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Developing and Managing Successful Bio-Outsourcing Relationships
Drug and Market Development Publishing, March 2006, Pages: 75
The bio-outsourcing trend is being influenced by recent developments such as dwindling biopharmaceutical financial support, increasing costs associated with building biomanufacturing facilities, increasing regulatory complexity surrounding biomanufacturing, shortages of qualified manufacturing and technical personnel, and the advent of disposable technologies. All of these topics are covered in detail. The guide will not only serve as a roadmap for achieving best practices in bio-outsourcing relationships but will also serve as a reference source for inexperienced sponsors who need a crash course on developing and managing productive bio-outsourcing relationships.
The 'Developing and Managing Successful Bio-Outsourcing Relationships' guide represents the first, concise, easy to follow, one-stop publication that answers all of the seminal questions necessary to create and effectively manage bio-outsourcing relationships. Individuals who read the guide and follow its suggestions should be well on their way to establishing long lasting and productive bio-outsourcing relationships. The guide outlines the essential ingredients that must be included in any successful bio-outsourcing relationship between sponsors and contract manufacturers. It also includes a directory of current contract biomanufacturing companies and providers.
Receive answers to key questions such as:
- Why do companies outsource biomanufacturing?
- How does a company determine whether outsourcing is right for them?
- What legal, business, and financial issues need to be considered before entering into a bio-outsourcing relationship?
- What are best practices for managing an effective bio-outsourcing relationship?
- What are the future trends for the bio-outsourcing industry?
Market Opportunities
- Emergence of disposable technologies industry, e.g. new bioreactors, purification equipment, plastic storage containers, new culture media etc. to support the emerging bio-outsourcing industry
- Increasing numbers of companies that specialize in the design, construction of both stainless steel and disposable manufacturing facilities
- Growth of the CBMO industry in Asia, India, Latin America and South America, a source of skilled and inexpensive labor
- Companies that specialize in biomanufacturing and regulatory compliance training (conventional and e-based) will emerge to support the personnel needs of the burgeoning CBMO industry
About the Author
Clifford S. Mintz, Ph.D. has an extensive background in pharmaceutical and biopharmaceutical drug development with special emphasis in anti-infective drug discovery. From 1987 to 1994, Dr. Mintz was a tenure track Assistant Professor in the Department of Microbiology and Immunology at the University Of Miami School Of Medicine where he conducted research on the molecular pathogenesis of infectious diseases. After leaving academia in 1994, Dr. Mintz joined Transcell
Technologies, a New Jersey-based biopharmaceutical company, to head an antibacterial drug discovery team.
Since 1997, Dr. Mintz has been a management consultant to a number of emerging and publicly-traded biopharmaceutical companies including Prolong Pharmaceuticals, Alchemia, Pty., IVT, Inc., Millenium Pharmaceuticals and Pharmacopeia where he provided strategic planning, business plan development expertise, corporate and business development support, or performed M&A due diligence work. He has also started two companies: Prolong Pharmaceuticals, a drug delivery company and BioInsights, Inc., a bioscience training and education company. He received a B.S. in microbiology/animal science from Cornell University, a Ph.D. in Bacteriology from the University of Wisconsin-Madison and performed his post-doctoral studies at the College of Physicians & Surgeons, Columbia University.
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