Tuesday, August 15, 2023 5:00:55 PM
Subhash Dhawan (from LinkedIn) Viral immunologist with a Ph.D. in biomedical research and more than 25 years of experience with the United States Food and Drug Administration (FDA) regulatory processes.
Viral immunologist with a Ph.D. in biomedical research and more than 25 years of experience with the United States Food and Drug Administration (FDA) regulatory processes. Served as a Principal Investigator and Chief of the Viral Immunology Section to direct and manage an independent research program involving infections: HIV-1, Ebola virus, West Nile virus, Zika virus, and mycoplasma. Actively participated in the FDA review process of 510(k), IDE, IND, and BLA submissions related to in vitro diagnostics, and conducted several US and foreign pre-approval/pre-licensure inspections of manufacturing facilities. Chaired or served as a member on several internal FDA regulatory committees, represented FDA as an ad hoc external committee member for developing guidance for diagnosis and monitoring of infectious diseases, and presented invited and keynote addresses at domestic and international conferences.
Work Experience
BIOMEDICAL SCIENTIST (INDEPENDENT) Graphic
Senior FDA Research & Regulatory Scientist (Retired)
BIOMEDICAL SCIENTIST (INDEPENDENT)
Jan 2019 - Present4 years 8 months
United States
• Independent science writer
• Invited reviewer of manuscripts for peer-reviewed scientific journals
• Can provide guidance on research and regulatory projects related to in vitro diagnostics, vaccines, and therapeutics
• Can provide short-term or long-term contractual and consulting services for advancing research and regulatory projects
• Can provide editorial assistance
Published six articles and filed a patent application (U.S. and PCT Patent Pending) after retiring (Wonder if the Patent Pending mentioned was this one for the Therapeutic Swabs????)…
FDA Graphic
Senior FDA Research & Regulatory Scientist
FDA
Apr 1993 - Dec 201825 years 9 months
United States
Senior Investigator and Chief, Viral Immunology Section, Laboratory of Molecular Virology
Laboratory Research:
• Directed a comprehensive research program to conduct investigation on HIV-1 and other viruses, including Ebola, Zika, and poxvirus. Other administrative responsibilities included planning, coordinating research with outside collaborators, management, and supervision of research fellows and students.
Product Regulation:
• Provided guidance and…
Scott Medway (following from LinkedIn)
United States Patent and Trademark Office
Feb 2008 - Present15 years 7 months
* Examining patent applications for medical devices (drug infusion pumps, catheters, angioplastics, surgical sealants, perfusion therapy, surgical methods, etc)
* Researching and analyzing prior art documents
* Communicating findings on novelty/non-obviousness and applying relevant case law
* Negotiating with patent practitioners upon the interpretation of patent language
* Passed USPTO Certification (Patent Bar Equivalency) Exam
IMO they must have seen something they really liked about Brilacidin
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