Faculty – Biosimilar Market Access and Commercialization Strategies Summit

John Coelho
Global Medical Strategy Leader,
MERCK

view speaker profile

Executive leader directing the development of medical affairs strategy and high-level tactics for in-line new-to-world compounds, biosimilars, and mature brands portfolio. Previously, Medical Affairs leader for Asia and international Head of Research and Development

Chrys Kokino
Head Global Biologics Commercial,
MYLAN

view speaker profile

Chrys has been engaged in the world of specialty drugs for over 30 years. He has held various positions within the pharma and biotech world and is currently the Global Commercial Head for Biologics and Insulins at Mylan. His broad base of experience spans across multiple therapeutic areas including oncology, immunology, endocrinology, and nephrology. He has launched and commercialized multiple specialty products both in the U.S. and worldwide with products ranging in value from $50M to over $1B. He has had the good fortune of representing top tier pharma and biotech companies such as Bristol Myers Squibb, Amgen, and Roche. In the most recent years, he has had a singular focus and passion for launching and commercializing biosimilars in the worldwide markets – first with Sandoz and now with Mylan where the team has successfully launched the worlds’ first biosimilar trastuzumab.

Molly Burich
Associate Director Public Policy,
BOEHRINGER INGELHEIM

view speaker profile

Molly Burich, M.S., is the Associate Director for Public Policy – Biosimilars, Pipeline, and Reimbursement at Boehringer Ingelheim, Inc. In her role, she focuses on key federal and state policy issues impacting the franchises of Boehringer Ingelheim, with a specific focus on biosimilars, pipeline products and reimbursement for in-line and pipeline products. Prior to her current role, Ms. Burich was at Otsuka Pharmaceutical Inc where she held a variety of roles in federal and state government affairs and reimbursement. Ms. Burich was also in reimbursement and health policy consulting at both Xcenda and Avalere Health. Ms. Burich received a master of science in public service management with an emphasis in public policy from DePaul University and a bachelor of arts in political science from the University of Northern Colorado.

Ambrose Carrejo, Pharm.D.
National Pharmaceutical Contracting and Strategies Leader,
KAISER PERMANENTE

view speaker profile

Doctor Carrejo received his Doctor of Pharmacy degree from the University of California at San Francisco’s School of Pharmacy in 1986. He completed his clinical residency at Long Beach Memorial Hospital in June of 1987.

With the schooling and residency completed, he began his professional career at the Pacific Presbyterian Medical Center in San Francisco, California. There he worked as a clinical pharmacist running the Total Parenteral Nutrition Service for Pharmacy and also providing clinical services to the medical/surgical ward. He left this position in February of 1990 to begin working for Kaiser Permanente.

He began his career with Kaiser as a Drug Education Coordinator (DEC) at Kaiser Richmond and was soon given responsibility for Kaiser Oakland Medical Center also. He was then promoted to Clinical Operations Manager where he had oversight of the drug use management efforts and the ambulatory clinic pharmacists. In June of 1999, Ambrose was promoted to Drug Use Manager for Northern California. In this role, he provided oversight and leadership for the Drug Education Coordinators of Northern California. In June of 2006, Dr. Carrejo was promoted to Assistant Director of Pharmaceutical Contracting. Finally, in May 2008, he was promoted to his current position of National Pharmaceutical Contracting Director.

Rakesh Dixit, Ph.D., DABT
Vice President, R&D, Global Head, Biologics Safety Assessment,
MEDIMMUNE, ASTRAZENECA GROUP

view speaker profile

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.

Ashish Dugar
former Officer and Vice-President, Commercial Development,
INTRA-CELLULAR THERAPIES

Joseph P. Fuhr
Professor of Economics,
WIDENER UNIVERSITY

view speaker profile

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
Researcher,
YALE UNIVERSITY SCHOOL OF MEDICINE

view speaker profile

Aaron graduated summa cum laude and Phi Beta Kappa from Yale University with a 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.

Bruce Leicher
Senior Vice President and General Counsel,
MOMENTA PHARMACEUTICALS

view speaker profile

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.

Patrick Lucy
Chief Business Officer,
PFENEX

view speaker profile

Patrick Lucy, a member of the founding team at Pfenex, has served as our Chief Business Officer since 2009. Prior to joining us, Mr. Lucy held the position of Director of Business Development at DowPharma, a business within The Dow Chemical Company, a chemicals manufacturer, from 2002 to 2009. From 1999 to 2002, he held the position of Director of Business Development at Collaborative BioAlliance, Inc., a biotechnology company, which was acquired by The Dow Chemical Company. From 1996 to 1999, Mr. Lucy worked at Lonza Biologics Inc. a chemicals and biotechnology company. While at Lonza Mr. Lucy held roles spanning Quality, Operations and Capital Project Management, playing a key role in the design, construction and commissioning of large scale biologics manufacturing facilities. From 1991 to 1996, Mr. Lucy worked at Repligen Corporation, a life sciences company, in various leadership roles focused on biochemistry.

Mr. Lucy holds a Bachelor’s degree in Biology from Villanova University.

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

view speaker profile

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

Kristi Sarno
Senior Consultant,
LATHAM BIOPHARM GROUP

Former Director Business Development, PFENEX, INC.

view speaker profile

Ms. Sarno is an experienced life sciences strategy and business development professional. As a Senior Consultant at Latham BioPharm Group, she is responsible for providing business development consulting and program management services to commercial and government clients. She holds more than twenty years of life sciences industry experience including successfully negotiating, closing, and maintaining research agreements and technology licenses with multiple biologics technology platforms. Prior to joining LBG, Ms. Sarno was Director of Business Development at Pfenex Inc., a biosimilar company that launched its product portfolio from its proprietary protein production platform, ultimately completing a successful IPO based on the strength of their pipeline. Before her work at Pfenex, Ms. Sarno held Business Development roles at Laureate Biopharmaceuticals and Crucell.

Ms. Sarno earned her Master of Liberal Arts in Biology at Harvard University, and her B.S. in Biology at Syracuse University, and is the National President Emeritus of Women in Bio (WIB).