Dr. Michelle Herrera Foster is Principal of CTD Quality Consulting and an independent regulatory affairs consultant with over 20 years experience in the pharmaceutical industry. This includes over 15 years experience in regulatory affairs in all phases of drug development, from pre- clinical to post-marketing, with biologics and drugs. With a Ph.D. in analytical chemistry, her expertise has been in the Chemistry, Manufacturing, and Controls (CMC) area.

Dr. Foster has prepared numerous CMC and CTD submission documents for global investigational and marketing applications for major pharmaceutical companies and smaller firms. She was co-instructor and director for two years for a course on the CTD/eCTD through the Center for Professional Innovation and Education and offers customized in-house training programs on preparing CTD/eCTD submissions. She was co-instructor for 2 years of the course on Chemistry, Manufacturing, and Controls in New Drug Applications - Details on the Common Technical Document (CTD) offered through the Center for Professional Advancement and has lectured internationally on CTD Quality submissions at major conferences.

In her five years with Biogen, Inc. Dr. Foster managed the preparation of the BLA for Avonex® (interferon beta-1a) and regulatory strategy and submission preparation for clinical development programs for biologics. Previous to that, she was in drug regulatory affairs with DuPont/Bristol Myers Squibb for five years. She is former Director of Regulatory Affairs with Ground Zero Pharmaceuticals, Inc. and has had long-term contracts with Wyeth Biopharma, Schering Plough, Millenium, Genzyme, Abbott Vascular, Boehringer Ingelheim, and numerous small to mid-size firms.

Dr. Foster specializes in assisting her clients in adopting an efficient and thorough approach to preparing regulatory submissions using the project team approach, mapping, and gap analysis to identify complete information needed for the submission, prepare a working plan, and resolve issues early to avoid regulatory delays. She developed the SMART approach for preparing submission-ready documents throughout clinical development.

Submission Experience:

• Managed overall preparation of INDs, NDAs, pre-IND, and pre-NDA meetings with various clients, including gap analysis and Mapping to the CTD, customization of CTD/eCTD templates, and preparation of submission-ready reports. – See list of companies below plus several smaller companies that prefer not to be listed. Regulatory lead for several NDAs, SNDAs, and INDs

• Managed CMC strategy and performed third-party reviews for numerous original IND, NDA, PMA (drug-device), BLA, ANDA, MAA, and post-marketing applications – Biogen,Wyeth, Schering Plough, Genzyme, Boehringer-Ingelheim, Boston Scientific, Abbot Vascular, Millenium, Acusphere , Dyax, Shire

• Converted MAA and NDA documents to CTD format. – Genzyme, Schering Plough, Therion Biologics

• Prepared Pharmaceutical Development CTD sections for non-standard processes – Genzyme, Schering Plough, Acusphere, Wyeth, Abbot Vascular

• Genzyme and Boehringer-Ingelheim: CMC Regulatory Affairs consultant on several projects

• Wyeth Biopharma: In a two-year contract, created CTD templates, used for some of the first INDs and CTAs submitted in the CTD format. Prepared Enbrel® marketing applications in Europe

• Boston Scientific: Led submission sub-team to prepare their first CTD for their first drug application, in an expedited timeline

• As a sub-contractor to McCulley-Cuppan, prepared CTD model documents for regulatory submissions for Schering Plough, and reviewed multiple clinical and CMC documents from major international pharmaceutical companies for writing quality

• Biogen: Led registration team for Avonex®, meeting the timeline set by the team 9 months before. Managed preparation of advisory committee meeting

• Biogen: Project Team regulatory representative for Amevive® development; prepared INDs and regulatory plan

• DuPont Merck: Regulatory team member for I.V. Persantine® co-marketed with Boehringer Ingelheim, worked on international submissions for all products, collaborating with affiliates/partners

• Managed third-party contractor submission preparations for several clients, with integrated submission processes

Teaching Experience:

• The Center for Professional Innovation and Education: Director for the course on "The CTD/eCTD: Building the Marketing Application Throughout Clinical Development", 2007-2008

• The Center for Professional Advancement: Co-instructor for the course on "Chemistry, Manufacturing, and Controls in the CTD format", 2004-2006

• Massachusetts College of Pharmacy lecturer on CTD course, 2007-2008

• Developed and presented customized courses on CMC submissions in the CTD/eCTD format for:

  • INDs, NDAs, BLAs, ANDAs, MAAs, DMFs, pre-IND and pre-NDA meeting packages

  • Small molecules, biotech, drug-device, non-standard formulations

  • Large and small companies (including Genzyme, Alkermes, Talecris, Abbot Vascular, Acusphere, and several smaller companies), and , kick-off meetings, CMOs, Japanese company (20-day intensive training), Korean course

• Training and presentations on Transitioning to the eCTD

Recent Presentations/Publications:

"Efficient Preparation of eCTD Documents for Chemistry, Manufacturing, and Controls” – DIA eCTD meeting 11/09 in San Diego

“Authoring eCTD Submissions” session host and presenter of “eCTD Case Studies – Chemistry, Manufacturing, and Controls” - DIA Annual Meeting 6/09

“Authoring and Managing eCTD CMC Documents” – DIA Electronic Document Management Conference, 2/09; Also delivered the CMC domain presentation for the DIA EDM Reference Model Project launched at the conference

“Authoring and Managing eCTD CMC Documents” – DIA Electronic Document Management Conference, 2/09; Also delivered the CMC domain presentation for the DIA EDM Reference Model Project launched at the conference

“Updates on CTD Submission-Ready Documents and Summaries” - Hosted session at DIA annual meeting 6/08

“Planning CTD/eCTD Submissions”, presented and hosted panel discussion for ISPE's meeting 1/08.

“Preparing Submission-Ready Documents”, American Chemical Society's The Nucleus, December 2007

“CTD Documents as Key Reviewer Tools”, presentation at Madrid 10/07 Drug Information Association (DIA) Clinical Trials meeting. (Click Here to view presentation)

Regulatory Affairs Professional Society’s (RAPS) Roundtable Sessions on Preparing CMC Submissions, annual meetings 2006 and 2007

“CTD Summaries as Key Reviewer Tools”, hosted session at DIA annual meeting 6/07 (Click Here to view presentation).

“Preparing CTD Submission-Ready Documents from IND to NDA”, hosted session at DIA annual meeting, 6/21/06. (Click Here to view presentation)

“Advantages of Preparing Submissions Electronically”, Hosted The Boston RAPS chapter presentation and panel discussion, 6/9/05 (Click Here to view presentation)

“The Chemist’s Contributions to the CTD and e-CTD: Regulatory Knowledge and Process are Keys to Success”, American Chemical Society’s The Nucleus, January 2004 (Click Here to view or print PDF document)

“Converting Your CMC Submissions to the CTD Quality Format”, DIA’s conference on Practical Implementation of the Common Technical Document (CTD) and the eCTD, 12/8/03 (www.diahome.org) (Click Here to view presentation)

“Transitioning to the CTD: Tips for Preparing Quality Submissions”, RAPS Annual Conference Sunrise Poster Session 10/22/03 (www.raps.org)

Massachusetts Biotechnology Council (MBC): Hosted conference on "Electronic Submissions", representative at DIA meetings - 1999

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