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www.mirrorreview.com February 2019

Trending

Top 5 reasons the novel eye-drilling Nanobots could cure complex eye diseases

Spirituality & Success BeneďŹ ts of Spiritual Practices For Successful Professional Life

Mike Suga

President & CEO

CMIC, Inc.

Performing Bioanalysis To Optimize Drug Development With Uncompromising Precision


EDITOR’S LETTER Challenges bringing opportunities in the biotech and pharma industry Given the very nature of its business, the biotech and pharmaceutical industry is continuously faced with challenges like cost aspects and stricter regulations. Similarly, these challenges are met with new trends that help navigate these issues and lead to new growth opportunities. Powered by the emergence of bioanalytics and advancements in genetics, the usefulness and safety of biopharmaceutical products have developed the ability to address previously untreatable conditions. This positive shift is therefore enabling the biotech and pharma companies to tackle high prices of drugs with innovative research and developments. Considering the high growth and drastic progress in the biopharmaceutical product development, we have featured prominent companies in our latest magazine, “The 10 Best Biotech & Pharma Companies to Keep an Eye On in 2019”. With their state-of-the-art approach, these leading companies are contributing the biotech and pharma industry. Out of these phenomenal organizations, we are privileged to feature CMIC Inc. on the cover of this magazine. CMIC Inc. has years of excellence in bioanalytical services. The President and CEO, Mike Suga is leading the company with a strong commitment to improving the lives of people around the world, ultimately enabling the organization to prosper with new achievements. Rolling to the next pages, we have covered innovative stories of leading biotech and pharma companies which are working towards enhancing the industry with advanced researches and products. This time, the team of Mirror Review has invited López Fernebrand (Senior VP, General Counsel & Corporate Secretary/Amadeus) to explain his expert viewpoints. López shared his opinions regarding the essence of technology for sustainable travel industry. As our promise to delight our precious readers with amazing articles, we bring you two articles covering the subjects related to spirituality in life and a novel nanobot technology. I hope you enjoy this info-packed magazine issue. Happy reading!

Mayur Shewale Assistant Editor


CREDIT PAGE Publisher : Archana Ghule Editor-in-Chief : Vikram Suryawanshi Managing Editor : Anuja Mulmule Assistant Editor : Mayur Shewale Contributory Writers : Bansidhar Tigga Gopal Khandelwal Deepali Sarwade Akshay Wande Business Development Rohan Yadav Project Managers : Abhishek Patil David Thomas Art Director : Vinod Alhat Visualizer : Mark Davis Graphic Designers : Poonam Magdum Sumit Bonage Head of Distribution & Production : Aakash Mahajan Head of Operations : Robert Smith Research Analysts : James Adams Maria Smith David Thomas Advertising : Jacob Eddy

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EXPERT’S VIEWS Why technology is crucial to achieving a sustainable travel industry ?

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Tomas López Fernebrand | Amadeus

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ARTICLES

Spirituality & Success Benefits of Spiritual Practices For Successful Professional Life

32 Trending

Top 5 reasons the novel eye-drilling Nanobots could cure complex eye diseases

COVER STORY

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CMIC Inc:

Performing Bioanalysis To Optimize DrugDevelopment With Uncompromising Precision


CONTENTS 18 AVM Biotechnology:

Bringing Breakthrough Cell Therapy Treatments to Frail Patients by Replacing Toxic Chemotherapy with a Better Alternative

24 BIA Separations:

Producing High-Quality Biopharmaceutical Solutions with Superior Research and Methods

30 SANDOZ Inc:

Driving Sustainable Growth in the Global Generics Market

36 Vitro Biopharma:

Proven Leaders in Stem Cell-based Regenerative Medicine


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E V CO

Y R O ST

Mike Suga

President & CEO


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Companies to Keep an Eye on in

2019

Performing Bioanalysis To Optimize Drug Development With Uncompromising Precision


COVER STORY

I

n today’s healthcare industry, medicine is becoming more and more personalized with patient focused approach. To drive such a personalized medicine avenue, Biomarker is a good example and a leading contract research organizations (CRO) like CMIC, Inc. have a responsibility to provide bioanalytical data meaningful enough for advanced medicines.

challenges in bioanalysis with expertise, rapid turn-around-time, and high quality services. History of Reputation and Continued Success CMIC has over 30 years of experience in bioanalytical analysis with a reputation for excellence and a strong commitment to helping improve lives of people around the

employs more than 6,000 employees worldwide with nearly $700M in sales revenue reported in 2018. Initially, CMIC grew in Asia Pacific countries and most recently, it expanded in the United States. Furthermore, CMIC Group acquired a Contract Development Manufacturing Organization (CDMO) in Cranbury, New Jersey, and JCL Bioassay, the bioanalytical test facility in Hoffman Estates,

We help clients to streamline drug development efforts to maximize success rate by reducing drug development time and costs.

CMIC, Inc. is a leading CRO and a provider specialized in bioanalytical services in support of toxicokinetics (TK) as well as pharmacokinetics (PK) studies for both pre-clinical and clinical developments, along with pharmacodynamics (PD) biomarkers. Located near Chicago, CMIC provides cutting-edge capabilities and sophisticated expertise in bioanalytical method development, method validation/qualification, and study sample analysis for small and large molecules as well as oligonucleotides. As a strategic drug development partner, CMIC helps sponsors to overcome

world. With dedication to the drug development market and continued success, CMIC has become a leading CRO in Japan and North America. Today, CMIC continues to grow and expand its facility and capabilities to meet the needs of clients and the changing drug development environment. Growing Worldwide with its Services and Acquisitions Founded in 1992, CMIC Group became the first company to provide Contract Research Organization (CRO) services that are essential for conducting clinical trials in Japan. Today, CMIC

Illinois, which is currently known as CMIC, Inc. After the acquisition, CMIC, Inc.’s laboratory in Hoffman Estates completed construction of an additional 5,000 sq. ft. of dedicated laboratory space, bringing its current footprint to 27,000 sq. ft. on over 5 acres of buildable land. Currently, it houses nearly 20 LCMS/MS instruments, bringing the CMIC global count to approximately 50 LC-MS/MS instruments. This addition provides with extensive testing capabilities and sample storage space to support increasing study demands.


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Managing High Volume Projects with World Class Facility Its Japan oriented-high quality, quick turn-around-time, and flexibility differentiates CMIC from its competitors. Following theses Japanese quality norms, CMIC’s GLP-compliant state-of-the-art facility has grown to accommodate quick turnaround and high volume projects from around the country. Conveniently located in Hoffman Estates only 20 minutes from Chicago O’Hare International Airport, CMIC’s location in the Midwest helps the leading CRO to conveniently serve pharmaceutical and biotechnology companies across the country.

humidity monitoring systems, video security and restricted entry, on site or off site archives, building management systems, and state-ofthe-art sample monitoring system (24/7). Friendly CEO Leading CMIC towards New Opportunities “Personalized medicine is out there and it is on us by leading in bioanalytical services that clients can trust to deliver high quality data, rapid turnaround, and unparalleled customer service”, says Mike Suga, the President and CEO of CMIC, Inc., when asked about the utilization of bioanalytical services to enhance personalized medicine.

Companies to Keep an Eye on in

2019

profits sustainable for shareholders, employees, clients, and societies. Mike earned bachelor’s and master’s degrees in agricultural biosciences from University of Tokyo. Today, he is based in Chicago, where he serves as the Senior Vice President of CMIC HOLDINGS Co., Ltd., reporting directly into the CMIC Group’s Tokyo Headquarters. Highly Skilled Staff at CMIC CMIC researchers are committed to the advancement of medicine. With every project, they provide unsurpassed excellence and innovative solutions driven by CMIC’s core values of trust,

Our mission is to contribute to high quality, efficient drug development and conduct science that contributes to the public welfare.

Purpose-built in 2008 to maximize efficiencies and provide scientists with a world-class quality environment, CMIC is equipped with features like on site emergency back-up power supply, Biosafety Level 2 lab, UV-free lab, controlled substance license (schedule III-V), temperature and

Mike likes to engage with his team members by motivating them to maintain a healthy work environment. At CMIC, Mike engages with both scientific and supporting teams throughout the company’s strategy and operation as well as delivers revenues and

teamwork, dedication, respect, and integrity. These highly educated and experienced scientists work directly with clients’ R&D scientists to ensure the best output from investments. CMIC’s project team is comprised of two technical experts for each assay performed to provide continuous verification of the assay conducted.


COVER STORY Technical expertise is shared and developed through extensive cross training between CMIC’s international laboratories. As testing methods and technology continue to improve at a rapid rate, researchers at CMIC are committed to staying at the forefront of progress with on-going education and training. Such regular external training from vendors and industry experts and regular attendance at industry conferences keeps researchers of CMIC up-to-date on the latest technology and techniques. Providing Best-In-Class Results with CMIC’s Quality Commitment The Quality Assurance Unit (QAU) at CMIC was established to provide data quality and study integrity in accordance with Good Laboratory Practice (GLP) regulations. With more than 20 years of combined experience of inspecting and auditing studies designed to comply with the US FDA and EPA as well as international regulations such as OECD and JMHW GLPs, CMIC QAU staff members are long-experienced Quality Assurance Professionals in Good Laboratory Practice (RQAP-GLP). To assure highquality, each QAU staff member at CMIC receives on-going training and education in Quality Assurance.

Our vision is to become the most respected and trusted bioanalytical laboratories in the world.


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Companies to Keep an Eye On in

2019

Company Name

Company Info

3Scan Todd Huffman CEO

A one-stop shop for digital and computational pathology, 3Scan’s KESM produces digital 3D tissue models with micron-scale resolution at 400 times the throughput of traditional microscopes. www.3scan.com

AVM Biotechnology Theresa A. Deisher CEO

Founded in 2008, AVM Biotechnology is developing AVM0703—a non-toxic replacement for chemotherapy preconditioning for CAR-T/NK/TCR/TAC and other cell-based immunotherapies. www.avmbiotech.com

BIA Separations Aleš Štrancar CEO

BIA Separations is the leading developer of monolith technology and the exclusive producer of CIM® (convective interaction media) chromatographic columns for the production, purification, and analysis of large biomolecules. www.biaseparations.com

CMIC Mike Suga President & CEO

CMIC, Inc. is a leading CRO and a provider specialized in bioanalytical services in support of toxicokinetics (TK) as well as pharmacokinetics (PK) studies for both pre-clinical and clinical developments, along with pharmacodynamics (PD) biomarkers. www.cmic-inc.com

Crescent Pharmaceuticals Ajeet Nigam CEO

Crescent Pharma Limited is committed to ensuring the manufacture of medicinal products to the highest quality, safety and efficacy by adhering to, and implementing quality systems in compliance with GMP and GDP. www.crescentpharma.com

Endo Pharmaceuticals Paul V. Campanelli President & CEO

Endo Pharmaceuticals Inc. engages in the research and development, production, sale, and marketing of branded and generic pharmaceutical products primarily in the United States. www.endo.com

Ipsen David Meek CEO

Ipsen is a global specialty-driven biopharmaceutical group committed to discovering new solutions for targeted debilitating diseases and improving quality of life for patients. www.ipsen.com

Novo Nordisk Lars Fruergaard Jørgensen CEO

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. www.novonordisk.com

SANDOZ Canada Inc. Carol Lynch President, Sandoz US, & Head of North America

Sandoz is a global leader in generic pharmaceuticals and biosimilars. www.us.sandoz.com

Vitro Biopharma Dr. Jim Musick President & CEO

Established in 1986, Vitro Biopharma provides a unique mix of research and clinical products used by leading universities and institutions worldwide. www.vitrobiopharma.com


Bringing Breakthrough Cell Therapy Treatments To Frail Patients By Replacing Toxic Chemotherapy With A Better Alternative

A

Theresa A. Deisher CEO

ccording to the American Cancer Society, children treated with chemotherapy have a 3 to 13 times increased risk of getting another cancer within a span of 20 to 30 years of treatment. Despite this, chemotherapy remains the widely accepted and standard regimen for children with cancer. Developed as alternatives to chemotherapy over the past decade, treatments like Protein Kinase Inhibitors, Proteasome Inhibitors, and new Biologic Antibodies have unfortunately been a disappointment in the community setting and 41% of blood cancer patients choose to stop taking these treatments due to the physical and financial toxicities. In most cases, blood cancer patients relapse and expire rapidly after stopping treatment. Unfortunately, chemotherapy remains an integral aspect of cancer treatment, and is a required preconditioning before transplant or the newly approved CarT therapies. Chemotherapy comes at a price of toxic, sometimes life-threatening, side effects such as: Nausea and Vomiting, Mucositis, Leukopenia, Thrombocytopenia, Granulocytopenia, Neutropenia, Cardiotoxicity, Infections,

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Pneumonia, Anemia, and Hair Loss. Therefore, in the Hematology as well as Oncology field, new nontoxic solutions are needed to reduce the physical and financial toxicities of conventional treatments. Founded in 2008, AVM Biotechnology is developing AVM0703—a non-toxic replacement for chemotherapy preconditioning for CART/NK/TCR/TAC and other cellbased immunotherapies. Specifically, AVM’s R&D is dedicated to the discovery, development, and commercialization of stem cellenabling technologies for regenerative medicine, immunooncology, and fully human biologics applications. AVM’s Fight against Human Exploitation Based in Seattle, Washington—AVM Biotechnology is on the mission to end human exploitation whether it is physical or financial. Physical exploitation includes selling of organs in the black market and financial exploitation would include the nonreimbursement of fees in the newer cancer and autoimmunity treatments. Exploitation also includes the absence of noninjurious treatments for particular


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patients like the elderly, children, the poor or disabled. AVM has set its goal to fight against such exploitation and work towards improving patients’ quality of life, reducing physical and financial toxicities of cancer and autoimmune treatments, and the elimination of the dread a cancer or autoimmunity diagnosis brings to patients and their loved ones. AVM0703 acute actions are relatively selective for lymphocytes, reducing the risks of infection, the need for hospitalization, transfusion requirements and patient toxicities. After a single acute IV dose, it delivers rapid clinical responses within 24 hours. Importantly, AVM0703 treatment can be safely repeated upon relapse allowing cancer or autoimmunity to be either cured or made chronic with good quality of life. How AVM0703 Reduces Toxicity? AVM0703 is used alone, or in combination with stem cell-based therapies, to significantly enhance stem cell tumor targeting and engraftment. AVM0703 lymphoablates all compartments and has the ability to replace chemotherapy preconditioning before transplant or adoptive cell therapy. It can be used as a stand-alone treatment which is projected to induce remission in relapsed/refractory lymphocytic blood cancers and patients with autoimmune disease who have not responded to DMAIDs (Diseasemodifying anti-inflammatory drugs). As compared to commercially available versions of the API, which

contain potentially toxic excipients, AVM0703 is a new formulation of an existing API with a composition of matter patent filed and it is ready for Phase 2 clinical trials. In addition to its general anti-inflammatory and lympho depleting properties, AVM0703 is dosed to transiently reduce the size and number of stem cell binding niches in the secondary lymphatic system. CEO’s Multifaceted Work towards the Mission of AVM Biotechnology Theresa A. Deisher, the CEO of AVM Biotechnology is leading the company on its mission to reduce physical and financial toxicities of cancer and autoimmune treatments, which will ultimately improve patients’ quality of life. At AVM Biotechnology, Theresa oversees all the Research and Development as well as clinical development. She also handles patent strategy and patent writing. Moreover, the multitalented CEO looks at recruitments of key personnel to further expand the corporate capabilities of AVM Biotechnology. Along with these key

We strive to develop products like AVM0703 that will end human exploitation in biomedical research and medical treatments.

Companies to Keep an Eye On in

2019

aspects, Theresa takes care of fund raising for new developments and improvements in the existing programs at AVM Biotechnology. Strategies to Reach UnderDeveloped Nations with New Partnerships When asked about her long term plans for AVM Biotechnology, Theresa said that they have plans to partner with a global pharmaceutical company for worldwide clinical development and commercialization of AVM0703 and their second generation candidate. An important part of their long-term mission is to provide AVM therapies to underdeveloped regions of the world. Additionally, Theresa and her team are working on accelerating clinical trials in autoimmunity and use of AVM0703 as a non-toxic preconditioning agent to optimize stem cell regenerative effects. For this, they are leveraging clinical dosing and safety data from relapsed/refractory lymphocytic blood cancer patients, where FDA commercial approval is rapid. The revenue generated from AVM0703 will be used to drive another development program leveraging induced pluripotent stem cells (iPS). This program will be useful for general and patient-specific biologic manufacturing. Likewise, AVM Biotechnology will partner and collaborate with companies who are developing novel bioreactors and NGOs to solve supply chain limitations of vaccine provision in under-developed countries.

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Spirituality & Success

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pirituality in the business is a movement that began in the early 1920’s and has emerged as a grassroot movement with individuals practicing spirituality in the workplace. Most recently, employees have started looking beyond the jaw-dropping salary packages, and for them money is not the only prominent motivator of good job performance, because they want mental satisfaction from their work as well. The feeling of fulfillment, in other words, is called as spiritual fulfillment, which is a major motivator for delivering a better job performance. Spirituality involves the attempt to seek one’s ultimate purpose in life, and spirituality in business involves developing a strong connection with oneself and one’s coworkers, having ideal beliefs and spiritual values. The spiritual values include values of work ethics, a good cause to work for the company, empowerment, and expression of emotion, which plays an important role in the employee’s life. Sometimes, spirituality is confused with religious tradition, but it does not involve a connection to any specific religion, rather it is based on the individual’s own personal values and philosophy. The present article elaborates how the business and spirituality work together for a successful professional and personal life. Ø Daily morning spiritual practices:

The spiritual practices balance the life. The practices such as meditation, yoga, and breathing exercises help people to connect with themselves. According to a book

Companies to Keep an Eye On in

2019

on spirituality written by Florence Scovel Shinn, the subconscious mind needs programming, and if it’s not done then someone else will program it. Nowadays, without spiritual practices, people let others do the programming through the social media, news, and other informative mediums filled with a mixed type of expressions, which disturbs the focused thought process of an individual. The morning practices make the mind more focused and program it in such a way that the employee can sustain the new work challenges and unexpected events throughout the day. The start of the day with these spiritual practices awakens the individual and makes him realize the happiness and peace within by detaching him from the deep dreams of other attractions. To make the mind feel great and alert throughout the day, starting the spiritual practices early in the morning after a complete 8 hours of sleep is beneficial as it is very peaceful and quiet in the morning. After starting to wake up early in the morning, it becomes a supplement for the healthy expansion of the entire life. Committing few spiritual rituals every day can absolutely change the life in a positive way. Sometimes, it’s difficult to meditate just after waking up, because many people go back to sleep while meditating. Taking a simple tea can change the entire ritual, because the caffeine in the tea is a perfect wakeup call so that one can work without dozing off. Those who don’t like tea can sit and write something to regenerate the energy. Writing opens the thoughts and ideas in the mind. If an employee is going through a tough time, writing is the best solution to find out the best solutions.

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Spirituality & Success

Ø Time to connect spiritual source during work:

Most of the successful professional individuals schedule a break during the day to do walking, meditation and jog while concentrating on breathing, or they sit quietly away from everyone and everything to meditate. Sitting quietly with eyes closed, along with the focus on breathing will help to clean the mind which is continuously thinking and analysing about something or the other. Even if these thoughts come and go, and one must not be taunted by them. With consistent practice, they will vanish keeping the mind a quiet place. These procedures generate the conscious power within and bring the inner bliss to come out and cherish. An alarm and a timer will be beneficial for doing such practices. This small time taken for connecting with oneself simplifies and makes the workday more successful. Organizations should promote these practices and create a calm and healthy atmosphere for them because employees desire to work in an organization that seeks to have a high sense of ethics or integrity and makes a good contribution to the welfare of employees, customers, and society than the typical company. Ø Trashing out the negative thoughts:

If the employee is filled up with negative thoughts and emotions, which are not serving him, then there won’t be enough space available for receiving the desired outcomes. Imagine a glass of dirty water filled to the brim. If one needs to add pure water in it, then it’s not possible to add pure water in an already full glass. The same is true for the mind. When the mind of an employee is full of worries, anger, grudges, judgments towards co-workers or himself, he won’t be able to utilize and think about pure thoughts of contentment, because the mind is already engaged in thoughts related to other negative feelings. It is essential to trash out such negative feelings to welcome positive things to happen. Finding a practice which releases negative emotions is the best way to deal with the negative thoughts because only a calm and happy mind can understand the inner intuition or the gut. A clear and happy mind helps employees understand how they feel about new tasks, projects, and organizational activities. There is a close relation between good thoughts and job satisfaction, because, in work, the positive organizational purpose is significantly associated with job satisfaction. With an increase in workplace spirituality, employees’ commitment increases towards the organization.

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Ø Spirituality for leadership:

For many years, spirituality and leadership were worlds apart. While spirituality concerns with intangible ideas and emotions, leadership is a practical area of scientific inquiry. However, a large number of evidences from studies show that these fields are much closer, and there is a transition between the two figures. A good leader needs to evaluate the situation and act accordingly. The key elements of modern leadership involve cooperation, consideration, agreement, and social quality. The new adaptability culture requires a leader to be autonomous, take initiatives for improvements and emerge with new objectives and strategies. There is growing interest in the issues related to the spirituality in the workplace. The spiritual values such as integrity, honesty, and humility have a great effect on leadership success. The practices which have been emphasized in many spiritual teachings, and found crucial for leadership development are: showing respect for others, demonstrating good treatment, expressing caring and concern, actively listening, recognizing and appreciating the contributions of others, and engaging in reflective practice. Leadership and spirituality play an essential role together in terms of ethics and values. Value-based leaders have the ability to utilize employee efforts and organizational goals more effectively by connecting them to the deeper values inside them. They motivate employees and improve their performance and commitment towards the organization by making them imagine a better tomorrow. The spiritual rituals have an uncanny ability to set the human mind for the rest of the life. These spiritual practices also give a loud and clear message that the professionals in organizations should be versed with their core values through a positive vision and personal actions. People commonly believe that there is a conflict between the values and practices included in spirituality and those required for successful business, but the above article explains the huge similarity between elements of success in both fields. Therefore, by incorporating these spiritual practices in professional life, employees can align good values with the strategy and roadmap to achieve massive success in the business.


Producing High-quality Biopharmaceutical Solutions With Superior Research And Methods

Ales Strancar CEO

T

raditional Pharma techniques have struggled for decades to make inroads into diseases whose roots lie deep in molecular biology. Today’s modern Biopharma has extended that reach into the foundations of cancer, heart disease, genetic disease, and a host of other afflictions. In the coming years, the therapies and cures offered by this extended reach will increasingly enable patients to live longer with productive and more fulfilling lives. Beyond that, these modern therapies will also enable the prevention of numerous diseases and conditions that have plagued humanity for centuries. Established in 1998, BIA Separations is the leading developer of monolith technology and the exclusive producer of CIM®, Convective Interaction Media chromatographic columns for the production, purification, and analysis of large biomolecules. Core Focus Areas of BIA Separations BIA Separations specializes in the

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manufacturing and sales of monolithic chromatography columns. Its columns comprise a range of large molecule isolation and purification products used in the development and production of gene therapy including Cas/Crispr, CAR-T, on colytic/viral vaccine, phage, exosome, and plasma products. The leading Slovenia-based company provides customers with significant yield, purity, cost, and process speed advantages over competing technological solutions as well as usage flexibility in downstream processing of pDNA, viruses, VLP, phages, exosomes, and large proteins. BIA Separations’ unique polymer composition, precise flowthrough channels, and high surface accessibility of binding sites result in elevated binding capacities, exceeding those of resin-based columns and allowing rapid mass transfer with very low shear force effects and product degradation. BIA Separations’ columns are differentiated by their flow independent performance, resulting in fast separation, concentration, purification, removal, and analytics of biopharmaceuticals. Additionally, they are available in different designs and capacities to meet the specific needs of its client base, which ranges from small-scale laboratories to fullscale manufacturing facilities.

Best Selling Services of BIA Separations Having 20 years of experience with over 500 running projects, BIA Separations helps clients with products like unique monolithic columns and Purification Process Development for clinical phase serotypes trials and market supply of AAV, Flu virus, Adeno, Vaccinia/MVA, exosome, pDNA, mRNA, IgMs, PEG-proteins, liposome, ribosomes, bacteriophages, vaccines, and other complex biomolecule based biopharmaceuticals. Ÿ Monolithic Columns: With well-

defined channel size distribution, CIM® monoliths contain highly cross-linked, porous polymethacrylate material. Moreover, the high surface accessibility of binding sites allows rapid mass transfer based on convection. BIA Separations’ chromatography products are distinguished for their flow-independent performance, low back pressure, and versatility, resulting in faster separation, concentration, purification, removal, and analysis of biologic materials. Using unique monolithic columns and Purification Process Development, the resulted process allows for higher yield and purity of client’s target product. This is possible due to BIA Separations’ capability to manage the interface between upstream and


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downstream processes, which is the key for complex biologics production, and use of monolithic chromatographic resins, which provide the best performance for complex biomolecule purification. Ÿ Products for Analytical

Applications: CIMac™ Analytical Columns combine all elaborate characteristics of CIM® monoliths at analytical scale and are perfect tools for analysis and control of manufacturing processes as well as they are ideal for process analytical technology (PAT). Ÿ Products for Preparative

Applications: CIMmultus™ is the new and improved line of prepacked chromatographic monolithic columns distinguished by large flow-through channels, designed for working with large proteins like IgG, IgM, PEGylated, and VLPs along with viruses like AAV, adenovirus, lentivirus, influenza, bacteriophages, and pDNA. TM

Ÿ PATfix : Using CIMac™

analytical columns, the PATfixTM HPLC system gives “at-line” analysis for the control of impurities and critical quality components using HPLC fingerprinting. CEO’s Contribution to BIA’s Success Since taking over the responsibility as the CEO of BIA Separations, Ales Strancar has been enhancing the capabilities of the leading biopharmaceutical solutions provider company. With a goal to make BIA Separations as the number one supplier of purification products and supporting services in the field of Gene Therapy, Ales handles numerous roles and responsibilities, which consists of managing the company, making everyday business decisions, advising the Managing Board, promoting

organization, supporting and motivating employees, formulating policies, overseeing organizational operations, looking for future opportunities, implementation of plans, and much more. In addition to these roles and responsibilities, the energetic CEO of BIA Separations also likes to be a part of the new product and process development. Standing Apart from Competitors with High-Performance Products BIA Separations is always one step ahead of its competitors with its genuinely unique and extraordinary fractionation performance. No other chromatography media format can match monoliths for capacity, speed, resolution, recovery, and convenience, especially with very large products like DNA plasmids, RNA, virus particles for vaccines and viral vectors, and extracellular vesicles. In addition, Slovenia-based company’s deep handson experience with method development for these same products puts its customers years ahead with process development, clinical evaluation, and manufacturing. Other than its products, BIA Separations is known for its following best-inclassfacilities comprising: 1. Process Development: As a contract research organization,

We offer a whole toolset for chromatographic analyses of molecules in up and downstream processes in minutes.

Companies to Keep an Eye On in

2019

BIA Separations’ facilities are fully equipped to handle process and analytical method development for particles up to biosafety level 2. Considering clients’ demands in mind, its sales and technical support team prepares a work plan as per their requirements. Moreover, clients’ may choose to be involved throughout the development via regular contact with the project manager. 2. Downstream Process Development: Ÿ Processes suited to different clinical phases up to market supply are developed exclusively on monolithic columns starting from lysis or capture to final polishing and formulation of biomolecule like viruses, pDNA, bacteriophages, extracellular vesicles, proteins, PEGylated proteins, etc. Ÿ Depending on clients’ products and requirements, the multistep process includes development of lysis method, chromatographic media selection and optimization, virus inactivation, filtration, and tangential flow filtration. Ÿ Recommendation of suitable analytical methods. Ÿ Tech transfer of standard operating procedures (SOP) to client’s facility or CMO. 3. HPLC Analytical Methods: Ÿ Methods for in-process control (PAT), which are developed to increase control, improve efficiency, and prevent rejection of batches of upstream and downstream. Ÿ Methods for final control that enable real-time release of products. Ÿ BIA’s HPLC methods use CIMac™ Analytical Monoliths and are developed on PATfix™ along with reference methods for characterization. All these methods can be validated.

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Expert’s Views

Why

TECHNOLOGY is Crucial to Achieving a Sustainable

TRAVEL INDUSTRY?

D

o you believe in the importance of a sustainable travel industry? The travel and tourism sector is expected to grow at an annual rate of 3.9% over the next decade. That is positive, but it also reminds us that we need to put in place measures to guarantee the sustainability of the sector in the long term. Amadeus takes this very seriously. Let me tell you why. We consider that a company’s responsibility goes beyond securing the growth of its results. At Amadeus we have a record for many years of limiting the environmental impact and optimizing the social reach of our commercial operations. We believe that environmental efficiency has to start with our internal operations. That is why we measure our environmental impact in order to identify improvements and implement solutions. Since 2009, we have been using the Amadeus Environmental Management System (EMS) as a solid methodology to analyze all our environmental data and help us identify and take measures to improve environmental performance.

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As a technology provider for the travel and tourism sector, Amadeus develops technology solutions that help our customers improve their environmental and economic efficiency. One of our technology solutions, Amadeus Altéa Departure Control-Flight Management, allows airlines to accurately calculate the fuel they need for a given flight, allowing them significant savings in CO2 emissions, fuel and economic costs. To achieve greater long-term results, we collaborate with other interest groups in the travel industry and participate in projects to improve environmental sustainability. For example, in order to help achieve the 2-degree objective set by the Paris Agreement and reach the carbon neutral level, Amadeus joined the United Nations’ Climate Neutral Now commitment. We have also established a long-term agreement with the International Civil Aviation Organization (ICAO) to contribute to a greater awareness of carbon emissions in aviation. Amadeus uses the ICAO carbon emissions calculator on its distribution platforms to provide travelers with information on the greenhouse gas emissions produced during their trips.


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Companies to Keep an Eye On in

2019

Tomas López Fernebrand

Senior Vice President, General Counsel & Corporate Secretary, Amadeus

Amadeus’ environmental commitment is reflected in our inclusion in several global sustainability indices. Among others, Amadeus has been chosen as one of the most sustainable companies in the world, ranking 16 in the 100 global companies chosen by Corporate Knights in 2018. In addition, our efforts in this regard have been recognized by the Dow Jones Sustainability Index for seven consecutive years. Looking at the social level, we believe that travel can play a key role in global economic development and can be a determining force for positive change. We seek to actively contribute to the communities in which we work, through investment, participation in local projects and partnerships with non-profit organizations around the world. To do so, during 2017 we developed 138 community support and social assistance projects and 69 training projects, providing young people with the qualifications required by the digitized sector of travel and tourism. In 2013, Amadeus launched Click for Change, a program that, thanks to the donation engine developed by Amadeus, allows donations from people who buy

their trips online. So far, travelers have donated almost 3 million dollars on the websites of Iberia, Finnair, Norwegian, Almundo and Avianca for programs to educate and vaccinate of children, and other development projects run by the United Nations Fund for Children (UNICEF). We also contribute our knowledge in travel intelligence for initiatives that benefit society. In this sense, Amadeus is part of a UNICEF global innovation program that collects and analyzes complex data sources from different sectors. In part, thanks to the data provided by Amadeus, they can better understand the patterns of the spread of epidemics, which helps them to control possible outbreaks in other areas. Our purpose to shape the future of travel and tourism is based on internal, external and collaborative actions with other entities in the sector. We are committed and proud to be able to use Amadeus’ technology, experience and global network to ensure the sustainability of the travel industry in the long-term and build a better future for all.

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Driving Sustainable Growth In The Global Generics Market

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andoz is a global leader in generic pharmaceuticals and biosimilars. As a division of Novartis, its purpose is to discover new ways to improve and extend people’s lives by pioneering novel approaches to provide access to high-quality medicines. Global headquarters are in Holzkirchen, Germany and US headquarters in Princeton, New Jersey.

Carol Lynch

President, Sandoz US & Head of North America, Sandoz Inc.

With its experience and capabilities in the development, manufacturing and commercialization of medicines, Sandoz is committed to increasing patient access to highquality, life-enhancing biosimilars and Value-Added Medicines (VAMs). According to estimates, 1.2 million US patients could gain access to biologics alone by 2025, which is beneficial to all, particularly the elderly, women and those with low or fixed incomes. Sandoz is boldly trailblazing novel approaches to supporting the growing healthcare needs across the world. Reducing the Rising Treatment Cost with Biosimilars and Generic Medicines As it continues to reimagine medicine, Sandoz has focused its

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strategy on specialization in biosimilars, VAMs, complex generics and prescription digital therapeutics, in order to contribute to helping patients gain access to cost-effective and advanced health treatments. Of note are three medicines that held top market share positions in ® 2018. Zarxio (filgrastim-sndz), which stimulates growth of certain white blood cells important to fighting infection, ® Omnitrope (somatropin injection), a human growth ® hormone, and Glatopa (glatiramer acetate injection) for relapsing forms of multiple sclerosis. As of October 2018, ® Zarxio led with over 45% share; Omnitrope® reached its highest total prescriptions (TRx) share with over 24% in a seven-player market and growth of more than 20% and Glatopa® 20 mg/mL continued as the market leader with 38% TRx share. The successful adoption of Zarxio® into clinical practice saved the US healthcare system about $500 million in less than two years. Backing the Prescription Digital Therapeutic (PDT) Arena Another exciting milestone on its


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journey to reimagine Sandoz was expanding its presence in the digital world. It has collaborated with Pear Therapeutics, enabling it to leverage new technologies and be at the forefront in the digital revolution. In December 2018, ® Sandoz launched reSET , the first and only FDA-authorized Prescription Digital Therapeutic (PDT) that leverages technology to strengthen Substance Use Disorder (SUD) therapy. Further, in January ™ 2019, it launched reSET-O , the first FDA-cleared PDT for patients with Opioid Use Disorder (OUD). These flagship launches are proof of Sandoz’s dedicated efforts in identifying innovative solutions to major healthcare issues like the opioid abuse crisis in the US. Biosimilars as the Solution for Expensive Health Treatments As stated by the Association for Accessible Medicines (AAM), biosimilars have the potential to improve the quality of life for American patients and save billions of dollars each year. It is estimated that biosimilars could save the US healthcare system more than $54 billion over 10 years. Sandoz was the first company to bring biosimilars to US patients. It is also further backing the movement for cost-effective medicines with eight biosimilar medicines approved worldwide. Sandoz’s Zarxio® is the first biosimilar to overtake market share

of an originator reference product in the US and remains in the top spot in volume share. Carol Lynch, Leading the US Transformation of Sandoz Carol Lynch has worked with Sandoz and Novartis for more than 20 years in various roles across several continents. Due to her dedication and extensive experience with Sandoz and Novartis, Carol became President, Sandoz US, Head of North America, Sandoz Inc. in March 2018 and is a member of the global Sandoz Executive Committee. Carol oversees commercial operations in the US (the largest commercial and country organization) and Canada and looks after 35% of Sandoz’s global revenue.

We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access highquality medicine.

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2019

Carol appreciates working with smart, strategic people because it helps to promote creativity that will fuel the reimagining of the US business. She believes that one must find purpose in their work and be empowered to improve ways of working to more positively impact patient’s lives. Currently, Carol and her team are taking bold actions to transform the US business for sustainable longterm growth. To create higher future value, Sandoz is reshaping its portfolio to complement complex generics and biosimilars with VAMs and prescription digital therapeutics. According to Carol, the company will continue to explore and implement cost-effective biosimilars, complex generics, and PDTs to innovate more accessible solutions that will enrich people’s lives. When asked about her upcoming strategies for Sandoz, Carol asserts, “Our work is not close to being finished. We have several exciting new product launches planned for early 2019, with more to come throughout the year. We are working hard to bring our own portfolio to the market, but more importantly, we are seeking innovative partners who need a strong commercialization collaborator to bring their products to market, too.”

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Trending

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team of scientists created specially coated nanometer-sized vehicles that can be used to move through dense tissue of the eye. Until now, scientists have successfully transported nanobots or nanovehicles in model systems or through biological fluids. This is the first time nanobots could drill into a real tissue of eyeball. These nanobots are just 500 nm wide and they can easily roam through the tight molecular matrix of an eye. To go further, a clear idea about nanobots is essential. What are nanobots or nanorobots or nano-vehicles? Nanobots are the robots of size close to the microscopic scale of a nanometer (10−9 meters). So far, nanorobotics considered as hypothetical nanotechnology engineering discipline of designing and building nanorobots. When nanobots in medicine are considered, the most popular idea is self-propelled nanomotors and other biodegradable nanodevices made of bio-nano components. They are used to carry cargo to the target sites. It means they deliver drugs to diseased cells.

Such drug delivery approach promises an effective and improved transport of drugs compared to conventional methods. For instance, scientists can program nanorobots to transport essential drugs to remove blood blockages, which can cure the tumors. A team of international scientists of the Micro, Nano and Molecular Systems Lab at the Max Planck Institute for Intelligent Systems in Stuttgart performed comprehensive research on these eyeball-drilling nanobots. The research is named as “A swarm of slippery micropropellers penetrates the vitreous body of the eye”, by Zhiguang Wu, Jonas Troll, Hyeon-Ho Jeong, Qiang Wei, Marius Stang, Focke Ziemssen, Zegao Wang, Mingdong Dong, Sven Schnichels, Tian Qiu, Peer Fischer, published in Science Advances (2018). Based on the above research, this article covers some aspects of these novel nanobots and their role in curing eye diseases. Here are some of their key features:

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Top

Companies to Keep an Eye On in

2019

5 reasons

the novel eye-drilling Nanobots could cure complex eye diseases

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Further, he added, “In the second step, we applied a liquid layer found on the carnivorous pitcher plant, which has a slippery surface on the peristome to catch insects. It is like the Teflon coating of a frying pan.”

A size which can easily roam inside an eye Covered in a non-stick coating, these nano-drills are 500nm wide size approximately matches the mesh size of the network in the vitreous. They are helical in shape and 200 times smaller than the diameter of a human hair. This size is even smaller than a bacterium's width. Researchers call it slippery micro-propellers.

The first film of slippery coating on these nanorobots consists of molecules bound to the surface, while the second is a coating with liquid fluorocarbon. This clever combination enables the nanorobots to go through the tight mesh of the eyeballs dense tissue.

Slippery surface coating inspired by nature Most tissues including the vitreous have a tight macromolecular matrix that acts as a barrier and prevents its penetration. Surprisingly, the slippery coating on these nanobots removed this barrier of penetrations. This enables the nanobots to move in the vitreous seamlessly. The slippery exterior allows them to be actively propelled through the vitreous humor to reach the retina. Primarily, all this happens without damaging the sensitive biological tissues around them. One of the authors of the study, Zhiguang Wu explains, “For the coating, we look to nature for inspiration”.

This slippery coating is crucial for the efficient propulsion of robots inside the eye, as it minimizes the adhesion between the biological protein network in the vitreous and the surface of nanorobots. Ÿ

Targeted delivery Traditional delivery methods rely on the random, passive diffusion of molecules. These methods do not allow for the rapid delivery of a concentrated cargo to a defined region of the eye. The use of particles promises targeted delivery but faces the challenge of macromolecular resistance.

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Proven Leaders In Stem Cell-based Regenerative Medicine

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Dr. Jim Musick President & CEO

he Need for Regenerative Therapies It is clear that the current healthcare sector needs a shift towards regenerative therapies to help the correction of underlying diseases by utilizing innate healing systems as opposed to therapies based on symptomatic interventions with attendant side effects, comorbidities and excessive costs. By “Harnessing the Power of CellsTM, the US-based Vitro Biopharma is focused on achieving the full potential of regenerative medicine. Established in 1986, Vitro Biopharma provides a unique mix of research and clinical products used by leading universities and institutions worldwide. Over the last 25 years, it has been providing human stem cell lines and related primary cells for use in research, drug discovery/development, and preclinical studies. Vitro provides a unique competitive advantage through the supply of the highest quality stem cells coupled with stem cell

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activation therapy and molecular diagnostics to track relevant biomarker profiles, allowing the assessment of stem cell regeneration. Along with this extensive experience, Vitro possesses expertise in highlyregulated, commercial biologics manufacturing. The Company is ISO 9001:2015 certified, cGMP compliant, FDA and CLIA registered as well as ISO 13485:2016 compliant. International Stem Cell Trials utilizing advanced medical diagnostics and therapies With its vast history of working in the healthcare sector, Vitro has developed innovative products in medical diagnostics, cancer research, cell line regeneration, and stem cells. Essentially, its cell lines include primary and cancerassociated fibroblasts and animal & human mesenchymal stem cells (MSCs) derived from various tissues together with MSCderived progenitor & terminally differentiated cells like dopaminergic neurons, cardiomyocytes, etc. Similarly, it carefully tests cell lines for purity, integrity, and contaminates. This leading biopharma company is


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also currently focused on stem cell therapies for a variety of conditions including neurodegenerative diseases, musculoskeletal conditions like osteoarthritis, and conditions characterized by inflammation. The company’s breadth of services and products is unique in the industry. Vitro’s strength in research provides a platform for extension to clinical studies, through the supply and knowledge of all essential components of modern stem cell therapeutics under appropriate oversight by regulatory agencies. The company has ongoing clinical trials in the Cayman Islands, New Zealand, the Czech Republic and has recently received approval for a new stem cell therapy trial for musculoskeletal conditions from the Ministry of Health in the Bahamas. Improved Results with Vitro Biopharma’s Stem Cell Activation Product At present, Vitro Biopharma offers a nutraceutical product, NutraVivo™/Brain Grow Technologies™ for health benefits of stem cell activation. With the use of NutraVivo™, the company has tested successful activation of human neural & mesenchymal stem cells by enhanced migration & proliferation as well as enhanced gene expression. These superior

Companies to Keep an Eye On in

2019

outcomes are the results of the dedicated efforts made by Vitro’s talented CEO and his skilled team.

CEO, Accelerating Vitro with Advanced Regenerative Medicine Applications

Through its outstanding portfolio of products and services and exemplary contributions to the healthcare industry, Vitro Biopharma has received several elite recognitions. In 2014, it was recognized by Frost and Sullivan as a “Thought Leader in Stem Cell Tools & Technology” in North America through the Receipt of a Technology Innovation Leadership Award. Similarly, the company was also recognized for its accomplishments in stem cell lines and media for supporting global stem cell research and its innovative stem cell activation technology. The company has numerous national and international patents and patents pending on its intellectual property.

Dr. Jim Musick, the President and CEO of Vitro Biopharma, is currently handling the operations of this rapidly growing stem cell firm. Along with his committed team, Jim is involved in research & development and oversees the essential processes including intellectual property development, marketing, sales, business development and new product releases.

Vitro Biopharma provides and continually improves the highest quality stem cells and related products and services in accordance to government regulations.

With his mission to ease patient care, Jim proudly asserts, “My greatest pleasure comes from seeing a patient’s favorable response to our stem cell therapy. We are beginning to see advances in diseases with limited or not treatment options other than stem cell therapy” Additionally, with these continual positive outcomes and deep insights, Jim is currently working towards expanding Vitro’s presence in international medical tourism while simultaneously pursuing opportunities in the US markets such as a new cosmetic stem cell serum product.

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Profile for Mirror Review

The 10 Best Biotech & Pharma Companies to Keep an Eye On in 2019  

In today’s healthcare industry, medicine is becoming more and more personalized with patient focused approach. To drive such a personalized...

The 10 Best Biotech & Pharma Companies to Keep an Eye On in 2019  

In today’s healthcare industry, medicine is becoming more and more personalized with patient focused approach. To drive such a personalized...

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