PLLC

A. Leander Fontaine, MD
Principal Consultant, Pharmiceutics LLC

Areas of Special Expertise:

US and EU labeling (content, regulatory aspects, format)
Global labeling, safety labeling harmonization
Development labeling (incl. development core safety information)
Global labeling life-cycle management, core labeling, labeling harmonization
Regulatory/labeling issue management, directing labeling negotiations with regulatory authorities worldwide
Design of global regulatory / labeling systems, organizations and technology

Brief Curriculum Vitae:

DEGREES

1979: Medical degree (physician), Saarland University, Germany
1985: Doctoral degree (Dr. med.), University of Ulm, Germany
1988: Certification in anesthesiology, Germany

CLINICAL EXPERIENCE

1980-1983 Internal medicine, German Army Hospital Ulm, Germany
1983-1988 Anesthesiology, intensive care and emergency medicine, University Hospital Ulm, Germany

PHARMACEUTICAL INDUSTRY EXPERIENCE

1988-1990: Clinical Project Manager Behringwerke, Germany
1990-1991: Head Clinical Pharmacology and Blood Donation Units, Behringwerke, Germany
1991-1993: Head of International Master Data Sheet Group, Hoechst Pharma, Germany
1993-1996: Head of Corporate Product Information, Hoechst Pharma, Germany
1996-1999: Head of Global Regulatory Medical Information, Hoechst Marion Roussel, USA
1999-2003: Vice President and Head of Global Labeling Division, Wyeth, USA
2003-2005: Vice President, International Labeling Liaison, Wyeth, USA
2005-present: President and principal consultant, Pharmiceutics LLC, USA

WORKING GROUPS AND SPECIAL PROJECTS (selection)

1998-2002: Working group on international labeling policy, International Pharmaceutical Federation (FIP)
2003-present: Founding member of the Labeling, Packaging and Promotion working group of the DIA Regulatory Affairs SIAC
2004-present: Member of the PhRMA / HL7 Task Group on Structured Product Labeling
2005: Member of MSSO Blue Ribbon Panel on the use of MedDRA in labeling
2005: Institute of Medicine, ADE reporting workshop. Subject matter expert invited to propose improvements to US safety labeling.

Conferences, Seminars

Frequent faculty member and chairperson at pharmaceutical conferences and seminars, covering the full range of global, US and EU medical labeling topics, including core labeling and labeling harmonization, US and EU labeling, developmental labeling, safety labeling decision making, labeling and risk management, emerging labeling trends.

Publications

Selection of labeling-related publications:

A. L. Fontaine. Current requirements and Emerging Trends for Labelling as a Tool for Communicating Pharmacovigilance Findings. Drug Safety; 27 (8): 579-589, 2004
B. Hardy, P. Elkin, J. Averback, A. L. Fontaine, S. Kahn. Building the Drug Safety Body of Knowledge to Enhance Confidence in Safety EyeForPharma, Oct 12, 2005. Available at URL: http://www.eyeforpharma.com/index.asp?news=48216

Awards

June 2007: DIA Outstanding Service Award

Recent and upcoming public presentations:

November 2008: Pharmiceutics - Company Core Data Sheets and Core Safety Information, Seminar - Philadelphia PA; Instructor
September 2008: Pharmiceutics - US Prescribing Information with Highlights & US Safety Labeling, Seminar, Philadelphia PA, Instructor
July 2008: PERI - Regulatory Review of Prescription Drug Labeling - Baltimore Topic: Criteria for including adverse reactions in Core Data Sheets, illustrating ADR frequency
June 2008: DIA - Annual Meeting - Boston Topic: Essential features of, and use of XML in, IT applications that support core labeling request management, decision documentation and implementation tracking (presentation)
June 2008: Pharmiceutics - Company Core Data Sheets and Core Safety Information, Seminar - Philadelphia PA; Instructor
March 2008: Pharmiceutics - US Prescribing Information with Highlights & US Safety Labeling, Seminar, Philadelphia PA, Instructor
Feb 2008: Pharmiceutics - Company Core Data Sheets and Core Safety Information, Seminar - Philadelphia PA; Instructor
Jan 2008: 7th Annual Conference on Contemporary Pharmacovigilance and Risk Management Strategies - Washington DC Topic: New developments in safety labeling
Sep 2007: Pharmiceutics - Global Labeling System Design and Evaluation, Workshop - Philadelphia PA; Instructor
Jul 2007: Pharmiceutics - Company Core Data Sheets and Core Safety Information, Workshop - Philadelphia PA; Instructor
Jun 2007: DIA - Annual Meeting - Atlanta Topic: SPL Indexing Elements (presentation and session chair)
June 2007: Pharmiceutics - US Safety Labeling Workshop - Philadelphia PA; Instructor
May 2007: DIA - SPL Indexing conference - Washington DC - Conference co-chair and presentation on lessons learned from indexing elements of the Highlights section
Mar 2007: PERI - Regulatory Review of Prescription Drug Labeling: The US, Canada & Europe - Baltimore Topic: Principles of safety labeling
Mar 2007: ViB - Pharmacovigilance & Risk Management - Philadelphia Topic: Safety labeling for clinical decision support
Mar 2007: Pharmiceutics - Core Labeling Practices Workshop - King of Prussia PA; Instructor
Feb 2007: Pharmiceutics - US Safety Labeling Workshop - King of Prussia PA; Instructor
Jan 2007: 6th Annual Conference on Contemporary Pharmacovigilance and Risk Management Strategies - Washington DC Topic: New developments in safety labeling
Dec 2006: Marcus Evans - Evolving Language of Electronic Labeling - Washington DC - Conference chair
Nov 2006: Quadrant e-Labeling - Highlights Data Elements Workshop - King of Prussia PA; Co-Instructor
Oct 2006: Pharmiceutics - Core Labeling Practices Workshop - King of Prussia PA; Instructor
Oct 2006: Quadrant e-Labeling - Highlights Data Elements Workshop - King of Prussia PA; Co-Instructor
Sep 2006: DIA - Conference: Global Electronic Labeling - Philadelphia; Session Chair
Sep 2006: Pharmiceutics - US Safety Labeling Workshop - King of Prussia PA; Instructor
July 2006: CSW XML Summer School, Wadham College - University of Oxford Chair of 'XML for Drug Information' track Lectures about design principles for global labeling systems and safety knowledge bases (beyond XML Core Data Sheets)
Jun 2006: DIA - Annual Meeting - Philadelphia Topic: Use of MedDRA in labeling
Jun 2006: Pharmiceutics - Core Labeling Practices Workshop - Clinton NJ; Instructor
May 2006: PERI - Regulatory Review of Prescription Drug Labeling - Baltimore Topic: Criteria for including adverse reactions in Core Data Sheets, illustrating ADR frequency
Mar 2006: Quadrant e-Labeling Workshop - Understanding the SPL Standard / SPL Quality Assurance - Clinton NJ; Co-Instructor
Feb 2006: Pharmiceutics - Core Labeling Practices Workshop - Clinton NJ; Instructor
Jan 2006: DIA - 5th Contemporary Pharmacovigilance and Risk Management Strategies - Washington DC Topic: Update on safety labeling initiatives
Nov 2005: Eyeforpharma - Conference: Drug Safety for Marketed Products - Amsterdam Topic: Terminology issues in communicating risk information
Nov 2005: IIR - Structured Product Labeling conference - Philadelphia Topics: Status of SPL initiative - Writing structurable labeling - Acceptable differences between SPL and FPL
Nov 2005: InnovationWell - Conference: Knowledge-based Innovation in Life Science Product Development - Basel, Switzerland Topic: Terminology issues in communicating risk information
Nov 2005: Institute of Medicine - Workshop: The Role of Consumers and Healthcare Professionals in Adverse Drug Event Reporting - Key Challenges and Opportunities - Washington DS Topic: Proposals for improving US safety labeling
Sep 2005: Barnett - SPL conference - Philadelphia Co-instructor of "Structuring Safety Labeling Content in SPL" workshop
Sep 2005: Pharmiceutics - Core Labeling Practices Workshop - Clinton NJ; Instructor
Aug 2005: DIA - Structured Product Labeling Conference - Co-chair; presentation topics: Acceptable differences between SPL and FPL - Semantic segmentation Jun
2005: Pharmiceutics - Core Labeling Practices Workshop - Clinton NJ; Instructor
May 2005: PERI - Regulatory Review of Prescription Drug Labeling: The United States, Canada and the European Union - Baltimore Topic: Impact of new/draft US, Canadian and EU guidelines on drug development activities
Jan 2005: DIA - 4th Contemporary Pharmacovigilance and Risk Management Strategies - Washington DC Topic: Update on safety labeling initiatives