CPCC works exclusively with early-to-mid clinical-stage biotech companies to efficiently navigate the path from candidate selection and confirmation to meaningful clinical inflection points: the data, regulatory decisions, and milestones that unlock program advancement and company growth.
Whether you need a senior thought partner to support interactions with inbounds, the board, or regulatory authorities, or just need someone to build the clinical and regulatory infrastructure and get the work done, CPCC covers the full range. High-level development strategy through hands-on execution and submission-ready deliverables.
Credible senior experience at the table for investor and regulatory interactions and program-level planning.
Clinical/Regulatory deliverbles with quality built in.
CPCC is led by Amanda McEwen — LinkedIn — SVP of Clinical Development at Salubris Biotherapeutics, where she leads the JK07 program, a first-in-class ErbB4 agonist in Phase 2b for heart failure.
Amanda has spent her entire career working within small amd mid-size biotech, where the boundaries between functional areas are rarely as clean as an org chart suggests. That breadth — built from years of doing the work across functions, not just overseeing it — is what CPCC brings to client teams. She embeds fluidly with both small founding teams that need a full clinical function built out, and larger organizations that need senior capacity on a specific workstream or at a critical juncture.
Her career highlights include key contributions to two FDA-approved therapies: Inbrija, for Parkinson's disease, and Rivfloza, for a rare genetic liver disease. She is especially passionate about early-phase development and has led several initiatives spanning preclinical research through clinical proof of concept.
Beyond her industry role, Amanda serves as an Executive Fellow at Harvard Business School, helping educate and mentor newly minted entrepreneurs in the biotech space and also serves as adjunct faculty in Northeastern University's MS in Regulatory Affairs program, where she teaches classes on therapeutic product development and pharmacovigilance. Amanda is a current PhD candidate in Business Analytics at Bentley University. She earned her BA from the College of the Holy Cross and a Master of Research Methods in Psychology from the University of York in England.
Over 18 years inside small and midsize biotech across Boston and Cambridge, Amanda has guided programs from first-in-human through FDA approval, exits, and partnerships. A career built entirely in small biotech — working across every function, and knowing how to move programs forward with lean teams and limited resources — spanning 25+ countries and four major regulatory regions.
The market has fundamentally reoriented around clinical data. Pharma is spending more than ever on licensing and acquisitions, but concentrating it across fewer, higher-conviction deals — and those deals are increasingly targeting companies with clinical-stage assets and de-risked data packages. The inflection point is the value inflection point.
Source: IQVIA Biopharma M&A blog series. 2019–2023 from IQVIA "Biopharma M&A Outlook for 2024"; 2024 and 2025 from IQVIA "Biopharma M&A Outlook for 2025/2026." Analysis covers majority-stake acquisitions ≥$1B enterprise value. 2022 interpolated from reported step-changes. Phase 2 share not separately broken out for 2022, 2023, or 2025 by IQVIA; shown as combined with adjacent segments per source methodology.
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