By Kevin Wall, principal consultant and owner, Cincero Consulting
The end game for many small biotech startups is acquisition by Big Pharma. How should small biotech companies prepare their chemistry, manufacturing, and controls (CMC) documentation for due diligence review? What are the mile markers that measure how far product and process have developed? While the CMC section may not add zeros to the sales price, poorly documented development can remove them.
The “courtship” of a biotech tenant and a landlord often takes months, with negotiations over lease length and costs. Initially, the “romance” expects that the two parties will exist together for the long term; however, that is rare. Here's how to break off negotiations on the proposed lease and pursue other properties.
If your business strategy doesn’t fully align with your organization’s capabilities in terms of expertise, capacity, and resources, it might be wise to consider outsourcing to a biologics CDMO for speed-to-market.