BOSTON–(BUSINESS WIRE)–PAREXEL, a leading innovator of global biopharmaceutical services, today
announced the appointment of four former senior executives from the U.S.
Food and Drug Administration (FDA) to its Regulatory Consulting group.
The new additions join more than 60 former global regulators in the
group and will be focused on helping companies understand and work
within the current FDA and global regulatory climates to optimize drug
development and mitigate risk of unnecessary delays.
The additions to PAREXEL’s team have broad experience in policy making,
including current regulations and guidance specific to biosimilars, cell
and gene therapy, and product safety and manufacturing.
Kurt Brorson, Ph.D.: Dr. Brorson joins PAREXEL following 26 years
with the FDA, primarily in the Center for Drug Evaluation and Research
(CDER). A recognized expert in viral safety of biopharmaceuticals and
clearance during manufacturing, Dr. Brorson brings expertise in
Chemistry, Manufacturing, and Controls (CMC) review and inspections for
biopharmaceuticals, including biosimilars, as well as policy development
within CDER’s scope. At PAREXEL, Dr. Brorson will be focused on
supporting clients in the development and regulatory strategy for
biosimilars and biotech products.
Changting Haudenschild, M.D.: Dr. Haudenschild brings to PAREXEL
in-depth, cross-disciplinary regulatory expertise and over 12 years of
experience with the Office of Tissue and Advanced Therapies (OTAT) in
the Center for Biologics Evaluation and Research (CBER), FDA. Dr.
Haudenschild’s regulatory expertise includes clinical safety and
efficacy and biomarker/surrogate endpoint development and utilization.
She also has significant experience avoiding and resolving issues that
often arise and stall development programs for cell and gene therapy
products for treatment of a wide range of clinical indications. Based in
Europe, Dr. Haudenschild will be responsible for strategic, scientific,
clinical, and regulatory support during all stages of product
development to help companies achieve their objectives.
Mohammad (Mo) Heidaran, Ph.D.: Dr. Heidaran is a recognized
expert in the development of cell and gene therapies with more than 9
years of experience at the FDA’s CBER, 15 years of biotech industrial
experience in research, product and intellectual property development,
and 9 years at the National Cancer Institute. In his role, Dr. Heidaran
will provide clients strategic CMC technical and regulatory support
during all stages of cell and gene therapy product development.
Mwango Kashoki, M.D., MPH: Dr. Kashoki brings over 16 years of
drug review, development and regulatory experience at the FDA, with
cross-disciplinary expertise in all phases of drug development from
preclinical development through marketing application and post-approval
assessments. At PAREXEL, Dr. Kashoki will provide strategic and
technical guidance on various regulatory and clinical aspects of drug
development, leveraging her expertise in clinical review as well as
pharmacovigilance and other post-approval safety requirements.
“As promising new innovations, such as regenerative medicines, use of
real-world evidence, and patient-centric approaches to clinical and
product development continue to advance in the industry, it will be
essential for sponsors to have the expertise to navigate the changing
regulatory environment,” said Dr. Paul Bridges, Worldwide Head of
PAREXEL Regulatory Consulting. “With these new additions to our
Regulatory Consulting Services team, PAREXEL will deepen its leadership
and expertise in areas that are priorities of the FDA, and are critical
to our clients on their journeys to deliver important new treatments to
patients in need across the globe.”
These new team members join other recent additions to the PAREXEL
Consulting, including Mr. Robert Iser, Vice President, Regulatory
Consulting Services, Dr. Bob (Bhardwaj) Desai, Vice President, Technical
(Oncology), and Dr. Chang Lee, Vice President, APAC. For full
biographies and to learn more about PAREXEL’s Global Regulatory
Services, visit https://regulatory.parexel.com/ex-healthcare-agency-experts.
About PAREXEL International
PAREXEL International Corporation is a leading innovator of global
biopharmaceutical services. We simplify our clients’ journey of
transforming scientific discoveries into new medical treatments for
patients with high-quality Phase I-IV clinical research, regulatory,
consulting and market access services. PAREXEL develops innovative
solutions by leveraging its comprehensive therapeutic, technical and
functional expertise, in more than 100 countries around the world. For
more information, visit our website
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PAREXEL is a registered trademark of PAREXEL International Corporation.
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Tel.: +1 781-434-4772
Kathryn McMahon Arrigg, PAN Communications
Tel.: +1 617-502-4300