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MARK STEVEN SHAEFER ViiV Healthcare Five Moore Drive Research Triangle Park, NC 27709 E-Mail: [email protected] (919) 483-4418 (Work) (919) 270-8520 (Cell) EDUCATION: July 1985- University of Nebraska June 1986 Medical Center Clinical Pharmacy Residency September 1981- University of California Pharm.D. June 1985 School of Pharmacy San Francisco, California September 1975- University of California B.A. June 1979 San Diego, California (Biology) EMPLOYMENT: January 2016 Global Medical Lead, Cabotegravir and Present Mature Products Responsible for global medical strategy for launch readiness for cabotegravir which includes collecting medical and payer feedback for development and eventual launch of the first injectable two drug long acting antiretroviral treatment and single drug pre- exposure HIV prophylaxis. Provide medical leadership and guidance over the mature antiretroviral portfolio. November 2014 Global Medical Lead, Cabotegravir January 2016 Acting Head, North American Medical Affairs Responsible for global medical strategy for launch readiness for cabotegravir which includes collecting medical and payer feedback for development and eventual launch of the first injectable two drug long acting antiretroviral treatment and single drug pre- exposure HIV prophylaxis. I have also continued responsibilities as Head of North American Medical Affairs until a suitable replacement is hired. November 2009 Head, North American Medical Affairs November 2014 ViiV Healthcare A member of the initial group to form ViiV Healthcare, an HIV focused company, from the portfolios of GSK and Pfizer. As one of three Medical Affairs Heads responsibilities include activities related to all medical affairs functions in Canada, Puerto Rico and the US. Activities include lifecycle management of the marketed portfolio, management of the Regional Medical Scientist staff, member of the North American and Medical Leadership Teams and risk management and control boards, and provide input to Mark S. Shaefer Page 2 strategy and development of the investigational HIV portfolio. From November 2011 through July 2012 took on added interim responsibility for medical affairs function in Mexico, Central and South America. Since the formation of ViiV have helped to develop and launch Tivicay and Triumeq for the treatment of HIV. March 2006- Group Director, HIV November 2009 Infectious Disease Medicine Development Center GlaxoSmithKline May 2005- Acting Vice President, HIV February 2006 Infectious Disease Medicine Development Center GlaxoSmithKline Responsible for the post-marketing portfolio which includes oversight of the IIIB/IV program, collaborative studies and the CHORUS observational database. Therapeutic lead for the US HIV program, co-chair of the US Commercial Strategy team and therapeutic area representative to the North American Medical Executive team. July 2002- Group Director, HIV May 2005 Infectious Disease Medicine Development Center GlaxoSmithKline Responsible for Phase IIIB/IV strategy and late stage clinical trial programs for the HIV Portfolio. Provided support for US HIV Specialty division of Marketing and Sales including launch of Lexiva and Epzicom. October 2001- Senior Director, Clinical Development July 2002 North American Medical Affairs, HIV GlaxoSmithKline Transitioned management of HIV group to Vice President. Assumed responsibility for management of global and regional nucleoside development groups. October 2000- Acting Vice President, Clinical Development September 2001 North American Medical Affairs, HIV GlaxoSmithKline Developed and implemented new group structure and departmental budget after merger. Negotiated appropriate staffing levels based on workload. Successfully integrated employees from two groups and facilitated study conduct of HIV studies with GSK Clinical Operations. Directed clinical input to commercial strategy as co-chair of HIV Commercial Strategy Team. Developed and successfully defended 2002 HIV clinical study plans to senior management. December 1998- Principal Clinical Program Head October 2000 US Medical Affairs, Oncology/HIV Glaxo Wellcome Inc. Managed the strategy, design and implementation of multiple Phase IIIB/IV clinical trials to support HIV portfolio. Medical reviewer of promotional material for Combivir, Ziagen, Agenerase and Mepron. Developed and interacted with multiple key HIV opinion leaders. Medical Affairs representative on the Nucleoside Project Team. Supported the strategy and launch of Ziagen, Agenerase and Trizivir. Mark S. Shaefer Page 3 July 1995- Senior Clinical Program Head December 1998 Medical Affairs Glaxo Wellcome Inc. Implemented a 1000 patient observational database of HIV patients using a computerized patient record. Developed and implemented a IIIB/IV plan for a fixed dose combination product of lamivudine/zidovudine. Author of IND for Combivir(fixed dose lamivudine/zidovudine) submission. Author of various portions of Combivir NDA including label and risk benefit analysis. Provided medical support and strategy for launch of Combivir. Developed and implemented new HIV therapeutic group for Medical Affairs. November 1994- Senior Clinical Research Scientist I July 1995 Clinical Support Department Burroughs Wellcome Co. Developed and implemented three US Phase IIIB protocols for Valtrex. International Phase IIIB/IV coordinator for Valtrex. Provided medical and strategic support for the launch of Valtrex for genital herpes and herpes zoster. Author of labels for herpes zoster and genital herpes NDA submissions for Valtrex. Primary medical review of promotional material for Valtrex and Zovirax. May 1993- Clinical Research Scientist II November 1994 Clinical Support Department Burroughs Wellcome Co. Successfully transitioned a long term genital herpes suppression trial and developed a strategy for closing the trial after all subjects completed 10 years of study. Member of Valtrex project team as IIIB/IV representative. Primary medical review of promotional material for Zovirax. July 1986- Clinical Pharmacist April 1993 General Surgery and Liver Transplant Team University Hospital, University of Nebraska Medical Center Omaha, Nebraska Summer 1983 & Intern Pharmacist Summer 1984 - Chula Vista Community Hospital June 1985 Chula Vista, California Winter & Spring, Intern Pharmacist 1983 Post Divisidero Medical Pharmacy San Francisco, California NON-PHARMACY EXPERIENCE: July 1979- Geophysicist September 1981 U.S. Naval Oceanographic Office Bay St. Louis, Mississippi September 1978- Independent Research March 1979 Dr. Palmer Taylor University of California Department of Medicine, Division of Pharmacology San Diego, California Mark S. Shaefer Page 4 ACADEMIC APPOINTMENTS: July 1991- Associate Professor, Pharmacy Practice April 1993 College of Pharmacy University of Nebraska Medical Center March 1991- Assistant Professor, Surgery April 1993 College of Medicine University of Nebraska Medical Center July 1986- Assistant Professor, Pharmacy Practice July 1991 College of Pharmacy University of Nebraska Medical Center Omaha, Nebraska LICENSURE (RPh): California #RPH 039605 Nebraska #10022 CONSULTING POSITIONS: 1993 - Present Reviewer, Hospital Pharmacy 1992 - 1993 Pharmacy Transplantation Advisory Board Ortho Biotech Pharmaceuticals 1990 - Present Reviewer, Clinical Pharmacy 1989 - Present Reviewer, DICP, The Annals of Pharmacotherapy 1989 - Present Reviewer, Pharmacotherapy 1987 - 1989 Beecham Antibiotic Consultation Panel Beecham Pharmaceutical Company AWARDS AND HONORS: 2009 Marketing Excellence Award - Epzicom 2007 HIV Emerald Award 2003 HIV Have You Helped a Field Rep Today Award 2000 HIV Diamond Award 1998 Oncology/HIV Presidents Club 1994 Excellence Award, Burroughs Wellcome 1994 Fellow, American College of Clinical Pharmacy Mark S. Shaefer Page 6 1988 - 1989 Faculty Advisor, Academy of Students of Pharmacy, University Of Nebraska 1988 - 1989 Board Member Nebraska Society of Hospital Pharmacists 1985 - 1990 Program Committee Nebraska Society of Hospital Pharmacists Co-Chairman, 1989 1984 - 1985 Public Affairs Committee San Diego County Pharmacists Association 1983 - 1984 Student Delegate, House of Delegates American Pharmaceutical Association 1983 - 1984 President, UCSF Chapter Student American Pharmaceutical Association 1983 - 1984 Master At Arms, Phi Delta Chi Zeta Chapter, UCSF 1983 Student Member, Long Range Planning Revision Committee, California Pharmacists Association 1983 Alternate Student Delegate, House of Delegates American Pharmaceutical Association 1982 - 1983 Vice-President, UCSF Chapter Student American Pharmaceutical Association MEMBERSHIPS IN PROFESSIONAL ORGANIZATIONS: Phi Delta Chi Pharmacy Fraternity Rho Chi Pharmacy Honor Society American College of Clinical Pharmacy Society of Infectious Disease Pharmacists COMMUNITY SERVICE: 2018 – Present Board of Directors, Welcome Federal Credit Union 2009 – 2018 Supervisory Committee, Welcome Federal Credit Union 1998 – 2002 Baseball coach, West Raleigh Exchange Club 1996 – 2005 Soccer coach, Capital Area Soccer League 1996 – 2000 Committee Chair, Cub Scout Pack 316 1986 - 1994 Advanced Cardiac Life Support, Instructor Mark S. Shaefer Page 7 BIBLIOGRAPHY: Scientific/Refereed 1. Ross LL, Shortino D, Shaefer MS. Changes from 2000 to 2009 in the prevalence of HIV- 1 containing drug resistance-associated mutations from antiretroviral therapy-naïve, HIV- 1-infected patients in the United States. AIDS Res Hum Retroviruses 2018, Epub ahead of print 2. Nan C, Shaefer M, Urbaityte R, Oyee J, Hopking J, Ragone L, Perger
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