Carexa Incorporated was founded by Jan Sedgeworth in 2003. Carexa
enables access to a network of experienced consultants providing
strategy and services for drug development and regulatory affairs.
The core members of the network are:
NORTH AMERICA
Jan Sedgeworth, PhD has over twenty
years of experience in the pharmaceutical and biotechnology industry.
Dr. Sedgeworth has held executive positions in regulatory affairs
at SmithKline Beecham, GlaxoSmithKline and Hemosol. Over a period
of 8 years with SmithKline Beecham, Dr. Sedgeworth was responsible
for the approval of more than 18 New Chemical Entities in Canada
in a variety of therapeutic and product areas, including CNS,
cardiovascular, diabetes and vaccines. At Hemosol, Dr. Sedgeworth
was responsible for world-wide regulatory affairs, focussing
on FDA, MCA and Health Canada. In 2003, Dr. Sedgeworth formed
Carexa Inc., providing consulting services to the pharmaceutical
and biotechnology industries.
Joan C. Pehta, MD is a seasoned medical
and regulatory professional in the pharmaceutical industry.
Prior to forming the consulting company The Alpha Bio Group
in 2000, Dr Pehta was responsible for Clinical and Medical
Affairs for 10 years at V.I.
Technologies, Inc. where she was
instrumental in the clinical development and US licensure of
a novel viral inactivated blood product, S/D Plasma. In addition,
Dr Pehta directed clinical operations, medical safety, clinical
regulatory affairs, and medical marketing. Dr Pehta has extensive
experience with the FDA including an in-depth knowledge of
regulations for drugs and biologics for human use, and requirements
for establishing and maintaining regulatory compliance for
the conduct of clinical research.
Lidia Derewlany, PhD has over 15 years
of experience in the Canadian pharmaceutical industry. Dr.
Derewlany has been responsible for securing regulatory approvals
in a wide variety of therapeutic areas encompassing both biologic
and pharmaceutical products. Dr. Derewlany began her career
at Eli Lilly and has held senior Regulatory positions at SmithKline
Beecham and GlaxoSmithKline. Dr. Derewlany's experience
includes serving as a representative to the pharmaceutical
industry on the APETI (Advisory Panel on the Electronic Transmission
of Information) and ACES (Advisory Committee on Electronic
Submissions) advisory committees to Health Canada. Dr. Derewlany
also holds an appointment as Assistant Professor in Paediatrics
at the University of Toronto.
Brian Hill, BSc has over 25 years experience in the pharmaceutical industry. He has worked in primary, secondary and sterile manufacturing facilities and has practical knowledge of early stage development/formulation development, clinical trial material manufacturing and packaging, biotechnological, radiopharmaceutical, nutrapharmaceutical and medical device operations. He started his career with GD Searle in the UK and then moved to Canada where he worked as a quality systems consultant with a number of different companies. Following that, for 13 years, he held senior quality management positions for SmithKline Beecham and GlaxoSmithKline at a number of their facilities, in Canada, Puerto Rico and France. He has a clear understanding of quality systems and their interdependencies with business, management and operational activities. Throughout his career Brian has demonstrated an ability to apply risk management decisions in crisis situations, provide pragmatic and practical solutions to problems, and deliver quality improvement projects.
EUROPE
Ulrich Granzer, Ph.D. has held senior
regulatory positions at a number of large pharmaceutical companies,
including Glaxo/Glaxo
Wellcome, BASF Pharma Knoll, and Bayer.
As head of regulatory affairs for Glaxo, he was a member of
the global regulatory board, and was responsible for European
and global drug development, and regulatory submissions. At
BASF Pharma Knoll, his areas of responsibility included regulatory
affairs, drug safety and GXP. Following his tenure as VP Global
Regulatory Affairs at Bayer, he founded his own company, Granzer
Regulatory Consulting and Services . He has a track record
of working on more than 50 NMEs (small molecules and biologicals)
covering a variety of therapeutic areas including HIV, asthma,
cardiovascular, CNS, oncology.
Carexa's experts maintain current regulatory knowledge through
ongoing contact with regulatory agencies, as well as through
active memberships in various industry associations including:
We can also provide access to additional resources with non-clinical
and clinical expertise to assist with your other drug development
needs.