341459 Succeeding At Transferring Complex Technologies: Partnering Across Organizations

Monday, November 4, 2013: 12:30 PM
Union Square 20 (Hilton)
Howard Stamato1, Faranak Nikfar1, Sameer Deshpande2, Otilia Koo1, Prakash Parab2, Chandrakant Patel3, Jingpin Jia4, Brian Yan4, Luis Alves2, Barry Scheer5, Arturo Marin1, Parminder Sidhu1, Mark Rabideau2, John Peragine2, Valerie Heeter2, Lawrence Freed1, Sailesh Varia1 and Peter Timmins6, (1)Drug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, NJ, (2)Global Manufacturing and Supply, Bristol-Myers Squibb, New Brunswick, NJ, (3)CMC Project Planning and Management, Bristol-Myers Squibb, New Brunswick, NJ, (4)Analytical and Bioanalytical Development, Bristol-Myers Squibb, New Brunswick, NJ, (5)Global Regulatory Sciences, Bristol-Myers Squibb, Hopewell, NJ, (6)Drug Product Science & Technology, Bristol Myers Squibb, Moreton, United Kingdom

Technology transfer, while rooted in the flow of materials and creation of documents, is also founded on the communication and relationships forged among organizations both internal and external to the enterprise.  Manufacture of pharmaceutical dosage forms involves many different technical disciplines, all with a unique perspective and a contribution of the culture necessary to support routine use of the technology at the receiving site.  The more complex the dosage form; the more complex, and risky, the transfer can be.   As a regulated activity the requirements and documentation to meet health authority standards must also be considered.   The presentation will discuss the various perspectives, their communication flow and how the overall transfer process can be orchestrated to a successful conclusion, as derived from the experiences in technology transfer of complex dosage forms both internally and externally.

Extended Abstract: File Uploaded
See more of this Session: Challenges and Best Practices in Technology Commercialization
See more of this Group/Topical: Process Development Division