For post - Series A Biotech
We serve biotech companies with:
• Flexible CMC Technical Operations: Providing expertise and establishing a phase-appropriate CMC roadmap and CDMO management from pre-clinical to clinical stages. CMC Strategy & Operations: Aligning CMC strategies with clinical and commercial milestones to maximize program viability.
• CDMO Selection and Management: Choosing the right manufacturing partners and optimizing the supply chain to support pipeline success
• Project/Programme/Portfolio Management: Translating strategy into operational plans, ensuring successful program delivery through solid execution roadmaps, scenario-based planning to predict burn rate and runway, and the use of risk management for strategic decision-making.
• Clinical Development & Operations Strategy: Providing expert guidance on clinical development strategies and operational execution
• Regulatory Affairs: Navigating regulatory landscapes to ensure compliance and streamline approval processes. Support with upcoming or submitted Regulatory dossiers
• IT Operations Tailored to Biotech: Offering specialized IT solutions to support biotech companies from early days to scaling.
• Lab Startup & Management: Overseeing or Assisting with the setup and management of laboratory facilities.
We work closely with you to ensure that your CMC, clinical, and corporate strategies come together seamlessly. Whether you need support for large projects or ad hoc assistance for specific tasks, our expertise ensures your investment is poised for success.
Preparation for funding rounds
CMC Strategy & Operations
Regulatory Affairs
Clinical Strategy & Operations
Programme / Portfolio Management
IT Operations
Lab Startup & Management
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.
