Design Thinking [
clear filter]
8:30am EDT
#104: Impact of Biologics, Vaccines, Oncology, and Breakthrough Therapy Designation on Traditional Global Drug Development Strategy
Chair
Director, Global Project & Alliance Management, Merck & Co., Inc.
Eva M. Finney, Ph.D., PMP, is Director, Global Project and Alliance Management at Merck, where she has been a Project Manager for 15 years. She has managed multiple development programs from early to late stage, including several NDA submissions leading to successful product approvals...
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Speakers DR
Principal Consultant, Robinson Vaccines and Biologics LLC
Independent consultant with 25 years experience in global vaccine and biologics product commercialization, process development and CMC regulatory strategy/execution (IND, BLA, PAS). Over 20 years at Merck, chaired the CMC development team that achieved approval of RotaTeq, an oral...
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Head of Regulatory Affairs Operations, Baxalta
Dr. Susan Uptain is currently Head of Global Regulatory Operations at Baxalta, where she is responsible for operational excellence in execution of global regulatory strategy and tactics. Previously, she was Director of Project Management and Alliance Management at Merck & Co., Inc...
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Head of Regulatory Affairs Operations, Shire
Dr. Susan Uptain is currently Head of Global Regulatory Operations at Baxalta, where she is responsible for operational excellence in execution of global regulatory strategy and tactics. Previously, she was Director of Project Management and Alliance Management at Merck & Co., Inc...
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Monday June 27, 2016 8:30am - 9:45am EDT
105AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 02: Proj-Port Mgt-Strat Planning,
Forum
- Credit Type ACPE, CME, IACET, PMI, RN
- Audience Advanced
- Featured Topics Approval Pathways, Design Thinking, Precision-Personalized Medicine-Targeted Therapy, Biologics-Biosimilars, Vaccines, Increasing Research and Development Innovation
- Interest Area Regulatory Affairs, R&D - Strategic Issues, Strategic Planning, Biotechnology, Rare - Orphan Diseases
- format json
- Interest Area Regulatory Affairs,R&D / Strategic Issues,Strategic Planning,Biotechnology,Rare / Orphan Diseases
- Featured Topics Approval Pathways,Design Thinking,Precision/Personalized Medicine/Targeted Therapy,Biologics/Biosimilars,Vaccines,Increasing Research and Development Innovation
- Credit Type ACPE, CME, IACET, PMI, RN
- Tags Forum
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
#137: Using Technology to Make Trials Accessible to More Clinical Trial Participants
Chair LC
Director, Human Research Protection Program, Yale University
Ms. Coleman is the Director of the Human Research Protection Program at Yale University. Prior to joining Yale, she was the Vice President of Regulatory and Legal Affairs at Quorum Review and an attorney at Bennett Bigelow & Leedom. Ms. Coleman has experience in research ethics, regulatory...
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Speakers
Principal, Global Compliance and Strategy, Medidata Solutions
Phil Coran is a Principal of Global Compliance & Strategy at Medidata. Prior to joining Medidata, Phil was at Pfizer for 12 years in the Medical Quality Assurance and Internal Audit groups. From 1999-2001, Phil was an IT Risk Consultant at Deloitte & Touche & Arthur Andersen accounting...
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Consultant, Innovation Lead, Eli Lilly and Company
Kevin works in the Clinical Innovation group at Lilly as an Innovation Lead focused on implementing eConsent and other technologies across the Lilly portfolio. Kevin participated in the CTTI Informed Consent project and is currently a member of the TransCelerate eConsent project...
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Monday June 27, 2016 10:45am - 12:00pm EDT
204A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:30am EDT
#218: Lessons Learned from Eight Years of Drug Development Tool/Novel Methodology Qualification
Chair
President and Chief Executive Officer, Critical Path Institute
Martha A. Brumfield, PhD, heads the Arizona-based non-profit in its mission to catalyze the development of new tools to advance medical product innovation and regulatory science. She has 20 years’ experience at Pfizer most recently as senior vice president of worldwide regulatory...
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Speakers
Director, Office of Translational Sciences, CDER, FDA
ShaAvhrée Buckman-Garner, MD, PhD, FAAP is the Director of the Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), at the FDA. Prior to serving as Director of OTS, Dr. Buckman-Garner served as Deputy Director for OTS and as medical team leader in the...
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Executive Director, Chair, ICMRA, The European Medicines Agency, Netherlands
Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to...
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Tuesday June 28, 2016 10:30am - 11:30am EDT
201B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 08: Reg Affairs,
Forum
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Partnership Strategies, Clinical Trial Transparency-Clinical Trial Disclos, Increasing Research and Development Innovation, Design Thinking, Approval Pathways
- Interest Area Regulatory Affairs, R&D - Strategic Issues, Clinical Safety & Pharmacovigilance
- format json
- Interest Area Regulatory Affairs,R&D / Strategic Issues,Clinical Safety & Pharmacovigilance
- Featured Topics Partnership Strategies,Clinical Trial Transparency/Clinical Trial Disclos,Increasing Research and Development Innovation,Design Thinking,Approval Pathways
- Credit Type ACPE, CME, IACET, RN
- Tags Forum
2:00pm EDT
#241: Disease Interception: Shifting the Paradigm from Treatment to Prevention of Disease
Chair
Head, Global Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson
Karin is leading the Global Regulatory Affairs organization at Janssen. She facilitates the relationship between the Janssen pharmaceutical companies and global health authorities, influencing and interpreting global regulatory requirements and enabling our companies to meet those...
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Speakers
Senior Medical Officer, European Medicines Agency, European Union
Dr. Eichler is responsible for coordinating activities between the European Medicine Agency's (EMA) scientific committees and giving advice on scientific and public health issues. Prior to joining EMA, Dr. Eichler was professor and chair of clinical pharmacology and vice-rector at...
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Senior Strategic Advisor, Center For Medical Technology Policy (CMTP)
Sean Tunis, MD, MSc, is Founder and Senior Strategic Advisor of the Center for Medical Technology Policy, an independent, non-profit organization that provides a neutral platform for multi-stakeholder collaborations that promote high value innovation by improving the quality, relevance...
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Director, Office of Drug Evaluation I, OND, CDER, FDA
Ellis F. Unger is the Director, Office of Drug Evaluation-I, Office of New Drugs, Center for Drug Evaluation and Research, FDA. His Office oversees the regulation of drugs for cardiovascular, renal, neurological, and psychiatric disorders. Dr. Unger is a board-certified internist...
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Tuesday June 28, 2016 2:00pm - 3:15pm EDT
201B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 08: Reg Affairs,
Forum
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Value-Based Evidence, Regulatory Harmonization-Convergence, Benefit-Risk, Design Thinking, Current Issues in Policy and Law
- Interest Area Regulatory Affairs, R&D - Strategic Issues, Public Policy - Health Care Compliance - Law
- format json
- Interest Area Regulatory Affairs,R&D / Strategic Issues,Public Policy / Health Care Compliance / Law
- Featured Topics Value-Based Evidence,Regulatory Harmonization/Convergence,Benefit-Risk,Design Thinking,Current Issues in Policy and Law
- Credit Type ACPE, CME, IACET, RN
- Tags Forum
2:00pm EDT
#246: Valuing the Signal and the Noise in Health Care Horizon Scanning
Chair
Senior Clinical Analyst, Health Technology Assessment Group, ECRI Institute
Clinical Analyst at ECRI Institute I worked on the Horizon Scanning program following the clinical development of close to 200 emerging oncology interventions and determining their potential to have an impact on the healthcare system. Postdoctoral Fellow at University Pennsylvania...
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Speakers EB
Director, Technology Assessment Program, Agency For Healthcare Research and Quality (AHRQ)
Dr. Berliner is the Director of the Technology Assessment Program at the Agency for Healthcare Research and Quality (AHRQ). The Technology Assessment Program provides technology assessments to the Centers for Medicare & Medicaid Services (CMS) to inform Medicare coverage decisions...
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Director, Health Technology Assessment, ECRI Institute
Served as ECRI Institute's project manager for the AHRQ Healthcare Horizon Scanning Program for 5 years. More than 30 years (including 22 with ECRI Institute’s Health Technology Assessment program) leading projects, health technology research and analysis, writing, and publishing...
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Tuesday June 28, 2016 2:00pm - 3:15pm EDT
103A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:30am EDT
12:00pm EDT
#331: Applying Design Thinking to Clinical Development: Human-Centered Approaches to Improve Quality and Efficiency
Chair
Chief Operating Officer, The Avoca Group
With 20 years in the pharmaceutical industry as a sponsor, provider, and consultant, Dennis Salotti's experience spans preclinical research, clinical operations, data management, quality assurance, eClinical, business operations, and strategic management. Prior to Avoca, he was Director...
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Speakers
Global Head Franchise Quality Assurance, Novartis Pharmaceuticals Corporation
JoAnn Muir is Global Head Quality Assurance/Vendor Oversight at Novartis. JoAnn has 20 years’ experience in clinical research and has spent her career in clinical trial management, drug development, and quality assurance. She supports clinical teams by providing regulatory compliance...
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Executive Director, Quality Consortium, The Avoca Group
Steven Whittaker, Executive Director, Avoca Quality Consortium (retired from Eli Lilly and Co.) , consults for the pharmaceutical, biotech, and CRO industries, providing expertise in project management, pharmaceutical development, clinical development, outsourcing strategies and execution...
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Wednesday June 29, 2016 12:00pm - 1:00pm EDT
Exhibit Hall A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA