Double Board Certified US gastroenterologist with 30 years in the global pharmA industry in Drug Safety, Clinical Research, Regulatory & Compliance, Training, Crisis Management, Change Management. Now consulting in drug safety & pharmacovigilance.
· BLCMD Associates LLC, Chapel Hill, NC, New York City, Paris – President, July 2008 – date
· Expert consultant in drug safety and pharmacovigilance systems, operations, processes and SOPs, Mock Advisory Committee Meetings, benefit/risk analysis and risk management, quality, audits & compliance in drug safety, signal detection, safety reviews and white papers, PSURs, expert reports, change management and re-engineering, registries, safety telephone call centers, drug safety crisis management, post-marketing safety strategies, medical writing, training and education. Consulting to industry, law firms and global health agencies. Website: www.blcmd.com
· Data safety management boards (DMSBs, DMCs)-Recent experience:
o Chair of a DSMB 2009-2014 covering 9 multi-center, multi-national hepatitis trials. Trials concluded, NDA in preparation
o Chair of a DMC 2012-2014 covering 2 pain trials. Trials concluded.
o Member phase I DMC covering first in man trial of a novel type II diabetes drug. Study stopped due to pharmacokinetic/dynamic issues.
o Chair of a DMC 2014 – ongoing on a product for Alzheimers
· Associate, ew hulihan and associates, Bangor, PA 2011- date
· Adjunct Associate Professor, Rutgers University (formerly University of Medicine & Dentisty of New Jersey), School of Health Related Professions 2010 – date.
· Clinical Teaching Assistant – Department of Medicine, University of Medicine & Dentistry of New Jersey, School of Medicine 1991 – 2012
· Clinical Teaching Assistant – Department of Medicine, New York University School of Medicine 1979 – date
· Jones & Bartlett Medical Publishers/Learning, Sudbury, MA – Medical Book Series Editor, June 2008 - date
· Medidata Solutions, Inc., New York, NY – Vice President, Global Regulatory Initiatives and Pharmacovigilance June 2007 – July 2008
· Subject matter expert on development team of drug safety software for the rapid, real time on-line collection of serious adverse event data from health care professionals and the public. Patent for this software now being applied for. Also developed regulatory department, headed response team for a governmental inspection (UK), corporate trainer for GCP, pharmacovigilance and inspection preparation. Developed regulatory document database/repository in the document management system.
· Novartis Consumer Health Inc., Parsippany, NJ – Global Head, Drug Safety and Pharmacovigilance Mar 2006 – May 2007
· Manage staff of 50 in NJ and 25 in Switzerland. Groups handle all clinical trial and post-marketing AEs for drugs, devices, cosmetics and nutritionals: receipt, data entry into Argus database, transmission to affiliates & subsidiaries & reporting to health authorities, co-licensors, internal customers and Novartis Pharmaceuticals (Basel) . Budget $13 million.
· Responsible for all PSURs, NDA periodic and IND annual reports, risk assessment and risk management plans, due diligence reviews of new products, call center, product recall & withdrawal analyses, safety exchange agreements with partners (J&J, BMS), covered ~250 products globally including 6 NDA products and 2 IND products; chairman of Product Stewardship Risk Management Committee. Initiated & supervised re-engineering of group with outside consultants (WCI).
· Forest Research Institute, Jersey City, NJ – Senior Director, Drug Safety Surveillance, Nov 2004 – Feb 2006
· Manage and coordinate staff of 20 including physicians, nurses, pharmacists, data entry and other administrative drug safety staff handling clinical trial AEs and non-US post-marketing and licensee-licensor AEs. Matrix interactions with the US post marketing group.
· Head, standards committee. Member Documentum IT group. Consultant on EU Clinical Trial Directive and privacy issues. Reviewer of AE exchange agreements with associated business partners. Representative meeting twice-yearly meetings with associated business partners (including Merz, Lundbeck, Paion, Cypress). Due diligence reviews for new products. Protocol reviewer for safety matters. Member steering committee for drug safety reengineering. Developed methodology for faxing case report form AE sheets to Drug Safety as email pdfs using Faxination software.
· Becton Dickinson, Franklin Lakes, NJ – Medical Director, Medical Affairs, Clinical Research & Operations, Jan 2004 – October 2004
· Responsible for all clinical trials done by Medical Department from protocol concept to final clinical study report. Supervises 8 nurses and CRAs. Included trials on devices, drugs and biologics. Consultant to Advanced Drug Delivery Group on their drug/device combination products. Brought in external consulting group (Metasolutions Inc.) to audit the clinical research functions.
· Schering-Plough Research Institute, Kenilworth, NJ - Senior Director Pharmacovigilance Compliance & Harmonization, Sept 2003-Jan 2004
· Prepared and analyzed clinical and medical data for Senior Vice President’s review regarding registries, urgent recall matters, legal issues and other safety issues. Attended and prepared analyses for the Corporate Senior Safety & Labeling Committee: CPSSC (Clinical Preclinical Safety Surveillance Committee). Reviewed safety summaries from external companies for in-licensing candidates. Participated in senior review of labeling for SP products. Member of labeling committee for joint venture and in-licensed products (including Zetia and Remicade). Prepared and coordinated SP responses for submissions to FDA, EMEA & other health authorities, PhRMA, EFPIA, ICH, CIOMS and other organizations. Represented SP on pharmacovigilance matters at PhRMA, EFPIA, CIOMS, ICH etc. Assisted Senior VP on matters of Risk Management and Epidemiology. Reviewed SOPs and audits of pharmacovigilance operations & other compliance related matters. Reviewed key PSURs. Ensured worldwide consistency and compliance with SP policies on pharmacovigilance. Continued on ICH E2B Working Group. Continued on SP MedDRA Steering Committee, SP Clinical Trial Directive Steering Committee, SP Benefit/Risk Working Group and Remicade/Rebetron Registries Groups. Member ICH E2B (Electronic Transmission of Individual Case Safety Reports) Working Group as PhRMA representative.
· Schering-Plough Research Institute, Kenilworth, NJ - Senior Director Global Head of Drug Safety, Medical & Safety Services, 1994-Sept 2003
· In charge of three groups (total budget ~$15 million):
1. Drug Safety Services: comprising >125 people 80 MD’s/nurses/pharmacists/PharmD’s/safety specialists plus support staff), training and operations group and compliance/icensing group. Handled global data entry of all clinical trial and post-marketing adverse events.
2. Medical Services: MDs & other medical personnel charged handling PSURs, signal development and workup, response to safety related queries from health care professionals and subsidiaries, risk assessment & management. Determined safe levels of residual product in Cleaning Validation of assembly line equipment and serves on the the Worker Safety Committee.
3. European Safety Group: based in the UK which includes the SP Qualified Person for the EMEA as well being responsible for reporting “centrally approved” and “mutually recognized” drugs’ AEs.
· Re-engineered department in 1994-5 with CSC Index Inc. Developed new PC based client-server computer system for AE processing (called “CAVIAR” -Computerized Adverse Event Information, Analysis and Reporting System) and reporting using an outside programming company. Version 1.0 launched May 6, 1995 with periodic updates through 2003. Licensed CAVIAR to the software company that developed it on a royalty basis for sale to other companies.
· Consultant to Legal Department and involved in depositions and litigation in safety matters. Represented company in various governmental safety meetings for SP investigational and marketed products (US FDA and health authorities in Australia, France, WHO, Italy, Canada, Finland, Pharmacovigilance Working Party of the EMEA etc.).
· Member of the senior corporate safety committee (Clinical Preclinical Safety Surveillance Committee) deciding all corporate safety issues and worldwide product label changes. Senior medical reviewer for all advertising pieces for US prescription products.
· Head of the MedDRA Transition Task Force (1998 – 2002). Head Complaint Handling Reengineering Task Force (2000-2001). Member ICH Expert Working Group on E2B(M); co-chairman of Expert Working Group on V1 (PSUR revisions). Responsible for the writing of the corporate policy on AE handling as well as review of all business units’ local SOPs on AE handling.
· Schering-Plough Research Institute, Kenilworth, NJ - Director, Medical & Safety Services, 1992-1994
· Reviewed all protocols and clinical trial reports for safety and medical content before submission to FDA. Reviewed all compendia articles concerning Schering products (AMA Drug Evaluations, Medical Letter etc.). Member of Promotion & Education Review Committee for medical review of all advertising. Consultant to Drug Safety Surveillance. Developed “phamacologically active doses” for all products for cleaning validation use. Consultant to Legal Department on litigation issues.
· Hoechst-Roussel Pharmaceuticals Inc., Somerville, NJ - Section Head/Director, Medical Research, Internal Medicine/Vasotherapeutics - 1987-1992
· Head of a clinical research team of ~15 medical professionals and support staff. Products handled:
· HOE 077 (Prolyl Hydroxylase Inhibitor). Responsible for development and implementation of the US clinical program for the development of this drug for liver cirrhosis.
· Trental (Pentoxiphylline). Responsible for design and implementation of phase IV trials and new indications (particularly for use in diabetic and arterial leg ulcers) in the U.S. and Canada. Rewrote investigator brochure. Wrote and directed the clinical hemorheology study required by FDA for NDA approval. Organized investigator meeting. Prepared clinical-statistical reports on studies completed. Assisted in preparation of publications. In charge of development and implementation of the clinical program for the use of Trental to treat and prevent cyclosporin/amphotericin B induced nephrotoxicity.
· HOE 760 (Roxatidine Acetate - H2 Blocker). Responsible for design, implementation and completion (on time and on budget) of the US and Canadian clinical development program (late phase I, II and III) for Roxatidine HOE 760. Wrote protocols, implemented and completed 4 major multi-center pivotal trials. Organized consultant and investigator meetings. Helped implement GCP (US style) in Eastern and Western Europe. Prepared and periodically revised investigator brochure. Wrote clinical-statistical reports. Primary participant in presentation of data to FDA's GI division. Chairman of overall project development committee and member of Frankfurt-based International Project Group. Liaison with phase IV group and marketing group. Member of Gastroenterology Worldwide Marketing Group (Frankfurt). Responsible for the preparation of the clinical portion of the NDA and chairman of the NDA preparation committee. Prepare responses to clinical questions from FDA on NDA. Wrote and prepared manuscripts of clinical trials and review articles for journal publication. Grant budget $2 million per year.
· HOE 843 (Aldose Reductase Inhibitor). Responsible for design and implementation of the US clinical program (late phase I, II and III) for development of this compound HOE 843. Organized methodology and new technology workshop and investigator meeting. Devised strategy to overcome FDA moratorium on new studies. Chairman of project development coordination committee and member of Frankfurt-based International Project Committee. Liaison to licensor of this product. Participant in meeting with FDA's endocrine division. Assisted in interim analysis of the major US clinical trial. Grant budget $2 million per year.
· HR 810 (Cefpirome - antibiotic). Responsible for clinical trials being done through third parties (contract research organizations) in the United States, Argentina and Mexico for pneumonia and skin and soft tissue infections. Chose third parties, negociated and wrote contracts and monitor the trials along with third parties.
· Hoechst-Roussel Pharmaceuticals Inc., Somerville, NJ - Associate Director, Medical Research, Internal Medicine - 1985-1987
· Member of clinical research group investigating Trental and HOE 760 (see above). Supervised 4 clinical research associates.
· Purdue Frederick Co., Norwalk, CT - Associate Medical Director 1984-1985
· Developed and implemented phase IV programs and new indications for Uniphyll (theophylline) and Fibermed Biscuit (OTC). Prepared data for response to FDA on lack of bioavailability of preparation. Developed phase II and III program for MS-Contin in acute cancer pain. Train sales representatives in GI. Reviewed advertising on marketed GI products.
· Ives Laboratories, Inc., New York - Assistant Medical Director 1981-1983
· Developed and implemented phase IV programs and new indications for iv and oral Isordil (isosorbide dinitrate) and Surmontil (tri-cyclic antidepressant). Review advertising on these agents. Responded to questions from physicians on marketed products. Prepared investigator brochures and scientific literature on marketed products for physicians, state formularies and conferences. Represented company at national medical conferences and at FDA meetings (Cardiorenal Division).
BARTON LEWIS COBERT
. New York University - University College B.A. 1970
. New York University School of Medicine M.D. 1974
. New York University - Veterans Hospital - Bellevue Hospital - Internal Medicine Internship & Residency 1974 - 1977.
. New York University-Bellevue Hospital - Gastroenterology Fellowship 1977-1979
. Institut National de la Santé et de la Recherche Médicale (INSERM) and Collège de Médicine des Hôpitaux de Paris - Fellowship in Hepatology - Service of Prof. J-P Benhamou, Hôpital Beaujon, Clichy, France 1979-1980
. North Carolina, New York, New Jersey (active)
. California (inactive)
. Diplomate: American Board of Internal Medicine in Internal Medicine 1977
. Diplomate: American Board of Internal Medicine in Gastroenterology 1981
. French (fluent), Italian (some), Dutch (some)
. Adjunct Associate Professor, Rutgers/UMDNJ, School of Health Related Professions 2010 - date
. Clinical Teaching Assistant, Rutgers/UMDNJ, Medical School 1991 - 2012
. Clinical Teaching Assistant, New York University School of Medicine 1979 - date
. Assistant Attending Physician, Bellevue Hospital 1979 - 2000
. Assistant Attending Physician, New York University Hospital 1983 - 1985
. Health Canada Consultant Database 2010 - date
BARTON LEWIS COBERT
. American College of Physicians - Fellow
. American College of Gastroenterology - Fellow
. Regulatory Affairs Professionals Association – Member
. American Gastroenterological Association – Member
. Phi Beta Kappa
. Pi Mu Epsilon (Mathematics)
Emergency Room Physician:
. New York University Hospital, New York City 1978 - 1979
. Gouverneur Hospital, New York City 1979
. St. John's Hospital, Far Rockaway, New York 1977 - 1979
. Month-long visits 1973 - 1978 to the Blood Bank and Hematology Laboratories of the University of Groningen, The Netherlands
. Free-lance medical editing for "Hospital Medicine" 1979 – 1984
. Expert Opinion on Drug Safety Journal 2004 - 2015
. Expert Opinion on Drug Safety Journal 2004 - 2015
. Drug Safety Journal (Adis) 2005 – 2010