Don Hill • Brian Neely • MaryJane Walling •
George E. Mark III, Ph.D. • Su C. Tso, Ph.D.
Don Hill
dhai@msn.com, phone: (301) 260-2200, fax: (301)260-2020
Donald Hill is President of Don Hill and Associates, Inc., a consulting
firm that has provided regulatory services to the biologic and
biopharmaceutical industry for the last 15 years. Previously, Mr. Hill
served as Director, Division of Product Certification, Center for
Biologics Research and Review (CBER), FDA where he was directly involved
in the licensing and control of biological products for 26 years. In
addition, he provided guidance to industry on facility and validation
requirements, compliance with the CGMPS, licensing and labeling
standards and contract manufacturing organizations (CMO). Mr. Hill
received his BS from the Ohio State University College of Pharmacy. He
has published several articles on FDA facility and licensing
requirements for the manufacture of biologic/biotech products and is a
frequent guest lecturer at industry and professional society meetings
and at educational seminars.
Mr. Hill continues to use his extensive biologic experience in conducting cGMP audits, performing mock FDA pre-approval inspections and providing guidance to companies on licensure requirements, facility controls and quality systems for manufacturing biological products.
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Brian Neely
bcneely@sbcglobal.net, phone: (317) 859-6310, fax: (317) 859-0751
Brian Neely is the Vice-President and Principal Consultant of Don Hill & Associates, Inc.
In his role, he provides expertise and guidance to the biotechnology and
the pharmaceutical industry on
aseptic and non-sterile manufacturing,
isolator technology, bulk product manufacturing, final dosage forms,
quality systems and environmental monitoring. Mr. Neely has 25 years of
industry experience with 18 years in Quality Control and Corporate
Quality Assurance. Prior to joining Don Hill & Associates, Inc., Mr.
Neely was a Regulatory Research Scientist for biotechnology products in
Global Regulatory Affairs at Eli Lilly and Company. In this role, he was
responsible for the regulatory functions and strategy for
biotechnology-derived products in a global environment and has reviewed
and edited CMC sections of Biologics License and Applications (BLA), New
Drug Applications (NDA), Annual Reports, European dossiers and
supplements. In addition, he conducted GMP audits and due diligence
assessments, has written and consulted on the implementation of quality
systems, quality policies, procedures and technical guidelines. As GMP
auditor and as Quality Assurance manager, Brian has worked closely with
several large and mid-sized European and Japanese drug and biotech
companies. Brian also coordinated an managed company liaison with the
inspection teams and written follow-up commitments and action plans.
Additionally, Mr. Neely has provided training on current Good
Manufacturing Practices (cGMPs), in-house auditing, inspection
interactions with agency inspectors, contract manufacturing, quality
systems and environmental monitoring. Mr. Neely has considerable
experience in working with U.S. FDA and international regulatory
agencies.
Since joining Don Hill & Associates, Inc., Mr. Neely has become a lead GMP auditor, for auditing vendors, biologic and drug manufacturers of active ingredients and final dosage form ,and cellular therapy laboratories. Additionally, he has worked closely with companies in preparing them for inspections by the FDA and EMEA. He received his B.A. in Biology-Chemistry at the university of Missouri.
MaryJane Walling
Mjwalling1@aol.com, phone: (301) 762-8182, fax: (301) 762-8183
Mary Jane Walling joined Don Hill & Associates, Inc. in February 2002
after retiring from FDA where she had most recently served seven years
as the Associate Director for Regulatory Affairs, Office of Drug Evaluation
V, Center for Drug Evaluation and Research (CDER). She oversaw the regulatory
and scientific consistency of review of products from three divisions;
Over the Counter Drugs, Anti-Inflammatory, Analgesic and Ophthalmic Drugs,
and Dermatologic and Dental Drugs. She supervised the project manager
staff and quality assured the administrative record for all actions taken
on drug applications subject to NDAs. Additionally, she also
reviewed publications for Federal Register notices governing monographs
for OTC drug Division and the Analgesic, Anti-Inflammatory and Ophthalmic
Division.
Prior to joining CDER in 1995, Mary Jane served for three years as the Associate Director for Regulatory Affairs, Office of Establishment Licensing and Product Surveillance, Center for Biologics Evaluation and Research (CBER). Mary Jane also served as a CBER reviewer and project manager for fractionation and monoclonal antibody products in the Division of Product Certification, CBER. Duties in this position included review of license applications, cGMP compliance, labeling and advertising as well as coordinating clinical, statistical and pre-clinical portions of the applications review. She conducted manufacturing site inspections and served as point of contact with the pharmaceutical industry.
In her current position, Ms Walling advises manufacturers of FDA regulations, guidelines and policies impacting on the manufacture of biological and drug products. She also performs audits of companies manufacturing biological products, including blood derived products and cellular therapy products for compliance with the cGMP regulations.
Ms. Walling
received her B.S. from the College of St. Elizabeth, New Jersey and
received graduate courses in Microbiology and Immunology at George
Washington University.
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George
E. Mark, III , Ph.D.
gemark3@gmail.com, phone
(voice and fax) (215) 598-3702, cell: (267) 240-2520
Dr. George E Mark, III recently joined
Don Hill and Associates, Inc. In his role, as Principal Associate, Dr.
Mark provides technical expertise and regulatory guidance to the
biotechnology and pharmaceutical industry on cell banking, process
controls/validation of monoclonal antibodies and vaccines, bioanalytical
assay development, viral clearance studies and stability testing. Dr.
Mark also provides assistance in the preparation as well as the
review/acceptability of CMC sections of IND and pre-approval marketing
applications for filings with regulatory agencies. Dr. Mark has more
than 30 years of experience in microbiology, virology, immunology,
molecular biology, and biotherapeutic discovery and development. Dr.
Mark was a Senior Director of Cellular and Molecular Biology and Virus
and Cell Biology with Merck and Co., Inc. where for 16 years he managed
the discovery and preclinical development of monoclonal antibodies and
vaccines. His experience included working with subunits (peptides,
purified polysaccharides, and purified native and recombinantly
expressed proteins) and lives attenuated viral and bacterial organisms
for vaccines against numerous infectious diseases including those
initiated by Rotaviruses and Human Papillomaviruses. More recently, Dr.
Mark directed the molecular engineering, cell line development, and
participated in the subsequent commercialization of several anti-tumor
monoclonal antibodies for a leading U.S. cancer research institute.
Dr. Mark provides expertise in many areas of biopharmaceutical product
development and commercialization including, but not limited to, product
characterization, release and stability testing, analytical test method
development and validation, product and process comparability studies,
biotechnology transfer projects, and the effective management of
outsourced biopharmaceutical testing and manufacturing.
Dr. Mark received his PhD in Microbiology from the Temple University
School of Medicine and his postdoctoral work was in the Department of
Biochemistry at the McGill University School of Medicine. He spent
nearly nine years at the National Cancer Institute, NIH, prior to
joining the Merck Research Laboratories.
George E. Mark, III , Ph.D. curriculum vitae
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Su C. Tso, Ph.D.
wangsuchu@comcast.com,
phone and fax: (301) 977-7234
Dr. Su C. Tso joined Don Hill & Associates, Inc. in March 2006
after retiring from the FDA. Dr. Tso served for over 14 years as a Chemistry, Manufacturing and Controls (CMC) reviewer in the Center
for Drug Evaluation and Research (CDER). Her responsibilities included review of Investigational New Drugs (INDs), New Drug Applications
(NDAs), Supplemental applications, Amendments and Annual Reports. Her review expertise included assessing the acceptability of the chemistry
and manufacturing processes, the applicant’s quality controls, product stability and technical aspects of labeling. Dr. Tso’s review style
was characterized by considerable interaction with the sponsor through her participation in CMC meetings/teleconferences and at other times
to insure completeness and adequacy of the application submission. Her timely suggestions and recommendations often aided in first cycle
approval of the application. Dr. Tso also participated as a team member of FDA pre-approval inspections (PAI) in evaluating acceptance of
CMC operations and in determining facility cGMP compliance status. She has also worked closely with the USP compendial liaison staff and
industry representatives in evaluating and recommending revisions to proposed and existing monographs for inclusion in the official compendia.
Dr. Tso received her Ph.D. in Organic Chemistry from New York University and her postdoctoral training at the University of Louisville.
Prior to joining FDA, Dr. Tso was employed for 20 years in the chemical industry as a senior research and development chemist. Her
responsibilities included development of novel chemical specialties for various industrial applications. Her experience ranged from
laboratory research in chemical synthesis and polymer modification to manufacture scale-up. Dr. Tso’s research work involved the use of
GC, NMR, HPLC, IR and other laboratory equipment for identifying chemical structure and analyzing chemical processes.
With her chemistry background and industrial experience and extensive knowledge of FDA regulations and the CDER processes for application
review, Dr. Tso can assist in the following areas:
Don Hill & Associates, Inc
Main Office (301) 260-2200 Fax (301) 260-2020
eMail: dhai@msn.com
