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Risk Mitigation for Late-Stage Clinical Assets

3 Minute Read

Post-pandemic, there is an increasing demand for the CDMO-Biopharma relationship to focus on, dare we say it, “strategic partnering.” Strategic partnering – that industry buzz term used so loosely, with such frequency and abundance, that it edges close to a cliché. Yet, while it is true that the term is often overused and loosely defined when it’s precisely broken down, its basic definition holds the truest of post-pandemic lessons learned.

In today’s unpredictable and challenging times, leveraging the competence and capabilities of the CDMO to bring forth innovative, flexible solutions to safeguard supply chains for their clients and, ultimately, for patients is crucial to strategic partnering. The value-add of a CDMO functioning on this level of partnership, as a trusted and experienced advisor that can provide flexible solutions for late-stage risk mitigation stretches far beyond what is expected in the manufacturing suite.

Late-stage Asset Risk Mitigation: Thinking Beyond Technology

It is the nature of the late-stage/pre-commercialization period that demands a deeper vetting process of your future (or current) CDMO partner that goes beyond a technical match. As a developer, your product has made it this far – meaning it has been years in the making, and you have likely overcome numerous clinical, technical, and/or financial hurdles to advance it to late-stage clinical studies. All the while, acknowledging that there is no guarantee your product will be granted regulatory approval, there is no debate around the higher probability and significant investment made for your business and the patients you hope to reach. Supply chain risk mitigation at this stage is crucial, and a biopharma with a late-stage asset must look much further down the road and incorporate all facets of pre and post-launch preparedness in its due diligence of a late-stage/commercial partner. The key is to ensure your CDMO cannot only support the technology and volume needs of your late-stage clinical study but also the volume and scale projected for commercial launch and growth. Thus, vetting a CDMO for its short and long-term capacity should be at the forefront of your due diligence.

Strategic Partners Offer Strategic Solutions

A strategic CDMO partner will initiate discussions around your commercial needs and bring innovative business continuity solutions to the table to support your goals and, ultimately, better safeguard your future supply chain.

This preparedness provides an insurance to reduce risk by safeguarding your supply chain and providing business continuity. In summary, late-stage risk mitigation:

  • Places PATIENTS at the forefront
  • Ensures capacity needs are met for growth
  • Offers an opportunity to onshore or re-onshore manufacturing
  • Offers cost savings (insurance vs. stock-out)
  • Provides healthy checkpoints by creating additional strategies around inventory and distribution
  • Can be flexible and affordable for biopharmas with insufficient funding or profitability via flexible contracting models or “partial” technical transfer

If you have a late-stage asset, now is the time to qualify an experienced and proactive CDMO partner that can be an asset to your late-stage asset. Simply put, strategic CDMO partnering post-pandemic should give you greater peace of mind for your future. Societal has a unique and smart approach to preparedness.