*Please note all agenda times are in Eastern Standard Time
Day 1: March 7, 2023
11:00am – 11:15am ET: Welcome and Symposium Objectives
Anne E. Johnson, BA, District Director for FDA Philadelphia District Office, Program Division Director of Bioresearch Monitoring Operations Division I (East), Office of Regulatory Affairs, FDA
11:15am – 12:00pm ET: The History of the Sponsor Investigator
Chrissy J. Cochran, PhD, Director of the Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs, FDA
12:00pm – 1:00pm ET: Sponsor Investigators and FDA Regulated Research
Elena Boley, MD, Senior Physician, Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Center for Drug Evaluation and Research, FDA
Leigh Marcus, MD, Senior Physician, Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Center for Drug Evaluation and Research, FDA
This presentation will give an in-depth overview of the sponsor-investigator responsibilities for a clinical investigation that is regulated by the FDA. Case examples and enforcement options will be included.
1:00pm-1:30 pm ET: Operation Compliance Case Study Alert - Drugs
Hugh M. McClure III, BS, National Expert, Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs, FDA
1:30pm-2:00 pm ET: Lunch Break
2:00pm – 3:00pm ET: The Art of Study Start-Up
Janelle Allen, MS, BS, CCRP, Consultant & Corporate Trainer & Faculty Miami University
This session will provide successful and helpful organizational tactics to assist in managing important aspects of the start-up of clinical research trials, whether a single-site or a multi-site study. These tactics will promote success in recruitment and retention, communication with the IRB and oversight of regulatory needs, and participant safety as well as encourage teamwork and ease in workflow for site research staff.
3:00pm – 4:00pm ET: Quality by Design and Beyond
Jean Mulinde, MD, Medical Officer, Policy Advisor, Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Center for Drug Evaluation and Research, FDA
In this session, the speaker will discuss the essential role of quality management systems, risk assessment and management, and clinical quality by design in investigational product development programs and clinical trials.
4:00pm – 5:00pm ET: Drug, Devices, and Biologics: Oh My!
CDR Nicole M. Bell, MS, Staff Director, Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs, FDA
There are marked similarities and differences in the regulations and structure of drug, device, and biologics research. This presentation will discuss the history and events that led to the regulatory framework we have today as well as the regulations and structure of drug/biologic and device clinical trials.
11:00am – 11:30am ET: Keynote Speaker: The Importance of Diversity in Clinical Trials
Namandjé N. Bumpus, PhD, FDA Chief Scientist, Office of the Chief Scientist
11:30am – 12:30pm: IND Submission - What, When, and How?
Xiaoxue Nehrbass, PharmD, BCPS, BCCCP, Regulatory Project Manager, Division of Regulatory Operations for Nonprescription Drugs, Center for Drug Evaluation and Research, FDA
CDR Trang Tran, PharmD, MBA, BCPS, Senior Regulatory Project Managers, Division of Regulatory Operations for Nonprescription Drugs, Center for Drug Evaluation and Research, FDA
The presenters will provide an overview of what an Investigational New Drug (IND) application is, when an IND application is needed, and how an IND submission is managed by the Food and Drug Administration.
12:30pm – 1:30pm: Regulatory Overview for Sponsor-Investigators of Medical Device Clinical Trials
Daniel Ramsey, MS, Lead Biomedical Engineer, Center for Devices and Radiological Health, FDA
Irfan Khan, MS, Consumer Safety Officer, Center for Devices and Radiological Health, FDA
This talk will provide a background on the regulatory considerations for investigational studies of medical devices as well as a brief overview of premarket submission types. Topics will include considerations for determining if an IDE application is needed, IDE submission types, the role of IRBs, sponsors and investigators in medical device clinical trials, and an overview of medical device clinical trial compliance considerations.
1:30pm-2:00pm ET: Lunch Break
2:00pm-2:30pm ET: Operation Compliance Case Study Alert - Biologics
Debra Boyd-Seale, PhD, MSN, MHA, RN, CCRA, CQIA, Consumer Safety Officer, Bioresearch Monitoring Operations Division II (West), Office of Regulatory Affairs, FDA
2:30pm – 3:30pm ET: ClinicalTrials.gov: Meeting Transparency and Reporting Requirements
Anna M. Fine, PharmD, MS, Acting Director ClinicalTrials.gov, National Center for Biotechnology Information, National Library of Medicine, NIH
Tracy L. Cutler, MPH, RAC-Drugs, Health Policy Analyst, Office of Clinical Policy and Programs & Office of Clinical Policy, Office of the Commissioner, FDA
The presenter will discuss the importance of and requirements for registering and submitting summary results information for applicable clinical trials described in Section 8T01 of the Food and Drug Administration Amendments Act (FDAAA 801) and the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) to ClinicalTrials.gov and provide an overview of FDA’s role and responsibilities related to Clinicalrials.gov. They will review key requirements, including certification of compliance with ClinicalTrials.gov requirements and a specific informed consent element for applicable clinical trials. In addition, they will describe FDA’s ClinicalTrials.gov compliance and enforcement activities including how FDA intends to identify noncompliance, under what circumstances civil monetary penalties would be sought, what procedures would apply, and what penalty amounts might be assessed.
3:30pm – 4:30pm ET: Source Records and Data Collection
Craig Garmendia, PhD, MS, Foreign Cadre Investigator, Specialist, Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs, FDA
Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality and Safety, Dartmouth-Hitchcock Medical Center
FDA Presenter: This presentation will provide a high-level overview of the regulatory requirements regarding source records and data collection for Clinical Investigators who are also Sponsors. Attendees can expect to learn about FDA’s Title 21 Code of Federal Regulation Part 312 (Investigational New Drug Application) and Part 812 (Investigational Device Exemptions), along with FDA’s Guidance Documents.
Non-FDA Presenter: This portion of the presentation will provide best practices for maintaining adequate and accurate records.
4:30pm – 5:00pm ET: Program Wrap-up and Q&A
11:00am-11:30 am ET: Operation Compliance Case Study Alert - Devices
Hugh M. McClure III, BS, National Expert, Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs, FDA
Robert M. Califf, MD, MACC, FDA Commissioner
11:45am – 12:45pm ET: The Art of Executing Study Start-Up
Janelle Allen, MS, BS, CCRP, Consultant & Corporate Trainer & Faculty Miami University
Once the protocol has been thoroughly analyzed, we will demonstrate methods and tools that will prepare the site for clinical trial success. Discussions will pertain to necessary considerations prior to study start-up. Attendees should leave the workshop with skills to ideally organize their sites for continued success in clinical trials.
12:45pm – 1:30pm ET: What to Expect During an Inspection: The Art of Wearing Two Hats- Sponsor Responsibilities
LCDR Jennifer Adams, MPH, US Public Health Service and International Work Planner, Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs, FDA
This presentation will provide an overview of sponsor responsibilities for Sponsor-Investigators from an inspectional standpoint and will review interactive examples of related observations and deficiencies. What do we look for on an inspection? What are common or serious compliance issues for Sponsor-Investigators to avoid?
1:30pm – 2:00pm ET: Lunch Break
2:00pm – 3:00pm ET: What to Expect During an Inspection: The Art of Wearing Two Hats- Clinical Investigator Responsibilities
Dawn Olenjack, DC, Foreign Cadre Investigator, Specialist, Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs, FDA
Intended for investigators with all levels of experience, this presentation will provide a brief review of Clinical Investigator responsibilities in the context of learning how to prevent the most common deficiencies observed during inspections. Real cases will highlight gaps in processes that can lead to significant observations.
3:00pm – 4:00pm ET: Safety Assessment in Clinical Trials and Beyond
Shabnam Naseer, DO, MMS, Medical Officer, Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, FDA
This presentation will discuss the sources of drug safety information available to sponsor-investigators, the limitations for safety assessment in clinical trials, the importance of monitoring and assessing safety data, and safety reporting to the FDA.
4:00pm – 5:00pm ET: Risk Based Monitoring (RBM)
Kassa Ayalew, MD, MPH, Division Director, Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Center for Drug Evaluation and Research, FDA
The presenter will discuss how Risk Based Monitoring (RBM) is one component of improving clinical trial quality. It is also the monitoring approach that is encouraged by FDA to enhance human subject safety and trial data reliability.
5:00pm – 5:15pm ET: Program Wrap-up and Q&A