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Experienced in regulatory affairs and product development for drugs, biologics and medical devices (Rx, Rx to OTC, OTC, ANDA, 510(k)). Experienced in small and large companies, including start-ups and large companies such as Schering Plough, Becton Dickinson and Block Drug. Extensive negotiations with all divisons at FDA, including DDMAC. Can help clients in CMC, clinical, strategy, FDA meetings, inspections, line extensions, due diligence. Over 19 new NDAs, 24 INDs, 6 CTAs, ANDAs, 510(k)s; many FDA meetings, 5 US patents, etc. Now retired.Specialties: Regulatory affairs expert and product development experience in drugs, biologics, medical devices, including NDAs, BLAs, CTAs, 510ks, advertising and promotion. CMC, clinical, FDA negotiations and meetings, regulatory strategy, product development strategy. Conducted expert reviews for 2 EU marketing applications, expert witness.
Bernhard Associates Inc.
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CeoBernhard Associates Inc. Jan 1996 - PresentPharmaceutical and medicval device consulting. Currently preparing 2 monoclonal antibody INDs for oncology indications. Prepared expert reviews for 2 Johnson & Johnson company EU marketing applications, etc.
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Vp, Global Regulatory AffairsGlenmark Therapeutics, Inc Dec 2007 - Dec 2008Mumbai, Maharashtra, InBuilt global regulatory affairs department for this new drug (NME) division of a successful Indian generic pharmaceutical company until funding forced closing US office. Worked closely with associates in India, Switzerland and the UK. Member of Operating Committee, member of due dilligence group. Filed US, EU and Indian INDs/CTAs for monoclonal antibody for RA and small molecules for RA, diabetes, etc. -
Senior Director And Head, Regulatory AffairsMedpointe Pharmaceuticals Mar 2005 - Dec 2007UsSpecialty pharmaceutical company, vertically integrated, now Meda Pharmaceuticals. Filed several new NDAs and INDs, numerous NDA supplements for line extensions to extend product life. Conducted numerous FDA meetings, including several successful (and one unsuccessful) dispute resolution meetings. Numerous interactions with DDMAC, DTC advertising negotiations with DDMAC, etc. -
Head, Us Regulatory Affairs And QaFerring Pharmaceuticals Mar 1999 - Mar 2005St-Prex, ChPrepared and filed 6 successful NDAs, most for fertility products, 2 device 510(k)s and 3 INDs. Conducted many FDA meetings, many negotiations with DDMAC. Worked closely with associates in Sweden and Denmark, manufacturing plants in these countries and contract manufacturers in the US. Responsible for release of all commercial and clinical drug batches, conduct of contractor audits, etc. -
Cso And Vp, Pharmaceutical DevelopmentFei Technologies Inc Mar 1998 - Mar 1999Developed several new sustained release silicone based drug delivery products. Left when company was sold.
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Director, R&DBecton Dickinson Transdermal Systems Mar 1995 - Mar 1998Responsible for developement of iontophoretic transdermal patches, including design, manufacture and oversight of clinical trials. Conducted 4 first in man phase 1 studies with partner companies (in the US and UK), developed several new patches, 5 US and international patents. Supervised over 25 professionals and designed manufacturing facility.
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Vp, Worldwide Product DevelopmentBlock Drug Company, Reed & Carnrick Aug 1990 - Mar 1995Started as Director, Regulatory Affairs and then promoted to VP, Worldwide Product Development. First new NDA in 10 years; developed numerous new OTC products, first NCEs in 20 years (Rx productss) FDA meetings and inspections, etc.
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Director, Regulatory AffairsSchering Plough Aug 1983 - Aug 1990Initially director of biologics research and biologics regulatory affairs at Key Pharmaceuticals and transferred to Schering-Plough after Schering purchased Key. At Schering, director of regulatory affairs for 1/3 of Schering products, including allergy/asthma, dermatologicals, some biologicals, all line extensions, all Rx-to-OTC switches. Responsible for all aspects of these product areas.
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Assistant General ManagerCoulter Immunology Aug 1982 - Aug 1983Developed monoclonal antibodies for tumor associated antiogens and for blood cell typings for FACS analysis; assisted in development of EPICS (FACS) machines.
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Acting Section Chief, Monoclonal Antibody SectionNational Cancer Institute Aug 1980 - Jul 1982Second scientist in Biological Response Modifiers Program. Established, staffed and directed largest monoclonal antibody lab in NIH. Developed tumor-associated monoclonal antibodies. Developed first monoclonal antibodies to solid tumors to locate (via radiolabel) and treat (by conjugation with ricin toxin) solid tumors in animal models preparatory to human trials. Left when appointment expired.
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Assistant Professor And Head, Breast Cancer Research LabUniversity Of Virginia Medical School Aug 1978 - Aug 1980Taught courses in immunology and oncology in the medical school and established and ran the University's first Breast Cancer Research Laboratory; obtained NCI grant.
Michael Bernhard Skills
Michael Bernhard Education Details
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Harvard UniversityBusiness -
Cornell UniversityBiochemistry Virology
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WheatleyHs
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New York UniversityTransplantion Immunolgy
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Tufts UniversityMedical Sciences
Frequently Asked Questions about Michael Bernhard
What company does Michael Bernhard work for?
Michael Bernhard works for Bernhard Associates Inc.
What is Michael Bernhard's role at the current company?
Michael Bernhard's current role is CEO at Bernhard Associates Inc..
What is Michael Bernhard's email address?
Michael Bernhard's email address is mi****@****ink.net
What is Michael Bernhard's direct phone number?
Michael Bernhard's direct phone number is +157067*****
What schools did Michael Bernhard attend?
Michael Bernhard attended Harvard University, Cornell University, Wheatley, New York University, Tufts University.
What are some of Michael Bernhard's interests?
Michael Bernhard has interest in Auto Races, Hiking, Canoeing And Kayaking, Arts.
What skills is Michael Bernhard known for?
Michael Bernhard has skills like Regulatory Affairs, Fda, Clinical Trials, Oncology, Pharmaceutical Industry, Quality Assurance, Clinical Research, Ind, Strategy, Biotechnology, R&d, Drug Development.
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