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Marketing Applications (NDAs/MAAs/NDSs)
1. Successful FDA filing/approval of the NDA for Edluar (sublingual Ambien). Led and managed all project activities/managed a team of 26+ professionals including data management/eCTD, etc. (Sept., 2008 to March, 2009)
2. Successful completion of CMC activities leading to FDA filing of NDA for an oncology/orphan drug product (sterile/semi-synthetic). Led all technical/regulatory activities including oversight of several CMOs and provided strategic direction and implementation of improved GMP compliance (May, 2009)
3. Successful completion of CMC activities leading to FDA filing of NDA for an oncology/opiod pain management product. Led all technical/regulatory activities including oversight of several CMOs with complicated contractural obligations and other service providers (July, 2009)
4. Successful completion and filing of the NDA for a CNS/MDD extended release product. Led all regulatory activities including managing project activities with numerous CRO/CMOs and other service providers (May, 2007)
5. Led regulatory activities leading to successful filing and approval of an in-licensed injectable anti-fungal drug. This contributed significantly to the financial value of the company resulting in its acquisition for about 2 billion US dollars (2002-2007)
6. Approval of NDA for oncology compounds. Made significant contributions to the chemistry, manufacturing and controls aspects of the NDA leading to its approval in global markets (2003)
7. Approval of NDA for a pain management drug. Made significant contributions to the chemistry, manufacturing/controls and regulatory aspects of the NDA leading to its US approval (2005/2006)
8. Approval of NDA/MAA/NDS for a cholesterol-lowering drug. Led the chemistry, manufacturing/controls and regulatory aspects of the
NDA leading to its approval in the US/EU/Canada (2005/2006)
9. Global Regulatory Agency Inspections – Led inspection activities for approval of over 24 clinical/manufacturing and laboratories (GLP/GCP & GMP) to support product approvals in global markets (2002-2008)
Global Strategic Regulatory Meetings, Negotiations/Development Submissions
• Led the successful completion of 39+ major strategic FDA/Canadian/EMEA meetings for over 31 products in all phases of development covering 8 therapeutic areas (March, 2002 –July, 2009)
• Obtained IND Exemption for an oncology device/combination product
for a University/Ethics Committee (2005/2006)
• Obtained FDA approval for designation of a drug/device combination product to be led by CDRH (2005)
• Received excellent recognition from FDA (CDER - Division of Neurologic/Psychiatric products) for strategic agency meeting preparation
• Averted/or resolved various issues related to clinical hold for numerous products in clinical trials
• Successful preparation of over 55 submissions (IND/CTA/IDE, etc.) for timely initiation of clinical/preclinical studies in 30+ countries
• Successful preparation of over 28 DMF/CEP submissions for numerous active ingredients (human/veterinary use) in 28+ countries
Post-Approval Product Recalls/Life-Cycle/Supply Chain Management
• Led and averted recall by the Canadian Agency (TPD) of a major NSAID. This included identifying all deficiencies and oversight of various PK/PD, manufacturing and regulatory activities (2007/2008)
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Pro-actively led strategic efforts for preventing facility/CRO compliance issues
and supported maintenance of products in global markets (2002-2008)
Major Professional Drug Development Training
• US National Institute Health (NIH, Divisions of Allergy/Immunology & Infectious Diseases) – Training in the Requirements, Processes & Implementation of the EU Clinical Trials Directive (2005/2006)
• Endo Pharmaceuticals, Inc. – Training in development of Prescription drugs (2005/2006)
• Elan Pharmaceuticals, Inc. – Training in Drug Development & Quality Systems (2005/2006)
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