DIA: What Started in Crisis, Evolved into 60 Years of Global Collaboration

By James Riddle, Senior Vice President, Global Review Operations

Advarra

Next week, our team is heading to the Drug Information Association’s ( DIA ’s) Annual Meeting in San Diego (June 16-20) where this landmark industry organization will celebrate its 60th anniversary.

The DIA was founded in 1964 by 30 pharmaceutical professionals, medical writers, and academics in response to the thalidomide controversy. (Read more about DIA’s founding here). Thalidomide was introduced as a sedative and medication for morning sickness without adequate testing on the effects to pregnant women. By 1964, 17 infants had been reported harmed. It was then when DIA founders created a platform for communication and to foster collaboration to address global healthcare challenges, beginning with the thalidomide tragedy. 

The DIA has since evolved into a distinguished #non-profit association that provides knowledge resources for medical product development and whose members include thousands of life sciences professionals from 80 countries. Each summer, the community gathers to engage in important discussion on the most urgent topics from the evolution of digital clinical trials to how to more efficiently work with regulatory authorities. Advarra team members have participated in these conversations for more than 20 of the DIA’s 60 years – and this year’s no exception.

Let’s connect! I’m looking forward to catching up with friends while also discussing the anticipated FDA #sIRB regulation mandating multisite, industry-sponsored trials to use a single, centralized institutional review board (sIRB). This change represents a stark departure from a decentralized model using many different local IRBs for a single trial. For years, federal research agencies have mandated the efficient sIRB approach with the National Insititute for Allergy and Infectious Disease (NIAID) recently awarding Advarra the first sIRB-of-record contract from the #NIH. When the FDA’s sIRB mandate extends to all clinical trials, it will induce a seismic shift in who controls IRB selection with significant impact on the entire clinical research environment. Learn more in my article just published in the DIA Global Forum.

The DIA Annual Meeting is the ideal environment to converse about the biggest issues we are all facing in today’s ever-changing and hypercomplex drug development environment. And it’s precisely the reason the DIA formed – so the industry’s brightest minds can share new ideas, evolve, and improve patient lives. We believe in the DIA’s foundational mission: open collaboration as the bedrock for medical innovation, growth and – ultimately – patient safety.

If you, too, will be descending on southern #California next week, I invite you to attend all our sessions.

I will be participating in a session on Tuesday, June 18 4:30-5:30pm called “Remote Regulatory Assessments: Examining Another Tool in the FDA Regulatory Toolbox.” This session will describe the evolution of remote regulatory assessments (RRAs), FDA’s authority to conduct an RRA in lieu of an inspection, the process for conducting an RRA, and recent RRAs conducted as part of the FY23 BIMO program. Additional speakers include:

Captain Kavita Dada, Associate Director of Regulatory Operations in the Office of Scientific Investigations, Office of Compliance, in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration.

Jennifer Evans, Compliance and Enforcement Specialist, Health Canada, Canada

Jan Hewett, Regulatory Counsel (Policy) at the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, Office of Compliance, Office of Scientific Investigations

My Advarra colleague, Stuart Cotter r, will also be participating in a roundtable presentation in Innovation Theater #2 on Tuesday, June 18 at 11:55am. Representatives from Fortrea , Veeva Systems , and Velocity Clinical Research, Inc. will also be on the panel to discuss how teamwork across sponsors, sites, and technology providers can enable a better clinical trial ecosystem for everyone.

Finally, join Advarra’s Chief Product Officer Elisa Cascade a Cascade in a panel discussion on Tuesday June 18 from 5-7:30pm at Pendry in San Diego, just minutes from the main event. Other panelists include IDC Health Insights analyst plus executives from eClinical Insights, Indaptus Therapeutics, and Takeda – to discuss how AI can drive greater productivity in clinical research.

Congratulations to the DIA and happy 60th anniversary. Your organization and its role in bringing the global drug industry together is critical to preventing tragedy as well as to driving progress – both big and small for the benefit of mankind.

At Advarra, we will continue to play our part in bringing sites, sponsors, CROs, and regulatory agencies together to improve the speed, effectiveness, and safety of clinical development. For now, I look forward to seeing everyone, learning new things, and… if there is time, taking a stroll on the USS Midway!