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Pharmaceutical Oncology Expert Witness

Provides Opinion & Testimony In:

Pharmaceutical, New Drug Application Under FDA, Medical Imaging, Oncology, Pain Management, Anti Infectives, Ophthalmics, Drug Development, Drug Identification, Drug Labeling, Drug Labels, Drug Warnings, Drug Safety, FDA Medical Device Regulation, FDA New Drug Review Approval Procedures, Medical Devices, Pharmaceutical Development, Pharmaceutical Process Chemistry, Pharmaceutical Science, Pharmaceuticals, Pharmaceuticals Manufacturing, Pharmaceuticals Regulatory Affairs, Quality Assurance, GXP, GMP, GLP, GCP Compliance, Regulatory Issues, Risk Management, Review FDA Correspondence,

Expert Witness No.3033

Maryland

EDUCATION

Post-Doctoral Research:                                   1979-1981
SUNY/Buffalo                                                  Buffalo, NY
Major: Organic Chemistry

Ph.D. Organic Chemistry                                   1974-1979
University of Pittsburgh                                   Pittsburgh, PA
Major: Synthetic Methods/Natural Products

B.S.                                                                1970-1974
Loyola College                                                 Baltimore, MD
Major: Chemistry
Minor: Secondary Education

EMPLOYMENT

Sr. Regulatory Consultant                         01/04 to Present
A Private Consulting Company in          Derwood MD
Works with clients primarily in the pharmaceutical, medical device (just beginning), biologic, and biotechnology industries to create strategic plans for drug development supported by quality assurance in compliance with FDA regulations.  Services include:
Strategic project planning and regulatory strategy development in CDER, CBER, and CDRH
Works collaboratively with FDA on critical path initiatives that have specifically addressed genomics (effective biomarkers) and microdosing
Due Diligence
Regulatory Intelligence
FDA submissions planning and development
Publishing
FDA liaison activities
Clinical and nonclinical report writing
Conducting assessments of client studies, procedures, and programs to determine compliance.
Assisting with development and implementation of quality systems and validation programs.
Developing and implementing corrective action plans to address deficiencies.
Presenting GMP/QSR training.
Developing quality policies and procedures as related to validation.
Vice President, Regulatory Affairs           06/04 to 10/05
GENE LOGIC INC.                                Gaithersburg, MD
Working with clients primarily in the pharmaceutical, medical device (just beginning), biologic, and biotechnology industries to create strategic plans for drug development supported by quality assurance in compliance with FDA regulations.  Services include:
Strategic project planning and regulatory strategy development in CDER, CBER, and CDRH; heavy focus on oncology products
Regulatory strategist bridging genomics and regulatory filings using the VGDS
FDA submissions planning and development
FDA liaison activities
Conducting assessments of client studies, procedures, and programs to determine compliance.
Developing and implementing corrective action plans to address deficiencies.
Regulatory compliance systems implement in Gene Logic Labs, Genomics and Drug Repositioning Systems.

Vice President Regulatory Affairs /           01/03 to 01/04
Quality Assurance & Compliance
AAIPHARMa ®  INC.                                         Wilmington, NC
Created key drug development strategies  for pain management products along with opportunities for the aaiPharma ® pipelineCreated a Spec Review Board, a Material Review Board, an Investigational Review Board and a Technical Report Review Board for improving efficiency on drug development projects
Successfully managed activities relating to all regulatory submissions
Interacted with Business Development leading to the acquisition of Schedule II and III control substances for aaiPhama ® Branded Products
Established collaborative and active relationships with FDA in several Divisions: One NDA scheduled for filing 1Q’04; Three NDA supplements (CMC) approved in 2003; Labeling negotiations in progress for an injectable Schedule II drug; and Three successful PAIs completed in our oral and parenteral manufacturing facilities
Completed Best in Class assessments for the Quality Programs
Functionally aligned the Quality and Regulatory Organizations
Formalized CAPA Training and instituted system audits
Successfully managed a department of 40 (10 RA; 30 QA) with recent increasing responsibilities to manage multiple departments in Quality & Compliance and Clinical Regulatory Compliance

Director, US Regulatory Affairs           01/01 to 01/03
ELAN PHARMACEUTICALS INC.              San Diego, CA
Established interactive and collaborative relationships with Elan Senior Executives and with several key FDA officials.
Actively managed 8 drugs from initial drug development to post approval in pain management for the US market. 
Key contributor to 10 due diligence projects of which five were actioned as strategic buys or sells for Elan. 
Responsible for implementing key regulatory strategies throughout the company.
First Accomplishment: approval of FROVa ® a migraine drug, in 2001.
Second Accomplishment: approval of an opioid pain drug in 2Q’™02
Initiated highly visible new drug development project for Elan with aggressive timeline actions for approval.
Implemented multiple number of programs for Regulatory group.
Key contributor to several project teams.
Managed two associate directors and several consultants.

Senior Director Regulatory Affairs, Worldwide          01/99 to 01/01
ALLIANCE PHARMACEUTICAL CORP.                    San Diego, CA
Responsible for implementing regulatory strategies for drug development and regulatory submission for earliest possible approvals for Phase I through marketing approval and Phase IV in US, Canada, and Europe. Managed a team of 7.
Major Accomplishment: Approval of Imavisto, now Imagento
Participated in senior management development strategy teams for registration of products worldwide.
Responsible for improving the quality of all regulatory paper and electronic documents that has led to Alliance’™s first NDA into CDER.
Responsible for the identification of key regulatory requirements, communicating and influencing in a matrix project team environment with in-house and international project teams for four drug candidates and two device candidates and with corporate partners.
Responsible for ensuring timely review and preparation of all regulatory submissions, negotiating with regulatory agencies and facilitating regulatory agency review of submissions.

Senior Director Regulatory Affairs, US              06/97 to 01/99
AMYLIN PHARMACEUTICALS, INC.              San Diego CA
(Note: promoted to Senior Director in 1998)
Responsible for recommending and implementing regulatory strategies for drug development; filing regulatory submission for earliest possible approvals for Phase I through marketing approval and Phase IV in US and Canada.  Indirectly involved in European submissions. 
Responsible for the identification of key regulatory requirements, communicating and influencing in a matrix project team environment with contract manufacturers, contract vendors, and corporate partners.
Responsible for ensuring timely preparation of organized, accurate, and scientifically valid submissions, negotiating with regulatory agencies and facilitating regulatory agency review of submissions. 

FDA CMC Reviewer in CDER                     01/91-06/97
FOOD & DRUG ADMINISTRATION                              Rockville, MD
Served on multi-disciplinary scientific/medical teams (Division of Medical Imaging and Radiopharmaceutical Products, Division of Dermatology and Dental Drug Products, Division of Ophthalmic Drug Products .
Served in overtime capacity to handle overflow of work assignments for Center that reviews, evaluates, and decides on the approvability of scientific submissions and applications that request FDA approval for clinical research; human testing, and human drugs.

Production Director                                      01/88 to 01/91
CAMBRIDGE ISOTOPE LABORATORIES          Wobum, MA
Supervised a relatively large group (6 PhDs and 15 BS) of scientists in the manufacture of stable isotopes for use in Investigational New Drug Applications and for industrial, governmental and academic use.

Senior Laboratory Supervisor /                       08/81-01/88
Senior Research Investigator
BRISTOL MEYERS SQUIBB                            Princeton, NJ
Responsible for .the design, development and execution of isotopically labeled compounds, their characterization and their preliminary analysis for clinical and non-clinical studies.

SUMMARY OF EXPERIENCE

Over 25 years of experience in positions of increasing responsibility in Pharmaceutical Industries;
Broad range of Regulatory/QA knowledge and experience on global pharmaceutical development that encompasses investigational development through marketed products over the last five years in industry;
Six years of work spent at FDA as a CDER Primary Chemistry Reviewer;  
More than 7 years of strategic planning and filing regulatory applications to the pain management division at FDA;
Over 10 years of regulatory drug development with CNS compounds;
Nearly 10 years of quality experience in support of IND and NDA applications
Over 2 years exposure to regulatory decision making on the critical path utilizing genomics and micro-dosing; most work targeting the Oncology Division at FDA in tandem with FDA’s science division;
Extensive knowledge of ICH guidelines and FDA guidance documents as well as general familiarity with EMEA guidances, relevant to global pharmaceuticals;
Nearly 20 years experience liaising with FDA on the regulatory and CMC interactions for approvals of products in medical imaging products, endocrine and metabolism, pulmonary, blood products and pain management. 
Nearly 25 years of experience in the preparation of Chemistry, Manufacturing and Control Sections of Global Regulatory Dossiers (IND, NDA, BLA and MAA) as well as post-approval supplements (NDA and BLA) and variations (MM).


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