7:30 a.m. Registration and Exhibits Open
Continental Breakfast (Exhibit Hall)
8:30 a.m. Welcome and Opening Remarks
PPTA Strengths - What Your Association Does for You
Speaker: Jan M. Bult, President & CEO
9:00 a.m. Keynote Address - FDA’s Approach to Rare Diseases
The U.S. Food and Drug Administration (FDA) has given greater prominence to rare diseases recently with the establishment of a newly created position within CDER, the Center from Drug Evaluation and Research, that will lead the development of the agency’s first-time drug center policies for reviewing and approving rare treatments. The Office of New Drugs will work in tandem with colleagues within the Center for Biologics Evaluation and Research (CBER) in order to coordinate FDA’s work and approach on rare disease drug and therapy development. Learn from two FDA representatives how this synergy within the agency will help patients coping with rare diseases and manufacturers seeking to bring orphan products that can treat them to market.
Moderator: Kym Kilbourne, Assistant Director, PPTA Communications
Speakers: Anne Pariser, MD, FDA Associate Director for Rare Diseases
Nisha Jain, MD, Chief, Clinical Review Branch, Office of Blood Research and Review, CBER FDA
NETWORKING BREAK with EXHIBITORS
10:15 a.m. Strategies to Improve Patient Access
PPTA is committed to working with external organizations to further patient access to all plasma protein therapies. Patients depend on access to plasma protein therapies to sustain their quality of life and, in some instances, life itself. Unfettered access to therapies can eliminate hospitalizations and other more costly forms of care, and provides flexibility for different dosages and different treatment regimens among specific patient populations or for specific individuals within those populations. This panel will explore the perspectives of consumer organizations around the globe and take a glimpse at a European program that reflects collaboration between patients, physicians and industry to promote access to therapy. This session is intended to challenge attendees to work together to identify solutions that promote patient access to plasma protein therapies.
Moderator: Julie Birkofer, Senior Vice President, PPTA North America
Speakers: Marcia Boyle, CEO and Founder, Immune Deficiency Foundation
Kimberly Haugstad, Executive Director, Hemophilia Federation of America
Miriam O’Day, Senior Director Public Policy, Alpha 1 Foundation / Alpha 1 Association
Charles Waller, Vice President, PPTA Europe
11:45 a.m. NETWORKING LUNCH (on your own)
1:30 p.m. The Impact of the Federal Budget on Health Care Policy
Addressing the current economic troubles is the highest priority for policymakers. Congress and the Administration recognize that the federal government is operating with an uncontrollable deficit that most would argue is not sustainable. Trust funds that support one of the largest entitlement programs - Medicare - are predicted to go bankrupt within a decade unless spending is curbed. What can be done to control the spending? The annual federal budget sets the spending blueprint for the nation. The budget drives policy and now more than ever with every vote being heavily scrutinized, the budget is forcing legislators to make difficult decisions. After giving an overview on the budget process, the speaker will describe the need to reduce health care spending and the delicate balance between cost containment measures and maintaining patient access.
Moderator: Jay Greissing, Director, PPTA Federal Affairs
Speaker: Jim Nussle, President and CEO, The Nussle Group
NETWORKING BREAK with EXHIBITORS
2:30 p.m. Pandemic Preparedness - Lessons Learned from H1N1
Four years ago the term pandemic influenza became part of our everyday vernacular. The pandemic pandemonium was triggered by the H5N1 influenza virus or bird flu. Health officials stressed the need to be prepared and it was a hot topic discussed around the world. H5N1 did not cause a pandemic. It appeared that the world had dodged a bullet until the spring of 2009 when a novel virus emerged, H1N1 or better known as swine flu. How prepared were we? This panel will explore pandemic preparedness and what we have learned from H1N1 on how to prepare for the possibility of future pandemics.
Moderator: Bridget Elis, Assistant Director, PPTA Regulatory Policy
Speakers: Don Baker, Ph.D., Baxter BioScience
Thomas Luke, MD, US Navy
Diane Maloney, Associate Director for Policy, Center for Biologics Evaluation and Research, CBER FDA
Toby Simon, MD, Corporate Medical Director, CSL Plasma
4:00 p.m. Recognition Awards
4:30 p.m. Announcements
NETWORKING RECEPTION [5:00 p.m. – 7 p.m.]
Presentation of the PPTA Robert W. Reilly Leadership Award
The first Robert W. Reilly Leadership Award was awarded in 1998 to recognize an individual who best exemplifies the leadership qualities of Robert W. Reilly, a leader of the plasma therapeutics industry association. As Executive Director and President of ABRA (now PPTA Source), 1978 to 1992, and President of the International Plasma Products Industry Association (now PPTA) until 1998, Mr. Reilly played a significant role in the development and acceptance of industry voluntary standards for quality plasma programs and was a leader in advancing relationships and open communication with regulatory authorities and consumer groups. In addition, he developed the first education programs and industry symposia focusing on challenges in the plasma collection facility and fractionation and plasma therapeutics issues worldwide.
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7:30 a.m. Registration and Exhibits Open
Continental Breakfast (Exhibit Hall)
8:30 a.m.
Welcome and Opening Remarks
8:45 a.m. Source Division Updates
Moderator: Joshua Penrod, Vice President, PPTA Source
Speaker: Ileana Carlisle, Biotest Pharmaceuticals, Chair Source Board of Directors
9:15 a.m. Ethics of Compensation
Sally Satel, MD, resident scholar at the American Enterprise Institute and a practicing psychiatrist, will discuss several items of consideration regarding the ongoing debates involving compensation and donation. Her personal experiences in this area complement her current research and writing interests and will offer thought-provoking context for ongoing dialogue within the plasma protein industry.
Moderator: Joshua Penrod, Vice President, PPTA Source
Speaker: Sally Satel, MD, American Enterprise Institute
NETWORKING BREAK with EXHIBITORS
10:30 a.m. Global Access to Plasma Protein Therapies
This session will host key medical opinion leaders who care for patients needing access to plasma protein therapies. The panel will discuss areas of their work such as medical education, generation of clinical evidence and diagnosis which are needed to ensure and enhance access. The panel will be invited to comment on which areas can be improved in order to increase awareness of rare disease states and how impediments in their specific areas have been overcome.
Moderator: Professor Albert Farrugia, Senior Director, PPTA Global Access
Speakers: Kenneth Chapman, Professor of Medicine, University of Toronto and GSK-CIHR Research Chair in
Respiratory Health Care Delivery, Director Asthma & Airway Centre, University Health Network
Donna DiMichele, MD, Medical Director of the Division of Blood Diseases and Resources at
the National Heart, Lung, and Blood Institute of the National Institutes of Health
Shigeaki Nonoyama, MD, Ph.D. Professor and Chairman, Department of Pediatrics,
National Defense Medical College
Jordan Orange, MD, Univ. of Pennsylvania School of Medicine
12:00 p.m. NETWORKING LUNCH (on your own)
1:30 p.m. An Insider’s Take on Health Reform and Reporting
After spending 18 hour days traveling the country on then-candidate Barack Obama’s historic presidential campaign, Carrie Budoff Brown covered one of the most significant, if not the biggest, stories of President Obama’s first year in office—health reform. Ms. Brown signed on with start-up POLITICO the day it launched more than three years ago, becoming an integral part of the newspaper’s meteoric rise to the “must read” political paper in D.C. Ms. Brown will offer insight on how she covered health care in the year leading up to the passage of health reform legislation; anecdotes from covering the President Obama’s campaign; how the news media and political reporting has changed over the years; and how health care news coverage has changed, since the legislation passed.
Moderator: Kym Kilbourne, Assistant Director, PPTA Communications
Speaker: Carrie Budoff Brown, Reporter, POLITICO
2:00 p.m. Health Reform: What happened? Where are we now?
Affordable quality health care coverage for all Americans is a top priority for both U.S. Congress and the Administration. More than 60 years after President Roosevelt proposed a second bill of rights including medical care for all, the House and the Senate each passed a version of comprehensive health reform. Panelists will detail some of the more controversial issues raised during the current health reform debate by providing an outlook on the challenges of regulatory implementation, illustrating the varying degrees to which health reform will impact the States, and examining the role politics are having on the ability to reconcile the differences between the bills passed by the House and the Senate.
Moderator: Bill Speir, Assistant Director, PPTA State Affairs
Speakers: Patricia Knight, Founder, Knight Capitol Consultants
Jon McKnight, Assistant Director, PPTA Federal Affairs
Jason Money, Director, Federal Government Affairs, Generic Pharmaceutical Association
Richard Ramsay, Vice President State Advocacy, America’s Health Insurance Plans
NETWORKING BREAK – EXHIBIT HALL
3:30 p.m. Questions & Answers with the FDA
A panel of staff from the Food and Drug Administration will respond to questions submitted by PPTA members on activities and policies of their respective agencies. This session offers the opportunity to get first-hand information from the regulators.
Moderator: Mary Gustafson, Vice President, PPTA Global Regulatory Policy
Speakers: Judy Ellen Ciaraldi, Consumer Safety Officer, Division of Blood Applications, FDA
Mary Malarkey, Director, Office of Compliance and Biologics Quality, FDA
Ginette Michaud, MD, Deputy Director, Office of Blood Research and Review, FDA
Mark Weinstein, PhD, Associate Deputy Director, Office of Blood Research and Review, FDA
4:30 p.m. Closing Announcements
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