Personnel  
 

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.

D. Hill curriculum vitae

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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.

Brian Neely curriculum vitae

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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.

M.J. Walling curriculum vitae

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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.

George E. Mark, III , Ph.D. curriculum vitae

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Don Hill & Associates, Inc
Main Office (301) 260-2200   Fax (301) 260-2020
eMail: dhai@msn.com