Trk 19: DIAmond [
clear filter]
8:00am EDT
#202: Changing Cultures to Advance Patient Engagement
Chair
Managing Director, FasterCures, A Center of the Milken Institute
Kim leads the Patients Count: Science of Patient Input program through which FasterCures aims to improve health by expanding opportunities for patients’ perspectives to shape the processes by which new therapies are discovered, developed and delivered. She has been involved in FasterCures...
Read More →
Speakers
Vice President and Chief Patient Affairs Officer, UCB
Lode Dewulf has a passion for patient perspectives and understanding. As medical practitioner he deeply realized that good health education was at least as important as good medicines. in 1989 he joined the pharmaceutical industry, to provide good education on diseases and new treatments...
Read More →
President and Chairman, LUNGevity Foundation
Andrea is the President and Chairman of LUNGevity. In her role as President of LUNGevity, Andrea is responsible for setting and executing the strategic direction of the organization and its science programs. Prior to LUNGevity, Andrea had a variety of management experiences. She worked...
Read More →
Global Patient Advocacy Lead, GlaxoSmithKline
Andrew leads GSK’s global work with patient organizations (excluding the US). He is responsible for leading the work to develop collaborations with patient organizations to bring patient insight into GSK, improve the management of diseases and to strengthen the capabilities of patient...
Read More →
Associate Director, Diversity and Patient Engagement, Bristol-Myers Squibb Company
As an Associate Director for Diversity and Patient Engagement at Bristol-Myers Squibb, Mary facilitates collaborations with disease-specific and community-based organizations to bring relevant clinical trial options to patients and representative populations. Mary has co-chaired the...
Read More →
President and Chief Executive Officer, Canadian Organization For Rare Disorders (CORD)
Durhane Wong-Rieger, PhD, is President, Institute for Optimizing Health Outcomes; President; Canadian Organization for Rare Disorders; Chair, Consumer Advocare Network; Past-Chair, International Alliance of Patient Organizations; Co-Chair, HTAi Patient / Citizen Involvement IG; Board...
Read More →
Tuesday June 28, 2016 8:00am - 9:30am EDT
103ABC
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
8:00am EDT
#203: Next Generation Collaborations: Transforming the Industry
Chair
Chief Executive Officer, TransCelerate BioPharma Inc.
Dalvir Gill has more than 25 years of drug development & leadership experience. Prior to his appointment as CEO of TransCelerate, he was the President of a major international CRO. Dr. Gill earned his BSc from the University of Hertfordshire and his PhD from the Royal Free Hospital...
Read More →
Speakers
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...
Read More →
Director, National Center for Advancing Translational Sciences, National Institutes of Health (NIH)
Christopher P. Austin has served as director of the NCATS since 2012. Prior to this role, he was NCATS’ scientific director, focusing on translating basic science discoveries into new treatments and technologies to improve the efficiency of therapeutic/diagnostic development. He...
Read More →
Senior Medical Advisor, FDA
Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director and chair of the medical policy council in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy and as deputy director of the Office of Hematology and Oncology...
Read More →
Executive Vice President, Brand R&D, Allergan
Dr. Nicholson joined Actavis as SVP, Global Brands R&D in August 2014. Previously, he served as Chief Technology Officer and EVP, R&D for Bayer CropScience from March 2012 to August 2014; VP of Licensing and Knowledge Management at Merck from 2009 to December 2011; and SVP, responsible...
Read More →
Co-Founder and Chief Technology Officer, Validic
Drew Schiller co-founded Validic and serves as the CTO. At Validic, Drew leads the product and technology strategy, drives key initiatives, and works closely with senior executives at partner organizations to stay ahead of the technology curve. Drew sits on the Consumer Electronics...
Read More →
Tuesday June 28, 2016 8:00am - 9:30am EDT
Ballroom A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
8:00am EDT
#201: International Regulatory Convergence, Collaboration, and Cooperation
Chair
Chair, ICMRA; Executive Director, European Medicines Agency (EMA), Netherlands
Es Cooke was nominated as Executive Director with a renewable five-year mandate by the Agency’s Management Board on 25 June 2020 and is the first woman at the helm of EMA. "I take up the role of Executive Director of EMA amid a public health crisis of unprecedented scale,” said...
Read More →
Speakers
Chair of the ICMRA; Assistant Deputy Minister, Health Products and Food Branch, Health Canada
Mr. Arora has a breadth of experience in the private and public sectors. He has worked internationally-bilaterally, as well as with the UN and the OECD, including leading a multi-year program with the National Bureau of Statistics in the modernization of China’s statistical system...
Read More →
Director- President, Agência Nacional De Vigilância Sanitária (ANVISA)
Jarbas Barbosa da Silva Jr. is a public health physician and epidemiologist, with national and international experience in public health, epidemiology applied to health services, health surveillance, prevention and control of diseases and illnesses, and management of health systems...
Read More →
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...
Read More →
Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tatsuya Kondo is Chief Executive of PMDA since 2008. He spent most of his career as a neurosurgeon after his graduation from the University of Tokyo in 1968. He has various experiences including a hospital doctor, a fellowship in Max-Planck Institute for brain tumor research...
Read More →
Director of Policy, Medicines and Healthcare products Regulatory Agency (MHRA),
Chief Executive, Health Products Regulatory Authority (HPRA)
Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming...
Read More →
Deputy Secretary for Health Products Regulation, Commonwealth Department of Health, Australia
Dr John Skerritt joined the Australian Department of Health in 2012 and is currently a Deputy Secretary and member of the executive team of the Department of Health. He was formerly the National Manager of the Therapeutic Goods Administration (TGA), until his role was expanded and...
Read More →
Tuesday June 28, 2016 8:00am - 9:45am EDT
114
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
8:00am EDT
#301: The Future of Big Data
Chair
President and Founder, Catalyst Healthcare Consulting, Inc
Nancy Bradish Myers, JD is President/Founder of Catalyst Healthcare Consulting, a boutique regulatory advisory firm that helps innovators navigate FDA and policy circles. She served as a senior advisor in FDA's Office of the Commissioner and held senior positions at PhRMA, BIO and...
Read More →
Speakers
Acting Chief Scientist, Office of the Chief Scientist, OC, FDA
Dr. Luciana Borio is FDA’s acting chief scientist. In this capacity, she is responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. The Office of the Chief Scientist works closely with FDA’s product centers, providing strategic leadership...
Read More →
Managing Director, Mobile Health, Medidata Solutions Worldwide
As managing director of mobile health, Kara leads Medidata’s efforts to support mobile-enabled clinical trials and launched mobile health (mHealth) as a new business unit in 2015. Prior to this, Kara served as chief of staff to the company's CEO and president, and a vice president...
Read More →
Head, Strategic Innovation, Pharma Dev; Exec Advisor, Foundation Medicine Inc., Hoffmann-La Roche Ltd.
Head of regulatory affairs at Roche and Genentech from 2002 to 2016. Currently head of strategic innovation at Roche and Executive adviser to Foundation Medicine.
Senior Medical Director, Flatiron Health
Dr. Hirsch is a practicing medical oncologist with Texas Oncology in Dallas. At Flatiron Health, he helps to lead multiple efforts including value based care initiatives, collaborations with life sciences companies, and the development of novel research capabilities. Prior he served...
Read More →
Head of Regulatory Affairs and Policy, Human Longevity, Inc.
Has more than two decades of health policy and regulatory expertise, leads all efforts related to federal and state regulatory oversight. She comes from the FDA where she served most recently as Senior Advisor and Acting Chief of Staff to the FDA Commissioner. She also spent two years...
Read More →
Wednesday June 29, 2016 8:00am - 9:30am EDT
103ABC
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
8:00am EDT
#302: Europe and the US: Making Outcomes-Based Health Care Possible
Chair
Managing Director, Vital Transformation
Duane is the Managing Director of Vital Transformation which consults to national health authorities, blue chip multi-national organisations, governments, and stakeholder groups on healthcare policy and technology. He and his firm have developed many unique techniques and methods...
Read More →
Speakers
Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA)
Richard Bergström has been the Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) since April 2011. Previously he served for nine years as the Director-General of LIF, the Swedish Association of the Pharmaceutical Industry, following...
Read More →
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...
Read More →
Executive Director, Massachusetts Institute of Technology (MIT) Center For Biomedical Innovation
Her current efforts are leading the New Drug Development Paradigms initiative (NEWDIGS), a “think and do tank” that is re-engineering pharmaceutical innovation to deliver new, better, affordable therapeutics to the right patients, faster. Within the broad strategic framework of...
Read More →
Senior Vice President and General Manager, Health Sciences Global Business Unit, Oracle Health Sciences
Steve Rosenberg, Senior Vice President and General Manager of Oracle Health Sciences Global Business Unit, has over 30 years of experience leading development, services, support, and consulting, in addition to significant industry experience in life sciences and healthcare. Some of...
Read More →
Wednesday June 29, 2016 8:00am - 9:30am EDT
114
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 19: DIAmond,
Forum
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Approval Pathways, Agency Participation
- Interest Area Comparative Effectiveness, Regulatory Affairs
- format json
- Interest Area Comparative Effectiveness,Regulatory Affairs
- Featured Topics Approval Pathways,Agency Participation
- Credit Type ACPE, CME, IACET, RN
- Tags Forum
8:00am EDT
#303: Value-Based Health Care Decision Making: The Quest for Smarter Spending
Chair
Director, Health Policy, Xcenda
Jennifer Snow, MPH, is a Director of Health Policy and keeps clients and stakeholders informed on the latest legislative and regulatory updates and their commercial impact. Her team analyzes the healthcare environment and provides strategic guidance on how to best navigate challenges...
Read More →
Speakers
Associate Director – Science Policy and Research, National Institute for Health and Care Excellence (NICE)
Professor Sarah Garner is a pharmacist specialising in the interface between Health Technology Assessment (HTA) and regulation. Sarah is the Associate Director for Scientific Policy and Research at NICE and an honorary professor at UCL and Manchester University. She leads Work Packages...
Read More →
President and Co-Founder, PatientsLikeMe
As President and Director of PatientsLikeMe, Benjamin Heywood is responsible for setting the company vision to improve healthcare and accelerate research, while directing its business growth strategy. Inspired by his brother Stephen’s battle with ALS, Heywood co-founded the company...
Read More →
Assistant Vice President, Center for Observational and Real-world Evidence, Merck & Co., Inc.
Newell McElwee, PharmD, MSPH, is Executive Director of U.S. Outcomes Research, Merck & Co., Inc. Dr. McElwee serves an active role on many committees including the Steering Committee for the AHRQ Centers for Education, Research, & Training, the Advisory Board for the Institute for...
Read More →
Chief Science Officer, International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
Dick became ISPOR’s first Chief Science Officer in 2016, where he develops, leads, and supports strategic initiatives related to research, scientific, and content priorities. Prior to ISPOR he worked for 25 years at Pfizer and its legacy companies, where he retired as a vice president...
Read More →
Wednesday June 29, 2016 8:00am - 9:30am EDT
Ballroom A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
9:00am EDT
#401: EMA/FDA Question Time
Chair
Liaison to the US FDA, European Medicines Agency, European Union
Sabine Haubenreisser, MSc, Ph.D., is a pharmacologist who joined the European Medicines Agency in 1997, where she held a variety of positions including scientific team leader and officer for external communications. In 2012 she was appointed EMA Liaison Official at the U.S. FDA in...
Read More →
Deputy Director, Europe Office, Office of Global Programs and Strategies, FDA, FDA, United States
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA. She is posted in Amsterdam, working alongside colleagues in the European Medicines Agency (EMA) to oversee a large portfolio of regulatory science working partnerships and collaborations that include experts...
Read More →
Speakers
Chair, ICMRA; Executive Director, European Medicines Agency (EMA), Netherlands
Es Cooke was nominated as Executive Director with a renewable five-year mandate by the Agency’s Management Board on 25 June 2020 and is the first woman at the helm of EMA. "I take up the role of Executive Director of EMA amid a public health crisis of unprecedented scale,” said...
Read More →
Acting Deputy Commissioner for Global Regulatory Operations and Policy, FDA
Leads a 5,000-member workforce devoted to FDA’s domestic and international product quality and safety efforts, including global data-sharing, development and harmonization of standards, field operations, compliance, and enforcement activities. She joined FDA in 2010, serving as...
Read More →
Head of Product Development Scientific Support Department, European Medicines Agency, European Union
Jordi Llinares is a medical doctor specialised in clinical pharmacology. He worked as clinical pharmacologist at Hospital de Sant Pau and has experience as member of an ethics committee. Jordi has academic experience as lecturer in clinical pharmacology. He has a Masters degree in...
Read More →
Director, Office of New Drugs, CDER, FDA
Dr. Jenkins is Board Certified in Internal Medicine and Pulmonary Diseases by the American Board of Internal Medicine. He joined FDA in 1992 and has been Director of the Office of New Drugs since 2002.
EMA Liaison Official to FDA, European Medicines Agency, Netherlands
Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas and she is currently Head of Committees and Inspections Department.
Assistant Commissioner, Office of Health and Constituent Affairs, OC, FDA
Heidi Christl Marchand, Pharm.D. is currently the Assistant Commissioner for Health and Constituent Affairs at FDA. She has held leadership positions in global regulatory affairs with Novartis, Pfizer and Amgen. Dr. Marchand leads FDA’s office responsible for engaging external stakeholders...
Read More →
Director, Center for Biologics Evaluation and Research, FDA, United States
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching...
Read More →
Head of Patients and Healthcare Professionals Department, European Medicines Agency, European Union
Qualified medical doctor from the University of Grenoble, specialising in endocrinology and metabolic diseases. She joined the European Medicines Agency in 1995. Since 2004, she has been developing the interaction with patients and healthcare professionals and was appointed Head of...
Read More →
Thursday June 30, 2016 9:00am - 10:30am EDT
114
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 19: DIAmond,
Forum
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Regulatory Harmonization-Convergence, Benefit-Risk, Agency Participation
- Interest Area Regulatory Affairs
- format json
- Interest Area Regulatory Affairs
- Featured Topics Regulatory Harmonization/Convergence,Benefit-Risk,Agency Participation
- Credit Type ACPE, CME, IACET, RN
- Tags Forum
9:00am EDT
#402: Protocol Development Is a Team Sport
Chair
Vice President and Deputy Chief Medical Officer, Merck & Co., Inc.
Dr. Murray joined Merck & Co., Inc. in November 1994, and since August 2014 he has held the position of Vice President and Deputy Chief Medical Officer, managing a team of physician scientists supporting the scientific and medical needs for the Office of the CMO at Merck across all...
Read More →
Speakers
Vice President, Global Head Quantitative Sciences, Janssen Pharmaceuticals, Inc.
Mike is a neurologist with a background in functional imaging. One of his early contributions was the ASTIN stroke study, illustrating how adaptive designs allow learning in real time and enable teams to make the correct decision at the earliest time point in the most efficient manner...
Read More →
Senior Vice President, Head of Global Clinical Trial Operations, Merck & Co., Inc.
Andy heads Global Clinical Operations at Merck and is responsible for all global/regional clinical trials. Andy has over 17 years industry experience with interests in Human Subject Protection, Multiregional Studies, Quality and Compliance and finding more efficient ways to run clinical...
Read More →
President, Society for Clinical Research Sites
Christine is the President of the Society for Clinical Research Sites, a global trade organization representing over 9,000 sites in 47 countries committed to providing sites a community and voice for site sustainability. Christine is an internationally recognized expert on the global...
Read More →
Chief Executive Officer, Sjögren's Syndrome Foundation
Since joining the Foundation as its CEO in 2003, Steve has focused on making Sjögren’s syndrome a household name by increasing awareness among the general public and healthcare professionals. In addition, under Steve’s leadership, the SSF has launched two major initiatives around...
Read More →
Thursday June 30, 2016 9:00am - 10:30am EDT
103ABC
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA