MTR 632: Drug Development Decision Criteria Fall 2014 Course Lecturers Course Director: Jeffrey S. Barrett, PhD, FCP Dr. Jeff Barrett is Vice President and Global Head of the Interdisciplinary Program in Pharmacometrics Program (IPP) and Global Head of Pediatric Clinical Pharmacology at Sanofi Pharmaceuticals. In this role he leads the modeling and simulation efforts across the scientific core platforms at Sanofi -- developing, testing, and exploiting quantitative relationships to facilitate critical decisions that span the drug discovery and development process. The IPP, led by Jeff and his steering committee, ensures that modeling aspects are covered in an integrated way across platforms, bringing together the multiple disciplines, and that resources are applied with priority to the most important questions and projects. Dr. Barrett also co-chairs the Sanofi Pediatric Network. Jeff spent the previous 10+ years at the University of Pennsylvania where he was Professor, Pediatrics and Director, Laboratory for Applied PK/PD at the Children’s Hospital of Pennsylvania (CHOP). His academic career was highlighted by sustained NIH support for pharmacometric research across numerous therapeutic areas in both adult and pediatric populations and he continues to serve as an Adjunct Professor of Pediatrics at the U Penn School of Medicine and teaches/directs two courses in the U Penn Masters in Translational Research (MTR) Program. Prior to his tenure at U Penn and CHOP, Jeff spent 13 years in various quantitative roles in the pharmaceutical industry, most recently as Head of Global Biopharmaceutics, Late-stage Clinical Pharmacology & Pharmacometrics at Aventis. Jeff received his B.S. in Chemical Engineering from Drexel University and Ph.D. in Pharmacokinetics from University of Michigan. He is a fellow of ACCP and AAPS and the recipient of numerous honors including ACCP awards for Young Investigator (2002), Mentorship in Clinical Pharmacology (2007) and the AAPS Award in Clinical Pharmacology and Translational Research (2011). Most recently Dr. Barrett was awarded for Exceptional Innovation and Advancing the Discipline of Pharmacometrics at the International Society of Pharmacometrics (2013). Dr. Barrett has co-authored over 135 manuscripts, 160 abstracts, 14 book chapters and has given over 120 invited lectures on PK/PD, clinical pharmacology and pharmacometrics. He serves on the Editorial Boards of the Journal of Pharmacokinetics and Pharmacodynamics and the ASCPT Pharmacometrics & Systems Pharmacology Journal and is the co-Specialty Chief Editor of the Frontiers in Obstetric and Pediatric Pharmacology Journal. He served as the acting chair of the FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology in 2013 and was a voting member of the committee for 8 years. Dr. Barrett continues to support the NIH and NICHD on several working groups and task forces supporting pediatric clinical pharmacology. Shashank Rohatagi, received his PhD from University of Florida in 1995 and his MBA from Saint Joseph’s University, PA in 2000. Currently he is working as Senior Director, Translation Medicine and Think Team. He has been working in the field of pharmaceutical drug development since 1992 and his industry experience includes working with several pharmaceutical companies in the United States and India such as Somerset Pharmaceuticals, Aventis, Daiichi Sankyo and Piramal Life Sciences. He is an expert in the field of clinical pharmacology and its applications in Drug Development including preclinical, Phase I/II/III and also life cycle management. His main focus has been in the area of model-based drug development including application of pharmacogenomics and biomarkers in drug development. He has published over 150 abstracts and manuscripts in various international Journals. He has also written 5 book chapters. He is an adjunct faculty at University of Florida (Since 2002) and an adjunct faculty at University of Tennessee (Since 2004). He is on the Editorial Board of Journal of Clinical Pharmacology. He is a Fellow of American College of Clinical Pharmacology (ACCP) and member of AAPS and ASCPT. Shashank has worked on various submissions, such as ANDA submission of selegiline capsules as part of generic defense strategy for the compound (1996); NDA submission of Azmacort HFA (2001), NDA submission of Alvesco (Ciclesonide, 2005), NDA submission of Azor (combination of Olmesartan and Amlodipine, 2007), Benicar Pediatric submission, NDA submission of Prasugrel (2008). He aided in several IND submissions (3VLA-4 antagonist compounds, endothelin antagonists, S1P1 modulator, fluoroquinolone, inhaled corticosteroids and others). He aided and participated in 2 Advisory Committee meetings, 1 IPRG Meeting, several Pre-IND, Pre-NDA, End of phase II and Labelling Meetings. Shashank has received various awards including McKeen Cattell Award for Best Manuscript, Journal of Clinical Pharmacology in 2009. He received the Young Alumnus Award at University of Florida in 2007. He received Graduate honors for his MBA, the Ex-Aequo Award by St. Joseph’s University in 2000. He also received Best Team award for modeling and simulation platform at Daiichi Sankyo in 2010 and also received several special achievement awards at Aventis in 2001, 2002, 2003 and 2004. Dr. Marc R. Gastonguay is President & CEO, and co-founder of Metrum Research Group LLC; a solution provider for biomedical research and development problems, via the application of quantitative modeling, simulation, and high performance computing. Dr. Gastonguay is also Scientific Director and Chairman of Metrum Institute; a non-profit organization with a mission of training, education, and research. He is a member of the graduate faculty in the Department of Biomedical Engineering at the University of Connecticut, and is on the adjunct faculty at the University of Pennsylvania, and at Long Island University. Dr. Gastonguay is a founding Director of the International Society of Pharmacometrics, a member of the Board of Directors of the New England Modeling and Simulation Consortium, and an active member in several professional organizations, including: the American Association of Pharmaceutical Scientists, the American College of Clinical Pharmacology, the American Society of Clinical Pharmacology and Therapeutics, The International Society of Pharmacometrics, and the Biomedical Engineering Society. He is also an active reviewer and editorial board member for several peer-reviewed journals in the field of pharmacometrics. Dr. Gastonguay has received multiple awards and distinctions, including: designation as a Fellow of the International Society of Pharmacometrics, the 2013 University of Connecticut Alumnus of Distinction Award, and the 2011 International Society of Pharmacometrics Innovation Award. His company, Metrum Research Group has received the Connecticut Tech Top 40 Award each year from 2010-2014. Dr. Gastonguay's training includes a B.S. in Pharmacy from the University of Connecticut, a Ph.D. in Pharmacology from Georgetown University School of Medicine, and a Post-Doctoral Fellowship in Pharmacokinetics at the U. S. Food and Drug Administration. Prior to founding Metrum Research Group, Dr. Gastonguay held positions as Research Scientist and Adjunct Professor in the Department of Pharmaceutical Sciences at the University of Connecticut, Senior Scientist and Manager of Pharmacometrics R&D at GloboMax, and as an independent contract researcher at Optimal Solutions. For over 20 years, Dr. Gastonguay has been applying modeling and simulation to biomedical research and clinical therapeutics in regulatory, academic, and industrial settings, publishing over 50 articles and book chapters, and more than 100 abstracts. His current research interests include Bayesian modeling methods, pediatric clinical pharmacology, and rare disorders. Shreeram (Ram) Agharkar, Ph.D., is the founder and president of PBDS, LLC. He started this consulting business after 38 years of successful career in Pharmaceutical R&D. He has excellent track record in CMC development and global registration of NCEs in many therapeutic areas. After receiving Ph.D. in Pharmaceutics from the University of Kansas, he joined Abbott laboratories, R&D in Chicago. He spent five years each at Abbott and Schering-plough before joining Bristol-Myers Squibb, R&D. During his tenure of 18 yrs at BMS he was responsible for formulation development of several new products, e.g., Taxol, Paraplatin, Videx, Cefzil and Abilify. He then joined Sanofi R&D as the global Vice President of Pharmaceutical development. During his 10.5 years at Sanofi he managed a large group of scientists in many countries, directed development of both small molecules and biologics, e.g., Lantus and LCM of allegra, taxotere and plavix. He led several task forces related to mergers and right sizing initiatives and alliance management. Dr. Agharkar is recognized as a global leader who ensures high performance with customer focus, scientific rigor and speed without compromising quality. He has published more than 25 scientific papers and holds 15 patents. Donna M. Humski CPIM Senior Director, North America Reliability Rapid Response Senior executive with extensive supply chain experience in the consumer product, pharmaceutical, and medical device markets. A leader who thrives on the challenge of developing and executing strategies to reinvent organizations. Known for consistently delivering outstanding results while developing future leaders. Drexel BS Mktg/Fin,