5:00 pm – 7:00 pm

Pre-Conference Registration
Welcoming Hospitality Suite
Register and pick up your program materials early and step into the Hospitality Suite - a fine place to meet, greet, and enjoy a refreshment before the start of Forum.

7:30 am

Registration
Continental Breaskfast

8:30 am

Welcome and Opening Remarks
Jan M. Bult, PPTA President

8:45 am

Chairman’s Message
Lawrence P. Guiheen, Baxter International Inc.
Chairman, PPTA Global board of Directors

9:15 am

Keynote Address: The Donor/Consumer Relationship
Speakers: Jerry Bigelow, Donor perspective
Matt Stinger, Consumer perspective

Inspired by the individuals who donate plasma and the patients who receive life-saving plasma protein therapies, this year’s Keynote Address will explore the vital relationship between donor and patient. The millions of patients worldwide who depend upon plasma-derived therapies are inextricably linked to donors. The Keynote Address will be delivered by a long time plasma donor who will share his story of commitment, followed by remarks from a consumer of plasma protein therapies who will share his personal story.

10:15 am

Networking Break

10:45 am

Primary Immunodeficiency: Access Imperatives
Speakers: Vicki and Fred Modell, Jeffrey Modell Foundation
Catharine and Jacob Beal, Consumer perspective
Moderator: Julie Birkofer, Vice President, PPTA North America

For persons with compromised immune systems that infuse lifesaving immune globulin therapies nothing is more important than access to care and access to the therapy. Vicki and Fred Modell, founders of the Jeffrey Modell Foundation, have dedicated their lives to making the world a safer place for persons with immune deficiency diseases. The Modell’s are known to many in the community as visionary leaders. They look within their community to groom the youth to become the leaders of tomorrow. In addition, PPTA is privileged to have Mr. Jacob Beal share his story of perseverance, determination and triumph as a young man with primary immune deficiency disorder and who aspires to be future leader in his community!

11:15 am

Global Access to Care Initiatives: International Perspectives
Speakers: Ian Clements, International Trade Specialist, Office of Japan, U.S. Dept. of Commerce
Ray Puth, PPTA Europe
Mark Skinner, World Federation of Hemophilia
Moderator: Charles Waller, Vice President, PPTA Europe

Access to life-saving plasma-derived and recombinant analogs (collectively, “plasma protein therapies”) is essential for persons worldwide. Over one million people globally rely upon access to these essential therapies. Access to care can be impacted by the country one resides in and often there are regional variations that have a real impact on an individual’s health and ability to access life-sustaining plasma protein therapies. This panel will delve into various global initiatives designed to enhance patient access to therapies.

12:30 pm

Lunch Recess (on your own)

2:30 pm

Food and Drug Administration Amendments Act: Breaking It Down
Speakers: Nancy Ostrove, PhD, Office of the Commissioner, FDA Len Wilson, Center for Biologics Evaluation and Research, FDA Bob Sausville, Center for Biologics Evaluation and Research, FDA
Moderator: Bridget Elis, Manager, Regulatory Policy

On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA). This landmark piece of legislation reauthorizes a number of important programs and amends the Food, Drug and Cosmetic Act and the Public Health Service Act. Many of these changes significantly increase FDA’s control over drugs once they are on the market. Additionally, FDAAA contains a number of provisions directed at making the drug review process more transparent and open. This panel will focus on the key provisions within the bill that are meaningful to the industry and highlight the steps the FDA has taken regarding its implementation.

3:45 pm

Networking Break

4:00 pm

FDA Proposed Rule on "Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use:" An Overview
Speakers: John McVey, Baxter BioLife
Dr. Bob Kratzel, Talecris Plasma Resources
Dr. Toby Simon, ZLB Plasma
Dr. Jon Knowles, ZLB Plasma
Moderator: Mary Gustafson, Vice President, PPTA Global Regulatory Policy

The FDA published the proposed rule on November 8, 2007. The proposed revisions to regulations were developed by the FDA over the past decade. The proposal is comprehensive and, if it becomes final, will impact the plasma industry in numerous areas in donor selection and plasma collection. With comments due to the FDA on August 4, 2008, this session will provide an overview of the proposed rule and progress that PPTA’s Regulatory Policy and Compliance Steering Committee and Medical Directors Task Force have made in addressing the many important provisions of the proposal.

5:30 pm – 7:30 pm

Networking and Award Reception

PPTA’s Robert W. Reilly Leadership Award
Presented by: Lawrence P. Guiheen, Baxter International Inc.
Chairman, PPTA Global board of Directors

The Reception features the presentation of the 2008 Robert W. Reilly Leadership Award. This Award recognizes an individual who, through their commitment and leadership, has had a positive influence on the plasma protein therapeutics industry and who demonstrates unquestionable professional character, ethics and commitment to the advancement of the industry. The Reception highlights the “Commitment to the Community” by PPTA’s members and offers an exciting atmosphere for networking with colleagues and customers.

7:30 am

Registration
Continental Breaskfast

8:00 am

Welcome
Joshua Penrod, Vice President, PPTA Source

8:15 am

Opening Remarks
Gordon Naylor, CSL Behring; Chairman, PPTA Source

8:30 am

Securing the Future: Energizing New Leaders
Speaker: Shelly Mattson, National Hemophilia Foundation; Chairman, Youth Leadership Council
Moderator: Julie Birkofer, Vice President, PPTA North America

Organizations are always looking for fresh perspectives and new energy. Investing in the future by grooming tomorrow’s leaders is vital to the longevity and success of any organization. The National Hemophilia Foundation (NHF) taps into its youth and provides opportunities for young people to express their views and engage in the important issues of access to care. Ms. Mattson is an extremely energetic and focused volunteer who will share her perspectives on the contributions of the NHF’s Youth Leadership Council.

9:00 am

The Importance of Access to Care: Overcoming the Hurdles
Speakers: Laurie Kelley, LA Kelley Communications
Marcia Boyle, Immune Deficiency Foundation
Evelien P. Mauser-Bunschoten, MD, PhD, Van Creveldkliniek Dept. of Hematology, University Medical Center Utrecht
Moderator: Julie Birkofer, Vice President, PPTA North America

With so many hurdles in health care systems, it can be difficult and in some cases almost impossible for patients to access critical plasma protein therapies. Government sponsored programs and private insurance plans impact patient access. Now, health care reform proposals are at the forefront of election year political debates and if enacted would impact access to therapies at various levels. Access to plasma protein therapies is a priority for all persons, young and old alike. It is important to consider the impact of access care on the aging populations. This panel will bring a variety of perspectives to this critical issue.

10:00 am

Networking Break

10:30 am

Plasma's Journey: From Human to Biologic
Speakers: Don Baker, PhD, Baxter BioScience
Ileana Carlisle, Biotest Pharmaceuticals
Gordon Naylor, CSL Behring
Nathan Roth, PhD, Talecris Biotherapeutics
Moderator: Joshua Penrod, Vice President, PPTA Source

Plasma’s journey from donor to fractionation is fascinating and complex. This panel will explore the various facets of this process. Attendees should expect a comprehensive view of the Source plasma collection processes as well as the manufacturing of this protein-rich fluid into a variety of life-saving plasma-derived therapies.

12:30 pm

Lunch Recess (on your own)

2:30 pm

Vision of the Industry: A Global Leadership Perspective
Opening Remarks: Paul C. Rosenthal, Esq., PPTA General Counsel
Speakers: PPTA Global Board of Directors
Moderator: Jan M. Bult, PPTA President

Don’t miss this unique opportunity to hear from PPTA’s leadership on the important issues facing the plasma protein therapeutics industry. The PPTA Global Board of Directors sets the priorities and vision of the Association. This panel promises to be engaging, fast-paced and exciting. As the industry’s leaders, panelists will share their expertise, insights and knowledge of key issues at the forefront of today’s agenda.

4:30 pm

Closing Announcements
Jan M. Bult, PPTA President

Note:

It may be necessary to alter the content of the program for reasons beyond the control of the Association.