Senior Consultant Biologics Consulting Group Inc.
Belle Mead, NJ

• Provides expert consulting services in regulatory affairs, product development, regulatory compliance, quality  systems and strategic assessments.
• Examples of strategic consulting services include:
  • Expert Witness Quality Assurance- provided expert testimony in an international arbitration assessing the adequacy of GCP quality assurance procedures and processes related to the oversight of Phase III clinical trials.
  • Health Care Private Equity Investments-determined the probability of FDA approval of four therapeutic recombinant drugs in various cancer indications.
  • Company Acquisition-due diligence- assessed the FDA approval and manufacturing compliance profiles of several drugs to estimate the return on investment of the acquisition.
  • Risk Assessments-BLA filings- determined the overall risk of FDA rejection of a BLA related GCP violations at several clinical study sites. Developed and implemented corrective actions to mitigate risks to FDA approval.
  • Quality Systems-development & implementation- assisted a start-up company in establishing quality systems and procedures to secure additional financing needed to further develop two early stage drug candidates.

Vice President, Worldwide Regulatory Affairs, Ethicon, Inc.
Somerville, NJ

• Led and directed worldwide regulatory affairs functions for new product registrations (devices and device combination products) and post-approval regulatory activities.
  
• Responsible for identifying and analyzing changes in worldwide regulatory requirements and developing strategies to address those changes relevant to the company's products.
  
• Responsible for regulatory review and approval of advertising/promotional materials and labeling.
  

Vice President, Regulatory Policy & Quality Assurance, Covance, Inc.,
Princeton, NJ

• Responsible for all regulatory, quality assurance and compliance activities associated with Phase II-IV clinical research.
  
• Directed multifunctional regulatory projects for client companies including preparing, and submitting clinical trial and marketing approval applications and developing strategies for drug approval.
  
• Launched strategic regulatory consulting unit to assist small pharmaceuticals and biotech companies in developing and gaining approval of novel drugs and biologics.
  
• Developed a regulatory policy unit to assess and address changes to regulatory requirements for the development and approval of drugs and biologics.
  
• Globalized clinical quality assurance organization; harmonized processes and procedures to address worldwide clinical research requirements.

Vice President, Regulatory Affairs & Quality Assurance, ImClone Systems, Inc.
Somerville, NJ

• Developed regulatory strategies and directed regulatory and quality activities to gain FDA approval of therapeutic monoclonal antibodies and vaccines.
  
• Expanded and upgraded the quality assurance, validations and regulatory affairs departments to support multiple product development and pre-commercialization programs.
  
• Directed the regulatory activities for several important FDA meetings clearing the path for successful BLA filings.
  
• Established the framework for FDA to grant Fast Track Designation for the company's lead product. Secured Orphan Drug Designation for the same product.
  

Vice President, Regulatory Affairs & Quality Assurance, Cytogen Corp.
Princeton, NJ

• Developed and directed regulatory and quality assurance activities to secure approval of prescription drugs and biologics (Phases I-IV).
  
• Established advertising /labeling policies and quality assurance systems.
  
• Developed a corporate quality policy for regulatory, clinical and manufacturing activities
  
• Developed quality systems and procedures for the manufacture of multiple biologic products.
  

Senior Director, Regulatory Affairs, Pharmacia, Inc.
Columbus, OH

• Developed and implemented regulatory strategies for the approval of prescription drug products within the U.S.
  
• Successfully coordinated NDA submission activities of drug products for cancer, urology, rheumatoid arthritis, ulcerative colitis and smoking cessation.
  
• Centralized the regulatory affairs organization enabling the standardization of practices and procedures resulting in higher quality NDA submissions and faster drug approvals.
  
• Key regulatory affairs representative in merger transition team between Pharmacia and UpJohn
  

Executive Director, Regulatory Affairs, Pharmacia Laboratories (Kabi Pharmacia, Inc.), Piscataway, NJ

• Directed US regulatory activities including new drug registration and compliance with FDA regulations and guidelines.
  
• Directed and coordinated the successful filing of several NDAs and NDA supplements.
  
• Spearheaded the company's US taskforce for expediting the global approval of new drugs.
  
• Led FDA negotiations and directed the regulatory activities to address compliance issues facing the company.
  
• Liaison to FDA during plant inspections. Conducted internal GMP, GLP and GCP audits
  

Investigator, U.S. Food and Drug Administration, East Orange, NJ

• Performed establishment inspections of drugs, medical devices and in-vitro diagnostics.
  
• Experienced with FDA regulations including GMP's, GCP's and GLP's.
  
• Received four letters of commendation for superior performance.
  

• Regulatory Affairs Certified (RAC) (through 2004)
  
• Chair, Ethics & Clinical Practice Committee, Association of Clinical Research Organizations (2004)
  
• Chair, Ethics Committee, Regulatory Affairs Professional Society (2005)
  
• Editorial Board, FOCUS, Regulatory Affairs Professional Society (2003-2008)
  
• Instructor, Regulatory and Legal Issues in Drug Development, Mercer County Community College (2003-2005)