The Academy of Pharmaceutical Physicians and Investigators (APPI) Program
The APPI Program has been expanded to 35 hours of physician education – an 82% increase in content. Hear from and interact with world renowned leaders who are shaping the future of clinical research.
The APPI Program will include a special curriculum dedicated to Pharmaceutical Medicine Frontiers in Drug Development — Not for Physicians Only on Saturday, April 24 and Sunday, April 25, 2010. This program will cover the science, the business and the ethics of drug development over the course of nine sessions held over two days. See a complete listing of these sessions.
APPI Program Schedule
Saturday, April 24, 2010
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Pre-Conference Workshops
Friday, April 23
Pre-Conference Workshops*
Enhance your conference experience – explore a single topic in-depth by participating in a Pre-Conference Workshop.
8:00 AM – 12:00 PM
W015 Facing the Ethical and Regulatory Challenges of Investigator Initiated Research
IIR studies require the investigator to assume the regulatory responsibilities of the investigator and the sponsor. Investigators may also have real or perceived conflicts of interest that must be managed to protect the integrity of the research and the welfare of patients and study participants. Successfully conducting an ethically and scientifically sound IIR study requires expertise in clinical research methodology, study management, and regulatory compliance throughout the research process.
SPEAKER(S): Ernest Prentice, MA, PhD, Associate Vice Chancellor for Academic Affairs,
University of Nebraska Medical Center; Susan Odum, MEd, CCRC, Manager, Scientific Studies andOutcomes, OrthoCarolina Research Institute
NEW Workshop
1:00 PM – 5:00 PM
W016 Fundamentals of Successful Clinical Trial Design - CANCELLED
There are many important considerations in designing clinical trials, but the key factors often are patient selection, dose selection, and endpoint selection. Thoughtful and correct decisions on these three factors will often spell the difference between success and failure. This workshop will discuss the fundamentals of making the correct decisions on these key factors.
SPEAKER(S): Richard Chin, MD, CEO, Institute for OneWorld Health
* Please note there are additional registration fees for Pre-Conference Workshops. | |
9:45 am – 12:00 pm
SP018 Cell Therapy Research: Challenges of NIH Network Trials
This session will explore: NIH trials from the perspective of a coordinator, provide an overview of the CCTRN, discuss screening logs and tracking demands in the Network, recruitment in cardiac cell therapy, especially when “yes” is not an option and processing and preparing cells in cardiovascular stem cell trials.
SPEAKER(S): Adrian Gee, MIBiol, PhD,_ Director, Clinical Applications Lab, Baylor College of Medicine; Eileen Handberg, PhD, ARNP,BC, FAHA, FACC, Director, Clinical Programs, University of Florida College of Medicine; LynetteWestbrook, RN, MS, CCRC, Research Nurse Specialist, Texas Heart Institute; Rachel Vojvodic,MPH, Project Manager, The University of Texas Health Science Center
SP019 FDA Final Guidance–Investigators: Medically Qualified Staff
Supervision of a clinical trial is the Investigator’s trial most important responsibility. The panel discussion includes an investigational site case study to specifically address “qualified” and “trained” staff.
SPEAKER(S): Brigid Hobbs, BSN, RN, CCRP, Clinical Trial Monitor, Genentech; Christina Eberhart, BS, CEO, PhaseCare, LLC; Liz Wool, BSN, CMT, CCRA, President/CEO, QD-Quality &Training Solutions; Stephen Raskin, MD, CMO,PhaseCare, LLC
12:00 pm – 6:00 pm
EXHIBIT HALL OPEN
12:00 pm – 2:00 pm
APPI Business Meeting & Policy Forum Luncheon
See Networking Events for details.
2:00 pm – 4:15 pm
Special Event
SP154 An Afternoon with Eva
See Special Events for details.
3:15 pm – 4:15 pm
S040 Introduction to Biomarker & Biomarker Research
What are biomarkers, biomarker research, pharmacogenomics, pharmacogenetics? Why are they important for drug development and public health?
SPEAKER(S): Feng Hong, PhD, CCRA, Research Operations Senior Manager, Amgen, Inc.
S041 Intellectual Optical Illusions and Clinical Trial Data - CANCELLED
Primate brains are not designed to interpret statistical data. There are some common intellectual optical illusions that often lead people astray during clinical trial data interpretation. This presentation will show how some such pitfalls can be avoided.
SPEAKER(S): Richard Chin, MD, CEO, Institute for OneWorld Health
Sunday, April 25, 2010
8:00 am – 9:00 am
S051 Advanced Business Concepts in Research for Physicians
Speaking from a physician perspective, this lecture would provide a discussion on the trial process for research sites. A presentation outline would include: solutions in clinical research budgeting, managing the revenue cycle for sites, operations and enrollment concerns, positive CTMS impact for sites.
SPEAKER(S): Alan Bank, MD, Medical Director of Research, St. Paul Heart Clinic
S052 Grand Opening: The Investigator Site: Before & After Pearls
This session is intended to give the new investigator/site staff an insight into what to be aware of before considering involvement in the clinical trial business and what to expect once one gets started.
SPEAKER(S): Anne Marie Baughn, RN, MSN, Director of Marketing and Business Development,Rx Trials, Inc; Randall Stoltz, MD, CPI, MedicalDirector, Covance
10:00 am – 11:00 am
S062 Data Quality & Integrity: From Monitoring To Approval
Regulatory authorities grant approval after a thorough review of safety/efficacy. The data
quality and integrity required to demonstrate substantial efficacy/safety summarized in clinical study reports is then critical and actions must be taken from the sites to ensure this requirement is met.
SPEAKER(S): Stéphanie Dubois, PhD, RAC, CCRP, Senior Clinical Scientist, Clinical Strategy,Cato Research
S063 Research Portals: Strategic Change in Research Methodology
Demonstrate insights of successfully deploying a next generation research-patient portal using web 3.0 technology. This portal will provide patients participating in research studies with the ability to enter, and share investigational research information online and will connect federal agencies and hospitals for responsible conduct of research.
SPEAKER(S): Sree Turlapati, BS, Chief Technology & Solutions Officer, Outcomes Online LLC; Vinod Podichetty, MD, MS, Director, Cleveland Clinic Florida
11:15 am – 12:30 pm
PLENARY SESSION
Social Responsibility and the Pharmaceutical Industry in the 21st Century —
A Global Perspective
KEYNOTE SPEAKER
Thomas Gorrie, PhD
President, T.M. Gorrie and Associates
Dr. Gorrie recently retired from a 35-year career with Johnson & Johnson, with his final post being Vice President of Government Affairs and Policy. He presently provides advice and consulting services to firms worldwide on business, government affairs, and management topics.
12:30 pm – 6:00 pm
EXHIBIT HALL OPEN
12:30 pm – 2:00 pm
Lunch – Exhibit Hall
2:00 pm – 4:15 pm
SP073 Device Post-Approval Studies: FDA Panel Discussion
The CDRH’s Post-Approval Studies Program encompasses design, tracking, oversight, and review of studies mandated as a condition of approval of a premarket approval (PMA) application.
SPEAKER(S): Art Sedrakyan, MD, PhD, (Invited) Senior Fellow, Center for Devices and
Radiological Health (FDA); Danica Marinac- Dabic, MD, PhD, (Invited) Chief, Epidemiology
Branch—Post-Market Surveillance and Biometrics, Center for Devices and Radiological Health (FDA); Michael Marcarelli, PharmD,MS, (Invited) Director, Division of Bioresearch
Monitoring, Center for Devices and Radiological Health (FDA); Sharon-Lise Normand, PhD,
Professor of Biostatistics, Harvard Medical School
SP074 Ethical Considerations in Patient Recruitment
This session explores methods to attract research patients while adhering to ethical rules and regulatory requirements. An experienced panel of investigators shares their insights using both didactic information and case studies. The group highlights past abuses and innovative new methods to reach appropriate subjects.
SPEAKER(S): Diana Anderson, RN, PhD, President and Chief Executive Officer, D.
Anderson & Company; Ira Spector, Vice President, Global Development Operations, Pfizer;
Michael Koren, MD, FACC, CEO & Director, Jacksonville Center for Clinical Research and
Director of Research, Encore Research Group; Michael McIvor, MD, Cardiologist and Principal Investigator, Cardiovascular Center of Excellence
3:15 pm – 4:15 pm
S083 Developing Drugs for Neglected Diseases - CANCELLED
Neglected diseases are diseases such as malaria, leishmaniasis, cholera, sleeping sickness, and other infectious diseases primarily affecting the developing countries. Hundreds of millions of patients suffer from one or more of these diseases, and new medicines for these patients are needed. Recent developments in global health have energized drug development for these diseases, but many challenges still remain.
SPEAKER(S): Richard Chin, MD, CEO, Institute for OneWorld Health
Monday, April 26, 2010
8:00 am – 9:00 am
S092 Office Emergency
Preparedness for Clinical Trials
A discussion of the rationale behind preparing for an office emergency, and describes potential emergencies that could occur in the office setting, and the components of emergency planning and training.
SPEAKER(S): Richard Craven, MD, CPI, Medical Director, Professional Place Medical Group, LLC
9:00 am – 11:00 am
EXHIBIT HALL OPEN
10:00 am – 11:00 am
S102 The Unique Challenges of Comparative Effectiveness
Research Comparative Effectiveness Research is a growing area for clinical research. This session is an introduction to what CER is, why it’s important, how it differs from industry sponsored trials and the unique opportunities and challenges CER projects present.
SPEAKER(S): Judi Forman, MPH, Research Associate, Dartmouth Medical School
11:15 am – 12:30 pm
PLENARY SESSION
FDA as a Public Health Agency
KEYNOTE SPEAKER
Joshua Sharfstein, MD
Principal Deputy Commissioner, U.S. Food and Drug Administration
Dr. Sharfstein was appointed by President Barack Obama to this position earlier this year, and had previously served as the Commissioner of Health for the City of Baltimore and on the staff of the Government Reform Committee of the U.S. House of Representatives for
Congressman Henry A. Waxman.
12:30 pm – 4:00 pm
EXHIBIT HALL OPEN
12:30 pm – 2:00 pm
Lunch – Exhibit Hall
2:00 pm – 3:00 pm
S113 Using PHR Platforms and Social Media for Patient Recruitment
New consumer-centric technologies such as Personal Health Records and social media are creating a paradigm shift in how patients consume and manage health information. This talk will introduce these technologies and discuss their potential for patient recruitment, drawing upon usage data from a solution that leverages these emerging technologies
SPEAKER(S): Sharib Khan, MBBS, MA, MPH, Co‑Founder, Applied Informatics
S114 Protecting Clinical Trial Participant’s Interest in Clinical Research: An Indian Perspective
The presentation describes the way in which a clinical trial participant’s confidence could be affected by various alleged clinical trial misconducts and how it can be tackled by various stakeholders of clinical research in the context of emerging countries like India.
SPEAKER(S): Sreekanth Gattu, MBBS, CPI, Junior Resident (Pharmacology), SriRamachandra Medical College
4:00 pm – 5:00 pm
S124 The Nuremberg Code and the 21st Century!
The Nuremberg code was written over 60 years ago. It’s relevance to human subject protection is as germane today as it was in the aftermath of World War II. Unfortunately, most researchers know the Nuremberg code by name but not content. We will review the Nuremberg code in detail including the background and actual content of the code.
SPEAKER(S): Bradford Harris, MD, Associate Professor, University of North Carolina at Chapel Hill; Claudia Christy, RN, MSN, CCRC, Nurse Consultant, University of North Carolina at Chapel Hill
S125 The Quality of Clinical Trials in China
This session will present studies conducted in China, and examines how IRB can respond to changes in international guidelines.
SPEAKER(S): Jenny Zhang, MD, MHA, Director of Business Development, Tigermed Consulting, Ltd
Tuesday, April 27, 2010
8:00 am – 9:00 am
S136 Site Selection—How Do You Do This Effectively in India
Careful investigator and site selection are critical for the successful completion of a study within budget, established timelines and the generation of high quality data. It is of utmost importance to extract a well-defined site management requirement in order to protect a company’s cash flow, ensure high performance and competitiveness as well as comply with global and local regulations and guidelines. There has been a steep rise in the global demand for world-class clinical trial management capacity and productivity in the last five years. With the average R&D expenditure growing at more than 19% per year, biopharm majors worldwide are realizing that the time-consuming and expensive affair of drug discovery and development can be done easier and better in India, given its rich technical resource pool, the relative ease and attractive economics of recruiting large numbers of patients, trained medical personnel, and the research support infrastructure.
SPEAKER(S): Sudhakar Bangera, MD, MMedSc,
Vice President, Trident Life Sciences
9:45 am – 10:45 am
S144 Multitasking in Academia: Research, Education and Community
This concurrent session focuses on an academic medical center clinical trials unit that has a threefold purpose in conducting research; Participating in the advancement of treatments for psychiatric illnesses, educating medical personnel, and a strong emphasis on community education rounds out these multiple missions.
SPEAKER(S): Anita Kablinger, MD, CPI, Professor, Louisiana State University Health
Sciences Center
9:45 am – 12:00 pm
Special Event
SP147 Clinical Trials on Trial
See Special Events [link to Special Events page] for details.
Networking Events
There are several Networking Events exclusively for physicians at the ACRP 2010 Global Conference & Exhibition. These events are a great opportunity to meet with colleagues and exchange ideas in a relaxed environment.
See complete information regarding Continuing Education Credits.
Program information is subject to change.