MEDICAL DIRECTOR – ONCOLOGY AND NEURO-ONCOLOGY
Reggie Jakacki

PERSONAL PROFILE

  • 23 years as an academic pediatric hematologist / oncologist, with a focus in neuro-oncology and drug development, establishing and overseeing three multi-disciplinary clinical programs, as well as designing and overseeing numerous oncology clinical trials.
  • 6 years as a pharma Oncology Senior Medical Director leading and monitoring Phase 1 through 3 oncology
    clinical trials.

EXPERTISE

Medical Director; Study Physician; Clinical Program Development and Oversight; Clinical Trial Design and Management; Investigational Plans; CRFs, Eligibility Checklists, Clinical Oversight of Clinical Trial Database Design and Study Materials; Quality Assurance; Pharmacovigilance; Safety and Efficacy Guidelines and Templates; Regulatory Medical Documentation; Bid Defense; Biotech Consulting; and Research / Academia / Instruction.

Has had nearly 40 committee appointments and clinical trials, 87 peer-reviewed articles, 13 book chapters, and 104 published abstracts. Earned a BS from the University of Michigan in Ann Arbor; an MD from the University of Pennsylvania Medical School in Philadelphia; and pediatric residency and fellowship in pediatric hematology/oncology at Children’s Hospital of Philadelphia.

PROFESSIONAL EXPERIENCE

Senior Medical Director, AstraZeneca

Senior Medical Director, Oncology, Janssen Pharmaceuticals

Medical Oncology Consultant, Incysus Therapeutics

Senior Medical Director, Oncology, Iqvia Biotech (CRO)

Pharmacovigilance and Oncology Consultant, Idera Pharmaceuticals

Participated in and/or designed and served as principal investigator on numerous multi-institutional and cooperative group Phase 1-3 pediatric oncology clinical trials in academics, including single-institution pilot studies of a novel peptide-vaccine against various subtypes of gliomas. As Senior Medical Director in the pharmaceutical industry, worked in clinical trial development and oversight of small molecule TKIs, clinical pharmacology studies, investigator-initiated studies, and the development of pediatric study and pediatric investigational plans. Assisted in the design and wrote the protocol for a prospective, randomized Phase 3 study of a novel TKI in a molecularly-targeted population, prepared regulatory documents, recruited investigators, and worked to obtain pre-market approval for a companion diagnostic. Served as study physician and senior medical director on Phase 2/3 oncology studies, evaluating safety and efficacy. Responsible for clinical components of the CSR and the other regulatory documents for a supplemental BLA of a product subsequently approved in the EU, Canada, and US. Developed a strategy to improve capture of overall survival data for sponsored studies. As Senior Medical Director in a CRO, helped strategize and present at bid defenses, and worked with sponsors and data management to develop trial-specific case review forms, eligibility checklists, and other materials to assist study sites. As a pharmacovigilance / oncology consultant, reviewed SAEs on pivotal Phase 3 immuno-oncology trial, and devised safety guidelines and templates to ensure consistency in AE reporting.    

ACADEMIC EXPERIENCE

Director, Neuro-oncology Program, James Whitcomb Riley Hospital for Children

Director, Neuro-oncology Program, Children’s Hospital of Pittsburgh

Director, Developmental Therapeutics, Pediatric Hematology / Oncology, Children’s Hospital of Pittsburgh

Professor of Pediatrics, University of Pittsburgh, Pediatric Hematology / Oncology

Chair, Quality Assurance Committee, NCI-sponsored Pediatric Brain Tumor Consortium

 

 

VIEW ALL EXPERTISE

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