APCR Issues Statement on COVID-19

Academy of Physicians
in Clinical Research

Academy of Physicians
in Clinical Research

APCR 2019 Annual Meeting

APCR 2019 Annual Meeting

Omni Orlando Resort at ChampionsGate

November 1-2, 2019



Why You Should Attend

  • Impact Policy
    • Through APCR, you can have an input on policy that affects the field of clinical research.
  • Network
    • Interact with experienced investigators to discuss the unique challenges that face clinical researchers.
    • Build lasting professional relationships with industry members.
    • Receive coaching and help from experienced investigators and industry leaders.
  • Grow Your Practice
    • Get advice from experienced investigators on how to grow your practice and gain insights on practice management best practices.



Coming soon

The Academy of Physicians in Clinical Research is accepting abstracts for its 2019 Annual Meeting. This meeting brings together physicians from the clinical trial community from academia, the pharmaceutical and device industries, government agencies, medical groups and centers and clinical research entities.

This is your opportunity to propose thought-provoking content in the realm of clinical research that is important to you, your colleagues, and the APCR community.

Submitted abstracts will be reviewed and considered for oral and/or poster presentations at the meeting

Abstract Submission Topics:

To ensure your abstract receives proper consideration, the abstract must relate to an appropriate topic in the field of clinical research.  Suggested topics include, but aren’t limited to:

  • Contracts
  • Budgets and Billing
  • Regulatory Compliance
  • Clinical Trial Design
  • Clinical Operations and Project Management
  • Site Activation and Management
  • Recruitment
  • Special Topics
  • Other

Submit your abstract here!

Important Dates:

Final Abstract Submission Deadline:

October 1, 2019

Abstract Acceptance Notification:

October 15, 2019

Presenting Author Registration Deadline for Annual Meeting:

October 30, 2019


Meeting Chair

Cara East, MD, FAPCR
President, Academy of Physicians in Clinical Research
Director, Baylor Soltero Cardiology Research Center
Clinical Professor, Texas A&M College of Medicine
Dallas, TX



Featured Faculty


Joan Chambers
Strategic Marketing, Communications and Operations Advisor
Marlborough, MA


Ricardo Correa, MD, EsD, FAPCR
Endocrinology, Diabetes and Metabolism Fellowship Director
University of Arizona College of Medicine, Phoenix
Mayo College of Medicine, Mayo Arizona
Creighton School of Medicine, Phoenix Campus
Staff Endocrinologist at Phoenix VAMC
Army Reserve Physician
Phoenix, AZ


Luca Foschini, PhD
Co-Founder and Chief Data Scientist
Evidation Health
Santa Barbara, CA

  Karen Freedle, MD, MPH
Clinical Research Medical Advisor
Novartis Pharmaceutical Corporation
East Hanover, NJ

Heather Good, PharmD
Sanofi Medical Affairs
Bridgewater, NJ

  Susan Greco, MD, MPH
Next Science
Jacksonville, FL

Corina Grancorvitz, PharmD
Amarin Pharmaceutical
Bedminster, NJ

  Robert Hardi, MD, CPI, FAPCR
Associate Clinical Professor of Medicine
George Washington University School of Medicine & Health Sciences
Washington, DC
Medical Director, Capital Research
Silver Springs, MD
  Michael Koren, MD, CPI, FAPCR
CEO and Director, Jacksonville Center for Clinical Research
Encore Research Group
Jacksonville, FL

Lyndon E. Mansfield, MD, CPI, FAPCR
CEO, Western Sky Medical Research
Clinical Professor of Pediatrics, Paul Foster School of Medicine
El Paso, TX


Patrick L. McLean, B.S. Chem.
Product Manger
RedHill Biopharma Ltd.
Montreal, QC


Sophia McLeod, MA
Association of Clinical Research Organizations
Washington, DC


S. David Miller, MD
Medical Director
Northeast Medical Research Associates
CEO, Clinical Research Network
North Dartmouth, MA


Nisha Nathan, MD
Regional Medical Scientist
Novo Nordisk
Charlotte, NC


Jeffrey Nelson
Research Director
Yardley, PA

  Mike Novotny
Founder and CEO
San Francisco, CA

Ernest D. Prentice, PhD
Professor Emeritus 
Department of Genetics, Cell Biology and Anatomy
University of Nebraska Medical Center
Omaha, NE


Peter H. Rheinstein, MD, JD, MS, FAPCR
AMA Delegate and Past President
Academy of Physicians in Clinical Research
President, Severn Health Solutions
Severna Park, MD


Orly Rumberg
Wood + Lamping
Cincinnati, OH

  Harry Sarles, Jr., MD, FAPCR
Medical Director / Principal Investigator / Gastroenterologist
Digestive Health Associates of Texas, PA
Richardson, TX

Jackson Snyder, MD, JD, PhD, CPI, FAPCR
Assistant Managing Director
Cato Research
Washington, DC

  Gillian van Kleeff
Hemut, CA
  Bei Yu, PhD
Division of Clinical Compliance Evaluation
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research (CDER)/FDA
Silver Spring, MD







Friday, November 1, 2019

7:00 – 7:30 AM Registration
APCR Presents GCP in Clinical Research Training for Physicians
7:30 – 7:35 AM Friday Welcoming Remarks/Overview
7:35 – 8:05 AM The Competent Investigator Understands Both Compliance & Excellence
Michael Koren, MD, CPI, FAPCR
8:05 – 8:50 AM Alphabet Soup: Decoding the Regulatory Fricassee
Susan Greco, MD, MPH
8:50 – 9:35 AM A 2000 Year History of Protecting Patients' Rights and Research Regulations in 45 Minutes
Michael Koren, MD, CPI, FAPCR
9:35 – 9:50 AM Break
9:50 – 10:35 AM Oversight Agencies and Institutional Review Boards
Ernst Prentice, PhD
10:35 – 11:55 AM

Case Studies in Protecting Patients' Rights
Michael Koren, MD, CPI, FAPCR
Ernst Prentice, PhD
Robert Hardi, MD, CPI, FAPCR
Susan Greco, MD, MPH

11:55 AM – 1:25 PM

Non-CME Lunch Symposium: Understanding Business Tools Used to Eliminate Lawsuits,
Protect your License and Increase Tax Savings

Steve Comer

1:25 – 2:00 PM

Significant or Not: The Art of Adverse Events & Lab Abnormality Assessments
Robert Hardi, MD, CPI, FAPCR 

2:00 – 3:00 PM

Role of Statistics in Clinical Research
Michael Koren, MD, CPI, FAPCR 

3:00 – 3:40 PM

Challenges of Non-Traditional Trials
Susan Greco, MD, MPH

3:40 – 3:55 PM


3:55 – 5:15 PM

Winning at Research: Case Studies in Scientific, Legal & Business Strategies for 21st Century Success
Michael Koren, MD, CPI, FAPCR

Research and Development and Legal Issues in Clinical Research

5:15 – 5:20 PM

Evening Session Opening Remarks

5:20 – 5:40 PM

How the American Medical Association Impacts Clinical Research
Peter Rheinstein, MD, JD, MS, FAPCR

5:40 – 6:10 PM Impact of IPI Reform on Patient Access
Jeffrey Nelson
6:10 – 6:30 PM Drug Pricing Dilemma
Michael Koren, MD, CPI, FAPCR
6:30 – 7:00 PM Panel Discussion

7:00 – 8:00 PM

Welcome Reception with Exhibitors

Saturday, November 2, 2019

7:00 – 8:00 AM Breakfast with Exhibitors
Hot Topics in Clinical Research
8:00 – 8:05 AM Saturday Welcoming Remarks/Overview
8:05 – 8:35 AM Current State of Clinical Research
Joan Chambers
8:35 – 9:05 AM

The Roles of CROs in Clinical Research
Sophia McLeod, MA

9:05 – 9:35 AM

Blockchain Technology and Cyber Security for Clinical Trial Data
Mike Novotny

9:35 – 9:55 AM

Refreshment Break with Exhibitors 

Running a Successful Research Site
9:55 – 10:25 AM

Contracting Tips to Protect Your Site: How to Minimize Risk in Clinical Research Contracts
Orly Rumberg

10:25 – 10:55 AM

Clinical Research Budgets - Stick to your Guns!
S. David Miller, MD

10:55  – 11:25 AM

Leveraging Social Media for the Recruitment of Patients
Gillian van Kleeff

11:25 – 11:55 AM FDA Inspections
Bei Yu, PhD
11:55 AM – 12:55 PM


Recent Advances and Future Directions in Clinical Research
12:55 – 1:25 PM The Importance of Pediatric Clinical Trials
Karen Freedle, MD, MPH
1:25 – 1:55 PM Developing Digital Measures from Person-Generated Health Data
Luca Foschini, PhD
1:55  – 2:25 PM Vaping Devices - Regulatory and Trial Issues
Jackson Snyder, MD, JD, PhD, CPI, FAPCR
Hot Topics in Various Therapeutic Areas
2:25 – 2:30 PM Session Overview
2:30 – 2:45 PM Hot Topics in the GI World
Harry Sarles, Jr., MD, FAPCR
2:45 – 3:00 PM Advances in Biologic Therapy of COPD and Asthma
Lyndon E. Mansfield, MD, CPI, FAPCR
3:00 – 3:15 PM Renal Protection in Heart Surgery: A Possible New Paradigm
Cara East, MD, FAPCR
3:15 – 3:30 PM Latest Research in Endocrinology
Ricardo Correa, MD, EsD, FAPCR
3:30 – 3:40 PM Refreshment Break
3:40 – 3:50 PM APCR Business Meeting (Non-CME)
The Encore Clinical Research You May Have Missed, But Need to See: A Special Non-CME Session

3:50 – 3:55 PM 

Session Overview

3:55 – 4:15 PM

Odyssey Outcomes 
Heather Good, PharmD 

4:15 – 4:35 PM

Corina Grancorvitz, PharmD

4:35 – 4:55 PM

GLP-1 and Recent CVOT Trials
Nisha Nathan, MD 

4:55 – 5:15 PM

Patrick L. McLean, B.S. Chem.

5:15 – 5:20 PM

Closing Remarks/Meeting Adjourned

Agenda subject to change. Check back for updates.


The APCR roomrate is $169/night plus taxes for singles and doubles with a reduced resort fee of $10/night​. Call now and ask about suite upgrade pricing. The room rate is available until September 30, 2019 or until the room block is filled. We recommend that you make your reservation early, the room block will sell out.

Make your hotel reservations by clicking herehttps://www.omnihotels.com/hotels/orlando-championsgate/meetings/apcr-10312019

Omni Orlando Resort at ChampionsGate​
1500 Masters Boulevard
ChamptionsGate, FL 33896
Phone: (407) 390-6664
View Hotel Online

Surrounded by 36 holes of championship Orlando golf, the Leadbetter Golf Academy World Headquarters and 15 acres of recreation, this Four Diamond resort is one of the nation's premier golf, meeting and leisure retreats. Rooms are equipped with every modern convenience and a host of luxury amenities. In addition to walk-out golf, guests may choose to relax in the signature Mokara spa, dine in one of nine restaurants or enjoy 15 acres of pools and recreation activities including the 850-foot lazy river and Orlando's only resort wave pool.

In addition to the standard offerings of the hotel, APCR guests receive:

  • Discounted oversight self-parking
  • 10% discount on all Massage Treatment Services at the Mokara Spa
  • Omni Guest pricing at ChampionsGate Golf




Target Audience
This program has been designed to meet the educational needs of physicians and other healthcare professionals engaged or wishing to engage in clinical research.

Learning Objectives
Upon completion of the educational activity, 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.
  • Describe patient management issues in clinical trials.
  • Discuss the roles of CROs in clinical research.
  • Analyze the budget and contract negotiation processes for clinical research contracts.
  • Define strategies to improve patient health outcomes through the use of digital medicine, social media, and wearable devices.
  • Examine blockchain technology for improving clinical trials.
  • Explain the importance of conducting pediatric clinical trials.
  • Assess available research evidence with existing and emerging therapeutic options for various disease states.


CME/CE provided by AKH, Inc., Advancing Knowledge in Healthcare

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AKH Inc., Advancing Knowledge in Healthcare and Academy of Physicians in Clinical Research. AKH Inc., Advancing Knowledge in Healthcare is accredited by the ACCME to provide continuing medical education for physicians.

AKH Inc., Advancing Knowledge in Healthcare designates this live activity for a maximum of 15.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Physician Assistants
NCCPA accepts AMA PRA Category 1 Credit™ from organizations accredited by ACCME.

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/claimed credit form. If you have questions about this CME activity, please contact AKH Inc. at tbrignoni@akhcme.com.

Commercial Support
Full notification of commercial support will be provided in the final course syllabus.




Save the date for the Academy of Physicians in Clinical Research 2019 Annual meeting at the Omni Orlando Resort at Championsgate on November 1st and 2nd. Connect with 100 clinical researchers and investigators as you showcase your products and services.

We have added new and exciting sponsorship opportunities to allow you maximum exposure throughout the weekend. We look forward to working with you to secure your booth and confirm your participation in the conference.

For more information on exhibiting or sponsoring please call Kristen Lauer at 904-309-6206 or email klauer@apcrnet.org




Amarin Pharma, Inc

Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Vascepa® (icosapent ethyl), Amarin's first FDA approved product, is a pure, EPA-only, omega-3 fatty acid product available by prescription. For more information about Vascepa visit www.vascepa.com. For more information visit www.amarincorp.com.

Legally Mine

Legally Mine is an asset protection and tax strategy group. The mission of Legally Mine is to empower members of the healthcare community with the knowledge and tools to protect their assets from lawsuits, build professional license safeguards into their legal structures and legitimately reduce their tax liability.



Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas. Headquartered in Cincinnati, Ohio, Medpace employs approximately 3,200 people across 37 countries.



The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Since 2000, PhRMA member companies have invested more than $600 billion in the search for new treatments and cures, including an estimated $79.6 billion in 2018 alone.  For information on how innovative medicines save lives, please visit:  www.PhRMA.org

PRA Health Sciences

PRA Health Sciences delivers innovative drug development solutions that improve patients’ lives. Our people are passionate about clinical research, working tirelessly to provide quality results. We offer exceptional experience across all phases and therapeutic areas and a broad spectrum of solutions, ranging from full-service clinical development to a pioneering embedded model.

With 16,000+ employees covering 90+ countries, we bolster an impressive global presence with keen local insights. Our project teams harness their understanding of local regulations, standards of care and cultural customs to effectively align our approaches with each study’s unique goals.

At PRA, we love what do because we are making a difference in the lives of patients and their family members worldwide. Over the years, we have contributed to the development of numerous drugs now available to countless patients. From our scientific and medical experts to therapeutically aligned project managers and monitors, we provide the commitment and expertise needed for today’s complex studies.


Recruit 4 Research

Recruit 4 Research is a social marketing company providing clinical research sites a cost-effective, efficient way to reach potential study participants. Having spent over 15 years delivering traditional and internet-driven media to medical-device businesses and healthcare professionals, Recruit 4 Research has seen the impact social media has on advertising and has dedicated the last three years to helping sites accelerate patient recruiting through targeted digital strategies.



We are people, patients, parents, caregivers, researchers… Together, we are Sanofi, a healthcare organization dedicated to improving the lives of people worldwide. Our teams work with passion and commitment to understand and solve everyone’s healthcare needs. We transform scientific innovation into healthcare solutions, accept challenges and challenge the accepted. We have the courage to fight for equal opportunity and to speak out against discrimination. We believe that better health begins with education.