SIX CONSIDERATIONS FOR SUCCESS WHEN SOURCING YOUR CMC PROGRAM
26 May 2021
80% of NMEs in clinical developments are outsourced by small pharma companies every year out of the 13,500+ preclinical/clinical programs in 2020/21 in the pharmaceutical industry. This leads to an ever growing need to find, nurture and partner with the right contract development and manufacturing organization (CDMO). With a 9 to 12-month window to file an IND and similar aggressive timelines for other phases of clinical programs, that’s a lot to get done in a very short time!
Drug development and manufacturing challenges in 2020 included overcoming difficulties in conducting facility audits, due diligence visits, staff attendance, logistical challenges and working from home under less than ideal circumstances.
Here are 6 considerations which will improve the chances of a successful partnership with a CDMO:
Know your program - Around 50% of all clinical programs are in-licensed,presenting gaps or challenges that are uncovered after a review of all transferred technical documents. Acknowledge the gaps with all stakeholders and work with your CDMO with transparency so that they can help to overcome these where appropriate and in a timely manner.
Know your consultants - Consultants could make up to 80% of CMC teams and are usually chosen based on their technical knowledge, familiarity and experience with a similar type of program challenge faced. What often is not considered is whether that consultant has the right experience and mind set to work with the desired types of CDMO which may be needed for your program.
Budget correctly - Consider longer lead times and higher sourcing costs for items that may face logistical challenges and compete for other uses/industries. Budget for qualifying secondary suppliers that are geographically diverse, particularly in the current business climate where supply chain limits are being stretched due to local lockdowns and supply uncertainties.
Pick the right CDMO - The usual characteristics companies consider when selecting a CDMO include positive relevant prior experience, technical fit, the ability to deliver within required timelines, cost competitiveness, successful track record, ability to scale up and quality. Other aspects to examine should include how well the CDMO coped in COVID, what strategies are being deployed to reduce risk to your program, and whether or not the CDMO is able to integrate the program end-to-end. Integration helps reduce the complexity of working with multiple CDMOs and can alleviate the burdens on your teams’ workload.
Build a partnership - A biotech knows its program best; similarly, a CDMO knows its delivery operations best. Make the CDMO a partner to your CMC team. Allow for open discussion around challenges faced in progressing the program, clinical issues, timelines and other pressures. The CDMO will be able to provide a much better and timely solution when the challenges are thoroughly understood in real time.
Communication - Many say they view their CDMO as an extension of their company, but do they communicate with a CDMO like an extension of their company? The frequency and richness of communication with internal delivery teams is difficult to replicate with an external partner. Budget to spend more “quality” time with your CDMO as it will help build a better relationship, provide you with insights in time to take corrective actions and gives way for the CDMO to “own” your program needs.
VP – Business Development (North America & RoW)
Piramal Pharma Solutions