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Biologics Consulting Group, Inc.
is pleased to make the following announcement:
John
E. Humphries, MD, joined Biologics Consulting Group, Inc., as
a Senior Clinical Consultant on January 31, 2008.
Dr.
Humphries received an AB in German and Biology from Middlebury College
in 1980; an MD from the Johns Hopkins School of Medicine in 1984;
completed an internship and residency in Internal Medicine at the
Johns Hopkins University School of Medicine in 1987; and subsequently
completed a Hematology Fellowship at the University of Virginia
School of Medicine in 1990. From 1990-1993, Dr. Humphries was involved
in NIH-funded basic research on fibrinolysis at the University of
Virginia while serving clinically as Instructor then Assistant Professor
in the Departments of Internal Medicine (Division of Hematology/Oncology)
and Pathology. Within the Pathology Department Dr. Humphries served
as Associate Director of the Special Coagulation Laboratory. In
1997, he was promoted to Associate Professor at the University of
Virginia in 1997. Dr. Humphries joined Bayer Pharmaceuticals, Biologics
Division, in 1998 as Associate Director, Scientific Studies, responsible
for all US phase IV activities. In 1999 he joined the International
Clinical Development Group as Director for International Clinical
Projects with responsibility for international trials of alpha-1-antitrypsin,
antithrombin III, plasmin and albumin. Later, as Director of Global
Clinical Strategy starting in 2001, strategic development of intravenous
immunoglobulin was added to his responsibility for development of
the above proteins. From 2005-2008 Dr. Humphries served as Vice
President of Drug Development at Biolex Therapeutics, in Pittsboro,
North Carolina, making transgenic protein therapeutics in Lemna
(duckweed) with strategic and operational responsibility for preclinical,
toxicological and clinical development for all products in development,
including a controlled-release interferon alfa and recombinant plasmin.
Dr.
Humphries has acquired diverse skills and competencies during his
20+ year professional career. While at the University of Virginia,
he was an accomplished researcher, educator and clinician with over
40 peer-reviewed journal publications, focused in the field of hemostasis,
thrombosis and fibrinolysis. While at Bayer he was involved in the
clinical development and regulatory interactions with FDA and EMEA
on a transgenic alpha-1-antitrypsin, was responsible for early clinical
development of a plasma-derived plasmin, clinical strategy for development
of intravenous immunoglobulin in neurologic disorders and clinical
strategy for new indications for plasma-derived antithrombin III.
During his years at Bayer served on the PPTA (Plasma Protein Therapeutics
Committee) subcommittee on Albumin, with responsibility of phase
IV studies of albumin. While at Biolex he produced the toxicology
and clinical sections of regulatory submissions for the controlled-release
interferon for the treatment of chronic hepatitis C and for recombinant
plasmin for the management of thrombotic disorders.
As
a Senior Clinical Consultant with Biologics Consulting Group, Inc.
Dr. Humphries will utilize his research and clinical expertise to
assist clients in the following aspects of drug development and
commercialization:
Technical
- Global
development planning for drugs and biologics, focusing on clinical
aspects
- Strategic
and operational input to streamline dossier development and maintenance
throughout the product lifecycle
- Assistance
in writing various sections of pre-IND and IND submissions
- Assistance
with the planning and conduct of clinical trials, including liaison,
and medical monitoring
- Preparation
for FDA, FDA Advisory Committee and International Regulatory Agency
meetings.
Managerial
- Project
and product lifecycle management approaches
- Assistance
with due diligence activities, including potential mergers, acquisitions,
in-licensing, and out-licensing
Marketing
Initiatives
- Assistance
with strategic and operational initiatives involving governmental
or other agencies and/or advisory groups
View
Dr. Humphries's Curriculum Vitae...
Page
Updated
August 21, 2008
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