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Michael Bernhard is listed as CEO at Bernhard Associates Inc. at Bernhard Associates Inc., based in Summit, New Jersey, United States. AeroLeads shows a work email signal at earthlink.net, phone signal with area code 570, 610, and a matched LinkedIn profile for Michael Bernhard.
Michael Bernhard previously worked as CEO at Bernhard Associates Inc. and VP, Global Regulatory Affairs at Glenmark Therapeutics, Inc. Michael Bernhard holds Business from Harvard University.
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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.
Listed skills include Regulatory Affairs, Fda, Clinical Trials, Oncology, and 24 others.
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Pharmaceutical 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.
Mumbai, Maharashtra, IN
Built 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.
US
Specialty 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.
St-Prex, CH
Prepared 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.
Developed several new sustained release silicone based drug delivery products. Left when company was sold.
Responsible 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.
Started 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.
Initially 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.
Developed monoclonal antibodies for tumor associated antiogens and for blood cell typings for FACS analysis; assisted in development of EPICS (FACS) machines.
Second 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.
Taught courses in immunology and oncology in the medical school and established and ran the University's first Breast Cancer Research Laboratory; obtained NCI grant.
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Michael Bernhard works for Bernhard Associates Inc..
Michael Bernhard is listed as CEO at Bernhard Associates Inc. at Bernhard Associates Inc..
AeroLeads has found 1 work email signal at @earthlink.net for Michael Bernhard at Bernhard Associates Inc..
AeroLeads has found 5 phone signal(s) with area code 570, 610 for Michael Bernhard at Bernhard Associates Inc..
Michael Bernhard is based in Summit, New Jersey, United States while working with Bernhard Associates Inc..
Michael Bernhard has worked for Bernhard Associates Inc., Glenmark Therapeutics, Inc, Medpointe Pharmaceuticals, Ferring Pharmaceuticals, and Fei Technologies Inc.
You can use AeroLeads to view verified contact signals for Michael Bernhard at Bernhard Associates Inc., including work email, phone, and LinkedIn data when available.
Michael Bernhard holds Business from Harvard University.
Michael Bernhard is listed with skills including Regulatory Affairs, Fda, Clinical Trials, Oncology, Pharmaceutical Industry, Quality Assurance, Clinical Research, and Ind.
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