Meeting Challenges in Contract R&D - Representatives from leading CROs weigh in on key challenges tied to the biopharmaceutical R&D, including issues regarding bioequivalence, platform

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Meeting Challenges in Contract R&D
Representatives from leading CROs weigh in on key challenges tied to the biopharmaceutical R&D, including issues regarding bioequivalence, platform technologies, process analytics, and more.


BioPharm International Supplements
Volume 25, Issue 3, pp. s12-s19

THE FUTURE OF CRO PROJECTS

BioPharm: From a CRO perspective, where do you see biopharmaceutical R&D outsourcing in say 5-10 years from now? What key changes may have occurred by then?

Gillett (Charles River): The driving forces in drug development are pushing all sponsors of all sizes to diversify their portfolios beyond the boundaries of their traditional product lines, to share risks, and to collaborate. In this era of increased collaboration, sponsors and CROs can be a powerful team because they share the common goal of developing successful new therapies, are non-competitive in their financial interests, and have complementary skill sets. CROs' experience can support sponsors who may be reaching outside their comfort zones towards novel technologies and regulatory practices.

Kauffman (Lancaster Labs): We predict a consistent increase in outsourcing. As sponsor companies transfer more of their expertise to contract laboratories, more testing will be outsourced. As pipelines grow, sponsors will look to outsourcing partners to help meet their objectives without having to build the capacity to support all of the work in-house. Key changes will most likely include improved analytical technology and bioinformatics.

Breau (MPI): The number of biologics being developed as a percentage of all pharmaceutical activity is growing. Many recent mergers and acquisitions were executed to increase the biological footprint of the acquiring company. As novel technologies to produce biologically derived products lose patent protection, the growth in this area should accelerate.

Reason (SGS): Market estimates indicate that biologics are taking an increasing share within R&D spending, thus offering huge opportunities. We expect to see R&D outsourcing follow the trend of the number of biopharmaceutical products in development with perhaps an increase in the outsourcing percentage. We also expect there to be an increased requirement among sponsor companies for CROs to provide a one-stop-shop. Finally, there is likely to be an increase in the number of high-level agreements between CROs and biopharmaceutical companies to provide an integrated approach for developing biopharma products.


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