Clora’s Top-tier Gene and Cell Therapy Experts

Access Clora’s expertise to develop an all star gene and cell therapy team for your pipeline

Preclinical Development


Senior Toxicologist

  • Initials: K.D.
  • Location: California
  • Therapeutic Areas: Autoimmune/Inflammatory, Infectious Disease, Oncology, Neurology, Metabolism, Allergy/Immunology, Virology
  • Years of Experience: 20 years in discovery of novel therapeutic entities with 17 years of development (safety assessment) of chemicals and biologics; experience with CROs and animal models of efficacy
  • Previous Companies: Deep experience working in large CRO’s and small biotech companies.

Director, Toxicology

  • Initials: D.M.
  • Location: New England
  • Therapeutic Areas: Gastrointestinal and Hematology
  • Years of Experience: Scientific responsibilities have included preparation of nonclinical regulatory documents, scientific oversight for finalization of numerous toxicology reports for new chemical and new biological entities and vaccines, and the conduct of due diligence for in-licensing candidate drugs and acquisition of companies. 35 years of experience interpreting complex clinical pathology data sets, conducting microscopic examination of bone marrow cytology, drafting clinical pathology reports, and integrating clinical pathology findings into toxicology and anatomic pathology reports.
  • Previous Companies: Gilead, Small Biotech

Director, Preclinical and Translational Development

  • Initials: C.P.
  • Location: California
  • Therapeutic Areas: Hematological, Oncology, Vaccines
  • Years of Experience: 20+ years of experience in preclinical and clinical management of a wide-variety of cell and gene therapy products that advanced into clinical studies. Products in development have included the first commercial sponsored gene therapy product, the first oncoloytic virus enrolled into pivotal clinical trials, the first modified cell product for the treatment of Parkinson’s Disease and cancer stem cell targeting monoclonal antibody used in clinical trials
  • Previous Companies: Previously held positions in academia – Cell Therapy Translational Laboratories (CTTL) and several startup immuno-oncology companies.

Clinical Development


Clinical Development

  • Initials: W.L.
  • Location: California
  • Therapeutic Areas: Autoimmune / Inflammatory, Hematological, Neurology, Oncology, Pediatrics, Allergy / Immunology
  • Years of Experience: 20+ years of experience in the hematology, immunology and oncology space, with a specific focus on cellular therapeutics. Specific expertise in stem cell transplantation and performed duties as a clinical inspector for Foundation of Accreditation of Cell Therapy.
  • Previous Companies: Pfizer and Various Small Biotechs

CMO and Senior VP, Medical Affairs

  • Initials: F.R.
  • Location: NYC
  • Therapeutic Areas:  Allergy/Immunology, Oncology, Rare Disease
  • Years of Experience: 20+ years in biopharma from the pre-clinical stage to Phase I-IV development. Deep experience with biologics, CAR-T therapies and involvement with over 25 immuno-oncology IND and BLA submissions.
  • Previous Companies:Previous roles leading the oncology pipeline at J&J, Celgene, Bayer, and several small biotechs focused on precision medicine

Regulatory Affairs and QA/QC


Vice President, Regulatory Affairs

  • Initials: A.M.
  • Location: NC
  • Therapeutic Areas: Infectious Disease, Virology, Oncology, Pediatrics
  • Years of Experience: 35+ years experience in Regulatory Affairs for drug and biologic products in a wide range of therapeutic areas, submitting over 100 INDs and NDAs
  • Previous Companies: Previously held positions at GSK and various small/mid-sized biotechs

Sr. Supplier Quality Engineer

  • Initials: M. P.
  • Location: Mid-Atlantic
  • Therapeutic Areas: Cardiovascular, Infectious Disease, Oncology, Opthalmology, Pain
  • Years of Experience: 20+ years of experience in Quality Assurance with expertise in developing solutions to complex problems resulting in enhanced quality, sustainable compliance, reduced complexity, and optimal manufacturing processes and operating procedures.
  • Previous Companies: Merck, Pfizer, Abbott, and Small Biotech

Quality Assurance/Control Manager

  • Initials: B.M.
  • Location: Midwest
  • Therapeutic Areas: Gastrointestinal, Hematological, Musculoskeletal
  • Years of Experience: QA/QC expert with over 15 years of demonstrated expertise in chemical and software engineering with specialization in Scrum Agile product ownership, project management, statistical analysis and fluid modeling. Additionally, highly trained in identifying potential issues and implementing cost-effective solutions within regulated environments. Multifaceted skill set has been proven to drive operational improvement in medical devices and complex software solutions across the board.
  • Previous Companies: Several Small Biotechs



Analytical Development, CMC

  • Initials: S.J.
  • Location: New England
  • Therapeutic Areas: Oncology, Vaccines, Pulmonary/Vaccines
  • Years of Experience: 20+ years as an accomplished leader in the BioPharmaceutical Industry with extensive experience in strategic, technical and operational leadership Quality Control and CMC analytical/regulatory areas for protein, antibody, gene therapy and small molecules. product development.
  • Previous Companies: NIH and Small Biotech

VP, Manufacturing

  • Initials: A.S.
  • Location: New England Area
  • Therapeutic Areas:  Oncology, Immunology/Allergy, Vaccines
  • Years of Experience: Ph.D. Chemist, Pharmacist and Biologist with 34 years of experience in quality affairs and drug product manufacture. Expertise in drug product development, aseptic processing-sterile formulations across a number of product technologies (small molecules, proteins, peptides, cell and gene therapy). Accomplishments include administering, coordinating, and streamlining the production, testing, and distribution of 441 radiolabeled doses to 19 clinical sites in order to treat 160 patients in TransMolecular phase 1 and 2 oncology trials.
  • Previous Companies: Previously held positions have been focused in small stage oncology companies.

Clinical Operations


Clinical Operations, VP Medical Affairs

  • Initials: R.M.
  • Location: Research Triangle Park
  • Therapeutic Areas: Cardiovascular, Hematology, Endocrine, Neurology, Oncology, Opthalmology, Urology, Women’s Health/OBGYN
  • Years of Experience: 30+ years of experience in the healthcare and clinical operations fields where responsibilities include development, leadership, and oversight of the global Medical Affairs and Pharmacovigilance departments.
  • Previous Companies: IQVIA and Small Biotech

VP Clinical Operations

  • Initials: E.K.
  • Location: New England Area
  • Therapeutic Areas: Rare Disease, Cardiovascular, Autoimmune/Inflammatory, Oncology, Metabolism/Nutrition, Pediatrics
  • Years of Experience: A dynamic executive with extensive global experience in successfully implementing bold initiatives in the clinical development of new drugs across a 20+ year career. Multi-therapeutic background with focus on rare genetic diseases, gene therapy, and cardiovascular medicine. Recognized for developing, leading and implementing complex operational plans, building high-performance teams and directing successful regulatory filings.
  • Previous Companies: Aegerion Pharmaceuticals, The Medicine Company, Small Biotech

DM / Stats / MW


Senior Clinical Data Manager

  • Initials: R.C.
  • Location: New England
  • Therapeutic Areas: Oncology, Nephrology, Musculoskeletal
  • Years of Experience: 20+ years experience in Data Management, working on early to late phase studies for Oncology programs
  • Previous Companies: Previously held positions at Takeda, Biogen and various small/mid-sized biotechs

Head of Clinical Data Sciences

  • Initials: A.S.
  • Location: Midwest
  • Therapeutic Areas: Cardiovascular, Oncology, Neurology, Opthalmology, Vaccines, Dermatology/Plastic Surgery
  • Years of Experience: 30+ years leading multiple cross functional teams from study startup through regulatory submission successfully by managing relationships within functional and cross-functional teams to enhance understanding and team collaboration. Provided complete oversight of the collection, analysis and reporting of clinical data for submission to regulatory agencies for products approval. Developed detailed project plans to ensure the timely completion of project deliverables from internal team members and CROs.
  • Previous Companies: Small Biotech

Senior Medical Writer

  • Initials: C.N.
  • Location: New England
  • Therapeutic Areas: Cardiovascular, Dermatology, Endocrine, Nephrology, Pain, Pulmonary/Respiratory
  • Years of Experience: 35 years experience providing statistical advice on clinical development plans, delivering statistical input to study protocols and regulatory briefing documents, integrating summaries of efficacy and safety, responding to regulatory queries, scientific publications, and authored statistical analysis plans. Has participated in Special Protocol Assessments (SPA), represented companies at FDA meetings and AdCom Committee meetings, as well as in legal challenges by competitors.
  • Previous Companies: GSK and Small Biotech