Article | June 15, 2022

Accelerating Novel Therapies To The Market

Source: SMC Ltd.

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.

access the Article!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Med Device Online? Subscribe today.

Subscribe to Med Device Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Med Device Online