PROJECT EXPERIENCE
FDA meeting and IND submission
- Write and prepare the letter and the list of questions to request a pre-IND meeting with the FDA
- Write and prepare pre-IND Package
- Attend ≈20 FDA meeting (i.e pre-IND meeting and Type C meeting) as a coordinator or scribe depending on the need from the Sponsor
- Write and prepare the IND in a eCTD format (modules 1, 2, 3, 4 and 5)
- Submit IND electronically
- Maintenance of IND as amendment and annual report
Product and therapeutic area
- Two (2) HIV viral vector vaccine and one investigational vaccine with the Division of Vaccines and Related Products Applications (CBER)
- One (1) rotavirus vaccine exUS development (Australia and South Africa))
- One (1) antibacterial vaccine (CBER)
- Eight (8) stem cell products with the Office of Cellular, Tissue and Gene Therapies (CBER)
- Three (3) investigational products with the Division of Cardiovascular and Renal Products
- Three (3) investigational products with the Division of Dermatology and Dental Products including one dermatological/cancer investigational product
- One (1) investigational products with the Division of Gastroenterology and Inborn Errors Products
- Two (2) investigational products (one biosimilar and one small molecule) with the Division of Pulmonary, Allergy and Rheumatology Products
- One (1) investigational product with the Division of Bone, Reproductive and Urologic Products
- Two (2) investigational products with the Division of Hematology Products
- Three (3) combination product for neuro/oncology products
- Three (3) investigational product with the Division of Neurology Products
Pre-NDA meeting and information package submission
- Write and prepare the letter and the list of questions to request a pre-NDA meeting:
- FDA Division of Anesthesia, Analgesia, and Addiction Products
- FDA Division of Division of Gastroenterology and Inborn Errors Products
- FDA Division of Pulmonary, Allergy and Rheumatology Products
- FDA Division of Vaccines and Related Products Applications (CBER)
- Write and prepare pre-NDA Package
Orphan designation Application
- Write and prepare the orphan designation application
- Write and prepare orphan grant application
Product and therapeutic area
- One stem cell product
- Two (2) cardiovascular investigational product
- One dermatological investigational product
- One small molecule GI tract
- One for DMD indication
- One for ALS indication
- One for combination product for oncology product
- Two (2) for pancreatic cancer
- One for narcolepsy
Clinical Investigator’s brochure
- Write and prepare/update IB from nonclinical and clinical study reports
Product and therapeutic area
- One HIV viral vector vaccine
- One Rotavirus Vaccine
- One stem cell product
- Two dermatological investigational products
- One dermatological/cancer investigational product
Clinical protocol
- Write and prepare a draft clinical protocol to be edited by the principal investigator
Product and therapeutic area
- One dermatological investigational product
- One Rotavirus product
BLA, NDA and ANDA submission
- Write and Prepare two NDA 505(b)(2) pathway for opioid product and injectable product
- Write and prepare NDA 505(b)(2) pathway (Module 3 and Module 2 QOS) for a combination product (pump and product)
- Write and prepare a BLA modules 2 and 3 for a blood product
- Write and prepare a BLA modules 2 and 3 for a stem cell product
- Write and prepare Module 3 for a BLA application from batch records and SOPs and Module 2 for two conjugate vaccines, submission through mutual recognition and centralised procedure in Europe and US and follow-up
- Write and preparation Modules 2, 3 and 4 of a CTD for an Hepatitis B vaccine
- Write and prepare Module 3 and Module 2 for a 505(b)(2) NDA for a opioid product
- Write and prepare 505(b)(2) NDA modules 1, 2, 3, 4 and 5 for a combination device-drug (reformulation of an existing product) – and submit electronically
- Prepare four (4) 505(b)(j) ANDA modules 1, 2, 3 and 5 and submit electronically
- Preparation of 8 DMFs for conjugate vaccine products and silver API
BLA, NDA and ANDA Post Approval submission/CRL Responses
- Assist in the preparation of 3 Complete Response Letters (CRL)
- Use several amendments to update a BLA NDA modules 2 and 3 for several vaccine products (Flu-type)
- Convert and update Module 2 and Module 3 for 4 antibiotic products
- Convert a PreApproval Supplement into a Type 2 Variation for European submission for a vaccine product
DMF submission
- Review and submit electronically 5 DMF for a European API facility
- Review and submit electronically 3 DMF for an Argentinian API facility
- Assist in FDA inspection
- Prepare and submit electronically Drug Establishment Registration and Self Identification
- Maintenance of all DMFs
Electronic Submission
- All IND and NDA/BLA were prepared for electronic submission
- Lorentz Software for publishing
- Submission via the FDA Gateway Portal
Regulatory Compliance
- Evaluation of the process validation for a monoclonal antibody with emphasis on leachables and extractables.
- Preparation of SOPs, Batch Records and technology transfer to GMP manufacturer for a viral vaccine delivery system.
- Audits of research laboratories (GLP oriented) for IND purposes and preparation of manufacturing plant (GMP oriented) for FDA pre-approval inspection.
- Review all CAPA for all vaccine products for a Big Pharma
PROFESSIONAL EXPERIENCE
2000-present Industry Consultant
Denver, CO, USA
1998-2000 Regulatory Affairs Associate
1996-1998 Senior Regulatory Affairs Executive
VALORUM Inc, Research Triangle Park, NC, USA
Regulatory Affairs Manager
PHARMAKOPIUS INTERNATIONAL Ltd - READING, UK
1995-1996 Regulatory Affairs Consultant
EUROPEAN REGULATORY AFFAIRS - READING, UK
1994-1995 Project Manager Assistant
APPLIED MICROBIOLOGY, Inc - NEW YORK, USA
1992-1994 Post-Doctoral Scientist
REGENERON, Inc - NEW YORK, USA
1987-1992 PhD Program (Mr le Professeur J Cros)
LABORATOIRE DE PHARMACOLOGIE ET TOXICOLOGIE FONDAMENTALES - TOULOUSE, FRANCE
1986-1988 Master of Science
SANOFI RECHERCHE - LIGNES PEPTIDES - TOULOUSE, FRANCE
EDUCATION
- PhD Program - Option Cell Biology and Biochemistry
Supervisor: Dr M Webber
Purification and characterisation of two cholinergic differentiation factors. Laboratoire de Pharmacologie et Toxicologie Fondamentales - Toulouse, France
- Master of NeuroSciences and Behavioural Studies
Study of neurodegenerative diseases of both central and peripheral nervous systems. Université Paul Sabatier - Toulouse, France
LANGUAGES
English - fluent
French - fluen