Salomon Stavchansky, Ph.D.
ICD2 Conference Scientific Chair
Alcon Centennial Professor of Pharmaceutics
The University of Texas at Austin College of Pharmacy
Salomon A. Stavchansky, Ph.D., received his B.Sc. degree in Pharmacy from The National Autonomous University of Mexico (Suma cum laude) in 1969, and his Ph.D. in Pharmaceutical Sciences from the University of Kentucky at Lexington in 1974. Dr. Stavchansky’s research at SloanKettering Institute for Cancer Research involved the synthesis of carbonII phenytoin with the purpose of following the in vivo distribution of phenytoin and the identification of gliomas and neuroblastomas. Dr. Stavchansky worked as an analytical chemist at the National Medical Center in Mexico where he helped develop an immunofluorescence antibody diagnostic test for toxoplasmosis. In 1968 he joined the research and development group of Syntex Laboratories developing steroidal formulations. Dr. Stavchansky joined the University of Texas in 1974 where he was awarded the Teaching Excellence Award and has received the Alfred and Dorothy Mannino Fellowship in Pharmacy, the James T. Doluisio Centennial Fellowship, and is now holder of the Alcon Centennial Professorship. Dr. Stavchansky serves as chair of the ICD2.
Linda S. Carter
Retired
Arthur A. Ciociola, Ph.D., F.A.C.G.
Vice President, Head of Global Regulatory Affairs
Alcon Research, Ltd.
Volker Fischer, Ph.D.
Vice President, DMPK
AbbVie Pharmaceutical
John M. Engel, Esq.
Founder and Managing Member
EngelNovitt, PLLC
John Engel is the Founder and Managing Member of EngelNovitt, PLLC (and previously was Founding Partner and Managing Partner of Engel & Novitt, llp), a science-based, boutique food and drug firm in Washington, D.C., which he originally established in January 2003. Mr. Engel specializes in food and drug law and administrative law, science and regulatory policy, and legislation impacting the life sciences industry. Mr. Engel is a recognized expert on a range of food and drug law issues confronting the biopharmaceutical industry, including biopharma due diligence, acquisitions, licensing, and other strategic transactions. Mr. Engel was awarded his J.D. magna cum laude from Georgetown University Law Center and his B.A. magna cum laude from The Catholic University of America. He is admitted to practice before the U.S. Supreme Court, the U.S. Court of Appeals for the D.C. Circuit, the U.S. Court of Appeals for the Fourth Circuit, the U.S. District Court for the District of Columbia, the Supreme Court of Virginia, and the District of Columbia Court of Appeals.
Rick Friedman, Ph.D.
Deputy Director
Science & Regulatory Policy
Center for Drug Evaluation and Research
US Food and Drug Administration
Richard L. Friedman is the Deputy Director, Science and Regulatory Policy, Office of Manufacturing and Product Quality, which is part of the compliance office in FDA’s Center for Drug Evaluation and Research (CDER). In this position, he is responsible for oversight of case review relating to drug manufacturing quality to assure scientific and risk‐based decisions. This position includes review of regulatory action recommendations regarding inspections and manufacturing site acceptability, and promoting sound regulatory policy development. Mr. Friedman joined FDA in 1990 and his positions have included New Jersey District Drug Specialist, CDER Senior Compliance Officer, Team Leader of Guidance & Policy, Associate Director, and Division Director. Mr. Friedman has been an adjunct faculty member of Temple University School of Pharmacy in their QA/RA graduate program since 2003. Prior to joining FDA, Mr. Friedman worked in the toxicology research division of Parke-Davis. Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989, and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.
Charles Hoiberg, Ph.D.
Executive Director
Pfizer, Inc
Chuck Hoiberg is an Executive Director in Pfizer’s Global Regulatory CMC group. He received a B.S. degree in Chemistry from the College of William and Mary and a Ph.D. degree in Biochemistry (Chemistry minor) from the Pennsylvania State University. He worked over eight years at Sterling Drug Inc. in R&D before joining the Food and Drug Administration. After 25 years of public service, he retired from the FDA where he had held numerous positions. When he left the Agency, he was the Deputy Director of the Office of New Drug Chemistry and the Associate Director for International Activities, Office of New Drug Chemistry, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research. He was the CDER International Conference on Harmonization Quality Coordinator and the ICH CDER Quality Topic Leads for the Common Technical Document-Q Guideline and the Q3A(R) and Q3B(R) Impurity Guidelines negotiations.
Kay Holcombe
Kay Holcombe recently retired at Senior VP for Science Policy at BIO. Kay served as lead BIO negotiator on PDUFA and BsUFA. Formerly, Kay was Senior Policy Advisor and VP for Government Relations, Sanofi-Genzyme; Executive VP, Policy Directions government relations firm; health legislative staff and senior health policy advisor, House Committee on Energy and Commerce; health legislative staff, Senate Committee on Labor and Human Resources; Deputy Associate Commissioner for Legislative Affairs, FDA; Executive Vice President, Foundation for Biomedical Research; Associate Director for Public Health Legislation, HHS; Deputy Associate Administrator for Planning, Evaluation, and Legislation, Health Resources and Services Administration; Special Assistant to the Director, Division of Legislative Affairs, NIH; Executive Secretary, NHLBI National Advisory Council; and researcher, NHLBI. Kay is a board member of the Reagan-Udall Foundation and of the National Blood Clot Alliance.
Pravin Jadhav, Ph.D, MPH, MPharm
Senior Director
Corporate Projects, R&D Innovation
Otsuka Pharmaceutical Development and Commercialization (OPDC)
Dr. Pravin Jadhav is Senior Director of Innovation and Business Transformation within Otsuka Pharmaceutical Development and Commercialization (OPDC) Corporate projects. He leads a multi-disciplinary team of data, information and knowledge experts to create science-driven, technology-enabled solutions of clinical and economic utility. The team is focused on clinical trial transformation and new business model by leveraging digital technology to bring therapeutic solutions for customers. Before joining Otsuka, he worked at Merck and Office of Clinical Pharmacology (OCP) at the US food and Drug Administration (FDA) in different leadership roles. Pravin received his BPharm and MPharm from India, PhD in Pharmaceutical Sciences from the Medical College of Virginia Commonwealth University (VCU) and MPH from Johns Hopkins University, Bloomberg School of Public Health. He has an adjunct faculty appointment in the College of Pharmacy at University of Florida and member of the Graduate Advisory Board of VCU School of Pharmacy.
Kenneth I. Kaitin, Ph.D.
Professor and Director • Tufts Center for the Study of Drug Development
Tufts University
Dr. Kaitin is Professor of Medicine and Director of the Tufts Center for the Study of Drug Development at Tufts University School of Medicine. Dr. Kaitin also holds appointments as Advisory Professor at Shanghai Medical College of Fudan University in China; Visiting Executive at the Tuck School of Business at Dartmouth College; and faculty of the European Center for Pharmaceutical Medicine at the University of Basel. A former President of the Drug Information Association, Dr. Kaitin is currently editor-in-chief of Expert Review of Clinical Pharmacology and serves as an expert consultant to the U.S. Department of Defense on bioterror countermeasure initiatives. An internationally recognized expert in drug development science and policy, Dr. Kaitin writes and speaks regularly on factors that contribute to the slow pace and high cost of drug development and efforts to improve R&D efficiency, and he has provided public testimony before the U.S. Congress on drug development and policy issues. Dr. Kaitin received a BS from Cornell University and PhD in pharmacology from the University of Rochester.
Sau (Larry) Lee, Ph.D.
Acting Associate Director for Research Policy and Implementation
FDA, CDER, OPS
Alice Loper, Ph.D.
Head, Drug Product R&D
Global Vaccines Technical R&D
GlaxoSmithKline
Alice Loper is the head of Product R&D in Global Vaccines Technical R&D at GlaxoSmithKline Vaccines. She leads a global team with sites in the US, Belgium and Italy and is based at the Slaoui Center for Vaccines Research in Rockville, Maryland.
Prior to joining GSK Vaccines, Dr. Loper was Head, Preclinical Development for the Alternative Development Program in GSK Pharma R&D. She led Pharmaceutical Technologies at the Adolor Corporation and was Vice President, Pharmaceutical Development at Schering Plough Research Institute. She started her industry career in Pharmaceutical R&D at Merck Research Laboratories after graduating with a Ph.D. in Pharmaceutics from the University of Texas at Austin.
Raj Madabushi Ph.D.
Team Lead, Guidance and Policy Team
Office of Clinical Pharmacology
OTS/CDER/FDA
Samuel D. Maldonado, M.D., MPH, FAAP
Vice President & Head Pediatric Drug Development Center of Excellence
Johnson & Johnson
Andrea Masciale
Vice President
Regulatory Policy and Global Analytics
Johnson & Johnson Worldwide Government Affairs & Policy
Andrea Masciale leads regulatory policy efforts across all product areas for Johnson & Johnson Worldwide Government Affairs & Policy, coordinating closely with regulatory affairs, law department, and other business functions, to shape the external policy and political environment. She also leads the center for policy excellence, a global team that partners with internal stakeholders to enable insight-driven advocacy by defining and communicating policy positions, developing actionable policy insights linked to priority platforms and critical business needs, implementing internal stakeholder programs to optimize connection with the external environment, facilitating coordination of efforts with regional and global trade organizations, and providing toolkits on key issues and approaches. Prior to joining Johnson & Johnson in 2003, Andrea served at the Food and Drug Administration in the Center for Drug Evaluation and Research as Regulatory Counsel in the Office of Regulatory Policy and finally the Director of the Division of Information Disclosure Policy. Andrea received her Bachelor of Arts in US Government from Georgetown University and Juris Doctor from the College of William and Mary.
Mehul Mehta, Ph.D.
Director, Division of Clinical Pharmacology I Office of Clinical Pharmacology
OTS, CDER, FDA
Dr. Mehta is the Director, DCP I (Division of Clinical Pharmacology I), OCP (Office of Clinical Pharmacology), in CDER (Center for Drug Evaluation and Research), FDA. His division is responsible for reviewing the clinical pharmacology and biopharmaceutical aspects of the CardioRenal, Neuropharmacological and Psychiatric drug products. He obtained his M.Sc. from University of Bombay in Synthetic Organic Chemistry in 1979, M.S. from University of Houston in Medicinal Chemistry in 1981, and his Ph.D. in Pharmacokinetics from the University of Pittsburgh in 1986 and joined FDA as a reviewer the same year. He has been with the Agency for last 29 years and in his current position for last 16 years. In addition to his review oversight, administrative, and management responsibilities, he continues to play a significant role in broad based regulatory needs. For example, currently he cochairs the CDER BCS (Biopharmaceutics Classification System) Committee, is a member of the CDER Lifecycle Management Board, is a member of the FIP BCS SIG, and is the Chair of the OCP Working Group for revising the CDER ‘PK in Hepatic Impairment’ guidance issued in 2003.
Robert J. Meyer, M.D.
Assc. Professor, Public Health Sciences Director
Inaugural Director of Virginia Center for Translational and Regulatory Sciences
University of Virginia School of Medicine
Robert Meyer, M.D., is the inaugural Director of the Virginia Center for Translational and Regulatory Sciences at the University of Virginia’s School of Medicine, as well as being an Associate Professor of Public Health Sciences. In this position, he is heading a group that will develop a regulatory science educational track, as well as provide regulatory and translational knowledge resources to University and external entities who seek to move basic science discoveries to the bedside. Prior to joining the faculty at UVA, Dr. Meyer was Vice President and head, Global Regulatory Strategy, Policy and Safety at Merck Research Laboratories (MRL), where he served on the Early and Late Stage Development Review Committees, the Safety Review Committee and chaired the Development Policy Committee. Externally, Dr. Meyer chaired the Regulatory Affairs Coordinating Committee for Pharmaceutical Research and Manufacturers of America (PhRMA) from 201213, and served as a key PhRMA negotiator on PDUFA V. Dr. Meyer received his medical degree from the University of Connecticut School Of Medicine and his bachelor’s degree from Lehigh University.
Terrance Ocheltree, Ph.D., R.Ph.
Sr. Director, Regulatory Policy and Intelligence
AbbVie
Terry is a Senior Director in Regulatory Policy and Intelligence at AbbVie with 30 years of Pharmacy and Pharmaceutical experience. He served as a Reviewer and Division Director with the Food and Drug Administration (FDA), Office of New Drug Quality Assessment (ONDQA) championing the use of Quality by Design (QbD), Process Analytical Technology (PAT), Real Time Release Testing (RTRT), and Quality Risk Management (QRM); as well as their incorporation into FDA submissions. Prior to joining FDA, Terry led the development of drug delivery systems and manufacturing of liquid, semi-solid and solid dosage forms, including immediate and modified release tablets and capsules. After earning a BS in Pharmacy at The University of South Caroline, Terry worked retail and hospital pharmacy, including starting an outpatient specialty service pharmacy before completing a PhD in Industrial Pharmaceutics at the Medical University of South Carolina.
Joanne Palmisano, M.D., FACP
Vice President • Drug Regulatory Affairs
Boehringer Ingelheim Pharmaceuticals, Inc.
Dr. Palmisano currently serves as Vice President, Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals Inc. (BI), responsible for defining and executing the regulatory strategy for BI drug and biologic development programs, CMC, US Product Labeling, Promotion & Advertising Compliance, and Regulatory Operations. Dr. Palmisano has also served as Assistant Vice President, Global Regulatory Affairs, Regulatory Head for Cardiovascular/Metabolism, GI, Anti-Infective/ Anti-Viral Products at Wyeth (now Pfizer), and Senior Medical Director of Clinical Development for cardiovascular/ lipid and & endocrinology products at Merck. Dr. Palmisano is a graduate of Columbia University College of Physicians & Surgeons and served as Senior Physician, Joslin Diabetes Center, Harvard Medical School, Assistant Professor of Medicine & Endocrinology, SUNY Health Science Center at Brooklyn and Director of the Diabetes Clinic, Kings County Hospital Center. Dr. Palmisano is a member of PhRMA Scientific and Regulatory Affairs Steering Group and sponsor for the Pediatric Charter. She served as Rapporteur on the Expert Working Group for ICH E11 Pediatric Drug Development, and is a Topic Leader for the Expert Working Group for ICH E8 General Considerations for Clinical Trials.
Nicholas Pelliccione, Ph.D.
Vice President, Regulatory Affairs
Turing Pharmaceuticals
Sarah Pope Miksinski, Ph.D.
Senior Director and Group Manager, GMD
Astra Zeneca
Sarah Pope Miksinski, Ph.D., is the Senior Director and Group Manager at Astra Zeneca. Recently, Sarah was the Acting Director of CDER’s Office of New Drug Products (ONDP), where her primary responsibilities included leadership of activities and operations related to quality review of newlyproposed drugs for clinical trials and U.S. commercialization. She obtained her B.A. from Earlham College (1994), her doctorate in Organic Chemistry from Oklahoma State University (1999), and a postdoctoral fellowship from NIH (20002002). Sarah joined FDA nearly 14 years ago, serving initially as a Chemistry Reviewer for reproductive/urologic drugs. Since that time, she has held additional positions including Chemistry, Manufacturing and Controls Lead as well as Branch Chief and Division Director.
Paula Rinaldi
North American Head of DRA
Novartis Pharmaceuticals
Maria Rivas M.D., FACP FACE
Senior Vice President
Global Medical Affairs
Merck
Dr. Maria Rivas currently leads the Global Medical Affairs (GMA) organization at Merck. As an organization of more than 1400 colleagues, GMA serves as a strategic partner to the Merck Global, Regional and Country commercial organizations and the Merck Research Laboratory to provide high quality scientific and value evidence information to physicians, patients and payers. GMA also generates scientific information and engages in scientific exchange with customers to improve patient outcomes and access to innovative therapies, She previously served as Vice President of Global Medical Affairs at Abbvie, where she started and transformed the company’s first global medical affairs organization. Before joining Abbvie, she was Vice President and Head of Medical Affairs for the Global Oncology, the US General Medicine, and the US Diagnostic Imaging franchises at Bayer Healthcare.
Lisa A. Shipley, Ph.D.
Vice President & Global Head
Pharmacokinetics,
Pharmacodynamics & Drug Metabolism
Merck & Co., Inc.
Dr. Shipley is Vice President of Pharmacokinetics, Pharmacodynamics and Drug Metabolism in Merck Research Laboratories. She is responsible for the all preclinical and clinical ADME activities, Bioanalytics and Quantitative Pharmacology and Pharmacometrics at all Merck research sites and their support of all programs from discovery through post product launch. Prior to joining Merck in 2008, Dr. Shipley spent the over 20 years at Eli Lilly and Company in roles of increasing responsibility including the positions of executive director, Lean Six Sigma and vice president Drug Disposition, PK/PD and Trial Simulations. Dr. Shipley obtained her undergraduate degree from McDaniel College and her doctoral degree in Pharmacology and Toxicology from the University of Maryland at Baltimore. Her postdoctoral training was conducted at the Walter Reed Army Institute of Research as a National Research Council Fellow. Dr. Shipley has authored or co-authored three book chapters, over 25 journal articles, 40 abstracts on drug metabolism, pharmacokinetics, analytical assay development, and drug disposition and has been granted five patents.
Paul Seo, Ph.D.
Director (Acting), Division of Biopharmaceutics
Office of New Drug Products
FDA, CDER, OPQ
Paul received his BS in Biochemistry from the University of Maryland at College Park in 1999. Shortly thereafter, he received his Ph.D. in Pharmaceutical Sciences in 2004, from the University of Maryland, Baltimore, focusing in the area of biopharmaceutics and pre-formulation. Paul has worked for the FDA for over 12 years. Upon joining the Agency, he spent 5 years in the Office of Generic Drugs, where he served as bioequivalence team leader and dissolution specialist. After his time at OGD, he also served as the lead for the Compendial Operations and Standards and Technology Team in CDER in the Office of Pharmaceutical Science. In this capacity, he was responsible for overseeing all activities as they related to the United States Pharmacopeial Convention as well as other standards setting organizations. In 2014, Paul joined the Office of New Drug Quality Assessment as lead of the Biopharmaceutics Staff. With the reorganization to the Office of Pharmaceutical Quality, he is currently the acting Director of the Division of Biopharmaceutics in the Office of New Drug Products, and oversees the direction and review processes of both NDA and ANDA related Biopharmaceutics issues. Additionally, his professional experience included time at the National Institute of Standards and Technology, Shire Labs, Inc., and the Walter Reed Army Institute of Research.
Ramesh K. Sood, Ph.D.
Senior Scientific Advisor (Acting)
Office of New Drug Product, OPQ/CDER/FDA
Dr. Ramesh K. Sood is a Senior Scientific Advisor (acting) in the Office of New Drug Product, Food and Drug Administration, Silver Spring. He received his Ph.D. in organic chemistry from Queen’s University, Kingston, Canada. Prior to joining the FDA, Ramesh has worked for several years in academic settings and biopharmaceutical industry. He joined FDA in 2001 as a review chemist. During his period at the FDA, he has held positions of a Team Leader, Branch Chief, Acting Division Director and Acting Deputy Office Director for Science and Policy in the Office of New Drug Quality Assessment.
Robert Temple, M.D.
Deputy Center Director for Clinical Science
FDA, CDER
Robert Temple serves as CDER’s Deputy Center Director for Clinical Science and also Acting Deputy Director of the Office of Drug Evaluation I (ODE-I). He has served in this capacity since the office’s establishment in 1995. In his current position, Dr. Temple oversees ODE-1 which is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug products. Dr. Temple has a long-standing interest in the design and conduct of clinical trials. He has written extensively on this subject, especially on choice of control group in clinical trials, evaluation of active control trials, trials to evaluate dose-response, and trials using “enrichment” designs.
Alfred Tonelli, Ph.D.
Compound Development Leader
Johnson & Johnson PRD
Gretchen Trout
Head, North America Policy & FDA Liaison
Regulatory Affairs
Novartis Pharmaceuticals Corp.
Gerald J. Yakatan, Ph.D.
Founder & Chairman
IriSys, Inc.
Gerald J. Yakatan, Ph.D. is a serial entrepreneur who has been a founder of multiple companies in the pharmaceutical R&D arena and currently serves as Chairman & CEO of IriSys, Inc., a CDMO specializing in formulation development, cGMP manufacturing of clinical trials materials and commercial products and consulting in drug development and FDA strategy. He served as President & CEO of Avanir Pharmaceuticals where he led development efforts resulting in the NDA submission for Nuedexta® and was responsible for the development, regulatory approval and commercialization of Abreva®. Dr. Yakatan has also served as Pharmaceutics Chair at University of Texas at Austin; VP for Product Development Worldwide at Warner Lambert/Parke Davis; and Founder and CEO at Tanabe Research Labs, USA. He has served on the Boards of numerous not-for-profit organizations and received distinguished alumnus awards from Temple University and from the University of Florida.
Lawrence Yu, Ph.D.
Deputy Director (Acting)
Office of Pharmaceutical Science
FDA, CDER
Issam Zineh, PharmD, MPH, FCP, FCCP
Director, Office of Clinical Pharmacology
Office of Translational Sciences
CDER, FDA
M. Lynn Crismon, Pharm.D., FCCP, BCCP
Dean, James T. Doluisio Regents Chair in Pharmacy Fellowship, Behrens Inc.,
Centennial Professor of Health Outcomes & Pharmacy Practice
The University of Texas at Austin College of Pharmacy
Conference Coordinators:
Glen Baumgart, Ph.D.
Director • Continuing and Professional Education
The University of Texas at Austin College of Pharmacy
Jody Michael Curtis
Events Coordinator • Continuing and Professional Education
The University of Texas at Austin College of Pharmacy
Jennifer Bosworth, PharmD
Assistant Director • Continuing and Professional Education
The University of Texas at Austin College of Pharmacy
