Examples of Consultant & Advisory Roles – Over 35 To-Date

INTERNATIONAL CONSULTING ROLES TO-DATE

  • Product development, Pharm/Tox, regulatory affairs, regulatory publishing, funding, and CMC lead or support for pluripotent stem cell-derived islets for both cell therapy and cell-based drug discovery applications for a small biotech (U.S.)

  • Regulatory strategy and translational research diligence for bone marrow transplant support project for a commercialization organization (Canada/U.S.)

  • Regulatory lead, IP and business strategies support, and regulatory publishing, for cell therapy and cell culture tool provider, including innovative Master Files (U.S./Global)

  • Technical due diligence for pluripotent cell derivation technical innovation for VC firm (U.S./Asia)

  • Regulatory Affairs and publishing support for gene-modified cell therapy (CAR) for solid tumors, and European strategy for supporting partner use of non-viral-based gene modification manufacturing-enabling technology for ATMPs, for a small biotech (U.S./Europe)

  • Start-up/entrepreneurial support for clinician investigator for arthritis project using HCT/Ps and protein therapeutic combination therapies (U.S./Europe)

  • Regulatory Affairs for established therapeutic MSC-based product (including combination product) Companies targeting numerous clinical indications, such as tissue/organ injury, CV, immune-mediated, orthopedic, and others (multiple; U.S./Asia)

  • Regulatory Affairs lead and quality for pluripotent-derived ophthalmologic and orthopedic HCT/Ps for non-profit organization (U.S.)

  • Regulatory Affairs lead or support for established and start-up therapeutic NK cell product Companies targeting cancer (multiple; U.S./Asia)

  • CMC and regulatory affairs lead, Pharm/Tox and quality support for novel engineered T start-up targeting liquid and solid tumors (Canada/U.S./Europe)

  • CMC and regulatory affairs lead for novel CAR-T start-up targeting solid tumors (U.S.)

  • Regulatory Affairs, CMC, Pharm/Tox and Quality lead, for a gene-modified cell therapies (CD34- and T cell-based) for HIV for a start-up and instrumental these disciplines for NASDAQ up listing (U.S./Europe)

  • Regulatory and quality support for HCT/P tissue establishment (U.S.)

  • Quality and regulatory affairs support for non-animal-derived cGMP enzyme (U.S.)

  • CMC Diligence for NASDAQ client next steps, such as M&A, restructuring, etc. for pluripotent-derived CNS pipeline (U.S./Asia)

  • NewCo multi-disciplinary lead or support for IP holding firm for innovative rare disease and anti-viral IP development strategy and implementation (U.S.)

  • Regulatory and CMC lead for pluripotent cell-derived product and indication (multiple) for U.S. FDA approval/commercialization (U.S./Asia)

  • Regulatory leader for parent firm with numerous regenerative medicine portfolio companies, including for medical devices that process HCT/Ps (U.S./global)

  • Regulatory, CMC and Pharm/Tox lead for platform technology development to advance partner licensing/tech support CAR-T and related gene-modified cell-based immunotherapy to advance solid tumor efficacy (Asia/Global)

  • RMAT Designation support for tumor cell-based gene-modified cell-based immunotherapy for solid tumor (U.S.)

  • CMC gap analyses and/or regulatory/product development strategy/plans and/or FDA meetings for large consulting firms for projects such as:

i) pluripotent-derived exosome-based neurological HCT/P project;

ii) reproductive HCT/P project;

iii) tissue engineered, decellularized HCT/P project;

iv) cell and tissue combined orthopedic HCT/P project;

v) pluripotent-derived multi-product type platform project;

vi) platelet-derived growth factor medical device for multiple indications.

  • Conduct phone consults for well-known U.S./world-wide investment and consulting firms for projects including:

    • gene therapy state-of-the-industry

    • challenges for commercial gene therapy CMC/manufacture/scale-up

    • competition in the gene therapy market

    • regulatory and reimbursement considerations for gene therapy U.S. versus Europe

    • assess impact public stock prices for gene therapy product developers

    • assess impact of 2017 gene therapy commercial approvals on future field landscape

    • IP considerations for gene therapy

    • BLA strategy for gene therapy

    • Cell/gene therapy regulatory pathway and services landscape

 

TITLED LONG-TERM ADVISORY ROLES TO-DATE

Executive Vice-President (EVP), Clinical & Regulatory Strategy (Global), RoosterBio Inc. (2016-2018)

  • Led all regulatory activities and managed resources for cGMP-compliant media and cell banks for use in clinical therapeutic product manufacture, including Master Files

  • Supported strategy for use of these cGMP products in differential customer-manufactured therapies world-wide

  • Supported Business Development and marketing activities.

 

Head, CMC & Regulatory Affairs (Global), Maxcyte Inc. (2016-2017)

  • Led global regulatory activities and managed resources for global partners for cell loading platform utilizing non-viral-based gene editing tools and mRNA, including commercial-stage readiness

  • Led regulatory activities and managed resources for in-house proprietary CMC, preclinical and clinical development for CAR programs and CMC support activities for partner gene correction (CRISPR-based) programs

  • Supported CMO activities for in-house proprietary clinical programs.