M.J. Walling curriculum vitae

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M.J. Walling curriculum vitae

  1. 1. January 2009 MARY JANE WALLING (301) 762-8653 e-mail:mjwalling1@aol.com 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 manufacturing. ACTIVITIES INCLUDE: 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 quality systems; Preparing manufacturers for FDA pre approval inspections; 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.
  2. 2. 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. Maywood, NJ. 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 University). 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- 1414, 1971. - 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
  3. 3. Rauscher leukemia virus. J. Natl. Cancer Inst. 53: 1169-1173, 1974 - 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- 2495, 1976 - Aoki, T., Liu, M., Walling, MH., Bushar, G. and Brandchaft, P.B.: - 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. 81;7392-7396. 1984 - Thiele,D., Walling, M.J and Hamer,D.H. Mammilian Metallothionein is Functional In Yeast. Science.231;854-856.1986 PRESENTATIONS cGMPs in the Biotech environment (1992) Joint DIA/FDA Project Management Workshops (program committee) 1997- 2000. 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
  4. 4. 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

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