RICHARD KATZ, MD
Myerstown,PA
Summary
Results-oriented Matrix Leader with 15+ years of experience spearheading clinical-stage programs in cell therapy, biologics, neuroscience, immunotherapy, hematology, and oncology. Proven expertise in medical affairs planning, budgeting, cross-functional alignment, real-world evidence (RWE) generation, and key opinion leader (KOL) engagement. Committed to improving patient health outcomes, optimizing innovation, and enhancing research/clinical trial efficiency.
Overview
16
16
years of professional experience
Work History
Associate Director, Medical and Scientific Affairs
B. Braun Medical, Inc. / Aesculap Biologics, LLC
11.2019 - Current
- Leadership: Lead, mentor, and coach clinical team
- Enhance medical affairs infrastructure and program operations.
- Drug Product Lead: Collaborate with cross-functional teams to align processes, regulatory strategy, and product development plans.
- Regulatory Affairs: Oversee BLA initiative, preparing clinical/CMC sections and serving as clinical representative in regulatory communications.
- Relationship Management: Build relationships with key stakeholders in Supply Chain, Manufacturing, Launch Excellence, Quality, Procurement, and Regulatory.
- Clinical Operations: Develop and implement strategies, manage research staff, ensure compliance and quality standards, and manage clinical trial budgets exceeding $1M.
- KOL Engagement: Engage with key opinion leaders, academic thought leaders, and clinical stakeholders.
- Vendor Management: Negotiate and establish contracts with CROs.
Global Clinical Submission Quality Lead (Contract)
Synectics, Inc.
07.2019
- Clinical Data Review: Ensured clinical data accuracy and completeness for global regulatory submissions (NDA, BLA).
- Project Leadership: Member of Submission Integrated Process Leadership Team for XALKORI, BAVENCIO.
Pharmaceutical Regulatory Consultant
Cello Health (Innovative Science Solutions)
07.2018 - 07.2019
- Regulatory Strategy: Developed and executed regulatory strategies for TECENTRIQ (breast cancer, lung cancer) and Opill (oral contraceptive).
- Advisory Committee Support: Supported Oncologic Drugs Advisory Committee Meeting preparation for breast cancer treatment.
Medical Consultant
VIVO Agency
10.2018 - 12.2019
- Product Launch: Supported global launch and development of new cardiovascular and orthopedic medical devices for Life Science companies.
Medical Advisory
Lehigh Valley Health Network
01.2008 - 01.2018
- Academic-industry collaboration: Fostered collaborations between biopharma, PIs, and KOLs.
- Clinical Trials: Conducted Phase II-IV CNS trials and outcomes-based research.
- Neuromarker Research: Evaluated neuromarkers for various neurological conditions.
- Scientific Publication Development: Provided expertise on regulatory compliance and industry standards for scientific publications.
Education
MD -
Université El Hadji Ibrahima Niasse (UEIN)
01.2004
Fellowship - Neuroscience -
Weill Medical College of Cornell University
01.2007
NIMH - Geriatric Translational Research Institute -
University of Pittsburgh
Skills
- Clinical Trials Expertise: Phase II-IV design & execution, GCP adherence, outcomes-based research, compliance monitoring, CAPA implementation
- Project & Scientific Oversight: Strategic leadership of study teams, vendor management, document development, regulatory timeline management, FDA/Health Canada communication
- Medical Affairs Leadership: Build strategic partnerships with centers of excellence, KOLs, patient advocacy groups, managed care organizations, government programs, regulatory bodies, and cross-functional teams
- Medical Writing: Development of clinical protocols, study reports, investigator brochures, publications (eg, white papers on Negative Pressure Wound Therapy [NPWT] and health economics and outcomes research [HEOR])
- Data Analysis & Interpretation: Expertise in analyzing and interpreting clinical trial data (including RWE/RWD) to inform targeted asset strategies and address regulatory demands
- Proficient in Microsoft Office Suite
- Electronic data capture (EDC) systems
- Statistical software (eg, SPSS, SAS)
Publications
- Alexopoulos GS, Kanellopoulos D, Murphy CF, Gunning-Dixon F, Katz R, Heo M: Placebo Response: Does It Predict Antidepressant Response of Geriatric Depression? Am J Geriatr Psychiatry. 2007 Feb 15 (2): 149-58.
- Alexopoulos GS, Kanellopoulos D, Murphy CF, Gunning-Dixon F, Katz R, Foxe JJ: Electrophysiological Responses to an Emotional Go/No-Go Test and Remission of Geriatric Depression. Neuroreport. 2007 Feb 12:18(3): 217-21.
- De Sanctis PF, Katz R, Wylie GR, Alexopoulos GS, Foxe JJ: Enhancement and bi-lateralization of early sensory processing in the ventral visual stream may be a feature of normal aging: A high-density electrical mapping study. Neurobiology of Aging doi:10.1016/j.neurobiolaging.2007.03.021
- Katz R, De Sanctis PF, Sehatpour P, Mahoney, Gomez MR, Murphy CF, Alexopoulos GS, Foxe JJ. Cognitive Control in Late-Life Depression: Response inhibition deficits and dysfunction of the Anterior Cingulate Cortex. The American Journal of Geriatric Psychiatry, 11 March 2010 doi: 10.1097/JGP.0b013e3181d695f2
Timeline
Associate Director, Medical and Scientific Affairs
B. Braun Medical, Inc. / Aesculap Biologics, LLC
11.2019 - Current
Global Clinical Submission Quality Lead (Contract)
Synectics, Inc.
07.2019
Medical Consultant
VIVO Agency
10.2018 - 12.2019
Pharmaceutical Regulatory Consultant
Cello Health (Innovative Science Solutions)
07.2018 - 07.2019
Medical Advisory
Lehigh Valley Health Network
01.2008 - 01.2018
MD -
Université El Hadji Ibrahima Niasse (UEIN)
Fellowship - Neuroscience -
Weill Medical College of Cornell University
NIMH - Geriatric Translational Research Institute -
University of Pittsburgh
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