Commit to Wellness This August

August is National Wellness Month, a reminder to slow down and take care of yourself. The idea is simple: build healthy habits, cut stress, and stay connected, both to yourself and to the people around you.

Many people mark the month by taking the "I Choose Wellness" pledge or leaning into practices like hydration, movement, mindfulness, and mindful eating. For site staff working alongside patients managing serious mental illness, and for the patients themselves navigating trial participation on top of daily life, this month is a good excuse to check in on the basics.

A strong culture of wellbeing grows out of small, consistent actions that add up over time. That's the idea behind our 31 day wellness calendar: simple habits you can build into your day, whether you're supporting patients or navigating a trial yourself. None of it takes a budget. It just takes showing up for each other a little more intentionally, one day at a time.

This August, The STARR Coalition is inviting sites, staff, and patients across our network to take the "I Choose Wellness" pledge and try out a few simple habits from our 31 day wellness calendar.

Take the pledge and get the full calendar here. ❤



Welcome the newest STARR Certified Site!

We're proud to welcome CenExel Tampa to the STARR Certified Site family, and to introduce the site's Principal Investigator, Marlene Patricia Hart, MD, MPH, BSW, RD.

Dr. Hart is a board-certified psychiatrist with more than 30 years of experience. She earned her medical degree from the University of Pittsburgh and completed her psychiatry residency at the University of South Florida. Since 2015, she has also served as owner and medical director of Wesley Chapel Mental Health and Wellness. Her Phase II–IV research spans Alzheimer's disease, ADHD, major depressive disorder, generalized anxiety disorder, migraine, and schizophrenia.

What sets Dr. Hart apart is how she carries that work beyond the research site. She sees community engagement as part of the job, not a side project. She recently joined her CenExel Tampa team at NAMIWalks, showing up alongside neighbors to support the National Alliance on Mental Illness, raise awareness, and remind people that mental health resources matter. It's the kind of presence that builds trust, and trust is what opens the door to research participation.

Colleagues describe her as thoughtful and collaborative, dedicated to conducting trials with rigor, integrity, and compassion. As CenExel Tampa grows its CNS program with a new 10,000-square-foot facility for inpatient and outpatient trials, that patient-centered focus stays front and center.



As Dr. Hart puts it, "Being part of that process and helping patients access innovative research is incredibly rewarding."

Read Dr. Hart's full profile here.

Celebrating Women's Equality Day at CenExel Decatur

For Women's Equality Day, August 26th, we're spotlighting the women of CenExel Decatur, GA, and the culture of excellence they've built through empathy and collaboration.

It started small. In 2010, CEO Heather Beitz and COO Sara Castle opened a one-room research facility with a bold idea: exceptional clinical research begins with exceptional experiences. That vision is now growing into more than 45,000 square feet of dedicated research space, with three new floors designed to help participants feel safe, seen, and comfortable.

The medical team carries that same spirit. Principal Investigators Dr. Kimball Johnson, Dr. Lisa Ortenzi, Dr. Sandra Maas-Robinson, Dr. Gayle Goldstein, and Dr. Mary Burns bring decades of expertise, but it's their compassion that leaves a mark. As Dr. Johnson puts it, "No matter how smart, one person can never know it all; yet the group experience can be genius."

At CenExel Decatur, the future of research is being shaped by women who lead by listening. They've proven that clinical excellence isn't just about protocols and data. It's about people. When participants feel heard and teams feel valued, trust follows, and trust is what turns clinical research into genuine care. That's the culture Heather, Sara, and their medical leaders have built, one thoughtful conversation at a time. This Women's Equality Day, their work is a reminder of what empathy and collaboration can do for the people research is meant to serve.

Eli Lilly announced July 16 it will acquire AtaiBeckley in a deal worth roughly $2.8 billion upfront, with up to $1 billion more tied to milestones. The prize is a pipeline of rapid-acting therapies for treatment-resistant depression, led by BPL-003, which earned FDA Breakthrough Therapy status and posted durable results in a Phase 2b study. It's a strong signal that momentum, and serious investment, are flowing into mental health research.

TG Therapeutics initiated a Phase 2 trial for Briumvi (ublituximab) in treatment-resistant schizophrenia, betting on the idea that immune dysfunction drives symptoms in some patients. The open-label, single-arm study will enroll about 60 participants, ages 18 to 60, who continue their standard antipsychotic therapy while adding the intravenous antibody. The primary endpoint is the proportion of participants achieving at least a 20% reduction in PANSS score at week 12.

The FDA approved Otsuka's Simtriyo (centanafadine) as a once-daily extended-release capsule for treating ADHD in adults and pediatric patients aged 6 years and older who weigh at least 20 kg (44 pounds). Simtriyo is the first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI).

LB Pharmaceuticals now expects topline results from its pivotal Phase 3 NOVA-2 trial of LB-102 in schizophrenia in the first half of 2027, ahead of prior guidance, citing faster-than-expected enrollment. A pre-NDA meeting with the FDA would follow in the second half of 2027. NOVA-2 aims to enroll about 460 patients across 25 US sites. LB-102, a once-daily methylated derivative of amisulpride, would be the first benzamide antipsychotic approved in the US.

Compass Pathways announced 26-week results from COMP006, its second Phase 3 trial of COMP360 psilocybin for treatment-resistant depression. In a highly treatment-resistant cohort of nearly 600 patients, 39% in the 25 mg arm achieved a clinically meaningful MADRS improvement of at least 25% by week 6 after two doses, with response maintained through week 26. A rolling NDA submission to the FDA is underway, with final filing expected in Q4 2026.

Draig Therapeutics raised a $65 million Series B to accelerate its pipeline of AMPA- and GABA-targeting drugs for major depressive disorder and other psychiatric conditions. The U.K. company's lead candidate DT-101, which Draig claims has "best-in-disease" potential, is now in a global Phase 2 monotherapy study with a separate U.S. add-on trial. With fresh capital and multiple programs advancing, Draig is worth watching for sites, as expanding trials could mean new study opportunities ahead.

A new analysis puts hard numbers behind long-acting aripiprazole for bipolar I maintenance. Over 52 weeks, once-monthly aripiprazole kept 73.5% of patients free from any mood episode, versus 48.9% on placebo, a number needed to treat of just 5. Even better, fewer people quit the drug than quit placebo because of side effects. The bottom line: patients were far more likely to be helped than harmed.

MapLight Therapeutics has announced positive topline results from the phase 2 ZEPHYR trial evaluating ML-007C-MA in adults with an acute exacerbation of schizophrenia. ML-007C-MA is an oral, extended-release, fixed-dose combination of betovumeline, an investigational M1/M4 muscarinic agonist, and fesoterodine, a peripherally acting anticholinergic intended to reduce peripheral cholinergic adverse effects.

Although MapLight Therapeutics' oral schizophrenia candidate ML-007C-MA met the primary endpoint of its Phase 2 ZEPHYR trial, a once-daily arm missed its endpoint, and analysts noted the result fell short of Bristol Myers Squibb's Cobenfy, which posted 8 to 10 point reductions in Phase 3. MapLight shares fell more than 60%. The company plans to discuss a late-stage trial with regulators.

Low-dose buprenorphine may enhance ketamine's antisuicidal effects in major depression. Because ketamine’s antidepressant and antisuicidal effects may involve mu-opioid receptor pathways, a study recently published in the American Journal of Psychiatry evaluated whether low-dose sublingual buprenorphine could extend ketamine’s antisuicidal benefit. The study showed buprenorphine significantly sustains and enhances the antisuicidal effects of ketamine in MDD.

A new study in the Journal of Psychopharmacology looked at what actually happens when support providers sit with participants during psilocybin dosing for PTSD. The answer surprised the researchers. In administration sessions, roughly 78% of the time was silent, far more than in prep or follow-up visits. Support was quiet but still mattered to participants, offering reassurance and room for their own experience. A fresh look at how psychedelic care really works.

At the 2026 Southern California Psychiatry Conference, Jason Kellogg, MD, reviewed a wave of investigational depression treatments spanning at least six mechanisms. With remission odds falling to 14% after two failed antidepressants, he said the field is shifting beyond serotonin toward rapid-acting, neuroplasticity-focused options. These include synthetic psilocybin COMP360, orexin antagonists like seltorexant, next-generation glutamatergic agents, sigma-1 compounds such as dextromethorphan-bupropion, and neurosteroids, several now in late-stage trials.

At the Southern California Psychiatry conference, Jacob Hanaie, PharmD, argued that long-acting injectable antipsychotics deserve earlier use in schizophrenia treatment. LAIs improve adherence by roughly 89% over oral agents and cut treatment failure 26% to 45%, yet fewer than 10% of US patients receive one. Hanaie urged clinicians to choose the right molecule first, then the delivery system, and pointed to barriers like guidelines, needle anxiety, and prior authorization.

At the Southern California Psychiatry Conference, keynote speaker Charles DeBattista, MD, told attendees that one or more psychedelic agents will likely gain FDA approval within the next one to two years for treatment-resistant depression. Their most distinctive feature, he said, is the potential for lasting antidepressant effects from a single or small number of doses. He cautioned about barriers, including restricted prescriber access, adverse effect risk, and unsuitability for some patients.

Biogen' BIIB080, targeting a tau protein, released new data from the mid-stage Celia trial (for Alzheimer's) showing that the lowest dose slowed cognitive decline by 26%, roughly matching what amyloid drugs deliver. This is the first real sign that reducing tau can protect thinking and memory. Questions remain about dosing, particularly why higher doses didn’t perform better, but Biogen is pushing ahead to late-stage testing.

MediPharm Labs reported that its Phase 2 LiBBY trial met its primary endpoint, showing significant reductions in agitation among patients with Alzheimer disease or other dementia. The trial randomized 120 hospice-eligible patients to placebo or an oral formulation of 2 mg THC/100 mg CBD twice daily for 12 weeks. Treatment produced a 6.27-point greater reduction in CMAI agitation scores versus placebo at week 2, growing to 8.23 points by week 12.

ProMIS Neurosciences reports positive blinded six-month interim safety and biomarker data for PMN310 in the PRECISE-AD phase 1b Alzheimer's disease trial. The amyloid-beta oligomer-targeting antibody showed no ARIA-E, even among high-risk APOE4 carriers, and total ARIA of just 4.4%, all mild and asymptomatic. Fluid biomarkers moved in a favorable direction, with declines in plasma pTau217 (68.5%) and CSF MTBR-tau243 (62.5%) versus expected natural-history increases. Unblinded 12-month topline data, including efficacy, are expected in Q1 2027.

More than a year of turnover at the top has left the FDA led by acting officials, and industry watchers are still guessing which policies survive. Experts told PharmaVoice that some priorities look durable, like faster early-stage trials and wider use of AI in reviews. Others may not. For a research community that runs on predictability, steadier leadership can't come soon enough. Stability is what lets science move forward.

Bristol Myers Squibb brought science, soccer, and community together at the BMS Kickoff for Community Health event in New Jersey, partnering with the FIFA World Cup 2026 New York/New Jersey Host Committee, the US Soccer Foundation, the City of Trenton, Mayor Reed Gusciora, and the Trenton Parks and Recreation Department. At the center of the day was the unveiling of a brand new mini pitch — a community hub designed to give kids and families a place to build healthy habits close to home. The event went well beyond the pitch, offering a free pop-up grocery shop, a healthy snack stand, hands-on health education, patient advocacy resources, and clinical research information.

At the heart of the day was a simple goal, creating access and building trust so individuals and families feel more informed, supported, and empowered in their health. Through connections to health care, nutritious foods, and resources to help families live healthier lives. ❤

Teva Pharmaceuticals spotlights the real-world experience of living with schizoaffective disorder through a patient and caregiver forum featuring Sally, who lives with the condition, and her mother Sophie, who has been her primary caregiver. The two share candid perspectives on diagnosis, treatment continuity, stigma, and what recovery actually looks like. Three takeaways stand out: lived experience is one of the most powerful tools for building community understanding; consistent, uninterrupted care matters enormously; and caregivers carry their own burden that deserves attention year-round, not just during awareness months.

Boehringer Ingelheim welcomed 94 interns across nine locations this summer, bringing in the next wave of talent shaping the future of healthcare and drug development. The 2026 intern class spans a range of disciplines, with each cohort contributing fresh thinking to Boehringer's mission of transforming lives. Programs like this one matter beyond the summer — early investment in emerging talent is how the breakthroughs of tomorrow get built. The clinical research community benefits when companies like Boehringer make developing the next generation a genuine priority.

Worth Sharing: A Quick Read on Where Psychedelics Research Is Headed

Every so often we read something and think, more people need to see this. Dr. Harry Tracy's July 16 NeuroGram+ was one of those.

It's a short, sharp breakdown of what's happening in the field right now. In just a page, Dr. Tracy unpacks Lilly's $2.8 billion acquisition of AtaiBeckley and what it signals for mental health research. Lilly helped build modern psychiatry with Prozac back in 1987, then stepped away for two decades. Now they've made the largest psychedelic acquisition ever. Dr. Tracy connects the dots on why that matters.

We're reprinting the NeuroGram in full below, with his kind permission. Think of it as a taste. The deeper analysis lives in his NeuroPerspective reports. If you want that kind of insight regularly, you can subscribe at www.niresearch.com.

CALL FOR SITES:

If you care for patients who are taking or about to start Cobenfy®, they may be eligible for a voluntary observational study focused on real‑world experiences.

Participation does not change treatment or care. Learn more at TheEaseStudy.com or on clinicaltrials.gov (NCT07379827).

Time Is Running Out to Weigh In on the Rules Around CMS Drug Pricing

CMS is finalizing the permanent rulebook for how Medicare negotiates drug prices, and the window to speak up closes August 17. That's less than two weeks away.

Here's the problem. Most of the rules are technical, and easy to scroll past. But a few pieces quietly work against how mental health treatments actually get developed, delivered, and used. If the mental health community stays quiet, the final rule will be shaped by other voices.

Start with delivery. In psychiatry, how a medicine is given often decides whether someone stays well. Long-acting and better-delivered formulations are some of the only tools that keep people in treatment and out of the hospital. One provision would treat those real improvements the same as paperwork tricks used to game the clock, and that could discourage the very innovation patients need.

Then there's off-label use. Psychiatric drugs are prescribed off-label more than almost any others. Yet the rule may set prices as if that real-world use barely exists, because it only counts when a drug company volunteers it.

And there's the pipeline. Most new mental health treatments start at small companies that get bought before a drug is ever approved. A protection meant to help those small innovators vanishes the moment they're acquired, which is exactly when it would matter.

CMS is asking for public input right now. This is our chance to put the mental health perspective on the record. If you have a stake in mental health research or care, say so plainly in your comment.

The comment does not need to be long. A few paragraphs grounded in your real experience carries weight. For more information and to access the STARR's comments, visit our website at

thestarr.org/ira-rulebook-public-comment/.



The deadline is August 17th.

This is important for the future of mental health treatments,

and your voice can be part of shaping it.

A Second Deadline Worth Your Time: Trial Compensation

If the notice above got your attention, here is another comment window closing soon, and this one is about the people at the heart of every study.

The HHS Office of Inspector General is deciding how clinical trials can pay participants. Comments close August 24.

The issue is simple, and a little surprising. When a sponsor pays someone for their time, covers a copay, or reimburses gas money, no federal rule actually says that is allowed. It has worked for years, mostly on the strength of past OIG advisory opinions. What has never existed is a permanent safe harbor that makes it clearly protected.

Small sites and nonprofits feel that uncertainty the most. They cannot easily tap the advisory process that large sponsors rely on. Third-party groups that administer compensation have no framework to stand on. And as participant support programs keep growing, "this is probably fine" is not a foundation anyone should build on.

Now OIG is asking whether it should write a formal rule. That is welcome news, as long as the rule protects what already works and widens access instead of narrowing it. Your comment can make that case.

If you have room for one more point, raise this: participant payments count as taxable income, which can put Medicaid and SNAP benefits at risk for low-income enrollees. Ask OIG to name that gap and recommend a federal exemption.

You do not need to write a lot to be heard. A few honest paragraphs from your own experience go a long way. To learn more and read STARR's comments to the OIG, visit thestarr.org/trial-compensation-public-comment.



The deadline is August 24.

Anyone with a stake in how participants are treated has a good reason to weigh in.

IRA Drug Price Negotiation Program: Who Actually Gets the Savings?

Medicare drug price negotiation raises real concerns for the research and innovation that patients depend on. But the policy is moving forward, so the practical questions matter now.

On May 9, 2025, federal regulators approved a new CMS system called the Medicare Transaction Facilitator (MTF), following public notice and comment through 2024 and 2025. MTF is the CMS system that makes sure pharmacies actually receive the negotiated price for 2026 and 2027, usually through a manufacturer refund, so the discount is real at the counter instead of getting stuck upstream.

That is a start. The harder question is whether patients feel the savings, or whether insurers and PBMs absorb them along the way. The MTF does not settle that.

Here's where you come in:

CMS has the 2028 version open for public comment through September 22, 2026.

Now is the moment to speak up, for a simpler system and for one that gets savings to patients, not middlemen. STARR has submitted comments and you can too.

For more information on the CMS system and call for comments, visit our webpage on it HERE.

Awareness opens the door. Treatment, access, and research are what carry people through it. As Overdose Awareness Month arrives, that next step is the part our field is uniquely positioned to advance.

For years, treatment for substance use barely changed. That's finally shifting. More than ten biopharma companies are now developing therapies for opioid use disorder, and the science is getting more creative. Indivior is testing an orexin receptor antagonist that works differently than anything on the market today. Eli Lilly, Alkermes, and Teva all have active programs. Some of the most exciting momentum comes from GLP-1 medications now being studied across alcohol, opioid, and other use disorders in more than 30 trials.

But there's a gap. Nearly 80% of addiction research still happens in academic settings, with industry only beginning to catch up. That's exactly where trust and access matter. New treatments only help people if communities know about the trials, believe in them, and can take part.

At The STARR Coalition, we see clinical research as care, not a last resort. Awareness brings people to the conversation. Research is how we keep it going.

This month, help your community learn the signs of an overdose, how to respond, and how research is working to save lives.

Manatee County was once the epicenter of Florida’s opioid crisis, leading the state in overdose deaths. But now, thanks to a community wide effort involving Manatee law enforcement agencies, emergency medical service providers, NAMI, and other local nonprofits and faith-based groups, those numbers have dropped dramatically. So much, in fact, that the Florida Department of Children and Families recently recognized Manatee County as the state’s top performer in reducing opioid-caused deaths.

Brenda Brooker, who spearheads NAMI’s peer recovery efforts as part of Manatee County’s Overdose Prevention and Education Program (OPEP), recently appeared on both television networks to discuss how NAMI and other community partners have helped drive down overdoses in the county from a high of 1,289 in 2016 to 204 last year. Overdose deaths were similarly reduced from 123 to 37 during that same period, including a dramatic 56% reduction in overdose deaths in Manatee County between 2023 and 2024 alone.

Click here to watch a clip about Manatee County’s success.

Get STARR Certified — Get Found, Get Connected, Get Supported

Pharma companies and CROs actively search the STARR Certified Sites list when identifying sites for their studies. Certification signals that your site is experienced, community-connected, and backed by the STARR Coalition network — all of which translates to better enrollment and stronger trial performance.

But the real value goes deeper than visibility.

Once certified, STARR gets to work for you. We identify community organizations within 30 miles of your site, open the door on your behalf, and provide a warm introduction — the kind of relationship-building that typically takes years. Then we track events those organizations are hosting so your team knows exactly where to show up to keep that momentum going.

Add practical, proven training tools — suicide prevention, empathy training, stigma reduction — and you have a certification that strengthens your team from the inside while expanding your reach in the community.

As for the $2,500 annual fee? Think of it as a marketing investment with a measurable return. The certification fee is tax-deductible — and for many sites, it’s coverable by pharma partners as part of a study marketing budget. What you’re funding: the infrastructure, introductions, and resources STARR builds on your behalf, year-round.

Start your pre-assessment today at thestarr.org/pre-assessment. It takes just a few minutes.

Mental Health America will hold their conference from October 8-9, 2026. The 2026 Mental Health America Conference will focus on the theme More Good Days, Together. Through this theme, the conference will explore how to make more good days possible for all by connecting people to the right support at the right time and recognizing that “good” is defined by unique mental health experiences and goals. Show your support for mental health and connect with thought leaders, innovators, and decision-makers.

The National Federation of Families 36th Annual Conference will be held October 13–15, 2026, in Orlando. The event will bring together hundreds of researchers, administrators, policymakers, clinicians, youth, family leaders, and other stakeholders working to strengthen supports for children and families affected by mental health challenges.

Site Solutions Summit will be held from October 15-18, 2026 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 provides a valuable experience.

The American Neurological Association (ANA) will hold their 151st Annual Meeting ANA2026 from October 17-20, 2026 in San Diego, CA. The Annual Meeting has been designed to foster discussions among investigators in academia, industry, and foundations toward the common goal of furthering translational science..

The CNS SUMMIT 2026 will be held November 1-4, 2026 in Boston at Encore Boston Harbor. The Summit brings together decision makers from pharma, biotech, CROs, investigator sites, technology, investors and other stakeholders.

The NEI Fall Congress, held November 5-8, 2026 in Colorado Springs, is for mental healthcare professionals dedicated to advancing their knowledge and skills. Designed for all members of the mental healthcare team to help clinicians make informed decisions by breaking down complex concepts through animation and a unique visual language exclusive to the NEI.

Neuroscience 2026 will be held November 14-18, 2026 in Washington DC. 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.

Share this one: What's it really like to join a mental health study?

Most people picture something clinical and cold. Jordan Lee's story is the opposite.

In this episode of Many Questions, Jordan, an Expert by Experience, opens up about joining the PAX-D trial after years of treatment-resistant depression. A simple Google search led him to it. What he found surprised him. He says he felt more supported during the trial than at almost any other point in his mental health care.

He doesn't sugarcoat the hard parts. The wait. The eligibility hurdles. The lack of pay. But he'd still tell anyone thinking about research to give it a go.

The conversation also digs into why patient involvement shapes what studies actually measure, the gap between research-led care and standard services, and why recruitment, not funding, is one of the biggest barriers facing the field.

It's an honest look at what participation feels like from the inside.

Watch it here: https://youtu.be/gZjel8WEGU8?si=-u-8N2HZhdUGEGRB

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.