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

Clinical Development 

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Medical Director

  • Initials: B.H.
  • Location: Research Triangle Park
  • Therapeutic Areas: Autoimmune/Inflammatory, Hematological, Neurology, Oncology, Pediatrics
  • Years of Experience: 20+ years of experience in the hematology, immunology and oncology space. Specific focus on cellular therapeutics and stem cell transplantation, including performing duties as a clinical inspector for Foundation of Accreditation of Cell Therapy.
  • Previous Companies: Previously held leadership positions at Pharmacyclics, Medical Review Institute, UCSF Bone Marrow/Transplant Program, and several small biotechs.
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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/ QA

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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
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VP, Quality Assurance

  • Initials: R.M.
  • Location: New England
  • Therapeutic Areas: Autoimmune/Allergy, Immunology, Oncology
  • Years of Experience: 20+ years experience in Quality Assurance, with expertise in GXP regulations, quality systems, risk management, and SOP development.
  • Previous Companies: Previously held positions at Boston Scientific, Genzyme and various small/mid-sized biotechs

Director, Regulatory Affairs

  • Initials: S.Z.
  • Location: New England
  • Therapeutic Areas: Allergy/Immunology, Oncology, Rare Disease
  • Years of Experience: RA Expert with over 15 years of experience in biologics and pharmaceutical development. Led teams towards 20+ IND submissions in the oncology/immunology space, as well as several BLA and NDA approvals. Products have included CAR-T Therapies, Vaccines, gene therapy, and monoclonal antibodies.
  • Previous Companies: Previously held positions at Verastem Oncology, Abbvie, and several immuno-oncology start-ups.

Clinical Operations

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Senior VP, Clinical Operations

  • Initials: S.W.
  • Location: New England Area
  • Therapeutic Areas: Autoimmune/Inflammatory, Infectious Disease, Oncology
  • Years of Experience: 25+ years experience in Clinical Operations, including management of global phase I-IV oncology clinical trials, driving gene and cell therapy program timelines/submissions, and deep expertise in a variety of oncology indications (lung, breast, blastomas, melanomas, colon, etc.)
  • Previous Companies: Previously held positions at Pfizer, Genentech and several small biotech companies. 
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Director, Clinical Operations

  • Initials: M.S.
  • Location: New England Area
  • Therapeutic Areas: Infectious Disease, Cardiovascular, Oncology
  • Years of Experience: 25+ years experience in Clinical Operations, successfully building clinical operations departments and deep expertise in vendor oversight, GCP auditing, US and EU regulatory submissions, and BIMO inspections
  • Previous Companies: Previously held positions at Millennium, Biogen, and Sepracor (Sunovion)

CMC/Manufacturing

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VP, Head of CMC Quality

  • Initials: M.T.
  • Location: California
  • Therapeutic Areas: Oncology, Rare Disease
  • Years of Experience: 25+ years experience in CMC (Manufacture of API, small and large scale, with registration and validation work) and expertise in the generation and review of IMPD and IND submissions. Projects have been focused in vaccine manufacturing, mRNA and Gene/ Cell Therapy assessments.
  • Previous Companies: Ultragenyx, Biomarin, and Genetech
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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. 

CMC/Manufacturing

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VP, Head of CMC Quality

  • Initials: M.T.
  • Location: California
  • Therapeutic Areas: Oncology, Rare Disease
  • Years of Experience: 25+ years experience in CMC (Manufacture of API, small and large scale, with registration and validation work) and expertise in the generation and review of IMPD and IND submissions. Projects have been focused in vaccine manufacturing, mRNA and Gene/ Cell Therapy assessments.
  • Previous Companies: Ultragenyx, Biomarin, and Genetech
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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. 

Preclinical Development

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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.
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Director, Toxicology

  • Initials: M.T.
  • Location: California
  • Therapeutic Areas: Autoimmune/Inflammatory, Cardiovascular, Gastrointestinal, Metabolism/Nutrition, Oncology, Allergy/Immunology
  • Years of Experience: Board certified regulatory toxicologist with over 20 years experience in industry. Extensive experience with a variety of biologic modalities including monoclonal antibodies, immunomodulators, bi-specifics, Fc and other fusion proteins, antibody-drug conjugates, cytokines/interleukins, protein replacement therapies, nanoparticles, CAR-T cells, and vaccines.
  • Previous Companies: Previously held positions at Pfizer and Amgen.
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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.

DM / Stats / MW

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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
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Vice President, Biostatistics & Data Sciences

  • Initials: D.F.
  • Location: PA
  • Therapeutic Areas: Infectious Disease, Oncology
  • Years of Experience: 25+ years experience in Biostats, Programming, and CDM, working on anti-infectives and oncology programs with three successful NDA’s
  • Previous Companies: Previously held positions at ViroPharma (Shire), Merck, and various small/mid-sized biotech
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Director, Medical Writing

  • Initials: D.G.
  • Location: Texas
  • Therapeutic Areas:Oncology, Immunology, Hematological, Vaccines
  • Years of Experience: Seasoned technical writer with with over 10 years in Gene and Cell Therapy. Recently worked as a Technical Writer at Novartis’ Pilot Plant in Cell & Gene Therapy. Expertise in Current Good Manufacturing Practices (cGMP), using aseptic techniques, GLP and lab safety for OSHA regulations.
  • Previous Companies: Novartis, J&J and Teva Pharmaceuticals