MAGI East 2023 Content highlights

PLEASE NOTE: This program is a work in progress and subject to change.

Keynotes

Keynote: Innovation in Clinical Research: Why Does it Take us So Long to Adopt New Solutions?

Ken Getz, executive director of the Tufts Center for the Study of Drug Development (CSDD), will discuss the recent CSDD study which demonstrated that although we are enamored with innovations supporting clinical trial execution, the adoption process is highly inefficient and takes each company, on average, almost 6 years to put a new solution into practice. Mr. Getz will discuss the stages of the adoption process and areas that are most challenging, identify key opportunities for improvement, and highlight practices associated with more effective and efficient innovation adoption.



Keynote: Race, Inequality, and the Testing of New Pharmaceuticals

In this thought-provoking session, Dr. Jill Fisher will discuss topics from her recent book Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals. She will present her research examining the motivations, goals and practices of the people who participate in Phase 1 clinical trials, with specific attention to the implications of race, ethnicity and underserved medical communities. (A book signing will be conducted in the Exhibit Hall during the lunch recess on May 23)



Back by popular demand!

Good Clinical Practice (GCP) Training

This full-day pre-conference session is designed to provide comprehensive training on ICH/FDA Good Clinical Practice guidelines for anyone who is new to clinical research, or for anyone who has had prior GCP training but needs re-accreditation or wants a thorough refresher.

This Good Clinical Practice Training session has been accepted by the TransCelerate Mutual Recognition (MR) Program of the TransCelerate Site Qualification and Training (SQT) initiative and is considered acceptable GCP training by any sponsor which recognizes the TransCelerate program.

Participants who have pre-registered for this session and who attend the full training will receive a certificate of training completion.



Exciting New sessions planned

Getting the Patient Voice in Drug Development

Participants will discuss successful and ongoing programs designed to incorporate the perspectives, opinions and expertise of patients into the drug development process. Panelists will include the leader of a comprehensive patient program in a large biopharma company, a representative from FDA’s Patient-Focused Drug Development division, and a representative from a clinical site, to share and discuss different ideas.



Pre-Approval Access to Investigational Products

Lisa Kearns, from the Division of Medical Ethics at NYU, will moderate a breakout session on current hot topics related to pre-approval access to experimental therapies. Topics to be presented and discussed will include a review of the difference between expanded access and Right-To-Try legislation; a review of an "N-of-1" clinical trial, and a discussion of best practices for biopharma companies in drafting and creating expanded access policies and programs.

  1. Expanded Access Versus Right-to-Try: What's the Difference - Lisa Kearns
  2. Best Practices for Biopharma Sponsors in Preparing for Expanded Access - Christine MacCracken


Dissecting a Clinical Trial Agreement Part 1

In this two-part workshop, experts will review and discuss all of the components of a Clinical Trial Agreement, using the WCG MAGI Clinical Trial Agreement template as a framework for discussion. In addition to standard contract topics, the discussion will focus on intellectual property ownership, publications rights, subject injury indemnification and compensation, and contract obligations for clinical trial quality practices.



Research Fundamentals: The Basics of Drug Development and Clinical Trial Design

Designed in response to requests for clinical research training for early-career clinical research professionals. Experts will provide training on the basics of the drug development process (FDA structure and interactions, the stages of drug development, and the contributions of chemistry, pharmacology, toxicology, regulatory, and other teams members as part of the overall development process), on the basic design of clinical trials (classic and advanced trial designs, control groups and placebo use, randomization and confounding, preventing and controlling selection and assessment bias).



Research Billing Compliance: Foundations

Join experts from sites, sponsors, and services in the field of research billing compliance as they introduce – and reinforce – the foundational concepts that drive effective Research Billing Compliance programs.  

Whether new to the field, or you are looking for a “refresher” course the Workshop will provide instruction on regulations, commonly accepted tools, and sharing of best practices.

Sites, Sponsors, and Investigators can all benefit from Workshop teachings which not only set the stage for more advanced discussions within the WCG  MAGI Clinical Research Conference but allow self-reflection on the current practices of your organization.



What You Need to Know About New FDA Reguations on Research Participant Protections

In September 2022, FDA released a Notice of Proposed Rule-Making (NPRM), which is an advance draft of planned revisions to regulations around IRBs and requirements for the protection of research participants, including requirements for informed consent. In this session moderated by David Borasky (VP of IRB Compliance at WCG IRB), experts will discuss the history of these proposed changes, what they mean for researchers and research sponsors, what you need to be doing to prepare for compliance, and anticipated regulatory timelines.



TBD


Dissecting a Clinical Trial Agreement Part 2

In this two-part workshop, experts will review and discuss all of the components of a Clinical Trial Agreement, using the WCG MAGI Clinical Trial Agreement template as a framework for discussion. In addition to standard contract topics, the discussion will focus on intellectual property ownership, publications rights, subject injury indemnification and compensation, and contract obligations for clinical trial quality practices.