2012 American College of Clinical Pharmacology (ACCP) Annual Meeting

Table of Contents

Letter of Invitation from President & President-elect . . . . . . . . . . 3

Program at a Glance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Keynote Speakers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2012 ACCP Recognition Award Winners . . . . . . . . . . . . . . . . . . . . . . 6

Students & Trainees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Abstract Submissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Guidelines for Poster Presentations . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Educational Accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Pre-meeting Workshops . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Symposia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Why Join ACCP? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Registration Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

International Attendees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Travel and Hotel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Who We Are . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Why Exhibit at ACCP? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Support Opportunities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Exhibitor Registration Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

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Ivan Nestorov, PhD, Co-Chair

Joseph D. Ma, PharmD, Co-Chair

Funmilayo Ajayi, PhD

Ayyappa Chaturvedula, PhD

Ronald J. Christopher, PhD

Lokesh Jain, PhD

Lucy Lee, PharmD

Wael Mohamed, MD, PhD

Robert Noveck, MD

Lakshmi Putcha, PhD

American College of Clinical Pharmacology2012 Program Committee

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Letter of Invitation from President & President-elect

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Dear Colleague:

It is our pleasure to invite you to attend the 2012 Annual Meeting of the American College of Clinical Pharmacology, September 23rd – 25th, at the Sheraton San Diego Hotel & Marina. This year’s meeting, Translating Clinical Pharmacology Research into Optimized Patient Care, encompasses a series of Pre-meeting Workshops and Symposia on such relevant content as the role of clinical pharmacology in speeding the development of new anti-infective drugs to combat drug resistance, pharmacometrics in hospital-based pharmacotherapy, innovations in drug therapies, clinical translational biomarkers, pediatric drug development, chronic pain, asthma and psychotropics. ACCP maintains its commitment to offer Continuing Education credit for Pre-meeting Workshops and Symposia, a particular value for pharmacists, physicians and other healthcare professional attendees.

We strongly encourage you and your colleagues to attend and be a part of this outstanding educational experience. Located just one mile from San Diego International Airport, the Sheraton San Diego Hotel & Marina provides a complimentary shuttle to and from the airport. The San Diego area offers outstanding restaurants, shopping, major league baseball, an internationally acclaimed zoo and the historic Gaslamp Quarter, most of which are within walking distance, and the weather in September should be ideal.

In reviewing this Preliminary Program, you will note that the 2012 Annual Meeting Program Committee, Co-Chaired by

Drs. Ivan Nestorov and Joseph D. Ma, have developed a varied and exceptional program adhering to the College’s commitment to excellence in science and education while permitting sufficient time to “network” with friends and colleagues, old and new. Topics should be of interest to not only clinical pharmacologists, but a broad range of healthcare professionals in academia, industry, government and private practice. Poster Sessions, held daily, will highlight new findings and preliminary data, stimulating discussion and hypothesis generation in a relaxed atmosphere. Of particular interest to Students & Trainees are specific programs intended to broaden their exposure to cutting-edge science and career guidance.

We strongly encourage you to register early, particularly for the Pre-meeting Workshops, as seating is limited. These Workshops are designed to be of interest to clinical pharmacologists and others in research and development, as well as a broad range of healthcare professionals. Each Symposium is timely and will critically challenge current practice and future directions, while encouraging audience interaction.

Take advantage of Early Bird Registration rates through July 1st. We encourage you to invite your colleagues, particularly those who may have never attended an ACCP Annual Meeting or may not be familiar with the College.

We look forward to welcoming you to an outstanding 2012 ACCP Annual Meeting in San Diego. Come to learn, network, and be part of a resurgent ACCP!

Michael J. Fossler, Jr., PharmD, PhD, FCPPresident

Join Us for the 2012 ACCP Annual Meeting! Translating Clinical Pharmacology Research into Optimized Patient Care

Lisa L. von Moltke, MDPresident-elect

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Program at a Glance

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SATURDAY, SEPTEMBER 22, 2012

WORKSHOP 1 l 8:15 am – 12:15 pm

Not For Students Only: How to Start and Manage Your Career in the Pharmaceutical IndustryCHAIR: Michael J. Fossler, Jr., PharmD, PhD, FCP

WORKSHOP 2 l 8:30 am – 12:30 pm

Update on the Pharmacologic Management of Asthma in ChildrenCHAIR: Michael J. Welch, MD, FAAP, FAAAAI

WORKSHOP 3 l 1:00 – 5:15 pm

Update on Psychotropics: New Agents and GuidelinesCHAIR: Kelly C. Lee, PharmD, BCPP, FCCP

SUNDAY, SEPTEMBER 23, 2012

SYMPOSIUM I l 8:00 – 11:15 am

Evaluating Drug-Drug Interactions with Therapeutic ProteinsCO-CHAIRS: Honghui Zhou, PhD, FCP Stanley A. Roberts, PhD, DABT

SYMPOSIUM II l 8:00 – 11:30 am

Developing Issues in Pediatric Clinical PharmacologyCO-CHAIRS: Edmund V. Capparelli, PharmD John van den Anker, MD, PhD, FCP

SYMPOSIUM III l 1:30 – 5:30 pm

The Changing Face of Pediatric Drug DevelopmentCO-CHAIRS: Robert L. Kunka, PhD Kathryn Blake, PharmD, BCPS, FCCP

SYMPOSIUM IV l 1:30 – 5:00 pm

The Evolving Face of First-in-Human (FIH) Studies from the Investigators’ Perspective – Cosponsored by ACPU

CO-CHAIRS: Charles H. Pierce, MD, PhD, FCP, CPI Angela Baker, MHA

MONDAY, SEPTEMBER 24, 2012

SYMPOSIUM V l 8:00 am – 4:15 pm

Innovations in Drug Therapies – The Future is NowCO-CHAIRS: Ronald J. Christopher, PhD Lakshmi Putcha, PhD

SYMPOSIUM VI l 8:00 – 11:30 am

Pharmacometrics Influencing Hospital-basedPharmacotherapyCO-CHAIRS: Ayyappa Chaturvedula, PhD Roger W. Jelliffe, MD, FCP

SYMPOSIUM VII l 1:30 – 5:00 pm

Clinical Translational Biomarkers Facilitating Transition From Bench to Bedside: Basic Concepts, Successful Case Studies and Regulatory ViewpointsCO-CHAIRS: Lucy Lee, PharmD, FCP Michael Tortorici, PharmD, PhD

TUESDAY, SEPTEMBER 25, 2012

SYMPOSIUM VIII l 8:00 – 11:30 am

Speeding Up the Development of New Anti-infective Drugs to Combat Drug ResistanceCO-CHAIRS: Hartmut Derendorf, PhD Vincent H. Tam, PharmD, BCPS (Infectious Diseases)

SYMPOSIUM IX l 8:00 am – 12:00 pm

Hepatitis C – An Expanding Area of Drug Development and Clinical PharmacologyCO-CHAIRS: Shirley M. Tsunoda, PharmD Alexander Kuo, MD

SYMPOSIUM X l 1:30 – 5:00 pm

Chronic Pain: Underdiagnosed, Undertreated and MisunderstoodCO-CHAIRS: Rabia S. Atayee, PharmD, BCPS Joseph D. Ma, PharmD

SYMPOSIUM XI l 1:30 – 5:00 pm

“Return on Investment” in PharmacometricsCO-CHAIRS: Jogarao Gobburu, PhD, FCP, MBA Ivan Nestorov, PhD

Keynote Speakers

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Michael Reed Barratt, MD, MS, NASA Astronaut

Dr. Barratt came to NASA JSC in May 1991 employed as a project physician with KRUG Life Sciences, working on medical systems for Space Station Freedom. In July 1992, he was assigned as NASA Flight Surgeon, working in Space Shuttle Medical

Operations. In January 1994, he was assigned to the joint U.S./Russian Shuttle - Mir Program, working and training extensively in the Cosmonaut Training Center, Star City, Russia, in support of the Mir-18/STS-71 and subsequent missions.

From July 1995 to July 1998, he served as Medical Operations Lead for the International Space Station (ISS). A frequent traveler to Russia, he worked with counterparts at the Gagarin Cosmonaut Training Center and Institute of Biomedical Problems as well as other international partner centers. Dr. Barratt served as lead crew surgeon for the first expedition crew to ISS from July 1998 until he was selected as an astronaut candidate.

Selected as a mission specialist by NASA in July 2000, Dr. Barratt reported for training in August 2000. Following the completion of two years of training and evaluation, he was assigned technical duties in the Astronaut Office Station Operations Branch.

Assigned to long duration flight training in 2005, Dr. Barratt launched on Soyuz TMA-14 on March 26, 2009 to the ISS, and served as a member of Expeditions 19 and 20. This time period included the transition from three to six permanent ISS crewmembers, two EVAs, two visiting space shuttles and the arrival of the first Japanese H-II Transfer Vehicle (HTV). Completing 199 days in space, Dr. Barratt landed on October 11, 2009.

Currently, Dr. Barratt manages the Human Research Program at NASA Johnson Space Center. This program guides applied research oriented toward mitigating the most prominent health and performance risks associated with human spaceflight. Dr. Barratt serves as Associate Editor for Space Medicine for the journal, Aviation, Space and Environmental Medicine and is senior editor of the textbook, Principles of Clinical Medicine for Space Flight.

Christopher P. Austin, MD, Senior Advisor to the Director for Translational Research at the National Human Genome Research Institute (NHGRI)

Dr. Austin is responsible for conceptualizing and implementing programs to derive biologic insights and therapeutic benefits from the newly completed human genome sequence.

At the Department of Human Genetics at Merck Research Laboratories, Dr. Austin built a group that took a variety of genetic and molecular approaches to target identification for schizophrenia, bipolar illness, Alzheimer’s disease and Parkinson’s disease. In order to expand the group’s target identification and validation capacities, Dr. Austin expanded the group into microarray technologies and a multifaceted molecular histology effort, and began the first company-wide initiative in pharmacogenomics. Later, he incorporated a group that identified many new G protein-coupled receptors (GPCRs) and identified ligands of several orphan GPCRs. Lastly, as Director of Genomic Neuroscience, he initiated a schizophrenia project team that developed small molecule modulators for two molecular targets for schizophrenia, which are now being tested for the treatment of the disease.

Dr. Austin moved to NHGRI in 2002 to spearhead efforts to translate the remarkable accomplishments of the Human Genome Project into benefits for human health. A prerequisite for this translation is the determination of function of a large number of novel genes, which will occur most efficiently if the biomedical research community has immediate access to tools and technologies for determining gene function. Dr. Austin is leading the development of a “toolbox” of publically accessible genomic reagents and technologies analogous to the genome sequence, but focused on elucidation of gene function.

One of these initiatives is an ambitious program in chemical genomics, which will bring the power and diversity of small molecule chemistry and informatics to the determination of gene function. This paradigm-shifting initiative promises to have a transformative effect on basic biomedical research, speeding functionation of the genome and development of new therapies for human disease.

2012 ACCP Recognition Award Winners

Honorary Fellowship AwardCharles Williams Flexner, MD – Professor, Medicine and Pharmacology and Molecular Sciences, The Johns Hopkins Univ School of MedicineThe Honorary Fellowship Award is given annually to a Non-member of the College and is meant to recognize primary activities within the immediate domain of clinical pharmacology. The award recognizes overall contributions to the field, rather than any particular scientific work, by a senior investigator or authority having a national or international reputation in the scientific, public service, legislative, governmental or other area of endeavor impacting on the field.

Dr. Flexner is receiving this award for his international reputation and impact in the medical education and translational areas of clinical pharmacology.

Nathaniel T. Kwit Memorial Distinguished Service AwardMichael D. Reed, PharmD, FCCP, FCP – Associate Chair, Dept of Pediatrics, Children’s Hosp Medical Ctr of Akron The Nathaniel T. Kwit Memorial Distinguished Service Award is given in memory of the late Nathaniel T. Kwit, MD, FCP, a founding Fellow of the College, who served as a Regent for 5 years and as Treasurer for 20 years. The primary intent of this award is to recognize accomplishments of a general nature which benefit the field of clinical pharmacology. These may be in the area of teaching, administration, service with ACCP, long-term and wide-ranging scientific studies having practical importance and other service-related functions. It is differentiated from the Distinguished Investigator Award in that it is not intended to recognize any distinct area of scientific investigation, but rather an overall contribution to the field. The candidate need not be an ACCP Member or Fellow.

Dr. Reed is receiving this award for his contributions to the field, as well as his service to the College.

McKeen Cattell Memorial AwardJoseph Kovalchin, PhD – Sr Scientist, In Vivo Pharmacology, Eleven Biotherapeutics The McKeen Cattell Memorial Award is made in memory of the late McKeen Cattell, MD, PhD, FCP, the first editor of The Journal of Clinical Pharmacology and co-founder of the College. This award is made annually, recognizing an outstanding research paper published in the JCP during the preceding year. The award is typically presented to the first author of the paper. Journal Article: “Safety, Pharmacokinetic, and Pharmacodynamic Evaluations of PI-2301, a Potent Immunomodulator, in a First-in-Human, Single-Ascending-Dose Study in Healthy Volunteers” Authors: Kovalchin J, Krieger J, Collins K, Genova M, Augustyniak M, Masci A, Avril T, Gandon G, Patat A, Fauchoux N, Toutin C, Lacoste E, Patel U, Mascioli E, Zanelli E. J Clin Pharmacol. 2011; May; 51(5):649-60

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2012 ACCP Recognition Award Winners

Distinguished Investigator AwardWilliam J. Jusko, PhD – Chair of Pharmaceutical Sciences, Univ at Buffalo, State Univ of New York The Distinguished Investigator Award is given annually and is intended to recognize superior scientific expertise and accomplishments by a senior investigator, usually involving a distinct area of research in basic or clinical pharmacology, for which the individual is internationally known. The candidate need not be a Member or Fellow of the College.

Dr. Jusko is receiving this award for his significant contributions and extensive involvement in the field of clinical pharmacology and in clinical, basic and theoretical pharmacokinetics and pharmacodynamics of corticosteroids, as well as drugs used to treat diabetes, inflammation, and cancer.

Tanabe Young Investigator Award Sriram Krishnaswami, PhD – Director, Clinical Pharmacology Specialty Care, Pfizer Inc The Tanabe Young Investigator Award is given on a biannual basis (on even numbered years) and is funded by a grant from Tanabe Research Labs, USA. The award recognizes the significant contributions of an investigator who has made unusual strides in research related to clinical pharmacology and whose career shows promise of outstanding achievements at a relatively early stage, typically 10 – 12 years post-research degree. The candidate need not be a Member or Fellow of ACCP.

Dr. Krishnaswami is a rising star in clinical pharmacology in both industrial and academic settings, making him highly deserving of this award. His personal interest in pharmacometrics in drug development and his command of the impact that quantitative pharmacology can have in decision making in drug development are gaining national as well as international reputation.

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Students & Trainees

Annual Meeting Events for Students & Trainees Student & Trainee membership and participation in ACCP’s Annual Meeting are strongly encouraged and are beneficial on several levels.

• Substantially discounted registration fees for the Annual Meeting, other educational events and online educational activities on cutting-edge, relevant topics related to clinical pharmacology and the optimal use of therapeutics. These interactions provide Students & Trainees with access to a forum for new scientific ideas and healthcare professionals of various disciplines meeting to discuss areas of common interest. • ACCP Student Abstract Awards Program is designed to recognize outstanding research abstracts submitted by Students & Trainees at the Annual Meeting. Each award consists of a certificate, a $1,000 honorarium, a complimentary Annual Meeting registration and an invitation to the Board of Regents Dinner at the Annual Meeting.

• FromthepoolofStudentAbstractAwardwinners,oneis selected to receive the Wayne A. Colburn Memorial Award, as judged by the Program Committee during the Poster Sessions at the Annual Meeting. The winner of the Wayne A. Colburn Memorial Award will also receive a plaque and an additional honorarium of $500. At the time the award is presented, the author will be asked to give a 5 – 10 minute presentation outlining the results, using 2 – 3 slides.

ACCP Awards and Previous Winners

Student Networking Wine & Cheese ReceptionDuring the Annual Meeting, Students & Trainees are encouraged to participate in the Student Networking Wine & Cheese Reception. A huge success in 2011, the reception provides a relaxed atmosphere where Students & Trainees can interact one-on-one or in groups with accomplished professionals who can answer questions and provide guidance on relevant issues. In advance of the event, the Student Outreach Committee will review the proposed list of ACCP Annual Meeting attendees and select a spectrum of respected and accomplished professionals to participate. An email invitation requesting an RSVP for the reception will be sent to all Students & Trainees that have registered for the Annual Meeting.

Poster Tours with MentorsDuring some of the Poster Sessions, small groups of Students & Trainees will be hosted by an ACCP Fellow or senior Member to tour the poster area and discuss preselected posters that provide exceptional educational material. An email invitation requesting an RSVP for the Poster Session tours will be sent to all Students & Trainees that have registered for the Annual Meeting.

Visit us at

ACCP Member Benefits

Learn more about ACCP’s Student Outreach Program at www.ACCP1.org > Student Outreach Join ACCP

The Student Outreach Committee is critical in providing guidance regarding Student & Trainee needs and ensuring that those needs are consistently met by ACCP. The committee is comprised of Student Members, Members and Fellows and it focuses on student-related activities at the Annual Meeting and provides guidance on programs, new and old, required to effectively support Students & Trainees. Have a great idea? Please share it with us at [email protected].

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Abstract Submissions

Please note: Poster presenters have the sole obligation of ensuring that all authors and poster content are accurate at the time of final submission. ACCP holds no responsibility for corrections after publication of any materials related to the meeting.

Abstracts Abstract Submission

April 15, 2012 Abstract Submission Deadline

Mid-May 2012Abstract notification letters sent by email to first authors regarding decisions by the Program Committee on the status of acceptance

June 8, 2012 Deadline to withdraw abstract

Areas of Abstract SubmissionSUBMISSION OF ABSTRACTS IN THE FOLLOWING AREAS IS ENCOURAGED:

•MechanismofAction

•TherapeuticDrugMonitoring

•Absorption,Distribution,MetabolismandExcretion

•SafetyandEfficacy

•Drug-DrugInteractions

•EffectivenessandImpactonqualityoflife

•SpecialPopulations,includingwomen,childrenandtheelderly

•Cost-effectiveness

•NewClinicalTrialDesigns

•ClinicalPharmacokineticsandPharmacodynamics

•ClinicalTrialsandHumanPharmacology

•ExperimentalPharmacologyinIn Vitro and In Vivo Studies

•ApplicationsofModelingandSimulation

•Pharmacoepidemiology/Pharmacogenomics

•Pharmacoeconomics/DiseaseManagement

•TranslationalMedicine/Biomarkers/Imaging

•Decision-makinginResearchandDevelopment

PRIMARY CRITERIA FOR ACCEPTANCE OF ABSTRACTS ARE:

•Applicabilitytoclinicalpharmacologyandtranslationalmedicine

•Innovationandscientificmerit

•RelevancetothemissionoftheCollege

EACH ABSTRACT MUST ALSO CONTAIN:

•Astatementofpurpose,innovationorhypothesis

•Descriptionofmethodsandmaterials

•Dataandresults

•Interpretation,conclusionandsignificance

Instructions for Abstracts & PostersWHEN PREPARING YOUR POSTER FOR PRESENTATION AT THE ACCP ANNUAL MEETING, WE KINDLY ASK THAT YOU ADHERE TO THE FOLLOWING GUIDELINES: •Allmaterialshouldbereadablefromdistancesofatleastthreefeet.

•Presenter’snamemustbeunderlinedthroughouttheentiredocument.

•Initialorfirstnamemustprecedelastname.

•Institutionalaffiliationandcityarerequired.

•Ensurethatthestreetaddress,zipcode,degreesandgrantsupportare NOT listed within the abstract.

•Useonlystandardabbreviations.

•Allcompoundsthataredesignatedbycodemustbeidentified adequately.

•Donotindentthetitle.

•Capitalizethefirstletteroftradenames.

•Nonproprietary(generic)namesarerequiredthefirsttimeadrugis mentioned, written in small letters.

•Abstractislimitedto350wordswhichincludestitlesandauthors. Tables and charts are permitted within this space but will be counted and applied to word limitations.

•Whenusingabbreviationsforcompounds,spelloutinfullthe first mention, followed by the abbreviation in parentheses. DO NOT ABBREVIATE COMPOUNDS WITHIN THE TITLE OF THE ABSTRACT.

•Specialcharactersarepermitted.

•Rememberthatyourabstractwillappearinprintexactlyasyou submit it. Any errors, misspellings, poor hyphenations and deviations from good grammatical usage will be glaringly apparent in the published abstract.

•ImportantSizeLimitations:Nolargerthanthesizeoftheposterboard which is 48 inches tall and 72 inches wide. (1.22 Meters by 1.80 Meters) All posters will be mounted horizontally.

NOTICES REGARDING DECISION BY PROGRAM COMMITTEE:

Corresponding authors will be notified by letter in early to mid-May regarding the status of their abstracts for the ACCP Annual Meeting. If you have not received a decision letter by mid-May, please contact the ACCP Executive Office at 240-399-9070, ext. 4.

Guidelines for Poster Presentations

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BOARD SIZE:

Posters will be displayed on poster boards with a usable space 72 inches wide by 48 inches tall, although for best viewing by poster attendees and convenient posting by authors, the ACCP recommends confining the displays to the 5 feet wide by 3.5 feet high area in the center of the poster board. Posters should be mounted on poster boards using pushpins.

BOARD MATERIAL:

Fabric that will accommodate pushpins.

GENERAL INFORMATION:

•Postersmustbeplacedonposterboardspriortothepostersession on the day your poster is scheduled. A schedule is provided in the next column.

•Theposterswillremainontheboardsduringthepostersessionfor viewing. The poster must be removed after the poster session is completed. Please contact ACCP Staff at the registration desk if your poster has been removed.

•Authors,ortheirassistants,mustbepresentattheirassignedboard location during the first hour of the scheduled poster session. Assistants may be used as necessary during the session.

•Bringonlyitemswhichcanbemountedonposterboards.Therewill be no electrical or projection facilities provided. You must provide your own pushpins. NO OTHER MOUNTING MATERIALS SHOULD BE USED.

•Allitemsforpostingshouldbepreparedinadvance,withposting alone remaining. Graphic supplies will not be available.

•Posterboardlocationnumberswillbemountedintheupperlefthand corner of each board. This number corresponds with the number assigned to you in the acceptance letter and will be so identified in the Final Program in registration packets. Please note, the board location is NOT the abstract number.

•Eachposterwillbeassignedaboardandwillbelabeledwitha number and the presenting author’s name.

•NewMemberabstractswillbeidentifiedwith“NewMember”ribbons placed on the board next to the board number.

•StudentAbstractAwardwinnerswillbeidentifiedwith“AwardWinner” ribbons placed on the board next to the board number.

2012 Poster Session & Judging SchedulePlease note: Posters will be judged the entire time the session is in progress.

POSTER SESSION l

Sunday, September 23, 2012

6:00 – 8:00 pm

Posters must be taken down after 8:00 pm in preparation for the next session.

POSTER SESSION ll

Monday, September 24, 2012

6:00 – 8:00 pm

Posters must be taken down after 8:00 pm in preparation for the next session.

POSTER SESSION lll

Tuesday, September 25, 2012

7:00 – 8:00 am

Posters must be taken down by 12:00 pm.

FOR QUESTIONS, PLEASE CONTACT: [email protected] or 240-399-9070, ext. 4.

Abstract Awards

To be considered for one of these abstract awards in a calendar year, participants must submit abstracts by the April 15th deadline.

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Educational Accreditation

Accreditation Statements The American College of Clinical Pharmacology is accredited by the Accreditation Council for Continuing Medical Education to provide Continuing Medical Education (CME) for physicians.

The American College of Clinical Pharmacology is accredited by the Accreditation Council for Pharmacy Education as a provider of Continuing Pharmacy Education (CPE).

CPE Monitor is a national, collaborative effort by NABP and the Accreditation Council for Pharmacy Education (ACPE) to provide an electronic system for pharmacists and pharmacy technicians to track their completed continuing pharmacy education (CPE) credits. It will also offer state boards of pharmacy the opportunity to electronically authenticate the CPE units completed by their licensees, rather than requiring pharmacists and technicians to submit their proof of completion statements upon request or for random audits.

This initiative will streamline processes for pharmacy practitioners to ensure they are maintaining professional competency requirements. CPE Monitor is expected to save pharmacists, pharmacy technicians, state boards of pharmacy and CPE providers time and money.

Get an Early Start!To prepare for the new process, pharmacists and technicians are encouraged to obtain their NABP e-Profile ID now to ensure their e-Profile is properly setup. Many ACPE-accredited CPE providers are now requiring pharmacists and pharmacy technicians to submit their e-Profile ID and date of birth to receive credit for completed CPE.

Don’t forget to Set up your NABP e-Profile to obtain your ID before the ACCP Annual Meeting! (Secure site with 24/7 availability)

For more information, please visit: CPE Monitor

New Continuing Education Processes for 2012! In continuing its tradition of providing high-quality, accredited educational sessions to Annual Meeting attendees, ACCP has listened carefully to your requests and has significantly streamlined its educational program procedures. We are pleased to share that, starting in 2012, ACCP will provide one convenient, user-friendly tool where you can:

•ObtaintheSyllabusandslidesforPre-meetingWorkshops and Symposia

•Completeageneralevaluationofthe2012ACCPAnnual Meeting

•Completepost-eventtestingrelatedtoCMEandCPE

•PrintCertificateofCMECreditorCPEStatementofCredit, as appropriate

As we approach the 2012 ACCP Annual Meeting, more detailed instructions will be provided via email to all meeting attendees.

Pre-meeting Workshops

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SATURDAY, SEPTEMBER 22, 2012WORKSHOP 1 l 8:15 am – 12:15 pm

Not For Students Only: How to Start and Manage Your Career in the Pharmaceutical IndustryAn interactive, high-energy session for the aspiring young pharmaceutical scientist embarking on his or her career in the pharmaceutical industry. Learn and practice the secrets of effective communication and career management from seasoned industry and academic professionals. This is NOT a session where you will just sit and listen – this will be hands-on and interactive!

{ THIS SESSION HAS NOT BEEN DESIGNATED FOR CME OR CPE CREDIT }

CHAIR:

Michael J. Fossler, Jr., PharmD, PhD, FCP, Director, Clinical Pharmacology Modeling & Simulation, GlaxoSmithKline Inc

TARGET AUDIENCE:

This session will be useful for graduate or post-doctoral students in the biomedical sciences contemplating a career in the pharmaceutical industry and will provide attendees with tools that they need in order to be successful. This session may also be of interest to those who have been in the work force for 3 – 5 years and who wish to further their careers.

BACKGROUND REQUIREMENT:

No specific background requirements, other than a desire to learn about the concepts described.

GOALS:

The educational goals of this session are to learn the best ways of working with an executive recruiter to land your first job in the pharmaceutical industry; to learn to use effective oral communication techniques that will get your ideas across to your audience; to explore ways to make your posters and slides more effective at scientific meetings; and to learn techniques for managing and furthering your career in the pharmaceutical industry.

OBJECTIVES:

At the conclusion of this program, participants should be able to:

1. List the advantages of working with an executive recruiter;

2. Explain what to look for in an executive recruiter and how to choose one who fits your career needs;

3. Give tips on getting the most from your recruiter;

OBJECTIVES CONT:

4. State the most common mistakes people make when speaking in public;

5. List the most effective ways to get your ideas across during your talk;

6. State the most common mistakes people make when creating slides and posters;

7. List the most important design elements of a successful poster;

8. List the most important elements of a successful slide presentation;

9. List the ways in which you can actively manage your career.

8:15 – 8:30 am

IntroductionMichael J. Fossler, Jr., PharmD, PhD, FCP, Director, Clinical Pharmacology Modeling & Simulation, GlaxoSmithKline Inc

8:30 – 9:15 am

How to Choose and Work with an Executive RecruiterK. David Cadieu, President and CEO, KDC Group

9:15 – 10:00 am

Essentials for Effective Oral Communication

Brookie M. Best, PharmD, MAS Clinical Research, Associate Professor of Clinical Pharmacy and Pediatrics, Univ of California, San Diego

10:00 – 10:15 am

Break

10:15 – 11:00 am

Creating Effective Slide Presentations and PostersJeffrey S. Barrett, PhD, FCP, Professor, Children’s Hosp of Philadelphia

11:00 – 11:45 am

Managing Your Career in the Pharmaceutical IndustryMichael J. Fossler, Jr., PharmD, PhD, FCP, Director, Clinical Pharmacology Modeling & Simulation, GlaxoSmithKline Inc

11:45 am – 12:15 pm

Panel Discussion

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SATURDAY, SEPTEMBER 22, 2012WORKSHOP 2 l 8:30 am – 12:30 pm

Update on the Pharmacologic Management of Asthma in Children238-000-12-010-L01-P - ACPE 3.75 CONTACT HOURS, 0.375 CEU – KNOWLEDGE-BASED ACTIVITY.

THE ACCP DESIGNATES THIS LIVE ACTIVITY FOR A MAXIMUM OF 3.75 AMA PRA CATEGORY 1 CREDIT(S)™.

PHYSICIANS SHOULD CLAIM ONLY THE CREDIT COMMENSURATE WITH THE EXTENT OF THEIR PARTICIPATION IN THE ACTIVITY.

CHAIR:

Michael J. Welch, MD, FAAP, FAAAAI, Co-Director, Allergy & Asthma Medical Group & Research Ctr, Clinical Professor of Pediatrics, Univ of California, San Diego, School of Medicine

TARGET AUDIENCE:

This session is useful for clinical pharmacists (community or clinic-based), physicians, asthma educators and other healthcare medical professionals who care for children with asthma.


A basic knowledge of asthma, its pathophysiology and the pharmacotherapy used in treating the disease.

GOALS:

The educational goals of this session are to inform attendees of the latest approach to controlling asthma in children with the current pharmacological agents available; to further the understanding and awareness of the most recent national guidelines to be followed in treating children with chronic and acute asthma; and to identify the challenges in using inhaled asthma therapy in children and, in particular, the infant and toddler.

OBJECTIVES:


1. State the criteria for distinguishing between persistent asthma and intermittent asthma, in particular “the rule of 2’s”, and how it determines pharmacotherapy;

2. List the different steps of asthma therapy based on asthma severity and control;

3. State at least one difference and one similarity in treating children versus adults with asthma;

4. Explain how children who have exercise as an important trigger should be managed;

5. Be able to correctly advise and counsel proper inhaler therapy technique, including the use of dry powder devices, metered dose inhalers (MDI’s) and nebulizers and the various spacers used with an MDI.

8:

8:30 – 8:45 am

IntroductionMichael J. Welch, MD, FAAP, FAAAAI, Co-Director, Allergy & Asthma Medical Group & Research Ctr, Clinical Professor of Pediatrics, Univ of California, San Diego, School of Medicine

8:45 – 9:30 am

2012 Look at the 2007 NHLBI Guidelines on Diagnosis and Management of Asthma

Susan Laubach, MD, FAAP, Allergy & Asthma Medical Group & Research Ctr, Univ of California, San Diego, School of Medicine

9:30 – 10:15 am

Selecting Controller Therapy for Children: Evidence for Rational ChoicesPaul Williams, MD, FAAP, FAAAAI, Clinical Professor of Pediatrics, Univ of Washington, School of Medicine

10:15 – 10:30 am

Break

10:30 – 11:15 am

Managing Acute Asthma and the Child with Exercise-induced AsthmaNancy Ostrom, MD, FAAP, FAAAAI, Co-Director, Allergy & Asthma Medical Group & Research Ctr, Associate Clinical Professor, Dept of Pediatrics, Div of Allergy and Immunology, Univ of California, San Diego

11:15 am – 12:00 pm

Benefits, Challenges and Controversies of Inhaled Asthma Therapy in ChildrenMichael J. Welch, MD, FAAP, FAAAAI, Co-Director, Allergy & Asthma Medical Group & Research Ctr, Clinical Professor of Pediatrics, Univ of California, San Diego, School of Medicine

12:00 – 12:30 pm

Panel / Case Discussion / Q&A


14

SATURDAY, SEPTEMBER 22, 2012WORKSHOP 3 l 1:00 – 5:15 pm

Update on Psychotropics: New Agents and Guidelines238-000-12-011-L01-P - ACPE 4 CONTACT HOURS, 0.4 CEU – KNOWLEDGE-BASED ACTIVITY.

THE ACCP DESIGNATES THIS LIVE ACTIVITY FOR A MAXIMUM OF 4 AMA PRA CATEGORY 1 CREDIT(S)™.


CHAIR:

Kelly C. Lee, PharmD, BCPP, FCCP, Assistant Professor of Clinical Pharmacy, Univ of California, San Diego, Skaggs School of Pharmacy & Pharmaceutical Sciences

TARGET AUDIENCE:

This session will be useful for physicians, pharmacists, nurses, psychologists and mental health professionals.


None

GOALS:

The educational goals of this session are to review the recently published treatment guidelines for the management of depression, bipolar disorder and schizophrenia and to discuss the newly approved drugs used to treat these disorders.

OBJECTIVES:


1. Discuss the pertinent details of the recently published APA guidelines for major depression;

2. Evaluate the advantages and disadvantages of treatment strategies for bipolar disorder;

3. Compare the newly approved agents for the treatment of schizophrenia.

1:00 – 2:15 pm

Management of Major DepressionKelly C. Lee, PharmD, BCPP, FCCP, Assistant Professor of Clinical Pharmacy, Univ of California, San Diego, Skaggs School of Pharmacy & Pharmaceutical Sciences

2:15 – 3:00 pm (Part I)

Management of Bipolar Disorder Rene Endow-Eyer, PharmD, BCPP, Psychiatric Clinical Pharmacy Specialist, VA San Diego Healthcare System

3:00 – 3:15 pm

Break

3:15 – 3:45 pm (Part II)

Management of Bipolar Disorder, contRene Endow-Eyer, PharmD, BCPP, Psychiatric Clinical Pharmacy Specialist, VA San Diego Healthcare System

3:45 – 5:00 pm

Management of Schizophrenia & Psychotic DisordersKimberly Tallian, PharmD, BCPP, FASHP, FCCP, Pharmacy Clinical Manager, Scripps Memorial Hosp

5:00 – 5:15 pm

Panel Discussion / Q&A

Symposia

15

SUNDAY, SEPTEMBER 23, 2012SYMPOSIUM I l 8:00 – 11:15 am

Evaluating Drug-Drug Interactions with Therapeutic Proteins238-000-12-001-L01-P - ACPE 3 CONTACT HOURS, 0.3 CEU – KNOWLEDGE-BASED ACTIVITY.

THE ACCP DESIGNATES THIS LIVE ACTIVITY FOR A MAXIMUM OF 3 AMA PRA CATEGORY 1 CREDIT(S)™.


CO-CHAIRS:

Honghui Zhou, PhD, FCP, Head, Pharmacokinetics & Pharmacometrics, Biologics Clinical Pharmacology, Janssen Research & Development Stanley A. Roberts, PhD, DABT, President, SAR Safety Assessment

TARGET AUDIENCE:

This session will be useful for academic and industrial/regulatory scientists involved in drug development.


The audience should have a basic understanding of therapeutic proteins, pharmacokinetics, pharmacodynamics and drug-drug interactions.

GOALS:

The educational goal of this session is to review the current understanding of mechanisms for drug interactions with therapeutic proteins, the approaches for evaluating these interactions in both preclinical and clinical settings, and the scientific, regulatory and industrial perspective of the issues, knowledge gaps and future direction.

OBJECTIVES:


1. Review the current understanding of mechanisms for DDI with TP;

2. Assess the status approaches for evaluating these interactions and the scientific, regulatory and industrial perspective of the issues.

8:00 – 8:40 am

Potential Mechanisms of DDI with TPDonald E. Mager, PharmD, PhD, FCP, Associate Professor, School of Pharmacy and Pharmaceutical Sciences, Univ at Buffalo, SUNY

8:40 – 9:20 am

In Vitro / Preclinical Case Studies for DDI with TP

Frank-Peter Theil, PharmD, PhD, Head Nonclinical Development, UCB Pharma

9:20 – 9:35 am

Break

9:35 – 10:15 am

Clinical Evaluations of DDI with TPHonghui Zhou, PhD, FCP, Head, Pharmacokinetics & Pharmacometrics, Biologics Clinical Pharmacology, Janssen Research & Development

10:15 – 10:55 am

DDI with TP – Scientific, Regulatory and Industrial PerspectivesStanley A. Roberts, PhD, DABT, President, SAR Safety Assessment

10:55 – 11:15 am

Case Presentation / Panel Discussion

16

Symposia

SUNDAY, SEPTEMBER 23, 2012SYMPOSIUM II l 8:00 – 11:30 am

Developing Issues in Pediatric Clinical Pharmacology238-000-12-002-L01-P - ACPE 3.25 CONTACT HOURS, 0.325 CEU – KNOWLEDGE-BASED ACTIVITY.



CO-CHAIRS:

Edmund V. Capparelli, PharmD, Clinical Professor, Pediatric Pharmacology and Drug Discovery, Univ of California, San Diego, Dept of Pediatrics, School of Medicine

John van den Anker, MD, PhD, FCP, Vice Chair of Pediatrics for Experimental Therapeutics, Evan and Cindy Jones Professor of Pediatric Clinical Pharmacology, Chief, Div of Pediatric Clinical Pharmacology, Children’s National Medical Ctr & Professor of Pediatrics, Pharmacology & Physiology, George Washington Univ School of Medicine and Health Sciences

TARGET AUDIENCE:

This session will offer important knowledge and education for pharmacists, physicians, nurses, physician assistants, other healthcare professionals and research scientists in academia, hospitals, the private sector and regulatory agencies.


None

GOALS:

The educational goal of this session is to provide the participants with an understanding and appreciation for developmental changes in clinical pharmacology throughout the pediatric continuum. This will help recognize how to best utilize preclinical and adult information in treating and studying drugs in infants, children and adolescents.

OBJECTIVES:


1. Comprehend the critical role of immature drug metabolism and elimination processes in successful neonatal trial design and drug therapy;

2. Recognize developmental and pharmacogenomic influences on pediatric adverse drug reactions;

3. Discuss how existing pharmacometric tools can be used to address pediatric knowledge gaps in clinical trials;

OBJECTIVES CONT:

4. Identify the key pharmacologic issues in adolescent therapeutics and challenges in designing successful therapy in this population.

5. 8:00 – 8:35 am

Neonatal Pharmacology – Lost in TranslationJohn van den Anker, MD, PhD, FCP, Vice Chair of Pediatrics for Experimental Therapeutics, Evan and Cindy Jones Professor of Pediatric Clinical Pharmacology, Chief, Div of Pediatric Clinical Pharmacology, Children’s National Medical Ctr & Professor of Pediatrics, Pharmacology & Physiology, George Washington Univ School of Medicine and Health Sciences

8:35 – 9:10 am

Pharmacogenomics and Implications for Drug Effects in Children

J. Steven Leeder, PharmD, PhD, Chair in Pediatric Clinical Pharmacology, Children’s Mercy Hosp

9:10 – 9:45 am

Characterization of Pediatric Adverse Drug Reactions Through the Canadian National NetworkBruce Carleton, PharmD, Director Pharmaceutical Outcomes

Program, British Columbia Children’s Hosp

9:45 – 10:00 am

Break

10:00 – 10:35 am

Adolescent Clinical Pharmacology: Transition and TranslationMichael Spigarelli, MD, PhD, Professor Pediatrics, Univ of Utah

10:35 – 11:10 am

Use of PK / PD Modeling and Simulation to Optimize Pediatric TherapeuticsEdmund V. Capparelli, PharmD, Clinical Professor, Pediatric Pharmacology and Drug Discovery, Univ of California, San Diego, Dept of Pediatrics, School of Medicine

11:10 – 11:30 am


17

Symposia

SUNDAY, SEPTEMBER 23, 2012SYMPOSIUM III l 1:30 – 5:30 pm

The Changing Face of Pediatric Drug Development238-000-12-003-L01-P - ACPE 3.75 CONTACT HOURS, 0.375 CEU – KNOWLEDGE-BASED ACTIVITY.



CO-CHAIRS:

Robert L. Kunka, PhD, President, The Kunka Group Inc Kathryn Blake, PharmD, BCPS, FCCP, Sr Research Scientist, Ctr for Pharmacogenomics & Translational Research, Nemours Children’s Clinic

TARGET AUDIENCE:

This session will be useful for clinical researchers, physicians, pharmacists, nurses, other healthcare professionals and students actively involved in or planning to get involved in pediatric research.


None

GOALS:

The educational goals of this session are to describe the significant regulatory initiatives fueling pediatric development strategies in the pharmaceutical industry, to examine study designs used to implement these strategies and to review limitations and solutions of working in this population.

OBJECTIVES:


1. Translate a clinical strategy into specific clinical studies;

2. Utilize existing adult data to support a pediatric indication;

3. Develop clinical strategies for overcoming the inherent limitations of working in this population.

1:30 – 2:15 pm

The Changing Regulatory Environment of Pediatric Drug DevelopmentAlison Bowers, MSc, RAC, FTOPRA, Sr Consultant, PAREXEL Consulting

2:15 – 3:00 pm

Bridging to Adult Data and Formulations

Robert L. Kunka, PhD, President, The Kunka Group Inc

3:00 – 3:15 pm

Break

3:15 – 4:00 pm

Issues (and Solutions) in Pediatric Clinical TrialsKathryn Blake, PharmD, BCPS, FCCP, Sr Research Scientist, Ctr for Pharmacogenomics & Translational Research, Nemours Children’s Clinic

4:00 – 4:45 pm

Challenges Conducting Early Phase Pediatric PK Trials: Overview of OTC and Pulmonary ProgramsKenneth T. Kim, MD, Chief Executive Officer, West Coast Clinical Trials

4:45 – 5:30 pm


18

Symposia

SUNDAY, SEPTEMBER 23, 2012SYMPOSIUM IV l 1:30 – 5:00 pm

The Evolving Face of First-in-Human (FIH) Studies from the Investigators’ Perspective Cosponsored by ACPU238-000-12-004-L01-P - ACPE 3.25 CONTACT HOURS, 0.325 CEU – KNOWLEDGE-BASED ACTIVITY.



CO-CHAIRS:

Charles H. Pierce, MD, PhD, FCP, CPI, Medical Director, Metabolic & Atherosclerotic Research Ctr

Angela Baker, MHA, Sr Director, Business Development, CRI Lifetree

TARGET AUDIENCE:

Pharmaceutical firm holders of the IND for new products, Principal Investigators and Sub Investigators, Clinical Research Scientists (PKs, Biostatisticians), Safety Nurses, Clinical Research Associates (CRAs) and Coordinators (CRCs), recruiting staff, QA/QC Auditors and staff, Monitors & Clinical Research Data Managers.


The audience should be well versed and have knowledge about all of the phases of drug development, so as to appreciate the differences in FIH studies, as compared to later in the drug development scheme.

GOALS:

The educational goal of this session is to provide the framework, so all who work in the drug development arena understand the changes that have occurred in Phase I, especially FIH studies.

OBJECTIVES:

At the conclusion of this program, participants should be able to:1. Describe the elements of a good CPU;2. Identify what is needed to make a Phase I program;3. Describe how the starting dose is chosen;4. Identify why extended safety testing is important;5. Recognize the importance of considering usability of data versus

need to collect data;6. Identify two potential problems with high volume data collection in

FIH studies;7. Identify how the “Adaptive Design” protocol works;8. Explain why monitoring in Phase I is different.

1:30 – 1:40 pm

IntroductionCharles H. Pierce, MD, PhD, FCP, CPI, Medical Director, Metabolic & Atherosclerotic Research Ctr

Angela Baker, MHA, Sr Director, Business Development, CRI Lifetree

1:40 – 2:25 pm

The Investigators’ Perspective of the Pre-study Feasibility Assessment and Dose Escalation Safety Review

Jon Ruckle, MD, Principal, Pacific Pharma Group LLC

Royce Morrison, MD, CPI, Chief Medical Officer, Comprehensive Clinical Development

2:25 – 3:00 pm

Be Careful If You Ask for the Kitchen Sink – It May Be Full of Dirty DishesDonna Dorozinsky, MSN, CCRC, President, DWD & Associates Inc

3:00 – 3:15 pm

Break

3:15 – 4:00 pm

Safety Challenges and Developing Models for Emergency Response Coverage for FIH StudiesRandall R. Stoltz, MD, CPI, Medical Director, Clinical Research Unit, Covance

Walter K. Kraft, MD, FACP, Director, Thomas Jefferson Univ Clinical Research Unit & Associate Professor, Pharmacology and Experimental Therapeutics, Thomas Jefferson Univ

4:00 – 4:45 pm

SAD / MAD Combined with POC and Patient CohortsWilliam B. Smith, MD, FACC, Professor of Medicine, Univ of Tennessee Medical Ctr and President, New Orleans Ctr for Clinical Research and Volunteer Research Group

Bradley D. Vince, DO, President and Medical Director, Vince and Associates Clinical Research

4:45 – 5:00 pm

Panel Discussion

19

Symposia

MONDAY, SEPTEMBER 24, 2012SYMPOSIUM V l 8:00 am – 4:15 pm

Innovations in Drug Therapies – The Future is Now{ THIS SESSION HAS NOT BEEN DESIGNATED FOR CME OR CPE CREDIT }

CO-CHAIRS:

Ronald J. Christopher, PhD, Vice President, Preclinical Development, Arena Pharmaceuticals Inc Lakshmi Putcha, PhD, Clinical Pharmacologist/Technical Manager, Human Adaptation & Countermeasures Div, SK/NASA Johnson Space Ctr

TARGET AUDIENCE:

This session will be useful for healthcare professionals, including physicians, pharmacists, and academic and industrial pharmaceutical/biotech professionals working in drug development who have an interest in the most current clinical testing paradigms in the industry. The information presented as part of this session will offer state-of-the-art technological advances in clinical testing and R & D strategies supporting their development.


Participants should have basic background knowledge of the drug development process. This session will be of special interest to those who are involved with clinical testing and have an interest in unique drug therapies currently being tested.

GOALS:

The educational goal of this session will be to provide practical aspects and critical strategic approaches in developing and applying novel drug therapies/diagnostics in clinical testing with a preventive healthcare perspective.

OBJECTIVES:


1. Understand practical aspects of novel therapies and clinical study designs from perspectives of pharmaceutical executives and clinical scientists from academia, the pharmaceutical industry and contract research organizations;

2. Describe new approaches and strategies applied to developing clinical advances relevant to unique drug therapies;

3. Identify unique challenges and examples of potential issues with developing small molecules, stem cell therapies and application of medical diagnostics;

4. Describe the current advances in novel medicines, medical diagnostics/devices and biomarkers supporting the development of such therapeutics.

8:00 – 8:15 am

Introduction and Overview of the Future of Novel Therapies & Medical DiagnosticsRonald J. Christopher, PhD, Vice President, Preclinical Development, Arena Pharmaceuticals Inc

8:15 – 8:45 am

Induced Pluripotent Stem Cell Technologies – Opportunities and Challenges

John Mendlein, PhD, Chief Executive Officer, Fate Therapeutics Inc

8:45 – 9:15 am

New Ways to Treat Bacterial InfectionsMichael N. Dudley, PharmD, Sr Vice President of Research and Development & Chief Scientific Officer, Mpex Pharmaceuticals Inc

9:15 – 9:45 am

New Therapeutic Approaches for Treating Pulmonary DiseaseGene Colice, MD, Professor & Director, Pulmonary, Critical Care and Respiratory Services, The George Washington Univ School of Medicine

9:45 – 10:00 am

Break

10:00 – 10:30 am

New Therapeutic Approaches Using Silencing RNA TechnologyAkshay K. Vaishnaw, MD, PhD, Sr Vice President & Chief Medical Officer, Alnylam Pharmaceuticals Inc

10:30 – 11:00 am


Lunch Break

1:30 – 1:35 pm

Introduction – Biopharmaceutical Challenges of Space MedicineLakshmi Putcha, PhD, Clinical Pharmacologist/Technical Manager, Human Adaptation & Countermeasures Div, SK/NASA Johnson Space Ctr

20

Symposia

1. 2. 1:35 – 2:05 pm

New Drugs in the Management of Intestinal Motility DisordersMark Pimentel, MD, Associate Professor of Medicine, GI Motility Program, Cedars-Sinai Medical Ctr

2:05 – 2:35 pm

Nanomedicine for Cancer Therapeutics – Opportunities and Challenges

Bruce D. Given, MD, Chairman, ICON Plc

2:35 – 3:05 pm

Engineering Nanoparticles for BiomedicineJunghae Suh, PhD, Assistant Professor, Dept of Bioengineering, Rice Univ

3:05 – 3:20 pm

Break

3:20 – 3:50 pm

An Astronaut’s Perspective on Human Healthcare for Space ExplorationMichael R. Barratt, MD, MS, Astronaut, Director of Human Research Program, NASA Johnson Space Ctr

3:50 – 4:15 pm


MONDAY, SEPTEMBER 24, 2012SYMPOSIUM VI l 8:00 – 11:30 am

Pharmacometrics Influencing Hospital-based Pharmacotherapy238-000-12-005-L01-P - ACPE 3.25 CONTACT HOURS, 0.325 CEU – KNOWLEDGE-BASED ACTIVITY.



CO-CHAIRS:

Ayyappa Chaturvedula, PhD, Visiting Assistant Research Professor,Director, Ctr for Pharmacometrics, Mercer Univ, Coll of Pharmacy and Health Sciences Roger W. Jelliffe, MD, FCP, Professor of Medicine, Dept of Medicine, Univ of Southern California, Keck School of Medicine

TARGET AUDIENCE:

This session is useful for physicians, pharmacists, clinical toxicologists, clinical pharmacologists and biomedical scientists with an interest in therapeutic drug monitoring, in population pharmacokinetic and pharmacodynamic modeling and especially in optimal individualization of drug therapy for direct patient care.


A basic understanding of pharmacokinetics and principles of therapeutic drug monitoring.

GOALS:

The educational goals of this session are to provide the rationale for individualized therapy; to illustrate pharmacometric tools for accomplishing individualized therapy; and to understand the implementation of pharmacometrics in a hospital-based setting for direct patient care.

OBJECTIVES:


1. Recognize the need for individualized pharmacotherapy;

2. Discuss the pharmacometric tools and applications in individualized pharmacotherapy;

3. Apply the technique in their current practice;

4. Identify the areas where further research is needed for successful implementation of clinical pharmacometrics.

8:00 – 8:15 am

The Need for Individualized Therapy – Review of Previous WorkAyyappa Chaturvedula, PhD, Visiting Assistant Research Professor,Director, Ctr for Pharmacometrics, Mercer Univ, Coll of Pharmacy and Health Sciences

8:15 – 8:45 am

An Overview of Individualized Therapy: Tools and Techniques

Roger W. Jelliffe, MD, FCP, Professor of Medicine, Dept of Medicine, Univ of Southern California, Keck School of Medicine

21

Symposia

8:45 – 9:45 am

Pharmacometrics-driven Daily Clinical Decision Making: Implementing Pharmacometrics Service in Hospital SettingMichael Neely, MD, FCP, Assistant Professor of Pediatrics, Univ of Southern California, Keck School of Medicine

9:45 – 10:00 am

Break

10:00 – 10:30 am

Optimization of Transplant Therapy by PharmacometricsAlexander A. Vinks, PharmD, PhD, FCP, Professor of Pediatrics and Pharmacology, Univ of Cincinnati, Coll of Medicine and Director, Div of Clinical Pharmacology, Cincinnati Children’s Hosp Medical Ctr

10:30 – 11:00 am

New Work to Be DoneDavid Bayard, PhD, Sr Scientist, Jet Propulsion Laboratory, California Inst of Technology

11:00 – 11:30 am

Panel Discussion

MONDAY, SEPTEMBER 24, 2012SYMPOSIUM VII l 1:30 – 5:00 pm

Clinical Translational Biomarkers Facilitating Transition From Bench to Bedside: Basic Concepts, Successful Case Studies and Regulatory Viewpoints238-000-12-006-L01-P - ACPE 3.25 CONTACT HOURS, 0.325 CEU – KNOWLEDGE-BASED ACTIVITY.



CO-CHAIRS:

Lucy Lee, PharmD, FCP, Associate Director, Translational Medicine & Clinical Pharmacology, Daiichi Sankyo Pharma Development Michael Tortorici, PharmD, PhD, Associate Director, Clinical Pharmacology, Pfizer Inc, Specialty Care Business Unit

TARGET AUDIENCE:

This session will be useful for physicians, scientists and clinical pharmacologists from academia, industry and regulatory agencies who are involved with drug development.


None

GOALS:

The educational goals of this session are to introduce participants to the use of translational medicine and biomarkers; to demonstrate successful case studies which use translational medicine and biomarkers in personalized medicine; to discuss the use of quantitative pharmacology and biomarker applications in identifying optimal dose/dosing regimens; and to update the current and prospective regulatory views on translational biomarkers in both exploratory (early) and validation (late) stages of development.

OBJECTIVES:


1. Describe translational medicine and different types of biomarkers and their uses in clinical development;

2. List a few examples of currently approved drugs where translational medicine and biomarkers were used in their development;

3. State, generally, the regulatory views on use of translational biomarkers in drug development.

1:30 – 2:00 pm

Basic Concepts in Translational Medicine and Biomarkers: Optimizing Patient CareChris H. Takimoto, MD, PhD, FACP, Vice President, Translational Medicine Early Development, Ortho Biotech Oncology R&D/Johnson & Johnson PRD

2:00 – 2:30 pm

Successful Case Studies – Personalized Medicine: Mutated V600E BRAF Inhibitor in Patients with Melanoma

Jeffrey A. Sosman, MD, Professor of Medicine, Medical Oncologist & Director, Melanoma and Tumor Immunotherapy Program, Vanderbilt-Ingram Cancer Ctr

22

Symposia

2:30 – 3:00 pm

Successful Case Studies – Functional Imaging: FDG-PET as Early Response Marker in Patients with GISTAnnick D. Van den Abbeele, MD, Professor of Radiology, Dept of Radiology, Harvard Medical School & Director, Ctr for Biomedical Imaging in Oncology (CBIO), Radiology, Dana-Farber Cancer Inst

3:00 – 3:15 pm

Break

3:15 – 3:45 pm

Applications of Quantitative Pharmacology: Pharmacokinetic – Pharmacodynamic Modeling & Simulation for Identifying Optimal Biologic DoseDonald E. Mager, PharmD, PhD, FCP, Associate Professor, School of Pharmacy and Pharmaceutical Sciences, Univ at Buffalo, SUNY

3:45 – 4:15 pm

Safety Biomarkers: Lessons Learned and Their Utility in Early Clinical DevelopmentJonathan Deutsch, MD, Therapeutic Area Safety Head, Oncology, Johnson & Johnson Pharmaceutical Research & Development LLC

4:15 – 4:45 pm

Regulatory Views: Current Status and Validation / Qualifications of Biomarkers in Phase II & III DevelopmentLawrence J. Lesko, PhD, FCP, Professor, Univ of Florida at Lake

Nona (Orlando), c/o Sanford-Burnham Medical Research Inst at Lake Nona

4:45 – 5:00 pm

Problem-based Case Study

TUESDAY, SEPTEMBER 25, 2012SYMPOSIUM VIII l 8:00 – 11:30 am

Speeding Up the Development of New Anti-infective Drugs to Combat Drug Resistance{ THIS SESSION HAS NOT BEEN DESIGNATED FOR CME OR CPE CREDIT }

CO-CHAIRS:

Hartmut Derendorf, PhD, Distinguished Professor and Chairman, Dept of Pharmaceutics, Univ of Florida Vincent H. Tam, PharmD, BCPS (Infectious Diseases), Associate Professor, Dept of Clinical Sciences and Administration, Univ of Houston Coll of Pharmacy

TARGET AUDIENCE:

This session will be useful for physicians prescribing anti-infective medications in guiding them to pay attention to appropriate dosing and length of therapy. This session will also be useful to pharmacists involved in antibiotic stewardship programs in guiding them to make appropriate decisions on drug selection and dosing. Furthermore, this session will be useful for scientists involved in anti-infective drug discovery and development, since rational development strategies will be presented that allow streamlining the process and thereby lowering drug development costs.


Participants should have a doctoral degree in a healthcare profession (medicine, pharmacy, clinical microbiology) or have an interest in patient care or drug development.

GOALS:

The educational goals of this session are to inform attendees of the rationale and approach to speed up the development of new anti-infective agents; to further the understanding of the impact of pharmacokinetic and pharmacodynamic modeling on anti-infective drug development; and to identify the impact of poor adherence on drug development, clinical outcome and resistance development.

OBJECTIVES:


1. Utilize and/or interpret modern modeling and simulation technologies to integrate pharmacokinetic and pharmacodynamic properties of new anti-infective drug candidates;

2. Be able to assess the impact of poor adherence on therapeutic outcome and resistance development, as well as recognize its impact on potential poor outcome of clinical trials.

23

Symposia

8:00 – 8:40 am

Pharmacokinetic Issues in Overcoming Resistance: Protein Binding and MicrodialysisHartmut Derendorf, PhD, Distinguished Professor and Chairman, Dept of Pharmaceutics, Univ of Florida

8:40 – 9:20 am

Pharmacodynamic Issues in Overcoming Resistance: Kill Curves and MICsVincent H. Tam, PharmD, BCPS (Infectious Diseases), Associate Professor, Dept of Clinical Sciences and Administration, Univ of Houston Coll of Pharmacy

9:20 – 9:35 am

Break

9:35 – 10:15 am

Drug Discovery and Development Strategies to Overcome ResistanceMichael N. Dudley, PharmD, Sr Vice President, Research &

Development and Chief Scientific Officer, Rempex Pharmaceuticals Inc

10:15 – 10:55 am

Ensuring Adherence – A Key to Combat ResistanceDonn Dennis, MD, Chief Science Officer, Xhale Inc

10:55 – 11:30 am

Case Presentation

TUESDAY, SEPTEMBER 25, 2012SYMPOSIUM IX l 8:00 am – 12:00 pm

Hepatitis C – An Expanding Area of Drug Development and Clinical Pharmacology238-000-12-007-L01-P - ACPE 3.75 CONTACT HOURS, 0.375 CEU – KNOWLEDGE-BASED ACTIVITY.



CO-CHAIRS:

Shirley M. Tsunoda, PharmD, Assistant Clinical Professor of Pharmacy, Univ of California, San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Alexander Kuo, MD, Assistant Professor and Medical Director of Liver Transplantation, Dept of Medicine, Div of Gastroenterology, Univ of California, San Diego

TARGET AUDIENCE:

This session will offer important knowledge and education for pharmacists, physicians, nurses, physician assistants and other healthcare professionals and research scientists in academia, hospitals, the private sector and regulatory agencies.


None

GOALS:

The educational goal of this session is to provide participants with practical, clinical and research-related information to support the assessment and management of patients with chronic hepatitis C.

OBJECTIVES:


1. Identify several hepatitis C viral targets for drug development;

2. Discuss new strategies for the treatment of hepatitis C virus including combination therapy;

3. Outline the FDA process for new drug applications for hepatitis C compounds;

4. Discuss strategies to incorporate pharmacogenetics to individualize hepatitis C therapy.

8:00 – 8:15 am

IntroductionAlexander Kuo, MD, Assistant Professor and Medical Director of Liver Transplantation, Dept of Medicine, Div of Gastroenterology, Univ of California, San Diego

8:15 – 9:00 am

Hepatitis C VirusRobert T. Schooley, MD, Professor & Head, Div of Infectious Diseases, Dept of Medicine & Executive Vice Chair for Academic Affairs, Univ of California, San Diego

24

Symposia

9:00 – 9:45 am

New Strategies in the Therapeutic Management of Hepatitis CRobert G. Gish, MD, Medical Director, Hepatobiliary Disease and Abdominal Transplantation, Chief of Hepatology, Professor of Medicine, Univ of California, San Diego

9:45 – 10:00 am

Break

10:00 – 10:45 am

FDA Perspectives on Trial Design and Submissions for Hepatitis CKimberly Struble, PharmD, Clinical Analyst Team Leader, Office of New Drugs, Food and Drug Administration

10:45 – 11:30 am

Future Directions of Hepatitis C Management, Individualized Therapy, New Drugs in the PipelineJohn G. McHutchison, MD, Sr Vice President, Liver Disease Therapeutics, Gilead Sciences Inc

11:30 am – 12:00 pm


TUESDAY, SEPTEMBER 25, 2012SYMPOSIUM X l 1:30 – 5:00 pm

Chronic Pain: Underdiagnosed, Undertreated and Misunderstood238-000-12-008-L01-P - ACPE 3.25 CONTACT HOURS, 0.325 CEU – KNOWLEDGE-BASED ACTIVITY.



CO-CHAIRS:

Rabia S. Atayee, PharmD, BCPS, Assistant Clinical Professor of Pharmacy, Univ of California, San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences and Doris A. Howell Palliative Care Service

CO-CHAIRS CONT:

Joseph D. Ma, PharmD, Assistant Professor, Univ of California, San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences

TARGET AUDIENCE:

This session will offer important knowledge and education for pharmacists, physicians, nurses, physician assistants, other healthcare professionals and research scientists in academia, hospitals, the private sector and regulatory agencies.


None

GOALS:

The educational goal of this session is to provide participants practical, clinical and research-related information to support the assessment and management of patients with chronic pain.

OBJECTIVES:


1. Recognize the various pharmacological agents used to treat and manage chronic pain;

2. Identify at least one misconception when treating chronic pain patients;

3. Calculate the importance of determining efficacy with human, chronic pain models;

4. Discuss study design aspects specific for chronic pain clinical studies.

1:30 – 1:40 pm

IntroductionRabia S. Atayee, PharmD, BCPS, Assistant Clinical Professor of Pharmacy, Univ of California, San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences and Doris A. Howell Palliative Care Service

1:40 – 2:20 pm

Overview and Clinical Pharmacology of Chronic PainMaria Foy, PharmD, CDE, Clinical Specialist, Pharmacy Dept, Abington Memorial Hosp

2:20 – 3:00 pm

Treating Chronic Pain Patients – A Challenge or An Opportunity?Chris M. Herndon, PharmD, Assistant Professor, Southern Illinois Univ, Edwardsville School of Pharmacy and St Louis Univ School of Medicine

3:00 – 3:15 pm

Break

25

Symposia

3:15 – 3:55 pm

Assessing Analgesic Efficacy with Human, Chronic Pain ModelsMark S. Wallace, MD, Clinical Professor, Dept of Anesthesiology, Univ of California, San Diego

3:55 – 4:35 pm

Clinical Trial Considerations and Design for Chronic PainMichael C. Rowbotham, MD, Scientific Director, California Pacific Medical Ctr Research Inst

4:35 – 5:00 pm

Q&A

TUESDAY, SEPTEMBER 25, 2012SYMPOSIUM XI l 1:30 – 5:00 pm

“Return on Investment” in Pharmacometrics{ THIS SESSION HAS NOT BEEN DESIGNATED FOR CME OR CPE CREDIT }

CO-CHAIRS:

Jogarao Gobburu, PhD, FCP, MBA, Professor, Univ of Maryland, School of Pharmacy Ivan Nestorov, PhD, Director, Pharmacometrics, Biogen Idec

TARGET AUDIENCE:

This session is intended not only for scientists with direct involvement in pharmacometric evaluations, but also for clinical pharmacologists, managers and biomedical scientists with an interest in drug development sciences in general.


Some knowledge of the drug development process will be necessary.

GOALS:

The educational goals of this session are to evaluate the contributions of pharmacometric activities in terms of time savings, cost savings, generating new scientific hypotheses and improvements in therapeutics, as well as ways to increase and improve the impact of pharmacometrics.

OBJECTIVES:


1. Forecast the benefit of pharmacometric activities in terms of time savings, cost savings, generating new scientific hypotheses and improvements in therapeutics;

2. Identify ways to increase and improve the impact of a pharmacometric exercise;

3. Demonstrate the cost and time benefits of a pharmacometric exercise.

1:30 – 2:00 pm

Introduction – Current Status and Future Trends in PharmacometricsJogarao Gobburu, PhD, FCP, MBA, Professor, Univ of Maryland, School of Pharmacy

2:00 – 2:30 pm

Case Study 1: First-in-Human / Transition from Discovery to DevelopmentJenny Chien, PhD, Sr Research Advisor, Early Clinical Implementation Team Leader, Global Pharmacokinetics/Pharmacodynamics and Pharmacometrics, Lilly Research Laboratories, Eli Lilly & Co

2:30 – 3:00 pm

Case Study 2: Early Development (Phases 1 and 2)Honghui Zhou, PhD, FCP, Head, Pharmacokinetics & Pharmacometrics, Biologics Clinical Pharmacology, Janssen Research & Development

3:00 – 3:15 pm

Break

3:15 – 3:45 pm

Case Study 3: Late Development (Phases 1 through 4) Business Impact of Modeling & Simulation in PfizerSriram Krishnaswami, PhD, FCP, Director, Specialty Care Clinical Pharmacology, Pfizer Inc

3:45 – 4:15 pm

Case Study 4: Approval & LabelingYaning Wang, PhD, Associate Director for Science, Div of Pharmacometrics, Food & Drug Administration

4:15 – 5:00 pm

Panel Discussion

Why Join ACCP?

26

Why Join ACCP?

Boasting a rich 40-year history, ACCP has a diverse global membership of healthcare professionals dedicated to improving health by optimizing therapeutics. ACCP seeks to improve the quality of instruction in clinical pharmacology and its position in curriculum planning at schools of medicine, pharmacy and other disciplines around the world. Individuals can participate in meetings or online educational activities on cutting-edge, relevant topics related to clinical pharmacology and the optimal use of therapeutics. These interactions provide a forum for new scientific ideas and bring together healthcare professionals of various disciplines to meet and discuss areas of common interest. ACCP is one of the few organizations to still offer Continuing Medical Education (CME) and Continuing Pharmacy Education (CPE) credit for qualified professionals. In addition to collegial exchange and networking opportunities, ACCP publishes The Journal of Clinical Pharmacology and the Clinical Pharmacology in Drug Development eJournal, both of which are provided to Members at no additional cost.

Join ACCP Today

GENERAL BENEFITS:

•Access to The Journal of Clinical Pharmacology and Clinical Pharmacology in Drug Development

•Interdisciplinary accredited educational programs

•International scientific forums

•Online resources & learning tools

•Educational program registration discounts

•Collegial exchange & networking opportunities

•Career-enhancing opportunities

•Multi-disciplinary environment

•Member-driven/Member-focused environment

BENEFITS THROUGH EMAIL:

•FDA News Drug Daily Bulletin

•Routine Recall/Drug Safety Notices from FDA MedWatch

•“Online First” and Table of Contents Alerts for The Journal of Clinical Pharmacology

•Quarterly Notifications on Clinical Pharmacology in Drug Development

•Relevant communications regarding ACCP and its activities

BENEFITS THROUGH THE ACCP WEBSITE:

•Continuing Education Programs

•Student & Trainee-specific materials

•Career Center Listing

•Public Policy Alerts

•Grants & Funding Opportunities

PASSWORD-PROTECTED MEMBERS ONLY AREA OF ACCP WEBSITE:

•Membership Directory

•Online access to The Journal of Clinical Pharmacology (archived issues from 1961) and Clinical Pharmacology in Drug Development

Registration Information

27

CANCELLATION / REFUND POLICY:

Meeting registration cancellations must be submitted via email to [email protected] no later than August 17th and are subject to a $250.00 nonrefundable processing fee.

The transfer of your registration to another person will be considered by contacting [email protected] or 240-399-9070, ext. 4.

REGISTRATION DEADLINE for Pre-meeting Workshops is August 17, 2012. This will minimize the possibility of cancellations due to failure to meet attendance requirements. ACCP reserves the right to cancel Pre-meeting Workshops due to low attendance. Should cancellation be required, registrants will receive a full refund for the cost of the Pre-meeting Workshop only.

Registration Information

ACCP continues to offer exciting educational opportunities for a broad spectrum of healthcare professionals to earn Continuing Education credit while attending live, concurrent Pre-meeting Workshops and Symposia. Register today and join a global audience of healthcare professionals in a focused, educational atmosphere that also provides time to network with colleagues, new and old. Join ACCP now and immediately enjoy Member Benefits, including discounts on registration for the Annual Meeting and other ACCP Continuing Education events.

REGISTRATION INFORMATION EARLY BIRD

4/1/2012 – 7/1/2012 REGULAR

7/2/2012 – 9/21/2012ONSITE

9/22/2012 – 9/25/2012

Member – Three Days $700 $975 $1,100

Member – One Day $350 $400 $450

Non-member – Three Days $1,100 $1,375 $1,500

Non-member – One Day $450 $500 $550

Student Member – Three Days $265 $315 $350

Student Member – One Day $140 $165 $180

Student Non-member – Three Days $385 $435 $470

Student Non-member – One Day $175 $200 $215

Pre-meeting Workshops – Member Half Day $250 $275 $300

Pre-meeting Workshops – Non-member Half Day $275 $300 $325

Pre-meeting Workshops – Student Member or Non-member Half Day $100 $100 $100

2012 ACCP ANNUAL MEETING

International Attendees

28

International Attendees

If you are not a US citizen and are planning to attend the ACCP Annual Meeting, please make your travel plans early and plan properly. You should begin applying for a US Visa at least 90 days before your travel dates for this event.

Additional information is available regarding the process for obtaining a US Visa.

CRITICAL ESTA INFORMATION:

Effective January 20, 2010, citizens of Visa Waiver countries will be unable to enter the United States without Electronic System for Travel Authorization (ESTA) approval from the US Government. Visa Waiver Program travelers who have not obtained proper approval through ESTA will not be allowed to board on any air carrier destined for the United States.

More information on this critical step is available at ESTA Travel.

Effective September 8, 2010, all Electronic System for Travel Authorization (ESTA) registration applications or renewals on or after that date will require a $14.00 fee payment by credit or debit card. Existing ESTA registrations remain valid through their expiration date. For more information, please visit the ESTA webpage on the Department of Homeland Security, Customs and Border Protection website.

Additional information is available at ESTA Video.

Learn more about ESTA at DHS Customs and Border Protection (CBP).

ESTA applications may be completed online at the DHS website.

Review the important DHS Advisory Warning about unauthorized third-party ESTA application related websites.

Please see the following sites for more information on Travel to the United States:

US-Visit (Department of Homeland Security)

US Embassies and Consulates Worldwide

US Department of State

Request a Letter of Invitation to Attend the ACCP Annual Meeting

Travel and Hotel

29

Travel

Please note: It is important that all travel arrangements be made for arrival at the San Diego International Airport – Airport Code: SAN

MEETING LOCATION:

The 2012 ACCP Annual Meeting is being held at the Sheraton San Diego Hotel & Marina, less than one mile from the San Diego International Airport. COMPLIMENTARY AIRPORT SHUTTLE:

The Sheraton San Diego Hotel & Marina provides a complimentary airport shuttle to and from San Diego International Airport 24 hours a day. From 4:45 am to 12:00 am, the shuttle runs every 20 minutes between the two locations. Outside of these hours, guests may request a pickup by phoning the hotel directly at (619) 291-2900. The shuttle vans are grey, blue and white and run between the Marina Hotel and Bay Towers and airport Terminals 1 & 2.

Shuttle service is available at the Transportation Plazas across from Terminals 1 and 2, and curbside at the Commuter Terminal. From Terminal 1, you must cross the skybridge, and take either the escalators or the elevators to street level. From Terminal 2, cross the Terminal 2 skybridge and take either the escalators or the elevators to street level, or use the pedestrian crosswalk conveniently located outside the Terminal 2 Baggage Claim Area to access the Transportation Plaza.

General Directions to the Hotel

Hotel Reservations at the Sheraton Hotel & Marina

Housing Reservation Deadline: August 29, 2012

ACCP is proud to host the 2012 Annual Meeting at the Sheraton San Diego Hotel & Marina, located within one mile of the San Diego International Airport.

Room rates are $169.00 + tax per night for a single or double room. Triple ($189.00 + tax per night) or Quad rooms ($209.00 + tax per night) are subject to availability. The tax rate for this hotel is 12.565%.

Hotel check-in: 3:00 pm & check-out: 12:00 pm Make Reservations online or directly by phone by calling ACCP’s Housing Bureau at (800) 456-3585 (9:00 am – 5:00 pm, Eastern Time). Meeting delegates residing outside of the US should call (302) 658-3585.

SHERATON EARLY CHECKOUT POLICY:

Guests who check out of the hotel prior to their scheduled departure date will be charged a penalty of $100. The departure date may be changed up until the day of arrival.

• Normal check-in date: 9/22/2012• Normal check-out date: 9/25/2012 If you would like to arrive at an earlier date and/or extend your stay for additional nights, rooms for the nights of 9/21/2012 through 9/25/2012 have limited availability and may be booked through the ACCP Housing Bureau.

Travel and Hotel

30

After completing your online reservation request, you will receive an email confirmation of your reservation. If you do not receive your reservation, please check any spam or bulk folders before contacting ACCP’s Housing Bureau.

CANCELLATION POLICY:

You may cancel your reservation up to three days (72 hours) before the check-in date without penalty. “No shows” will be charged for a one-night stay. To make changes or to cancel, please do so ONLY by contacting ACCP’s Housing Bureau or by calling (800) 456-3585 (9:00 am – 5:00 pm Eastern Time). Please note that ACCP cannot guarantee that cancellations made using any other method will be processed appropriately and that ACCP holds no responsibility in such an event.

Learn more about the amenities at the Sheraton San Diego Hotel & Marina.

Onsite Restaurants at the Sheraton San Diego Hotel & Marina

Harbor’s Edge – the main dining room, open for breakfast, lunch and dinner, caters to your palate with contemporary American cuisine.

Shoreline Restaurant – poolside snacks, drinks and grilled favorites.

Tapatini - Tapas & Wine Bar – enjoy martinis and Spain’s legendary tapas.

Quinn’s – friendly sports bar has views of the WaterWorks pool and Marina and features entertainment, billiards, signature favorites, and local micro brews.

Bay Tower Lounge – located in Bay Tower, this quaint lounge offers a light breakfast alternative in the morning or comfort food and a cocktail in the afternoon.

Starbucks – treat yourself to coffees, tasty baked goods, and select merchandise at the convenient on-site location.

Travel and Hotel

31

Things to do

LOCAL AREA:

Sheraton San Diego Hotel & Marina enjoys a prime waterfront location on lovely San Diego Bay. Many of the area’s most popular attractions are within walking distance or a short drive, including the San Diego Zoo, Gaslamp Quarter and Sea World Park. Shops and restaurants abound at nearby Horton Plaza, and the famous border town of Tijuana beckons you to sunny Mexico, less than an hour away.

Semi-tropical San Diego, with its mean temperature of 70° F, Mediterranean-like, white-washed stucco buildings and strong cultural influences from sunny Mexico, is as close to visiting a foreign country as visitors could get and yet, is as American as apple pie.

Spanning from the North County beach areas to the South Bay cities along the Mexican border, San Diego is one of the top ten largest cities in the United States. While all these areas fall under the San Diego umbrella, each individual community maintains its own personality, geography and identity. Truly, in San Diego’s case, the whole is greater than the sum of its parts.

Less than three miles from the airport is downtown proper. This thriving commercial area with its active waterfront is a bustling, colorful combination of major hotels, convention facilities, restaurants, nightclubs and shopping venues. Its focal point is the Horton Plaza, an architectural masterpiece that holds trendy shops, lively restaurants, a theatre and even an ice rink during the holiday season. Just east of the Horton Plaza is the Gaslamp Quarter, a 16-block source of civic pride. Once slated for destruction, this area has been reclaimed by the people of San Diego thanks to the 1970’s Redevelopment Plan. Where once dilapidated warehouses and run-down Victorian houses

stood, and where no one dared to enter after dark, the Gaslamp Quarter has now become the pulse of the city.

Due west of the city proper is the Embarcadero, a fun daytime location where visitors can take in leisurely views of the bay, hop aboard a harbor cruise or enjoy seafood at its finest. For shopping, visit Seaport Village, a 14-acre shopping and dining complex designed to emulate early California-style architecture.

LOCAL ATTRACTIONS INCLUDE:

San Diego Embarcadero

San Diego Zoo

Balboa Park

Gaslamp Quarter

La Jolla

Old Town

Coronado

Del Mar

Sea World

Please also visit: San Diego Convention & Visitors Bureau for more information on surrounding areas and a calendar of events for September.

Who We Are

Who We Are

Boasting a rich 40-year history, ACCP has a diverse global membership dedicated to improving the quality of patient care by optimizing the use of therapeutics. The College achieves this by providing Continuing Education to a broad range of clinicians and healthcare professionals involved in patient care and research. Individuals can participate in meetings or in online and Internet enduring educational activities that provide a forum for new scientific ideas and bring together healthcare professionals of various disciplines to meet and discuss areas of common interest.

ACCP is one of the few organizations to still offer Continuing Medical Education (CME) and Continuing Pharmacy Education (CPE) credit for qualified professionals. In addition to collegial exchange and networking opportunities, ACCP publishes The Journal of Clinical Pharmacology and the Clinical Pharmacology in Drug Development eJournal, both of which are provided to Members at no additional cost.

DISTRIBUTION OF MEMBERSHIP BY DEGREE

Other

PharmD

MD

PhD

Academic Medical Center

Biotech

Community Hospital

Pharma

CRO

Government Regulatory

Private Practice

Other

PharmD

MD

PhD


Biotech

Community Hospital

Pharma

CRO


Private Practice

DISTRIBUTION OF ACCP MEMBERSHIP BY ORGANIZATIONAL AFFILIATION

Other

PharmD

MD

PhD


Biotech

Community Hospital

Pharma

CRO


Private Practice

Other

PharmD

MD

PhD


Biotech

Community Hospital

Pharma

CRO


Private Practice

32

33

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.

Why Should You Exhibit at, Sponsor or Support the 2012 ACCP Annual Meeting?

ACCP’s meeting attendees have indicated that exhibits help them evaluate and plan future purchases for their own clinical and research institutions and private practices. Attendees are particularly interested in new, cutting-edge tools to increase the efficiency of patient care and drug development. Get direct access to decision makers who are seeking face-to-face interactions and who are interested in more information from valuable product and service providers that can help them achieve their goals. Exhibiting at the ACCP Annual Meeting directly positions you to present your products, solutions or services and can help your company meet sales and business development objectives. Typical ACCP Annual Meeting attendees consist of a blend of:

• Clinical Pharmacologists

• Primary Care and Other Physicians

• Pharmacists

• Physician Assistants

• Clinical Research Associates and Managers

• Basic Scientists Involved in Drug Development

• Students & Trainees in the above noted disciplines

If you are looking to market your product or service, network with peers or make new contacts, the 2012 ACCP Annual Meeting is the place to be! You won’t find a better opportunity to interact with your target audience than at the ACCP Annual Meeting. Please take a moment to peruse the educational sessions currently planned. We are confident that these sessions will encourage you to make your commitment without hesitation.

• Not For Students Only: How to Start and Manage Your Career in the Pharmaceutical Industry

• Update on the Pharmacologic Management of Asthma in Children

• Update on Psychotropics: New Agents and Guidelines

• Evaluating Drug-Drug Interactions with Therapeutic Proteins

• Developing Issues in Pediatric Clinical Pharmacology

• The Changing Face of Pediatric Drug Development

• The Evolving Face of First-in-Human (FIH) Studies from the Investigators’ Perspective

• Innovations in Drug Therapies – The Future is Now

• Pharmacometrics Influencing Hospital-based Pharmacotherapy

• Clinical Translational Biomarkers Facilitating Transition From Bench to Bedside: Basic Concepts, Successful Case Studies and Regulatory Viewpoints

• Speeding Up the Development of New Anti-infective Drugs to Combat Drug Resistance

• Hepatitis C – An Expanding Area of Drug Development and Clinical Pharmacology

• Chronic Pain: Underdiagnosed, Undertreated and Misunderstood

• “Return on Investment” in Pharmacometrics

Why Exhibit at ACCP?

Why Exhibit at ACCP?

34

We invite you to commit now to become an Exhibitor or Sponsor of the 2012 ACCP Annual Meeting. Commercial support of the 2012 ACCP Annual Meeting will boost visibility to key audiences. Your support will elevate awareness of your organization while sustaining education for practitioners, pharmaceutical and biotechnology professionals and students in direct patient care, clinical and preclinical research, regulatory, academia, private practice and related specialties under the umbrella of clinical pharmacology and drug development. Reserve your space now by contacting Tami Stevens at [email protected] or 240-399-9070, ext. 4. Deadline for final Exhibitor, Sponsor or Support commitments is June 15, 2012.

CANCELLATION POLICY:

Cancellations in writing will be accepted until June 14, 2012. Cancellations of Exhibitor commitments are subject to a $500 administrative fee.

EDUCATIONAL GRANTS:

Educational grants are used to support ACCP Annual Meeting live educational events, as well as online and Internet enduring materials. For more information, please contact the ACCP Executive Office at 240-399-9070 to obtain additional information.

COMPLIANCE WITH PHRMA CODE:

ACCP asks that Exhibitors, Sponsors and Supporters comply with the PhRMA Code on interactions with healthcare professionals.

PLATINUM

35

Support Opportunities


LOGOS AND COMPANY NAMES PROMINENTLY DISPLAYED IN:

• ACCP Final Program, including company description (must be received by 6/1/12)

• A first quarter issue (2013) of The Journal of Clinical Pharmacology

• Annual Meeting portion of the ACCP website

• Electronic Syllabus for the Annual Meeting

• Appropriate signage at the Annual Meeting

SPECIFIC LEVELS OF SUPPORT:

PLATINUM

• Two complimentary Annual Meeting Registrations (Continuing Education credit cannot be earned through this mode of registration; payment is required to earn credit as enforced by the accreditation guidelines)

• One full-page color ad in the ACCP Final Program • Complimentary one-page insert in all attendee meeting materials• Recognition at all educational events • Recognition with logo in ACCP HTML Newsletter in August and September

PLATINUM Level Support of $10,000+ Annually includes:

• Two complimentary Annual Meeting Registrations (Continuing Education credit cannot be earned through this mode of registration; payment is required to earn credit as enforced by the accreditation guidelines)

• One half-page color ad in the ACCP Final Program • Complimentary one-page insert in all attendee meeting materials • Recognition at all educational events• Recognition with logo in ACCP HTML Newsletter in August and September

GOLD Level Support of $5,000+ Annually includes:

GOLD

• One complimentary Annual Meeting Registration (Continuing Education credit cannot be earned through this mode of registration; payment is required to earn credit as enforced by the accreditation guidelines)

• One quarter-page color ad in the ACCP Final Program • Complimentary one-page insert in all attendee meeting materials • Recognition at all educational events

SILVER Level Support of $3,000+ Annually includes:

SILVER


36

Mobile App – $5,000 – Exclusive OpportunityAn unparalleled opportunity to get your brand/company information in front of meeting attendees. During the meeting, the mobile app will provide a rich, easy-to-navigate tool containing all meeting logistics and information. After the meeting, they’ll continue to utilize the mobile app to recall contacts they made. The mobile app must be reserved by June 1, 2012.

Coffee Breaks – $3,000 – Exclusive or Shared Sponsorship(s)Scheduled refreshment breaks during educational Symposia are held inside the Exhibit Hall, Sunday through Tuesday.

Lunch during the Awards Sessions – $7,000 – Exclusive or Shared Sponsorship(s)Choose from three lunches for Annual Meeting attendees during the Awards Sessions and/or Keynote Presentations on Sunday, Monday or Tuesday.

Wine and Cheese & Poster Receptions – $5,000 – Exclusive or Shared Sponsorship(s)Exclusive or shared opportunity to provide wine and cheese for Annual Meeting attendees at one of two receptions in the Exhibit Hall, available for Sunday and Monday.

Breakfast Poster Reception – $5,000 – Exclusive or Shared Sponsorship(s)Exclusive or shared opportunity to provide breakfast for Annual Meeting attendees at the Tuesday morning Poster Session and Continental Breakfast in the Exhibit Hall.

Student Networking Wine and Cheese Reception – $3,000 – Exclusive OpportunityExclusive opportunity to prominently display your company name and logo while Students & Trainees are gathered at a Wine and Cheese Reception to network with experts in the field of clinical pharmacology.

Regents/Awards Reception and Dinner – $5,000 – Exclusive OpportunityExclusive opportunity to sponsor the recognition of all 2012 ACCP Award Winners and ACCP Regents. Your company name and logo will be prominently displayed at the entrance to the invitation-only dinner, and two (2) company representatives will be invited to attend this dinner and will be acknowledged during the event.

Hotel Guest Room Key Cards – $5,000 – Exclusive OpportunityHotel guest room key cards will be used for the duration of the entire meeting, providing visibility for your company name or product. The keys will be distributed to all attendees upon check-in. This item must be reserved by June 1, 2012.

Meeting Bag Inserts –$2,000 – Available to AllACCP will be happy to insert your company’s promotional flyers in the Annual Meeting attendee tote bags. All promotional pieces must be approved in advance by ACCP. Price reflects one promotional piece.

37


Rates are as follows:

Back Cover $4,000 • Inside Back Cover $3,000

Full Page $2,000 • Half Page $1,200

Quarter Page $750

* Tote Bags $4,000 – Exclusive OpportunityExclusive opportunity to sponsor tote bags with your company name and logo

that will be provided to all Annual Meeting attendees.

* Lanyards $2,500 – Exclusive OpportunityExclusive opportunity to sponsor lanyards with your company name and logo

that will be provided to all Annual Meeting attendees.

* These items must be reserved by June 1, 2012.

Final Program AdvertisingLimited advertising opportunities are available in the 2012 ACCP Final Program,

the dimensions of which are 8 1/2” x 11”. Programs are distributed to all Annual Meeting attendees and participants.

Deadline for submission of ads is June 15, 2012.

Additional Advertising Opportunities

Exhibitor Registration Form2012 ACCP Annual Meeting

EXHIBIT COMPANY ___________________________________________________________________________ ADDRESS ___________________________________________________________________________

CITY _______________________________ STATE __________ COUNTRY _______________________ ZIP ______________

CONTACT PERSON ___________________________________________________________________________ PHONE _______________ CELL PHONE _______________ FAX _______________ EMAIL _____________________________

EXHIBIT FEE (Includes Two Exhibit Personnel*): $2,000 ______

EXHIBIT FEE (Includes Two Exhibit Personnel PLUS One Full Registration to the Annual Meeting*): $2,550 ______ ADDITIONAL EXHIBITOR FEE: $200 each______

A/V Requirements? (Please specify) Costs incurred to provide this equipment will be billed to the Exhibitor.

______________________________________________________________________________________________________

METHOD OF PAYMENT (check one): q Check (Payable to ACCP) in US Dollars drawn on a US Bank q VISA q American Express q MasterCard q Bank TransferCardholder name (print): _______________________________________________________________________ Card Number: ___________________________________________________ Expiration Date: __________/____________Authorized signature: ______________________________________________________________________________ Amount in US Dollars authorized to charge: _______________________ For 2012 ACCP ANNUAL MEETING EXHIBIT FEE Complimentary Exhibit Staff Person #1: Name ____________________________ Cell Phone ______________Address ____________________________________________________________________________________City _____________________________ State ___________ Country ____________________ Zip ____________Phone _____________________ Fax _____________________ Email ____________________________________ Complimentary Exhibit Staff Person #2: Name ____________________________ Cell Phone ______________Address ____________________________________________________________________________________City _____________________________ State ___________ Country ____________________ Zip ____________Phone _____________________ Fax _____________________ Email ____________________________________

Additional ($200 Fee) Exhibit Staff Person #3: Name ______________________________ Cell Phone __________Address ____________________________________________________________________________________City _____________________________ State ___________ Country ____________________ Zip ____________Phone _____________________ Fax _____________________ Email ____________________________________

Additional ($200 Fee) Exhibit Staff Person #4: Name ______________________________ Cell Phone __________Address ____________________________________________________________________________________City _____________________________ State ___________ Country ____________________ Zip ____________Phone _____________________ Fax _____________________ Email ____________________________________

*Continuing Education credit cannot be earned through this mode of registration; payment is required to earn credit as enforced by the accreditation guidelines.

COPY THIS PAGE AS REQUIRED FOR ADDITIONAL EXHIBITOR PERSONNEL.DESCRIPTION OF COMPANY: (50 words or less) Must be included with payment. Alternatively, please send your company description and high-resolution logo in EPS, JPEG, PNG, or GIF format to [email protected] at the time of Exhibitor registration.

__________________________________________________________________________________________

__________________________________________________________________________________________

________________________________________________________________________________________

ACCP’s Tax ID number is 22-1950891

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2012 American College of Clinical Pharmacology (ACCP) Annual Meeting

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