Tuesday-Wednesday, October 21-22, 2008

Course Instructors:
Howard L. Levine, Ph.D.. President and Principal Consultant, BioProcess Technology Consultants, USA
Susan Dana Jones, Ph.D., Vice President and Senior Consultant, BioProcess Technology Consultants, USA

Objectives of the Course:
The objective of this course is to provide an overview of interdependencies in the activities that form a biopharmaceutical product development program and to introduce effective project management approaches to coordinate these activities and streamline the development programs.

Brief Introduction of the Course:
This course is intended to provide scientists involved in biopharmaceutical development with an in-depth introduction to the many inter-related activities that form the basis of an effective and efficient biopharmaceutical manufacturing program. The course will provide a detailed description of activities including analytical and process development, scale up and cGMP manufacturing for clinical trials, drug product manufacturing, and validation of the manufacturing process prior to market launch. The timing of these activities relative to the clinical development program and intended product launch will be described. We will discuss the risks and benefits of cost and time-saving strategies in early development and the potential impact on later development timelines.

In many cases some or all of the activities needed for biopharmaceutical manufacturing are outsourced to contract manufacturing or research organizations (CMOs and CROs). Effective project management approaches that are necessary to insure seamless coordination of the internal and external activities will be described. Under proper project management, companies are able to identify critical path items, address and mitigate the impact of unforeseen technical setbacks during development, reduce manufacturing risk, and insure on-time and successful regulatory submissions.

Who Should Attend:
This course is intended to provide an introduction and management overview of biopharmaceutical development. This course would most benefit:

• Bench scientists in discovery and development
• Project managers at biotechnology companies or the service organizations that support biotechnology
• Program managers and directors who implement and achieve the development milestones
• Business development and alliance management executives and investors who need to make partnership and financial decisions that impact timelines and development risk

Schedule and Topics Covered

Tuesday October 21

Wednesday October 22

Course Registration
Participants registered for the 2-day Training Course will have access to the exhibit hall and networking events with participants of the BPI Asia Pacific main conference.

Course registration does not include access to sessions at BPI Asia Pacific main conference.

Instructors' Biographies

Howard L. Levine, Ph.D. has over 25 years of experience in successful product companies and as founder of BioProcess Technology Consultants, Inc., the leading biopharmaceutical CMC consulting group. Prior to founding BioProcess Technology Consultants, Dr. Levine was Vice President of Manufacturing Operations at Repligen Corporation. He was responsible for all process development and manufacturing activities, including production of therapeutic proteins, monoclonal antibodies and recombinant Protein A. Dr. Levine has also held positions in process development and manufacturing at Xoma, Genentech, and Amgen. Throughout his career, Dr. Levine has assisted in the development of over 20 different biological products and the successful commercialization of 3 of these products. Dr. Levine is currently a member of the Editorial Advisory Boards of BioPharm Magazine and Bio/Pharmaceutical Outsourcing Report and is also a member of the Advisory Boards of Acretia Inc., and Nexbio, Inc. He was chairperson of the Parenteral Drug Association's (PDA) Task Force on Chromatography Validation and has been an invited lecturer on manufacturing strategy, downstream processing, validation, and commercialization of biotechnology products. He holds a Ph.D. in chemistry from the University of Chicago and completed a post-doctoral fellowship at Harvard University.

Susan Dana Jones, Ph.D. has more than 20 years of discovery, product development, and strategic planning experience in biotechnology. She co-founded two biotechnology companies and has managed discovery and product development programs in multiple organizations and for multiple disease areas. She currently manages several outsourced biopharmaceutical process development and manufacturing programs for client products, assists and advises clients and vendors regarding applicable cGMP regulatory guidelines, performs regulatory compliance audits, prepares CMC sections of client regulatory submissions to FDA, EMEA, and other competent authorities, and performs due diligence of manufacturing and analytical operations for investors or clients considering acquiring products in development. In addition, Dr. Jones serves as an Adjunct Assistant Professor of Pharmaceutical Sciences at the Massachusetts College of Pharmacy and Health Sciences, as a member of the Board of Directors of Virginia-based start up company Gene Solutions, and as a member of the Editorial Advisory Board of BioProcess International. Dr. Jones received her Bachelor's degree from Harvard University, her Ph.D. from the University of California, San Francisco, and performed post-doctoral research at the Dana-Farber Cancer Institute of Harvard Medical School.