Description
Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetings with these authorities in rapid succession to discuss our preferred regulatory strategy approach and push the scientific arguments to abbreviate the need for extensive Phase 3 study requirements * Set up with my Clinical Trial Manager and a CRO to execute Phase 1 trial logistics in Thailand * Strategized and assembled a proposed risk-based Phase 2 trial and accelerated approach strategy * Developed a GXP Quality/Compliance (Quality System) and a Supply Chain Management System suitable with many CRO and CMO partners and vendors * Developed a Project Planning System * Developed a Business Plan integrating an innovative development program with an aggressive R&D plan to generate promising new molecules in a virtual financial setting Principal and Senior Director, Global Regulatory Consulting, Catalent Pharma Solutions, Somerset, NJ (2012 - 2013) Provided expert, senior-level, worldwide regulatory and GXP compliance services to external and internal Catalent clients. Worked closely with Catalent CMO business units, Business Development, Sales and Marketing, and Operations teams to develop proposals, sell work, communicate, and execute regulatory capabilities to internal and external clients to meet corporate growth goals and objectives. Of particular note, developed a quality, compliance and regulatory Quality System for incorporation of a drug-device combination product into an existing Catalent drug manufacturing facility. Lead Regulatory Advisor - Endo Implant Technology R&D, Cranbury, NJ 2011 - 2012 Developed and established a regulatory pathway for a drug-device combination product (determined to be filed with CDER with CDRH advisory input) for various oncology and CNS API's encapsulated within proprietary coated beads and precision manufactured within a tool-like device for implantation under the skin to achieve steady-state drug delivery. Vice President Global Regulatory Affairs, Anthera Pharmaceuticals, Inc., Hayward, CA (2011) * Led a group of 4 employees in a 18-person firm * Participated in Senior Leadership strategy and business execution * A-002 (Investigational CV drug): Successfully prosecuted Special Protocol Assessment (SPA) with FDA to accelerate development with one Phase 3 trial. Pursued Orphan Drug status with FDA. * A-623 (Investigational Biologic Lupus drug): Successfully handled the IND through Phase 1 into Phase 2. Accomplished a complex analytical comparability filing with major CMC changes that simplified operations, vendors, and saved the firm significant cash. * Left Anthera in California to return to NJ for family reasons in 2011. Senior Director Regulatory, Drug Development, Quality & Compliance Practice: The Weinberg Group Quintiles Independent Consulting (1998 - 2011 Provided a wide range of consulting services to almost 100 clients as a Senior Director at The Weinberg Group, as a Principal Consultant at Quintiles, and as an independent Principal. Directly handled: . Drug Development R&D Pharmaceuticals and Biotechnology Risk/Benefit Assessments . CMC Regulatory Affairs Pre - IND through Post-Marketing . FDA Liaison Applications: Pre - IND through Post-Marketing Fast Track Submissions . NME, Generic and 505 (b) (2) Products Combination Products . GXP Quality Systems (Materials Management Incoming Supplier Quality Supply Chain Management QA/Investigations CAPA Regulatory Compliance Batch Records Document Control Manufacturing Quality QC Validation Change Control Supplier Quality Agreements Clinical and Preclinical GCP/GLP) . Due Diligence Technology Transfer Alliance/Portfolio Management Business Plans . Methods Development Validation Analytical Comparability Plans/Protocols . Technical Writing and Public Speaking . Management of Team Members Matrix Environment Support Project/Program Budgets Selection of Vendors and Contractors Vice President Regulatory Affairs & Compliance, Elan Pharmaceuticals and Athena Neurosciences, South San Francisco, CA (1996 - 1998 Joined Athena Neurosciences during the merger with Elan in 7/96. Responsible Head for all (Clinical, Preclinical, CMC, Project Teams, Labeling, DDMAC (now OPDP), PAI, Due Diligence) regulatory and compliance activities with FDA for cutting-edge pharmaceutical and biotechnology products in the neurological therapeutic area for Athena-derived products within the Elan organization. Obtained approvals for Diastat 505 (b) (2) and Zanaflex NDA's/ sNDA's with CDER. Filed IND's for Tysabri (natalizumab) and MyoBloc (Botulinum B product) with CBER. Prepared initial IND regulatory plan for bapineuzamab. Key participant in the successful FDA Advisory Committee meeting for Diastat 505 (b) (2). Director of Regulatory Affairs & Compliance for Biopharmaceutical Products, Taught courses in Chemistry at Drexel University and seminars in Regulatory Affairs Quality and Organizational Topics at The University of Pennsylvania and The University of California Santa Cruz Extension.
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