Faculty – 2nd Biosimilar Market Access Strategies Summit

Joanna Brougher
Adjunct Professor, CORNELL LAW SCHOOL

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Joanna is a patent attorney who focuses on all aspects of services related to patents in the life sciences. She is the owner and principal of BioPharma Law Group, a law firm dedicated to helping biotech and pharma companies navigate IP, corporate, and regulatory issues. Joanna is also an Adjunct Professor at Cornell Law School, a former Adjunct Lecturer at the Harvard School of Public Health, a frequent author of articles related to patent law and healthcare, and a frequent speaker at both domestic and international conferences. In 2013, Joanna published a book called Intellectual Property and Health Technologies: Balancing Innovation and the Public’s Health which examines the relationship between patents and public health in the context of medical technologies. In 2014, Joanna was selected to the National Law Journal’s list of Boston’s Rising Stars.

Jay Brown
Senior Director, Outpatient Pharmacy Support Services, NOVANT HEALTH

Divya Chadha Manek
Head, Business Development, NIHR

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Divya has worked for the NIHR CRN for the past nine years. She has hands experience of delivering clinical research from both a site-level and national perspective.

Divya’s current role is to maintain strategic relationships with global and UK life sciences companies. Within this role, Divya provides advice and works collaboratively with companies to optimize how companies utilize government-funded support services to ensure clinical studies are set up quickly and efficiently and recruit to time and target.

Divya also leads on keeping the NIHR CRN abreast of study delivery innovations. In doing so she helps to ensure that the services we provide continually evolve meet the needs of the life sciences industry.

Divya has a degree in Clinical Psychology, a Masters in Clinical Research and is currently undertaking a Ph.D. in Dementia Care.

Dr. Niraj Chhaya
Risk Management, Biosimilars, BOEHRINGER INGELHEIM

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Dr. Niraj Chhaya is a Risk Management expert for biosimilar portfolio within Global Pharmacovigilance at Boehringer Ingelheim based out of its corporate office in Ingelheim, Germany. After completing post?graduation in Internal medicine, he started his career by joining Tertiary Care hospital in Mumbai, India. Apart from clinical practice, he was involved with clinical research as an investigator covering various therapeutic areas. After a decade of work in hospital setting, Dr. Chhaya joined pharmaceutical industry in 2006. He is extensively working in the field of biosimilars since 2010 through his involvement in clinical development, medical monitoring and pharmacovigilance at Dr. Reddy’s Laboratories and Boehringer Ingelheim.

Rakesh Dixit
Vice President, R&D, Global Head, Biologics Safety, MEDIMMUNE

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Dr. Dixit conducted extensive graduate and post-graduate training in Toxicology–Biochemistry with both Indian and US Institutions (Case Western Reserve University, Medical College of Ohio, University of Nebraska) and is board certified in Toxicology from the American Board of Toxicology, Inc. since 1992. Rakesh served as a Senior Toxicologist with Midwest Research Institute between 1987 and 1992.

In December 1992, Rakesh joined the Department of Safety Assessment, Merck and Co., Inc, West Point, PA where he served in various management positions. During his about 14 years with Merck, Rakesh contributed to the successful filings of many blockbuster drugs. For about a year, Rakesh was associated with Johnson and Johnson PRD, La Jolla/Alza as Senior Director of Toxicology.

In Aug 2006, Rakesh joined MedImmune, Inc. (an AstraZeneca Biologics company) as Senior Director (R &D) & Global Head of Biologics Safety Assessment, Experimental Pathology, and Laboratory Animal Medicine. In his current position as a Vice President of R &D, Rakesh is responsible for providing guidance on research and development of biological products; including nonclinical toxicology/safety support for all AstraZeneca-MedImmune biologics products, including monoclonal antibodies and vaccines. Rakesh has published more than 60 papers in renowned international journals and has given over 100 invited lectures/presentations/workshops in national and international meetings.

Rakesh’s areas of expertise are mainly in the area of pharmaceuticals and biologics drug development, safety assessment of small molecule drugs, biologics, vaccines and in exploring mechanisms of toxicity and biologics pharmacological activity. Rakesh has helped to bring several blockbuster pharmaceuticals to the market while working at Merck. Rakesh a recognized expert in safety and pharmacology biomarkers and their applications.. Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and Associate Editor for Toxicology Applied Pharmacology, and Journal of Toxicology and Environmental Health. Rakesh also serves as an expert reviewer and in appointed committee for many programs managed by the prestigious U.S. National Academy of Sciences and US National Institutes of Health, including National Cancer Institute.

Joseph P. Fuhr, Ph.D.
Adjunct Faculty College of Population Health and Professor Emeritus Economics, WIDENER UNIVERSITY

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Dr. Joseph P. Fuhr, Jr. is a lecturer at College of Population Health Thomas Jefferson University and retired professor of economics at Widener University. He currently serves as a senior fellow with The American Consumer Institute and Ambassador for the Internet Innovation Alliance. Dr. Fuhr received his M.A. and Ph.D. from Temple University and his B.A. from LaSalle University. His primary research areas are antitrust, health economics, pharmacoeconomics, telecommunications and sports economics. In healthcare, he has written on ACOs, hospital mergers, specialty hospitals, exclusive arrangements, health insurance, bundling and doctor’s fees. In pharmacoeconomics, he has written on cost benefit analysis, biosimilars and predictive modeling. He has published more than 60 journal articles, of which 10 are on biosimilars. Professor Fuhr has been an expert witness on numerous cases and has worked on various consulting projects.

Aaron Hakim

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Aaron graduated summa cum laude and Phi Beta Kappa from Yale University with an M.S. in Molecular, Cellular and Developmental Biology and a B.S. in Economics and Molecular Biology. His Master’s thesis was published in and featured on the cover of the Journal of Biological Chemistry, and his more recent work has appeared in JAMA and JAMA Internal Medicine. His research interests include the costs, availability, and use of prescription drugs in the United States. Aaron is currently a third-year MD student at the Yale School of Medicine. Prior to medical school, Aaron was an Associate at a life sciences investment fund in Greenwich, CT.

Nacer Hedroug
Director of Global Quality Assurance, Aseptic Vertical, MYLAN

Ruediger Jankowsky
Managing Director, CINFA BIOTECH

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Ruediger leads Cinfa Biotech’s international organisation. That includes the leadership of the team and their biosimilar development activities, as well as the development and implementation of strategies for product commercialisation. Under his leadership, Cinfa Biotech has developed the first biosimilar B12019 (pegfilgrastim), being currently under EMA review for marketing authorisation.

Ruediger was appointed to this position in 2014. He has over 18 years of experience in the pharmaceutical industry where he held various international executive positions in global and mid-size pharmaceutical companies. During this time he developed an in-dpeth expertise in medicinal product development and business development. Before joining Cinfa Biotech, Ruediger was responsible for the global management of biosimilars development projects at a leading biopharmaceutical manufacturer. He holds a PhD in protein biochemistry.

Bruce A. Leicher
Sr. Vice President and General Counsel, MOMENTA PHARMACEUTICALS, INC.

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Mr. Leicher is Senior Vice President and General Counsel at Momenta Pharmaceuticals Inc., an innovator biotechnology company engaged in the development of complex generic products, biosimilars, interchangeable biologics and novel products. Mr. Leicher has advised biotechnology companies for over 25 years. Mr. Leicher is a frequent lecturer on biotechnology law. Mr. Leicher is also Chair of the Board of the Biosimilars Council, a Division of the Association for Accessible Medicines (AAM). Before joining Momenta, he served in senior legal positions at Altus Pharmaceuticals Inc., Antigenics Inc., Millennium Pharmaceuticals, Inc., Curis, Inc., Genetics Institute, Inc., and Wyeth. In private practice, he served as the Co-Chair of the Life Sciences Practice Group at Hill and Barlow, was an attorney at Hale and Dorr and Butler & Binion, and served as a law clerk to the Honorable Thomas F. Hogan in the U.S. District Court for the District of Columbia after receiving his J.D. from Georgetown University Law Center and his B.A. from the University of Rochester.

John J. Molenda, Ph.D.

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John Molenda is co-chair of Steptoe’s Healthcare & Life Sciences Industry Practice, is head of the Intellectual Property Practice for the New York office, and has served on the firm’s Executive Committee. He focuses on patent litigation at the district court and appellate levels, opinions of counsel, due diligence, and post-grant proceedings, including inter partes reviews (IPRs) and reexaminations. He represents clients across technologies, including biotherapeutics (biologics), pharmaceuticals (Hatch-Waxman), biochemical research tools, genetically modified plants, medical devices, semiconductors, fiber optics, and computer software.

With respect to John’s appellate practice, he litigates regularly in the US Court of Appeals for the Federal Circuit, including briefing, oral argument, and complex motion practice. He has held substantial roles in over 20 Federal Circuit appeals, including arguing one of the first pharmaceutical-related IPR appeals. John is active in the Federal Circuit community, currently serving as a Vice Chair of the Federal Circuit Bar Association’s Bench & Bar Planning Committee. He has previously held leadership roles on the FCBA’s Patent Litigation, Legislation, and Rules Committees. Prior to private practice, he served as a Federal Circuit law clerk for the Honorable Alan D. Lourie.

With respect to his district court and IPR practices, John has served as lead or co-lead counsel in district court litigations across the United States and has played key roles in multiple trials, mediations, and Markman proceedings. At the same time, John routinely counsels clients on the strategic use of IPRs as part of litigation and settlement strategy, and has served as lead counsel in numerous IPR proceedings on behalf of both petitioners and patent owners. John has served as co-chair of PLI’s Fundamentals of Patent Litigation program since 2014 and speaks regularly about current topics and trends in IPR practice.

While John’s work encompasses a wide range of technologies, he has developed a particular expertise in the area of biologics and biosimilars. He currently represents two pharmaceutical companies in a case involving blockbuster biologics to lower cholesterol and is coordinating pre-litigation strategy and counseling for a global biosimilars program involving high-value monoclonal antibody and cytokine products. John has also led biologics teams conducting transaction-related diligence and pre-petition diligence in advance of IPR filings. He speaks frequently on recent developments involving biologics and biosimilars for organizations including ACI, World Congress, Knowledge Group, BIOTECanada, Canaccord Genuity, and the FCBA.

Ryann M. Muir, Ph.D.

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Ryann Muir represents major pharmaceutical and biotechnology companies in high profile patent matters involving pharmaceutical and biotechnology products, molecular diagnostics, biochemical research tools, and chemical manufacturing processes. Ryann focuses her practice on complex patent litigation, counseling, and intellectual property transactions.

Ryann has litigated patent cases in federal courts throughout the country, and has managed teams through all phases of litigation including summary judgment motions, claim construction (Markman) proceedings, trials, and Federal Circuit appeals. She also has extensive experience in pre-suit investigations, opinions of counsel, due diligence, and USPTO post-grant proceedings, including inter partes reviews (IPRs).

Prior to practicing law, Ryann was a molecular biologist where she studied the synthesis of large molecules in different protein expression systems.

Sarfaraz Niazi, Ph.D.
Adjunct Professor, Department of Biopharmaceutical Sciences, UNIVERSITY OF ILLINOIS AT CHICAGO, COLLEGE OF PHARMACY

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Sarfaraz K. Niazi, Ph.D., Adjunct Professor, University of Illinois is the founder of Adello Biologics, a fully integrated biosimilar products company and a consultant to pharmaceutical and biotechnology industry as Founding Chairman of Pharmaceutical Scientist Inc. He has written over 100 research papers, over 60 books and owns over 120 patents in bioprocessing and other technologies and drug discovery. He has 20+ years of experience in taking biosimilars from concept to market across the globe. He is also a patent law practitioner.

Complete Biography

Thomas Sachnik
Strategic Associate to the EVP Commercial Europe, TEVA PHARMACEUTICALS

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Thomas is supporting the Executive Vice President Commercial Europe and the European commercial management team in managing a 5,2 billion USD business of pharmaceutical specialty, biosimilar, generic and OTC products at Teva Pharmaceuticals. Among a wide range of responsibilities, he is in charge of the European long term strategy including biosimilars. His background includes a Master’s degree in Pharmaceutical Bioprocess Engineering at the Technical University of Munich as well as strong knowledge in immunology and protein engineering based on an one year research assignment at Harvard Medical School. Combined with his commercial experience as an European product manager of a therapeutic antibody for severe asthma at Teva, he gathered an unique perspective and understanding of the pharmaceutical biologics business.