scientists need to take care of all regulatory requirements (bound and unbound) based on current approval trend while developing a product. Thus, going forward, online experimental tools need to be supported by computational softwares to achieve design space for a better formula, process, analytical technique and thereby, a robust and commercially viable product in short approval time
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 15
Anil Kumar R- FDD handbook_OK SD.qxd
6/7/2018
12:02 PM
Page 16
EDUCATION M Pharm
DESIGNATION Assistant VP, Formulation Development, Strides Shasun
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 18 years
06
SPECIALITIES Development of PIV FTF formulation of solid and liquid orals, semisolids & suppository formulation for regulated markets. Novel drug delivery systems & complex generics. Differentiated products, 505(b)2, NDA, Process development and Tech transfer. Extensive knowledge in development & manufacturing of soft gelatin capsules
AWARDS/ACCOLADES
Anil Kumar R
• Strides GLC (Group Leadership Committee) Award for outstanding contribution in development and commercialisation of a key product for the US market
Anil Kumar R- FDD handbook_OK SD.qxd
6/7/2018
12:02 PM
SUCCESS MANTRA
Page 17
Lead by example. Demonstrate innovation and creativity. Embrace new technologies. Be open to new ideas. Learn from mistakes
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He is fondly recognised as one of the ‘Supermen’ at Strides Shasun - Men nominated for being swift, energetic and fixing issues in no time
FUTURE OF FDD
Express Pharma
• Strong fundamentals and domain knowledge will be key to being a successful formulation scientist • Applying common sense and simplicity in experimental design and data generation will accelerate product development process • Embrace change and upgrade your knowledge. Through novel thoughts and lateral thinking, aspire to develop differentiated products to make patients’ life better
Formulation development will continue to be the growth engine in product development process and determine the future of pharma and biologics. Novel ideas and innovation will be key for sustainability and growth. Super generics, differentiated products and biologics using novel drug delivery platforms will determine the future of FDD. Cost sensitivity in every walk of product development process will be key for profit maximisation, improving margins and cash flow. Product design to support continuous manufacturing could be a differentiator to produce cost-efficient products. Compliance to regulatory norms and continuous improvement will be non-negotiable
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 17
Arjun Dasoondi- FDD handbook_OK SD.qxd
6/7/2018
12:07 PM
Page 18
EDUCATION M. Pharm, Diploma in Business Management, ICFAI, Tripura
DESIGNATION Sr Manager Business Sustaining & Technology Transfer, Amway
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA Over 17 years
Nil
SPECIALITIES Pharmaceutical, Nutrition & Wellness; Product and Process Development of Immediate and Sustained Release Solid Oral Dosage Form, Functional Coating Technologies. Proficient in Regulatory and Quality Systems in Pharma and Nutritional supplements segments
AWARDS/ACCOLADES • Best Paper Publication award in IJPS by IPA,in the field of Medicinal and Synthetic Chemistry
Arjun Singh Dasoondi
• R&D Award for most valuable project of process development and TechnologyTransfer • R&D Sparkle Award for resolving FSSAI challenges and securing India nutrition business • R&D award for successful product development and on time launch
Arjun Dasoondi- FDD handbook_OK SD.qxd
6/7/2018
12:07 PM
SUCCESS MANTRA
Page 19
Think beyond the obvious possibilities, be decisive and innovative in your chosen field
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He is a voracious reader with a personal library of more than 500 books on various topics. He is also a fitness freak and a marathon runner
• To be successful in FDD requires an outside-inapproach, crowdsourcing and working with innovative partners to shorten development time and get early breakthroughs • Be a quick learner and agile. It is imperative to keep learning new technologies and be updated on the rapidly changing regulatory frameworks • Speed to market and being first is key to any business.
FUTURE OF FDD
Express Pharma
The impact of deteriorating lifestyles, environment and poor food habits is quite visible and devastating on human beings.The future of FDD lies in a research focus on prevention of illness and maintenance of good health.There is an untapped opportunity and potential for basic research and formulation development in “Health and Nutrition”. This will pave the way for industry’s future success as globally, governments are beginning to focus on prevention rather than treatment.With a special emphasis on kids’nutrition, who are building blocks of the future generation, it will be unavoidable for the industry to not put research efforts on formulation development around wellness.
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 19
Bijay K. Padhi, Unichem_OK SD.qxd
6/7/2018
10:15 AM
Page 20
EDUCATION M.Pharm, PhD
EXPERIENCE IN PHARMA 17+ years
DESIGNATION Associate VP & Head- Product Development, Unichem Laboratories
NUMBER OF PATENTS FILED 5 granted patents 20+ patent applications
SPECIALITIES Differentiated Formulations, 505(b)2 and Complex generics
AWARDS/ACCOLADES • Received ‘Innovative Formulators’ award from Dr Reddy’s Lab management • Received special recognition award for pioneering ‘bottom up innovation’
Dr Bijay Kumar Padhi
Bijay K. Padhi, Unichem_OK SD.qxd
6/7/2018
10:16 AM
SUCCESS MANTRA
Page 21
Answer ‘Why’ before ‘What’. Be focussed and believe in simplicity
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He is an explorer and has a passion for travelling and meeting people
FUTURE OF FDD
Express Pharma
• Data-driven decision making is very crucial • Challenge the status quo to bring about positive change • Out-of-the-box approach towards problem solving is very important
From 3D printing to non-oral delivery of biologics, the future for FDD lies in patientcentric approach and product differentiation. Bringing product differentiation requires a new way of thinking, questioning the status quo. Nurture an environment where vastly different ideas can be tested, and all data, positive or negative can be analysed thoroughly as they have equal importance. Think of the end user at the beginning of formulation design and keep them in focus, throughout the product development cycle. Decisions on technology design should be part of the initial drug development strategy or as soon as the need for reformulation is identified
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 21
Dhananjay Sapra, Charak.qxd
6/7/2018
5:28 PM
Page 22
EDUCATION M.Sc. (Analytical Chemistry)
DESIGNATION GM (R&D), Charak Pharma
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 35 years
03
SPECIALITIES Formulation Development – Natural Products
Dhananjay Shashikant Sapre
Dhananjay Sapra, Charak.qxd
6/7/2018
5:29 PM
Page 23
SUCCESS MANTRA
Determination, willingness to take risks, a talented team, and a spirit of adventure
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He is an analytical chemist by qualification and f ormulation development scientist by accident
FDD scientists should understand these points well: • Purpose of research: Identify and describe the goal of a study to identify solutions • Hypothesis to experimentation : Development of new ideas, and products as a series of experiments to determine whether an expected outcome will be achieved. • Analysis & Conclusion : To ensure that deductive and inductive processes are correctly used
FUTURE OF FDD
Express Pharma
As people become aware of the side effects of synthetic drugs, there is an increasing interest in the natural product remedies. A number of scientific investigations have highlighted the importance and contribution of many plants. Medicinal plants play a vital role for the development of new drugs. In fact, almost, 70 per cent modern medicines are derived from natural products. However, to compete with a growing market, there is an urgency to expeditiously utilise and scientifically validate medicinally useful plants. Bioactive extract should be standardised on the basis of active compounds and they should undergo safety studies
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 23
Elayraja_OK SD.qxd
6/7/2018
1:57 PM
Page 24
EDUCATION M. Pharm (Pharmaceutical Sciences), Certificate course in
DESIGNATION Associate Director – Formulation R&D, Rubicon Research
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA Nearly 13 years
Nil
SPECIALITIES Complex generics, FTF, proficient in technologies and techniques such as MUPS, HMEs, Wax Matrix, pulsatile drug delivery system, colon target specific drug delivery system, Liquid Sustained Release by Ion-exchange Resin, Tab in Tab etc. Acquired knowledge from QA and handled different PAI and cGMP inspections
AWARDS/ACCOLADES • Awarded as FLAG member of organisation based on fast progress with technical expertise
Elayaraja Natarajan
• Success in fast track ANDAs and complex generics • Delivered a talk on ‘USFDA warning letters – How to respond to it ?’, at a summit on Data Integrity, Quality and Compliance in Clinical Trials • Adjudged winner in preliminary round of National Elocution Competition by IPA
Elayraja_OK SD.qxd
6/7/2018
1:57 PM
Page 25
SUCCESS MANTRA
I strongly believe in positive working culture, leadership, team work, scientific thinking and reliability
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He aspires to write a book about ‘expectations of the pharma industry from new risers’
• Nothing is complex if we keep an open mind and have the ability to learn along with thinking ability and framework • As a formulator, we should build quality right from the development stage. If quality of ANDA submission is good, we should get the approval in 1-2 cycles • Forecasting at the R&D stage always reduces problems at pilot and commercial scale
FUTURE OF FDD
Express Pharma
FDD focus shifts towards customised drug delivery system, ARV therapies with appropriate drug efficacy, oncology, haematology, parenteral formulations (besides oral solid dosage),monoclonal antibodies (mAbs), biosimilars, etc. Based on literature, it is estimated that around 90 per cent of NCEs belong to BCS class II and IV, which are known to be associated with low solubility/permeability. The challenge in formulation development is likely to increase further due to this. The future of formulation drug delivery is highly dependent on innovative and technological solutions along with fundamental scientific work.
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 25
Ganesh Narayan Phadtare, GSK_OK SD.qxd
6/7/2018
10:23 AM
Page 26
EDUCATION M. Pharm
DESIGNATION Sr. Manager, GSK
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 05
20 years
SPECIALITIES • Formulation Development as per ICH Q8,Q9 and Q10 • Process robustness and Product Life Cycle Management
AWARDS/ACCOLADES • President Award for best product launches at Abbott Healthcare • President Award for cost saving project at Piramal Healthcare
Ganesh Narayan Phadtare
Ganesh Narayan Phadtare, GSK_OK SD.qxd
6/7/2018
10:23 AM
SUCCESS MANTRA
Page 27
Determination with good planning is a must to achieve success.One must make his/her decisions based on facts and figures
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He is an avid cyclist. He feels that one cannot be sad while riding a bicycle and believes that the activity keeps him motivated and full of energy
FUTURE OF FDD
Express Pharma
• Be compose and calm in challenging situations • Do an end-to-end situation analysis with facts and figures • Solutions to challenges must be close to fundamentals and backed by scientific rationales
Technologically, the world is changing. More advancements in drug delivery has been seen in the last two decades. With rapid change, challenges are also becoming more complex. One must keep a close track of these while designing formulation and process
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 27
Hemant Bhagwat_OK SD.qxd
6/7/2018
2:48 PM
Page 28
EDUCATION M. Pharm
DESIGNATION Deputy GM, Laurus Labs
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 18 years
01
SPECIALITIES Formulation development and Technology Transfer
AWARDS/ACCOLADES Invited as speaker at ‘Pharmaceutical Technical Seminar’ held at Jakarta, Indonesia on the subject of ‘Rational Binder Selection’
Hemant Bhagwat Narkhede
Hemant Bhagwat_OK SD.qxd
6/7/2018
2:48 PM
Page 29
SUCCESS MANTRA
Be honest and believe in yourself. Success will definitely follow
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? A post graduate in synthetic organic chemistry, he has made a mark with a career in formulation development and technology transfer
FUTURE OF FDD
Express Pharma
• FDD scientists should have an eye for details • It is imperative to stay updated and keep pace with the latest technologies • Rational thinking is a pivotal quality for FDD scientists
The future of FDD is very bright as new technologies and applications are making their way to the market. Deep knowledge of materials in the formulation would be key for success
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 29
I.Srinivas_OK SD.qxd
6/7/2018
3:01 PM
Page 30
EDUCATION M.Pharm, MCPM
DESIGNATION MD, Neuheit Pharma
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 22 years
12
SPECIALITIES Started career as a bench scientist, master in critical chain project management, handling techno-commercial activities right from product selection to commercialisation of generics business in highly regulated markets such as the US and the EU
AWARDS/ACCOLADES Number of recognitions at Dr Reddy’s Labs for outstanding performance as a bench scientist, Project Manager and Delivery Head for North America
I. Srinivas
I.Srinivas_OK SD.qxd
6/7/2018
3:01 PM
Page 31
SUCCESS MANTRA
No individual can achieve organisational goals without team effort. I strongly believe in team work to achieve success
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He is one of the scientists credited with ushering the first wave of generics product development in India
FUTURE OF FDD
Express Pharma
• Basic understanding of all areas of operations is important for any product development scientist. • It is important to address any issue, even if it is trivial, at an early stage of product development than to find a solution at the time of scale up/ launch. • FDD scientists need to be updated with current trends in technologies, at least in their segment of product development activities
The ever changing pharma sector poses various challenges for scientists looking for ideal delivery systems to minimise side effects. However, scientists need to integrate pharma science with advanced technological development to find solutions to a number of unmet medical needs. It is a big opportunity for FDD scientists to find affordable delivery/dosage form systems and improve patient compliance in emerging markets.
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 31
Jatin Gajjar, Amneal_OK SD.qxd
6/7/2018
11:17 AM
Page 32
EDUCATION M. Pharm (Pharmaceutics and Pharmaceutical Technology); D.P.P.M.
EXPERIENCE IN PHARMA + 26 years
DESIGNATION Executive VP and Head R&D, India, Amneal Pharmaceuticals
NUMBER OF PATENTS FILED More than 15
SPECIALITIES Generic solid oral dosage with complex active ingredients; Complex formulations (liposomes, suspensions, emulsions); Complex dosage forms (injectables , ophthalmic, transdermal , mDPIs); Drug-device combinations; global technology transfer; Design of discriminatory and bio-relevant in-vitro methods; Product development and scale up using Quality-by-Design; Global quality and regulatory affairs.
AWARDS/ACCOLADES • University topper in M. Pharm
Jatin Gajjar
• Gold Medal Diploma in Pharmaceutical Production Management (D.P.P.M.) • Selected as a global expert in granulation and compression in Aventis Pharma (India) • Team of the year (Amneal) • Presented at Global Green Nanotechnology Conclave • Presented on various topics in national and international conferences and workshops
Jatin Gajjar, Amneal_OK SD.qxd
6/7/2018
11:18 AM
SUCCESS MANTRA
Page 33
Have goals that stretch you. Go the extra mile. Deliver value. Encourage innovation. Keep learning. Build leaders.
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? Credited for successful submission of over 200 products in the US and the EU; responsible for launch of several first-time generics in the US market
FUTURE OF FDD
Express Pharma
• Remember that a R&D scientist is paid to bring value to the market on time • Speed, proper strategy and planning is very important in FDD • Learning and unlearning are both important. Continue to learn both from your successes and failures
The pharma industry is facing multiple challenges and opportunities. The current environment is both complex and dynamic. Complex because there is tremendous pressure from the new completion and pricing pressure due to consolidation of buyers. Also, drug delivery systems and technology platform are becoming complex. Dynamic, because rate of change is very fast. The FDA now publishes guidance at an unprecedented rate. Therefore, R&D has to be innovative, productive, cost competitive and reliable. This will require leaders, team and organisations to build on their best and bring out the true potential of each individual
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 33
KaVITA inamdar, Indoco_OK SD.qxd
6/7/2018
2:25 PM
Page 34
EDUCATION M. Pharm., Ph.D. (Tech.)
DESIGNATION Chief Technical Officer Indoco Remedies
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 22 years
19
SPECIALITIES Development of various dosage forms and development of several injectables and complex ophthalmic suspensions involving bio waiver strategies. Strong expertise in successfully responding to several queries from health authorities of regulated markets. Successfully developed bioequivalent products with narrow therapeutic indices for Europe and Australian markets. Development of anti-malarial products with inherently high in vivo variability
AWARDS/ACCOLADES
Dr Kavita Inamdar
• Member of technical sub-committee for IDMA • Selected as External Referee in Viva – Examination of M.Pharm / Ph.D held by University of Mumbai and SNDT
KaVITA inamdar, Indoco_OK SD.qxd
6/7/2018
2:25 PM
SUCCESS MANTRA
Page 35
The price of success is hard work, dedication and determination. There are no shortcuts to success
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? She is an ardent pet lover. She believes that they are great stress busters as well
• Being scientist you should be full of ideas.Any small clue, anytime, can crack the formulation and drive innovation in its own way • While formulating a dosage form, as a scientist, don’t limit your thoughts just to R&D.Think of your product commercialisation in the market • Critical thinking and analysis are very important in this profession
FUTURE OF FDD
Express Pharma
Pharma alliance has evolved a long way and we are part of that profession. The ability to adopt positive changes like technology, automation, outsourcing elaborate tasks etc. will take us a long way. Now it’s time to deliver new innovative drugs.
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 35
Kishor Deo, Biologics E_OK SD.qxd
6/7/2018
11:15 AM
Page 36
EDUCATION M. Pharm
EXPERIENCE IN PHARMA 25 years
DESIGNATION Senior VP, R&D, Biological E
NUMBER OF PATENTS FILED More than 30
SPECIALITIES Formulation development and drug delivery technology
AWARDS/ACCOLADES • Member of the Formulation Committee for PREFAR/WHO • Invited as a Chief Guest at Sanjivani Institute for evaluation of national level poster presentations
Kishor Deo
Kishor Deo, Biologics E_OK SD.qxd
6/7/2018
11:15 AM
SUCCESS MANTRA
Page 37
Do the right thing at the first time itself with science and technology
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He has been instrumental in formulation development for domestic and regulated markets with speciality in drug delivery systems for fast growing organisations
FUTURE OF FDD
Express Pharma
• Leadership qualities like creativity, science, experience and efforts are essential to drive FDD. Leadership in FDD is also about being able to carry along future leaders • A successful scientist creates more and more capacity to absorb greater knowledge about their passion • Building a strong and focussed team and creating subject matter experts based on their strengths help keep up momentum in technology development
Based on the current scenario, to succeed as a pharma scientist, one needs to be vigilant about changes in guidelines and its application, FDA expectations, quality and data interpretation. The ability to understand and adopt latest technological advancements is the key ingredient for success
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 37
J&J_Manjurahamad S Momin_OK SD.qxd
6/7/2018
11:02 AM
Page 38
EDUCATION Master in Pharmaceutical Sciences
EXPERIENCE IN PHARMA 22+ Years
DESIGNATION Head Technical, Johnson & Johnson
NUMBER OF PATENTS FILED Around 10
SPECIALITIES Pharma solid and semi-solid products end-to-end developmental life cycle from concept to product launch for highly regulated as well as local markets. Passionate about formulation/analytical/ BA-BE study/packaging/process and equipment design, develop, characterise and smooth commercialise on time
AWARDS/ACCOLADES
Manjurahamad S Momin
• Excellence Award (Sense of Urgency) – From CEO of Sandoz (2013) • Sandoz Value of the year (2009) • Best Development Contributor Group of the year (2009) • Best Development Project for an extremely challenging project. (2007) • Best Formulation Development Scientist
J&J_Manjurahamad S Momin_OK SD.qxd
6/7/2018
11:02 AM
SUCCESS MANTRA
Page 39
Satisfaction never comes from being in the comfort zone. Keep things simple, honest and transparent in whatever you do, and respect others’ perspective
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He is credited with many formulations for highly-regulated generic markets like the US, the EU and Japan
• Always keep final goal for the customer in mind. Keep track of cost, time and productivity • Ensure best gelling of 3Ms i.e. Man, Material and Machine • Always have a data-based, quality risk management approach
The future of FDD comprises: • Innovative dosage forms – Patient centric dosing and targeted therapy technology
FUTURE OF FDD
• Improved manufacturing technology – Continuous manufacturing processes with continuous process verification – online control vs tradition in process control • More efforts on development design/screening using 3Ms – Man, Material and Machine
Express Pharma
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 39
MANISH CHAWLA- FDD handbook_OK SD.qxd
6/7/2018
11:41 AM
Page 40
EDUCATION M. Pharm, Ph.D
DESIGNATION VP (Operations); Xylopia Labs
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA Around 20 years
50+ patents filed globally. Two granted patents in India and one in the US
SPECIALITIES Expertise in the development and commercialisation of solid orals [IR, ER, Osmotic, MUPS etc; both generic as well as 505(b)(2)s] for global markets (majorly the US)
AWARDS/ACCOLADES • University gold medalist (M. Pharm) • Numerous organisational awards for collaboration, team work, cost optimisation
Dr Manish Chawla
MANISH CHAWLA- FDD handbook_OK SD.qxd
6/7/2018
11:41 AM
SUCCESS MANTRA
Page 41
Do not be afraid of taking decisions. Weigh all options, decide and move ahead. It is better to be moving than to be stagnant
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He has been responsible for setting up a new, state-of-the-art, R&D facility spread over 35K sq ft for his organisation
FUTURE OF FDD
Express Pharma
• Think ‘out of the box’. There are always different and better ways of doing any activity • Mentor people. As a leader, it is the responsibility to develop more leaders • Do not compromise on system compliance or quality
Competition is continuously increasing. To be successful, one has to be significantly ahead of the competitors, not only in terms of speed but also better COGS and newer ways of thinking. Innovation is going to be the key. We need to continuously explore, challenge and improvise the way we think. Customised and targeted delivery will certainly remain the prime focus of formulation scientists. In times to come, sophisticated in vitro techniques and characterisation will become extremely important in deciding (at times replacing!) the pathway for in vivo studies.
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 41
Manutosh_FDD_OK SD.qxd
6/7/2018
3:09 PM
Page 42
EDUCATION M.Pharm, Ph.D
DESIGNATION VP R&D, OmniActive Health Technologies
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 15
23 years
SPECIALITIES Pharmaceutical Product Development (Generic and Novel delivery system), Delivery Technology Development for Natural Dietary Ingredients (Microencapsulation Technology)
AWARDS/ACCOLADES • Performance Awards for accomplishment in R&D from employers including Wockhardt, DRL, and Pharmaniaga Berhad Malaysia
Dr Manutosh M Acharya
Manutosh_FDD_OK SD.qxd
6/7/2018
3:09 PM
Page 43
SUCCESS MANTRA
Don’t restrict your vision or learning to your current expertise. Explore, learn and expand your expertise in allied fields
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He has done pioneering work in probiotics. Has developed various formulation formats with strains of probiotics, introduced for first time in the Indian market
FUTURE OF FDD
Express Pharma
• It is better to stick to basics in complex situations of development • One should always learn from failures • Observation is key for new ideas and problem solving
Formulation scientists have a great future ahead, however, they should not restrict themselves to only pharma generic product development but leverage their formulation expertise and knowledge to wider aspects. While formulation scientists understand the technology/science behind development, it is equally important to understand the target market requirements and ensure quick turnaround time for development to ensure business growth. Cosmetics and nutraceutical product development is the future potential for formulation scientists
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 43
Munish
Talwar, Lupin_OK SD.qxd
6/7/2018
11:54 AM
Page 44
EDUCATION M. Pharm (Pharmaceutics) Delhi University
EXPERIENCE IN PHARMA 25 years
DESIGNATION VP, Pharma Research, Lupin
NUMBER OF PATENTS FILED Coauthored about 20 national and international patents
SPECIALITIES Pharmaceutical product development and technology for varied dosage forms and markets
AWARDS/ACCOLADES • Gold Medal for first position in M. Pharm from Delhi University
Munish Talwar
Munish
Talwar, Lupin_OK SD.qxd
6/7/2018
11:54 AM
SUCCESS MANTRA
Page 45
Positive attitude and continuous learning is important. Help your team members develop their true potential
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He is a huge sports enthusiast and actively participates in sports like badminton, table tennis and cricket
• In research and development, there is nothing called pass or fail. It is either being successful or needs more efforts • Attention to detail is a must, a small slip at the development level will lead to a major fall on the shop floor • Risk taking ability is a must, one should learn to take calculated risks based on scientific logic
FUTURE OF FDD
Express Pharma
The future looks very exciting. There are pricing pressures, not only in the US or other highly regulated markets, but also on the domestic front and other RoW markets. It is time to reinvent ourselves and find various means for speedy and cost-effective development of products with compliance to all regulatory requirements and without compromising on quality. In the Indian market, there is a challenge from Jan Aushadhi which can also be leveraged into opportunity
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 45
Narendra Soni, Cadila Pharma_OK SD.qxd
6/7/2018
12:31 PM
Page 46
EDUCATION Ms Pharma ,Ph.D
EXPERIENCE IN PHARMA
DESIGNATION GM, Cadila Pharma
NUMBER OF PATENTS FILED More than 10 patents globally
22 years
SPECIALITIES • In depth understanding of ingredients in generic s and novel drug delivery systems • Pharmaceutical technology development and implementation for generic drug products and novel drug delivery systems • Expertise in global upscaling • Hands on experience in quality and regulatory affairs
AWARDS/ACCOLADES
Dr Narendra Soni
• Recognition from McKinsey Consultancy Services • Expert member of the Academic Advisory Committee-NIPERPharmaceutics
Narendra Soni, Cadila Pharma_OK SD.qxd
6/7/2018
12:31 PM
SUCCESS MANTRA
Page 47
There are no short cuts and no dependency in research
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He has been awarded for being instrumental in accruing more than `10 crore annualised saving for his organisation on existing five to ten products
• It is important to correctly interpret patents and apply novel technologies to bypass patents • Effective use of pharma chemistry can help to resolve or avoid stability concerns of drug substances and drug products • Effective use of solubility profile of critical excipients and drug substances to achieve bioequivalence compliance
The future of FDD will comprise: • Product development with the use of NDDS concept
FUTURE OF FDD
Express Pharma
• Development of biotechnological products • Development of nutraceuticals products with improved bioavailability
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 47
Nitin Deshmukh- FDD handbook_OK SD.qxd
6/7/2018
12:36 PM
Page 48
EDUCATION M. Pharm
DESIGNATION GM, Glenmark Pharmaceuticals
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 13
22 years
SPECIALITIES • Core competencies include Research Operations, Formulation Development, Technology Transfer, Patent & Intellectual Property Rights, Clinical and Bioequivalence Strategies, Statutory Compliance, Analytical Techniques etc. • Has extensive and in-depth experience in pharma product development and technology with deep insight into global quality and regulatory affairs
AWARDS/ACCOLADES
Nitin Deshmukh
• Chairman’s Excellence Award for Best Innovative Team • Two times Chairman’s Excellence Award for Best Collaborative Team
Nitin Deshmukh- FDD handbook_OK SD.qxd
6/7/2018
12:36 PM
SUCCESS MANTRA
Page 49
Put enthusiasm into your work
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He is a cycling enthusiast. His passion is to explore the high terrains, nature and cities by cycling
• There will be times when it will seem like the team is walking into unknown territory. And then there will be times when there seems to be a lot of progress. It is important to understand this dynamic so trust the process and your team • It is important to be very persuasive • Small actions lead to the big picture. Think big while also paying attention to the details
FUTURE OF FDD
Express Pharma
Formulation development is an art which demands strong command over science and theory along with excellent communication. Novel drug delivery systems highlighting pelletisation, homogenisation, use of novel excipients etc. will be in demand. Focus will also be on modernisation of equipment in lab and plant for successful development of new dosage forms. A new concept of personalised medicine will be quite fascinating for the formulators.Although, in India compounding pharmacies are not so popular, in future, the talents of formulation experts will be in great demand to aid in the fortification of some of the products produced with an emphasis on shelf-life or stability.
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 49
Pankaj Mandpe_OK SD.qxd
6/7/2018
2:08 PM
Page 50
EDUCATION M.Pharm, M.M.M., Ph.D (pursuing)
DESIGNATION VP R&D, Micro Labs
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA Over 25 years
14
SPECIALITIES • Product development, including complex generics. Strategic Planning, a New Technologies Facility and its Technology Transfer
AWARDS/ACCOLADES • Best perfomance award in 1997 and 1998 • Appreciation letter and reward from Micro Labs
Pankaj Sharad Mandpe
Pankaj Mandpe_OK SD.qxd
6/7/2018
2:08 PM
Page 51
SUCCESS MANTRA
You can give quality product only if you think in the best positive way right from the design stage. Be passionate for your job profile
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He was one of the key people who started generic development in Micro Labs. He was instrumental in setting up R&D outside India
FUTURE OF FDD
Express Pharma
• Decision making ability is a must for leader • Leading from the front while taking the onus of all the activities • Empower team members, delegate responsibilities and create future leaders
The current generation is very enthusiastic but often lack practical experience. We need to blend our experience with them for all theoretical purposes. The pharma industry has gone through a rough patch in the recent years and in order to be more uniform and focussed at the workplace, a lot of training needs to be given. We should use the software expertise of the new generation to make workplaces more efficient while keeping the integrity of the entire development work. This will surely help in retention of manpower which will ultimately lead to effective technology transfer and commercialisation of ideas.
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 51
Packiaraj Jeyachandran- FDD handbook_OK SD.qxd
6/7/2018
3:19 PM
Page 52
EDUCATION M.Pharm (Pharmaceutics). Ph.D (Industrial Pharmacy)
DESIGNATION Associate VP – Formulation Development, Par Formulations
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 15 years
Nil
SPECIALITIES Drug delivery for oral and parenteral routes
AWARDS/ACCOLADES Reached AVP position within 12 years of professional experience
Dr Packiaraj Jeyachandran Manohari
Packiaraj Jeyachandran- FDD handbook_OK SD.qxd
6/7/2018
SUCCESS MANTRA
3:20 PM
Every experiment in bench (lab scale is very valuable – it’s imperative to extract as much data as possible
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? Irrespective of project complexity, he is credited for consistent output of two project filings per year per formulator
FUTURE OF FDD
Express Pharma
Page 53
• Merits are not judged by the efforts we put but by the results we produce • Learn, respect and appreciate failures. • Ensure that mistakes once committed are not repeated in future
Role of excipients in future formulation approach will not be conventional, rather it would be transformational. Use of solubilisers and permeation enhancers will be more since most of the drug candidates belongs to BCS class II & IV drugs. Multifunctional as well as co-processed excipients will be preferred over unifunctional excipients. Drug delivery system targeting disorders orienting to circadian rhythms will be designed. Individualised dosing regimen through 3D printing will be realistic.
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 53
Dr Praveen Khullar- FDD handbook_OK SD.qxd
6/7/2018
10:41 AM
Page 54
EDUCATION M. Pharm, PhD, PGDBM, PGDHRM
EXPERIENCE IN PHARMA Over 30 years
DESIGNATION Head of Global Development Centre, Group Sanofi, Goa
NUMBER OF PATENTS FILED More than 25
SPECIALITIES Pharma Product Development and Technology (Generic Medicines, New Fixed Dose combination Products and Novel Drug Delivery Systems); Expertise in Regulatory Affairs, Bio-equivalence studies and Global Quality Assurance; Expertise in Technology Transfer and Project Management for Global Strategic Projects
AWARDS/ACCOLADES
Dr Praveen Khullar
• Goa Management Association – Manager of the Year Award in 2009 • India International Friendship Society’s, ‘Bharat Jyoti Award’ in 2011 • Nine global and local innovation awards within Sanofi • Award for Excellence from the Indian Pharmaceutical Association, Delhi Branch
Dr Praveen Khullar- FDD handbook_OK SD.qxd
6/7/2018
SUCCESS MANTRA
10:42 AM
Passionately pursuing innovation to develop value-added products and cater to unmet medical needs of patients
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He is extensively involved in industry-academia interactions over three decades, and has authored a book titled 'Career by Design' for student community
FUTURE OF FDD
Express Pharma
Page 55
• Visualise the invisible while developing new formulations using quality by design concept • Knowledge of in-vivo behaviour of drugs helps to develop robust bio-equivalent products • Utilisation of reverse engineering by solid state techniques would empower formulation scientists to deliver high quality, commercially viable products
Therapeutic efficacy of any drug product depends on consistent drug plasma level and its availability at targeted site. Modified release drug delivery systems, ensure consistent drug level, over a period of time.Therapeutic efficacy of drugs can be increased manifold by sustained release formulations, due to less fluctuations in drug plasma levels. Emerging technologies like nano-particles, liposomes, transdermal drug delivery systems, provide delivery mechanisms of poorly soluble drugs.Life cycle management of small drug molecules would act like a growth engine, in view of shifting focus of research towards biologicals and biosimilar products
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 55
Preeti Prashant Raut, Cipla_OK SD.qxd
6/7/2018
12:52 PM
Page 56
EDUCATION BSc (Tech. Pharma); BSc. Chemistry
DESIGNATION VP, Formulation Development, Cipla
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 29 years
25+
SPECIALITIES Expertise in development, execution of complex generics and innovative technologies across all dosage forms. Nanoparticulate solids and injection, liposomal injections,nano and micro emulsion orals, injections, topicals, transdermal patches and topicals, OROS technology solids, MUPS technology, drug device combinations etc.
AWARDS/ACCOLADES IPA Award and IDMA Award for excellence
Preeti Prashant Raut
Preeti Prashant Raut, Cipla_OK SD.qxd
6/7/2018
12:52 PM
SUCCESS MANTRA
Page 57
Believe in consistency, vigilance, facts, honesty, opportunities in difficulties, and capabilities of your team members. Have a result-oriented approach
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? She loves reading fiction, books on self development and spiritualilty. She also loves travelling
FUTURE OF FDD
Express Pharma
• There is no limit to the innovation. There will be always a scope for improvement • Attitude matters along with intelligence to be a great achiever • Every thing is possible with focussed approach and team work
The future of FDD is promising yet very challenging owing to a dynamic scenario. The pharma industry has been rapidly moving towards digitisation and automation of drug product manufacture. The industry is expected to be focussed on science-intensive development and excellence. There is a great opportunity for innovation, considering the current shift to new ventures such as personalised medicines and continuous manufacture
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 57
H.B. Pushpalatha, Himalaya Drugs_OK SD.qxd
6/7/2018
10:31 AM
Page 58
EDUCATION B. Pharm, M.Sc., MDPM, PhD (Pharmaceutics)
DESIGNATION GM- Formulation & Development (Pharma), R&D Center, The Himalaya Drug Company
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA Overall 20+ years
Nil
SPECIALITIES • Formulation of conventional and novel herbal dosage forms with wider application as pharma products and wellness promoters • Implementing ‘green and eco-friendly technologies’ in formulation and development
AWARDS/ACCOLADES
Dr Pushpalatha HB
• A distinguished formulator in the field of both conventional and unconventional herbal dosage forms. Her work involving the technology for developing a preservative-free/self-preserving herbal dosage is largely appreciated by scientific community as novel • She has been invited as a speaker/resource person in various women-centric conferences/symposiums facilitated by both government and NGOs to motivate the women entrepreneurs/researchers • She and her team is behind some of the recent well-known formulations of The Himalaya Drug Company, sold in India and over 80 countries across the globe
H.B. Pushpalatha, Himalaya Drugs_OK SD.qxd
6/7/2018
SUCCESS MANTRA
10:31 AM
Success is an easy term to spell but only hard work, perseverance, patience, passion and continuous improvement defines it
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? She is a pioneer in developing preservativefree/self-preserving herbal dosage forms, and introducing eco-friendly processes
FUTURE OF FDD
Express Pharma
Page 59
• FDD is a vibrant science involving cross-functional knowledge • Keep up-to-date on dynamic consumer behaviour and global regulatory norms • Optimise the formulation and process parameters with latest technologies, and this will be critical to manufacture cost-effective quality products
The pharma industry is highly dynamic. Keeping pace with its growth and achieving success will depend on how fast we adopt innovative approaches and technologies. Global regulatory challenges, quality, patient compliance and consumer preferences, along with cost consciousness will be future drivers of FDD. Formulation technologies aimed at maximising therapeutic outcomes with minimal adverse reactions will propel us towards excellence. Green and eco-friendly technologies are also likely to gain global acceptance. Disruptive innovation in both, conventional and unconventional dosage forms, with aforementioned benefits may change the existing trends in FDD.
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 59
Rajan Verma- FDD handbook (need to put fresh image).qxd
6/7/2018
10:34 AM
Page 60
EDUCATION M.Pharm, Ph.D, Executive Program in Business Mgmt
EXPERIENCE IN PHARMA Over 20 years
DESIGNATION Director, Formulation Development, Abbott Healthcare India
NUMBER OF PATENTS FILED More than 20
SPECIALITIES Drug delivery, Product development (NDA, 505(b)(2), Generics), Quality by Design, IVIVC, Lean Six Sigma
AWARDS/ACCOLADES • During the course of career, part of teams that have won multiple awards such as ‘Best Innovation Team’, ‘Complex Product Development’, and ‘Best non-manufacturing unit of global generics’.
Dr Rajan Verma
• ‘Senior Research Fellowship’awarded by CSIR during Ph.D. and recipient of ‘UGC Fellowship’during M. Pharm.
Rajan Verma- FDD handbook (need to put fresh image).qxd
SUCCESS MANTRA
6/7/2018
THREE LESSONS AS AN FDD SCIENTIST
He has a keen interest in playing squash and badminton. In his free time, he enjoys reading books and watching movies
Express Pharma
Page 61
Never stop learning new things and taking on more responsibilities. Take risks based on data and chances are that they will pay off in the long run
DID YOU KNOW?
FUTURE OF FDD
10:34 AM
• Always have the end product in mind while finalising the product and process • Continuous innovation and good science should always be the backbone for robust product development • Quality should be built in the product right from the beginning. Never ignore small problems encountered during development as it will surely aggravate during scale up and commercialisation
There is a strong need for product and packaging innovation based on patient insights. Many pharma companies are shifting from the traditional model of ‘me too’(aka generics) to product differentiation, thereby enabling more patient compliant pharma products.With convergence of biotechnology, electronics, material science, and pharma, personalised medicine is becoming a reality and is going to be a boon for the patients. Personalisation, right from diagnosis to treatment, and preventive healthcare will be something to watch out for in the near future
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 61
Rajesh Sirwani_OK SD.qxd
6/7/2018
3:28 PM
Page 62
EDUCATION M. Pharm., Ph. D
DESIGNATION GM, Shalina Laboratories
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA Over 22 years
06
SPECIALITIES • Expertise in pharma product development for regulated and non-regulated market, technology transfer • Expertise in development and filing of pharma products for complex markets like Brazil
AWARDS/ACCOLADES • Awarded for exemplifying the ‘Zydus First Spirit’ in 2017 • Awarded with Certification of Appreciation from Piramal Healthcare in 2008
Dr Rajesh Sirwani
• Obtained second position in ISO 9000 Internal Auditors Training Program • Diploma in General Knowledge, Moral Education and Yoga
Rajesh Sirwani_OK SD.qxd
6/7/2018
3:29 PM
Page 63
SUCCESS MANTRA
When you decide on something, there are no limits to what you can do to accomplish your goals, except for the limits you place on your thinking
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He is an explorer and likes to visit new places. He seeks adventure in all walks of life
• Both, young scientists and senior management should be open to learning and adapting to newer and efficient technologies. We should let go of outdated technologies and processes • The FDD scientist should always keep the organisation as a priority • It is of utmost importance to adapt to the changing regulatory requirements
FUTURE OF FDD
Express Pharma
The future of FDD lies in the reduction of drug prices, without affecting the quality, so that even the common man can have access to a better range of medicines. One of the main methods of drug price reduction is through automisation in the manufacturing process. The quality of drug design and development can be improved by making use of Quality Based Design (QbD) and Process Analytical Tools (PAT). The robust design of the product will help to reduce the cost of the drugs and help to achieve better quality drugs. The future of FDD also lies in biologics-based drugs and FDD scientists need to start working towards it.
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 63
RATNAKAR P. MEHENDRE_OK SD.qxd
6/7/2018
3:35 PM
Page 64
EDUCATION M.Pharm., Ph.D.(Tech)
EXPERIENCE IN PHARMA
DESIGNATION Technical Director, SRS Pharmaceuticals
NUMBER OF PATENTS FILED More than 10
24 years
SPECIALITIES • Formulation development, bioequivalence, novel drug delivery systems, US/UK generic filings & Paragraph IV filings. Global regulatory strategies and liasioning, designing of facilities – manufacturing & BE
AWARDS/ACCOLADES • Various awards by Alkem laboratories as Head of R&D over 12 years
Dr Ratnakar P Mehendre
RATNAKAR P. MEHENDRE_OK SD.qxd
6/7/2018
3:35 PM
Page 65
SUCCESS MANTRA
There is no substitute to hard work. Intelligence alone cannot take you up the ladder of success
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He was awarded ‘Man of the Series’ for interclass cricket tournament at The Bombay College of Pharmacy, in 1991
• Innovation can happen in all formats – be it in FDDgeneric, novel delivery system, or manufacturing, quality systems, regulatory strategy • The scaling up of product developed in FDD needs co-ordination and team building for ultimate objective of successful regulatory filing • If you do not patent, or publish, somebody else will do
FUTURE OF FDD
Express Pharma
Future of FDD lies in knowledge of complex formulations and patient-specific delivery systems. With revolution of information technology, FDD has to keep pace with the use of such technologies in the product development.
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 65
Dr. Rahul S Dabre- FDD handbook.qxd
6/7/2018
5:18 PM
Page 66
EDUCATION Ph.D in Pharmaceutical Technology
EXPERIENCE IN PHARMA About 20 years
DESIGNATION Head Formulation Development, Alembic Pharmaceuticals
NUMBER OF PATENTS FILED More than 20
SPECIALITIES Extensively work for US/EU/Canada Market. Majority of experience in oral solid dosage form. But also worked in Injection/Derma/Topical foam
AWARDS/ACCOLADES CSIR fellowship for PhD
Dr Rahul S Dabre
Dr. Rahul S Dabre- FDD handbook.qxd
6/7/2018
5:18 PM
SUCCESS MANTRA
Page 67
Build team of highly motivated good scientist and groom them to take multiple challenges.
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He is an ardent fan of cricket and likes playing the game immensely
• Priorities keep on changing due to market dynamics and challenges at API supply and manufacturing front, hence one should be ready to accommodate all this in development plan. • Building quality in the product during development as most important. • Quality suppliers are key for successful ANDA approval and launches
FUTURE OF FDD
Express Pharma
FDD have great future due to increase requirement of low cost medicine across all geographic. Product mix is getting more complex along with expectations of regulator. Lot of innovation/improvement is happening /will happen at manufacturing level. New technologies in bio. Availability enhancement and patient compliance will be key drivers for bringing existing molecule in improved dosage form. Excipients supplier will play key role in the innovation by bringing superior products with enhance functionality
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 67
Raveendra Pai-replace pic.qxd
6/7/2018
1:16 PM
Page 68
EDUCATION M Pharm. PhD.
EXPERIENCE IN PHARMA 18+ years
DESIGNATION VP, Formulation Development, Glenmark Pharmaceuticals
NUMBER OF PATENTS FILED 10 + applications filed
SPECIALITIES Generic formulation development for, US, EU, CA, AU, Japan and ROW markets. Well versed with specific market requirements to strengthen dossier quality in order to get early approval. Strong exposure on the eFTF products, which is the future of generic industries
Dr Raveendra Pai
Raveendra Pai-replace pic.qxd
6/7/2018
1:17 PM
Page 69
SUCCESS MANTRA
Work hard,apply logic and remain updated with time
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? Though a pharmacist by choice, he also takes pride in being an artist. He is interested in sports and music as well
FUTURE OF FDD
Express Pharma
• FDD is the culmination of various critical milestones with a common goal, achieved together as a group • As an FDD scientist one has to be very careful in taking timely decisions to finally see the product on shelf • Drugs/delivery systems can create wonders. It is a field which has direct impact on the quality of human life
The future of FDD is very bright. Though, with the changing scenario it will be very challenging to meet the expectations, manage regulatory compliance and ensure affordability, FDD will bring more innovation, creativity and opportunities. There is always ample scope for therapeutic innovation keeping compliance in mind
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 69
Raviraj Pillai_OK SD.qxd
6/7/2018
1:21 PM
Page 70
EDUCATION Ph.D. (Chemical Engineering)
EXPERIENCE IN PHARMA 25 years
DESIGNATION Sr Director and Site Head, Innovation and Development, Abbott Healthcare
NUMBER OF PATENTS FILED 25 (Issued 4)
SPECIALITIES Pharmaceutical Product Development (Generics, Branded Generics and NCE) and Novel Drug Delivery Systems
AWARDS/ACCOLADES
Dr Raviraj Pillai
• Member of Sigma Xi Scientific Research Society • Listed in Who’s Who in America in Science and Engineering • Outstanding Paper, American Association of Pharmaceutical Scientists (AAPS) Midwest Regional Meeting, 1992 • Top Downloaded Article in AAPS PharmSciTech (from November 2011 – January 2012) • Scientific reviewer for number of prestigious international journals in the areas of Pharmaceutical Sciences and Drug Delivery Technology
Raviraj Pillai_OK SD.qxd
6/7/2018
1:21 PM
Page 71
SUCCESS MANTRA
The secret of success lies in our ability to persevere. Once you start working on something don’t be afraid of challenges and failure, don’t abandon it
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? Established the external development engine for global generics across dosage areas and platforms with partners located globally
FUTURE OF FDD
Express Pharma
• Product development scientists should keep the patient in mind – Quality, Performance and Affordability • Leadership is about people, their growth and development and thus providing an opportunity to transform potential into reality • Connect your work to a larger purpose, what we do help people live not just longer but better
The future of drug delivery will involve designing systems based on insights to improve patient outcomes. These could include novel drug delivery systems that can provide tailored release for better efficacy and/or improved safety, engineered nanoparticles incorporating novel biomaterials for targeted delivery and, digital medicines - a drug-devise combination that help improve medication effectiveness by monitoring adherence, physiological parameters and activity level to patients and healthcare providers. Much of these innovations will come from better understanding of human physiology, anatomy and the diseases being targeted.
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 71
Sapna Ramesh, Indoco_OK SD.qxd
6/7/2018
1:26 PM
Page 72
EDUCATION M.Pharm.Sci, Pursuing Phd from C.U. Shah College of Pharmacy
DESIGNATION Associate VP- R&D Formulations, Indoco Remedies
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 26 years
08
SPECIALITIES Development of complex ophthalmics, injectables, solid orals; identifying molecules for development, devising designs around strategies for formulations, development of complex dosage forms, achieving FTF status for products. Identifying unmet needs, liaisoning with customers on technical front etc
AWARDS/ACCOLADES • Won Award For ‘BEST Development Project twice at Sandoz
Sapna Ramesh
Sapna Ramesh, Indoco_OK SD.qxd
6/7/2018
1:27 PM
Page 73
SUCCESS MANTRA
There is no substitute for hard work and knowledge. Give to the world the best you can and the best will come back to you
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? She is an avid traveller and wants to go to lesser travelled places. She has been to Mansarovar and Kailash Parbat in Tibet
FUTURE OF FDD
Express Pharma
• Don’t ever take things for granted and never assume. Keep the biases aside while experimenting • Keep yourself updated with the constantly changing regulatory environment • Be inquisitive in your quest for knowledge. Innovate and think out of the box
Though nanoparticles have been an area of interest for many researchers, only a handful of products have made it to the commercial market. The future of formulation development would see many targeted drug delivery systems based on nanotechnology. Bringing down the cost of technology by some innovations by the machine manufacturers is the need of the hour
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 73
Dr Srinivas Arutla- FDD handbook_OK SD.qxd
6/7/2018
10:46 AM
Page 74
EDUCATION M.pharm, Ph.D
DESIGNATION VP - Product Development, Apotex
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 21 Years
06
SPECIALITIES Pharmaceutical Drug Delivery Systems, Global Regulatory Affairs and Intellectual Property Management, Project Management and Quality Compliance
AWARDS/ACCOLADES PPL Leadership Award 2018
Dr Srinivas Arutla
Dr Srinivas Arutla- FDD handbook_OK SD.qxd
6/7/2018
SUCCESS MANTRA
10:46 AM
There are no short cuts to success. It’s a result of hard work and learning from experience
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He has unique experience of handling both, human and veterinary generic formulations made of same molecules
FUTURE OF FDD
Express Pharma
Page 75
• Always keep the end product in mind ensuring quality, manufacturability, cost and time • Successful product delivery is an activity of team work and cross-functional collaboration • Passion for your work and upgrading your knowledge are key to success
The future of pharma drug delivery industry is positive as the molecules need improved drug delivery systems to ensure ease of delivery including enhanced bioavailability or stability.There is a need for leaders in this sector to drive and address the unmet needs of existing drug delivery systems. Industry also needs skilled and talented formulation scientists who can demonstrate their application ability coupled with innovative ideas
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 75
Dr Sumedha Nadkar- FDD handbook_OK SD.qxd
6/7/2018
4:20 PM
Page 76
EDUCATION M.Pharm, PhD, DBM
DESIGNATION Site head and Senior Director, Perrigo India Consumer Health Care
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA Nil
29 years
SPECIALITIES Formulation development innovator and generic, novel drug delivery systems, Technology Transfer, Quality Audits of Third Party manufacturers, Expertise in R&D setup including government approvals such as DISH,MPCB DSIR, USFDA readiness etc.
AWARDS/ACCOLADES • Nominated for Global Leadership Development programs • Several publications and presentations in international conferences
Dr Sumedha Nadkar
• Award in Inter-State University Post PG Research Award at Amravati • USP India stakeholder committee member
Dr Sumedha Nadkar- FDD handbook_OK SD.qxd
6/7/2018
SUCCESS MANTRA
4:20 PM
Page 77
Never become so much of an expert that you stop gaining expertise! Continuously learning and improving is the only way to grow
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? As a woman leader, she is involved in several activities that encourage and mentor women professionals
• Master the dynamic regulatory science paradigms to develop effective strategies for drug development and beyond • Be proactive in developing scientifically sound risk management strategies. • Utilise statistical tools to the maximum! Apply Information technology tools to shorten product development cycle time such as predictive pharmacokinetics and beyond
FUTURE OF FDD
Express Pharma
Increasing pricing pressure and technological changes in the pharma industry — from powerful new drug chemistries, biotechnology to innovative R&D partnerships and marketing plans — are reshaping the business strategies of many pharma companies. Pharma companies need to collaborate with external organisations for specialty product development to fill their product pipeline. Contract research firms, platform technology firms, drug discovery, biotechnology, medical devices and bioinformatics are some of the multifaceted sciences that integrate to produce breakthrough innovations and harnessing these is of utmost importance.
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 77
Subhrangsu Sengupta_replace pic.qxd
6/7/2018
1:31 PM
Page 78
EDUCATION M.Tech ( Pharmaceutical Technology)
DESIGNATION VP, R &D (Formulation), Ipca Laboratories
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 27 years
18
SPECIALITIES Formulation development (Generic , OCRS & neutraceuticals)
Subhrangsu Sengupta
Subhrangsu Sengupta_replace pic.qxd
6/7/2018
1:31 PM
SUCCESS MANTRA
Page 79
Learn to see the end in the beginning. Continuous upgradation is key to success. Support customers, even out of the way
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He has received international patents (PCT) for both, pharmaceutical and nutraceutical products
FUTURE OF FDD
Express Pharma
• Do not leave any stone unturned...Solutions may come from unexpected areas. • Integrate knowledge of several areas,viz. development, regulatory and scale up • Identify and develop young talents for future leadership
I think that the future of formulation and drug delivery in India is very bright though the industry is going through several new challenges. Integration of knowledge from different, relevant fields will definitely help to overcome the challenges and to take the industry towards greater heights.
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 79
Dr TG Chandrashekhar- FDD handbook_OK SD.qxd
6/7/2018
3:39 PM
Page 80
EDUCATION MSc, PhD
DESIGNATION Global Head-Quality, R&D & Regulatory Affairs, Kusum Group of Companies
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA Over 30 years
05
SPECIALITIES Formulation Research & Development; Analytical Development; Global Quality; Regulatory Affairs
AWARDS/ACCOLADES • Selected as one of the 100 most inspiring people,as a MENTOR in the Global Pharmaceutical Industry by PharmaVoice,a US Pharmaceutical Magazine for Industry Executives • Ranbaxy Excellence Award in July 2002 for PROJECTAXETIL • Outstanding Analyst Award for 2003 from IDMA-PAC
Dr TG Chandrashekhar
Dr TG Chandrashekhar- FDD handbook_OK SD.qxd
6/7/2018
SUCCESS MANTRA
3:39 PM
Page 81
Don’t wish for it, work for it
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He has completed a full time High Potential Leadership Program course from Harvard Business School
• FDD requires careful planning, performed by experienced, responsive professionals • Leaders set the direction and help scientists to do the right things. To do this, they create an inspiring vision, and then inspire others to achieve that vision • Design of experiments (DOE) and statistical analysis are tools which will be used widely in future for formulation development
FUTURE OF FDD
Express Pharma
Formulating liposomes, emulsions, micro-emulsions, suspensions, tablets etc., are predicted as future scope of formulation development. Demand for speed-to-market in the current development climate will be an empirical approach to formulation development.The concept of personalised medicine will lead to the new modality of treatment which will extend into support of local manufacturing.As the regulatory climate rapidly changes, the talents of formulation experts will be in demand to fortify some of the products produced with an emphasis on shelf-life or stability.
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 81
Vallabh Pansuriya_OK SD.qxd
6/7/2018
2:16 PM
Page 82
EDUCATION PhD
DESIGNATION Vice President – R&D, J B CHEM & PHARMA
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 28 years
03
SPECIALITIES Formulation development, Technology transfer and Analytical development
AWARDS/ACCOLADES • Best production support award in Cadila by Mr I A MODI, the Chairman of the company
Dr Vallabh Pansuriya
Vallabh Pansuriya_OK SD.qxd
6/7/2018
2:17 PM
Page 83
SUCCESS MANTRA
Team building is paramount and work is worship
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He is a great advocate of exercise as it offers manifold benefits. He also enjoys learning and completed his PhD at 50 years of age
FUTURE OF FDD
Express Pharma
• Truthfulness is a very important characteristic for a researcher • Good analytical skill is a prerequisite • One should focus on deadline to complete projects on time
The future will have in-house drug substance and active pharma ingredient (API) manufacturing capability. There will be enhanced drug product development and manufacturing capability of small molecule, large molecule and biologics in a variety of dosage forms. APIs will be developed with improved properties, reducing the time required for formulating drugs in a suitable delivery system. There will be consolidation of the drug and device industry, which will prove beneficial when better devices to deliver drugs will be utilised in the preclinical and early clinical phase of drug development.
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 83
VenkataRamana Naidu_replace pic.qxd
6/7/2018
1:44 PM
Page 84
EDUCATION M.Pharm, Ph.D
EXPERIENCE IN PHARMA 20 years
DESIGNATION VP – R&D, Intas Pharma
NUMBER OF PATENTS FILED More than 35
SPECIALITIES Pharma Formulation Development of Generic/ NCE Formulations; • Unique combination of Manufacturing and R&D; Vast exposure in Global Technology Transfer Operations; Manufacturing Science and Technology; Development and Implementation of Process Analytical Technologies (PAT)
AWARDS/ACCOLADES • Best poster and Paper presentation in EuPAT 8 (3 – 4th Oct 2016), Cork, Ireland
Dr Venkataramana Naidu
VenkataRamana Naidu_replace pic.qxd
6/7/2018
1:45 PM
SUCCESS MANTRA
Page 85
We need to understand the problem in depth, for for which you want to find the solution. Common science may not work without common sense
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He has done extensive work on process analytical technology (PAT). He is one of the few scientists who have acquired a Ph.D on a PAT related topic
FUTURE OF FDD
Express Pharma
• Relying on science is the only logical approach for fast track formulation development • FDD scientists needs to acquire statistical and engineering knowledge in pharma product development and manufacturing • The task of formulation development is not complete until a product is successfully produced in manufacturing for continuous commercial supplies
I believe, the next few years should be quite interesting in the area of Process Analytical Technology (PAT) applications in batch or continuous manufacturing operations. The concept of PAT may well be the new modality of manufacturing. This will lead to a new set of opportunities for the formulators to identify CMAs and CQA’s and monitor the manufacturing process. These opportunities will extend into the support of manufacturing as a tool to monitor the quality of product while producing and enables 100 per cent non-destructive testing and releasing.
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 85
Ad.qxd
6/7/2018
4:32 PM
Page 86
Notes.qxd
6/8/2018
11:13 AM
Page 87
Notes
Express Pharma
FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018 | 87
Notes.qxd
6/8/2018
11:13 AM
Page 88
Notes
88 | FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2018
Express Pharma
FDD LEADERS HANDBOOK
PRESENTS
F D D L E A D E R S H A N D B O O K
2018