Bethesda, MD & Sarasota, FL, United States
£7,000 - £225,000
Initially a published scientist (100+publications, NIH grants/study section member) Ph.D. in Microbiology/Immunology. Attorney in FDA regulatory areas - device, drugs, biologics, biotech,...) for 28 years (retired) with leading law firms, Venture Partner, TVM (retired) and now high net worth investor and participant in start-up biomedical companies as Board member, Management Team and fund raiser. Using the experience of counseling large and mid-size and early stage pharma (traditional, biotech, generic,...), as Board member with several drug, vaccine and medical technologies companies in which I have invested
As an Immunologist/microbiologist publishing over 100 publication, I have a good grasp of scientific nuances impacting on biomedical companies, and have used this scientific knowledge in interacting with FDA, Health Canada, EMA, PMDA (Japan) etc. I was on both an NIH study section as a reviewer, then on a NHLI SBIR/STTR review group until 2020. I have spent almost 30 years as a private attorney in the FDA, USDA, EPA,...areas counseling companies developing products - medical/diagnostic devices, traditional/biotech new drugs and generics, biologics, and companies developing biotech products.
As an attorney, I performed FDA due diligence for venture capital groups, and was a consultant/venture Partner to TVM (Muinch/Boston). Retiring from FDA practice I have helped start several biomedical companies, invested in several start-ups, on the Board of several drug, vaccine and medical technologies companies, and been an investor in several early biomedical startups ($10,000-$300,000).
Ethicann Pharmaceuticals (Sarasota/Bethesda MD/Toronto, CN) based specialty pharma company that reformulates approved drugs with safety issues into safer, metered sublingual doses and achieves rapid approvals using abbreviated new drug approval strategies (2025 > Canada, UK, Germany, EU & FDA). Have had successful meetings with FDA and Health Canada to confirm approval strategies. First product to treat MS spasticity only requiring human bioequivalence for new drug approval Canada, UK, Germany & EU; US 505b2 NDA. Using proprietary oral disintegrating tablet (ODT) delivery (Catalent) and ultra-high purity APIs to avoid impurities. www.ethicann-pharma.com . Have just closed $1.5M convertible note, executed license for proprietary Zydis oral disintegrating tablets (ODT) with Catalent, UK. Active fund rasier for Ethicann, will be at JP Morgan Healthcare Conference, talking with investment bankers, VCs and ultra-high net worth investors.
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