Senior Consultant Biologics Consulting Group Inc.
Germantown, MD.

• Expert in regulatory pharmacology/toxicology and product (i.e., CMC) evaluations of biotechnology-derived products, including cytokines, growth factors, enzymes, toxins, thrombolytics and monoclonal antibody products.
  
• Experienced with pharmacology/toxicology regulation of vaccines, blood products, cell, tissue and gene therapy products, RNAi and peptides.
  
• Experienced with new developments regarding biotechnology-derived products within the CDER small molecule environment.
  
• Responsibilities include:
  
  • aiding drug sponsors in the overall strategy and development of biologic products
    
  • performing GAP analysis and/or review of nonclinical product development packages
    
  • designing and interpreting toxicology studies, including relevant species and immunogenicity issues and appropriate PK/TK and biodistribution studies
    
  • interfacing with toxicology contract research organizations
    
  • aiding in the preparation of regulatory submissions (including pre,pre-IND, pre-IND, IND, BLA, NDA, response to hold, etc)
    
  • performing product review for biotechnology-derived products
    
  • planning and participating in FDA meetings
    
  • providing insights into the changes occurring with the review of nonclinical biotechnology-derived products in CDER and in particular within the Office of Oncology
    

Oct. 2006 - Feb. 2007

Consultant, Aclairo, Pharmaceutical Development Group, Inc.,

• Provided preclinical advice on scientific and regulatory issues, due diligence, and strategic planning for biologic and small molecule drug development.
  
• Provided complete regulatory pharmacology/toxicology support, including data interpretation and presentation and pre-IND, IND, BLA, NDA and ANDA preparation for FDA submission.
  
• Authored a manuscript pertaining to relevant species selection for biologic products (see Publications section).
  

Pharmacologist, CDER, FDA, ODEVI, Division of Therapeutic Biological Oncology Products

• Responsible for the review and maintenance of Pharmacology/Toxicology sections of Investigational New Drug (IND) submissions and original Biological License Applications (BLA) and supplements for biotechnology-derived products, including cytokines, growth factors, enzymes, toxins and monoclonal antibody products.
  
• Regulated biologic products for all clinical indications for approximately 1 ½ years. Regulation of biologic products specific for oncology indications started with the establishment of OODP in October 2005.
  
• Designed toxicology studies for all stages of clinical development and provide collaborative reviews and consults for Office of Blood Research and Review (OBRR) and Office of Vaccine Research and Review (OVRR).
  
• Chair of the committee, editor and major contributing author of Guidance for Industry and Reviewers: Nonclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (Draft Guidance completed August 2006, currently internal)
  
• Author of three manuscripts-two focusing on the regulation of monoclonal antibody products and one on the assays required for clinical pharmacokinetics and one on the role of PK and PD in selecting relevant species (see Bibliography section)

Product Reviewer, CBER, OTRR, Division of Therapeutic Proteins

• Responsible for the review and maintenance of Chemistry, Manufacturing and Controls (CMC) of IND submissions and original BLA and supplements for all indications.
  
• Served on and chaired BLA review committees for toxins, cytokines and several enzymes and participated in a pre-approval manufacturing facility inspection.
  
• Reviewed IND applications for toxins, imaging agents, cytokines, growth factors, tumor vaccines, thrombolytic agents and enzymes.
  
• Involved in the training of new product reviewers
  
• Participated in the following committees: Comparability Database Working Group, PhRMA Statistics Working Group, Review Guide Working Group, Complex Drug Substances Coordinating Committee (TSE working group, OBP alternate) and OBP Training Committee
  

Postdoctoral Fellowship, NCI, NIH, Dept. of Pathology, Women's Cancers Section, Cancer Research Training Award (CRTA)

• Identified signaling components involved in Nm23-regulated inhibition of breast carcinoma metastasis by utilizing protein, biochemical and molecular biology techniques (e.g., microarrays, immunoprecipitation, polyacrylamide gel electrophoresis, Western blot, radiolabeling kinase assays, Boyden cell motility assays, transfections, thin layer chromatography and small-scale, recombinant protein and antibody purification)
  
• Analyzed the role of CpG methylation patterns of the Nm23 gene as a cause of Nm23 down-regulation in metastatic breast carcinoma cells by molecular biology techniques (e.g., polymerase chain reaction, Southern blot)
  
• Maintained a variety of cell lines, including breast carcinoma cells, in culture
  
• Reviewed grants and manuscripts (see Scientific (non-regulatory) Review Experience section)
  
• Lecturer for graduate "Cancer Biology" course at Columbia University, NY. Title of presentation: Metastasis, Angiogenesis and Experimental Therapeutics
  
• Trained and supervised technician, medical student and college student in laboratory techniques, interpretation of data and trouble shooting
  

Doctoral Research, Penn State Univ. College of Medicine, Dept. of Pharmacology

• Dissertation title: Identification of Components involved in TGF-ß Signaling in Intestinal Epithelial Cells
  
• Assessed and identified the involvement of a variety of proteins (particularly protein kinases) in the signal transduction pathway of Transforming Growth Factor-ß (TGF-ß) resulting in the inhibition of intestinal epithelial cell growth by performing protein and biochemical techniques (e.g., immunoprecipitations, radiolabeled kinase assays, Western blots and DNA synthesis assays)
  
• Cloned a novel gene, rsmad1, that participates in TGF-ß signaling, utilizing molecular biology techniques (e.g. DNA and RNA isolation, Northern blots, polymerase chain reaction, library construction and screening and transfections)
  
• Maintained a variety of intestinal, colon carcinoma and breast carcinoma cell lines in culture
  
• Trained and supervised high school and college students in laboratory techniques, interpretation of data and troubleshooting
  

• University of Wisconsin Tenth Annual International Conference on Drug Metabolism/Applied Pharmacokinetics (September 17-21, 2007, Merrimac, WI) Title of Presentation: Exploratory IND: Phase 0 Studies
• World Vaccine Congress post-Conference Workshop: Vaccine Development: Better, Faster and Cheaper Pathways to Success (March 22, 2007, Washington DC). Title of Presentation: Current Toxicology Requirements for Vaccines (presented for Dr. Martin Green, DVRPA, OVRR, CBER, FDA.
• PERI course. Biologics Drug Development: an Integrated Overview of Manufacturing, Nonclinical, Clinical and Regulatory Requirements (2007, Bethesda, MD). Title of Presentation: Biologic Manufacturing 101: Basic Steps
• AAPS: Annual meeting (October 2006, San Antonio, TX). Title of Presentation: Immunomodulatory Biological Products- A Regulatory Perspective
• NIAID/CMCR Workshop: Applications for Radiation Countermeasures after a Large-Scale, Radiological Incident (June 2006, Gaithersburg, MD). Title of Presentation: Nonclinical Development of Biotechnology-Derived Products and Small Molecules… What are the Differences?
• DIA 42nd Annual meeting (June 2006, Philadelphia, PA). Title of Presentation: Regulatory Considerations of Developmental Toxicity Testing of Biological Drugs
• PERI course. Biologics Drug Development: an Integrated Overview of Manufacturing, Nonclinical, Clinical and Regulatory Requirements (2006, Bethesda, MD). Title of presentation: Regulatory Concerns for Biologics: Scientific and Regulatory Perspective
• PERI course. Pharmaceutical Toxicology: Toxicology in the Nonclinical Development of Drugs and Biologics (2005, Arlington, VA and 2006, Baltimore, MD). Title of presentations: Preclinical Development of Biotechnology-Derived Products: Parts 1 and 2.
• Protein and Peptides: Scientific Foundation for Reviewers (2004). Title of presentation: Downstream Processing of Biotechnology Products.
  

PUBLICATIONS