2012 American College of Clinical Pharmacology (ACCP) Annual Meeting
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  • 1. Table of ContentsLetter of Invitation from President & President-elect........... 3 American College of Clinical PharmacologyProgram at a Glance............................................ 4 2012 Program CommitteeKeynote Speakers............................................... 5 Ivan Nestorov, PhD, Co-Chair2012 ACCP Recognition Award Winners. ...................... 6 Joseph D. Ma, PharmD, Co-ChairStudents & Trainees. ............................................ 8 Funmilayo Ajayi, PhD Ayyappa Chaturvedula, PhDAbstract Submissions. .......................................... 9 Ronald J. Christopher, PhDGuidelines for Poster Presentations........................... 10 Lokesh Jain, PhD Lucy Lee, PharmDEducational Accreditation. ..................................... 11 Wael Mohamed, MD, PhDPre-meeting Workshops........................................ 12 Robert Noveck, MD Lakshmi Putcha, PhDSymposia.. ...................................................... 15Why Join ACCP?............................................... 26Registration Information........................................ 27International Attendees. ........................................ 28Travel and Hotel. ............................................... 29Who We Are.. ................................................... 32Why Exhibit at ACCP? ......................................... 33Support Opportunities. ......................................... 35Exhibitor Registration Form. ................................... 382
  • 2. Letter of Invitation fromPresident & President-electtext starts here for the 2012 ACCP Annual Meeting! Join Us Translating Clinical Pharmacology Research into Optimized Patient Care Dear Colleague: It is our pleasure to invite you to attend the 2012 Annual Drs. Ivan Nestorov and Joseph D. Ma, have developed a varied Meeting of the American College of Clinical Pharmacology, and exceptional program adhering to the College’s commitment September 23rd – 25th, at the Sheraton San Diego Hotel to excellence in science and education while permitting & Marina. This year’s meeting, Translating Clinical sufficient time to “network” with friends and colleagues, old Pharmacology Research into Optimized Patient Care, and new. Topics should be of interest to not only clinical encompasses a series of Pre-meeting Workshops and pharmacologists, but a broad range of healthcare professionals Symposia on such relevant content as the role of clinical in academia, industry, government and private practice. Poster pharmacology in speeding the development of new anti- Sessions, held daily, will highlight new findings and preliminary infective drugs to combat drug resistance, pharmacometrics data, stimulating discussion and hypothesis generation in in hospital-based pharmacotherapy, innovations in drug a relaxed atmosphere. Of particular interest to Students & therapies, clinical translational biomarkers, pediatric drug Trainees are specific programs intended to broaden their development, chronic pain, asthma and psychotropics. ACCP exposure to cutting-edge science and career guidance. maintains its commitment to offer Continuing Education credit for Pre-meeting Workshops and Symposia, a particular value We strongly encourage you to register early, particularly for pharmacists, physicians and other healthcare professional for the Pre-meeting Workshops, as seating is limited. attendees. These Workshops are designed to be of interest to clinical pharmacologists and others in research and development, We strongly encourage you and your colleagues to attend and as well as a broad range of healthcare professionals. Each be a part of this outstanding educational experience. Located Symposium is timely and will critically challenge current practice just one mile from San Diego International Airport, the Sheraton and future directions, while encouraging audience interaction. San Diego Hotel & Marina provides a complimentary shuttle to and from the airport. The San Diego area offers outstanding Take advantage of Early Bird Registration rates through July 1st. restaurants, shopping, major league baseball, an internationally We encourage you to invite your colleagues, particularly those acclaimed zoo and the historic Gaslamp Quarter, most of which who may have never attended an ACCP Annual Meeting or may are within walking distance, and the weather in September not be familiar with the College. should be ideal. We look forward to welcoming you to an outstanding 2012 In reviewing this Preliminary Program, you will note that the ACCP Annual Meeting in San Diego. Come to learn, network, 2012 Annual Meeting Program Committee, Co-Chaired by and be part of a resurgent ACCP! Michael J. Fossler, Jr., PharmD, PhD, FCP Lisa L. von Moltke, MD President President-elect 3
  • 3. Program at a Glancetext starts hereSATURDAY, SEPTEMBER 22, 2012 MONDAY, SEPTEMBER 24, 2012WORKSHOP 1 l 8:15 am – 12:15 pm SYMPOSIUM V l 8:00 am – 4:15 pmNot For Students Only: Innovations in Drug Therapies – The Future is NowHow to Start and Manage Your Career CO-CHAIRS: Ronald J. Christopher, PhDin the Pharmaceutical Industry Lakshmi Putcha, PhDCHAIR: Michael J. Fossler, Jr., PharmD, PhD, FCP SYMPOSIUM VI l 8:00 – 11:30 amWORKSHOP 2 l 8:30 am – 12:30 pm Pharmacometrics Influencing Hospital-basedUpdate on the Pharmacologic Management Pharmacotherapyof Asthma in Children CO-CHAIRS: Ayyappa Chaturvedula, PhDCHAIR: Michael J. Welch, MD, FAAP, FAAAAI Roger W. Jelliffe, MD, FCPWORKSHOP 3 l 1:00 – 5:15 pm SYMPOSIUM VII l 1:30 – 5:00 pmUpdate on Psychotropics: New Agents and Guidelines Clinical Translational Biomarkers FacilitatingCHAIR: Kelly C. Lee, PharmD, BCPP, FCCP Transition From Bench to Bedside: Basic Concepts, Successful Case Studies and Regulatory Viewpoints CO-CHAIRS: Lucy Lee, PharmD, FCP Michael Tortorici, PharmD, PhDSUNDAY, SEPTEMBER 23, 2012SYMPOSIUM I l 8:00 – 11:15 amEvaluating Drug-Drug Interactions with Therapeutic Proteins TUESDAY, SEPTEMBER 25, 2012CO-CHAIRS: Honghui Zhou, PhD, FCP Stanley A. Roberts, PhD, DABT SYMPOSIUM VIII l 8:00 – 11:30 am Speeding Up the Development of New Anti-infective Drugs to Combat Drug ResistanceSYMPOSIUM II l 8:00 – 11:30 am CO-CHAIRS: Hartmut Derendorf, PhDDeveloping Issues in Pediatric Clinical Pharmacology Vincent H. Tam, PharmD, BCPS (Infectious Diseases)CO-CHAIRS: Edmund V. Capparelli, PharmD John van den Anker, MD, PhD, FCP SYMPOSIUM IX l 8:00 am – 12:00 pm Hepatitis C – An Expanding Area of Drug DevelopmentSYMPOSIUM III l 1:30 – 5:30 pm and Clinical PharmacologyThe Changing Face of Pediatric Drug Development CO-CHAIRS: Shirley M. Tsunoda, PharmDCO-CHAIRS: Robert L. Kunka, PhD Alexander Kuo, MD Kathryn Blake, PharmD, BCPS, FCCP SYMPOSIUM X l 1:30 – 5:00 pmSYMPOSIUM IV l 1:30 – 5:00 pm Chronic Pain: Underdiagnosed, UndertreatedThe Evolving Face of First-in-Human (FIH) Studies from the and MisunderstoodInvestigators’ Perspective – Cosponsored by ACPU CO-CHAIRS: Rabia S. Atayee, PharmD, BCPSCO-CHAIRS: Charles H. Pierce, MD, PhD, FCP, CPI Joseph D. Ma, PharmD Angela Baker, MHA SYMPOSIUM XI l 1:30 – 5:00 pm “Return on Investment” in Pharmacometrics CO-CHAIRS: Jogarao Gobburu, PhD, FCP, MBA Ivan Nestorov, PhD4
  • 4. Keynote Speakers Michael Reed Barratt, MD, Christopher P. Austin, MD, MS, NASA Astronaut Senior Advisor to the Director Dr. Barratt came to NASA JSC for Translational Research at in May 1991 employed as a the National Human Genome project physician with KRUG Research Institute (NHGRI) Life Sciences, working on Dr. Austin is responsible for medical systems for Space conceptualizing and implementing Station Freedom. In July programs to derive biologic 1992, he was assigned as insights and therapeutic benefits NASA Flight Surgeon, working from the newly completed human in Space Shuttle Medical genome sequence.Operations. In January 1994, he was assigned to the joint At the Department of Human Genetics at Merck ResearchU.S./Russian Shuttle - Mir Program, working and training Laboratories, Dr. Austin built a group that took a variety ofextensively in the Cosmonaut Training Center, Star City, Russia, genetic and molecular approaches to target identificationin support of the Mir-18/STS-71 and subsequent missions. for schizophrenia, bipolar illness, Alzheimer’s disease andFrom July 1995 to July 1998, he served as Medical Operations Parkinson’s disease. In order to expand the group’s targetLead for the International Space Station (ISS). A frequent identification and validation capacities, Dr. Austin expandedtraveler to Russia, he worked with counterparts at the Gagarin the group into microarray technologies and a multifacetedCosmonaut Training Center and Institute of Biomedical molecular histology effort, and began the first company-wideProblems as well as other international partner centers. initiative in pharmacogenomics. Later, he incorporated a groupDr. Barratt served as lead crew surgeon for the first expedition that identified many new G protein-coupled receptors (GPCRs)crew to ISS from July 1998 until he was selected as an astronaut and identified ligands of several orphan GPCRs. Lastly, ascandidate. Director of Genomic Neuroscience, he initiated a schizophreniaSelected as a mission specialist by NASA in July 2000, project team that developed small molecule modulators for twoDr. Barratt reported for training in August 2000. Following molecular targets for schizophrenia, which are now being testedthe completion of two years of training and evaluation, he for the treatment of the disease.was assigned technical duties in the Astronaut Office Station Dr. Austin moved to NHGRI in 2002 to spearhead efforts toOperations Branch. translate the remarkable accomplishments of the HumanAssigned to long duration flight training in 2005, Dr. Barratt Genome Project into benefits for human health. A prerequisitelaunched on Soyuz TMA-14 on March 26, 2009 to the ISS, for this translation is the determination of function of a largeand served as a member of Expeditions 19 and 20. This time number of novel genes, which will occur most efficiently if theperiod included the transition from three to six permanent biomedical research community has immediate access to toolsISS crewmembers, two EVAs, two visiting space shuttles and and technologies for determining gene function. Dr. Austin isthe arrival of the first Japanese H-II Transfer Vehicle (HTV). leading the development of a “toolbox” of publically accessibleCompleting 199 days in space, Dr. Barratt landed on October genomic reagents and technologies analogous to the genome11, 2009. sequence, but focused on elucidation of gene function.Currently, Dr. Barratt manages the Human Research Program One of these initiatives is an ambitious program in chemicalat NASA Johnson Space Center. This program guides applied genomics, which will bring the power and diversity of smallresearch oriented toward mitigating the most prominent health molecule chemistry and informatics to the determination of geneand performance risks associated with human spaceflight. function. This paradigm-shifting initiative promises to have aDr. Barratt serves as Associate Editor for Space Medicine for transformative effect on basic biomedical research, speedingthe journal, Aviation, Space and Environmental Medicine and is functionation of the genome and development of new therapiessenior editor of the textbook, Principles of Clinical Medicine for for human disease.Space Flight. 5
  • 5. 2012 ACCP Recognition Award Winners Honorary Fellowship Award Charles Williams Flexner, MD – Professor, Medicine and Pharmacology and Molecular Sciences, The Johns Hopkins Univ School of Medicine The 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 Award Michael 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 Award Joseph 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):649-606
  • 6. 2012 ACCPRecognition Award Winners Distinguished Investigator Award William 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. 7
  • 7. Students & TraineesAnnual Meeting Events for Students & Student Networking Wine & Cheese ReceptionTrainees During the Annual Meeting, Students & Trainees are encouragedStudent & Trainee membership and participation in ACCP’s to participate in the Student Networking Wine & CheeseAnnual Meeting are strongly encouraged and are beneficial Reception. A huge success in 2011, the reception provides aon several levels. relaxed atmosphere where Students & Trainees can interact one-on-one or in groups with accomplished professionals who• Substantially discounted registration fees for the Annual can answer questions and provide guidance on relevant issues. Meeting, other educational events and online educational In advance of the event, the Student Outreach Committee will activities on cutting-edge, relevant topics related to clinical review the proposed list of ACCP Annual Meeting attendees and pharmacology and the optimal use of therapeutics. These select a spectrum of respected and accomplished professionals interactions provide Students & Trainees with access to a to participate. An email invitation requesting an RSVP for the forum for new scientific ideas and healthcare professionals reception will be sent to all Students & Trainees that have of various disciplines meeting to discuss areas of common registered for the Annual Meeting. interest.• ACCP Student Abstract Awards Program is designed to Poster Tours with Mentors recognize outstanding research abstracts submitted by During some of the Poster Sessions, small groups of Students Students & Trainees at the Annual Meeting. Each award & Trainees will be hosted by an ACCP Fellow or senior Member consists of a certificate, a $1,000 honorarium, a complimentary to tour the poster area and discuss preselected posters that Annual Meeting registration and an invitation to the Board of provide exceptional educational material. An email invitation Regents Dinner at the Annual Meeting. requesting an RSVP for the Poster Session tours will be sent to all Students & Trainees that have registered for the Annual• From the pool of Student Abstract Award winners, one is Meeting. 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 Visit us at 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 ACCP Member Benefits presentation outlining the results, using 2 – 3 slides. Learn more about ACCP’s Student Outreach Program at ACCP Awards and Previous Winners 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 SOC@ACCP1.org.8
  • 8. Abstract SubmissionsAbstracts EACH ABSTRACT MUST ALSO CONTAIN:Abstract Submission • A statement of purpose, innovation or hypothesis • Description of methods and materials April 15, 2012 Abstract Submission Deadline • Data and results Abstract notification letters sent by email to first • Interpretation, conclusion and significance Mid-May 2012 authors regarding decisions by the Program Committee on the status of acceptance Instructions for Abstracts & Posters June 8, 2012 Deadline to withdraw abstract WHEN PREPARING YOUR POSTER FOR PRESENTATION AT THE ACCP ANNUAL MEETING, WE KINDLY ASK THAT YOUPlease note: Poster presenters have the sole obligation of ensuring that all ADHERE TO THE FOLLOWING GUIDELINES:authors and poster content are accurate at the time of final submission. ACCPholds no responsibility for corrections after publication of any materials related • All material should be readable from distances of at least three feet.to the meeting. • Presenter’s name must be underlined throughout the entire document. • Initial or first name must precede last name. • Institutional affiliation and city are required.Areas of Abstract Submission • Ensure that the street address, zip code, degrees and grant support areSUBMISSION OF ABSTRACTS IN THE FOLLOWING AREAS NOT listed within the abstract.IS ENCOURAGED: • Use only standard abbreviations.• Mechanism of Action • All compounds that are designated by code must be identified• Therapeutic Drug Monitoring adequately.• Absorption, Distribution, Metabolism and Excretion • Do not indent the title.• Safety and Efficacy • Capitalize the first letter of trade names.• Drug-Drug Interactions • Nonproprietary (generic) names are required the first time a drug is• Effectiveness and Impact on quality of life mentioned, written in small letters.• Special Populations, including women, children and the elderly • Abstract is limited to 350 words which includes titles and authors.• Cost-effectiveness Tables and charts are permitted within this space but will be counted and applied to word limitations.• New Clinical Trial Designs • When using abbreviations for compounds, spell out in full the• Clinical Pharmacokinetics and Pharmacodynamics first mention, followed by the abbreviation in parentheses. DO NOT• Clinical Trials and Human Pharmacology ABBREVIATE COMPOUNDS WITHIN THE TITLE OF THE ABSTRACT.• Experimental Pharmacology in In Vitro and In Vivo Studies • Special characters are permitted.• Applications of Modeling and Simulation • Remember that your abstract will appear in print exactly as you• Pharmacoepidemiology / Pharmacogenomics submit it. Any errors, misspellings, poor hyphenations and deviations• Pharmacoeconomics / Disease Management from good grammatical usage will be glaringly apparent in the• Translational Medicine / Biomarkers / Imaging published abstract.• Decision-making in Research and Development • Important Size Limitations: No larger than the size of the poster board which is 48 inches tall and 72 inches wide. (1.22 Meters by 1.80 Meters)PRIMARY CRITERIA FOR ACCEPTANCE OF All posters will be mounted horizontally.ABSTRACTS ARE:• Applicability to clinical pharmacology and translational medicine NOTICES REGARDING DECISION BY PROGRAM COMMITTEE:• Innovation and scientific merit Corresponding authors will be notified by letter in early to mid-May• Relevance to the mission of the College 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. 9
  • 9. Guidelines for Poster PresentationsBOARD SIZE: 2012 Poster Session & Judging SchedulePosters will be displayed on poster boards with a usable space 72 Please note: Posters will be judged the entire time the sessioninches wide by 48 inches tall, although for best viewing by poster is in progress.attendees and convenient posting by authors, the ACCP recommendsconfining the displays to the 5 feet wide by 3.5 feet high area in thecenter of the poster board. Posters should be mounted on poster POSTER SESSION lboards using pushpins. Sunday, September 23, 2012 6:00 – 8:00 pmBOARD MATERIAL: Posters must be taken down after 8:00 pm in preparation for theFabric that will accommodate pushpins. next session.GENERAL INFORMATION: POSTER SESSION ll• Posters must be placed on poster boards prior to the poster session Monday, September 24, 2012 on the day your poster is scheduled. A schedule is provided in the next column. 6:00 – 8:00 pm• The posters will remain on the boards during the poster session for Posters must be taken down after 8:00 pm in preparation for the viewing. The poster must be removed after the poster session is next session. completed. Please contact ACCP Staff at the registration desk if your poster has been removed. POSTER SESSION lll• Authors, or their assistants, must be present at their assigned board Tuesday, September 25, 2012 location during the first hour of the scheduled poster session. 7:00 – 8:00 am Assistants may be used as necessary during the session.• Bring only items which can be mounted on poster boards. There will Posters must be taken down by 12:00 pm. be no electrical or projection facilities provided. You must provide your own pushpins. NO OTHER MOUNTING MATERIALS SHOULD FOR QUESTIONS, PLEASE CONTACT: BE USED. TStevens@ACCP1.org or 240-399-9070, ext. 4.• All items for posting should be prepared in advance, with posting alone remaining. Graphic supplies will not be available.• Poster board location numbers will be mounted in the upper left hand Abstract Awards 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 To be considered for one of these abstract awards in a location is NOT the abstract number. calendar year, participants must submit abstracts• Each poster will be assigned a board and will be labeled with a by the April 15th deadline. number and the presenting author’s name.• New Member abstracts will be identified with “New Member” ribbons placed on the board next to the board number.• Student Abstract Award winners will be identified with “Award Winner” ribbons placed on the board next to the board number.10
  • 10. Educational AccreditationAccreditation StatementsThe American College of Clinical Pharmacology is accredited bythe Accreditation Council for Continuing Medical Education toprovide Continuing Medical Education (CME) for physicians.The American College of Clinical Pharmacology is accredited bythe Accreditation Council for Pharmacy Education as a providerof Continuing Pharmacy Education (CPE).New Continuing Education Processes for 2012! • Obtain the Syllabus and slides for Pre-meeting Workshops In continuing its tradition of providing high-quality, accredited and Symposiaeducational sessions to Annual Meeting attendees, ACCP • Complete a general evaluation of the 2012 ACCP Annual has listened carefully to your requests and has significantly Meetingstreamlined its educational program procedures. We are • Complete post-event testing related to CME and CPEpleased to share that, starting in 2012, ACCP will provide one • Print Certificate of CME Credit or CPE Statement of Credit,convenient, user-friendly tool where you can: as appropriate As we approach the 2012 ACCP Annual Meeting, more detailed instructions will be provided via email to all meeting attendees.CPE Monitor is a national, collaborative effort by NABP and the Get an Early Start!Accreditation Council for Pharmacy Education (ACPE) to provide To prepare for the new process, pharmacists and techniciansan electronic system for pharmacists and pharmacy technicians are encouraged to obtain their NABP e-Profile ID now toto track their completed continuing pharmacy education (CPE) ensure their e-Profile is properly setup. Many ACPE-accreditedcredits. It will also offer state boards of pharmacy the opportunity CPE providers are now requiring pharmacists and pharmacyto electronically authenticate the CPE units completed by their technicians to submit their e-Profile ID and date of birth to receivelicensees, rather than requiring pharmacists and technicians to credit for completed CPE.submit their proof of completion statements upon request or forrandom audits. Don’t forget to Set up your NABP e-Profile to obtain your ID before the ACCP Annual Meeting! (Secure site with 24/7This initiative will streamline processes for pharmacy practitioners availability)to ensure they are maintaining professional competencyrequirements. CPE Monitor is expected to save pharmacists, For more information, please visit: CPE Monitorpharmacy technicians, state boards of pharmacy and CPEproviders time and money. 11
  • 11. Pre-meeting WorkshopsSATURDAY, SEPTEMBER 22, 2012 OBJECTIVES CONT:WORKSHOP 1 l 8:15 am – 12:15 pm 4. State the most common mistakes people make when speaking in public;Not For Students Only: How to 5. List the most effective ways to get your ideas across during your talk; 6. State the most common mistakes people make when creating slidesStart and Manage Your Career in the and posters;Pharmaceutical Industry 7. List the most important design elements of a successful poster; 8. List the most important elements of a successful slide presentation;An interactive, high-energy session for the aspiring young pharmaceuticalscientist embarking on his or her career in the pharmaceutical industry. 9. List the ways in which you can actively manage your career.Learn and practice the secrets of effective communication and careermanagement from seasoned industry and academic professionals. This 8:15 – 8:30 amis NOT a session where you will just sit and listen – this will be hands-onand interactive! Introduction{ THIS SESSION HAS NOT BEEN DESIGNATED FOR CME OR CPE CREDIT } Michael J. Fossler, Jr., PharmD, PhD, FCP, Director, Clinical Pharmacology Modeling & Simulation, GlaxoSmithKline IncCHAIR:Michael J. Fossler, Jr., PharmD, PhD, FCP, Director, 8:30 – 9:15 amClinical Pharmacology Modeling & Simulation, GlaxoSmithKline Inc How to Choose and Work with an Executive RecruiterTARGET AUDIENCE: K. David Cadieu, President and CEO, KDC GroupThis session will be useful for graduate or post-doctoral students inthe biomedical sciences contemplating a career in the pharmaceutical 9:15 – 10:00 amindustry and will provide attendees with tools that they need in order tobe successful. This session may also be of interest to those who have Essentials for Effective Oral Communicationbeen in the work force for 3 – 5 years and who wish to further their Brookie M. Best, PharmD, MAS Clinical Research,careers. Associate Professor of Clinical Pharmacy and Pediatrics, Univ of California, San DiegoBACKGROUND REQUIREMENT:No specific background requirements, other than a desire to learn 10:00 – 10:15 amabout the concepts described. BreakGOALS:The educational goals of this session are to learn the best ways 10:15 – 11:00 amof working with an executive recruiter to land your first job in thepharmaceutical industry; to learn to use effective oral communication Creating Effective Slide Presentations and Posterstechniques that will get your ideas across to your audience; to explore Jeffrey S. Barrett, PhD, FCP, Professor, Children’s Hospways to make your posters and slides more effective at scientific of Philadelphiameetings; and to learn techniques for managing and furthering yourcareer in the pharmaceutical industry. 11:00 – 11:45 amOBJECTIVES: Managing Your Career in the Pharmaceutical IndustryAt the conclusion of this program, participants should be able to: Michael J. Fossler, Jr., PharmD, PhD, FCP, Director,1. List the advantages of working with an executive recruiter; Clinical Pharmacology Modeling & Simulation, GlaxoSmithKline Inc2. Explain what to look for in an executive recruiter and how to choose 11:45 am – 12:15 pm one who fits your career needs;3. Give tips on getting the most from your recruiter; Panel Discussion12
  • 12. Pre-meeting Workshops 8:SATURDAY, SEPTEMBER 22, 2012 8:30 – 8:45 amWORKSHOP 2 l 8:30 am – 12:30 pm Introduction Michael J. Welch, MD, FAAP, FAAAAI, Co-Director, Allergy & AsthmaUpdate on the Pharmacologic Medical Group & Research Ctr, Clinical Professor of Pediatrics,Management of Asthma in Children Univ of California, San Diego, School of Medicine238-000-12-010-L01-P - ACPE 3.75 CONTACT HOURS,0.375 CEU – KNOWLEDGE-BASED ACTIVITY. 8:45 – 9:30 amTHE ACCP DESIGNATES THIS LIVE ACTIVITY FOR A MAXIMUM OF 3.75 2012 Look at the 2007 NHLBI Guidelines on DiagnosisAMA PRA CATEGORY 1 CREDIT(S)™. and Management of AsthmaPHYSICIANS SHOULD CLAIM ONLY THE CREDIT COMMENSURATE WITHTHE EXTENT OF THEIR PARTICIPATION IN THE ACTIVITY. Susan Laubach, MD, FAAP, Allergy & Asthma Medical Group & Research Ctr, Univ of California, San Diego, School of MedicineCHAIR:Michael J. Welch, MD, FAAP, FAAAAI, Co-Director, Allergy & Asthma 9:30 – 10:15 amMedical Group & Research Ctr, Clinical Professor of Pediatrics, Selecting Controller Therapy for Children:Univ of California, San Diego, School of Medicine Evidence for Rational ChoicesTARGET AUDIENCE: Paul Williams, MD, FAAP, FAAAAI, Clinical Professor of Pediatrics,This session is useful for clinical pharmacists (community or clinic- Univ of Washington, School of Medicinebased), physicians, asthma educators and other healthcare medicalprofessionals who care for children with asthma. 10:15 – 10:30 amBACKGROUND REQUIREMENT: BreakA basic knowledge of asthma, its pathophysiology and thepharmacotherapy used in treating the disease. 10:30 – 11:15 am Managing Acute Asthma and the Child withGOALS: Exercise-induced AsthmaThe educational goals of this session are to inform attendees of thelatest approach to controlling asthma in children with the current Nancy Ostrom, MD, FAAP, FAAAAI, Co-Director, Allergy & Asthmapharmacological agents available; to further the understanding and Medical Group & Research Ctr, Associate Clinical Professor, Dept ofawareness of the most recent national guidelines to be followed in Pediatrics, Div of Allergy and Immunology, Univ of California, San Diegotreating children with chronic and acute asthma; and to identify thechallenges in using inhaled asthma therapy in children and, in particular, 11:15 am – 12:00 pmthe infant and toddler. Benefits, Challenges and Controversies of InhaledOBJECTIVES: Asthma Therapy in ChildrenAt the conclusion of this program, participants should be able to: Michael J. Welch, MD, FAAP, FAAAAI, Co-Director, Allergy & Asthma1. State the criteria for distinguishing between persistent asthma Medical Group & Research Ctr, Clinical Professor of Pediatrics, and intermittent asthma, in particular “the rule of 2’s”, and how it Univ of California, San Diego, School of Medicine determines pharmacotherapy;2. List the different steps of asthma therapy based on asthma severity 12:00 – 12:30 pm and control; Panel / Case Discussion / Q&A3. 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. 13
  • 13. Pre-meeting WorkshopsSATURDAY, SEPTEMBER 22, 2012 1:00 – 2:15 pmWORKSHOP 3 l 1:00 – 5:15 pm Management of Major Depression Kelly C. Lee, PharmD, BCPP, FCCP, Assistant Professor of ClinicalUpdate on Psychotropics: Pharmacy, Univ of California, San Diego, Skaggs School of Pharmacy & Pharmaceutical SciencesNew Agents and Guidelines238-000-12-011-L01-P - ACPE 4 CONTACT HOURS, 2:15 – 3:00 pm (Part I)0.4 CEU – KNOWLEDGE-BASED ACTIVITY.THE ACCP DESIGNATES THIS LIVE ACTIVITY FOR A MAXIMUM OF 4 Management of Bipolar DisorderAMA PRA CATEGORY 1 CREDIT(S)™. Rene Endow-Eyer, PharmD, BCPP, Psychiatric Clinical PharmacyPHYSICIANS SHOULD CLAIM ONLY THE CREDIT COMMENSURATE WITH Specialist, VA San Diego Healthcare SystemTHE EXTENT OF THEIR PARTICIPATION IN THE ACTIVITY.CHAIR: 3:00 – 3:15 pmKelly C. Lee, PharmD, BCPP, FCCP, Assistant Professor of Clinical BreakPharmacy, Univ of California, San Diego, Skaggs School of Pharmacy& Pharmaceutical Sciences 3:15 – 3:45 pm (Part II)TARGET AUDIENCE: Management of Bipolar Disorder, contThis session will be useful for physicians, pharmacists, nurses, Rene Endow-Eyer, PharmD, BCPP, Psychiatric Clinical Pharmacypsychologists and mental health professionals. Specialist, VA San Diego Healthcare SystemBACKGROUND REQUIREMENT: 3:45 – 5:00 pmNone Management of Schizophrenia & Psychotic DisordersGOALS: Kimberly Tallian, PharmD, BCPP, FASHP, FCCP, Pharmacy ClinicalThe educational goals of this session are to review the recently Manager, Scripps Memorial Hosppublished treatment guidelines for the management of depression,bipolar disorder and schizophrenia and to discuss the newly approved 5:00 – 5:15 pmdrugs used to treat these disorders. Panel Discussion / Q&AOBJECTIVES:At the conclusion of this program, participants should be able to: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.14
  • 14. SymposiaSUNDAY, SEPTEMBER 23, 2012 8:00 – 8:40 amSYMPOSIUM I l 8:00 – 11:15 am Potential Mechanisms of DDI with TP Donald E. Mager, PharmD, PhD, FCP, Associate Professor, School ofEvaluating Drug-Drug Interactions with Pharmacy and Pharmaceutical Sciences, Univ at Buffalo, SUNYTherapeutic Proteins 8:40 – 9:20 am238-000-12-001-L01-P - ACPE 3 CONTACT HOURS,0.3 CEU – KNOWLEDGE-BASED ACTIVITY. In Vitro / Preclinical Case Studies for DDI with TPTHE ACCP DESIGNATES THIS LIVE ACTIVITY FOR A MAXIMUM OF 3 Frank-Peter Theil, PharmD, PhD, Head Nonclinical Development,AMA PRA CATEGORY 1 CREDIT(S)™. UCB PharmaPHYSICIANS SHOULD CLAIM ONLY THE CREDIT COMMENSURATE WITHTHE EXTENT OF THEIR PARTICIPATION IN THE ACTIVITY. 9:20 – 9:35 amCO-CHAIRS: BreakHonghui Zhou, PhD, FCP, Head, Pharmacokinetics & Pharmacometrics,Biologics Clinical Pharmacology, Janssen Research & Development 9:35 – 10:15 amStanley A. Roberts, PhD, DABT, President, SAR Safety Assessment Clinical Evaluations of DDI with TPTARGET AUDIENCE: Honghui Zhou, PhD, FCP, Head, Pharmacokinetics & Pharmacometrics,This session will be useful for academic and industrial/regulatory Biologics Clinical Pharmacology, Janssen Research & Developmentscientists involved in drug development. 10:15 – 10:55 amBACKGROUND REQUIREMENT:The audience should have a basic understanding of therapeutic DDI with TP – Scientific, Regulatory and Industrialproteins, pharmacokinetics, pharmacodynamics and drug-drug Perspectivesinteractions. Stanley A. Roberts, PhD, DABT, President, SAR Safety AssessmentGOALS: 10:55 – 11:15 amThe educational goal of this session is to review the currentunderstanding of mechanisms for drug interactions with therapeutic Case Presentation / Panel Discussionproteins, the approaches for evaluating these interactions in bothpreclinical and clinical settings, and the scientific, regulatory andindustrial perspective of the issues, knowledge gaps and futuredirection.OBJECTIVES:At the conclusion of this program, participants should be able to: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. 15
  • 15. SymposiaSUNDAY, SEPTEMBER 23, 2012 OBJECTIVES CONT:SYMPOSIUM II l 8:00 – 11:30 am 4. Identify the key pharmacologic issues in adolescent therapeutics and challenges in designing successful therapy in this population.Developing Issues in Pediatric 5. 8:00 – 8:35 amClinical Pharmacology238-000-12-002-L01-P - ACPE 3.25 CONTACT HOURS, Neonatal Pharmacology – Lost in Translation0.325 CEU – KNOWLEDGE-BASED ACTIVITY. John van den Anker, MD, PhD, FCP, Vice Chair of PediatricsTHE ACCP DESIGNATES THIS LIVE ACTIVITY FOR A MAXIMUM OF 3.25 for Experimental Therapeutics, Evan and Cindy Jones ProfessorAMA PRA CATEGORY 1 CREDIT(S)™. of Pediatric Clinical Pharmacology, Chief, Div of Pediatric ClinicalPHYSICIANS SHOULD CLAIM ONLY THE CREDIT COMMENSURATE WITH Pharmacology, Children’s National Medical Ctr & Professor ofTHE EXTENT OF THEIR PARTICIPATION IN THE ACTIVITY. Pediatrics, Pharmacology & Physiology, George Washington Univ School of Medicine and Health SciencesCO-CHAIRS:Edmund V. Capparelli, PharmD, Clinical Professor, Pediatric 8:35 – 9:10 amPharmacology and Drug Discovery, Univ of California, San Diego,Dept of Pediatrics, School of Medicine Pharmacogenomics and Implications for Drug EffectsJohn van den Anker, MD, PhD, FCP, Vice Chair of Pediatrics in Childrenfor Experimental Therapeutics, Evan and Cindy Jones Professor J. Steven Leeder, PharmD, PhD, Chair in Pediatric Clinicalof Pediatric Clinical Pharmacology, Chief, Div of Pediatric Clinical Pharmacology, Children’s Mercy HospPharmacology, Children’s National Medical Ctr & Professor ofPediatrics, Pharmacology & Physiology, George Washington Univ 9:10 – 9:45 amSchool of Medicine and Health Sciences Characterization of Pediatric Adverse Drug ReactionsTARGET AUDIENCE: Through the Canadian National NetworkThis session will offer important knowledge and education for Bruce Carleton, PharmD, Director Pharmaceutical Outcomespharmacists, physicians, nurses, physician assistants, other healthcareprofessionals and research scientists in academia, hospitals, the private Program, British Columbia Children’s Hospsector and regulatory agencies. 9:45 – 10:00 amBACKGROUND REQUIREMENT: BreakNoneGOALS: 10:00 – 10:35 amThe educational goal of this session is to provide the participants with Adolescent Clinical Pharmacology:an understanding and appreciation for developmental changes in Transition and Translationclinical pharmacology throughout the pediatric continuum. This will help Michael Spigarelli, MD, PhD, Professor Pediatrics, Univ of Utahrecognize how to best utilize preclinical and adult information in treatingand studying drugs in infants, children and adolescents. 10:35 – 11:10 amOBJECTIVES: Use of PK / PD Modeling and Simulation to OptimizeAt the conclusion of this program, participants should be able to: Pediatric Therapeutics1. Comprehend the critical role of immature drug metabolism and elimination Edmund V. Capparelli, PharmD, Clinical Professor, Pediatric processes in successful neonatal trial design and drug therapy; Pharmacology and Drug Discovery, Univ of California, San Diego,2. Recognize developmental and pharmacogenomic influences on Dept of Pediatrics, School of Medicine pediatric adverse drug reactions;3. Discuss how existing pharmacometric tools can be used to address 11:10 – 11:30 am pediatric knowledge gaps in clinical trials; Panel Discussion / Q&A16
  • 16. SymposiaSUNDAY, SEPTEMBER 23, 2012 1:30 – 2:15 pmSYMPOSIUM III l 1:30 – 5:30 pm The Changing Regulatory Environment of Pediatric Drug DevelopmentThe Changing Face of Pediatric Drug Alison Bowers, MSc, RAC, FTOPRA, Sr Consultant,Development PAREXEL Consulting238-000-12-003-L01-P - ACPE 3.75 CONTACT HOURS,0.375 CEU – KNOWLEDGE-BASED ACTIVITY. 2:15 – 3:00 pmTHE ACCP DESIGNATES THIS LIVE ACTIVITY FOR A MAXIMUM OF 3.75 Bridging to Adult Data and FormulationsAMA PRA CATEGORY 1 CREDIT(S)™. Robert L. Kunka, PhD, President, The Kunka Group IncPHYSICIANS SHOULD CLAIM ONLY THE CREDIT COMMENSURATE WITHTHE EXTENT OF THEIR PARTICIPATION IN THE ACTIVITY. 3:00 – 3:15 pmCO-CHAIRS: BreakRobert L. Kunka, PhD, President, The Kunka Group IncKathryn Blake, PharmD, BCPS, FCCP, Sr Research Scientist, 3:15 – 4:00 pmCtr for Pharmacogenomics & Translational Research,Nemours Children’s Clinic Issues (and Solutions) in Pediatric Clinical Trials Kathryn Blake, PharmD, BCPS, FCCP, Sr Research Scientist,TARGET AUDIENCE: Ctr for Pharmacogenomics & Translational Research,This session will be useful for clinical researchers, physicians, Nemours Children’s Clinicpharmacists, nurses, other healthcare professionals and studentsactively involved in or planning to get involved in pediatric research. 4:00 – 4:45 pmBACKGROUND REQUIREMENT: Challenges Conducting Early Phase Pediatric PKNone Trials: Overview of OTC and Pulmonary Programs Kenneth T. Kim, MD, Chief Executive Officer, West Coast Clinical TrialsGOALS:The educational goals of this session are to describe the significant 4:45 – 5:30 pmregulatory initiatives fueling pediatric development strategies in thepharmaceutical industry, to examine study designs used to implement Panel Discussion / Q&Athese strategies and to review limitations and solutions of working in thispopulation.OBJECTIVES:At the conclusion of this program, participants should be able to: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. 17
  • 17. SymposiaSUNDAY, SEPTEMBER 23, 2012 1:30 – 1:40 pmSYMPOSIUM IV l 1:30 – 5:00 pm Introduction Charles H. Pierce, MD, PhD, FCP, CPI, Medical Director,The Evolving Face of First-in-Human Metabolic & Atherosclerotic Research Ctr(FIH) Studies from the Investigators’ Angela Baker, MHA, Sr Director, Business Development, CRI LifetreePerspective Cosponsored by ACPU 1:40 – 2:25 pm238-000-12-004-L01-P - ACPE 3.25 CONTACT HOURS,0.325 CEU – KNOWLEDGE-BASED ACTIVITY. The Investigators’ Perspective of the Pre-studyTHE ACCP DESIGNATES THIS LIVE ACTIVITY FOR A MAXIMUM OF 3.25 Feasibility Assessment and Dose Escalation SafetyAMA PRA CATEGORY 1 CREDIT(S)™. ReviewPHYSICIANS SHOULD CLAIM ONLY THE CREDIT COMMENSURATE WITH Jon Ruckle, MD, Principal, Pacific Pharma Group LLCTHE EXTENT OF THEIR PARTICIPATION IN THE ACTIVITY. Royce Morrison, MD, CPI, Chief Medical Officer, ComprehensiveCO-CHAIRS: Clinical DevelopmentCharles H. Pierce, MD, PhD, FCP, CPI, Medical Director,Metabolic & Atherosclerotic Research Ctr 2:25 – 3:00 pmAngela Baker, MHA, Sr Director, Business Development, CRI Lifetree Be Careful If You Ask for the Kitchen Sink –TARGET AUDIENCE: It May Be Full of Dirty DishesPharmaceutical firm holders of the IND for new products, Principal Donna Dorozinsky, MSN, CCRC, President, DWD & Associates IncInvestigators and Sub Investigators, Clinical Research Scientists (PKs,Biostatisticians), Safety Nurses, Clinical Research Associates (CRAs) 3:00 – 3:15 pmand Coordinators (CRCs), recruiting staff, QA/QC Auditors and staff,Monitors & Clinical Research Data Managers. BreakBACKGROUND REQUIREMENT: 3:15 – 4:00 pmThe audience should be well versed and have knowledge about all of Safety Challenges and Developing Models forthe phases of drug development, so as to appreciate the differences inFIH studies, as compared to later in the drug development scheme. Emergency Response Coverage for FIH Studies Randall R. Stoltz, MD, CPI, Medical Director, Clinical Research Unit,GOALS: CovanceThe educational goal of this session is to provide the framework, so all Walter K. Kraft, MD, FACP, Director, Thomas Jefferson Univ Clinicalwho work in the drug development arena understand the changes that Research Unit & Associate Professor, Pharmacology and Experimentalhave occurred in Phase I, especially FIH studies. Therapeutics, Thomas Jefferson UnivOBJECTIVES: 4:00 – 4:45 pmAt the conclusion of this program, participants should be able to:1. Describe the elements of a good CPU; SAD / MAD Combined with POC and Patient Cohorts2. Identify what is needed to make a Phase I program; William B. Smith, MD, FACC, Professor of Medicine, Univ of3. Describe how the starting dose is chosen; Tennessee Medical Ctr and President, New Orleans Ctr for Clinical Research and Volunteer Research Group4. Identify why extended safety testing is important;5. Recognize the importance of considering usability of data versus Bradley D. Vince, DO, President and Medical Director, need to collect data; Vince and Associates Clinical Research6. Identify two potential problems with high volume data collection in FIH studies; 4:45 – 5:00 pm7. Identify how the “Adaptive Design” protocol works; Panel Discussion8. Explain why monitoring in Phase I is different.18
  • 18. SymposiaMONDAY, SEPTEMBER 24, 2012 8:00 – 8:15 amSYMPOSIUM V l 8:00 am – 4:15 pm Introduction and Overview of the Future of Novel Therapies & Medical DiagnosticsInnovations in Drug Therapies – Ronald J. Christopher, PhD, Vice President, Preclinical Development,The Future is Now Arena Pharmaceuticals Inc{ THIS SESSION HAS NOT BEEN DESIGNATED FOR CME OR CPE CREDIT } 8:15 – 8:45 amCO-CHAIRS: Induced Pluripotent Stem Cell Technologies –Ronald J. Christopher, PhD, Vice President, Preclinical Development, Opportunities and ChallengesArena Pharmaceuticals Inc John Mendlein, PhD, Chief Executive Officer, Fate Therapeutics IncLakshmi Putcha, PhD, Clinical Pharmacologist/Technical Manager,Human Adaptation & Countermeasures Div, SK/NASA Johnson 8:45 – 9:15 amSpace Ctr New Ways to Treat Bacterial InfectionsTARGET AUDIENCE: Michael N. Dudley, PharmD, Sr Vice President of Research andThis session will be useful for healthcare professionals, including Development & Chief Scientific Officer, Mpex Pharmaceuticals Incphysicians, pharmacists, and academic and industrial pharmaceutical/biotech professionals working in drug development who have an 9:15 – 9:45 aminterest in the most current clinical testing paradigms in the industry.The information presented as part of this session will offer state-of- New Therapeutic Approaches for Treatingthe-art technological advances in clinical testing and R & D strategies Pulmonary Diseasesupporting their development. Gene Colice, MD, Professor & Director, Pulmonary, Critical Care and Respiratory Services, The George Washington Univ School of MedicineBACKGROUND REQUIREMENT:Participants should have basic background knowledge of the drugdevelopment process. This session will be of special interest to those 9:45 – 10:00 amwho are involved with clinical testing and have an interest in unique drug Breaktherapies currently being tested. 10:00 – 10:30 amGOALS:The educational goal of this session will be to provide practical aspects New Therapeutic Approaches Using Silencingand critical strategic approaches in developing and applying novel drug RNA Technologytherapies/diagnostics in clinical testing with a preventive healthcare Akshay K. Vaishnaw, MD, PhD, Sr Vice President & Chief Medicalperspective. Officer, Alnylam Pharmaceuticals IncOBJECTIVES:At the conclusion of this program, participants should be able to: 10:30 – 11:00 am1. Understand practical aspects of novel therapies and clinical study Panel Discussion / Q&A designs from perspectives of pharmaceutical executives and clinical scientists from academia, the pharmaceutical industry and contract Lunch Break research organizations;2. Describe new approaches and strategies applied to developing clinical 1:30 – 1:35 pm advances relevant to unique drug therapies; Introduction – Biopharmaceutical Challenges of3. Identify unique challenges and examples of potential issues with Space Medicine developing small molecules, stem cell therapies and application of medical diagnostics; Lakshmi Putcha, PhD, Clinical Pharmacologist/Technical Manager, Human Adaptation & Countermeasures Div, SK/NASA Johnson4. Describe the current advances in novel medicines, medical diagnostics/ Space Ctr devices and biomarkers supporting the development of such therapeutics. 19
  • 19. Symposia1. 2. 1:35 – 2:05 pm CO-CHAIRS: Ayyappa Chaturvedula, PhD, Visiting Assistant Research Professor,New Drugs in the Management of Intestinal Motility Director, Ctr for Pharmacometrics, Mercer Univ, Coll of Pharmacy andDisorders Health SciencesMark Pimentel, MD, Associate Professor of Medicine, GI Motility Program, Roger W. Jelliffe, MD, FCP, Professor of Medicine, Dept of Medicine,Cedars-Sinai Medical Ctr Univ of Southern California, Keck School of Medicine2:05 – 2:35 pm TARGET AUDIENCE: This session is useful for physicians, pharmacists, clinical toxicologists,Nanomedicine for Cancer Therapeutics – clinical pharmacologists and biomedical scientists with an interestOpportunities and Challenges in therapeutic drug monitoring, in population pharmacokinetic andBruce D. Given, MD, Chairman, ICON Plc pharmacodynamic modeling and especially in optimal individualization of drug therapy for direct patient care.2:35 – 3:05 pm BACKGROUND REQUIREMENT:Engineering Nanoparticles for Biomedicine A basic understanding of pharmacokinetics and principles of therapeuticJunghae Suh, PhD, Assistant Professor, Dept of Bioengineering, drug monitoring.Rice Univ GOALS:3:05 – 3:20 pm The educational goals of this session are to provide the rationale for individualized therapy; to illustrate pharmacometric tools forBreak accomplishing individualized therapy; and to understand the implementation of pharmacometrics in a hospital-based setting for3:20 – 3:50 pm direct patient care.An Astronaut’s Perspective on Human Healthcare for OBJECTIVES:Space Exploration At the conclusion of this program, participants should be able to:Michael R. Barratt, MD, MS, Astronaut, Director of Human Research 1. Recognize the need for individualized pharmacotherapy;Program, NASA Johnson Space Ctr 2. Discuss the pharmacometric tools and applications in individualized pharmacotherapy;3:50 – 4:15 pm 3. Apply the technique in their current practice;Panel Discussion / Q&A 4. Identify the areas where further research is needed for successful implementation of clinical pharmacometrics. 8:00 – 8:15 amMONDAY, SEPTEMBER 24, 2012SYMPOSIUM VI l 8:00 – 11:30 am The Need for Individualized Therapy – Review of Previous WorkPharmacometrics Influencing Ayyappa Chaturvedula, PhD, Visiting Assistant Research Professor, Director, Ctr for Pharmacometrics, Mercer Univ, Coll of Pharmacy andHospital-based Pharmacotherapy Health Sciences238-000-12-005-L01-P - ACPE 3.25 CONTACT HOURS,0.325 CEU – KNOWLEDGE-BASED ACTIVITY. 8:15 – 8:45 amTHE ACCP DESIGNATES THIS LIVE ACTIVITY FOR A MAXIMUM OF 3.25AMA PRA CATEGORY 1 CREDIT(S)™. An Overview of Individualized Therapy:PHYSICIANS SHOULD CLAIM ONLY THE CREDIT COMMENSURATE WITH Tools and TechniquesTHE EXTENT OF THEIR PARTICIPATION IN THE ACTIVITY. Roger W. Jelliffe, MD, FCP, Professor of Medicine, Dept of Medicine, Univ of Southern California, Keck School of Medicine20
  • 20. Symposia8:45 – 9:45 am CO-CHAIRS:Pharmacometrics-driven Daily Clinical Decision Lucy Lee, PharmD, FCP, Associate Director, Translational Medicine & Clinical Pharmacology, Daiichi Sankyo Pharma DevelopmentMaking: Implementing Pharmacometrics Service in Michael Tortorici, PharmD, PhD, Associate Director,Hospital Setting Clinical Pharmacology, Pfizer Inc, Specialty Care Business UnitMichael Neely, MD, FCP, Assistant Professor of Pediatrics,Univ of Southern California, Keck School of Medicine TARGET AUDIENCE: This session will be useful for physicians, scientists and clinical9:45 – 10:00 am pharmacologists from academia, industry and regulatory agencies who are involved with drug development.Break BACKGROUND REQUIREMENT:10:00 – 10:30 am NoneOptimization of Transplant Therapy by GOALS:Pharmacometrics The educational goals of this session are to introduce participants to theAlexander A. Vinks, PharmD, PhD, FCP, Professor of Pediatrics and use of translational medicine and biomarkers; to demonstrate successfulPharmacology, Univ of Cincinnati, Coll of Medicine and Director, case studies which use translational medicine and biomarkers inDiv of Clinical Pharmacology, Cincinnati Children’s Hosp Medical Ctr personalized medicine; to discuss the use of quantitative pharmacology and biomarker applications in identifying optimal dose/dosing regimens;10:30 – 11:00 am and to update the current and prospective regulatory views on translational biomarkers in both exploratory (early) and validation (late)New Work to Be Done stages of development.David Bayard, PhD, Sr Scientist, Jet Propulsion Laboratory,California Inst of Technology OBJECTIVES: At the conclusion of this program, participants should be able to:11:00 – 11:30 am 1. Describe translational medicine and different types of biomarkers andPanel Discussion 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 biomarkersMONDAY, SEPTEMBER 24, 2012 in drug development.SYMPOSIUM VII l 1:30 – 5:00 pm 1:30 – 2:00 pmClinical Translational Biomarkers Basic Concepts in Translational Medicine andFacilitating Transition From Bench to Biomarkers: Optimizing Patient CareBedside: Basic Concepts, Successful Chris H. Takimoto, MD, PhD, FACP, Vice President, Translational Medicine Early Development, Ortho Biotech OncologyCase Studies and Regulatory Viewpoints R&D/Johnson & Johnson PRD238-000-12-006-L01-P - ACPE 3.25 CONTACT HOURS,0.325 CEU – KNOWLEDGE-BASED ACTIVITY. 2:00 – 2:30 pmTHE ACCP DESIGNATES THIS LIVE ACTIVITY FOR A MAXIMUM OF 3.25AMA PRA CATEGORY 1 CREDIT(S)™. Successful Case Studies – Personalized Medicine:PHYSICIANS SHOULD CLAIM ONLY THE CREDIT COMMENSURATE WITH Mutated V600E BRAF Inhibitor in Patients with MelanomaTHE EXTENT OF THEIR PARTICIPATION IN THE ACTIVITY. Jeffrey A. Sosman, MD, Professor of Medicine, Medical Oncologist & Director, Melanoma and Tumor Immunotherapy Program, Vanderbilt-Ingram Cancer Ctr 21
  • 21. Symposia2:30 – 3:00 pm TUESDAY, SEPTEMBER 25, 2012Successful Case Studies – Functional Imaging: SYMPOSIUM VIII l 8:00 – 11:30 amFDG-PET as Early Response Marker in Patientswith GIST Speeding Up the Development ofAnnick D. Van den Abbeele, MD, Professor of Radiology, Dept of New Anti-infective Drugs to CombatRadiology, Harvard Medical School & Director, Ctr for BiomedicalImaging in Oncology (CBIO), Radiology, Dana-Farber Cancer Inst Drug Resistance { THIS SESSION HAS NOT BEEN DESIGNATED FOR CME OR CPE CREDIT }3:00 – 3:15 pm CO-CHAIRS:Break Hartmut Derendorf, PhD, Distinguished Professor and Chairman, Dept of Pharmaceutics, Univ of Florida3:15 – 3:45 pm Vincent H. Tam, PharmD, BCPS (Infectious Diseases),Applications of Quantitative Pharmacology: Associate Professor, Dept of Clinical Sciences and Administration, Univ of Houston Coll of PharmacyPharmacokinetic – Pharmacodynamic Modeling &Simulation for Identifying Optimal Biologic Dose TARGET AUDIENCE:Donald E. Mager, PharmD, PhD, FCP, Associate Professor, School of This session will be useful for physicians prescribing anti-infectivePharmacy and Pharmaceutical Sciences, Univ at Buffalo, SUNY medications in guiding them to pay attention to appropriate dosing and length of therapy. This session will also be useful to pharmacists3:45 – 4:15 pm involved in antibiotic stewardship programs in guiding them to make appropriate decisions on drug selection and dosing. Furthermore,Safety Biomarkers: Lessons Learned and Their Utility this session will be useful for scientists involved in anti-infective drugin Early Clinical Development discovery and development, since rational development strategies willJonathan Deutsch, MD, Therapeutic Area Safety Head, Oncology, be presented that allow streamlining the process and thereby loweringJohnson & Johnson Pharmaceutical Research & Development LLC drug development costs. BACKGROUND REQUIREMENT:4:15 – 4:45 pm Participants should have a doctoral degree in a healthcare professionRegulatory Views: (medicine, pharmacy, clinical microbiology) or have an interest in patientCurrent Status and Validation / Qualifications of care or drug development.Biomarkers in Phase II & III Development GOALS:Lawrence J. Lesko, PhD, FCP, Professor, Univ of Florida at Lake The educational goals of this session are to inform attendees ofNona (Orlando), c/o Sanford-Burnham Medical Research Inst at Lake the rationale and approach to speed up the development of newNona anti-infective agents; to further the understanding of the impact of pharmacokinetic and pharmacodynamic modeling on anti-infective drug4:45 – 5:00 pm development; and to identify the impact of poor adherence on drug development, clinical outcome and resistance development.Problem-based Case Study OBJECTIVES: At the conclusion of this program, participants should be able to: 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.22
  • 22. Symposia8:00 – 8:40 am CO-CHAIRS:Pharmacokinetic Issues in Overcoming Resistance: Shirley M. Tsunoda, PharmD, Assistant Clinical Professor of Pharmacy, Univ of California, San Diego, Skaggs School of PharmacyProtein Binding and Microdialysis and Pharmaceutical SciencesHartmut Derendorf, PhD, Distinguished Professor and Chairman, Alexander Kuo, MD, Assistant Professor and Medical Director ofDept of Pharmaceutics, Univ of Florida Liver Transplantation, Dept of Medicine, Div of Gastroenterology, Univ of California, San Diego8:40 – 9:20 am TARGET AUDIENCE:Pharmacodynamic Issues in Overcoming Resistance: This session will offer important knowledge and education forKill Curves and MICs pharmacists, physicians, nurses, physician assistants and otherVincent H. Tam, PharmD, BCPS (Infectious Diseases), Associate healthcare professionals and research scientists in academia,Professor, Dept of Clinical Sciences and Administration, Univ of Houston hospitals, the private sector and regulatory agencies.Coll of Pharmacy BACKGROUND REQUIREMENT:9:20 – 9:35 am NoneBreak GOALS: The educational goal of this session is to provide participants with9:35 – 10:15 am practical, clinical and research-related information to support the assessment and management of patients with chronic hepatitis C.Drug Discovery and Development Strategies toOvercome Resistance OBJECTIVES:Michael N. Dudley, PharmD, Sr Vice President, Research & At the conclusion of this program, participants should be able to:Development and Chief Scientific Officer, Rempex Pharmaceuticals Inc 1. Identify several hepatitis C viral targets for drug development; 2. Discuss new strategies for the treatment of hepatitis C virus including10:15 – 10:55 am combination therapy; 3. Outline the FDA process for new drug applications for hepatitis CEnsuring Adherence – A Key to Combat Resistance compounds;Donn Dennis, MD, Chief Science Officer, Xhale Inc 4. Discuss strategies to incorporate pharmacogenetics to individualize hepatitis C therapy.10:55 – 11:30 amCase Presentation 8:00 – 8:15 am Introduction Alexander Kuo, MD, Assistant Professor and Medical Director ofTUESDAY, SEPTEMBER 25, 2012 Liver Transplantation, Dept of Medicine, Div of Gastroenterology, Univ of California, San DiegoSYMPOSIUM IX l 8:00 am – 12:00 pm 8:15 – 9:00 amHepatitis C – An Expanding Area Hepatitis C Virusof Drug Development and Clinical Robert T. Schooley, MD, Professor & Head, Div of Infectious Diseases,Pharmacology Dept of Medicine & Executive Vice Chair for Academic Affairs, Univ of California, San Diego238-000-12-007-L01-P - ACPE 3.75 CONTACT HOURS,0.375 CEU – KNOWLEDGE-BASED ACTIVITY.THE ACCP DESIGNATES THIS LIVE ACTIVITY FOR A MAXIMUM OF 3.75AMA PRA CATEGORY 1 CREDIT(S)™.PHYSICIANS SHOULD CLAIM ONLY THE CREDIT COMMENSURATE WITHTHE EXTENT OF THEIR PARTICIPATION IN THE ACTIVITY. 23
  • 23. Symposia9:00 – 9:45 am CO-CHAIRS CONT: Joseph D. Ma, PharmD, Assistant Professor, Univ of California,New Strategies in the Therapeutic Management of San Diego, Skaggs School of Pharmacy and Pharmaceutical SciencesHepatitis CRobert G. Gish, MD, Medical Director, Hepatobiliary Disease and TARGET AUDIENCE:Abdominal Transplantation, Chief of Hepatology, Professor of Medicine, This session will offer important knowledge and education forUniv of California, San Diego pharmacists, physicians, nurses, physician assistants, other healthcare professionals and research scientists in academia, hospitals, the private9:45 – 10:00 am sector and regulatory agencies.Break BACKGROUND REQUIREMENT: None10:00 – 10:45 am GOALS:FDA Perspectives on Trial Design and Submissions forHepatitis C The educational goal of this session is to provide participants practical, clinical and research-related information to support the assessment andKimberly Struble, PharmD, Clinical Analyst Team Leader, Office of management of patients with chronic pain.New Drugs, Food and Drug Administration OBJECTIVES:10:45 – 11:30 am At the conclusion of this program, participants should be able to:Future Directions of Hepatitis C Management, 1. Recognize the various pharmacological agents used to treat and manage chronic pain;Individualized Therapy, New Drugs in the Pipeline 2. Identify at least one misconception when treating chronic pain patients;John G. McHutchison, MD, Sr Vice President, Liver Disease 3. Calculate the importance of determining efficacy with human, chronicTherapeutics, Gilead Sciences Inc pain models; 4. Discuss study design aspects specific for chronic pain clinical studies.11:30 am – 12:00 pmPanel Discussion / Q&A 1:30 – 1:40 pm Introduction Rabia S. Atayee, PharmD, BCPS, Assistant Clinical Professor ofTUESDAY, SEPTEMBER 25, 2012 Pharmacy, Univ of California, San Diego, Skaggs School of PharmacySYMPOSIUM X l 1:30 – 5:00 pm and Pharmaceutical Sciences and Doris A. Howell Palliative Care ServiceChronic Pain: Underdiagnosed, 1:40 – 2:20 pmUndertreated and Misunderstood Overview and Clinical Pharmacology of Chronic Pain Maria Foy, PharmD, CDE, Clinical Specialist, Pharmacy Dept,238-000-12-008-L01-P - ACPE 3.25 CONTACT HOURS,0.325 CEU – KNOWLEDGE-BASED ACTIVITY. Abington Memorial HospTHE ACCP DESIGNATES THIS LIVE ACTIVITY FOR A MAXIMUM OF 3.25AMA PRA CATEGORY 1 CREDIT(S)™. 2:20 – 3:00 pmPHYSICIANS SHOULD CLAIM ONLY THE CREDIT COMMENSURATE WITHTHE EXTENT OF THEIR PARTICIPATION IN THE ACTIVITY. Treating Chronic Pain Patients – A Challenge or An Opportunity?CO-CHAIRS: Chris M. Herndon, PharmD, Assistant Professor, Southern Illinois Univ,Rabia S. Atayee, PharmD, BCPS, Assistant Clinical Professor of Edwardsville School of Pharmacy and St Louis Univ School of MedicinePharmacy, Univ of California, San Diego, Skaggs School of Pharmacyand Pharmaceutical Sciences and Doris A. Howell Palliative Care Service 3:00 – 3:15 pm Break24
  • 24. Symposia3:15 – 3:55 pm OBJECTIVES: At the conclusion of this program, participants should be able to:Assessing Analgesic Efficacy with Human, 1. Forecast the benefit of pharmacometric activities in terms of timeChronic Pain Models savings, cost savings, generating new scientific hypotheses andMark S. Wallace, MD, Clinical Professor, Dept of Anesthesiology, improvements in therapeutics;Univ of California, San Diego 2. Identify ways to increase and improve the impact of a pharmacometric exercise;3:55 – 4:35 pm 3. Demonstrate the cost and time benefits of a pharmacometric exercise.Clinical Trial Considerations and Design forChronic Pain 1:30 – 2:00 pmMichael C. Rowbotham, MD, Scientific Director, California Pacific Introduction – Current Status and Future Trends inMedical Ctr Research Inst Pharmacometrics4:35 – 5:00 pm Jogarao Gobburu, PhD, FCP, MBA, Professor, Univ of Maryland, School of PharmacyQ&A 2:00 – 2:30 pm Case Study 1: First-in-Human / Transition fromTUESDAY, SEPTEMBER 25, 2012 Discovery to DevelopmentSYMPOSIUM XI l 1:30 – 5:00 pm Jenny Chien, PhD, Sr Research Advisor, Early Clinical Implementation Team Leader, Global Pharmacokinetics/Pharmacodynamics and“Return on Investment” Pharmacometrics, Lilly Research Laboratories, Eli Lilly & Coin Pharmacometrics 2:30 – 3:00 pm{ THIS SESSION HAS NOT BEEN DESIGNATED FOR CME OR CPE CREDIT } Case Study 2: Early Development (Phases 1 and 2)CO-CHAIRS: Honghui Zhou, PhD, FCP, Head, Pharmacokinetics & Pharmacometrics,Jogarao Gobburu, PhD, FCP, MBA, Professor, Univ of Maryland, Biologics Clinical Pharmacology, Janssen Research & DevelopmentSchool of PharmacyIvan Nestorov, PhD, Director, Pharmacometrics, Biogen Idec 3:00 – 3:15 pm BreakTARGET AUDIENCE:This session is intended not only for scientists with direct involvement 3:15 – 3:45 pmin pharmacometric evaluations, but also for clinical pharmacologists,managers and biomedical scientists with an interest in drug Case Study 3: Late Development (Phases 1 through 4)development sciences in general. Business Impact of Modeling & Simulation in Pfizer Sriram Krishnaswami, PhD, FCP, Director, Specialty Care ClinicalBACKGROUND REQUIREMENT: Pharmacology, Pfizer IncSome knowledge of the drug development process will be necessary.GOALS: 3:45 – 4:15 pmThe educational goals of this session are to evaluate the contributions Case Study 4: Approval & Labelingof pharmacometric activities in terms of time savings, cost savings, Yaning Wang, PhD, Associate Director for Science, Div of Pharmacometrics,generating new scientific hypotheses and improvements in therapeutics, Food & Drug Administrationas well as ways to increase and improve the impact of pharmacometrics. 4:15 – 5:00 pm Panel Discussion 25
  • 25. Why Join ACCP?Why Join ACCP?Boasting a rich 40-year history, ACCP has a diverse global BENEFITS THROUGH EMAIL:membership of healthcare professionals dedicated to improving • FDA News Drug Daily Bulletinhealth by optimizing therapeutics. ACCP seeks to improve the • Routine Recall/Drug Safety Notices from FDA MedWatchquality of instruction in clinical pharmacology and its positionin curriculum planning at schools of medicine, pharmacy and • “Online First” and Table of Contents Alerts for The Journal of other disciplines around the world. Individuals can participate Clinical Pharmacologyin meetings or online educational activities on cutting-edge, • Quarterly Notifications on Clinical Pharmacology inrelevant topics related to clinical pharmacology and the optimal Drug Developmentuse of therapeutics. These interactions provide a forum for • Relevant communications regarding ACCP and its activitiesnew scientific ideas and bring together healthcare professionalsof various disciplines to meet and discuss areas of common BENEFITS THROUGH THE ACCP WEBSITE:interest. ACCP is one of the few organizations to still offerContinuing Medical Education (CME) and Continuing Pharmacy • Continuing Education ProgramsEducation (CPE) credit for qualified professionals. In addition • Student & Trainee-specific materialsto collegial exchange and networking opportunities, ACCP • Career Center Listingpublishes The Journal of Clinical Pharmacology and the Clinical • Public Policy AlertsPharmacology in Drug Development eJournal, both of which areprovided to Members at no additional cost. • Grants & Funding OpportunitiesJoin ACCP Today PASSWORD-PROTECTED MEMBERS ONLY AREA OF ACCP WEBSITE:GENERAL BENEFITS: • Membership Directory• Access to The Journal of Clinical Pharmacology and • Online access to The Journal of Clinical Pharmacology Clinical Pharmacology in Drug Development (archived issues from 1961) and Clinical Pharmacology in • Interdisciplinary accredited educational programs Drug Development• 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 environment26
  • 26. Registration InformationRegistration Information 2012 ACCP ANNUAL MEETINGACCP continues to offer exciting educational opportunities for a REGISTRATION DEADLINE for Pre-meeting Workshopsbroad spectrum of healthcare professionals to earn Continuing is August 17, 2012. This will minimize the possibility ofEducation credit while attending live, concurrent Pre-meeting cancellations due to failure to meet attendance requirements.Workshops and Symposia. Register today and join a global ACCP reserves the right to cancel Pre-meeting Workshops dueaudience of healthcare professionals in a focused, educational to low attendance. Should cancellation be required, registrantsatmosphere that also provides time to network with colleagues, will receive a full refund for the cost of the Pre-meetingnew and old. Workshop only.Join ACCP now and immediately enjoy Member Benefits,including discounts on registration for the Annual Meetingand other ACCP Continuing Education events. REGISTRATION INFORMATION EARLY BIRD REGULAR ONSITE 4/1/2012 – 7/1/2012 7/2/2012 – 9/21/2012 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 $100CANCELLATION / REFUND POLICY:Meeting registration cancellations must be submitted via email to Reg@ACCP1.org 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 TStevens@ACCP1.org or 240-399-9070, ext. 4. 27
  • 27. International AttendeesInternational AttendeesIf you are not a US citizen and are planning to attend the ACCP Please see the following sites for more information onAnnual Meeting, please make your travel plans early and plan Travel to the United States:properly. You should begin applying for a US Visa at least 90days before your travel dates for this event. US-Visit (Department of Homeland Security)Additional information is available regarding the processfor obtaining a US Visa. US Embassies and Consulates WorldwideCRITICAL ESTA INFORMATION: US Department of StateEffective January 20, 2010, citizens of Visa Waiver countrieswill be unable to enter the United States without ElectronicSystem for Travel Authorization (ESTA) approval from the USGovernment. Visa Waiver Program travelers who have notobtained proper approval through ESTA will not be allowed to Request a Letter of Invitation to Attend theboard on any air carrier destined for the United States. ACCP Annual MeetingMore information on this critical step is available atESTA Travel.Effective September 8, 2010, all Electronic System for TravelAuthorization (ESTA) registration applications or renewals onor after that date will require a $14.00 fee payment by credit ordebit card. Existing ESTA registrations remain valid throughtheir expiration date. For more information, please visit theESTA 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 BorderProtection (CBP).ESTA applications may be completed online at the DHSwebsite.Review the important DHS Advisory Warning aboutunauthorized third-party ESTA application related websites.28
  • 28. Travel and HotelTravel Hotel Reservations at the Sheraton Hotel & MarinaPlease note: It is important that all travel arrangements Housing Reservation Deadline: August 29, 2012be made for arrival at the San Diego International Airport –Airport Code: SAN ACCP is proud to host the 2012 Annual Meeting at the Sheraton San Diego Hotel & Marina, located within one mileMEETING LOCATION: of the San Diego International Airport.The 2012 ACCP Annual Meeting is being held at theSheraton San Diego Hotel & Marina, less than one mile Room rates are $169.00 + tax per night for a single or doublefrom the San Diego International Airport. room. Triple ($189.00 + tax per night) or Quad rooms ($209.00 + tax per night) are subject to availability. The tax rate for thisCOMPLIMENTARY AIRPORT SHUTTLE: hotel is 12.565%.The Sheraton San Diego Hotel & Marina provides acomplimentary airport shuttle to and from San Diego Hotel check-in: 3:00 pm & check-out: 12:00 pmInternational Airport 24 hours a day. From 4:45 am to 12:00 am,the shuttle runs every 20 minutes between the two locations. Make Reservations online or directly by phoneOutside of these hours, guests may request a pickup by phoning by calling ACCP’s Housing Bureau at (800) 456-3585the hotel directly at (619) 291-2900. The shuttle vans are grey, (9:00 am – 5:00 pm, Eastern Time). Meeting delegatesblue and white and run between the Marina Hotel and Bay residing outside of the US should call (302) 658-3585.Towers and airport Terminals 1 & 2. SHERATON EARLY CHECKOUT POLICY:Shuttle service is available at the Transportation Plazas across Guests who check out of the hotel prior to their scheduledfrom Terminals 1 and 2, and curbside at the Commuter Terminal. departure date will be charged a penalty of $100. The departureFrom Terminal 1, you must cross the skybridge, and take either date may be changed up until the day of arrival.the escalators or the elevators to street level. From Terminal 2, • Normal check-in date: 9/22/2012cross the Terminal 2 skybridge and take either the escalators • Normal check-out date: 9/25/2012or the elevators to street level, or use the pedestrian crosswalkconveniently located outside the Terminal 2 Baggage Claim Area If you would like to arrive at an earlier date and/or extend yourto access the Transportation Plaza. stay for additional nights, rooms for the nights of 9/21/2012 through 9/25/2012 have limited availability and may be bookedGeneral Directions to the Hotel through the ACCP Housing Bureau. 29
  • 29. Travel and HotelAfter completing your online reservation request, you will receive Onsite Restaurants at thean email confirmation of your reservation. If you do not receive Sheraton San Diego Hotel & Marinayour reservation, please check any spam or bulk folders beforecontacting ACCP’s Housing Bureau. Harbor’s Edge – the main dining room, open for breakfast, lunch and dinner, caters to your palate with contemporaryCANCELLATION POLICY: American cuisine.You may cancel your reservation up to three days (72 hours)before the check-in date without penalty. “No shows” will be Shoreline Restaurant – poolside snacks, drinks and grilledcharged for a one-night stay. To make changes or to cancel, favorites.please do so ONLY by contacting ACCP’s Housing Bureau orby calling (800) 456-3585 (9:00 am – 5:00 pm Eastern Time). Tapatini - Tapas & Wine Bar – enjoy martinis and Spain’sPlease note that ACCP cannot guarantee that cancellations legendary tapas.made using any other method will be processed appropriatelyand that ACCP holds no responsibility in such an event. Quinn’s – friendly sports bar has views of the WaterWorks pool and Marina and features entertainment, billiards,Learn more about the amenities at the Sheraton San Diego signature favorites, and local micro brews.Hotel & Marina. 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.30
  • 30. Travel and HotelThings to doLOCAL AREA: stood, and where no one dared to enter after dark, the GaslampSheraton San Diego Hotel & Marina enjoys a prime waterfront Quarter has now become the pulse of the city.location on lovely San Diego Bay. Many of the area’s mostpopular attractions are within walking distance or a short drive, Due west of the city proper is the Embarcadero, a fun daytimeincluding the San Diego Zoo, Gaslamp Quarter and Sea World location where visitors can take in leisurely views of the bay,Park. Shops and restaurants abound at nearby Horton Plaza, hop aboard a harbor cruise or enjoy seafood at its finest. Forand the famous border town of Tijuana beckons you to sunny shopping, visit Seaport Village, a 14-acre shopping and diningMexico, less than an hour away. complex designed to emulate early California-style architecture.Semi-tropical San Diego, with its mean temperature of 70° F,Mediterranean-like, white-washed stucco buildings and strong LOCAL ATTRACTIONS INCLUDE:cultural influences from sunny Mexico, is as close to visiting aforeign country as visitors could get and yet, is as American as San Diego Embarcaderoapple pie. San Diego ZooSpanning from the North County beach areas to the South Baycities along the Mexican border, San Diego is one of the top Balboa Parkten largest cities in the United States. While all these areasfall under the San Diego umbrella, each individual community Gaslamp Quartermaintains its own personality, geography and identity. Truly, inSan Diego’s case, the whole is greater than the sum of its parts. La JollaLess than three miles from the airport is downtown proper. This Old Townthriving commercial area with its active waterfront is a bustling,colorful combination of major hotels, convention facilities, Coronadorestaurants, nightclubs and shopping venues. Its focal pointis the Horton Plaza, an architectural masterpiece that holds Del Martrendy shops, lively restaurants, a theatre and even an ice rinkduring the holiday season. Just east of the Horton Plaza is the Sea WorldGaslamp Quarter, a 16-block source of civic pride. Once slatedfor destruction, this area has been reclaimed by the people of Please also visit: San Diego Convention & Visitors BureauSan Diego thanks to the 1970’s Redevelopment Plan. Where for more information on surrounding areas and a calendar ofonce dilapidated warehouses and run-down Victorian houses events for September. 31
  • 31. Who We Are Who We Are Academic Medical Center Academic Medical Cen Biotech Boasting a rich 40-year history, ACCP has a diverse global ACCP is one of the few organizations to still offer Continuing Biotech membership dedicated to improving the quality of patient care Medical Education (CME) and Continuing Pharmacy Education Community Hospital Community Hospital by optimizing the use of therapeutics. The College achieves (CPE) credit for qualified professionals. In addition to collegial this by providing Continuing Education to a broad range of exchange and networking opportunities, ACCP publishesPharmaPharma The clinicians and healthcare professionals involved in patient care Journal of Clinical Pharmacology and the Clinical Pharmacology CRO and research. Individuals can participate in meetings or in in Drug Development eJournal, both of which are provided to CRO online and Internet enduring educational activities that provide Members at no additional cost. Government Regulatory Government Regulator a forum for new scientific ideas and bring together healthcare Private Practice professionals of various disciplines to meet and discuss areas of Private Practice common interest.DISTRIBUTION OF ACCP MEMBERSHIP BY ORGANIZATIONAL AFFILIATION DISTRIBUTION OF MEMBERSHIP BY DEGREE Academic Medical Medical Center Academic Center Biotech Biotech PhD PhD Community Hospital Hospital Community MD MD Pharma Pharma PharmD PharmD CRO CRO Other Other Government Regulatory Government Regulatory Private Practice Practice Private PhD PhD MD MD PharmD PharmD Other Other 32
  • 32. Why Exhibit at ACCP?Vision & Mission• To improve health by optimizing therapeutics; If you are looking to market your product or service, network with• Provide innovative leadership and interdisciplinary education peers or make new contacts, the 2012 ACCP Annual Meeting is that will enable the generation, integration and translation of the place to be! You won’t find a better opportunity to interact scientific knowledge to optimize research, development and with your target audience than at the ACCP Annual Meeting. utilization of medication for the benefit of all. 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.Why Should You Exhibit at, Sponsor orSupport the 2012 ACCP Annual Meeting? • Not For Students Only: How to Start and Manage YourACCP’s meeting attendees have indicated that exhibits help Career in the Pharmaceutical Industrythem evaluate and plan future purchases for their own clinical • Update on the Pharmacologic Management of Asthmaand research institutions and private practices. Attendees are in Childrenparticularly interested in new, cutting-edge tools to increase • Update on Psychotropics: New Agents and Guidelinesthe efficiency of patient care and drug development. Getdirect access to decision makers who are seeking face-to-face • Evaluating Drug-Drug Interactions with Therapeuticinteractions and who are interested in more information from Proteinsvaluable product and service providers that can help them • Developing Issues in Pediatric Clinical Pharmacologyachieve their goals. Exhibiting at the ACCP Annual Meeting • The Changing Face of Pediatric Drug Developmentdirectly positions you to present your products, solutions or • The Evolving Face of First-in-Human (FIH) Studies fromservices and can help your company meet sales and business the Investigators’ Perspectivedevelopment objectives. Typical ACCP Annual Meetingattendees consist of a blend of: • Innovations in Drug Therapies – The Future is Now • Pharmacometrics Influencing Hospital-based• Clinical Pharmacologists Pharmacotherapy• Primary Care and Other Physicians • Clinical Translational Biomarkers Facilitating Transition From Bench to Bedside: Basic Concepts, Successful Case• Pharmacists Studies and Regulatory Viewpoints• Physician Assistants • Speeding Up the Development of New Anti-infective Drugs• Clinical Research Associates and Managers to Combat Drug Resistance• Basic Scientists Involved in Drug Development • Hepatitis C – An Expanding Area of Drug Development• Students & Trainees in the above noted disciplines and Clinical Pharmacology • Chronic Pain: Underdiagnosed, Undertreated and Misunderstood • “Return on Investment” in Pharmacometrics 33
  • 33. Why Exhibit at ACCP?We invite you to commit now to become an Exhibitor or Sponsor CANCELLATION POLICY:of the 2012 ACCP Annual Meeting. Commercial support of the Cancellations in writing will be accepted until June 14, 2012.2012 ACCP Annual Meeting will boost visibility to key audiences. Cancellations of Exhibitor commitments are subject to a $500Your support will elevate awareness of your organization while administrative fee.sustaining education for practitioners, pharmaceutical andbiotechnology professionals and students in direct patient care, EDUCATIONAL GRANTS:clinical and preclinical research, regulatory, academia, privatepractice and related specialties under the umbrella of clinical Educational grants are used to support ACCP Annual Meetingpharmacology and drug development. Reserve your space live educational events, as well as online and Internet enduringnow by contacting Tami Stevens at TStevens@ACCP1.org or materials. For more information, please contact the ACCP240-399-9070, ext. 4. Deadline for final Exhibitor, Sponsor Executive Office at 240-399-9070 to obtain additional information.or Support commitments is June 15, 2012. COMPLIANCE WITH PHRMA CODE: ACCP asks that Exhibitors, Sponsors and Supporters comply with the PhRMA Code on interactions with healthcare professionals.34
  • 34. Support OpportunitiesSupport 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 MeetingSPECIFIC LEVELS OF SUPPORT:PLATINUM 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 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 GOLD GOLD Level Support of $5,000+ 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 SILVER SILVER Level Support of $3,000+ Annually includes: • 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 35
  • 35. Support OpportunitiesMobile App – Student Networking Wine and Cheese$5,000 – Exclusive Opportunity Reception –An unparalleled opportunity to get your brand/company $3,000 – Exclusive Opportunityinformation in front of meeting attendees. During the Exclusive opportunity to prominently display your companymeeting, the mobile app will provide a rich, easy-to-navigate name and logo while Students & Trainees are gathered at atool containing all meeting logistics and information. After Wine and Cheese Reception to network with experts in thethe meeting, they’ll continue to utilize the mobile app to recall field of clinical pharmacology.contacts they made. The mobile app must be reservedby June 1, 2012. Regents/Awards Reception and Dinner – $5,000 – Exclusive OpportunityCoffee Breaks – Exclusive opportunity to sponsor the recognition of all$3,000 – Exclusive or Shared Sponsorship(s) 2012 ACCP Award Winners and ACCP Regents. Your companyScheduled refreshment breaks during educational Symposia name and logo will be prominently displayed at the entrance toare held inside the Exhibit Hall, Sunday through Tuesday. the invitation-only dinner, and two (2) company representatives will be invited to attend this dinner and will be acknowledgedLunch during the Awards Sessions – during the event.$7,000 – Exclusive or Shared Sponsorship(s)Choose from three lunches for Annual Meeting attendees during Hotel Guest Room Key Cards –the Awards Sessions and/or Keynote Presentations on Sunday, $5,000 – Exclusive OpportunityMonday or Tuesday. Hotel guest room key cards will be used for the duration of the entire meeting, providing visibility for your company nameWine and Cheese & Poster Receptions – or product. The keys will be distributed to all attendees upon$5,000 – Exclusive or Shared Sponsorship(s) check-in. This item must be reserved by June 1, 2012.Exclusive or shared opportunity to provide wine and cheese forAnnual Meeting attendees at one of two receptions in the Exhibit Meeting Bag Inserts –Hall, available for Sunday and Monday. $2,000 – Available to All ACCP will be happy to insert your company’s promotionalBreakfast Poster Reception – flyers in the Annual Meeting attendee tote bags. All promotional$5,000 – Exclusive or Shared Sponsorship(s) pieces must be approved in advance by ACCP. Price reflectsExclusive or shared opportunity to provide breakfast for Annual one promotional piece.Meeting attendees at the Tuesday morning Poster Session andContinental Breakfast in the Exhibit Hall.36
  • 36. Support Opportunities * Tote Bags $4,000 – Exclusive Opportunity Exclusive opportunity to sponsor tote bags with your company name and logo that will be provided to all Annual Meeting attendees. * Lanyards $2,500 – Exclusive Opportunity Exclusive 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. Additional Advertising Opportunities Final Program Advertising Limited 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. Rates are as follows: Back Cover $4,000 • Inside Back Cover $3,000 Full Page $2,000 • Half Page $1,200 Quarter Page $750 Deadline for submission of ads is June 15, 2012. 37
  • 37. Exhibitor Registration Form 2012 ACCP Annual MeetingEXHIBIT 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 FEEComplimentary 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 GIFformat to TStevens@ACCP1.org at the time of Exhibitor registration.____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ ACCP’s Tax ID number is 22-1950891