“Staying on the Cutting Edge of Clinical Pharmacology Developments”

2 0 1 4 ANNUAL REPORT

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Executive Message2014 was another outstanding year for the American College of Clinical Pharmacology (ACCP). The primary mission of the organization is to provide exceptional education on clinical pharmacology-related topics for professionals working across a spectrum ranging from research and drug development to treating patients in practice settings. The Annual Meeting, ACCP’s pre-eminent educational event, was held Sept 14–16, 2014 in Atlanta, GA. A full day of Pre-meeting Workshops and three days of current, relevant educational Symposia were attended by a global audience of attendees participating as keynote speakers, faculty, attendees, award winners, poster presenters and exhibitors. Heralded as an outstanding educational program, the event further emphasized ACCP’s reputation as a leader in providing excellence in continuing education.

As a Member-driven/Member-focused organization, ACCP continues to strive to meet Member needs and enhance the membership experience with highly desirable benefits and participation in a vibrant professional community with similar goals and objectives. ACCP Members are provided with free access to the latest scientific information in ACCP’s premier publication, The Journal of Clinical Pharmacology, including archives that date back to 1961, and its sister journal, Clinical Pharmacology in Drug Development, which is focused on publishing high-quality clinical pharmacology studies in drug development which are primarily performed in early clinical development phases. Both publications are peer-reviewed and serve a global audience. In 2014, CME and CPE credits were available each month for selected articles in The Journal of Clinical Pharmacology, providing an easy option for completing continuing education activities during the course of the year. An Editor’s Choice article was selected each month and made available in Open Access.

Members build professional relationships that last a lifetime through networking opportunities and participating in ACCP’s committees,

mentoring students and young professionals, and proposing and organizing educational events. Staying on the cutting edge of clinical pharmacology developments is facilitated with discounted registration fees to our growing offering of live and online educational events, plus access to routine FDA notifications and ACCP updates.

In 2014, ACCP continued to develop its organizational road map for the future. In an effort to contain operational expenditures and improve the work environment for ACCP staff, the College relocated its Executive Office to northern Virginia and restructured support services to provide efficiencies and enhanced performance. A fresh perspective was applied to organizational Policies and Procedures to ensure that daily processes remain current, relevant and highly efficient.

ACCP leadership, Staff and Members look forward to the future and remain committed to ACCP’s strategic goals and to supplementing recent initiatives with new efforts to meet the needs of Members, maintaining ACCP’s role as a leading organization in clinical pharmacology and related scientific disciplines.

We hope you will join us in San Francisco, CA, Sept 27th–29th, for the 2015 ACCP Annual Meeting, “Clinical Pharmacology in the Development & Use of Biologics & Small Molecules.” Make ACCP your membership organization of choice for continuing education, networking and staying current on all matters clinical pharmacology-related.

Sincerely,

Bernd Meibohm, PhD, FCPPresident

2014 HighlightsANNUAL MEETING The 2014 Annual Meeting, held Sept 14th–16th in Atlanta, GA, was hailed by attendees as having offered an exceptional scientific program that made a significant impact on professional skills. Building on years of tradition, the meeting brought together a global audience for a series of fast-paced and informative Pre-meeting Workshops and Symposia. Equally important was the intimate nature for which the ACCP Annual Meeting is noted, where attendees experience a high quality of networking and interaction on all levels. As a result of participating in the meeting, more than 85% of attendees indicated that the content would enhance professional activities and/or their practice, and would improve patient outcomes.

In the year and a half leading up to the meeting, the 2014 Program Committee, co-chaired by Drs. Ayyappa Chaturvedula and Walter K. Kraft, along with the Workshop and Symposia chairs, were instrumental in developing and implementing a successful Annual Meeting. The Education Committee and CE Compliance Subcommittee, chaired by Dr. Lawrence Cohen, were critical in reviewing Annual Meeting content to ensure the program met attendee needs. Keynote presentations included “The 10 Trends and Issues that will Determine the Future of Cancer in the World,” by Richard Wender, MD, Chief Cancer Control Officer of the American Cancer Society Inc, and “Prescription Drug Overdose Prevention: The CDC’s Perspective,” by Deborah Dowell, MD, MPH, LCDR, USPHS, Team Lead, Prescription Drug Overdose Team, Div of Unintentional Injury Prevention, National Ctr for Injury Prevention and Control, Ctrs for Disease Control and Prevention.

THE 2014 RECIPIENTS OF THE ANNUAL ACCP RECOGNITION AWARDS WERE AS FOLLOWS:• Distinguished Investigator Award – Kathleen M. Giacomini, PhD – Professor, Dept of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, Univ of California, San Francisco

• Honorary Fellowship Award – Julie A. Johnson, PharmD, FCCP, BCPS – Dean and Distinguished Professor, Coll of Pharmacy, Univ of Florida• Nathaniel T. Kwit Memorial Distinguished Service Award – Carl Peck, MD, Dr hc – Adjunct Professor, Dept of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, Univ of California, San Francisco, Ctr for Drug Development Science, UC - Washington, Washington, DC and Chairman and Co-founder, NDA Partners LLC • ACCP Tanabe Young Investigator Award – Namandjé N. Bumpus, PhD – Dept of Pharmacology & Molecular Sciences, Johns Hopkins Univ School of Medicine• McKeen Cattell Award – Alexander Berg, PharmD, PhD – Sr Clinical Research Scientist, Clinical Pharmacology Group, Upsher-Smith Laboratories Inc• New Member Abstract Award – Xiaoyan Zhang, PhD, MD, Univ of Florida Coll of Pharmacy• Wayne A. Colburn Memorial Award – Fausto Zaruma Torres, MSc, National Polytechnic Inst of Mexico

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Alexander K. Berg PharmD, PhD

Julie A. Johnson, PharmD, FCCP, BCPS

Namandjé N. Bumpus, PhD

Carl Peck, MD, Dr hc

Kathleen M. Giacomini, PhD

42014 Student Abstract Award Winnerswith Lisa L. von Moltke, MD, FCP

2014 STUDENT ABSTRACT AWARD WINNERS WERE AS FOLLOWS:• Puneet Gaitonde, Univ of Florida• Jennifer Hibma, Univ of California, San Francisco• Kumpal Madrasi, Mercer Univ • Nivea Maria Simoes Falcao, Univ of Florida• Ravishankar Prasad Singh, Univ of Florida• Amit Somani, Univ of Florida• Lei Wu, Univ of Houston• Fausto Zaruma Torres, National Polytechnic Inst of Mexico

ACCP continues to be an organization focused on meeting the needs of its Members and Annual Meeting attendees. With a vision of the value that clinical pharmacology will bring to the future of drug development and healthcare, ACCP strives to provide healthcare professionals and scientists with a forum for exchange of knowledge, from research to clinical settings.

EDUCATION PROGRAM EXPANSION2014 was a year of educational program expansion. ACCP increased its educational offerings to a total of fifteen in 2014, including the Annual Meeting, a monthly journal continuing education activity, one webinar and one on demand (online) activity. 2014 also offered an opportunity for ACCP to illustrate its commitment to quality education. ACCP is periodically reviewed by the Accreditation Council for Continuing Medical Education (ACCME) and the Accreditation Council for Pharmacy Education (ACPE) in order to continue to offer CME and CPE credits, respectively. In 2014, ACCP provided the accrediting bodies with reports that described how ACCP meets their standards. ACCP was notified in 2015 that it had been reaccredited by the ACCME and the ACPE until 2019. This re-accreditation is due to the hard work of the ACCP Staff and Education Committee, particularly Director of Education, Keri Sperry, and Education Committee Chair, Lawrence Cohen, PharmD, BCCP, FASHP, FCCP, FCP, FNAP. It is a crucial milestone in further advancing and expanding ACCP’s role as a leader in clinical pharmacology education.

NEW EDITOR FOR THE JOURNAL OF CLINICAL PHARMACOLOGYThe impact of the new Editor-in-Chief of The Journal of Clinical Pharmacology (JCP), Joseph S. Bertino Jr., PharmD, FCP, FCCP, was evident in 2014. Building on its rich, 50-year history, the outstanding reputation of the journal was enhanced with the publication of a series of new clinical pharmacology review articles. The Editor received 405 original manuscripts, 40% of which were accepted for publication. The efforts of a newly recruited, high-quality editorial review staff resulted in a substantial decrease in time to first decision. For the first time in the College’s history, articles in the JCP were offered each month for CE credit and a monthly Editor’s Choice article was implemented that has reached an enhanced audience through the efforts of our publisher.

CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT INCREASES THE NUMBER OF ISSUES IN 2014Clinical Pharmacology in Drug Development, ACCP’s journal focused on publishing high-quality clinical pharmacology studies in drug development which are primarily performed in early development phases, has evolved to six issues per year and provides an excellent forum for high-level science that is crucial to drug development and a source of critical information for regulatory agencies. Editor-in-Chief, David J. Greenblatt, MD, has diligently managed the evolution of the journal, noting that scientific merit is critical in the acceptance of manuscripts. The inclusion of review articles and point-counterpoint editorial features, plus increasing the impact on teaching and education, will continue to drive the future success of the journal.

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FOCUS ON STUDENTS AND TRAINEESACCP remains devoted to mentoring the next generation of clinical pharmacology professionals. Students & Trainees benefit from a number of ACCP Student Outreach Programs designed to provide internships or career opportunities, awards recognition through competition for poster presentations, leadership opportunities within ACCP and its Student Chapters and a mentoring program designed to provide guidance and support. Additionally, ACCP’s outstanding continuing education program encourages student participation in educational meetings or online educational Workshops and Symposia on cutting-edge topics related to clinical pharmacology and the optimal use of therapeutics, providing a forum for new scientific ideas and to discuss areas of common interest.

Students & Trainees pay substantially discounted registration fees for the Annual Meeting, other educational events and online educational activities. Student attendees of the 2014 Annual Meeting were provided with an exceptional opportunity to acquire essential skills that can help their research efforts by attending tutorials on Poster Presentation Skills to increase confidence and effectiveness at presenting research posters at academic sessions and professional conferences and Finding the Right Journal for Your Work to gain insight into approaches used by experienced professionals in targeting journals for manuscript submissions. Students also participated in Podium Presentations given by the Student Award Winners, mentored tours of the Poster Sessions and CV reviews by ACCP Mentors.

Amit Somani, PhD2014 Student Abstract Award Winner

“Being a Member of ACCP has greatly helped me in my career. In 2014, I was a recipient of one of the 8 Student Abstract Awards, for which I was very thankful, and I was invited to give a Podium Presentation to share my research findings. ACCP provided the Student Award Winners an opportunity to present a poster about their research for all three days during the Annual Meeting. I highly recommend that Students/Post-doctoral Fellows present a poster and attend the Annual Meeting because it provides you an excellent opportunity to know and interact with many fellow clinical pharmacologists and leaders in the field, some of whom you may be working with in the future in some capacity.” — Amit Somani, PhD

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HISTORY & PHILOSOPHYIn the 1960s, a group of eminent physicians formulated the concept of an organization dedicated to a new branch of pharmacology that dealt with the effectiveness and safety of drugs in man. As a result of their efforts, the American College of Clinical Pharmacology (ACCP) was founded on September 11, 1969. Today, ACCP consists of a full spectrum of healthcare professionals and scientists who remain dedicated to advancing clinical pharmacology with the ultimate goal of providing exceptional patient care.

As an organization whose primary role is education, ACCP does not concentrate on any one aspect of the discipline. Rather, the College seeks to address the educational needs of its diverse membership and all healthcare professionals, covering a range of topics from drug discovery to application. These areas include, but are not limited to, drug interactions, pharmacokinetics, pharmacodynamics, pharmacometrics, pharmacogenomics, clinical pharmacology practice in the outpatient and inpatient settings and clinical drug trials. The diversity of ACCP is expressed not only in the composition of its membership, but also in

its leadership. Maintaining a balance of elected Regents and Officers from all pertinent professional backgrounds ensures that ACCP remains attuned to the needs of all professionals engaged in the practice of or with a strong interest in clinical pharmacology, from the research laboratory (academic and industrial) to the classroom, and from clinical trials to improved patient care.

OBJECTIVESThe objectives of the College are to advance the science of clinical pharmacology in all its phases and to engage in appropriate educational efforts in the public interest. These goals are to be attained in a manner consistent with the highest ethical and scientific standards.

VISION & MISSION• To improve health by optimizing therapeutics; • Provide innovative leadership and interdisciplinary education that will enable the generation, integration and translation of scientific knowledge to optimize research, development and utilization of medication for the benefit of all.

“In the fifth decade of its existence, the American College of Clinical Pharmacology has entered a new phase of refocusing

and launching new initiatives to serve the needs of its membership and the clinical pharmacology community in

the 21st century. With the strategic visioning process completed, many new education and public policy initiatives are in preparation or well underway, and its

operations aligned with these goals in its new location in Virginia, the College is poised to continue being a major

player in the world of clinical pharmacology that benefits its Members, the scientific community and patients worldwide.” — Bernd Meibohm, PhD, FCP

President, American College of Clinical PharmacologyBernd Meibohm, PhD, FCP

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Lakshmi Putcha, PhD, FCP

“I joined ACCP as an NRC Post-doc at NASA Johnson Space Ctr in the early 80s and attended my first international conference in Stockholm, Sweden in 1987. As a Fellow of the College since 1990, I have enjoyed participating in the organization’s research and educational outreach activities. Fellowship in the organization provided an opportunity to reach out and partner with research scientists and regulatory colleagues to address the pharmacotherapeutic challenges of space missions. The organization’s excellent student mentor and outreach efforts offered a platform for familiarizing and involving young students and scientists in NASA’s clinical pharmacology research, which is obscure for the research community in general. I truly believe the College strives for excellence in clinical pharmacology education by collating and housing national and international experts in the field, and I am very proud to be a long-standing Member of this accomplished group of scientists and young researchers.” — Lakshmi Putcha, PhD, FCP

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Organizational Affiliation Degree(s)

PhD

MD

PharmD

ACCP Member Geographic Distribution

0.81%0.58%

79.54%

1.85%

8.79%8.21%

0.12%

OtherClinical

Academia

Industry

Gov’tConsulting

Expenses

53.98%

0.12%

60%

50%

40%

30%

20%

10%

0%

45.90%

Program Activities: Supporting Activities: Fundraising Educational Programs Management and General and Forums

56.19%

43.77%

0.04%

2014 2013

2014 2013 Public Support & Other Revenue

Dues Annual Journal Contributions Investment Website Other Meeting Revenue Income Job Revenue Center

12.79%

23.10%

37.94%

0.01% 0.17% 0.04%

45%

40%

35%

30%

25%

20%

15%

10%

5%

0%

13.06%

23.53%

40.41%

25.95%

22.61%

0.00% 0.27% 0.13%

9Consistent with the principles of good governance, ACCP contracted with independent accountants to perform the audit of the 2014 financial statements. The audit report is available upon request.

Statement of Activities: 2014 vs 2013

President Bernd Meibohm, PhD, FCPUniv of Tennessee

President-elect John van den Anker, MD, PhD, FCP Children’s National Health System & Univ Children’s Hosp, Basel

Secretary Vikram Arya, PhD, FCP US Food & Drug Administration

Treasurer Michael W. Jann, PharmD, FCP Univ of North Texas System Coll of Pharmacy

Immediate Past President Lisa L. von Moltke, MD, FCP Alkermes Inc

ACCP Officers* ACCP Regents*Vikram Arya, PhD, FCP US Food & Drug Administration Megan A. Gibbs, BSc Pharm, PhD, FCP Amgen Inc Guenther Hochhaus, PhD, FCP Univ of Florida Joan Korth-Bradley, PharmD, PhD, FCP Pfizer IncNancy A. Lass, MD, FAAP, FCP, LLD NL Specialty Consulting Inc Donald E. Mager, PharmD, PhD, FCP Univ of Buffalo, SUNY Diane R. Mould, PhD, FCP Projections Research IncMichael N. Neely, MD, MSc, FCP Univ of Southern California Keck School of MedicinePeter H. Wiernik, MD, FCP Cancer Research FdtnHonghui Zhou, PhD, FCP Johnson & Johnson

Executive Director Krista L. Levy

Director of Education Keri J. Sperry

Staff

Board

10*Represents Officers & Regents as of December 31, 2014

American College of Clinical Pharmacology21750 Red Rum Dr, Ste 137, Ashburn, VA 20147

mailing address: PO Box 1758, Ashburn, VA 20146-1758phone: 571.291.3493

website: www.ACCP1.org

*Represents Officers & Regents as of December 31, 2014