Academy of Physicians
in Clinical Research

Academy of Physicians
in Clinical Research




2017 Annual Meeting


2017 Annual Meeting

Wyndham Grand Orlando Resort Bonnet Creek

Orlando, FL

APCR will host its second annual meeting on October 20–22, 2017 at the Wyndham Grand Resort Bonnet Creek in Orlando, FL. Join your colleagues from around the country as expert faculty present insights on a diverse range of topics geared towards physicians engaged or wishing to engage in clinical research.

Meeting Highlights:

  • The Prescription Drug Price Dilemma
  • Access to New Medicines
  • The Changing World of Medicines Development
  • How to Get Studies
  • Patient Involvement in Clinical Research
  • Innovations in Clinical Trials
  • Legal and Ethical Issues in Clinical Research

Register for the 2017 APCR Annual Meeting Registration

Personal Information

Contact Information

Registration

Must be logged in to get the Member price or print paper registration to mail or fax in
Choose one below or choose bundle Member Non-Member Trainee**
GCP and Beyond Preconference Course
Friday, October 20, 2017
$395.00 $795.00 $95.00
APCR 2017 Annual Meeting
Friday, October 20-22, 2017
*Includes one admission badge to Exhibit Hall for all food functions.
$695.00 $1095.00 $145.00
APCR Member Bundled Rate for GCP Preconference Course and Annual Meeting
Friday, October 20-22, 2017
Available only to APCR Members. Sign up to be an APCR member and take advantage of the discounted bundle rate. Please email brawls@apcrnet.org for more information on how to become a member.
$995.00 NA $240.00
Coordinator Bundle*
*Only Available for APCR Member Physician when purchasing the $995 Bundle price. Limit 4 per $995 purchase.
$400.00
per
person
Add Guest Name
Industry Council Registration*
*Only Available for Industry Council
with promotional code.
$0.00
per
person


**Trainee Rate: Available for those individuals actively enrolled in a graduate or postgraduate training program with an interest in clinical research studies. A letter from the program director or the school registrar must be faxed to 904-998-0855, attention Nicole Woodsmall. Once approved, you will be provided with a discount code to register for the meeting for the Trainee Registration Rate.



Guest Tickets

Registration: Registration and payment must be received no later than September 20, 2017. After this date, meeting materials and name badge cannot be guaranteed.

Disclaimer: By registering for the 2017 APCR Annual Meeting, I also give the Academy of Physicians in Clinical Research, the right to publish all photos, videos, etc. taken at this Conference.

By registering for the 2017 APCR Annual Meeting, attendee understands and agrees that attendee’s name, city, and state may be shared with other attendees and exhibitors. By allowing an exhibitor to scan the conference badge, attendee understands, agrees and consents to the sharing of attendee’s contact information with the company that scanned the conference badge.

Cancellation: Telephone cancellations will not be accepted. A written notice of cancellation must be received no later than September 20, 2017. There will be a $100 fee for all cancellations. There will be no refunds if cancelling within 30 days of the start of the meeting date.

FACULTY

Meeting Chair

koren

  Michael Koren, MD, FACC, FAPCR, CPI
  Annual Meeting Chair
  Pre-Conference Course Director

  Vice President, APCR
  CEO and Director, Jacksonville Center for Clinical Research
  Encore Research Group
  Jacksonville, FL

 

Featured Faculty

Ashish Atreja, MD, MPH

Ashish Atreja, MD, MPH
Chief Innovation and Engagement Officer, Medicine
Icahn School of Medicine at Mount Sinai
New York, NY

Peter Bach, MD, MAPP

Peter Bach, MD, MAPP
Director, Center for Health Policy and Outcomes
Memorial Sloan Kettering Cancer Center
New York, NY

Seth Baum, MD

Seth Baum, MD
Medical Director, Women's Preventive Cardiology
Christine E. Lynn Women's Health and Wellness Institute
Boca Raton Regional Hospitall
Clinical Affiliate Professor of Biomedical Science
Charles E. Schmidt College of Medicine
Florida Atlantic University
Founder, Chief Medical Officer
Excel Medical Clinical Trials, LLC
Boca Raton, FL

Dale Bramlet, MD, CPI

Dale Bramlet, MD, CPI
Founder and CEO, Advent Clinical Research
President, Acension Research
Pinellas Park, FL

Paul Carney, MD

Craig Curtis, MD, CPI
Chief Medical Officer
Compass Research
Orlando, FL

Christopher da Costa, MD, PhD, MBA
Synthetic Biologics
Philadelphia, PA

Norman Goldfarb
Chairman, MAGI

Editor, Journal of Clinical Research Best Practices
San Francisco, CA

John Isidor, MD

John Isidor, JD
CEO, Human Subject Protection Consulting, LLC
Founder, Schulman Associates Institutional Review Board
Cincinnati, OH

Lindsay McNair, MD, MPH, MSB

Lindsay McNair, MD, MPH, MSB
Chief Medical Officer
WIRB-Copernicus Group
Princteon, NJ

George Mensah, MD

George Mensah, MD
Director, Center for Translation Research and Implementation Science
National Heart, Lung, and Blood Institute
National Institutes of Health
Bethesda, MD

S. David Miller MD

S. David Miller, MD, FAPCR
Chief Operating Officer
CRN Clinical Research Network, LLC
North Dartmouth, MA

S. David Miller MD

Joshua Pevnick MD, MSHS
Assistant Professor, Division of General Internal Medicine
Department of Medicine
Associate Director, Division of Informatics
Department of Biomedical Sciences
Cedars-Sinai Health System
Los Angeles, CA

 
J. Sanford Schwartz, MD

J. Sanford Schwartz, MD
Leon Hess Professor, Medicine
Perelman School of Medicine
Professor, Health Care Management
Wharton School
University of Pennsylvania
Philadelphia, PA

Michael Santoro, PhD, JD

Michael Santoro, PhD, JD
Professor, Management
Leavey School of Business
Santa Clara University
Santa Clara, CA

Jonathan Seltzer, MD

Jonathan Seltzer, MD
President and CEO
ACI Clinical
Bala Cynwyd, PA

Michele Trucksis, PhD, MD

Michele Trucksis, PhD, MD
Executive Vice President and Chief Medical Officer
Seres Therapeutics
Cambridge, MA

AGENDA

Friday, October 20, 2017

3:45 – 4:00 PM
Welcoming Remarks
Michael Koren, MD, FAPCR, CPI
APCR Town Hall – The Prescription Drug Price Dilemma
4:00 – 4:40 PM
Keynote Address Lecture: Can Physician’s Solve the Drug Price Dilemma?
J. Sanford Schwartz, MD
4:40 – 5:30 PM
Panel Discussion:
J. Sanford Schwartz, MD, Peter Bach, MD, and other panelists
5:30 – 6:00 PM
Q&A with Panel
6:00 – 7:00 PM
Welcome Reception

Saturday, October 21, 2017

7:00 – 8:00 AM
Breakfast
8:00 – 8:10 AM
Welcome/Overview
Session 1: The Changing World of Medicine Development and Clinical Research
8:10 – 8:40 AM
Current Applications of Wearable Devices in Clinical Trials
Joshua Pevnick, MD
8:40 – 9:10 AM
Non-traditional Income Opportunities for Physicians in Clinical Research
Jonathan Seltzer, MD
9:10 – 9:40 AM
Legal Issues in Clinical Research
John Isidor, JD
9:40 - 10:10 AM
Chris P. Allen Memorial Lecture: The Physician's Role in Medicines Development: Pharmaceutical Medicine as a Discipline and Profession
Christopher da Costa, MD, PhD, MBA
10:10 - 10:50 AM
Diversity in Clinical Trials
George Mensah, MD
10:50 - 11:05 AM
Refreshment Break
Session 2: Technology in Clinical Research
11:05 - 11:35 AM
Potential Impact of Social Media on the Integrity of Clinical Trials
Lindsay McNair, MD, MPH, MSB
11:35 AM - 12:05 PM
The Evolving Relationship Between the First Amendment, Clinical Research and the FDA
Michael Santoro, JD, PhD
12:05 - 12:35 PM
Disruption 101: Digital Medicine, the Empowered Patient, and How Clinical Research will Change Forever
Ashish Atreja, MD, MPH
12:35 - 1:50 PM
Lunch
Session 3: Emerging Developments in Therapeutics
1:50 - 2:20 PM
Microbiome-based Clinical Research: Opportunities and Challenges (Non-CME)
Michele Trucksis, PhD, MD
2:20 - 2:50 PM
The 411 on Medical Marijuana Research
Lisa Kirven-Dawes, MD, MPH
2:50 - 3:00 PM
Refreshment Break
Session 4: Successful Site Management
3:00 - 3:30 PM
Site/Sponsor Collaborations: Solutions to Key Issues
Dale Bramlet, MD, CPI
3:30 - 4:00 PM
Managing Clinical Trials in Your Practice: Site Management/Logistics
Craig Curtis, MD CPI
4:00 - 4:15 PM
APCR Business Meeting
NON-CME Special Session: Getting Studies and Finding Qualified Investigators: An Interactive Experience
4:15 - 4:45 PM

Bring your business card to this unique interactive session to learn 5 secrets for both getting studies and finding qualified investigators.
4:45 - 5:45 PM
Industry Council Reception

Sunday, October 22, 2017

7:00 – 8:00 AM
APCR Networking Breakfast
Session 5: Addressing Barriers in Clinical Research
8:00 - 8:30 AM
Hiring, Training, Managing and Retaining Study Coordinators
Norman Goldfarb, MBA
8:30 -9:00 AM
How to Manage a Successful Physician Owned Research Network
S. David Miller, MD
9:00 9:30 AM
Barriers in Access to CVD Therapies
Seth Baum, MD
9:30 – 10:0 AM
Budgeting Issues in Clinical Research
S. David Miller, MD
10:00 – 10:20 AM
Closing Remarks/Meeting Adjourns

VENUE

Wyndham Grand Orlando Resort Bonnet Creek
14651 Chelonia Parkway
Orlando, FL 32821
Phone: 407-390-2300
Book hotel room

Experience sophisticated charm and Mediterranean-inspired comfort while exploring the world’s most renowned theme parks, championship golf courses, and exciting attractions - only minutes away. Located within the Walt Disney World gates and surrounded by 500 pristine acres of woodlands, our idyllic AAA Four-Diamond-rated resort offers upscale amenities, stellar service, and distinctive dining in a unique lakeside setting.

ACCREDITATION

2017 APCR ANNUAL MEETING

PROGRAM OVERVIEW
The rapid development of new drugs, therapies, and devices has created a dramatic increase in the number of clinical research studies that highlights the need for greater participation in research by physicians. Physicians who participate in clinical research contribute to the expanding knowledge base of medicine and have opportunities to offer their patients cutting-edge therapies. This 3-day live activity will present insights from world-renowned faculty on a range of topics in clinical research.

ACTIVITY TYPE
Live

TARGET AUDIENCE
This activity is intended for physicians engaged or wishing to engage in clinical research.

LEARNING OBJECTIVES
After completing this activity, the participant should be better able to:

  • Identify controversial issues impacting drug pricing.
  • Examine cost analysis, funding, and economic and public considerations associated with new drug development.
  • Discuss the regulations and policies governing research with investigational drugs, biologicals and devices.
  • Summarize common barriers to access new medicines.
  • Describe consulting opportunities available for physicians in clinical research.
  • Describe conflict of interest considerations in clinical research.
  • Define the core competencies required of physicians working as pharmaceutical physicians.
  • Discuss the scientific and developmental research principles in support of biosimilars, medical cannabis, medical foods, and microbiome-based therapeutics.
  • Define strategies to improve patient health outcomes through the use of digital medicine, social media, and wearable devices.
  • Develop strategies for managing a successful research network, including ethical and regulatory considerations.
  • Discuss the value of increasing diversity in clinical trial participation.
  • Assess available research evidence with existing and emerging therapeutic options for various disease states.

CRITERIA FOR SUCCESS
Statements of credit will be awarded based on the participant’s attendance and submission of the activity evaluation form. A statement of credit will be available upon completion of an online evaluation/claim credit form at www.apcrnet.org. The deadline to claim credit is November 22, 2017.

COMMERCIAL SUPPORT
Full notification of commercial support will be provided in the final course materials.

 

CME provided by Postgraduate Institute for Medicine (PIM)

 

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Postgraduate Institute for Medicine and the Academy of Physicians in Clinical Research (APCR). Postgraduate Institute for Medicine is accredited by the ACCME to provide continuing medical education for physicians.
Postgraduate Institute for Medicine designates this live activity for a maximum of 12 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

DISCLOSURE CONFLICTS OF INTEREST
Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy.  The existence or absence of COI for everyone in a position to control content will be disclosed to participants prior to the start of each activity.

DISCLAIMER
This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. APCR and PIM specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through reader’s misunderstanding of content.

CANCELLATION POLICY
Telephone cancellations will not be accepted. A written notice of cancellation must be received no later than September 20, 2017. There will be a $100 fee for all cancellations. There will be no refunds if cancelling within 30 days of the start of the meeting date.

2017 GOOD CLINICAL PRACTICE AND BEYOND

PROGRAM OVERVIEW
GCP and Beyond is a unique CME course taught primarily by physicians for physicians. This course reviews the skills necessary to succeed in the clinical research field including patient care, clinical research site management techniques, patient recruitment, and leadership skills. The course features innovative, interactive case presentations of real life clinical research scenarios. GCP and Beyond will also present ideas to help research sites operate more efficiently and become more profitable and ethically sound.

ACTIVITY FORMAT
Live

TARGET AUDIENCE
This activity is intended for physicians engaged or wishing to engage in clinical research.

EDUCATIONAL OBJECTIVES
At the conclusion of this activity, all participants should be able to:

  • Distinguish between compliance and excellence using clinical research case scenarios;
  • Discuss the roles and responsibilities of a principal investigator in a research practice;
  • Recognize the importance of FDA rules and regulations for good clinical practice;
  • Evaluate ethical issues in clinical research using case scenarios and role playing;
  • Discuss the impact of the political environment in clinical research on patients in various
  • Communities;
  • Describe patient management issues in clinical trials;
  • Discuss methods of outreach to underrepresented patients and investigators;
  • Define the Statement of Clinical Investigator Competence.

CRITERIA FOR SUCCESS
Statements of credit will be awarded based on the participant’s attendance and submission of the activity evaluation form. A statement of credit will be available upon completion of an online evaluation/claim credit form at www.apcrnet.org. The deadline to claim credit is November 22, 2017.

COMMERCIAL SUPPORT
Full notification of commercial support will be provided in the final course materials.

CREDIT DESIGNATION

  CME provided by Postgraduate Institute for Medicine (PIM)

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Postgraduate Institute for Medicine and the Academy of Physicians in Clinical Research (APCR). Postgraduate Institute for Medicine is accredited by the ACCME to provide continuing medical education for physicians.

Postgraduate Institute for Medicine designates this live activity for a maximum of 7.75 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

DISCLOSURE CONFLICTS OF INTEREST
Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy.  The existence or absence of COI for everyone in a position to control content will be disclosed to participants prior to the start of each activity.

DISCLAIMER
This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. APCR and PIM specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through reader’s misunderstanding of content.

CANCELLATION POLICY
Telephone cancellations will not be accepted. A written notice of cancellation must be received no later than September 20, 2017. There will be a $100 fee for all cancellations. There will be no refunds if cancelling within 30 days of the start of the meeting date.

AMERICANS WITH DISABILITIES ACT
Event staff will be glad to assist you with any special needs (ie, physical, dietary, etc). Please contact Maggie Kincaid prior to the live event at 904-309-6271.

EVENTS

APCR Town Hall: The Prescription Drug Price Dilemma
Keynote Lecture and Expert Panel
Friday, October 20, 2017
The increasing cost of prescription drugs in the United States has become a source of concern for patients, prescribers, payers, and policy makers. This session will address the current trends, future directions, challenges, and solutions to this spiraling problem affecting every segment of healthcare.

Welcome Reception
Friday, October 20, 2017
Network with your fellow colleagues on Friday evening immediately following the opening session.

SPONSORS/EXHIBITORS

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VIRTUAL EXHIBIT HALL

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EXPERT THEATERS

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Good Clinical Practice (GCP) and Beyond

Friday, October 20, 2017

GCP and Beyond is a unique CME course taught primarily by physicians for physicians. This course reviews the skills necessary to succeed in the clinical research field including patient care, clinical research site management techniques, patient recruitment, and leadership skills. The course features innovative, interactive case presentations of real life clinical research scenarios. GCP and Beyond will also present ideas to help research sites operate more efficiently and become more profitable and ethically sound.

Course Agenda

7:00-7:30 AM Registration
7:30-8:00 AM The Competent Investigator Understands Both Compliance & Excellence
Michael Koren, MD, FAPCR, CPI
8:00-8:45 AM Alphabet Soup: Decoding the Regulatory Fricassee
Susan Greco, MD, MPH
8:45-9:30 AM A 2000 Year History of Protecting Patient' Rights and Research Regulations in 45 Minutes
Michael Koren, MD, FAPCR, CPI
9:30-9:45 AM Break
9:45-10:30 AM

Oversight Agencies and Institutional Review Boards
John Isidor, JD

10:30-11:45 AM

Case Studies in Protecting Patient's Rights
Michael Koren, MD, FAPCR, CPI
Susan Greco, MD, MPH
John Isidor, JD
Robert Hardi, MD, FAPCR, CPI

11:45-12:30 PM Significant or Not: The Art of Adverse Events & Lab Abnormality Assessments
Robert Hardi, MD, FAPCR, CPI
12:30-1:30PM Working Lunch: Sandwiches & Statistics
Michael Koren, MD, FAPCR, CPI
1:30-2:10 PM Challenges of Non-Traditional Trials
Susan Greco, MD, MPH
2:10-3:30 PM Winning at Research: Case Studies in Scientific, Legal & Business Strategies for 21st Century Success
Michael Koren, MD, FAPCR, CPI

 

Faculty

Susan Greco, MD, MPH
Clinical Investigator
Jacksonville Center for Clinical Research
Jacksonville, FL

Robert Hardi, MD, FAPCR, CPI
Associate Clinical Professor of Medicine
George Washington University School of Medicine & Health Sciences
Clinical Faculty, Georgetown University School of Medicine
Washington, DC
Medical Director, Principal Investigator
Chevy Chase Clinical Research, Capital Digestive Care
Silver Spring, MD

Michael Koren, MD, FAPCR, CPI (Course Director)
Vice President, APCR
CEO and Director, Jacksonville Center for Clinical Research
Encore Research Group
Jacksonville, FL

John Isidor, JD
CEO, Human Subject Protection Consulting, LLC
Founder, Schulman Associates Institutional Review Board
Cincinnati, OH