Dr. Keith Meloff

Scientific Advisory Board Member

Keith Meloff MD, FRCPC

PROFESSIONAL EXPERIENCE

Medical Advisor/Consultant:

  • Executive Committee-Israel Cancer Research Fund-Toronto
  • Delegate to Council: Ontario Medical Association
  • Medical Advisor/Consultant Neurologist-Ministry of Transportation, Province of Ontario
  • Board Member-Kensington Health-Toronto

 2008-2019                   

  • Peer Assessor- Pediatric and Adult Neurology-College of Physicians and Surgeons of Ontario

 Consultant Neurologist/Medical Director – MS Clinic: 2003 – 2014 Baycrest Centre Toronto

 Consultant (Contract): Jan-Mar 2004 Sanofi Canada

  • Avapro/Avalide/Plavix- chaired KOL meetings

Medical Director & Consultant   Isotechnika (Now Aurinia): 2002 – 2003

  • Developed ISAtx247, a novel Cyclosporine analogue with a therapeutic window for immunosuppression in transplantation and the treatment of psoriasis (in collaboration with Roche).
  • Worked with internal and external partners to conclude phase 1 and phase 2 studies and to plan and execute pivotal phase 3 studies (including pharmacovigilance and pharmaco-economics)

Medical Director / Chief Medical Officer / Executive Committee Wyeth Canada: 1999 – 2002 

  • Managed Associate Director, Clinical Affairs, Assistant Director, Medical Information Pharmacovigilance and Drug Safety group, Scientific Affairs Liaison, Clinical Project Managers, and Support Staff – 16 in total
  • Member of Commercial Operations Team for evaluating new opportunities

Organized Coordinated and Chaired Advisory Boards in several therapeutic areas including   Transplantation, Mental health/Neuroscience, Women’s Health, Rheumatology, Vaccines, Hemophilia, etc. Liaison with USA headquarters in developing a vaccine for Alzheimer’s disease.

  • Supervised Phase IV clinical trials in support of marketing for diverse product portfolio including Effexor, Enbrel, Rapamune, Tazocin, Premarin, Alesse, Prevnar, Benefix, Refacto (Hemophilia), Myelotarg.
  • Launched Rapamune (Sirolimus), novel immunosuppressant for transplantation; Enbrel (etanercept), a unique anti-TNF protein for Rheumatoid Arthritis; Prevnar 7-valent Pneumococcal conjugate vaccine.
  • Coordinated, planned and executed Prevnar/Pentacel immunogenicity study for worldwide market. Assessment of the compatibility of co-administered 7-Valent pneumococcal conjugate, DTaP.IPV/PRP-T Hib and hepatitis B vaccines in infants 2-7 months of age.

David W. Scheifele, Scott A. Halperin, Bruce Smith, Keith Meloff, Denzyl Duarte-  Monteiro. Poster 28. Eighth Annual conference on Vaccine Research. Baltimore May 2005 http://www.nfid.org/conferences/vaccine05/

Assessment of the compatibility of co-administered 7-Valent    pneumococcal    conjugate, DTaP.IPV/PRP-T Hib and hepatitis B vaccines in infants 2-7 months of age. David W. Scheifele, Scott A. Halperin, Bruce Smith, Keith Meloff, Denzyl Duarte-Monteiro. Vaccine 2006, vol. 24, no12, pp. 2057-2064 [8 page(s) (article)] (33 ref.)

  • Crisis management: product withdrawals, safety issues, supply chain/force majeure shortages.
  • Created and chaired PIVOT (Phase IV Operational Team) team with sales, marketing, finance, medical

and regulatory to enhance Phase IV performance across all therapeutic areas.

  • Recipient of President’s Award – CANADA Effexor Team.

Medical Advisor-Director-Major Part-Time Glaxo Canada: 1996 – 1998

  • Developed both CNS and Oncology compounds: e.g. Lamictal, Amerge, Navelbine.
  • Developed new compounds for Alzheimer’s disease, epilepsy, migraine, Parkinson’s disease, stroke, attention-deficit disorder, smoking cessation, hypertension, congestive heart failure, depression, pain, and other neurological and psychiatric disorders.
  • Recruited key opinion leaders and chaired disease-specific Medical Advisory Boards in Oncology: Leukemia/Lymphoma, Breast, Lung, GI, and Prostate.
  • Medical Advisory Boards in Neurology/Psychiatry: Lamictal – Epilepsy; Imitrex-Amerge – Migraine

 

Consultant-Medtronic: 1994 -1995  

  • Seconded to Medtronic (from Ciba -Geigy) to assist in market access for their implantable infusion device for treating severe spasticity and dystonia with Baclofen.
  • Use and Role of Intrathecally Administered Baclofen to Control Spasticity.: Symposium for the Canadian Paraplegia Association Annual Meeting. Moderated and organized by Dr. K. Meloff on behalf of Medtronic of Canada. Toronto, Ontario. November 11,1995.

Associate Medical Director: 1992 – 1995       

Ciba-Geigy (Novartis) • Medical/ Marketing interface with respect to Ritalin, Anafranil, Tegretol, Aredia, Estraderm, Habitrol, Voltaren and Voltaren Emugel.

  • Prepared business assessment reports on Foradil (formoterol), beta 2 agonist for asthma; and Lentaron (formestane), an aromatase inhibitor for the treatment of estrogen sensitive breast cancer.
  • Organized a Symposium on “Longitudinal Assessment in Alzheimer’s disease”.
  • Chairman – “International Symposium on Free Radicals, Anti-oxidants and Vitamin E in Clinical Medicine and Preventive Cardiology” Toronto – May 14, 1994
  • Developed medications for Neurology, Psychiatry, Oncology, Respiratory, Cardiology, Rheumatology.
  • Launched Habitrol and registered Tegretol (Mania) and Tegretol (Suspension) in pediatric epilepsy
  • Managed/supervised emergency access program for legacy medications across Canada.

EDUCATION AND PROFESSIONAL BACKGROUND

MD (Honors) – University of Manitoba

Board Certified in Pediatrics – Canada

Board Certified in Neurology – Canada

Adjunct Professor, Pediatric Neurology – University of Western Ontario

Consultant Neurologist, Child & Adult Neurology – University Health Network

Consultant Neurologist – Ministry of Health, Province of Ontario

Consultant Neurologist – Ontario Telemedicine Network

Professor/Director, Pediatric Neurology – New Jersey Neuroscience Institute

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