Don Hill • Brian Neely • MaryJane Walling •
George E. Mark III, Ph.D.
Don Hill
dhai@msn.com, phone: (301) 260-2200, fax: (301)260-2020
Don
Hill is founder and President of Don Hill & Associates, Inc., a
consulting firm that has provided regulatory advisory services to the
biologics and biopharmaceutical industry for over 18 years. Previously,
Mr. Hill served as Director, Division of Product Certification, Center
for Biologics Research and Review (CBER), FDA where he directed
licensing of biological products for over 18 years. During his tenure
at CBER, he developed the current FDA facility requirements for
manufacturing biotechnology derived products. In addition, he provided
guidance to the industry on facility and validation requirements, FDA
expectations for compliance with cGMPs, licensing and on contract
manufacturing arrangements. Mr. Hill also served as a FDA inspector for
over 25 years. 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 an invited guest lecturer at industry and educational
seminars.
Mr. Hill continues to use his extensive biologic knowledge and experience in conducting cGMP audits, performing mock FDA pre-approval inspections and providing guidance to companies on BLA licensure, facility requirements, quality systems and validation requirements for manufacturing biotech and biological products.
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Brian Neely
bcneely@sbcglobal.net, phone: (317) 859-6310, fax: (317) 859-0751
Brian Neely is Senior Advisor and Principal Consultant of Don Hill &
Associates, Inc. Mr. Neely provides expertise and guidance to the
biotechnology and the pharmaceutical industries on aseptic and
non-sterile manufacturing, isolator technology, bulk product
manufacturing, final dosage forms, quality assurance and 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. Mr. Neely has
reviewed and edited CMC sections of BLA license applications, NDAs,
annual reports, European dossiers and supplements. In addition, he
conducted GMP audits and due diligence assessments, has written and
provided guidance on the implementation of quality systems, quality
policies, procedures and technical guidelines. As a GMP auditor and as
a QA manager, Brian has worked closely with several European and
Japanese drug and biotech companies. Additionally, Mr. Neely has
provided training and guidance to companies on cGMPs, in-house auditing,
proper interactions with FDA and EMEA inspectors, contract manufacturing
arrangements, quality systems and equipment and process validations.
Mr. Neely has also provided training to FDA personnel on requirements
for manufacturing biotech derived products
In his role, Mr. Neely is a lead auditor for auditing biologic and drug manufacturers of active ingredients and final dosage forms. 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) 762-8653
Mary
Jane Walling is Senior Consultant of Don Hill & Associates, Inc. In this
role, Ms. Walling provides regulatory advice to manufacturers on
interpreting the FDA regulations, guidance documents and polices
impacting on the manufacture of biological and drug products. Mary Jane
also performs cGMP audits for companies manufacturing biological
products under development and for those awaiting BLA approval. Her
product expertise includes vaccines, monoclonal antibodies, cell culture
derived products, blood fractionation products and cell therapy
products..
Ms. Walling was Associate Director for Regulatory Affairs, Office of Drug Evaluation V, Center for Drug Evaluation and Research (CDER) from 1995 to 2002. In her position, 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 coordination 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.
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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 is Principal Consultant at Don Hill and Associates,
Inc. 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, assay
development and validation, 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.
Don Hill & Associates, Inc
Main Office (301) 260-2200 Fax (301) 260-2020
eMail: dhai@msn.com
