(TAMPA, FLORIDA, USA, 13 October 2011) – ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, today announced that Timothy C. Tyson, Chairman and CEO of Aptuit, Inc., Brett P. Giroir, Chief Medical Officer for Caliber Biotherapeutics and Vice Chancellor for Strategic Initiatives for the Texas A&M University System, John Menna, Director for Healthcare Strategy for UPS, and J. David Doleski, Acting Supervisory Consumer Safety Officer, Office of Manufacturing and Product Quality (OMPQ), Division of Good Manufacturing Practice Assessment with the FDA will kick off the ISPE 2011 Annual Meeting as keynote speakers. The yearly event, highlighting practical solutions to daily challenges in the pharmaceutical industry, new ideas from thought leaders, and the accomplishments of ISPE Members, will be held 6-9 November at the Gaylord Texan in Grapevine, Texas, USA.
“We’re extremely fortunate to have such engaging and high profile speakers at our biggest event of the year,” said Bob Best, President and CEO of ISPE. “We are confident that their presentations will be a perfect fit for this year’s theme, Preparing Professionals and Organizations for Rapid Change. The entire program is designed to ensure that ISPE’s role in bringing together the most forward-thinking leaders and industry experts remains undisputed. It is always our goal to ensure that professionals who want both practical solutions to today’s challenges and a view of the future find both at ISPE’s Annual Meeting.”
About the Keynote Presentations
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, Chief Medical Officer for Caliber Biotherapeutics, Vice Chancellor for Strategic Initiatives, The Texas A&M University System
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 applications.
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.
Other Annual Meeting Highlights
Education sessions at the 2011 ISPE Annual Meeting will follow five tracks of interest: Regulatory; Manufacturing Operations, Including Emerging Markets; Facilities and Project Delivery; Investigational Products; and Technology. These sessions will consist of all-new content and presentations from some of the industry’s top companies, such as Eli Lilly & Co, Merck & Co., Inc., GlaxoSmithKline, Pfizer, MedImmune, and AstraZeneca, as well as global regulatory authorities, to provide fresh perspectives on modern GMP challenges and help prepare attendees for the changes currently underway in the industry.
The Announcement of the 2011 Overall Facility of the Year Award Winner will take place during the Keynote Address. The Facility of the Year Awards program is one of the industry’s most prestigious recognition programs, and the only one to focus on innovation and quality in the field of pharmaceutical manufacturing. The Overall Winner was chosen by an independent judging panel of experts with global expertise in all facets of the pharmaceutical manufacturing industry from a field of six Category Winners. The Category Winners, along with a Winner of Honorable Mention, were named earlier this year. The 2011 Facility of the Year Award Category Winners and Winner of Honorable Mention are: F. Hoffmann – La Roche, Process Innovation; MedImmune, LLC, Project Execution; Merck & Co., Inc., Facility Integration; Novartis Vaccines and Diagnostics GmbH, Equipment Innovation; Pfizer Health AB, Operational Excellence; Pfizer Manufacturing Deutschland GmbH, Sustainability; and Shire HGT, Honorable Mention. More information on the Facility of the Year Awards can be found at www.FacilityoftheYear.org.
The annual ISPE Membership Luncheon and Awards Ceremony will be held 8 November. The Luncheon will feature a recap of Society events for 2011, a look forward to 2012, and the 2011 Society Awards presentation, during which the winners of the ISPE Member of the Year, Company of the Year, Chapter or Affiliate of the Year, and International Student Poster Competition, among other awards, will be announced.
The 4th Annual Communities of Practice (COP) Night will be held 7 November. The evening will feature a Pre-Game Party hosted by all 19 COPs followed a choice of three different COP dinners being held at the resort’s two restaurants, Riverwalk Cantina and Zeppole.
A Table Top Exhibition will be held 6-8 November to showcase products and services from the industry and facilitate Manufacturer and Supplier interaction to solve industry challenges. For information, contact John Phillips at +1-813-739-2292 or Daniel Murphy at +1-813-739-2274, or visit www.ISPE.org/2011-annual-meeting/exhibits-and-sponsors.
Complete program and registration details for the 2011 ISPE Annual Meeting can be found at www.ISPE.org/2011AnnualMeeting. For press passes to attend this event, please contact ISPE Communications Manager Danielle Hould at +1-813-960-2105, ext. 277, or email email@example.com.
ISPE, the International Society for Pharmaceutical Engineering, is a Society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. ISPE is “Connecting a World of Pharmaceutical Knowledge” by providing Members with opportunities to develop their technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.