2011 Plasma Protein Forum Agenda

Main Menu

Program / Agenda

Sponsorship and Exhibiting

Practical Information

Diamond Sponsors

Platinum Sponsors

PPTA Deutschland PPTA France PPTA Netherlands

> > Agenda

Thank you for another successful year!
SAVE THE DATE: JUNE 21-22, 2012

2011 Program / Agenda

Tuesday, June 14, 2011 [8:00 a.m. – 7:00 p.m.]
8:30 a.m. WELCOME 8:35 a.m. PRESIDENT’S MESSAGE 8:45 a.m. KEYNOTE ADDRESS - Immunomodulating Effects of IVIG: New Insights in Mechanisms of Action PPTA is honored to have Professor Herold Metselaar, MD, deliver the Keynote Address at this year’s conference. Dr. Metselaar is a Professor of Liver Failure and Transplantation at Erasmus University Hospital in Rotterdam, The Netherlands. Much of his career has been dedicated to renal and liver transplant success. Dr. Metselaar is also recognized as an innovator and leader in the field of the immunomodulating effects of IVIG. Throughout his career, he has seen first-hand that anti-hepatitis B immunoglobulin (HBIG) has saved the lives of many liver transplant patients infected by the hepatitis B virus. In those patients, liver transplantation was not a real option due to the high recurrence rate of infection, with a high incidence of graft failure within five years after transplantation. Therefore, hepatitis HBIG prevented recurrence of HBV and now the long-term survival rate after transplantation is excellent. Dr. Metselaar also recognized the immune suppressive ability of IG – more effective than one’s own immune system. His address will touch upon his experiences as a liver transplant expert and also explore the effect on the innate and adaptive immune system. Moderator: Jan M. Bult, PPTA President & CEO Speaker: Professor Herold Metselaar, MD, Erasmus Univeristy Hospital 9:30 a.m. REFLECTIONS ON THE PPTA MISSION A distinguished industry veteran reflects on the mission of PPTA and significant accomplishments over the years. He will offer insights into opportunities for the association and its member companies. Moderator: Jan M. Bult, PPTA President & CEO Speaker: Don Baker, Ph.D. 10:00 a.m. NETWORKING BREAK 10:30 a.m. CLINICAL EXPERIENCES WITH ALBUMIN: NEW DEVELOPMENTS Albumin was the first product of the plasma therapeutics industry, and for many years was the unquestioned therapy of choice for a number of acute conditions. In particular, shock from injury, burns and other types of fluid loss were treated by albumin. Doubts on its safety raised in the late 1990’s have now been totally dispelled as a result of many clinical studies, and new applications for albumin in hepatology, cardiology and intensive care have increased albumin’s relevance to clinical care. A panel of international experts in these various disciplines will discuss current perspectives on fluid therapy and the role of albumin in a range of medical indications. Moderator/Speaker: Professor Albert Farrugia, Vice President, PPTA Global Access Speaker: Professor Vincente Arroyo, Chief of Liver Unit, Hospital Clinic, Barcelona, Spain 11:30 a.m. NETWORKING LUNCH 1:30 p.m. ORPHAN DRUG ACT AND RARE DISEASE POPULATIONS This panel will discuss whether the current incentives under the Orphan Drug Act are sufficient to continue to spur the development of new drugs and biologicals for rare disease populations. In exploring ideas on how to increase incentives for manufacturers beyond merely increasing the seven years of marketing exclusivity that the U.S. Food and Drug Administration (FDA) is authorized to grant orphan designated drugs, the panel will examine challenges manufacturers face under the existing U.S. regulatory framework for obtaining orphan designation and approval for certain rare disease indications, stress the importance of harmonization between the European medicines Agency (EMA) and the FDA to reduce the cost of clinical trials, and discuss the impact of coverage and reimbursement on orphan drug development. Moderator: Jay Greissing, Senior Director, PPTA Federal Affairs Speakers: Kay Holcombe, Senior Policy Advisor, Genzyme Corporation Jason Money, Senior Director, Federal Government Affairs, Generic Pharmaceutical Association Mark Skinner, President, World Federation of Hemophilia Patricia Knight, President, Knight Capitol Consultants 3:00 p.m. NETWORKING BREAK 3:30 p.m. WHAT IS OPTIMAL CARE? This panel will explore medically appropriate treatment regimes for patients using plasma protein therapies. Optimal treatment is a question that the medical community has answered over the years through sound clinical research. Increasingly, payors are asking the same question. What is appropriate treatment? How much therapy is necessary to improve outcomes? Why are there variations among patient populations? Medical experts from the bleeding disorders, primary immune deficiency disorders and alpha-1 communities will come together to answer these and other questions. Moderator: Charles Waller, Vice President, PPTA Europe Speakers: R. Michael Blaese, MD, Consulting Medical Director, Immune Deficiency Foundation Marion A. Koerper, MD, Medical Advisor, National Hemophilia Foundation and Professor of Pediatric Hematology, Univeristy of California SF Charlie Strange, MD, Professor of Medicine, Division of Pulmonary & Critical Care Medicine, Medical University of South Carolina 5:00 p.m. Closing Announcements 5:00 p.m. AWARDS RECEPTION and Presentation of the PPTA Robert W. Reilly Leadership Award
Wednesday, June 15, 2011 [8:00 a.m. - 4:00 p.m.]
8:30 a.m. WELCOME 8:35 a.m. PPTA SOURCE MESSAGE Speaker: Ileana Carlisle, Chair, PPTA Source Board of Directors 9:00 a.m. MILESTONES THAT MADE A DIFFERENCE The history of plasma protein therapies is studded with important events which made a huge difference to the industry and to patient care. These watershed events include experiences in product development, in product safety and in the search for new indications. A panel of experts in various areas of plasma protein therapy usage will discuss these milestones from the point of view of manufacture and patient care. Moderator: Professor Albert Farrugia, Vice President, PPTA Global Access Speakers: Thomas R. Kreil, PhD., Associate Professor of Virology, Senior Director, Viral Vaccines & Global Pathogen Safety, Baxter BioScience Lynn K. Boshkov, MD, Associate Director, Transfusion Medicine, Oregon Health & Science University David Aronson, MD, Former Head of the Coagulation Section, Division and Blood Products, FDA 10:30 a.m. NETWORKING BREAK 11:00 a.m. PPTA STANDARDS PROGRAM: PAVING THE WAY FOR TOMORROW The industry standards program, consisting of IQPP and QSEAL, have long been a cornerstone and foundation for many of the industry’s activities, including stakeholder relations, advocacy, and safety and quality. This panel will explore the structure, purpose, relevance, and future of the IQPP and QSEAL programs through stakeholder relations, importance to industry, and the program’s relationship with the regulatory authorities. Moderator: Joshua Penrod, Vice President, PPTA Source Speakers: Joseph Rosen, Director of Business Development and Planning, Baxter Biolife Miriam O’Day, Senior Director of Public Policy, Alpha 1 Foundation/Alpha 1 Association Tommaso Paoli, PhD, Quality Assurance Statistics Manager, Kedrion SpA 12:30 p.m. NETWORKING LUNCH 2:30 p.m. FDA & EMA: WORKING TOGETHER FOR ALL Regulatory harmonization is on everyone’s wish list. Regulators from the U.S. and Europe will present information on progress made in recent years to open communication and cooperation among global regulators. Representatives from the U.S. Food and Drug Administration and Europe’s European Medicines Agency are invited to share with the audience their perceptions on regulators’ interactions and hurdles to true regulatory harmonization. Moderator: Mary Gustafson, Vice President, PPTA Global Regulatory Policy Speakers: Mark Weinstein, PhD, Associate Deputy Director and Senior Scientific Advisor, FDA/CBER/OBRR Hilde Boone, Pharm., MSc, Liaison Official at the U.S. FDA, European Medicines Agency 3:30 p.m. Closing Announcements
Program is subject to change.