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2015 Speakers

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Regulatory

Industry

Academic / Associations

Martha B. Donoghue, M.D.
Medical Officer
FDA, CDER, OND, OHOP

Marc Berger, M.D.
VP Real World Data and Analytics
GH&V Real World Data Lead
Pfizer, Inc.
Joel Brill, M.D.
Medical Director
FAIR Health, Inc.

Sarah Pope Miksinski, Ph.D.
Director (Acting) Office of New Drug Quality Assessment
FDA, CDER, OPS

Jesse Berlin, Sc.D.
Vice-President, Pharmacoepidimiology
Pharmaceutical Research and Development
Johnson &Johnson
John J. Castellani
President and CEO
Pharmaceuticial Research and Manufacturers of America (PhRMA)
Richard A. Moscicki, M.D.
Deputy Center Director for Science Operations
FDA, CDER
John M. Engel, Esq.
Founder and Managing Member
EngelNovitt, PLLC
The Honorable James C. Greenwood
President and CEO
Biotechnology Industry Association (BIO)
Mehul Mehta, Ph.D.
Director, Division of Clinical Pharmacology I Office of Clinical Pharmacology
FDA, CDER, OTS
Paul Huckle, Ph.D.
Chief Regulatory Officer
GlaxoSmithKline
Ben Heywood
Co-Founder, President
PatientsLikeMe
Paul Seo, Ph.D.
Lead (Acting), Biopharmaceutics Staff
Office of New Drug Quality Assessment
FDA,OMPT,CDER,OPS
Lynn Marks, M.D.
Senior VP of Projects Clinical Platform and Science
GlaxoSmithKliine
M. Lynn Crismon, Pharm.D., FCCP, BCCP
Dean, Centennial Professor of Health Outcomes & Pharmacy Practice
UT Austin College of Pharmacy
Lawrence Yu, Ph.D.
Deputy Director (Acting)
Office of Pharmaceutical Science
FDA, CDER
Charles Hoiberg, Ph.D.
Executive Director
Pfizer, Inc
Jane Perlmutter, Ph.D., M.B.A.
President and Founder of
Gemini Group
Isaam Zineh, PharmD, MPH, FCP, FCCP
Director, Office of Clinical Pharmacology
Office of Translational Sciences
FDA, CDER
Paula E. Rinaldi, RPh, MPH
US Head DRA
Novartis Pharmaceuticals

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

  Joseph Tarnowski, Ph.D.
Senior Vice President of Chemistry, Manufacturing and Controls Biopharm R&D
GlaxoSmithKline
 
  Joanne Wadestricher, M.D.
Chief Medical Officer
Johnson and Johnson
 



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Marc L. Berger, M.D.
Vice President
Real World Data and Analytics (RWDnA)

Marc L. Berger, MD, is Vice President, Real World Data and Analytics (RWDnA). Marc has held senior-level positions in industry including Executive Vice President and Senior Scientist at OptumInsight; Vice President, Global Health Outcomes at Eli Lilly and Company; and Vice President, Outcomes Research and Management at Merck & Co., Inc.

Marc has served on the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) for CMS, the steering committee for the AHRQ Centers for Research and Education on Therapeutics (CERTs), the board of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and the editorial advisory board of Value in Health.  Currently, he serves as chair of the Innovative Technology Advocacy Committee of PhRMA and he is a member of the Advisory Council for North America (ACNA) of the DIA.
 
Marc has written or co-written more than 100 peer-reviewed articles, book chapters, and other publications on a range of topics including health services research, outcomes research, health economics, and health policy. He co-edited “Health Care, Cost, Quality, and Outcomes – ISPOR Book of Terms” which was published in 2003 and was subsequently translated into nine languages.

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Jesse Berlin, Sc.D.
Vice-President, Pharmacoepidimiology
Pharmaceutical Research and Development
Johnson &Johnson

Dr. Berlin received his doctorate in biostatistics from the Harvard School of Public Health in 1988. After spending 15 years as a faculty member at the University of Pennsylvania, in the Center for Clinical Epidemiology and Biostatistics, under the direction of Dr. Brian Strom, Jesse left Penn to join Janssen Research & Development, as a Senior Director in Biostatistics.  After 2 years, he was promoted to Vice President for Epidemiology. He now serves as Vice President of Epidemiology across all of Johnson & Johnson, with responsibility for pharmaceuticals, devices and consumer products. He has authored or coauthored over 230 publications in a wide variety of clinical and methodological areas, including papers on the study of meta-analytic methods as applied to both randomized trials and epidemiology.  He served on an Institute of Medicine Committee that developed recently-released recommendations for the use of systematic reviews in clinical effectiveness research, and currently serves on the Scientific Advisory Committee to the Observational Medical Outcomes Partnership, a public-private partnership aimed at understanding methodology for assessing drug safety in large, administrative databases. He serves as a member of working group X for CIOMS (The Council for International Organizations of Medical Sciences), which is developing guidelines for meta-analysis of drug safety data in the regulatory context. He was elected as a fellow of the American Statistical Association in 2004.  In 2013, Dr. Berlin received the Lagakos Distinguished Alumni Award from the Department of Biostatistics at the Harvard School of Public Health.

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Joel Brill, M.D.
Medical Director
FAIR Health, Inc.

Joel V. Brill, MD FACP is a physician whose focus is strategy for coverage, reimbursement, quality improvement, bundled payments and accountable care. 

Dr. Brill is Board Certified in Internal Medicine and Gastroenterology.  He has run risk-bearing Independent Practice Associations and Physician-Hospital Organizations in California and Arizona.  He is the Medical Director for FAIR Health, Inc. and the Chief Medical Officer of Predictive Health, LLC. He has held management positions and currently serves on Scientific Advisory Boards / Committees for several managed care companies, Section Editor for GI & Hepatology News, and a member of the Editorial Advisory Boards for several journals.  He works extensively with the Centers for Medicare and Medicaid Services (CMS) and the American Medical Association (AMA) on coding, coverage and reimbursement issues, served as the Co-Chair of the Part D medication measures Technical Expert Panel for CMS, and works with specialty societies and other organizations on quality improvement, accountable care, bundled payment, and measure development projects.

Dr. Brill participates in the CPT Editorial Panel, the Physician Consortium for Performance Improvement (PCPI), and the AMA RBRVS Update Committee (RUC).  He is the author of several guidelines / quality measures in Gastroenterology and Preventive Services, and the lead physician for the American Gastroenterological Association (AGA) Colonoscopy Bundled Payment Project, which has developed an episode methodology, claims payment, warranty and outcomes measures for outpatient procedures.  He is the co-founder of the AGA Center for GI Innovation and Technology, which has developed observational comparative effectiveness registries, the AGA Payor Policy Workgroup, and Physician Advisor to the AGA Digestive Health Recognition Program in conjunction with Bridges to Excellence.  He is a member of the Board of Directors of the American Board of Quality Assurance and Utilization Review Physicians, Inc.

Dr. Brill is an Assistant Clinical Professor of Medicine at the University of Arizona College of Medicine, and an Adjunct Assistant Professor of Medicine at Midwestern University.  He has lectured at the School of Health Management & Policy at the WP Carey School of Business at Arizona State University. 

Dr. Brill received his undergraduate A.B. Biology at the University of California, Los Angeles, and graduated from the Rosalind Franklin University of Medicine and Science - Chicago Medical School.  He completed his Internship and Residency in Internal Medicine at the UCLA – San Fernando Valley Program, and a fellowship in Gastroenterology at Los Angeles County – USC Medical Center.  Dr. Brill completed the Management Program for Health Care Organizations at the UCLA School of Public Health.

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John J. Castellani
President and CEO
Pharmaceuticial Research and Manufacturers of America (PhRMA)

John J. Castellani is President and Chief Executive Officer of the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents America’s leading biopharmaceutical research companies. The biopharmaceutical sector directly employs over 810,000 Americans, and invested more than $50 billion in 2013 alone to develop new medicines that help patients fight disease and live longer, healthier lives.

At the nexus of public policy, health and business, Mr. Castellani leads PhRMA’s work to preserve and strengthen a healthcare and economic environment that fosters medical innovation, new drug discovery and access to life-saving medicines. He is a passionate advocate for a strong American biopharmaceutical research industry that plays a critical role in helping improve patients’ health in the U.S. and around the world.

Recognized each year by The Hill newspaper as one of America’s top health care policy experts, Mr. Castellani is a member of the Board of Trustees at Sibley Memorial Hospital and a member of the Board of Directors of the National Health Council. He was also honored with the Bryce Harlow Foundation’s prestigious Business-Government Relations Award, recognizing his leadership and exemplary, life-long contribution to the public affairs and advocacy profession.

Mr. Castellani is a former President and CEO of Business Roundtable, an association of chief executive officers of leading U.S. corporations with a combined workforce of nearly 12 million employees and $6 trillion in annual revenues.

Prior to Business Roundtable, Mr. Castellani was Executive Vice President of Tenneco, Inc.

Mr. Castellani, who began his career as an environmental scientist at General Electric, earned his bachelor’s degree at Union College in Schenectady, New York.

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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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Martha B. Donoghue, M.D.
Medical Officer, Neuro-Oncology, Pediatric Oncology, and Rare Tumors Group
FDA/CDER/OND/OHOP

Martha Donoghue is a Medical Officer with the Neuro-Oncology, Pediatric Oncology, and Rare Tumors Group in the Division of Oncology Products 2, Office of Hematology and Oncology Products, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA).  She is also the Scientific Liaison for Pediatric Solid Tumors.  Dr. Donoghue provides regulatory oversight, is engaged in clinical review activities, and provides advice to stakeholders for drugs and therapeutic biologics for the diagnosis, prevention, and treatment of cancer.  Dr. Donoghue has also served as a member of several FDA and external working groups aimed at advancing development of treatments for pediatric and adult patients with cancer.   Areas of special interest include neuroblastoma, neuro-oncology, and the use of clinical outcome assessments in clinical trials.   Prior to joining FDA in 2009, Dr. Donoghue completed a fellowship in Pediatric Hematology and Oncology at the Children’s National Medical Center after having worked for several years as a general pediatrician in private practice.  

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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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The Honorable James C. Greenwood
President and CEO of the
Biotechnology Industry Organization (BIO)

The Honorable James C. Greenwood is President and CEO of the Biotechnology Industry Organization (BIO) in Washington, D.C., which represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the annual BIO International Convention, the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. Since his appointment in January of 2005, he has markedly enhanced the trade association’s capacity – increasing both its staff and budget by nearly fifty percent. BIO is now a world class advocacy organization playing a leading role in shaping public policy on a variety of fronts critical to the success of the biotechnology industry at the state and national levels as well as internationally. Mr. Greenwood represented Pennsylvania's Eighth District in the U.S. House of Representatives from January 1993 through January 2005. A senior member of the Energy and Commerce Committee, he was widely viewed as a leader on health care and the environment. From 2001 to 2004, Mr. Greenwood served as Chairman of the Energy and Commerce Committee Subcommittee on Oversight and Investigation with oversight authority over issues in the full Committee's vast jurisdiction. He led hard-hitting investigations into corporate governance at Enron, Global Crossing and WorldCom; terrorist threats to our nation's infrastructure; and waste and fraud in federal government agencies. Prior to his election to Congress, Mr. Greenwood served six years in the Pennsylvania General Assembly (1981-86) and six years in the Pennsylvania Senate (1987-1992). Mr. Greenwood graduated from Dickinson College in 1973 with a BA in Sociology. From 1977 until 1980, he worked as a caseworker with abused and neglected children at the Bucks County Children and Youth Social Service Agency. Mr. Greenwood is married with three children and resides in Upper Makefield, Pennsylvania.

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Ben Heywood
Co-Founder, President
PatientsLikeMe

During its 10 year history, Ben has overseen all stages of PatientsLikeMe’s growth, including financing, the expansion of patient communities, and business partnerships. Today he defines the company's product strategy and roadmap and directs the user experience (UX) and engineering teams. Combined, these roles ensure PatientsLikeMe's website continuously evolves to meet patient needs, and that the patient voice continues to define value in healthcare. Ben also serves as the company’s Chief Privacy Officer.

Ben is a frequent speaker at conferences and an expert source for media on patient issues and patient-centered care. Earlier in his career, he served in manufacturing and business development roles at Target Therapeutics, the leading designer and manufacturer of microcatheter-based products for the treatment of stroke, which was later acquired by Boston Scientific. He earned his bachelor’s degree in Mechanical Engineering from the Massachusetts Institute of Technology (MIT) and his master’s degree in Business Administration from UCLA’s Anderson Graduate School of Management.

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hoiberg

Charles Hoiberg, Ph.D.
Executive Director
Pfizer, Inc

Chuck Hoiberg 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. Dr. Hoiberg has been a frequent lecturer at domestic and international programs for DIA, FIP, AAPS, PDA, ISPE, ICH, etc. on various technical and regulatory topics. He has served as the Chairman and other positions on the International Board of Directors of the International Society of Pharmaceutical Engineers and is currently on the Board of Directors of the FDA Alumni Association.  He is an Executive Director in Pfizer’s Global Regulatory CMC group.

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Paul Huckle, Ph.D.
Chief Regulatory Officer
GlaxoSmithKline

Dr. Paul Huckle is Chief Regulatory Officer and Senior Vice President-Global Regulatory Affairs at GlaxoSmithKline.  He is responsible for the filing of new submissions and support for existing licences Worldwide. He is also responsible for leading global regulatory support groups (CMC, preclinical, labelling, systems and operations), as well as Quality Assurance for the worldwide R&D organisation. He was previously Senior Vice-President of European and International Regulatory Affairs and US Regulatory Affairs in GlaxoSmithKline.

Before entering the regulatory field, he worked for ten years in pharmaceutical development with responsibility for leading the development of prescription and OTC products for both US and non-US markets.

Dr. Huckle is a Member PhRMA of the Regulatory Affairs Committee; Board Member for NUS-Duke Centre of Regulatory Excellence, Singapore; Advisory and Management Board Member of Centre for Medicines Research International Institute for Regulatory Science; and the PhRMA Topic Leader for ICH Benefit-Risk workstream.

Prior to joining industry he was a Teaching Fellow at The School of Pharmacy, University of London.  He holds an Honours degree in Pharmacy and a Ph.D. in Pharmaceutics from the University of London and is a Member of the Royal Pharmaceutical Society of Great Britain.

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Lynn Marks, M.D.
Senior VP of Projects Clinical Platform and Science
GlaxoSmithKliine

Dr. Marks currently has operational accountability for clinical trials over a broad range of disease and therapeutic areas on a global scale ranging across the Phase I to IV development landscape. Additionally he has responsibility for business support functions such as performance metrics, clinical systems support, clinical trial contracting, outsourcing strategy & implementation and GCP, as well as, core training across R&D. Further, his remit includes key capabilities such as Project Planning & Management, Study & Data Management, clinical trial Monitoring, Programming and Statistics (non-clinical and clinical). Areas of analytical science and modeling are included through the Global Health Outcomes, Genetics, Computational Biology, PK/PD modeling and Epidemiology teams. More recently the Clinical Development teams in Japan and China are his accountability. He also leads the Simplifying Clinical Development Change Initiative which focuses on increasing productivity across R&D by bringing together a focus on behaviors, processes, standards and technology. This concept has expanded to include a collaborative effort across more than 15 Pharma companies in a newly formed TransCelerate BioPharma Inc., not-for-profit entity. He is a member of multiple R&D committees focusing on the pipeline as well as people development, including being the Chair of the R&D Inclusion Council.

He joined the company in 1993 working in the Infectious Diseases Clinical organization with increasing levels of accountability. He then transferred to the Consumer Healthcare R&D team to lead an Rx to OTC switch initiative and subsequently became head of Consumer Health Medical and Regulatory Worldwide. Next he returned to Pharma R&D as head of the Infectious Diseases Therapy area. Over the next 10 years, he had the opportunity to grow and learn from varying organizational changes with resultant shifts in accountability as head of the Infectious Diseases Development group. Subsequently, he transitioned to lead the Center for Project and Study Excellence in 2008 which has now expanded to become the Projects, Clinical Platforms & Sciences team.

Dr. Marks is Board Certified in Internal Medicine and Infectious Diseases. Before joining GSK, he was on faculty at the University of South Alabama Medical Center with joint appointments in Infectious Diseases, Microbiology and Pharmacology. In addition to teaching and patient care responsibilities, he led a NIH grant funded research effort focused on the molecular genetics of bacterial pathogenicity.

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Sarah Pope Miksinski, Ph.D.
Director (Acting) Office of New Drug Quality Assessment
FDA, CDER, OPS

Sarah Pope Miksinski, Ph.D., is the Acting Director of CDER's Office of New Drug Quality Assessment (ONDQA), where her primary responsibilities include the leadership of activities and operations related to the 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 13 years ago, serving initially as a Chemistry Reviewer for reproductive/urologic drugs. Since that time, she has held additional positions within ONDQA including Chemistry, Manufacturing and Controls Lead as well as Branch Chief and Division Director. Sarah's areas of technical expertise include the characterization of complex drug substances/products, manufacture of injectable dosage forms, and spectroscopic methodology. She is currently involved in the development of the proposed Office of Pharmaceutical Quality, and she is also active in the development of enhanced collaborative approaches to facilitate the quality review of urgently needed medications.

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

 

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Richard A. Moscicki, M.D.
Deputy Center Director for Science Operations
FDA, CDER

Richard (Rich) A. Moscicki (Mo-shis-ke), M.D., serves as CDER’s Deputy Center Director for Science Operations. He shares in the executive direction of Center operations and provides leadership in overseeing the development, implementation, and direction of our programs.

Before joining CDER, Dr. Moscicki served as senior vice president (SVP), Head of Clinical Development at Genzyme Corporation. He joined Genzyme in 1992 as medical director and became the chief medical officer and SVP of biomedical and regulatory affairs in 1996 -- holding that post until 2011. Over the past two decades, Dr. Moscicki has been responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company.

Dr. Moscicki received his medical degree from Northwestern University Medical School. He is board certified in internal medicine, diagnostic and laboratory immunology, and allergy and immunology. He completed his residency with a focus on immunology, followed by a four-year fellowship at Massachusetts General Hospital (MGH) in immunology and immunopathology. He remains on staff at MGH and on the faculty of Harvard Medical School.

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Jane Perlmutter, Ph.D., M.B.A.
President and Founder of
Gemini Group

Jane Perlmutter is a long-term cancer survivor and has been involved in a number of organizations committed to educating the public cancer, supporting people affected by it, and eradicating the disease.   She is an advocate representative in several clinical trials consortia, multi-institutional grants, clinical guideline committees, grant review panels, NCI working groups, IMEDs Steering Committee and IOM Policy Committee.  She has also been an active member of the Clinical Trials Transformation Initiative.  She is especially committed to training less experienced patient advocates, has written articles and tutorials on this topics and is often involved in advocate training.

Jane has a Ph.D. in Cognitive Psychology and Masters Degrees in Educational Psychology, Computer and Information Science as well as an MBA.  She started her career as an experimental cognitive psychologist at the University of Texas in Austin, spent most of her career at Bell Labs.  She has run the Bell Technical Training Center and held and officer position in DeVry Inc., a publically traded for-profit higher education company. Jane currently runs her own consulting company—Gemini Group.  Her consulting focuses on process improvement for small businesses, not-for-profits and institutions of higher learning. 

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Paula E. Rinaldi, RPh, MPH
US Head DRA
Novartis Pharmaceuticals

Paula Rinaldi is the Vice President and US Head of Drug Regulatory Affairs for Pharmaceuticals at Novartis Pharmaceuticals Corporation.  Paula previously held the position of Global Therapeutic Area Lead in both the Primary Care and Critical Care Franchises.  
Paula began her career at E.R. Squibb and Sons (now Bristol-Myers Squibb), and subsequently held positions in Regulatory Affairs at Schering-Plough (now Merck) and Warner-Lambert (now Pfizer).  She worked in several therapeutic areas including asthma/allergy, dermatology, cardiovascular and rare diseases.  

Under her leadership, Paula has successfully brought dozens of new products to the market, including multiple new chemical entities across a wide array of therapeutic areas.  Paula is a Registered Pharmacist and received her Bachelor of Science in Pharmaceutical Sciences at Rutgers University College of Pharmacy.  She received her Master’s Degree in Public Health/Epidemiology at the University of Medicine and Dentistry of New Jersey. 

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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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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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Joseph Tarnowski, Ph.D.
Senior Vice President of Chemistry, Manufacturing and Controls (CMC) Biopharm R&D
GlaxoSmithKline

Joseph Tarnowski, Ph.D. is Senior Vice President of Chemistry, Manufacturing and Controls (CMC) Biopharm R&D at GlaxoSmithKline (GSK).  He has spent over 34 years in the pharmaceutical industry focused primarily on the research, development, registration and commercialization of biopharmaceutical products made using recombinant DNA technology.  He holds 13 patents and several patent applications for biologic products.

Joe earned a B.S. degree in chemistry from Southeast Missouri State University, a Ph.D. degree in Biochemistry from the University of Tennessee Center for the Health Sciences,  and was a post-doctoral fellow in Molecular Biology at the prestigious Roche Institute of Molecular Biology, in Nutley, NJ. 

Joe has held critical roles in the manufacturing, process development, registration, and launch of several FDA and internationally approved human therapeutic products, including Roferon® A, Alpheron N®, Fiblast® Spray, CEPRATE® SC Stem Cell Concentration System, Natrecor®, Erbitux® and Orencia®. He has a thorough understanding of the biologics drug registration process and has had extensive experience in developing the Chemistry, Manufacturing and Controls (CMC) sections of many Investigational New Drug and Biologics License Applications. 

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Joanne Waldstreicher
Chief Medical Officer
Johnson & Johnson

Joanne Waldstreicher, M.D., is Chief Medical Officer, Johnson & Johnson.   In this role, Joanne has cross-sector oversight for safety of all Johnson & Johnson products worldwide. In addition, Joanne also plays a leadership role for epidemiology, internal and external partnerships and collaborations, and development of the corporate science, technology, and R&D policies, including those related to clinical trial transparency.  Joanne also chairs the pharmaceuticals R&D Development Committee, which reviews all late stage development programs in the pharmaceutical pipeline.

Under Joanne’s leadership in her prior role as both Chief Medical Officer of the Pharmaceutical sector and Head of Asia Pacific Medical Sciences, four legacy safety groups were integrated into one independent Global Medical Safety organization. In addition, Joanne reshaped and realigned the R&D and medical affairs groups across Asia Pacific, resulting in an industry leading drug pipeline in Japan, and the company’s first ever international drug approval from a team based in China. 

Prior to becoming Chief Medical Officer in the pharmaceutical sector, Joanne served as Head of Global Drug Development for the Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) CNS/Internal Medicine business unit. In this role she was responsible for late-stage development of the CNS/Internal Medicine pipeline, spanning the areas of psychiatry, neurology, pain, infectious disease, cardiovascular medicine, urology, metabolism and other emerging areas. 

Prior to joining J&JPRD in 2002, Joanne was head of the Endocrinology and Metabolism clinical research group at Merck Research Laboratories, and responsible for overseeing clinical development of Mevacor®, Zocor®, Proscar® and Propecia®, and for clinical development programs in atherosclerosis, obesity, diabetes, urology, dermatology, and oncology. During that time, she received numerous distinctions, including the Merck Research Laboratory Key Innovator Award.

Joanne received both the Jonas Salk and Belle Zeller scholarships from the City University of New York and graduated Summa Cum Laude from Brooklyn College, and Cum Laude from Harvard Medical School.  She completed her fellowship in endocrinology and metabolism at Massachusetts General Hospital, has won numerous awards and scholarships, and has authored numerous papers and abstracts.  Joanne combines broad experience in science, medicine, and pharmaceutical development with a passion for advancing transparency and trust in our industry, and a dedication to advancing patient safety.

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Lawrence Yu, Ph.D.
Deputy Director
Office of Pharmaceutical Science
FDA, CDER

Lawrence X. Yu, Ph.D., is the Deputy Director, Office of Pharmaceutical Quality, Food and Drug Administration. He is also adjunct Professor of Pharmaceutical Engineering at the University of Michigan. Prior to joining the FDA, Dr. Yu had worked at Pfizer (Upjohn) and GlaxoWellcome for 8 years. Dr. Yu joined the FDA in 1999 and has served as Team Leader, Deputy Division Director, Division Director, and Deputy Office Director. Dr. Yu’s research interests have centered on the prediction of oral drug delivery and the development of pharmaceutical Quality by Design. His compartmental absorption and transit (CAT) model has laid the foundation for the commercial software, GastroPLUSTM and Simcyp®, which are being widely used in the pharmaceutical industry. Dr. Yu is a fellow and the past section Chair of the American Association of Pharmaceutical Scientists and an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored over 130 papers, and presented over 100 abstracts, and given over 200 invited presentations. He is a co-editor of the books entitled “Biopharmaceutics Applications in Drug Development” and “FDA Bioequivalence Standards”. Dr. Yu is the winner of numerous awards including AAPS Regulatory Science Achievement award, AIChE PD2M Drug Product QbD Achievement Award, Japan Naigai Foundation Distinguished Lectureship, China Beijing University IPEM graduation commencement address, Department of Health and Human Service Outstanding Leadership Award, FDA Commissioner’s Special Citation, Outstanding Achievement, Group Recognition, and Team Excellence awards.

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Isaam 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 20, 2015

ACPE The University of Texas at Austin College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
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