Timothy C. Tyson, Chairman and CEO, Aptuit, Inc.
The technical aspects of the Biotechnology and Pharmaceutical Industry are increasing in significance in
relation to business survival and growth. Tim Tyson will address the need for providing a leadership role in
making the technologies of the future a part of today’s solutions. He will present his vision for the future
of our industry and introduce a road map for making this vision a reality.
Brett P. Giroir, Vice Chancellor for Strategic Initiatives, The Texas A&M University
The traditional paradigm for vaccine and biotherapeutics development has been challenged by three factors:
emerging infectious diseases requiring low cost, rapid response solutions; a reduction in the number of
viable candidates for clinical trials; and the rapid progress in personalized therapeutics. Brett Giroir will
describe the work of a team of Texan academic and commercial entities addressing these challenges by
developing flexible, affordable, and scalable manufacturing technologies for both biosecurity and commercial
John Menna, Director for Healthcare Strategy, UPS
The supply chain for biotechnology and pharmaceutical products has never faced so many challenges: global
sourcing; increasing levels of third-party manufacturing; theft and counterfeiting; and environmental risks.
All these issues increase the risk to the integrity of the supply chain. John Menna will discuss how UPS is
dealing with these challenges, many of which are not unique to our industry. He will address lessons we can
learn from other industries, which can be applied to protect our products, and hence, the patient.
J. David Doleski, Acting Director of the Division of Good Manufacturing Practice Assessment in the
Office of Compliance, Center for Drug Evaluation and Research (CDER), FDA
Mr. Doleski will discuss current priorities and initiatives within CDER's Office of Compliance pertaining to
pharmaceutical quality. He will describe some of the areas of greatest focus for inspection and enforcement
activities. Case studies involving recent manufacturing issues will illustrate some areas of increased
attention by regulators. Trends in pharmaceutical manufacturing will be discussed, along with the impact on
regulators, manufacturers and patients.
2011 Facility of the Year Awards
Don’t miss the much-anticipated announcement of the Overall Winner for the 2011 Facility of the Year Awards
(FOYA) program, taking place at the beginning of the Keynote Session. The 2011 Facility of the Year Awards
Overall Winner was selected from the Category Award Winners by an independent panel of global industry
experts from the pharmaceutical design, construction, and manufacturing sectors. The 2011 Facility of the
Year Awards Category Winners and Honorable Mention include:
- F. Hoffmann – La Roche Ltd
- MedImmune, LLC
- Merck & Co., Inc.
- Novartis Vaccines and Diagnostics GmbH
- Pfizer Health AB
- Pfizer Manufacturing Deutschland GmbH
- Shire HGT