IAMB/TbT Groups’ history includes years of engagement in clinical research, Good Clinical Practice, public health, community development, and federal regulatory conversations. This page documents key milestones, correspondence, presentations, and recognitions that help tell that story.
2009 | White House Correspondence
IAMB/TbT Groups’ history includes direct correspondence with the White House. In July 2009, Rena E. Starks received a response from President Barack Obama following her communication regarding the economy and America’s future.
White House Correspondence
to The Founder and CEO | July 08, 2009
A Broader Federal Commitment to American Innovation
— President Barack Obama,
Remarks on American Manufacturing, Boeing Plant,
Everett, Washington, February 17, 2012
That broader federal challenge—to build American capacity, create jobs, manufacture, innovate, and succeed at home—aligns with IAMB/TbT Groups’ long-term vision of developing research, healthcare, manufacturing, pharmacy, workforce, and public-access infrastructure in the United States.
So Again, the Direction Was Clear
2012 | Federal Clinical Research Participation
On April 23, 2012, the U.S. Food and Drug Administration held its Part 15 Public Hearing, “Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice,” at the FDA White Oak Campus in Silver Spring, Maryland.
The official agenda lists Rena Starks, Super Admin, as a scheduled presenter from 3:05–3:20 p.m., followed by an FDA panel question period from 3:20–3:25 p.m.
FDA Part 15 Public Hearing Agenda | April 23, 2012
The Feds Own the Meds™
For IAMB/TbT Groups, “The Feds Own the Meds” is a legacy phrase describing the federal government’s central role in regulating drug development, clinical research, controlled substances, approval pathways, and access to investigational and approved therapies.
IAMB/TbT Groups seeks to help provide the bridge to safe, compliant access — connecting federal requirements with qualified researchers, healthcare professionals, clinical infrastructure, pharmacy participation, patients, and the public.
Federal regulation establishes the pathway. IAMB/TbT Groups seeks to help make safe, compliant access executable.
2016 | FARS
IAMB/TbT Groups also continued to follow federal regulatory developments affecting cannabis research and lawful research access. In 2016, a DEA Federal Register policy statement—reflected in IAMB’s FARS materials—recognized the need to expand the number of federally registered entities able to supply marijuana and cannabinoid materials to legitimate researchers, while maintaining DEA registration, HHS scientific review, security, recordkeeping, diversion control, and other federal safeguards.
For IAMB/TbT Groups, that development reinforced a principle that continues to guide our work: research access should expand through compliance, not around it.
2026 | Federal Direction Moves Toward Research and Access
In 2026, federal policy again emphasized the need to expand clinical-trial participation, strengthen evidence generation, coordinate regulatory pathways, prepare the healthcare workforce, and responsibly move promising therapies from research toward care.
President Trump’s Executive Order 14401 directed HHS and FDA to collaborate with the Department of Veterans Affairs and, where appropriate, the private sector to increase clinical-trial participation, data sharing, and real-world evidence generation for psychedelic therapies.
On July 13, 2026, HHS and VA signed a Memorandum of Understanding calling for increased clinical-research participation, workforce training, evidence-based clinical protocols, safety and effectiveness data, regulatory coordination, patient and provider education, and preparation for responsible implementation of future FDA-approved rapid-acting psychiatric treatments.
The Federal Direction is Clear:
More Research, Better Coordination, Stronger Evidence, and Responsible Access.
IAMB/TbT Groups seeks to help provide the bridge that connects those goals to executable clinical-research infrastructure.
Recognition & Community Impact
IAMB/TbT Groups’ broader history includes community-health initiatives, public-service programs, youth development, education, prevention, and recognition received through affiliated and legacy programs.
