FINNBRIT CONSULTING AND LENK DESIGN - Key Persons

Job Titles:

• Member of the Excipient Monographs 2 Expert Committee of the United States' Pharmacopeia

Chris has wide experience in all phases of drug development, from preformulation through formulation design, development and scale-up, clinical trials supply and technical transfer for validation and commercial manufacture. He has authored and/or reviewed CMC reports to support Exploratory IND (human micro dosing), IND and NDA filings, and updates for development projects in the US, and equivalent filings in Europe, South East Asia and Australia, including most recently the Telbivudine (Tyzeka) NDA. Chris is familiar with intellectual property issues; both as an inventor and as an expert witness in patent litigation. He has undertaken due diligence investigations for potential in-licensing of products, and merger and acquisition of businesses, and is also familiar with due diligence from potential out-licensing partners. During his extensive career Chris has directly supervised staff, facilities and projects (up to 60 staff, in multiple locations and annual budgets of up to USD 20 million). He has also been involved with facilities design of both non-GMP laboratories and GMP clinical manufacturing units. He has extensive experience working with contract development organizations. Chris is a respected member of the pharmaceutical scientific community established through authored and editorial contributions to professional publications, invited presentations, and membership of several scientific organizations and committees. Chris is currently a member of the Excipient Monographs 2 Expert committee of the United States' Pharmacopeia (2005 to present). He is past Chair of IPEC-Americas (2003 - 2004); past Chair of the AAPS Excipients Focus Group (2005 - 2007), IPEC-Americas representative to the Drug Product Technical Committee of PQRI (1996 - 2007), and the Development Technical Committee (2007 - present). He is also currently a Member of the Board of IPEA (2005-present) and on the Board of the IPEC Foundation.