Trk 09: Med Devices-InVitro-CombProd [
clear filter]
8:30am EDT
#113: Clinical Developments in Immuno-Oncology, Part 1 of 2: Science, Current Methodologies, and Achievements
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 TC
Director, Global Clinical Biomarkers and Companion Diagnostics, EMD Serono
Ti Cai joined EMD Serono in March 2015 as Director, Clinical Biomarkers and Companion Diagnostics. He is currently leading clinical biomarker development for avelumab (anti-PD-L1 antibody) program. Prior to EMD Serno, Ti worked at Celgene, Sanofi and Amgen where he led biomarker research...
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Vice President, Head of Clinical Immuno-Oncology, Medimmune
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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Monday June 27, 2016 8:30am - 9:45am EDT
108B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:30am EDT
#221: Envision the Future: How Big Data and Artificial Intelligence Change Our Regulatory Environment
Chair
Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer
Joseph Scheeren, Pharm.D. is Senior Vice President, Global Head of Regulatory Affairs Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of the DIA Board of Directors...
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Speakers
Commissioner, FDA
Robert M. Califf, MD, MACC, is the Food and Drug Administration's commissioner of food and drugs. As the top official of the FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public healt...
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Senior Principal, Real World Evidence Solutions, IMS Health
Partner, Covington & Burling LLP
Tuesday June 28, 2016 10:30am - 11:45am EDT
103A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:30am EDT
#317: Global Medical Device Development: Regulatory Concordance or Discordance?
Chair MA
DRA Policy Head of Medical Device and Combination Products, Novartis Pharmaceuticals Corporation
Mary Ann Smith is Regulatory Policy Director, Digital Medicine & Devices, with Novartis since 2009 focused on software as a medical device, technology applications and enabled clinical trials, combination products and regulatory strategy. Ms. Smith has regulatory experience at Nektar...
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Speakers NS
Special Advisor, International Programs Division, Health Canada
DIA
Associate Vice President, Regulatory Affairs - Devices, Sanofi US
Anthony Watson is the Head of Regulatory Affairs - Devices, for Sanofi, in Cambridge, Massachusetts. Before Sanofi, he was the Director of Regulatory Affairs, CMC, Combination Products at Biogen. Prior to Biogen, he was a Division Director responsible for drug delivery devices in...
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Wednesday June 29, 2016 10:30am - 11:45am EDT
103C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:45am EDT
#409: Current Status of Genetic Testing in Medical Therapies: What Regulations We May Need in a Convergent Regulatory Environment
Chair
Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer
Joseph Scheeren, Pharm.D. is Senior Vice President, Global Head of Regulatory Affairs Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of the DIA Board of Directors...
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Speakers SF
Executive Director and Founder, Facing Our Risk of Cancer Empowered (FORCE)
Dr. Friedman was a practicing veterinarian in 1996 when she was diagnosed at age 33 with breast cancer and later learned she carried a BRCA2 mutation. She founded the nonprofit organization Facing Our Risk of Cancer Empowered (FORCE) in 1999 to improve the lives of people affected...
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Clinical Pharmacologist, Genomics and Targeted Therapy, OTS, CDER, FDA
Robert Schuck, Pharm.D., Ph.D. is a Clinical Pharmacologist in the Genomics and Targeted Therapy Group at the FDA. In his current position, Dr. Schuck contributes to regulatory review of investigational new drug (IND), new drug (NDA), and biologic licensing (BLA) applications to effectively...
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Vice President and Head, Enterprise Scientific Technology Operations, Pfizer Inc
Morten has been with Pfizer since 2009 and is VP, Enterprise-wide Scientific Technology Operations and a member of Pfizer’s R&D leadership team . He oversees technology investment and Pfizer’s human genetics, computational biomedicine, diagnostics and bio-banking organizations...
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Thursday June 30, 2016 10:45am - 12:00pm EDT
113C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 09: Med Devices-InVitro-CombProd,
Session
- Credit Type ACPE, CME, IACET, RN
- Audience Basic
- Featured Topics Current Issues in Policy and Law, Regulatory Harmonization-Convergence
- Interest Area Medical Devices & Diagnostics, Public Policy - Health Care Compliance - Law
- format json
- Interest Area Medical Devices & Diagnostics,Public Policy / Health Care Compliance / Law
- Featured Topics Current Issues in Policy and Law,Regulatory Harmonization/Convergence
- Credit Type ACPE, CME, IACET, RN
- Tags Session