Greg Hansch Honored with The STARR Coalition Lew Yagodnik Award for Advocacy Excellence

The STARR Coalition proudly presented the 2024 Lew Yagodnik Award—affectionately known as the Lewey—to Greg Hansch, Executive Director of NAMI Texas and one of STARR’s founding members. This award recognizes an individual whose unwavering dedication has meaningfully advanced mental health advocacy. For Greg, this recognition is both well-earned and long overdue.

Presented by last year’s Lewey recipient, Michelle Roberts, this year’s award celebrates Greg’s exceptional leadership and impact. Since joining NAMI Texas in 2012, Greg has led with vision and tenacity, advocating for policies that expand access to mental health care across the state. His impact includes championing funding for 988, promoting suicide prevention initiatives, expanding Coordinated Specialty Care programs, and elevating the role of Clubhouses in recovery and independence. A Licensed Master Social Worker and a family member of someone living with serious mental illness, Greg’s advocacy is both professional and deeply personal.

Greg’s commitment extends far beyond legislative work—he engages communities at health fairs, testifies at the Texas Capitol, and presents regularly at state agencies and conferences. He recently co-authored a chapter in Redesigning the US Mental Health Care System (Oxford University Press), and during a recent Senate testimony, even a power outage couldn’t stop him—he used his phone’s flashlight to continue reading his remarks.

In his heartfelt acceptance speech, Greg reflected on 12 years of advocacy, gratitude for his “small but mighty” team at NAMI Texas, and a shared belief in the power to create change. Citing Patrick Kennedy, he reminded us that mental health advocacy is more than a career—it’s a calling.

Congratulations, Greg—your passion, persistence, and unwavering kindness shine through in everything you do. The STARR Coalition is incredibly fortunate to have you as part of our community, and the people of Texas are even more fortunate to have you in their corner, fighting every day for a better, more compassionate mental health system. Thank you for being a true champion and an inspiration to us all. ❤

Despite recent administrative shifts reducing support for diversity, equity, and inclusion (DEI) initiatives, the pharmaceutical industry remains steadfast in its commitment to addressing disparities faced by minority and medically underserved communities. National BIPOC Mental Health Month highlights the ongoing need to confront barriers that prevent equitable participation in mental health clinical trials and access to treatment.

Pharmaceutical companies and clinical research organizations continue to proactively bridge these gaps. By investing in culturally competent outreach, patient education, and community partnerships, the industry is enhancing representation and trust among historically marginalized populations. Initiatives include multilingual trial resources, diverse community advisory boards, and targeted awareness campaigns tailored to the unique needs of minority populations.

Additionally, industry stakeholders emphasize the importance of inclusive clinical trial recruitment to ensure the efficacy of treatments across diverse demographics. Collaborative programs involving community health centers and local advocacy groups play a crucial role in removing systemic barriers and encouraging minority participation in clinical research.

Even as governmental backing for DEI programs fluctuates, industry-led efforts demonstrate a sustained dedication to equity in mental health care, underscoring the ethical imperative and scientific necessity of ensuring diversity in clinical trials and healthcare access. ❤

The STARR Coalition is dedicated to improving the landscape of mental health clinical research by cultivating public trust, increasing awareness, and connecting individuals to research opportunities through education and community partnerships.

We work with advocacy groups, local organizations, and mental health professionals to help demystify clinical research, educate communities about its value, and raise awareness of trial opportunities that may benefit individuals living with serious mental illnesses.

By promoting accurate, accessible information and reducing stigma, we help foster broader patient engagement and position clinical trials as a trusted, viable option within the continuum of care

The STARR also supports legislative and regulatory initiatives aimed at breaking down participation barriers. This includes advocacy for the Harley Jacobsen Act, supporting making trial participation compensation tax-free, and updates to the Family and Medical Leave Act, which would formally recognize clinical trial participation as a valid reason for medical leave, and efforts that can significantly ease the burden on participants and caregivers alike.

We collaborate with research sites and sponsors to identify actionable strategies that improve trial engagement—from empathy exercises and trauma-informed care training to tools for patient and caregiver outreach.

Together, we can ensure mental health clinical research is accessible, supported by policy, and trusted by the communities we serve.🎯

Key Policies The STARR Coalition Is Championing

Looking for Ways to Take Action?

With legislative sessions well underway across the country and changes happening at the federal level, check and follow the STARR's Key Policies page to stay abreast of important legislation and efforts to have your voice heard.

Lyndra Therapeutics' once-weekly capsule loaded with the antipsychotic risperidone, LYN-005, provided similar bioavailability and symptom control as daily doses of the drug in a phase 3 trial of patients with schizophrenia or schizoaffective disorder. The study was stopped early for success after an interim analysis showed all pharmacokinetic values met primary endpoint criteria. Weekly LYN-005 could bridge the gap between daily oral medications and long-acting injectable antipsychotics, which are not universally offered or accepted by patients, the researchers noted.

Compass Pathways achieves primary endpoint in first Phase 3 trial evaluating COMP360 psilocybin for treatment-resistant depression (TRD). The ongoing Phase 3 COMP005 trial is the first study of an investigational, synthetic psilocybin, and the first classic psychedelic to report Phase 3 efficacy data. Second ongoing pivotal Phase 3 COMP006 trial continues to enroll well, with 26-week data expected in the second half of 2026.

Draig Therapeutics emerges from stealth with $140M for clinical tests of novel neuropsychiatric drugs. Draig Therapeutics’ lead drug is designed to safely target the AMPA receptor as a way of mediating the interplay between two neurotransmitters whose imbalance is associated with mood disorders. The startup is one of several that have recently raised mega rounds of financing to support programs in the clinic or entering clinical testing.

Atai Life Sciences plans to merge with psychedelic startup Beckley Psytech, dependent on the outcome of Beckley’s Phase 2b study, which sees its intranasal 5-MeO-DMT candidate (BPL-003) tested for treatment-resistant depression (TRD). The merge would give the new company a pipeline that includes potentially transformative, rapid-acting psychedelic assets differentiated by their convenient route of administration and short time-in-clinic.

Syndeio Biosciences launched and revealed $90 million raised to date to support its therapies intended to repair and enhance synaptic function impaired by central nervous system diseases. The Indianapolis-based biotech’s lead drug candidate, zelquistinel, is in Phase 2 testing for major depressive disorder; Alzheimer’s is the next indication planned for this oral small molecule.

A large 20-year study — the longest and most detailed of its kind, with 81,298 observations from 12,822 WTC responders — shows that posttraumatic stress disorder (PTSD) symptoms can endure for decades, challenging conventional timelines for recovery and offering new insights to guide future treatment. Researchers analyzed data from the World Trade Center Health Program (WTCHP), which is administered by the US CDC’s National Institute for Occupational Safety and Health (NIOSH), and found symptoms of PTSD persisted for as long as two decades in 10% of first responders involved in the World Trade Center disaster of September 2001.

Exploratory plans for a new iteration of the Diagnostic and Statistical Manual of Mental Disorders (DSM) were presented publicly for the first time at American Psychiatry Association (APA) 2025 Annual Meeting. The APA stopped short of calling it a full sixth version of the DSM (DSM-6), but in March 2024, the APA’s Board of Trustees approved the creation of the Future DSM Strategic Committee, with Oquendo becoming its chair. The full group was tasked with monitoring new developments that could affect the structure, definition, and criteria of DSM disorders. “The rapidity of scientific developments in psychiatry has never been faster. The idea is: We want to integrate critical feedback on the DSM and work towards [including] classification models, measurements, and advances in neuroscience,” Oquendo said.

BMS published 'Science Firsthand: The renaissance of neuroscience R&D', offering insight into how AI, machine learning, and advanced computational methods are helping transform what’s possible in neuroscience. Check out the video at the top of the page - it's worth the 6+ minutes.

Fitbit data streams enabled accurate prediction of mood shifts in patients with bipolar disorder. Preliminary studies suggest that predictions based on passive sensor data from personal digital devices can accurately detect mood episodes (e.g., between routine care appointments), but studies to date do not use methods designed for broad application. The study showed there was predictive accuracy of 80.1% for depression and 89.1% for (hypo)mania. 

Boehringer Ingelheim has co-created the podcast mini-series “Road to the Global Mental Health Community Summit” with patient advocate Roi Sternin to explore how to address unmet needs, improve perceptions of mental illness, and influence policy together for better outcomes worldwide. Listen to the first episode, where Roi meets Vanessa Pott, BI's Head of Global Patient Engagement. 

ChatGPT is telling people with psychiatric problems to go off their meds. Following an article about people developing intense obsessions with ChatGPT and spiraling into severe mental health crises (here), Futurism published another article on how AI and ChatGPT in particular, is telling people with SMIs to go off their medications and how chatbots are being used as a therapist or confidante to their detriment.

The NIH has stopped canceling biomedical research grants after a federal judge said hundreds of those cuts were illegal. U.S. District Judge William Young ordered the NIH to restore more than 900 canceled grants. An internal email sent on June 24th by Michelle Bulls, director of the NIH’s Office of Policy for Extramural Research Administration, said no more grant cancellations should move forward. “Effective immediately, please do not terminate any additional grant projects," Bulls wrote. "Please unrelease all grant projects that are in the [queue] to be terminated. Again, do not terminate any additional grant projects."

Arkansas is leading the nation in banning PBMs from owning pharmacies, as other states advance new restrictions. In 2023, PBMs took $140 billion in rebates and fees, driving up US medicine costs. With just three PBMs controlling nearly 80% of the U.S. market, they dictate what medicines patients can get and what they will pay. Congress has been weighing PBM reform for several years, but continues to do nothing, so state legislatures are stepping up to reign in the PBMs. Currently, all 50 states have bills that would impact PBMs or drug benefits.

The Health Resources and Services Administration (HRSA), which oversees the 340B Drug Pricing Program, is on the verge of releasing guidance on whether to allow a model that could give pharma companies more oversight power. The 340B program was created to help low-income patients afford the medications they need. But, because there is no oversight and no guardrails on how the profits from the program are used, the program is being abused by hospitals, with instances where large, tax-exempt hospitals are buying medicines at steep discounts and marking them up for patients by as much as 1,000%. 

Research!America just released their 25th annual poll data summary, and the results are in: America Speaks! provides a look at the findings of recent research and public health-focused surveys.  Of note, respondents identified cost as the single most important issue in U.S. health care – but the percentage of respondents citing cost dropped by six percentage points this year (16% vs. 22%) compared with 2024. Cancer (15%) supplanted mental health (12%) for second place in this category, while access to care, opioid addiction, obesity and firearm violence all ranked highly in respondents’ minds. It is concerning that only a fourth of respondents believe that upon reaching adulthood, today’s children will be better off than people are today. However, an overwhelming majority said it was important that the new administration and Congress assign a higher priority to accelerating medical progress.

AAMC released a report on the Impact of NIH Grant Terminations. This brief utilizes available data as of May 20, 2025, and summarizes the current state and impact of NIH grant terminations on U.S. institutions, with a focus on medical schools and hospitals, drawing from a dynamic database that is tracking grant terminations. One-hundred thirty of the terminated grants were associated with 160 active NIH-funded clinical trials and represented 30% of lost NIH funding ($739 million). Of these terminated grants, 50 (38%) focused on mental or behavioral health.

Why This Matters to the STARR Community

The termination of NIH grants - particularly those supporting clinical trials in mental and behavioral health - is deeply concerning to The STARR Coalition community. These cuts don’t just halt scientific progress; they disrupt care, derail innovation, and can leave patients in vulnerable situations, especially those who were enrolled in now-shuttered studies. As a community of mental health clinical researchers, advocates, and care providers, we understand how vital these trials are, not just to advance treatment, but to offer individuals real access to care and hope.

🡺 If your site or organization has the capacity to support patients affected by these terminations either by helping transition them into new studies or connecting them to resources, please reach out. Together, we can help ensure these individuals are not left behind and that the momentum in mental health research continues forward.

Teva Launched LAI‑CARE: A Resource to Support Adherence and Shared Decision‑Making in Schizophrenia Treatment

The LAI‑CARE educational platform is designed to facilitate informed, collaborative conversations about long-acting injectable antipsychotics (LAIs) for schizophrenia. Aimed at healthcare professionals, people living with schizophrenia, and care partners, this resource supports person-centered, adherence-focused discussions around treatment planning.

Of particular note for mental health advocates and research professionals is the LAI-CARE for Caregivers section, which offers practical, stigma-sensitive resources to help families navigate one of the most persistent challenges in treatment: adherence.

This section answers key questions like “Why is adherence so important?” and “How can I help my loved one stay on track?”—equipping caregivers with tips on building trust, identifying early warning signs, and providing support without diminishing the individual’s autonomy.

The platform includes downloadable conversation guides, educational tools, and plain-language explanations that help demystify the role of LAIs in relapse prevention and long-term stability. For clinical researchers, this resource may also support improved patient engagement and retention strategies—particularly in studies involving LAIs.

Why This Matters to the STARR Community

The STARR Community is committed to supporting not only research participants, but also their families and support networks. LAI-CARE is a powerful tool that sites can share with caregivers of patient study volunteers to improve understanding, reduce stigma, and foster shared decision-making beyond the research setting. As we work together to promote trust in clinical research and support continuity of care, tools like LAI-CARE help bridge the gap between research participation and real-world mental health outcomes. 🡺 We encourage all STARR Site teams and advocates to explore the platform and consider integrating it into participant education and caregiver outreach.

Attention Sites: Opportunity for You or Your Patients to Win up to $500!

The CURESZ Foundation invites submissions for an essay competition on serious psychiatric disorders, especially schizophrenia or bipolar disorder. Two $500 prizes will be awarded: one for authors aged 25 or younger and another for authors over 25. Runners-up in each category receive $250.

CureSZ welcomes submissions from students, professors, caregivers and anyone who has a story to tell. Essays (1,000-1,500 words) can share personal stories of overcoming psychiatric brain disorders in yourself or in relatives and friends. Also of interest are articles related to governmental policies, experience with navigating the system of mental health care in the US or abroad, suicide, homelessness, substance abuse, anosognosia, and other conditions that are associated with schizophrenia and related psychoses.

Winning essays will be published in CURESZ News, with potential for publication in peer-reviewed journals.

Submit entries by email to bethany.yeiser@curesz.org or by mail by August 15, 2025. Winners announced September 15, 2025.

ANA2025 will be held Sept 13 – 16 in Baltimore, MD. The Annual Meeting has been designed to foster discussions among investigators in academia, industry, and foundations toward the common goal of furthering translational science. As usual, it will include professional development workshops offering daily sessions designed for early career, mid-career, and residency directors. 

Psych Congress is the nation's conference on practical psychopharmacology and a community of passionate mental health clinicians. The 38th annual Psych Congress will be in San Diego from Sept. 17-21. For five days this fall, engage in a unique, integrated forum full of practical, real-world training, covering the latest techniques, treatments, best practices, and evidence-based care. The 2025 event will feature more sessions, more credits, and more opportunities than ever before.

The Global Site Solutions Summit will be held from Sept. 28-Oct. 1 in Orlando, FL. The Summit provides a unique hub where sites, sponsors, CRO executives, and regulators come together to discuss best practices and ideas while developing strategic partnerships through ideation sessions, workshops, and focus groups. Whether your priority is networking with sponsors and CROs or learning best practices built for research sites, the Summit will provide a valuable experience for your business.

The Mental Health America 2025 Conference will be held October 16-17 in Washington D.C. and will explore the theme "Turn Awareness Into Action". The conference will bring together experts, innovators, and advocates who are implementing strategies that work — approaches that improve mental health care, expand access, and create lasting change.

CNS SUMMIT 2025 will be held Nov. 2-5 at the

Encore Boston Harbor. The Summit brings together a curated group of top decision makers from pharma, biotech, CROs, investigator sites, patient advocacy groups, investors and other stakeholders. Your event registration also provides access to our year-round programming and community activities. 

The National Federation of Families (NFF) will be hosting its 36th Annual Conference on November 3rd, 5th, and 7th, 2025, virtually. The event will welcome hundreds of key researchers, administrators, policymakers, family members, youth, clinicians, and other stakeholders across the nation. Join The STARR Coalition at our panel session on Leveraging Clinical Research to Fill Gaps in Mental Health Care for Families!

Neuroscience 2025 will be held Nov. 15-19 in San Diego. Each year, scientists from around the world congregate to discover new ideas, share their research, and experience the best the field has to offer. Attend so you can: present research, network with scientists, attend session and events, and browse the exhibit hall at the premier global neuroscience event.

Prescription digital therapeutics represent a rapidly expanding sector—valued at around $2.8 billion in 2024, expected to nearly triple by 2033. Meanwhile, the broader digital therapeutics market is already approaching $10 billion, growing at 25–28% annually.

(PDT Market Overview)

The Harley Jacobsen Clinical Trial Participation Income Exemption Act seeks to exclude all payments to participants in clinical trials from being treated as taxable income so welfare benefits are not put at risk.



WHAT CAN YOU DO TO SUPPORT THIS IMPORTANT LEGISLATION?

1. Sign the petition on Change.org to show your support for the Harley Jacobsen Act. Share the petition with your network and colleagues.

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2.  Sign on the Mural Health website, supporting the Harley Jacobsen Act.

Thank you for reading!

If you have questions, comments, or would like to submit an item to be included in an upcoming newsletter, please email erica@thestarr.org.