Trk 18: Global Regulatory [
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2:00pm EDT
#253: Update from Health Canada
Chair 
Director, Evaluation of Radiopharmaceuticals and Biotherapeutic Products, Health Canada
Agnes V. Klein MD is currently the Director, CERB in the Biologics and Genetic Therapies Directorate. Dr. Klein trained in Endocrinology at UofT and has interests in drug development and medical bioethics. SHe represents Canada at ICH and is member of several medical international...
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Division Chief, Monoclonal Antibodies, Health Canada
Jeffrey Skene has been with Health Canada since 2003. He began his career at Health Canada in Regulatory Affairs and later joined the group responsible for the review of monoclonal antibodies as a CMC reviewer. Today, Mr. Skene is the Chief of the Monoclonal Antibodies Division that...
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Tuesday June 28, 2016 2:00pm - 3:00pm EDT
202AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
2:00pm EDT
#254: CBER Town Hall: State of the Center and Plans for the Future
Chair 
Director, Center for Biologics Evaluation and Research, FDA, United States
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching...
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Associate Director for Research, Office of Biostatistics and Epidemiology, CBER, FDA
Richard Forshee is the Associate Director for Research for the Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration. He works on a wide range of issues related to the risks and benefits of blood and blood...
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Associate Div Director, Policy, Office of Vaccines Research and Review, CBER, FDA
Dr. Gagneten completed her graduate studies at the Uniformed Services University for the Health Sciences (USUHS) in Maryland and conducted research in virology and genetic recombination before joining the Office of Vaccines Research and Review (OVRR) at CBER, FDA. Currently she is...
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Biologist, Office of Cellular, Tissue and Gene Therapies, CBER, FDA
Principal Investigator, OTAT, CBER, FDA, United States
Zuben E. Sauna is a Principal Investigator and also a CMC Reviewer at the US Food and Drug Administration. His research interests lie in understanding the pharmacogenetic basis of the immune response to proteins used in therapeutic interventions as these affect efficacy and safety...
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Tuesday June 28, 2016 2:00pm - 3:15pm EDT
203AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
4:00pm EDT
#277: PMDA Town Hall
Chair 
Associate Executive Director (for International Programs), Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tominaga is Associate Executive Director for International Programs. He supervises the overall strategy and conduct of international operations by PMDA. He joined MHLW after acquired PhD from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, he...
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Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tatsuya Kondo is Chief Executive of PMDA since 2008. He spent most of his career as a neurosurgeon after his graduation from the University of Tokyo in 1968. He has various experiences including a hospital doctor, a fellowship in Max-Planck Institute for brain tumor research...
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Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW)
Dr. Nakashima joined Pharmaceutical and Food Safety Bureau of Ministry of Health, Labor, and Welfare in 1992. He spent his career in the international field such as at WHO and OECD, not only in the domestic field. He has been Director of the Office of International Programs, PMDA...
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Chief Safety Officer, Pharmaceuticals and Medical Devices Agency (PMDA)
Ms.Tomiko Tawaragi is in position of the Chief Safety Officer of PMDA since July 2014. She is responsible for post-marketing safety measures and GMP/QMS for pharmaceuticals and medical devices. She spent most of her careear as a technical officer of Ministry of Health, Labour and...
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Tuesday June 28, 2016 4:00pm - 5:15pm EDT
202AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:30am EDT
#327: FDA–Health Canada Regulatory Cooperation Council Town Hall
Chair SH
Director, Office of Regional and Country Affairs, OIP, OC, FDA
Ms. Hashemi has made significant contributions to FDA, having worked for the Agency since 1998 and serving in OIP for over 15 years in a variety of positions including Acting Director, Asia-Pacific Office; Acting Deputy Country Director China Office in Beijing; Deputy Director, ORCA...
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Director General, Policy, Planning and International Affairs Directorate, HPFB, Health Canada
In this position, Ed oversees regulatory policy development for health products and food, and provides strategic advice on advancing horizontal health policy and international agendas. Before joining Health Canada, Ed was Director of Operations for the Operations Committee of Cabinet...
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Wednesday June 29, 2016 10:30am - 11:30am EDT
201C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:45am EDT
#412: CDER Town Hall
Chair 
Adjunct Professor, Temple University, FDA Alumni
Nancy Smith, PhD, retired from the FDA after almost 25 years in the Center for Drug Evaluation and Research. Nancy is past-Chair of the Biopharmaceutical Section of the American Statistical Association, and she served as a DIA board member of from 2002-2008. She was Chair of the DIA...
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Associate Director for Therapeutic Biologics, TBBT, OND, CDER, FDA
Dr. Christl is the Director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in the Office of New Drugs in the FDA's CDER. TBBS is responsible for ensuring consistency in the scientific and regulatory approach and advice to sponsors regarding development programs for biosimilar...
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Director, Office of New Drugs, CDER, FDA
Dr. Jenkins is Board Certified in Internal Medicine and Pulmonary Diseases by the American Board of Internal Medicine. He joined FDA in 1992 and has been Director of the Office of New Drugs since 2002.
Director, Office of Pharmaceutical Quality, CDER, FDA
With more than 25 years of pharmaceutical industry experience, Dr. Kopcha’s areas of expertise include formulation and process development, process validation, technology transfer, off-shoring/outsourcing, and change management. Before joining FDA, Dr. Kopcha served as vice president...
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Associate Director for Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads efforts including Patient-Focused Drug Development, Rare Disease Cures Accelerator, and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee...
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Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the...
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Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, MD, is the Director, Office of New Drugs, Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research, US Food and Drug Administration. The Division of Pediatric and Maternal Health oversees quality initiatives within the Office of New Drugs...
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Thursday June 30, 2016 10:45am - 12:00pm EDT
114
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
