Expedited Approval Pathways Increase Risk and Burden on CMC and Manufacturing: risk reduction strategies include earned value analysis and partnering. As discussed in a recent article in in-Pharma (http://tinyurl.com/zufbd88), accelerated regulatory drug approval increases the risks for commercial manufacturing. This risk comes largely from the time lag to securing or building commercial capacity in conjunction with uncertainty about the clinical and commercial success of a developmental product. In general, the CMC pathway should never be on the critical path for clinical or commercial development. Therefore, an accelerated pathway will present organizations with unique challenges in dealing with this risk. There are a number of ways organizations can reduce CMC risk. These include:
1) understand the risk of your development portfolio and make GO/NO GO analysis that appropriately balances the needs of early stage development programs with those of late stage development programs. Traditional financial analysis will always favor late stage programs and starve early stage programs. By incorporating the CMC investment needs and risk into the analysis, Earned Value Analysis (EVA) can be an invaluable tool in making more rationale and faster decisions;
2) partner programs with product company partners who with excess commercial manufacturing capacity to share the risk;
3) leverage CMOs to outsource any additional capacity needs that may be needed;
4) develop strategic partnerships with consulting firms to rapidly ramp up and complement internal resources when commercial success becomes highly probable;
5) leverage single-use or lower and flexible cost manufacturing facilities for commercial launch that can be expanded later;
6) use dedicated commercial launch facilities near development groups and perform a tech transfer to another facility after approval after demad increases; and
7) explore revenue sharing models with capacity partners to reduce your upfront payments and reduce the risk from upfront capital outlays.
Our expertise in EVA, Supply Chain, Process Development and Manufacturing, and CMO management can be helpful to organizations considering risk reduction strategies. For more information contact us at firstname.lastname@example.org or (+1) 844-686-5750.