Therapeutic development programs face several challenges that are distinct to this product category. Specifically, development of new and follow-on products must be done under strict timelines to capture the greatest return on the investment. Further, the manufacturing process needs to be optimized for the product under development – especially if the therapeutic is not a monoclonal antibody.
A program with tight timelines often cannot wait for new hires to come onboard. In other instances, a company’s internal resources may be focused on a higher priority program. LBG addresses this issue by bringing in consultant teams that provide the necessary quality, regulatory, clinical, CMC, and business development expertise that can progress a program without delay.
LBG consultants have worked on a range of product development programs, including:
- Monoclonal Antibodies (mAbs), mAb Toxin Conjugates, and Radiolabeled mAbs
- Fab Fragments made in E. coli
- Wound Healing
- Small Molecules: Ophthalmic, Dermatological, Radiological
- Influenza Antibodies
- Ebola Antibodies
All product development programs have numerous moving parts that must fit together seamlessly if the program is to progress on time and on budget. Many times companies simply don’t have the expertise in all categories of regulatory, CMC, quality, program management, and contractual support to keep the program moving without any slippage in the timelines, particularly at the beginning stages of a program. LBG can provide entire product development teams on demand, or fill in the gaps with any of the knowledge areas listed above.
It is our experience that investors of all types are more likely to invest when they see that the program is being expertly managed by a team of knowledgeable professionals. LBG can provide that support and keep the program moving forward while you search for long-term strategic hires, or can become integrated into the on-going product development team.
We also provide ready access to business development support, when your program is ready for partnering. We can provide the technical and strategic expertise necessary to guide your company’s progression to a marketed product.