Trk 09: Med Devices-InVitro-CombProd [
clear filter]
10:45am EDT
#135: Clinical Developments in Immuno-Oncology, Part 2 of 2: Clinical Implementation of Biomarkers
Chair
Senior Vice President and Managing Director, DIA EMEA
Dr. Holger G. Adelmann, MD PhD. Board certified Clinical Pharmacologist. Clinical training in internal medicine. Several leading positions in pharma since 1989 with Bayer & Tropon (Germany), AstraZeneca (UK and Sweden), and Merck Serono (Germany). He is member of the American Association...
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Speakers
Senior Director, Clinical Biomarkers and Companion Diagnostics, EMD Serono Research & Development Institute, Inc.
Director, MedImmune
Dr. Higgs leads the Bioinformatics function within Translational Medicine at MedImmune. He has 15+ years of industry experience in biomarker development within indications of oncology, autoimmunity, inflammation, CNS, and transplantation. He has a PhD in Computational Biology and...
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Associate Director of Immunotherapeutics, OHOP, OND, CDER, FDA
Dr. Theoret is a medical oncologist and the Associate Director of Immunotherapeutics in the Office of Hematology and Oncology Products, CDER, FDA. In his role as Associate Director, Dr. Theoret is leading initiatives in immuno-oncology product development—regulatory, scientific...
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Monday June 27, 2016 10:45am - 12:00pm EDT
108B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
4:00pm EDT
#267: FDA Institutes/Centers of Excellence: A Step Toward Patient Focused Drug Development?
Chair
Executive Director, FasterCures, A Center of the Milken Institute
Margaret Anderson is the executive director of FasterCures, a Washington, DC-based center of the Milken Institute, which is driven by a singular goal – to save lives by speeding up and improving the medical research system. FasterCures focuses on spurring cross-sector collaboration...
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Speakers
Former Senior FDA Counsel for the Senate HELP Committee, NA
Wade Ackerman recently served as Senior FDA Counsel for Ranking Member Patty Murray on the US Senate Committee on Health, Education, Labor and Pensions (HELP) where he handled issues related to pharmaceuticals, medical devices, animal products, cosmetics, and other FDA-related areas...
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Senior Vice President, Global Regulatory Affairs and Safety, Amgen Inc.
Dr. Steven Galson is Senior Vice President - Global Regulatory Affairs & Safety at Amgen. Prior to Amgen, Galson spent more than 20 years in government service, including two years as acting Surgeon General of the United States. He also served as director of FDA’s Center for Drug...
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Senior Vice President, Global Regulatory Affairs and Safety, Amgen Inc.
Dr. Steven Galson is Senior Vice President - Global Regulatory Affairs & Safety at Amgen. Prior to Amgen, Galson spent more than 20 years in government service, including two years as acting Surgeon General of the United States. He also served as director of FDA’s Center for Drug...
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Vice President and Therapeutic Area Head, Merck Research Laboratories
ES
Chairperson and Founder, Friends of Cancer Research
Dr. Ellen Sigal has been a devoted patient advocate and stanch supporter of cancer research. She founded Friends of Cancer Research in 1996 to mark the anniversary of the National Cancer Act. Friends is a cancer research think tank and advocacy organization based in the Washington...
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Tuesday June 28, 2016 4:00pm - 5:15pm EDT
105AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 09: Med Devices-InVitro-CombProd,
Forum
- Credit Type CME, IACET, RN
- Audience Intermediate
- Interest Area Combination Products, Public Policy - Law, Regulatory Affairs, Patient Engagement
- format json
- Interest Area Combination Products,Public Policy / Law,Regulatory Affairs,Patient Engagement
- Credit Type CME, IACET, RN
- Tags Forum
2:00pm EDT
#344: Companion Diagnostics: Driving New Business Models for Successful Outcomes
Chair
Chief Executive Officer, Health Decisions, Inc.
Dr. Phillips is an experienced and respected clinical development executive and industry leader. He is responsible for executive oversight and strategic leadership of Health Decisions. Before his appointment as CEO, Dr. Phillips served for over two years as Health Decisions’ Vice...
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Speakers
Head, Medical and Clinical Affairs, Abbott Molecular
Following medical school (Rosalind Franklin Univ/Chicago Medical School), Dr. Bilkovski focused on research in sepsis and noninvasive hemodynamic management. After 5 years, he identified his zeal for entrepreneurship and pursued his MBA (Notre Dame). His primary focus has been in...
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Vice President, Research & Development, Site Manager - Colorado Operations, Corgenix, Inc.
Kelly R. Pitts, PhD is Vice President of R&D at Corgenix, Inc., an IVD company specializing in cardiovascular, autoimmune, and companion diagnostics. He previously held leadership positions at Myogen, Gilead Sciences, and Amgen, focused on drug discovery, development, and commercialization...
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Wednesday June 29, 2016 2:00pm - 3:15pm EDT
103A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
4:00pm EDT
#365: Cross-Labeling of Drugs and Devices: How Can It Be Done?
Chair
Partner, Hogan Lovells US LLP
Heidi Gertner is a partner at Hogan Lovells in their drug regulatory group. Heidi began her professional career with a focus on bioethics and law, completing two post-doctoral bioethics fellowships-at the Cleveland Clinic and at NIH. Heidi then worked at the FDA's Office of Chief...
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Speakers
Senior Director, North American Regulatory Affairs Policy and Intelligence, Johnson & Johnson
Diane is responsible for providing key strategic direction and regulatory intelligence across the North America device sector. Supports shaping of growth plans by translating the impact of regulatory environmental changes/trends on Strategic Business Plans. 20yrs of experience in...
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Vice President, RA Devices, Novo Nordisk A/S
VP of Regulatory Affairs Devices at Novo Nordisk A/S. Responsible for regulatory strategies for development of devices as well as maintenance of devices on the market. She has more than 18 years of experience in the world of pharmaceuticals (medical devices). She has wide experience...
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Associate Director for Policy, FDA
John Barlow Weiner is the Associate Director for Policy in the Office of Combination Products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA's Office of Chief Counsel and in private practice. He received a BA from Princeton University and a JD with honors...
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Wednesday June 29, 2016 4:00pm - 5:15pm EDT
103A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA