Join us December 13 – 14 in Boston for our 2023 Annual Meeting! The MRCT Center welcomes you to engage in dynamic and stimulating discussions and presentations of our programmatic work. This year, we are enhancing the meeting to a two-day program featuring a keynote address from Peter Arlett, Head of Data Analytics and Methods at the European Medicines Agency (EMA), several panel discussions related to our ongoing work, and Research, Development, & Regulatory Roundtable (R3) and Bioethics Collaborative (BC) forums, all open to registrants at no cost.
Click here to register. While in-person attendance is encouraged, virtual participation is welcome.
Frequently Asked Questions (FAQ)
What is the schedule?
I am attending in person. What do I need to know?
The Annual Meeting will take place in two locations:
- Wednesday, December 13, 8:00 AM – 6:15 PM: Ropes & Gray, 800 Boylston St., Boston, MA 02116
- Thursday, December 14, 8:30 AM – 11:45 AM: Loeb House, 17 Quincy St., Cambridge, MA 02138
You will need a photo ID to enter both locations.
There is no charge to attend the MRCT Center Annual Meeting.
On Wednesday, a continental breakfast, lunch, and cocktails/appetizers are offered. Please let us know if you have dietary restrictions.
On Thursday, a continental breakfast is offered.
Meeting slides and related resources will be shared with all registrants after the meeting.
Please share the registration information with others in your network.
For your convenience, we have included information about hotels in Harvard Square and near the Prudential Center.
Parking is available for a fee. Click here for detailed Parking Information and links.
Ropes & Gray parking information
Parking for the Prudential Tower is best accessed via the South Garage, which has two entrances on Huntington Avenue, one on Dalton Street and one on Belvidere Street. The Red and Yellow levels are both part of the South Garage. Attendant parking is available on both levels at no additional charge.
Loeb House parking information
Parking is available at paid public parking in Harvard Square, including the Harvard Square Parking Garage (65 JFK Street), Charles Square Garage (1 Bennett Street), Propark Church Street Lot (41 Church Street) and University Place Garage (124 Mt. Auburn Street).
I am attending virtually. What do I need to know?
There are two separate Zoom coordinates, one for Wednesday’s program and one for Thursday’s. Those coordinates will be shared one week in advance via email.
What are the topics for the research, Development, and regulatory Roundtable (R3) on December 13?
Topics:
- Update on the European Union (EU) General Data Protection Regulation (GDPR), including discussion of the EU/US data privacy framework
- Considerations in Ensuring Accurate Clinical Trials Data
This session will involve a panel discussion exploring developments occurring in the past year related to the effect of the European Union’s privacy law, the General Data Protection Regulation (“GDPR”), on clinical research. GDPR was the topic of a one-day meeting held in conjunction with the MRCT Center annual meeting in December 2022, and the intent of this panel is to explore what has changed in the intervening 12-month period. Topics addressed will include the Trans-Atlantic Data Privacy Framework, the UK-US Data Bridge, ongoing litigation in the EU regarding the definition of anonymization, and the latest relevant European Data Protection Board guidance. The panel will include representatives from leading life sciences companies who advise on data privacy issues as well as a representative of the U.S. Department of Commerce who worked on the Trans-Atlantic Data Privacy Framework.
More about the Research and Regulatory Roundtable (R3)
The Research, Development, and Regulatory Roundtable (R3) is a forum to discuss pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. Meetings convene policymakers, legal counsel, academicians, industry representatives, and global regulators. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.
Each R3 meeting focuses on one or two timely discussion topics related to the domestic and global impact of new legislation, regulations, guidance, and policies on research community stakeholders. At the end of each R3 meeting, we will consider whether the topic warrants further discussion or development as a publication, position paper, case study analysis, or commentary. To promote open dialogue, the meetings are run by the ‘Chatham House Rule,’ by which commentary will not be attributed to any individual nor their institutional affiliation.
While R3 meetings are open to organizations that sponsor R3, for the 2023 Annual Meeting, this R3 session is open to the public.
What is the topic for THE Bioethics Collaborative on December 14?
Topic: Gene Therapies: Probing the Ethics
There is understandable excitement about the potential for cellular products and gene therapies to transform the therapeutic landscape for many medical conditions. Although a number of cell and gene therapy therapies have already been approved and are available on the market, hundreds more are in various stages of research and development. However, this new class of therapeutics raises distinctive ethical issues that deserve careful consideration. Cell and gene therapies may have a transformative impact on research participants, manifesting not only in extended benefit but also in the need for additional safety monitoring far beyond what is typical in clinical research. Further, individuals can generally participate in only one of several clinical trials investigating possible treatments for the same condition and may need to forego alternative treatments that are developed in the future. Finally, there are issues of access to these experimental therapies. These features of cell and gene therapies can raise the stakes, making questions about how to apply traditional bioethical principles of autonomy, beneficence, non-maleficence, and justice more challenging. How can researchers and developers of cell and gene therapies design trials with due consideration for the distinct ethical issues raised by these therapies? Given the significance of the choice to receive cell and gene therapies and how this may impact and/or limit future options, what are best practices for the informed consent process? What key information should be disclosed to potential participants and caregivers and what measures should be taken to ensure comprehension? How does the acuity, instability, and chronicity of the disease impact these decisions? In this session, we will consider these ethical issues and others, assessing them in light of the need for scientifically robust research on cell and gene therapies while striving to do justice to research participants, patients, and their families.
Please find the suggested pre-reads here:
https://dev.mrctcenter.org/wp-content/uploads/2023/12/Ward-Clinical-Therapeutics-2022.pdf
More about the Bioethics Collaborative (BC)
The Bioethics Collaborative is a forum to propose, share, and discuss ethical challenges in multi-national clinical trials. Meetings convene individuals from academia, industry, patient/participant groups, ethics committees, government, and others.
The Bioethics Collaborative Planning Committee chooses discussion topics in advance. The MRCT Center then prepares a case statement of the topic to be discussed and circulates the case statement, relevant examples, and readings before the meetings. At the end of each Bioethics Collaborative meeting, we consider whether the topic warrants further discussion or development as a publication or other deliverable. To promote open dialogue, the meetings are run by the ‘Chatham House Rule,’ by which commentary will not be attributed to any individual nor their institutional affiliation.
While BC meetings are open to organizations that sponsor BC, for the 2023 Annual Meeting, this BC session is open to the public.
