Headlining this new conference program will be a series of keynote presentations, open to all badge holders and presented by leading subject matter experts who will provide comprehensive overviews in critical areas:
What the New Bio/Pharma Business Model Means for CMOs and CROs:
James C. Miller, President and CEO of PharmSource Information Services, Inc., will outline the transformation of today's bio/pharma business model and the opportunities and challenges it presents to providers of development and manufacturing services. Miller is a recognized expert in bio/pharmaceutical outsourcing, and editor and publisher of the Bio/Pharmaceutical Outsourcing Report and Emerging Markets Outsourcing Report newsletters. He is a judging panel member of the annual European Outsourcing Awards, and serves on the Board of Directors and Technical Committee of the American Type Culture Collection (ATCC). He is also an editorial advisory board member for Advanstar Communications' Pharmaceutical Technology and BioPharm International magazines. Pharmaceutical Technology is the keynote sponsor. When: Tuesday, May 1, 9:15 am - 10:15 am.
Control, Capability, and Capacity: Elements Assuring a Reliable Drug Supply:
Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products, Center for Drug Evaluation & Research, FDA. A central part of the FDA mission is the assurance of a safe, effective drug supply, which has evolved from a focus on safety in the 1930s to safety and efficacy in the 1960s and the inclusion of Quality Management Systems in the 1990s. Incorporated into this has been Quality by Design and supply chain or cold chain management, plus growing attention to issues associated with capacity management. The presentation will provide a technical/historical context for discussions currently underway in which FDA is partnering with industry to better understand and control factors that can compromise the ability to deliver high quality medicines in a reliable way. Prior to his FDA appointment, Dr. Baker led the Manufacturing Science and Technology component at MedImmune, following his work at Eli Lilly & Co., where he led development of several commercial bioproducts from bench top purification to global launch. He later became the firm's Senior Research Advisor for Manufacturing Sciences and Technology and founded its Global Validation Practices Team. When: Tuesday, May 1, 1:30 pm - 2:30 pm.
Creating Innovative Cold Chain Solutions for your Pharmaceutical and Biopharmaceutical Products:
Richard Smith, Director, Life Sciences & Specialty Services, FedEx. The international healthcare market is valued at more than $1 trillion in goods and spending is expected to grow five percent annually through 2013. The significant growth within this industry extends to the global distribution network, and Smith will address the role of FedEx's global air network, visibility, and intervention capabilities in cold chain supply. This includes a number of services and temperature-controlled capabilities to overcome challenges faced by the pharmaceutical and biopharmaceutical companies, in addition to cost-effective global room temperature solutions. Smith is the son of FedEx founder Frederick W. Smith and prior to his current position has been Manager of Supply Chain Solutions and Managing Director of Life Science and Specialty Services. When: Wednesday, May 2, 10:15 am - 11:15 am.
“We're very fortunate to have these speakers, each of whom is a leader in his topic area,” said R.J. Palermo, Vice President of Strategic Initiatives. “We realize these are the issues that our attendees are facing, and being able to provide 'big picture' developments in these presentations complements the tightly-focused track sessions.”
More Details and Connections
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