Raymond Pratt

About Raymond Pratt

An accomplished Physician Executive in drug development, and pharmaceutical industries. Extensive experience in regulatory approval of drugs and devices and providing development strategies for global pharmaceutical companies. Broad areas of expertise include clinical development, clinical pharmacology, regulatory affairs and data analysis and presentation.Specific Achievements:• Study reports, IB’s, briefing documents and expert reports for 10 drugs in all stages of development from Phase I to IV. Responsible for scientific content for 5 NDA’s, 3 MAA and 5 sNDA’s and Type II Variations. Principal in 4 FDA Advisory Committees (Neuro-Pharm, Cardio-Renal, Hem-Onc). Pediatric Plans for US and EMA• Wrote and reviewed Expert Reports in support of EU MAA’s, Health Canada NDS, China, Japan and India INDs.• Designed and oversaw clinical studies and SAE reporting for over 30 trials.• Developed product profiles and clinical development plans for multiple drugs • Good knowledge of GXP’s, ICH requirements and guidelines for US, EU and China drug registrations. • Alliance management for global partners• Principal in meetings with Psychiatry, Neurology, Cardio-Renal and Hematology divisions at FDA. • Dossiers for EMEA Scientific Advice, arbitration procedures, Pediatric Investigation Plans. • Responsible for strategic scientific coordination between commercial and R&D functions, to include clinical trial design, regulatory strategy, CMC, KOL management and Scientific Advisory boards.• Over 40 peer reviewed publications plus abstracts and posters for presentation at scientific meetingsSpecialties: Board Certified Internal Medicine and Nephrology

Experience

1. Senior Medical Advisor

   Savara Inc.

   Oct 2025 — Present

Education

• University of Illinois College of Medicine

  MD, Medicine

  1972 — 1976

• Northwestern University

  BA, Chemistry

  1968 — 1972

Skills

• Good Clinical Practice (Gcp)
• Phase I
• Phase I- Iv
• Life Sciences
• Infectious Diseases
• Vaccines
• Biologics
• Pharmacovigilance
• Ind
• Hematology
• Pharmaceutical Industry
• Sop
• Fda
• Medical Affairs
• Clinical Development
• Neuroscience
• Therapeutic Areas
• Pharmacology
• Ctms
• R&D
• Cardiology
• Translational Medicine
• Nephrology
• Psychiatry
• Mineral and Electrolyte Metabolism
• Immunology
• Drug Development
• Gcp
• Biopharmaceuticals
• Strategy
• Biotechnology
• Clinical Trials
• Research and Development (R&D)
• Alzheimer's Disease
• Medical Devices
• Clinical Research
• Regulatory Submissions
• CRO
• Disease
• Standard Operating Procedure (Sop)