Global prescription spending exceeded $1 trillion in 2014 and revenues from biopharmaceuticals accounted for nearly 15% of this spending. Almost a third of all drug products in development are biopharmaceuticals that will contribute to the total pharmaceutical spend going forward. This anticipated biopharmaceutical sector growth will have a significant impact on future pharmaceutical company revenue. An increase in biopharmaceutical development will also drive growth for contract manufacturing services. On June 17 at BIO 2015 in Philadelphia, Patti Seymour, Senior Consultant at BioProcess Technology Consultants, will lead a panel discussion in the BioProcess Theater on “Managing the Contract Relationship”. Joining Ms. Seymour in this discussion will be Stephen Taylor, SVP, Commercial at FujiFilm Biotechnologies; Justin Skoble, Senior Director, Technical Operations at Aduro Biotech, Inc.; Tom Douville, Director, Biopharmaceutical Development at Kolltan Pharmaceuticals, Inc.; and Lily Vakili, Senior Counsel at Faber Daeufer & Itrato PC.
This panel will explore the selection and contracting process for developing and manufacturing biopharmaceuticals beginning with a detailed request for proposal (RFP). Preparing an RFP helps the client think through its needs and allows the CMO to provide an appropriate proposal, which can then form a basis for CMO evaluation and negotiation. A step-by-step negotiation process might begin with a letter of intent leading to a master services agreement that represents the appropriate interests of both parties. Contracts for biopharmaceutical develop and manufacturing services require both sides to consider a number of critical issues including risk management, intellectual property ownership, dispute resolution, cost control, access to data and information and timely performance.
The panel, representing the client and contractor perspectives, will use results from BPTC’s most recent bioPULSE® survey, Key Considerations for Selecting an Outsourcing Partner, and contract negotiation case studies to illustrate approaches and outcomes to achieve mutual agreement regarding risk, failed batches, timelines, costs and data/information access, etc. This shift toward collaborative working relationships is good business for the CMOs. Clients benefit by in getting their biopharmaceutical into the clinic. Next week’s panel is sure to provide insight into the issues facing clients and CMOs. Visit us at booth #3230 after the panel to continue the conversation.