Herbert Wayne Hutman, M.D.

Advise pharmaceutical, Biotech, and CROs on a broad spectrum of clinical, safety, and regulatory affairs issues. Serve as a medical monitor, safety physician, or sponsor representative for Phase I to III studies.

Clinical Consultant - Independent

(2024-05)

• Advise pharmaceutical, Biotech, and CROs on a broad spectrum of clinical, safety, and regulatory affairs issues.
• Serve as a medical monitor, safety physician, or sponsor representative for Phase I to III studies.

Principal Clinical Consultant - DataRevive / Validant / Eliquent - Rockville, MD

(2019-05 - 2024-05)

Regulatory Consulting Firm

• Advise pharmaceutical sponsors on clinical development from first-in-man through marketing application across a variety of therapeutic indications.
• Extensive experience with FDA interactions, including end-of-phase 1, 2, and pre-marketing applications.
• Advise on clinical hold remediation strategies.
• Clinical team filed 20 INDs, 8 orphan drug designations, and 5 expedited pathways per year.
• Write/review protocols, ICFs, IBs, narratives, and other regulatory documents.
• Training and mentoring of the clinical team.

Clinical Research Physician - AstraZeneca - Gaithersburg, MD

(2014-12 - 2019-04)

• Lead physician of two multi-national Phase III studies in SLE.
• Investigator meeting presentation, site selection, inclusion/exclusion criteria questions.
• Lead safety and medical quality calls with CRO and sites.
• Point person for all safety-related events, lead safety submission, and CSR prototype.
• DSMB and CV adjudication committee liaison and presentations.
• Medical input on regulatory documents (protocol, ICF, IB, IRB/EC communications).

Clinical Consultant to Pharmaceutical and Device Companies (Medical-Safety Monitor) - Independent

(2010-07 - 2014-12)

• 2 Years: Phase III Diabetic Foot Ulcer study (Biological) – 30 sites, US and Canada. Document writing (IND, IB, Protocol + Amendments, CRF, Study reports...). Safety monitoring and reporting (SAE, PSUR) individual case narratives, coding, sponsor representative to DSMB, inclusion/exclusion questions from sites, CRO oversight.
• 1 Year: Phase IV Oncology studies in sarcoma, tumors of unknown origin, ovarian cancer. Study start-up activities: Protocol, CRF writing, vendor selection, investigator identification, safety plan.
• Project work in wound care, weight loss, carotid artery embolic protection, nutritional support in ICU, coronary stenting, surgical sealant.

Director, Clinical Research / Complaint Handling and Safety Surveillance - Cordis (Johnson & Johnson) - New Jersey

(2005-02 - 2010-07)

• Filed two IDEs in peripheral artery diseases.
• Medical Safety Monitor for multiple cardiovascular clinical studies (drug-eluting stents).
• SAEs & AEs causality/expectedness assist adjudication of events with DSMBs.
• Medical input and review for reports and filings to regulatory bodies.
• Medical due diligence for the new product acquisition team.
• Interact and meet with the FDA on product safety and new indications.
• Recipient of "Team Excellence Award" (July 2006) for new product launch.
• Assess the medical impact of manufacturing issues on product safety.

Director, Medical Affairs / Director, Clinical Operations, Consumer and Personal Products Worldwide - Johnson & Johnson - NJ

(2002-01 - 2005-02)

• Phase I through IV studies for NDA products in women's health and dermatology.
• Medical Safety Monitor for women's health-marketed products.
• Manage investigator relations and meetings.
• Medical due diligence for new business opportunities.
• Medical presentations for a sales force.
• Member, Healthcare Compliance Committee.

Associate Director, Clinical Research and Development - Aventis Behring - King of Prussia, PA

(2000-05 - 2002-01)

• Clinical Project Manager for fibrin sealant.
• Member Pharmacovigilance Team.
• Manage Phase III studies.
• Protocol development / CRO oversight.
• Write clinical reports for regulatory submission.
• Prepare budgets and manpower allocation.
• Oversee SAE monthly meetings.

Medical Director and Principal Investigator - South Florida Bioavailability Clinic

(1996-01 - 2000-05)

Phase I-IV studies - 100 studies were personally conducted.

• Protocol development, design, and writing.
• Ensure GCP, ICH, and FDA regulation compliance.
• AE / SAE is reporting to the sponsor and FDA.
• Personnel selection, training, and evaluation.
• Budget preparation and contract negotiation.
• Clinical study oversight and management.
• Screening and dosing of participants.
• Case report form review and design.

Medical Director, Miami Shores Office - Greater Miami Medical Center - Miami, FL

(1993-09 - 1995-07)

• Direct patient care in office, hospital, and nursing home settings.

PGY II and PGY III - Internal Medicine - St. Joseph's Hospital and Medical Center (1991-07 - 1993-07)

PGY I - Internal Medicine - Sinai Samaritan Medical Center, University of Wisconsin (1990-06 - 1991-06)

Doctor of Medicine - Medicine - Ross University School of Medicine (1988-06)

BS - Chemistry - University of Miami (1985-06)