In the biologics industry, many small or start-up companies lack the resources to perform all aspects of their business on their own. Even mid- or large-size companies don’t always have the personnel, equipment, space, or bioprocess technology to carry out every step in the research, development, biomanufacturing and marketing chain that is required to take a new biologics drug candidate from preclinical research stages to clinical trial through to commercial licensing. The common solution is to rely on pharmaceutical outsourcing of these tasks to a service provider, particularly when biomanufacturing (biologics manufacturing) is involved, which allows for the channelling of precious financial resources into the new drug candidate instead of expensive biopharmaceutical manufacturing infrastructure.
Over the past 20 years, pharmaceutical outsourcing has seen a significant change as the industry has grown and matured. A decade ago, the drug industry backed away from the ‘vertically integrated’ business model that had been popular in the 1990’s, and moved toward an outsourcing model. At that time, companies were receiving more funding, and their investment backers began to acknowledge the value that biologics manufacturing companies, and other outsourcing firms, added to new candidate products. At present day, with the biologics industry’s maturation, we are witnessing more established operating strategies, evolving to suit the demands of biomanufacturing innovation. Approximately 50% of all biopharmaceutical companies are currently outsourcing some form of their biomanufacturing, and this growth trend is expected to continue in the coming years.
Given this growing trend, and the importance of pharmaceutical outsourcing in the biologics industry, BPAI has developed a systematic approach for managing Request for Proposal (RFP) processes that assists our clients in the selection of an ideal outsourced service provider – balancing program costs against biologics process development and GMP biomanufacturing timelines and risks. Our RFP process uniquely solicits critical, decision making information from service providers in a standardized way so that when the proposals are received they can be quickly normalized and presented in a logical and data driven way, making final selection decisions clear and simple. Services related to RFP processes include:
- Creating a comprehensive statement of work for the program
- Developing the Request for Proposal through an iterative, client-driven process
- Establishing confidentiality agreements with candidate biologics manufacturing service providers
- Negotiation and on-going dialogue to assist service providers in publishing a meaningful proposal
- Normalization of submitted proposals, with graphical and tabulated data presentation
- Qualification of short-listed service providers
- Navigation assistance for final selection decisions
Over the years, BPAI has worked as biologics consultants to award more than $40 million dollars in biomanufacturing programs globally on behalf of our clients, and have assisted with the technical program management on nearly all of these following contract awards.
Whether you’re just starting an RFP process, are in the middle of one, or are struggling with numerous proposals, let BPAI’s biologics experts assist you through our innovative pharmaceutical outsourcing services.