Trk 04: Preclin Transl-Early Clin Dev [
clear filter]
8:30am EDT
#107: Fatal Drug Trials in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost
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
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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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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Adjunct Professor, University of Wisconsin
Dr. Mary Westrick holds a BS in Chem, and MS & PhD degrees in pharmacology from Purdue University. She has held leadership positions in Global Clinical Pharmacology at Covance, Astellas and Quintiles and currently teaches Project Management and Leadership in the MS Program in Biotechnology...
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Monday June 27, 2016 8:30am - 9:45am EDT
202AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
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
10:45am 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
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
10:30am EDT
#312: Human Tissue Models: A Look into the Future of Safety Pharmacology Studies
Chair
Senior Non-Clinical Assessor, Medicines and Healthcare products Regulatory Agency (MHRA)
Michelle spent 4 years in the pharmaceutical Industry as a regulatory/investigative toxicologist, then joined the MHRA and is now a Senior Pharmaco-Toxicologist. Principally, this involves the assessment of nonclinical data for Clinical Trials and Marketing Authorisation applications...
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Speakers AH
Head, Technology Development, NC3Rs
Anthony Holmes is Head of Technology Development at the NC3Rs. He oversees a programme of work focusing on the interface between academia and industry and the acceleration of technologies out of the science base and in to application to reduce animal use and address scientific and...
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Wednesday June 29, 2016 10:30am - 11:30am EDT
113C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
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
4:00pm EDT
#360: Biomarkers and Sample Stability: Bottlenecks in Study Planning, Ensuring Sample Stability as the Key for Reliable Lab Results
Chair HS
Executive Vice President, Synlab Pharma Institute
Before founding INTERLAB in 1994, Hermann Schulz held senior R&D positions in Pharma for 12 years. He was a Board member of the German Society of Pharmaceutical Medicine for 6 years, is visiting professor for applied clinical pharmacology and has written more than 35 scientific publications...
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Speakers
Exec. Director, Medpace Global Labs, Medpace
Paul Travis MSc, Executive Director of Global Business Strategy at Medpace Laboratories. +25 years of Experience in R&D within the pharma and contract research industries. Attained MSc in Biomedical Science & began career with Ciba Geigy UK, working in early research and development...
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Wednesday June 29, 2016 4:00pm - 5:00pm EDT
105AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 04: Preclin Transl-Early Clin Dev,
Session
- Credit Type CME, IACET, RN
- Audience Intermediate
- Featured Topics Biologics-Biosimilars, Clinical Trial Designs
- Interest Area Biotechnology, CMC-GMP, QA-QC, R&D - Strategic Issues, Clinical Research, Project Management
- format json
- Interest Area Biotechnology,CMC/GMP,QA/QC,R&D / Strategic Issues,Clinical Research,Project Management
- Featured Topics Biologics/Biosimilars,Clinical Trial Designs
- Credit Type CME, IACET, RN
- Tags Session
10:45am EDT
#405: Hot Button Protocol and Operational Issues Between Sponsors and Sites in Clinical Pharmacology Studies
Chair
President, Medexetech
Gary Steinman has degrees in Electrical & Systems Engineering from RPI where he also served on the faculty and as Director of the Center for Biomedical Engineering. He then joined the Stanford Cardiology Division, launched Pharmiya Medical Technologies in the People’s Republic of...
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Speakers
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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Adjunct Professor, University of Wisconsin
Dr. Mary Westrick holds a BS in Chem, and MS & PhD degrees in pharmacology from Purdue University. She has held leadership positions in Global Clinical Pharmacology at Covance, Astellas and Quintiles and currently teaches Project Management and Leadership in the MS Program in Biotechnology...
Read More →
Thursday June 30, 2016 10:45am - 12:00pm EDT
107AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA