Frontiers in Drug Development - Not for Physicians Only
Saturday, April 24 and Sunday, April 25, 2010
Frontiers in Drug Development – Not for Physicians Only is a special curriculum, within the Academy of Pharmaceutical Physicians and Investigators (APPI) Program at the ACRP Global Conference & Exhibition, that is dedicated to pharmaceutical medicine.
This program will cover the science, the business and the ethics of drug development over the course of nine sessions held over two days. Each session has been carefully designed to address the information and issues involving each segment of the pharmaceutical enterprise and how it adapts to today’s current clinical development and regulatory environment.
Each stakeholder is represented by speakers who not only have expertise on the topic but also have been actively participating in the implementation of the principles governing each area. Attendees are advised to attend all sessions as scheduled in order to receive the maximum benefit of learning, as each session relates to the next, culminating in a more comprehensive roadmap of the pharmaceutical industry of today and what it may become.
Who Should Attend: Physicians involved in/affected by developments in Pharmaceutical Medicine and all other members of the clinical research team.
Learning Objectives:
- Define the core principles of pharmaceutical medicine in drug and device development
- Develop effective relationships among regulatory bodies, sponsors and investigators
- Recognize the systems which build effective regulatory approval for clinical drug and device development
- Identify ethical principles which govern pharmaceutical medicine
- Develop risk minimization and management plans
Program Schedule
Saturday, April 24, 2010
8:00 am – 9:00 am
S007 Has Regulation Gone Too Far?
As the volume of regulations governing drug development increases the number of new drug entities decreases. Have we come to that stage when the mass of regulations is having the opposite effect expected by stifling creativity and enterprise? Have the benefits expected from a better regulated system especially with regard to improving healthcare for patients been overstated? Are our industries losing out to more liberal countries? Could better protection and accountability be achieved by a different, less coercive and onerous system? Where lay the happy medium for regulations?
SPEAKER(S): TBD
9:45 am – 10:45 am
S015 When Can Biomarkers Accelerate Drug Development? Breathing New Life Into an Old Question
Biomarkers are increasingly integrated into drug development and clinical trials. However, many challenges remain e.g. full understanding has not yet been reached on the impact of analytical and biological variability, on the evaluation of novel biomarkers, the evaluation of samples and on the comparability of methods. All this affects trial design and timelines to trial completion and eventually the success of the development program. The speaker will discuss the development of new volatile biomarkers of disease in breath, and discuss how these and other biomarkers can be employed to accelerate the development of new drugs.
SPEAKER(S): Michael Phillips, MD, FACP, FRCP, President and CEO, Menssana Research
11:00 am – 12:00 pm
S024 Risk Benefits Management
The speaker will cover the risk-benefit assessment process for all stages of product development. Examples will be given of mitigation strategies used by pharmaceutical and device manufacturers, regulatory agencies, and healthcare providers. Examples of risk-benefit communication strategies e.g. to the public will also be covered.
SPEAKER(S): Kasia Petchel, MD, Vice President, Global Head of Safety, Roche
12:00 pm – 6:00 pm
EXHIBIT HALL OPEN
12:00 pm – 2:00 pm
APPI Business Meeting & Policy Forum Luncheon
See Networking Events for details.
2:00 pm – 3:00 pm
S032 Frontiers of Clinical Trial Design
The speaker will cover alternatives and adaptations to the traditional clinical trial design based on classifying trial design by stages of drugs development. As resources become increasingly limited, novel designs such as ‘adaptive trials’ represent opportunities to make significant savings. But the savings from the incorporation of novel designs require judicious planning and a thorough understanding of the design and logistical challenges. Comparative effectiveness and study design/importance will also be discussed. The need for these types of studies is being discussed as part of the healthcare overhaul in the US. The speaker will give examples of novel trial designs and assess their value in the contexts that they have been used.
SPEAKER(S): David Feigal, MD, MPH, Vice President for Global Regulatory Affairs, Amgen
3:15 pm – 4:15 pm
S038 Ethical Mess-ups in Drug Development
Description: coming soon
SPEAKER(S): Michael Santoro, PhD, JD, Associate Professor of Business Ethics, Rutgers University School of Business
Sunday, April 25, 2010
8:00 am – 9:00 am
S049 Outcomes Research
Research focused on economic and patient reported outcomes is often as important as traditional clinical trial outcomes. This session will describe the importance of outcomes research, identify the various types of outcomes research studies, and describe different methods to analyze observational data. A basic understanding of technology assessment for health care interventions will also be covered.
SPEAKER(S): Charles Alexander, MD, FACP, FACE, Senior Director, Global Medical Affairs,
Merck & Co., Inc.
10:00 am – 11:00 am
S060 Pharmaceutical Medicine Survey Results and Applications
A recent survey of physicians practicing in the pharmaceutical industry recognizes the importance of pharmaceutical medicine as a distinct medical discipline. This session will report the results of the survey. Requirements of a pharmaceutical medicine discipline, the training needs and important skills for the pharmaceutical physician will be discussed.
SPEAKER(S): Peter Stonier, MB, ChB, PhD, FRCP, FFPM, Professor, Director of Education of the Faculty of Pharmaceutical Medicine, Royal College of Physicians
11:15 am – 12:30 pm
PLENARY SESSION
Social Responsibility and the Pharmaceutical Industry in the 21st Century —
A Global Perspective
KEYNOTE SPEAKER
Thomas Gorrie, PhD
President, T.M. Gorrie and Associates
Dr. Gorrie recently retired from a 35-year career with Johnson & Johnson, with his final post being Vice President of Government Affairs and Policy. He presently provides advice and consulting services to firms worldwide on business, government affairs, and management topics.
12:30 pm – 6:00 pm
EXHIBIT HALL OPEN
12:30 pm – 2:00 pm
Lunch – Exhibit Hall
2:00 pm – 3:00 pm
S071 The Boundary Between Information and Promotion
As regulations and compliance obligations increase within the pharmaceutical industry, so do the challenges of disseminating appropriate information to health care professionals and patients. Who should be the preferred information provider for medical information, and how do we deal with the challenge of information vs. promotion?
SPEAKER(S): Christopher Allen, MD, FRCA, FFPM, Executive Director, Global Medical Affairs,Merck
3:15 pm – 4:15 pm
S081 Debate Under the Oxford Rules
Under the Oxford Rules delegates debate the opportunity to make follow-on biological products available worldwide as soon as possible. The areas in question will include biosimilars vs. biogenerics, the evidence of efficacy and safety, the costs vs. constraints in this area, exclusivity issues and the paramount need for patient protection. The panel will discuss these issues and the audience will vote on whether or not the House should encourage the availability of follow-on biologics to the worldwide population as soon as possible.
SPEAKER(S): Christopher Allen, MD, FRCA, FFPM, Executive Director, Global Medical Affairs,Merck; Peter Stonier, MB, ChB, PhD, FRCP, FFPM, Professor, Director of Education of theFaculty of Pharmaceutical Medicine, RoyalCollege of Physicians; Thomas Gorrie, PhD,
President, T.M. Gorrie and Associates; Yafit Stark, PhD, Vice President and Chief Clinical
Officer, Teva Pharmaceutical Industries
Please note the following events occurring at the ACRP 2010 Global Conference & Exhibition that may be of interest:
Saturday, April 24
2:00 pm – 4:15 pm
Special Event
SP154 An Afternoon with Eva
Eva Mozes-Kor captivated attendees as a keynote speaker at the 2009 Global Conference. When she shared her experiences of being an unwilling human subject in Dr. Mengele’s experiments on twins at Auschwitz there wasn’t a dry eye in the audience.
By popular request, Eva Mozes-Kor returns to the ACRP Global Conference to share her unforgettable story. She poignantly reminds us of the need for obtaining proper consent and the need to remain vigilant of human subject protection. She discusses her personal, yet controversial, decision to forgive the Nazis for the torture they inflicted on her and her twin sister Miriam in order to live her life with grace, compassion, and purpose.
Learning Objectives
- Describe experiences of a patient involved in an unethical clinical trial
- Recognize the changes made in clinical trials since the Nuremburg Code
- Identify the need to respect human subjects
Eva Mozes-Kor’s presentation will be followed with a question and answer session moderated by David Vulcano, Immediate Past Chair of the Association Board of Trustees. Afterwards, Eva will hold a book signing in the Exhibit Hall.
Speaker(s): Eva Mozes-Kor
Moderator: David Vulcano, LCSW, MBA, CIP, RAC, AVP, Clinical Research, Hospital Corporation of America
Monday, April 26, 2010
11:15 am – 12:30 pm
PLENARY SESSION
FDA as a Public Health Agency
KEYNOTE SPEAKER
Joshua Sharfstein, MD
Principal Deputy Commissioner, U.S. Food and Drug Administration
Dr. Sharfstein was appointed by President Barack Obama to this position earlier this year, and had previously served as the Commissioner of Health for the City of Baltimore and on the staff of the Government Reform Committee of the U.S. House of Representatives for
Congressman Henry A. Waxman.
See complete information regarding Continuing Education Credits.
Program information subject to change.