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2016 Speakers

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REGULATORY / GOV INDUSTRY ACADEMIC / ASSOCIATIONS
The Honorable Michael C. Burgess, M.D.
26th District of Texas
United States House of Representatives

John Baldoni, Ph.D.
Senior Vice President
Platform Technology & Science
GlaxoSmithKline

M. Lynn Crismon, Pharm.D., FCCP, BCCP
Dean, Centennial Professor of Health Outcomes & Pharmacy Practice
UT Austin College of Pharmacy


Rick Friedman, Ph.D.
Deputy Director
Science & Regulatory Policy
FDA, CDER, OMQ

John M. Engel, Esq.
Founder and Managing Member
EngelNovitt, PLLC

Jogarao Gobburu, Ph.D.
Professor, Executive Director
Center for Translational Medicine
Schools of Pharmacy & Medicine
University of Maryland

Jonathan P. Jarow, M.D.
(Representing Janet Woodcock)
Senior Medical Officer to the Director
FDA, CDER


Matthew C. Fontana, M.D.
Vice President and Chief Medical Officer, Pharmacy
Health Care Service Corporation


Kay Holcombe
Senior Vice-President
Science Policy
Biotechnology Industry Association (BIO)

Lisa M. LaVange, Ph.D.
Director
Office of Biostatistics Organization
Center for Drug Evaluation and Research


Prajakti Kothare, Ph.D.
Director
Global Preclinical ADME
Merck


Kenneth I Kaitin, Ph.D.
Professor and Director
Tufts Center for the Study of Drug Development
Tufts University School of Medicine

Mehul Mehta, Ph.D.
Director, Division of Clinical Pharmacology I Office of Clinical Pharmacology
FDA, CDER, OTS


Sriram Krishnaswami, Ph.D.
Senior Director
Clinical Pharmacology
Pfizer


Robert J. Meyer, M.D.
Associate Professor
Public Health Sciences Director
Inaugural Director of Virginia Center for Translational and Regulatory Sciences
University of Virginia School of Medicine

Sarah Pope Miksinski, Ph.D.
Acting Director
Office of New Drug Products
FDA, CDER, OPQ

Ann D. Kwong, Ph.D.
Founder and CEO
TREK Therapeutics, PBC


Kara M. Morgan, PhD.
Research Leader
Health and Analytics
Battelle Memorial Institute


Paul Seo, Ph.D.
Lead (Acting), Biopharmaceutics Staff
Office of New Drug Quality Assessment
FDA, CDER,OPS

Manfred Maeder, Ph.D.
Head of Group Compliance & Audit for Devices and Combination Products
Novartis


Brian Otis, Ph.D.
Director
Google Life Sciences
Research Associate Professor
University of Washington


Robert Temple, M.D.
Deputy Center Director for Clinical Science
Acting Deputy Director of the Office of Drug Evaluation I (ODE-1)
FDA, CDER


Mark McCamish, M.D., Ph.D.
Head Global Biopharmaceutical Development
Sandoz


Anne McDonald Pritchett, Ph.D.
Vice-President
Policy and Research
PhRMA

Issam Zineh, PharmD, MPH, FCP, FCCP
Director, Office of Clinical Pharmacology
Office of Translational Sciences
FDA, CDER


Roger Nosal
Vice President of Global Chemistry Manufacturing and Controls
Pfizer


Kara M. Morgan, Ph.D.
Research Leader, Health and Analytics
Battelle Memorial Institute

 

Karen Weiss, M.D.
Vice President
Global Regulatory Policy and Intelligence
Janssen Pharmaceutical Companies of Johnson & Johnson


Ellen V. Sigal, Ph.D.
Chairperson and Founder
Friends of Cancer Research

    Salomon Stavchansky, Ph.D.
ICD2 Conference Scientific Chair
Professor of Pharmaceutics
UT Austin College of Pharmacy

     

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John Baldoni, Ph.D.
Senior Vice President
Platform Technology & Science
GlaxoSmithKline

John Baldoni is Senior Vice President, Platform Technology and Science (PTS), GSK Pharma R&D.  PTS spans the entire spectrum of drug discovery and development contributing to target characterization and pre-candidate selection through commercial launch and life-cycle management of marketed medicines. Working in partnership with pipeline owners, PTS conducts a range of major activities including provision of materials and knowledge needed to test the potential of a molecule in early drug discovery; assessment of risks associated with candidate molecules using in vitro and non-clinical models; and provision of the chemistry, formulation and manufacture of the physical drug product for Global Manufacturing and Supply.  These accountabilities cover the pharmaceutical pipeline of small molecules, biopharmaceuticals, and cell and gene therapies.  In addition to these activities, PTS is a key contributor to the modernization of R&D. 

John joined GSK in 1989 and has worked in the pharmaceutical industry for 34 years.  His experience spans new chemical entity design, development and commercialization, and biopharmaceutical development.  In progressing to his current role, John has held various positions at GSK including Senior Vice President, Preclinical Development; Vice President, Product Development; Director, Product Development; and Assistant Director, Biopharmaceutical Formulation Development, among others.  He has led a number of key cross-functional problem- solving and strategic initiatives.  He co-chairs the New Product Supply Board with the President of Global Manufacturing and Supply and is a former member of GSK’s Pharma Portfolio Investment Board , R&D’s Scientific Review Board and Technology Investment Board.  John has a BS in biochemistry (1974), and MS and PhD degrees in chemistry (1980) from Penn State University. 

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The Honorable Michael C. Burgess, M.D.
26th District of Texas
United States House of Representatives

After spending nearly three decades practicing medicine in North Texas The Honorable Micheal C. Burgress has served the constituents of the 26th District since 2003 in the United States House of Representatives.

Burgress currently serves on the prestigious House Energy and Commerce Committee where he serves as Chairman of the House Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade and sits on the Subcommittees on Health and Oversight and Investigations. He is a member of the Rules Committee and the Helsinki Commission. In 2009, Burgress founded the Congressional Health Caucus, on which he serves as co-chairman.

Because of his medical background, he has been a strong advocate for health care legislation aimed at reducing health care costs, improving choices, reforming liability laws to put the needs of patients first, and ensuring there are enough doctors in the public and private sector to care for America’s patients and veterans. He has voted to repeal the Affordable Care Act 54 times. He has played an important role in bipartisan efforts to reform the Food and Drug Administration.

- Bio copied from: http://burgess.house.gov/about/#sthash.sOF2auPW.dpuf

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M. Lynn Crismon, Pharm.D., FCCP, BCCP
Dean, Centennial Professor of Health Outcomes & Pharmacy Practice
UT Austin College of Pharmacy

Dr. Crismon received his BS degree in Pharmacy from The University of Oklahoma and his Doctor of Pharmacy degree from a joint program of The University of Texas at Austin and The University of Texas Health Science Center at San Antonio. He completed residencies in pharmacy practice at the USPHS Gallup Indian Medical Center and in psychiatric pharmacy practice at The University of Texas and San Antonio State Hospital, and completed a National Endowment for the Humanities–funded summer fellowship in biomedical ethics, with a focus in cross cultural ethics, at the Kennedy Institute for Ethics, Georgetown University. He served as a visiting professor for the Institute of Mental Health, National Health Group, Singapore, and for the pharmacy program at the University of Technology, Kingston, Jamaica. He is board certified in psychiatric pharmacy by the Board of Pharmaceutical Specialties, and he is a Diplomat of the American Board of Clinical Pharmacology.

Dr. Crismon served as Co-Director of the Texas Medication Algorithm Project and as Director of the Children’s Medication Algorithm Project. He co-chaired the revisions and updates of the Psychotropic Medication Prescribing Parameters for the treatment of foster children with mental disorders for the Texas Department of Family and Protective Services, and he is a member of the steering committee for the Mini- Fellowship in Primary Pediatric Psychopharmacology sponsored by the REACH Institute, NYC, NY. He serves as a member of the Internal Advisory Panel for the Veterans’ Affairs VISN 17 Center of Excellence for Research on Returning War Veterans. In addition to over 240 articles, chapters, or handbooks to his credit, he has over 200 abstracts in print or in press, and has delivered more than 400 invited lectures or presentations. He served as associate editor of the APhA Drug Treatment Protocols, 2nd edition, and he is a member of the editorial advisory boards for The Annals of Pharmacotherapy and the APhA DrugInfoLine, and is a reviewer for numerous journals.

Dr. Crismon developed a nationally recognized training program in psychiatric pharmacotherapy and mental health outcomes research. He supervised 39 post Pharm.D. psychiatric pharmacy residents, research fellows, or graduate students. He served as supervisor for the ASHP Foundation Psychiatric Drug Therapy Research Fellowship (twice), the American College of Clinical Pharmacy (ACCP) Psychopharmacy Research Fellowship, U.S. Pharmacopoeia Fellowship, and the NIMH F 32 post professional doctorate research training award. Seven of his research trainees were awarded New Investigator Awards by the NIMH at the New Clinical Drug Evaluation Unit Meeting.

Dr. Crismon served as a member of the ACCP Board of Regents, and he is an ACCP fellow. A past chair of the ASHP Specialty Practice Group on Psychopharmacy and the task force to recognize psychiatric pharmacy as a specialty by the Board of Pharmaceutical Specialties (BPS), he was the first chair of the BPS Specialty Council on Psychiatric Pharmacy Practice. He currently serves as chair-elect for the AACP Council of Deans and as a member of the AACP Board of Directors, member of the ACCP Research Institute Board of Trustees, and as a 2011-12 member of the ASHP Commission on Goals. He is a recipient of the University of Oklahoma College of Pharmacy Distinguished Alumnus Award, the Robert G. Leonard Memorial Lecture Award, the Philip C. and Ethyl F. Ashby Endowed Lecture Award, the CPNP Judith K. Saklad Lecture Award, he was the 2010 Teacher of the Year for the UT Southwestern Medical Center - Austin Child and Adolescent Psychiatry Residency Program, and a First Tennessee Chair of Excellence Distinguished Visiting Professor, College of Pharmacy, The University of Tennessee Health Sciences Center, April 2011.

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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 after 15-plus years with another Washington boutique firm.  Mr. Engel specializes in food and drug law and administrative law, science and regulatory policy, and legislation impacting the life sciences industry.  In his practice, Mr. Engel provides legal counsel and strategic advice on regulatory, intellectual property, promotion and advertising, and manufacturing compliance issues confronting multinational and domestic biopharmaceutical and health-care companies, biomedical researchers, academic institutions, health-care providers, and patient advocates.  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.  He has worked extensively on the full range of legal/regulatory issues arising in connection with drug and biologic R&D, including developing the entirety of regulatory submissions (e.g., briefing documents, Citizen’s Petitions, white papers, and INDs and NDAs) and managing sponsors’ interactions with FDA and other global regulatory authorities.  He also is routinely engaged as a regulatory expert witness in various litigations and to provide expert affidavits in legal proceedings in the U.S. and overseas under the Hague Convention.  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.  Mr. Engel is a member of the Virginia State Bar and District of Columbia Bar.  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.

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Rick Friedman, Ph.D.
Deputy Director
Science & Regulatory Policy
FDA, CDER, OMQ

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 authored several publications on topics including sterile drugs and quality systems, and was awarded The George M. Sykes Award by the Parenteral Society for outstanding journal paper for the year 2005. He also recently received the 2011 Kenneth Chapman Achievement Award from the Institute of Validation Technology, and the 2012 Gordon Perseneus Award from PDA for scientific contributions in the area of drug quality.  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.  

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Matthew C. Fontana, M.D.
Vice President and Chief Medical Officer, Pharmacy
Health Care Service Corporation

As Vice President and Chief Medical Officer of Pharmacy, Dr. Matthew Fontana manages the design and execution of HCSC pharmacy benefits and programs. In this role, he leads a team of pharmacists, clinicians and other healthcare specialists in developing tools and relationships that enable pharmacotherapeutics and pharmacy related services to be delivered at lower costs and with enhanced quality. Dr. Fontana received his bachelor’s degree from Harvard University where his course of study was concentrated in biology and molecular evolution. He attended the Medical College of Pennsylvania and completed his Internal Medicine residency at the University of Texas Health Science Center at San Antonio. He is a diplomate of the American Board of Internal Medicine and serves as an elected officer of the New Mexico Medical Society. Dr. Fontana joined HCSC in 2008 as the Chief Medical Officer for Blue Cross and Blue Shield of New Mexico before assuming his current role in 2011.

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Jogarao Gobburu, Ph.D.
Professor, Executive Director
Center for Translational Medicine
Schools of Pharmacy & Medicine
University of Maryland

Dr. Gobburu is a Professor with the School of Pharmacy and the School of Medicine, University of Maryland, Baltimore, MD, USA. He held various positions at the US FDA between 1999 and 2011. Under his leadership, a Division of Pharmacometrics was formed at the FDA and several policies were established. He is a world-recognized scientific leader in the area of quantitative disease models and their application to decisions. Dr. Gobburu is best known for transforming the field of Pharmacometrics across the world into a decision-supporting science. He also established a Pharmacometrics Fellowship program at the FDA. He received numerous FDA awards such as the Outstanding Achievement Award. He also received the Outstanding Leadership Award from the American Conference on Pharmacometrics (2008) and the Tanabe’s Young Investigator Award from the American College of Clinical Pharmacology (2008). Dr. Gobburu is on the Editorial Boards of several journals. He has published over 60 papers and book chapters.

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Kay Holcombe
Senior Vice-President Science Policy
Biotechnology Industry Association

Kay Holcombe, Senior Vice President for Science Policy at the Biotechnology Industry Organization, works with the organization on all major policy initiatives, with a particular focus on regulatory policy. Prior to joining BIO, she was Vice President, FDA Alliances and Federal Agency Relations, at Sanofi and Vice President for Government Relations at Genzyme Corporation. Kay works with government relations, policy, and legal staff as well as with principals of BIO member companies to develop and implement policies that advance the public health through biotechnology and to develop appropriate responses to government initiatives that affect the biopharmaceutical industry broadly.

Before joining Genzyme in 2006, Kay spent 8 years as Executive Vice President of Policy Directions Inc., a government relations firm specializing in strategic planning and legislative and regulatory advocacy regarding health care and related issues. She represented a variety of clients in the pharmaceutical and biotechnology, food, and consumer products industries and in academia, providing strategic advice and assistance and advocacy at federal regulatory and funding agencies and in the U.S. Congress.

Kay received her B.S. in chemistry education from the University of Illinois and her M.S. in chemistry from the University of Virginia. She graduated with honors and was elected to Phi Beta Kappa, Phi Kappa Phi, and Iota Sigma Pi.

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Jonathan P. Jarow, M.D.
(Representing Janet Woodcock)
Senior Medical Officer to the Director
FDA, CDER

Dr. Jonathan P. Jarow has worked at the FDA for five years.  He is the Senior Medical Officer to the Director, Center for Drug Evaluation and Research. Jonathan previously served as acting director, Office of Medical Policy and the associate director of the Office of Hematology and Oncology Products.  He is a Board Certified Urologist and prior to joining the FDA he was in academic medicine for over 20 years.  His last appointment was Professor of Urology, Pathology, Radiology, and Molecular Biology & Biochemistry at Johns Hopkins University. 

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Lisa M. LaVange, Ph.D.
Director
Office of Biostatistics Organization
Center for Drug Evaluation and Research

Lisa LaVange, PhD, is Director of the Office of Biostatistics in the Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA).  As Director, she oversees approximately 195 statistical reviewers and staff members involved in the development and application of statistical methodology for drug regulation.  Prior to joining the FDA, Dr. LaVange was Professor and Director of the Collaborative Studies Coordinating Center (CSCC) in the Department of Biostatistics, Gillings School of Global Public Health at the University of North Carolina at Chapel Hill (UNC), where she served as Principal Investigator (PI) of the coordinating centers for several large-scale multi-center clinical trials, epidemiology studies, and patient registries.  Before joining academia, Dr. LaVange spent 10 years in the pharmaceutical industry and 16 years in non-profit research.  She is a Fellow of the American Statistical Association, served as President of the Eastern North American Region of the International Biometric Society (IBS; 2007), and served on the IBS Executive Board (2013-2014).  She was formerly co-editor of the Journal of Pharmaceutical Statistics and editor-in-chief of the ASA-SIAM book series. 

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Kenneth I Kaitin, PhD
Professor and Director
Tufts Center for the Study of Drug Development
Tufts University School of Medicine

Dr. Kaitin is a Professor at Tufts University School of Medicine and is Director of the Tufts Center for the Study of Drug Development. Dr. Kaitin also holds appointments as Advisory Professor at Shanghai Medical College of Fudan University in Shanghai, 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. An internationally recognized expert on drug development science and policy, Dr. Kaitin writes and speaks regularly on factors that contribute to the slow pace and high cost of pharmaceutical R&D and efforts to improve the development process. He has provided public testimony before the U.S. Congress on pharmaceutical development, regulation, and policy issues, and he currently serves as an expert consultant to the U.S. Department of Defense on bioterror countermeasures initiatives. Dr. Kaitin is frequently quoted in the business and trade press on global R&D trends and new models of innovation. A former President of the Drug Information Association, Dr. Kaitin is currently Editor-in-Chief of Expert Review of Clinical Pharmacology. He is on the editorial boards of a number of peer-review journals, and he serves on the boards of directors and scientific advisory boards of several public, private, and not-for-profit life sciences companies and organizations. In 2011, Dr. Kaitin received the Dr. Louis M. Sherwood Award, granted by the Academy of Pharmaceutical Physicians and Investigators. Dr. Kaitin received a B.S. from Cornell University and an M.S. and Ph.D. in pharmacology from the University of Rochester.

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Prajakti Kothare, Ph.D.
Director
Global Preclinical ADME
Merck

Dr. Kothare is Director of ADME at Merck Research Laboratories. She is responsible for leading a group of Principal Investigators and laboratory-based personnel and oversight of ADME deliverables in support of various programs from discovery through life-cycle management.  Since joining Merck in 2011, Dr. Kothare has assumed leadership positions of increasing responsibility, including most recently as Early Phase Scientific Lead and Diabetes Therapeutic Area lead for Quantitative Pharmacology and Pharmacometrics. Dr. Kothare has played a critical role in building quantitative translational sciences at Merck currently as the co-lead of a Merck Research Laboratories Initiative to develop capabilities in Model Informed Drug Discovery (MIDD) and co-leading a cross-functional Translational PKPD (TPKPD)/MIDD Strategy team.  From 2001-2011, while in Global Pharmacokinetics & Pharmacodynamics at Eli Lilly and Company, she was significantly involved in the development and registration of multiple drugs.  Dr. Kothare has drug discovery, development and regulatory experience in small molecules and biotherapeutics programs across multiple therapeutic areas with deep expertise in Diabetes and Neuroscience.  Dr. Kothare has a track-record of driving change through innovation projects including the application of Dried Blood Spots in late-stage clinical trials, approaches for modernization of clinical trials, and application of in silico TPKPD in early discovery.  Dr. Kothare received a Bachelor’s degree in Pharmaceutical Sciences from the University of Bombay, India and a Ph.D. in Pharmaceutics (with a specialization in PKPD) from the University of Minnesota.

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Sriram Krishnaswami, Ph.D.
Senior Director
Clinical Pharmacology
Pfizer

Dr. Sriram Krishnaswami is Senior Director in the Department of Clinical Pharmacology at Pfizer, Groton, CT. He received his B.S. in Pharmacy from the Birla Institute of Technology and Science, Pilani, India and Ph.D. in Pharmacokinetics/Pharmacodynamics in 2000 from the University of Florida, Gainesville. Dr. Krishnaswami is clinical pharmacology group lead and is member of therapeutic area strategy and review committees for new molecular entities in the inflammation and immunology disease area. His research interests include designing dose-finding strategies using modeling and simulation for new chemical entities for diseases such as rheumatoid arthritis, psoriasis, psoriatic arthritis, lupus, atopic dermatitis and for the prevention of transplant rejection. He has won several awards including the Young Investigator Award at the American College of Clinical Pharmacology for his contributions to applying modeling and simulation methods to optimize drug therapy, and the Hench Award as a co-author of a publication in the New England Journal of Medicine. Dr. Krishnaswami has published ~50 manuscripts and ~100 abstracts, and book chapters and has an adjunct appointment at the University of Florida. He has served as chair of the AAPS modeling and simulation focus group and is currently the chair of the pharmacometrics and pharmacokinetics community at ASCPT.

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Ann D. Kwong, Ph.D
Founder and CEO
Trek Therapeutics

Ann D. Kwong, Ph.D earned her PhD in virology from the University of Chicago and is an industry leader with more than 20 years’ experience in developing successful drug candidates. She played a leading role in the development of telaprevir, a HCV protease inhibitor with > $2B in sales; and VX-787 a flu inhibitor currently in ph2. Lessons learned from the development of telaprevir can be found in Kwong, et al. (2011) Discovery and development of telaprevir: an NS3-4A protease inhibitor for treating genotype 1 chronic hepatitis C virus. Nat Biotech 29:1-11. Prior to joining Vertex, Ann worked on HSV and HCV antiviral drug discovery at Schering Plough Research Institute and helped to solve the crystal structure of HCV helicase. She is a founder of HCV DRAG (HCV Drug Development Advisory Group), a consortium of industry, clinical trial, community, and regulatory leaders working to optimize HCV drug development. Ann developed the concept of InnovaTID (Innovative Thinking for Innovative Drugs) that informs the work of her current company.

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Manfred Maeder, Ph.D.
Head of Group Compliance & Audit for Devices and Combination Products
Novartis

Manfred Maeder is currently Head of Group Compliance & Audit for Devices and Combination Products overseeing the relevant Alcon, Sandoz and Novartis Pharma sites. He joined Novartis Pharma in 2011 as Global Head of Technical R&D QA, from the medical devices company Ypsomed where he was Senior VP of Quality Management & Regulatory Affairs since 2007.

Prior to Ypsomed, he worked for Aventis, in Frankfurt/ Germany holding different positions in QA and QC. Then in Kansas City/ US where he held global responsibility for Quality and Regulatory for one of the Aventis Blockbuster products (from 2002 through 2004) and later on in charge of Quality Assurance Management for the Sanofi-Aventis Frankfurt Injectables site.

Manfred is a pharmacist by education and holds a doctorate degree in pharmaceutical analytics and statistics from the University of Wuerzburg/ Germany

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Mark McCamish, M.D., Ph.D.
Head Global Biopharmaceutical Development
Sandoz

Dr. McCamish is the Global Head of Biopharmaceutical and Oncology Injectable Development for Sandoz International, a Division of Novartis. He leads research and development of all biologics at Sandoz Biopharmaceuticals, which is the world leader in development and commercialization of biosimilars. He led the submission and approval of the first biosimilar approved by the US FDA (Zarxio) with a 14:0 Oncology Drug Advisory Committee recommendation. His responsibilities include oversight of cloning, technical development, scale-up, pre-clinical and clinical development of biologics including interfaces with regulatory authorities worldwide. He is a senior executive with extensive therapeutic and commercial experience in global pharmaceutical and biotechnology companies. He has held professorships and maintained academic practices at the University of California, Davis and The Ohio State University.

He has published broadly in several therapeutic areas in multiple journals including The New England Journal of Medicine, Journal of the American Medical Association, and Lancet. The 2013 European Antibody Congress Dr. McCamish as the 12th most influential person in the global antibody industry.

 He earned his bachelor’s and master’s degrees in exercise physiology from the University of California, Santa Barbara. His PhD is in human nutrition from Penn State University and his M.D. is from the University of California, Los Angeles. Dr. McCamish is Board Certified in Internal Medicine and Nutrition and Metabolism and he is licensed as a physician and surgeon in California.

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Mehul Mehta, Ph.D.
Director, Division of Clinical Pharmacology I Office of Clinical Pharmacology
FDA, CDER, OTS

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 Cardio-Renal, 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 co-chairs 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. Current research interests include therapeutic equivalence of complex modified release products, disease progression modeling in Parkinson’s disease, efficacy extrapolation in pediatrics for epilepsy drugs, and possible extension of BCS based biowaivers. He has authored numerous publications, guidances and book chapters. He was recognized as AAPS Fellow in 2012.

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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.  He is a member of the United States Pharmacopeia Expert Panel revising the Medicare Model Guidelines and on the Benefit-Risk Advisory Council for FasterCures.  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 was responsible for leading an organization of over 1000 individuals in the oversight of all regulatory strategy and operations, global regulatory policy and intelligence, and global product safety and pharmacovigilance.  At Merck, Dr. Meyer 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 2012-13, and served as a key PhRMA negotiator on PDUFA V.

Prior to Merck, Dr. Meyer worked for the U.S. Food and Drug Administration (FDA) from 1994-2007.  In his last 5 years at the FDA,  Dr. Meyer was as the Director for the Office of Drug Evaluation II (ODEII) within Center for Drug Evaluation and Research (CDER), with responsibilities for pulmonary and allergy, metabolic and endocrine, and analgesics, anesthetics and rheumatologic drug products.  Dr. Meyer was involved in several CDER initiatives, amongst them chairing the development of the Pre-Market Risk Assessment guidance.  Additionally, he participated with the FDA negotiation team for PDUFA III and IV.  While at FDA, Dr. Meyer served as a technical expert to the Medical Aerosols Technical Options Committee to the Montreal Protocol on the Protection of the Ozone Layer, work for which he was recognized by both United Nations Environmental Programme and the US EPA.   He also served on the third expert panel for the National Heart, Lung and Blood Institute's National Asthma Education and Prevention Program (NAEPP EPR3).  Prior to joining FDA, Dr. Meyer was a practicing pulmonologist and critical care specialist on the faculty of the Oregon Health Sciences University, where he helped create the medical service for the Lung/Heart-Lung Transplantation service.  Dr. Meyer received his medical degree from the University of Connecticut School Of Medicine and his bachelor’s degree in natural science from Lehigh University.

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Sarah Pope Miksinski, Ph.D.
Acting Director
Office of New Drug Products
FDA, CDER

Sarah Pope Miksinski, Ph.D., is the Acting Director of CDER's Office of New Drug Products (ONDP), where her primary responsibilities include leadership of activities and operations related to quality review of newly-proposed 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 (2000-2002). 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.

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Kara M. Morgan, PhD.
Research Leader
Health and Analytics
Battelle Memorial Institute

Dr. Morgan has sixteen years of experience in risk analysis and decision analysis. She earned her B.S. in Mathematics from Michigan State University, her M.S. in Environmental Science from Indiana University, and her Ph.D. in Engineering and Public Policy from Carnegie Mellon University.  After earning her Ph.D., she worked for four years at Research Triangle Institute, supporting the Environmental Protection Agency with the use of data-based decision making methods.  Then, she spent 10 years at the U.S. Food and Drug Administration, working to support the development and implementation of risk-based decision making tools and to implement strategic program planning for improving the achievement of outcomes.  She is currently a research leader at Battelle Memorial Institute in the Health and Analytics sector.  In that role, she works with clients to improve their use of data to inform decision making, supports knowledge management tasks related to quality measures for healthcare improvement, and works with clients to assess the outcomes their programs are achieving.  She is also an adjunct professor at the Ohio State University’s Glenn College of Public Affairs, where she teaches courses on risk and decision analysis.

Dr. Morgan’s professional focus has been on developing tools and methods for supporting effective data-driven risk management decisions.  Her areas of emphasis include performance measurement, strategic planning, program evaluations, knowledge management, risk and decision analysis, and application of these tools and methods to improve decision making and improve outcomes.

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Roger Nosal
Vice President of Global Chemistry Manufacturing and Controls
Pfizer

Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer.  He is accountable for investigational, commercial & post approval regulatory CMC submissions globally for new chemical, biological, vaccine & device candidates & consumer health products.  Roger has contributed to the evolution of Quality by Design & has been an advocate for global regulatory harmonization through several technical PhRMA, ICH, ISPE, ILF, AAPS, IFPAC, ACS & DIA committees.  He is currently Chair of ISPE Pharmaceutical Engineering and DIA Program Committee - Quality Co-Chair.

Roger’s 34 years of experience at G. D. Searle, Monsanto, Pharmacia & Pfizer, includes 21 years in regulatory CMC.  Prior to his regulatory role, Roger was a Medicinal Chemist, author on 24 patents for several medicinal candidates (PAF, leukotriene, 5-HT3 & 5-HT4 antagonists & agonists, COX-2 & serotonin inhibitors) & a Process Chemist, focused on synthetic development & analytical control of derivatives of aspartame & manufacturing optimization of prostaglandin syntheses.

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Brian Otis, Ph.D.
Director
Google Life Sciences
Research Associate Professor
University of Washington

Dr. Brian Otis is a Director at Google Life Sciences and a Research Associate Professor at the University of Washington, Seattle. He received a B.S. in electrical engineering from the University of Washington, Seattle, and a M.S. and Ph.D. degree in electrical engineering from the University of California, Berkeley. He joined the faculty of the University of Washington in 2005 where he founded a chip design research lab that develops tiny, low power wireless chips for a variety of applications (neural recording, implantable devices, wearable on-body wireless sensors, environmental monitoring, etc). He has previously held positions at Intel Corporation and Agilent Technologies and has been with Google Inc since 2012. He is a founder of Google [x]’s smart contact lens project and leads the engineering efforts at Google Life Sciences. He has served as a member of the Technical Program Committee of the International Solid-State Circuits Conference (ISSCC) and Associate Editor of the Journal of Solid State Circuits (JSSC). His research interests include low power SoC design, exploring limitations of power and size of wireless systems, and the realization of novel biomedical devices.

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Anne McDonald Pritchett, Ph.D.
Vice-President
Policy and Research
PhRMA

Anne McDonald Pritchett, Ph.D., is Vice President, Policy and Research, at the Pharmaceutical Research and Manufacturers of America (PhRMA). Her primary focus is overseeing the development of legislative and policy analysis and research studies on a range of issues impacting innovative biopharmaceutical companies including intellectual property issues, FDA policy issues, and other issue areas impacting the environment for innovation. In addition to her public policy work, she and her team lead the development of a range of educational and other materials focused on explaining the R&D process, the value of innovation, and the role and contributions of the innovative biopharmaceutical industry.

Previously, she served as Deputy Vice President, Strategic Planning, for PhRMA.  She continues to staff PhRMA’s strategic planning efforts as well as serves as policy lead on a range of issues from biologics and biotechnology issues to intellectual property and competitiveness issues.  She also focuses on the broad range of policies related to fostering a favorable environment for innovation and the industry’s sustainability and growth.

She has 20 years’ experience in strategy, policy analysis, program development, and research.  Prior to joining PhRMA, she served in the White House Drug Policy Office for almost 8 years focusing on policy development and analysis as well as oversaw a range of research efforts including a multi-year evaluation of the National Anti-Drug Media Campaign. Before joining the White House Drug Policy Office, she held positions as the Director of Government Affairs and Public Relations for a small medical association as well as senior positions with several contract research firms providing communications, policy analysis, and research and evaluation support to a range of federal agencies from the U.S. Department of Justice to the Centers for Disease Control and Prevention and several Institutes of the National Institutes of Health.

She holds an MPA from George Mason University and a PhD in public administration and public affairs from Virginia Polytechnic Institute and State University

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Paul Seo, Ph.D.
Lead (Acting), Biopharmaceutics Staff
Office of New Drug Quality Assessment
FDA/OMPT/CDER/OPS/

Dr. Paul Seo has worked for the FDA for over 10 years. Paul received his Ph.D. in Pharmaceutical Sciences in 2004, under the direction of Dr. Jim Polli at the University of Maryland, Baltimore, focusing in the area of biopharmaceutics and pre-formulation. Upon joining FDA, Paul spent 5 years in the Office of Generic Drugs, where he served as a bioequivalence reviewer, bioequivalence review team leader, dissolution specialist, and USP Biopharmaceutics Expert Committee liaison. He has also served as the lead for the Compendial Operations and Standards and Technology Team in the Office of Pharmaceutical Science Immediate Office. 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 his current role as the Director (Acting) of the Division of Biopharmaceutics in the Office of New Drug Products, he oversees the direction and review processes of the Division, as they pertain to 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.

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Ellen V. Sigal, Ph.D.
Chairperson and Founder
Friends of Cancer Research

Ellen V. Sigal, PhD, is Chairperson and Founder of Friends of Cancer Research (Friends), an organization based in Washington, DC. Friends spearheads groundbreaking partnerships to accelerate the pace of innovation for patients. 
Friends’ unique collaborative model convenes key thought leaders to enhance innovation through scientific, cultural, regulatory, and legislative solutions. Friends works with federal health agencies, Congressional leadership, academic research centers and private sector industry, producing real results.
Dr. Sigal is Vice Chair, and currently Acting Chair of the inaugural board of directors of the ReaganUdall Foundation, a partnership designed to modernize medical product development, accelerate innovation and enhance product safety in collaboration with the U.S. Food and Drug Administration. She serves on the Board of the Foundation for the National Institutes of Health, where she chairs its Public Private Partnerships Committee.
In 2010, Dr. Sigal was appointed to a six-year term on the Board of Governors of the Patient Centered Outcomes Research Institute (PCORI) as a representative of patients and health consumers.
She also holds leadership positions with a broad range of cancer advocacy, public policy organizations and academic health centers including: MD Anderson Cancer Center External Advisory Board, the Duke University Cancer Center Board of Overseers, and The Sidney Kimmel Comprehensive Cancer Center Advisory Council.

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Salomon Stavchansky, Ph.D.
ICD2 Conference Scientific Chair
Professor of Pharmaceutics
UT 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 Sloan-Kettering Institute for Cancer Research involved the synthesis of carbon-II 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 recently served as an ad-hoc member in the Clinical Pharmacology and Pharmaceutical Sciences Advisory Committee of the Food and Drug Administration. Dr Stavchansky is a fellow of the American Association of Pharmaceutical Scientists (AAPS), an expert member of the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation (FIP). Corresponding Member of the National Academy of Pharmaceutical Sciences of Mexico, Corresponding Member of the National Academy of Pharmaceutical Sciences of Chile, Honorary member of the Mexican Pharmaceutical Association, Honorary Member of the United States Pharmacopeial Convention, and has served as advisor and external tutor of The Council of Science and Technology of Mexico. The jury presided by the President of the Commission of Honor and Justice of the Colegio Nacional de Químico Farmacéuticos Biólogos of Mexico, the oldest pharmacy guild in Mexico, recently awarded Dr. Stavchansky the Recognition to Pharmaceutical Excellence in the category of Professional Trajectory in Research and Education. Dr. Stavchansky presently served as Chair of the International Health Committee and served as a member of the Executive Committee of the Council of Experts of the United States Pharmacopeia (USP), Chair of the USP Expert Committee on Bioavailability and Nutrients Absorption and member of the Policy Committee of the USP. He recently served on the Advisory Committee to the Office of Generic Drugs and on the Pharmaceutical Science Advisory Committee of the Food & Drug Administration. Dr. Stavchansky was a member of the review committee on drug delivery systems for The National Institute of Child Human Development and The National Institute on Drug Abuse and served as an ad-hoc reviewer for the National Institute of Health and reviewer for NIH Small Business Grants. Dr. Stavchansky served in the expert panel of the World Health Organization and the Pan American Health Organization (PANHDRA) in the area of bioavailability and bioequivalence drugs and biologics. He served as a special advisor to the National Agency of Sanitary Vigilance in Brazil during the drafting of the regulation of generic drug products. Dr. Stavchansky was also a member of the Bioavailability Steering Committee of the American Pharmaceutical Association. He served as Chairman of the Translation Committee of the USP into Spanish.

Dr. Stavchansky presently serves in The University of Texas at Austin Policy Committee on Promoting Objectivity in Research Managing, Reducing or Eliminating Financial Conflict of Interest, and served in the Faculty Council, the Budget Committee, the Graduate Assembly, the Academic Committee of the Graduate Assembly, and the Committee for International Studies
Dr. Stavchansky has directed and participated in research concerning: 1) the development of analytical methodology for the measurement of drugs in biological fluids, the absorption, metabolism, distribution, and elimination of drugs from biological fluids in animals and man, and the evaluation and design of drug delivery systems, 2) the link of solubility, permeability, and drug transport through biological membranes, and 3) the conduct morphometric studies of the intestinal epithelium to elucidate the effect of formulation excipients.

Presently, Dr. Stavchansky's research group is exploring cytoprotection from oxidative stress at the molecular level, 2) integration of system biology to pharmacodynamics and pharmacokinetics, and 3) targeted nano-delivery of drugs. Dr Stavchansky continues his research efforts in the area of generic drugs and biosimilars. This work has resulted in over 150 publications, more than 270 national and international presentations and two book chapters. Dr. Stavchansky has supervised and contributed to dissertations, theses, and reports for many Master and Ph.D. students.

Dr. Stavchansky has served on the ICD2 planning committee since 1974, and has served as the Conference Scientific Chair since 1987.

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Robert Temple, M.D.
Deputy Center Director for Clinical Science
Acting Deputy Director of the Office of Drug Evaluation I (ODE-1)
FDA, CDER

Dr. Robert Temple has been Deputy Center Director for Clinical Science at FDA’s Center for Drug Evaluation and Research since 2009, participating in the direction of the Center’s operations. He is also Acting Deputy Director of the Office of Drug Evaluation I (ODE-I).  ODE-I is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug products.  Dr. Temple served as Director, Office of Medical Policy from 1999-2009. The Office of Medical Policy is responsible for regulation of promotion through the Office of Prescription Drug Products (formerly, Division of Drug Marketing, Advertising, and Communication) and for assessing quality of clinical trials. Dr. Temple has a long-standing interest in the design and conduct of clinical trials and has written extensively on this subject, especially on choice of control group in clinical trials, evaluation of active control and non-inferiority trials, trials to evaluate dose-response, and trials using “enrichment” designs.

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Karen Weiss, M.D.
Vice President
Global Regulatory Policy and Intelligence
Janssen Pharmaceutical Companies of Johnson & Johnson

 

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Janet Woodcock, M.D.
Director
FDA, CDER

NOTE: Due to new scheduling conflicts, Dr Woodcock will not be in attendance at ICDD. She is sending Jonathan P. Jarow, MD as her represenative. Dr Woodcock will still be a contributor to the ICDD, and we thank her for her continued support of this event. We hope to see her in 2017.
- February 3, 2016

Janet Woodcock is Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). As of January 2015, Dr. Woodcock also assumed the role of Acting Director of CDER’s newly formed Office of Pharmaceutical Quality, (OPQ). Dr. Woodcock first joined CDER in 1994.  For three years, from 2005 until 2008, she served FDA’s Commissioner, holding several positions, including as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations, and Chief Operating Officer.  Her responsibilities involved oversight of various aspects of scientific and medical regulatory operations.  Before joining CDER, Dr. Woodcock served as Director, Office of Therapeutics Research and Review, and Acting Deputy Director in FDA’s Center for Biologics Evaluation and Research.  Dr. Woodcock received her M.D. from Northwestern Medical School and completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco.  She joined FDA in 1986.

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Issam Zineh, PharmD, MPH, FCP, FCCP
Director, Office of Clinical Pharmacology
Office of Translational Sciences
CDER, FDA

Dr. Zineh is Director, Office of Clinical Pharmacology (OCP), and Co-Director of the Biomarker Qualification Program, Office of Translational Sciences, CDER, U.S. FDA.  From 2008-2012, Dr. Zineh was the Associate Director for Genomics in OCP.  He is an experienced clinical pharmacist who was formerly on the faculty of the University of Florida (UF) Colleges of Pharmacy and Medicine and Associate Director of the UF Center for Pharmacogenomics.  Dr. Zineh received his PharmD from Northeastern University and completed his residency at Duke University Medical Center.  He did a fellowship in cardiovascular pharmacogenomics at UF where he also obtained his MPH in Health Policy and Management.  He is a recognized expert in the field of clinical pharmacology, pharmacotherapy, and personalized medicine.  As Director of OCP, Dr. Zineh is a member of the CDER Senior Management Team and leads a 200 person staff in FDA’s efforts to enhance drug development and promote regulatory innovation through applied clinical pharmacology

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Last Reviewed: February 4, 2016

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