Anne Busser

Manage CMC dossiers preparation activities for all French projects (new chemical entities and biotech products), with three teams located in Montpellier, Chilly-Mazarin and Vitry-sur-Seine, representing 14 associates.
Ensure highest quality, timely availability and scientific consistency of CMC dossiers prepared by local teams for clinical trials requests and Marketing Authorization Application including responses to questions raised by agencies.
Approve all CMC dossiers intended for Phase I, II and III clinical trials.
Manage, develop and coach local CMC dossier managers. Coordinate resources and set priorities within region. Share lessons learned and recommend best practices for implementation. Continue to lead working group on definition of format and content of CMC dossiers for INDs/IMPDs and CTDs. Contribute to organization of corresponding training sessions. Implement e-CTD for upcoming submissions.
The portfolio of projects in France includes several e-CTDs for global submission in 2008-2009.

Main achievements:
Managed CMC dossiers preparation activities for Paris and US regions, with four teams located in Bridgewater, NJ (USA), Malvern, PA (USA), Chilly-Mazarin and Vitry-sur-Seine.
144 dossiers and 46 responses to questions were prepared in 2006 in the US/Paris region.
Approved all CMC dossiers intended for Phase I clinical trials.

Head of Analytical Sciences Department Documentation Paris
Managed a team in charge of writing of analytical part of CMC dossiers, management in the Documentation Management System of scientific departmental documentation (monographs, development reports), management of Standard Operating Procedures and departmental archives.

Main achievements:
Managed a team of 32 scientists, technicians to managers, in charge of physico-chemical analysis of development projects: development and validation of analytical procedures, study of physico-chemical characteristics, stability and degradation pathways, release testing of batches of drug substance and drug product for clinical studies (solid oral dosage forms, pediatric suspensions, injectables).
Supervised managers, defined analytical development plans for ongoing projects, ensured high scientific standards, defined training plans for associates, defined capital investments needs.

Main achievements:
Recruited, trained and managed a team of 4 senior research scientists.
Prepared CMC documentation for new chemical entities and biotech products: provided technical/regulatory expertise, ensured high quality, consistency and regulatory compliance for CMC documentation., conducted their review, compiled, and published the CMC dossier for global submissions, wrote the Quality Overall Summaries for CTD submissions (solid oral dosage forms, aerosols, suspensions and injectables). Participated to meetings with the Food and Drug Administration for IND, End-of-Phase 2 and pre-NDA.
Coordinated, for Bridgewater Global Pharmaceutical Development, the development, validation and implementation of the electronic document management system GRESDA, including global harmonization of more than 100 CMC templates for GMP and submission documents.

Main achievements:
Coordinated analytical documentation issued by Process Chemistry: Developed and maintained quality systems, insured compliance of documents with respect to quality/regulatory standards, participated to the writing/compiling of regulatory dossiers, contributed to the preparation of inspections.
One of the leaders in the design and implementation of Documentation Management System (a Documentum™ based project) in Chemical and Pharmaceutical Development.
Coordinated pilot plants occupancy, projects activities, budget and resources for the Global Process Chemistry management team.

Main achievements:
Managed a team of 2 scientists and 2 associate research scientists. Analytical package for INDs and CTXs: Developed and validated Starting Materials, Key Intermediates and Drug Substances methods, elucidated impurity profiles and degradation pathways. Provided analytical support to chemists, developed In-Process Controls methods.
Leader of « DMS/Analytical Methods Task-Force »: created more than 50 harmonized Word templates for the writing of analytical methods, validation reports, impurities reports and physico-chemical properties.

Main achievements:
Managed a team of 1 to 4 scientists. Developed and validated drug substance methods for TaxotereTM; analytical package, elucidated impurity profile and degradation pathway, wrote the CMC documentation for MAA, NDA and Japanese NDA, answered to questions from Regulatory Authorities (Europe, USA, Australia, Japan...), participated to Pre-Approval Inspection with FDA in Vitry-sur-Seine.