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Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Shulman, Michael, MD
Business Name BioMedical Resources for Global Drug Development (Founder/President)
Certifications ABIM
Education
  • University of North Carolina - Chapel Hill 1958-61 (Pre-medical, Advanced Freshmen Program, Phi Eta Sigma, Phi Beta Kappa, Morehead Scholar)
  • Columbia University College of Physicians & Surgeons (MD 1965, Alpha Omega Alpha) 
  • Internship/Residency in Medicine, Fellowship in Renal Disease and Inorganic Metabolism (1965-69), Clinical Assistant  Professor of Medicine (Nephrology), Grady Memorial Hospital and Emory University School of Medicine, Atlanta, Georgia                                                                             
Business Address BioMedical Resources for Global Drug Development
1360 Jones Street, Suite 401
San Francisco, California 94109-0302
USA
Contact information
Telephone:
Fax:
Mobile Number:
Email address:
Website URL:
(415) 771-7468
(415) 771-7468
(415) 971-4629
mshulman@biomedical-resources.com
http://www.biomedical-resources.com
Specialties
  • Bench-to-bedside translational research
  • Assess new technology
  • Due diligence
  • Opportunity-finding
  • Clinical program feasibility
  • Protcol review
  • Central BILAG review, SLE
  • Clinical research & drug development (small molecules & biologics, Phase 1-4)
  • Clinical & regulatory strategy, planning, trial design, protocol development & implementation 
  • Medical monitoring, safety, pharmacovigilance, DSMB charter & liaison, medical writing
  • MedDRA AE coding, SAE assessment & reporting to regulatory agencies
  • Therapeutic areas: Acute & chronic renal disease including renal anemia, dialysis, transplantation, autoimmune disease, SLE, inflammation, organ preservation, diabetes mellitus, hypertension, cardiovascular, metabolic, endocrine, neuropathic pain, multiple sclerosis, neuro-oncology
  • DSMB roles & responsibilities
  • US liaison for ex-US biopharmaceutical companies [virtual team to expedite US IND, regulatory strategy, clinical trial design & implementation]                                                                                                                                                                                                                                                                                                                                                                                        
Experience

Versatile, seasoned clinical drug development professional: 21 years clinical research & development (Phase 1-3), Medical Affairs (Phase 4), biologics and small molecules                  

 --Industry Experience

  • Clinical trial design, analysis, & study report completion
  • Clinical support for feasibility assessment (global Phase 3 trials)
  • Central Reviewer, BILAG grading in clinical trials evaluating safety and efficacy of novel biologics for treatment of patients with systemic lupus erythematosus (SLE)
  • Protocol development and review; Medical monitoring (Phase 1-3)
  • Safety oversight & regulatory reporting
  • pre-IND, IND, ISS, sBLA, 510(k), NDA
  • DSMB organization, Charter development, clinical liaison, implementation
  • Medical writing/editing & presentations, clinical sections of regulatory documents, PSURs, Annual Reports, Investigator’s Brochures, MedWatch reports, abstracts, posters, manuscripts
  • Medical Affairs: trained sales representatives, directed medical services, medical clearance of advertising & promotional materials, design/oversight Phase 4 studies
  • OC-RDC, MediData RAVE, Clintrial
  • Please refer to Linkedin profile [http://www.linkedin.com/in/michaelshulman] or request CV for company- & product-specific industry experience. 

--Pre-industry Experience

  • Private practice, Nephrology & Internal Medicine, 1974-1991, Atlanta, GA
  • Clinical Assistant Professor of Medicine (Division of Nephrology), Emory University School of Medicine, Atlanta, GA
  • Medical Director/Co-Director, free-standing dialysis centers
  • Major, US Army Medical Corps, 2nd General Hospital Landstuhl, Germany

--Affiliations/Memberships/Licenses

  • Medical Licensure, California (active and current)
  • Chairman, Medical Advisory Board, Greater Atlanta Lupus Foundation
  • Diplomate, American Board of Internal Medicine & National Board of Medical Examiners
  • American Societies of Transplantation (Emeritus), Nephrology (Emeritus)
  • American College of Rheumatology (Research, Emeritus)
  • Society for Neuro-oncology 

--Bibliography available upon request

 

 

 

 

 

 

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