MARY JANE WALLING
Title: Senior Consultant
Topic Area: Regulatory Affairs and Specialized Expertise in Assay
Development, Process Validation, cGMPs and Good Documentation
Education: B.S. College of St. Elizabeth, New Jersey
Graduate courses in Microbiology and Immunology at
George Washington University, Washington, D.C.
February 2002 - PRESENT Senior Consultant of Don Hill and Associates,
Inc., an independent consulting firm providing
expertise and guidance to the biopharmaceutical
industry on FDA laws and Regulations, current Good
Manufacturing Practices (cGMPs), NDA approval
and Product Licensing requirements standards, facility
design and process validation requirements, and contract
Advising Start-Up Companies, Joint Ventures, Contract
Manufacturers on Government Regulatory Controls and
Requirements for Manufacturing Biologic, Biotechnology
Derived Products and Cell Therapy Products;
Developing BLA/NDA strategies for obtaining FDA product
approval; Reviewing CMC for BLA/NDA/IND applications;
Reviewing New Drug Applications, Biological License
Applications/Supplements, INDs, Chemistry, Manufacturing
and Controls Sections (CMC) and Master Files for
submission to FDA;
Conducting GMP audits on facilities, operations, and
Preparing manufacturers for FDA pre approval
Establishing appropriate agendas and conducting
rehearsals for FDA/manufacturer meetings;
Providing in-house training on GMPs, facilities,
operations, environmental monitoring, quality systems
and manufacturing processes and controls.
Sept. 1995 – Jan. 2002
Associate Director for Regulatory Affairs, Office of
Drug Evaluation V, CDER. Oversaw the regulatory and
Scientific Consistency of Review of Products from 3
Divisions; Over the Counter Drugs, Anti-inflammatory,
Analgesic and Ophthalmic Drugs, and Dermatologic and
Dental Drugs. Supervised Project Managers and Quality
Assured the Administrative Record for all actions taken
on drug applications subject to NDAs. Administratively
reviewed publications for Federal Register notices
governing monographs for OTC products. Served as acting
chief of the project management staffs in the OTC drug
and analgesic division from May 2001 to October 2001.
October 92–September 95 Associate Director for Regulatory Affairs, Office of
Establishment Licensing; and Product Surveillance, CBER.
Oversaw regulatory consistency of actions taken on ELAs
and supplements for Biological products. Oversaw
advertising and promotional labeling staff as well as
lot release and biostatistics and epidemiology;
April 89-October 92 Review and project manager for immunoplabolism and
monoclonal antibody products in the Division of Product
Certification, CBER. Duties included review of license
applications, GMP compliance, labeling and advertising
as well as coordinating clinical, statistical, and Pre-
clinical portions of the applications review. Conducted
manufacturing site inspections and served as point of
contact with pharmaceutical industry.
PREVIOUS POSITIONS Research Associate in Cell Biology laboratories in
National Cancer Institute. Labortory research assistant
at Viral Oncology laboratory, Charles Pfizer, Inc.
EDUCATION BS, 1964, college of St. Elizabeth, NJ.
Graduate courses in Microbiology and immunology at
George Washington University. Graduate courses in
Public Health at USC California. Advanced Biologics Law
(FDA). Biotechnology Quality Control (Georgetown
PUBLICATIONS - Chopra H.C., Shibley, G.P. and Walling, MJ.: Electron
microscopic cytochemistry of Herpes simplex virus using
enzyme extraction and autoradiography. J. deMicroscopie
9: 167-176, 1970
- Chopra, H.C., Zelljadt, I., Woodside, N. and Walling,
MJ.: Studies on virus particles resembling oncogenic
RNA viruses in monkey breast sarcoma. Cancer 28: 1406-
- Chopra, H., Hooks, J., Walling, MJ. and Gibbs, C.J.:
Morphology of simian foamy virus. J. Natl. Cancer Inst.
48: 451-463, 1972.
- Andrese, A.P., Vande Woude, G.F. and Walling, MJ.:
Ultrastructural studies of Herpes simplex virus
infection of mouse cells chronically infected with
Rauscher leukemia virus. J. Natl. Cancer Inst. 53:
- Aoki, T., Potter, M., Sturm, M., Liu, M. and Walling,
MJ.: Cell populations and known surface antigens of
tumors induced by Aabelson Virus in Pristane Primed
BALD/c mice; analysis by immunoelectron microscopy. J.
Natl. Cancer Inst. 55: 1097-1106, 1975.
- Aoki, T., Walling, MH., Bushar, G., Liu, M. and Hsu,
K.C.: Natural antibodies in sera from healthy humans to
antigens of surfaces of type C RNA viruses and cells
from primates. Proc. Natil. Acad. Sci. USA 73: 2491-
- Aoki, T., Liu, M., Walling, MH., Bushar, G. and
- Specificity of naturally occurring antibody in normal
gibbon serum. Science 191: 1180-1183, 1976
- Aoki, T., Liu, M. and Walling, MJ.: Surface antigens
on transplantable tumor cell lines producing mouse type
C viruses. J. Natl. Cancer Inst. 58: 1069-1078, 1977
- Gallo, R.C., Gallagher, R.E., Wong-Staal, F. Aoki, T.,
Markham, P.D., Schetters, H., Ruscetti, F., Valerio, M.,
Walling, MJ., O’Keefe, R.T., Saxinger, W.C., Smith, R.
G., Gillespie, D.H. and Reitz, Jr., M.S.: Isolation and
tissue distribution of Type-C virus and viral components
from a gibbon ape (Hylobates lar) with lymphocytic
leukemia. Virology 84: 359-373, 1978.
- Hamer, D.H. and Walling, MJ.: Regulation in vivo of a
cloned mammalian gene: Cadmium induces the transcription
of a mouse metallothionein gene in SV40 vectors. J.
Molec. Appl. Genet. 1: 273-288, 1982.
- Carter, A.D., Walling, M. and Hamer, D.H.: Distinct
promoter and control sequences of an inducible
metallothionenin gene. In Enhancers and Eukaryotic Gene
Expression, Gluzman, Y. and Shenk, T. (eds.), Cold
Spring Harbor Laboratory, New York, pp. 170-174, 1983.
- Carter, A.D., Felber, B., Walling, M.J., and Hamer,
D.H. Duplicated Heavy Metal Control Sequences of the
Mouse Metallothionein GeneI..Proc.Natl. Acad.Sci.
- Thiele,D., Walling, M.J and Hamer,D.H. Mammilian
Metallothionein is Functional In Yeast.
PRESENTATIONS cGMPs in the Biotech environment (1992) Joint DIA/FDA
Project Management Workshops (program committee) 1997-
AWARDS Group Recognition – Desert Storm/Shield Task Force, 1992
Commendable Service – Monoclonal Antibodies, 1993
FDA Commendable Service Award, 1993
Commissioner’s Special Citation – User Fees, 1994
CBER Distinguished Service Award, 1994
FDA Commendable Service Award-Project Management, 1995
On the Spot Award, 1996
On the Spot Award, 1997
Certificate of Appreciation, 1998
Group Recognition – DIA, workshop, 1999
Special Recognition - 1999
Group Recognition – OTC Drugs 2000
Excellence In Communication – DIA workshop, 2000
FDA Outstanding Service Award-CDER, 2001
Certificate of Recognition- ODE V, 2001
FDA Group Recognition Award-Accutane, 2001
PROFESSIONAL Regulatory Affairs Professional Society
AFFILIATIONS Drug Information Society
REFERENCES AND ADDITIONAL INFORMATION AVAILABLE UPON REQUEST