Trk 04: Preclin Transl-Early Clin Dev [
clear filter]
10:30am EDT
#212: Special Populations in Clinical Pharmacology Studies
Chair
CEO, Alliance for Multispecialty Research/NOCCR
William B. Smith, MD, FACC, is a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. Dr. Smith is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care. Dr. Smith is the President of New Orleans Center for Clinical...
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Speakers
Chief Scientific Officer, DaVita Clinical Research
Chief Scientific Officer for DaVita Clinical Research a CRO, located in Minneapolis Minnesota and Lakewood Colorado. He has served as PI on over 150 protocols and Sub Investigator on over 300 protocols which have included Renal (Full and Adaptive), Hepatic and Pulmonary, along with...
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Chief Medical Officer and Vice President, Global Cardiology, ERT
Dr. Kleiman is a cardiac electrophysiologist who has performed research in both basic and clinical electrophysiology and practiced clinical electrophysiology for 12 years before joining ERT in 2003. Dr. Kleiman is currently ERT’s Chief Medical Officer, and works with pharmaceutical...
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Vice President, Medical, Medpace
Dr. Richard Scheyer is VP Medical at Medpace. Prior to Medpace, he led Experimental Medicine, BM, and PGx functions at Daiichi Sankyo. He served in leadership roles at Sanofi-Aventis and CMO at Neurotrope Bioscience. Dr. Scheyer received his BS Physics from Stanford, MD from SUNY...
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Tuesday June 28, 2016 10:30am - 11:45am EDT
113A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 04: Preclin Transl-Early Clin Dev,
Symposium
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Clinical Trial Designs, Pediatrics, Women's Health
- Interest Area Pharmaceutics, Statistics, Rare - Orphan Diseases
- format json
- Interest Area Pharmaceutics,Statistics,Rare / Orphan Diseases
- Featured Topics Clinical Trial Designs,Pediatrics,Women's Health
- Credit Type ACPE, CME, IACET, RN
- Tags Symposium
4:00pm EDT
#260: A Risk-Benefit Approach to Planning Early Clinical Development
Chair
Medical Safety Officer, Janssen Research and Development, LLC
Dr. Greenberg is a Medical Safety Officer for Janssen Pharmaceuticals R&D, and Adjunct Associate Professor in the Department of Pharmacology & Experimental Therapeutics of Thomas Jefferson University. He is a Clinical Pharmacologist with education and experience in chemical engineering...
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Speakers
President, Just In Time GCP
Donna is a business consultant who has over 25 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. She encourages strategic thinking and implementation of solutions not only...
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Senior Director, Scientific Affairs - Clinical Pharmacology, PRA Health Sciences
Dr van Iersel is an MD with 25 years of experience in clinical development. He is trained in Clinical Pharmacology in the UK and the Netherlands. Currently he is a Senior Director of Science at PRA. Previously he worked as Researcher at Urology and as Principal Investigator, Medical...
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Biologics and Advanced Therapies Expert, NDA Group
Trained in Internal Medicine. Currently providing strategic support and advice to Biotech/Pharma companies on regulatory science primarily in Biotechnology, Cell and Gene Therapy. Previously Head of Biotechnology Unit, MHRA, UK and Expert Medical Assessor; Member of Committee for...
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Tuesday June 28, 2016 4:00pm - 5:15pm EDT
113C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 04: Preclin Transl-Early Clin Dev,
Symposium
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Benefit-Risk, Biologics-Biosimilars
- Interest Area Clinical Safety & Pharmacovigilance, Pharmaceutics, Clinical Research, R&D - Strategic Issues
- format json
- Interest Area Clinical Safety & Pharmacovigilance,Pharmaceutics,Clinical Research,R&D / Strategic Issues
- Featured Topics Benefit-Risk,Biologics/Biosimilars
- Credit Type ACPE, CME, IACET, RN
- Tags Symposium
2:00pm EDT
#338: Evolving Methods in Pain Trials: Evaluating Abuse Deterrence, Drug Interactions, and Appropriate Patient Selection
Chair
Vice President, Clinical Pharmacology, Early Phase, INC Research
Dr. Setnik has been working in the area of CNS research and clinical drug development for over 16 years and is an expert in the area of abuse and dependence potential evaluation of drugs. Dr. Setnik is currently the Vice President of Clinical Pharmacology at INC Early Phase and oversees...
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Speakers
Director of Pharmacometrics, Early Phase, INC Research
Dr Galina Bernstein received PhD in Biochemistry from Moscow State University, postdoctoral training from College of Pharmacy, U of Michigan, and pharmacokinetics training at Pfizer GRD PDM department. She has 15+ years’ experience in analytics, PK and PK/PD modeling for IVD, small...
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Director, Regulatory Affairs, Pfizer Ltd
Andrew Whiles has 29 years’ regulatory experience in researching , registering and maintaining pharmaceuticals and devices on the market. Over the last four years he has focused on early development regulatory strategies from Phase 1 through to Proof of concept studies within the...
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Wednesday June 29, 2016 2:00pm - 3:15pm EDT
201A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 04: Preclin Transl-Early Clin Dev,
Symposium
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Precision-Personalized Medicine-Targeted Therapy, Risk Evaluation and Mitigation Strategies (REMS)
- Interest Area Clinical Safety & Pharmacovigilance, Pharmaceutics, Statistics, R&D - Strategic Issues, Clinical Research
- format json
- Interest Area Clinical Safety & Pharmacovigilance,Pharmaceutics,Statistics,R&D / Strategic Issues,Clinical Research
- Featured Topics Precision/Personalized Medicine/Targeted Therapy,Risk Evaluation and Mitigation Strategies (REMS)
- Credit Type ACPE, CME, IACET, RN
- Tags Symposium