Advisory Board

The Pharma IQ advisory board consists of key thinkers and thought leaders in the Pharma space. These seasoned industry experts guide the topics on the Pharma IQ site in addition to frequently contributing content and media. These industry leaders were selected due to the caliber of their work within their respective areas of expertise.

 

About our Advisors

André Bourgouin

André Bourgouin is the Vice-President of Corporate Intellectual Property of Ipsen Pharma which he joined in 1996. He began his career in the Patent Department of Roussel Uclaf and then joined Pasteur Merieux Connaught (now Sanofi Pasteur) where he held the position of Director, Corporate Intellectual Property.

André holds a Doctorate degree in Organic Chemistry and studied law at the University of Paris (Licence en droit and DESS degrees). He graduated from the CEIPI and is a registered French and European patent attorney and a European Trade mark attorney.
 

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Stephen Brown

Stephen Brown is CTO and is in charge of Biomanufacturing activities for Vivalis, based in Nantes, Western France. Prior to that, Dr Brown was Director, Biological Process Development for Merial and before that, responsible for the GMP manufacturing site at Transgène, France. Dr Brown received his Ph.D. in Fermentation Technology from the University of Kent at Canterbury, UK and holds a B.Sc. in Microbiology from the University of Wales (University College Cardiff), UK.

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David Elder

David P. Elder has over 32 years experience in the pharmaceutical industry working for Sterling, Syntex, SmithKline Beecham and GlaxoSmithKline, where he has worked at various director level positions.  He is currently a director in the Externalization group (SCINOVO).

He obtained a BSc degree in Applied Chemistry in 1977 from Northumbria University, Newcastle upon Tyne, UK, an MSc in Analytical Chemistry investigating polymorphic transitions from the same institute in 1982.  He obtained a PhD in crystallography from Edinburgh University, UK in 1992.

He is a member of the BP-Committee PCY: Pharmacy. He is a committee member of the Joint Pharmaceutical Analysis Group (JPAG). He is a member of the Chartered Quality Institute, a fellow of the Royal Society of Chemistry (RSC), a Chartered Chemist, a Chartered Scientist, a Chartered Quality Professional and is a Qualified Person.

Dr Elder has lectured worldwide on a variety of topics including externalization and solid state chemistry.  He is a member of EfPIA and PhRMA genotoxic impurities interest groups. He has authored two book chapters and is in the process of authoring a further four book chapters. In addition he has presented more than 60 technical and review articles on a variety of subjects.  He has 7 patents to his name. 

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Ronaldo Galvão

Ronaldo Galvão is the Quality Operations Director -GPSG Brazil at Janssen-Cilag. A role he has held since 2007. Ronaldo's responsibilities include, providing leadership and direction for ANVISA issues for GPSG and J&J site, supporting new product launches in the Brazilian market, and providing leadership for BBC (Behavior Based Compliance) concept introduction to all employees.

 

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Michael Liebman

Michael N. Liebman, Ph.D. is the Managing Director of Strategic Medicine, Inc and also of Strategic Medicine, BV (the Hague, NL)  after serving as the Executive Director of the Windber Research Institute since November, 2003.  Previously, he was Director, Computational Biology and Biomedical Informatics at the University of Pennsylvania Cancer Center since September, 2000.  He served as Global Head of Computational Genomics at Roche Pharmaceuticals and Director, Bioinformatics and Pharmacogenomics at Wyeth Pharmaceuticals.  He was also Director of Genomics for Vysis, Inc and Director of Bioinformatics at the Amoco Technology Company.  He has served on the faculty of Mount Sinai School of Medicine in Pharmacology and Physiology/Biophysics.

He serves on 14 international scientific advisory boards, consults for 5 pharma/biotech companies, the economic development programs in the Philadelphia Life Sciences Sector and the State of Illinois Biotechnology Commission and is on the Board of Directors of the Nathaniel Adamczyk Foundation for Pediatric ARDS.  He is an Invited Professor at the Shanghai Center for Bioinformatics Technology and is currently on the Human Health and Medicinal Chemistry Commission of the IUPAC.  He received his PhD in protein crystallography and theoretical chemistry.  His research focuses on computational models of disease progression stressing risk detection, disease process and pathway modeling and analysis of lifestyle interactions and causal biomarker discovery and focuses on moving bedside problems into the research laboratory to improve patient care and their quality of life.  Recent activities also include computational approaches to drug safety and toxicology with specific emphasis on reducing animal testing.

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Melissa Mudrick

Melissa Mudrick, JD, is Director of Drug Safety and Risk Management at Biogen Idec.  In this capacity she is responsible for oversight of global compliance for Drug Safety, through management of corrective actions, auditing, oversight of training and documentation control, and fostering continuous quality improvement worldwide.

Melissa has over 8 years of experience in Drug Safety at Biogen Idec with experience in management of operations, oversight of CROs, establishing a CQI program for Drug Safety, and management of contracts and budget.  Melissa joined Biogen Idec in 2002, and has been Director, Drug Safety Quality since November 2009.  Prior to joining Biogen Idec Melissa has supported research in various roles at the Boston University Medical Campus and the Veterans Affairs Medical Center.

Melissa received her B.A. degree in Psychology from Dickinson College, Carlisle, Pennsylvania and her law degree at Suffolk University Law School in Boston, Massachusetts.  She is a member of both the New Hampshire and Massachusetts bar.

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Samantha O'Connor

Samantha O'Connor trained as a molecular biologist before joining the pharmaceutical industry in 1997, when she joined the Australian Pharmaceutical Manufacturers Association (APMA), now called Medicines Australia, the non-profit professional and trade association representing Australia's prescription pharmaceutical industry. Her role in APMA covered a broad range of project management activities in relation to the advancement of scientific, medical, regulatory and technical matters on behalf of the pharmaceutical industry.

Sam joined Pfizer in 1999 to lead Pfizer’s investment program of building collaborations with the Australian medical research community. She initiated, implemented and managed this A$30m program, sourcing investment opportunities that strategically aligned with the company's global research portfolio. During this time Sam also served as a Non-Executive Director on the National Board of Directors of AusBiotech, the non-profit association representing the Australian biotechnology industry.

Sam moved to Pfizer’s UK operations in 2003 to join the Worldwide Business Development team responsible for the protection, acquisition and divestiture of products, technologies and intellectual property. Over the years she has been responsible for planning, negotiating, implementing and managing many hundreds of partnerships across many therapeutic and technology areas, interacting with a range of stakeholders across academia, biotechnology and pharmaceutical companies, venture capitalists and policy makers.

Sam sits on Pfizer’s R&D Business Development Leadership Team and Pfizer’s Sandwich UK Site Leadership Team, and is currently completing her MBA.

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Tomas Skacel

Tomas Skacel is Medical Director at Amgen International. His past experience includes, International Medical Director at Amgen International, Zug Switzerland, Clinical Resarch Physician at Eli Lilly Regional Medical Ctr, Vienna, Austria, Product manager, Oncology at Eli Lilly Czech Republic and Physician at University Hospital Olomouc, Czech Republic.

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Beat Widler

Dr. Widler has a Ph.D. in Microbiology and has been in the Pharma industry since 1983, his experience covers Drug Regulatory Affairs and Clinical Science.  In 1993 he joined the QA department of Hoffmann-La Roche and in September 1997 was appointed International Head of QA.

Dr. Widler is a member in a variety of GCP working parties eg: EFPIA, IFPMA, DIA, EFGCP.

In 2008 Dr. Widler was appointed as a Member of Strategic Advisory Committee (SAC) of Empowerment with the WHO and as a DIA Board Director and chair of the Advisory Committee Europe for the term 2008 / 2009 and 2009 / 2010.

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Manuel Zahn

For almost 12 years, Dr. Zahn has been involved in International Conference for Harmonisation (ICH) Quality topics, starting as European pharmaceutical industry (EFPIA) topic leader ‘Stability’ in 1991. He has been a member of the ICH Expert Working Group developing the ICH Stability Guidelines until 2003. As EFPIA co-topic leader from 1997 to 2001, he contributed to the development of the ICH Common Technical Document (CTD) Guideline M4-Q.

From 2001 to 2005 Dr. Zahn represented the international pharmaceutical manufacturers (IFPMA) when the Association of the Southeast Asian Nations (ASEAN) Stability Guideline has been developed.

As a World Health Organization (WHO) Temporary Advisor, he has been involved in developing a regional stability guideline for the WHO Eastern Mediterranean Region as of 1993. A revised version of the guideline has been released in 2006. This document was then used as a draft for the new global WHO Stability Guideline released in 2009.

Dr. Zahn supported the innovative Process Analytical Technology / Real Time Release (PAT / RTR) concept in discussions with the EMEA Quality regulators and inspectors. He took over the regulatory lead for a PAT/RTR project in 2006, and managed the submission of the first pilot product for PAT/RTR using the pilot EU Worksharing Procedure, and achieved a positive decision in 2007.

Dr. Zahn is a member of the Steering Committee of the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group.

Over 30 papers in journals and textbooks have been published since 1978, and presentations delivered at many international conferences and training courses since 1988. Since 1998, Dr. Zahn is an active member of the Editorial Board of ”The Regulatory Affairs Journal – PHARMA”.

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