Page 150 - ALMExperts 2024 National Medical Directory

NON-MEDICAL RESUMES ALM EXPERTS: National Medical Edition 2024

Joshua Sharlin, Ph.D.

Washington, D.C.  C: 410-231-8900  [email protected]
February, 2024 (page 1 of 8)
Professional Summary

Broad and deep skills in drug, biologic and medical device development. Hands-on experience in the
entire lifecycle of product development from initial regulatory strategy, clinical trial planning and
execution, to submission preparation and review at FDA. Authority in the collection, analysis,
interpretation, and presentation of information to FDA. Expert in understanding FDA reviewer’s
actions and reactions.
Based on experience training over 40,000 staff at FDA-regulated companies on technical and
regulatory topics, skilled in explaining FDA related topics to juries.
Worked as an FDA regulatory expert witness in over 50 cases, deposed 16 times and testified 5 times.
Specialist in analyzing FDA compliance information to answer three questions: 1) What did the
company know and when did they know it? 2) What should the company have known and when
should they have known it? 3) What should the company have done and when should they have done
it?
Provide FDA related regulatory support to attorneys in cases involving; (i) death or injury caused by
drugs, biologics, or medical devices, (ii) patent infringement, (iii) insurance claims, (iv) wrongful
termination, (v) trade secrets, (vi) merger and acquisitions, (vii) stock fraud, (viii) software
development, (ix) data integrity.

FDA Related Skills, Experience & Qualifications

 Former FDA reviewer  Identify and fix data integrity problems
 Improve regulatory strategy  Audit and improve Trial Master Files
 Audit companies, CROs,
vendors and clinical sites for  Evaluate adverse event reporting compliance for
drugs and medical devices
FDA compliance
 Instructor on FDA topics  Perform software validation
 Prepare clinical sites and  Expert witness in lawsuits with an FDA
companies for an audit by FDA regulatory component
 Speaker at meetings at FDA as a representative of
 Answer written FDA questions
drug and medical device companies
 Write and improve clinical study  Expert in analysis and interpretation of FDA
protocols and clinical study safety databases; MAUDE (medical devices),
reports FAERS (drugs)
 Write drug and medical device  Conduct statistical analysis
submissions
 Secret clearance (Dept of  Identify, prevent and solve compliance problems
Defense)

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