PAREXEL Expands Global Regulatory Services with Addition of Senior Executives from FDA and Oncology Industry
November 15 2017 - 9:00AM
Business Wire
New Appointments Enhance PAREXEL’s Leadership
and Expertise in Bringing Commercially Viable, Reimbursable
Products to Market
PAREXEL, a leading global biopharmaceutical services provider,
today announced the appointment of three former senior regulatory
consulting executives from the U.S. Food and Drug Administration
(FDA) and Oncology industry positions. The new hires are part of
PAREXEL’s Global Integrated Product Development and Compliance team
and will be focused on helping PAREXEL clients deliver commercially
viable, reimbursable products to market faster and more
cost-effectively.
Robert Iser, Vice President of Regulatory Consulting
Service: Mr. Iser joins PAREXEL from his post as Director of
the FDA’s Office of Process & Facilities, and will be focused
on helping clients avoid market delays due to compliance or quality
problems. Over more than 14 years with the agency, Mr. Iser
reviewed product quality and assessed manufacturing processes and
pre-approval inspections, and was responsible for developing and
implementing CMC guidance. Prior to joining the FDA, he spent seven
years in the pharmaceutical industry managing quality systems, and
supporting manufacturing process development, scale-up, and
validation.
Dr. Bob (Bhardwaj) Desai, Vice President of
Consulting, Technical (Oncology): With more than 10 years of
experience leading global oncology and biologic/biosimilar drug
development programs for Astellas Oncology, Pfizer, Hospira, and
Abbott/Abbvie, Dr. Desai’s expertise extends to all phases of
oncology drug development and all product classes, from chemical
compounds to recombinant biologics, including mAbs, biosimilars and
antibody drug conjugates (ADCs). Dr. Desai has worked closely with
the FDA and other global regulatory authorities to expedite the
review and approval of multiple compounds, including a successful
oral presentation to the European Medicines Agency (EMA) for the
approval of the first biosimilar monoclonal antibody.
Dr. Chang Lee, Vice President of Consulting, APAC:
Dr. Lee brings both industry and regulatory agency experience to
PAREXEL. He led Regulatory and Clinical Affairs at Capsugel, KV
Pharmaceuticals, Morton Grove Pharmaceuticals, TAP Pharmaceutical
Products Inc., Novartis OTC, and Igenix, and served as a Medical
Officer at the FDA’s Center for Drug Evaluation. U.S.
board-certified in Clinical Pathology, he is knowledgeable in
global clinical and regulatory product development, including risk
management, and has worked with many global regulatory authorities,
including FDA, EMA, the Medicines and Healthcare products
Regulatory Agency (MHRA), Health Canada, the Central Drugs Standard
Control Organization (CDSCO) in India, and the China Food and Drug
Administration (CFDA).
These new team members join other recent additions to the
PAREXEL Consulting, Integrated Product Development teams, including
former FDA Clinical Team Leader Ron Farkas, Vice President,
Technical.
“At PAREXEL, our approach to drug development necessitates an
integrated strategy that demonstrates product value and mitigates
risk. As such, we are always focused on building a robust team with
global and diverse expertise,” said Dr. Paul Bridges, Worldwide
Head of PAREXEL Consulting. “These new team members will contribute
to our mission of helping clients take their products through
development swiftly, successfully, and profitably, and ultimately,
to the patients who need them most.”
About PAREXEL International
PAREXEL International Corporation is a leading global
biopharmaceutical services company, providing a broad range of
expertise-based clinical research, consulting, medical
communications, and technology solutions and services to the
worldwide pharmaceutical, biotechnology, and medical device
industries. Committed to providing solutions that expedite
time-to-market and peak-market penetration, PAREXEL has developed
significant expertise across the development and commercialization
continuum, from drug development and regulatory consulting to
clinical pharmacology, clinical trials management, and
reimbursement. PAREXEL Informatics provides advanced technology
solutions, including medical imaging, to facilitate the integrated
clinical development and regulatory information management process.
Headquartered near Boston, Massachusetts, PAREXEL has approximately
18,900 employees with offices in 85 locations in 52 countries
around the world. For more information about PAREXEL International
visit www.PAREXEL.com.
PAREXEL and PAREXEL Informatics are trademarks or registered
trademarks of PAREXEL International Corporation or its affiliates.
All other trademarks are the property of their respective
owners.
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PAREXEL Media Contacts:Wendy RyanTel.: +1
781-434-5104Email: Wendy.Ryan@PAREXEL.comorJenny Radloff, PAN
CommunicationsTel.: +1 617-502-4300Email: PAREXEL@pancomm.com
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