Bruce Imbert MD, PhD

I am leading Aether’s mission to address the global opioid epidemic through dependence modulators—a novel therapeutic class that targets mu opioid receptor dysregulation. I direct clinical development strategy for ATX-1209, a first-in-class compound that attenuates opioid dependence via sustained central receptor modulation and gradual reversal of upregulated basal mu activity, while fully preserving analgesic efficacy across chronic pain, opioid use disorder (OUD), and neonatal opioid withdrawal syndrome (NOWS). Dedicated to advancing precision therapeutics that decouple analgesia from addiction liability, delivering safer treatment paradigms with transformative clinical impact.

As the founder of this strategic advisory, I leverage 20+ years of experience as a physician-executive to guide venture-backed biotech and digital health companies. My focus areas include shaping clinical development and regulatory strategy for novel neuropsychiatric, addiction, and pain therapies; navigating the FDA; helping secure funding; and optimizing pathways to key value inflection points.

Senior Leadership Team member shaping global strategy for CNS and addiction assets, including Sublocade®, Opvee®, CT-102, and alcohol-use disorder programs (GABA-B PAMs, Orexin-1 antagonists), with strategic and medical oversight of Phase I–IV trials. Directed cross-functional global teams delivering multimillion-dollar programs with strong budget governance, risk management, and portfolio alignment, while remaining hands-on in clinical protocol design, regulatory briefing preparation, and data interpretation to ensure scientific and operational excellence. Co-authored FDA submissions and led agency interactions, influencing regulatory pathways and accelerating key milestones. Led cross-disciplinary scientific and strategic due diligences across psychedelics, GLP-1 receptor agonists, orexin and mGluR5 modulators, and digital therapeutics—driving portfolio prioritization, partnership decisions, and long-term R&D strategy.

As CMO reporting to the President and Board of Directors, secured $5.3M in NIH/NIDA non- dilutive funding to advance Phase I clinical programs. Built IND readiness and directed all Phase I studies (SAD, MAD, DDI) across multiple substance use disorder indications (alcohol, cocaine, opioid, polysubstance). Led clinical and regulatory strategy and operations, authoring key filings (pre-IND, IND, Fast Track) and achieving FDA agreement on the clinical development plan. Oversaw corporate communications, investor relations (VCs, family offices), and business development, including provisional patents, global KOL advisory boards and a digital companion to enhance trial data collection.

Directed global clinical strategy and R&D for FDA-authorized Prescription Digital Therapeutics (reSET®, reSET-O®, reSETA),securing $1.2M NIH/NIDA funding and advancing programs for SUD, OUD, and AUD. Led cross-functional teams to design and execute clinical trials, analyze data, and support regulatory submissions and commercialization. Drove publications, KOL engagement, and evidence generation, integrating results into lifecycle and market-access strategy to enhance differentiation and growth.

Invited to relocate from France to Indivior US headquarters as a Clinical Science Fellow and was subsequently advanced to Medical Director and Clinical Physician Lead based on performance and expanding responsibilities. Provided clinical oversight for Phase I-III trials, contributing to two NDA submissions and one EMA approval. Shaped clinical strategy for SUD and psychiatric comorbidities, aligning with regulatory and commercial objectives. Served as sponsor medical lead and a therapeutic area expert for clinical studies, providing oversight of CRO medical monitoring while authoring and reviewing key clinical and regulatory documents. Led due diligence on 20+ in-licensing opportunities and fostered collaborations with key academics and KOLs in the US/EU to advance translational research.

Advisory Board member, KOL engagements, and consulting in the Substance Use Disorder and Mental Health Therapeutic arena. Served as a trusted advisor on Clinical Development Plans, Clinical Study Design, and Target Product Profiles, integrating scientific expertise with regulatory strategy to optimize development pathways and enhance product positioning.

Scientific Advisor and Principal Investigator for a Phase II Pilot study to evaluate the effectiveness and tolerance of methylphenidate for the treatment of cocaïne dependence.

Principal Investigator for a Phase II Pilot study to evaluate the effectiveness and tolerance of methylphenidate for the treatment of cocaïne dependence in collaboration with UMR 912 SESSTIM (INSERM-IRD-AMU)

Founded and led ACR Healthcare Consulting, providing expert guidance to pharma and biotech sectors. Collaborated with top clients including Reckitt Benckiser, Indivior, Lundbeck and Merck Serono on clinical development and communication. Achieved successful outcomes in clinical education and development projects for leading pharmaceutical companies.

I have served as a Principal Investigator or Co-Investigator on a number of clinical trials, focusing on the development of novel treatments for substance use disorders, particularly alcohol, psychostimulants (such as cocaine and amphetamines), and cannabis. My educational activities have included lecturing to medical students, Psychiatry residents, and Addiction Psychiatry residents on pharmacotherapies for addiction.

Led integrated treatment for substance use and co-occurring psychiatric disorders, incorporating methadone, buprenorphine, and targeted behavioral therapies like CBT and MBCT. Spearheaded medical research in baclofen's clinical pharmacology for alcohol dependence, guiding phase II/III studies. Collaborated closely with academic, governmental, and industry entities to advance addiction and psychiatry treatments.

Provided consultations and integrated treatment for patients with substance use disorders (alcohol, nicotine, stimulants, cannabis, and opioid use disorder, including methadone and buprenorphine maintenance treatment) and co-occurring psychiatric comorbidities (depression, bipolar disorder, ADHD, psychotic disorder, anxiety).

Therapeutic experience in Internal Medicine, Cardiology, Oncology, Pneumology, Pediatric/Adult Emergency Medicine, Primary care Medicine, Psychiatry & Addiction Medicine. Clinical Research experience.

Pharmacology of Baclofen and its clinical applications in addiction medicine.

Developed a dynamic web portal/database for sharing radiology resources using php/javascript/html/css

Studied Finances and International Business during two years at Marseille Business school (ESC Marseille/ISEFI) - Dropout