For VCs & Angel investors
For VCs and Angel Investors: Technical / CMC due diligence of Biotech startups as preparation for investment
Every biotech startup is unique, and we tailor our due diligence process to address the specific concerns of each prospective investor. Before you invest in a new biotech startup or asset, it is crucial to assess its manufacturability, regulatory compliance, and cost-effectiveness. Our due diligence services help you de-risk and protect your investment by providing actionable risk mitigation steps to ensure on-time delivery of key milestones.
Delays in delivery can significantly impact future company valuation, by eroding remaining market time before patent expiration, market exclusivity for orphan indications or clinical access due to competition.
We can assess the overall program viability by examining how CMC, clinical, and corporate strategies come together. Additionally, we can help the biotech company choose the right manufacturing partners and optimize the supply chain, which are critical to the success of the pipeline. Leveraging our expertise, we identify and foresee risks and issues and propose effective solutions to help ensure your investment is poised for success.
-
CMC strategy - scalability
-
Programme viability & timeline review
-
Regulatory compliance
-
Risk mitigation
Our founding team
We built our experience in prestigious companies to include CRISPR, GammaDelta, Oxford Biomedica, Lonza, NightStar, Takeda and Biogen. We are supported by a team of trusted experts and former colleagues to bring CMC, Programme, Regulatory, Clinical, IT and Lab support.
How can we help you meet your goals?
Evi Dimitriadou
Evi’s career, which spans near two decades, started with successfully developing platforms for difficult-to-manufacture biologics. Her passion for innovation led her into technology evaluation and development of a personalised medicine platform. Over the last 10 years, Evi has leveraged her scientific background in Programme and Portfolio management in biotech startup, global CDMO and Big Pharma environments, each requiring tailored approaches. She helps biotech companies make holistic and healthy decisions and make breakthrough therapies possible through solid planning and execution.
Mardon McFarlane
Mardon brings almost two decades of experience in the biotech industry having biologics (recombinant proteins, antibodies) and cell and gene therapy (viral vectors, CAR Ts and CRISPR mediated therapies) experience. He has enjoyed developing and leading process development and manufacturing activities for many modalities. Having worked on more than 20 IND/CTA submissions and two first-in-class BLA candidates, Mardon has a deep understanding of the current CMC challenges and opportunities and is passionate about translating excellent science into accessible therapies.
