By Asmita Khanolkar, Sr. Director Medical Device / Pharma Strategy & Commercialization, Cambridge Pharma, SMC
Pharmaceutical trends today are shifting towards targeted therapies, precision and personalized medicine for smaller patient populations. With the growth of novel therapeutics, “speed to clinic” is more critical than ever. These novel therapeutics target a more specific indication resulting in a smaller potential market, and the overall revenue projection along with available clinical study patients are reduced, as seen in markets for oncology. The formulations involved are more complex bio-therapeutics, large molecules yet fragile, and pose many unknowns and uncertainties throughout the development. Bioavailability and immunogenicity is often not well understood which requires multiple iterations for therapy optimization. In addition, delivery of these formulations is difficult, often non-Newtonian or high viscosities, and requires custom high-pressure primary drug containers and devices. This requires flexibility to support adaptive and flexible sterile manufacturing towards an integrated approach for a path from development, small batch manufacturing to commercialization that can save time to clinic.