Anthony Davies

Anthony Davies, Ph.D.

FOUNDER & CEO

Founded Dark Horse Consulting in 2014. Over 20 years of experience in CMC leadership of cell and gene therapy companies.

ABOUT ANTHONY
Founder & CEO

Anthony founded Dark Horse Consulting in 2014, bringing his 20+ years of leadership experience in product, process and manufacturing development to cell and gene therapy companies in need. His extensive network within the biotechnology industry allowed him the privilege of hand-picking the exceptional team of consultants working at Dark Horse, chosen for their top-notch performance, broad abilities, and unique expertise. Anthony’s responsibilities as Chief Executive Officer include defining the strategic growth and focus of the practice, team building, liaising with key clients and developing business for the company. He is a highly sought-after keynote speaker and chair of national and international conferences and seminars, noted for his provocative, thoughtful and sometimes contrarian presentations.

Prior to the founding of Dark Horse Consulting, Anthony served as a senior executive for multiple publicly traded and privately held companies, building a reputation of innovation, dedication and competency. His proven track record in managing pharmaceutical pipelines, skilled liaison with international regulatory agencies, and intense familiarity with a wide range of biologics, and cell and gene therapies engenders confidence and trust in industry partners and clients.

A certified Six Sigma Champion, Anthony’s most recent industry positions were at 4D Molecular Therapeutics, where he served as Chief Operating Officer, Capricor Therapeutics, where he served as Chief Technology Officer, and Geron Corporation, where he was Vice President of Product Development. At Geron, Anthony led the process development, technical operations, pilot plant, analytical development, and cGMP manufacturing functions, including driving the reorganization and renovation of the first cGMP facility to gain U.S. and state licensures for hESC-derived biologics manufacturing. He was also responsible for all CMC related regulatory filings, including the first ever IND to secure FDA clearance for initiation of clinical testing of an hESC-derived product.

At Capricor Therapeutics, Anthony was responsible for development and expansion of the company’s cardiovascular therapeutics portfolio, including but not limited to in-house and in-licensed stem cell and peptide products. He quickly restructured Capricor’s manufacturing operations and implemented de novo quality infrastructure, bringing the company into state and federal regulatory compliance. Anthony was also the technical lead and key negotiator of a ~$325M collaboration agreement with Janssen Biotech and provided critical input into the execution of a reverse merger of Capricor with Nile Therapeutics.

At Onyx Pharmaceuticals, after critical contributions to the development of the oncology drugs Nexavar® and Ibrance® (both now multi-billion-dollar franchises), Anthony built the process and engineering teams for the manufacturing of the first-generation oncolytic gene therapy ONYX-015. His team developed and ran a multi-thousand litre, pre-commercial process for this first-in-class anti-tumor adenovirus.

 

EXAMPLES OF RECENT WORK

  • Led due diligence team advising a venture capital firm, evaluating a potential >$100M financing of a  privately held US-based company advancing clinical development of a novel cell therapy
  • Led due diligence team advising a US-based hedge fund sponsor, evaluating a potential mezzanine  financing of a privately held Europe-based gene therapy company
  • CMC lead on a UK-based trade mission to the Asia, building East-West relationships from both a  technical and a regulatory perspective
  • Non-Executive Director of TrakCel Ltd., providing counsel especially regarding processes and governance to  contribute to the firm’s growth plans
  • Sits on the Scientific Advisory Boards of multiple therapeutics and technology-focused companies  in the field of cell & gene therapy
 
 

PAST EXPERIENCE

4D Molecular Therapeutics
Chief Operating Officer

Capricor Therapeutics, Inc.
Chief Technology Officer

Geron Corporation
Vice President — Product Development

Serologicals, Inc. (now EMD Millipore)
Director — Process Development

Zymequest, Inc. (now Velico Medical)
Senior Director — Manufacturing

Syrrx, Inc. (now Takeda Pharmaceuticals)
Associate Director — Process Development

Onyx Pharmaceuticals
Associate Director — Process Sciences

 

EDUCATION

University of Birmingham
Ph.D. in Biochemical Engineering “Cell Culture Systems for Epstein-Barr Virus Production” (Dudley Docker Scholarship for scholastic excellence, 1988)

University of Cambridge
M.A. (Hons) in Biochemistry (Seraphim Prize for Biochemistry, 1986)