Rod Triana-Del Rio, PhD, MS,BC-MAS

-> Lead the execution of clinical trials in PTSD, anxiety, sleep disorders, and neuropsychiatric symptoms in Alzheimer’s disease, integrating scientific oversight with day-to-day operational leadership across the study lifecycle. -> Contribute to study design and document development for trials in neuropsychiatric and CNS indications, with a focus on feasibility, data quality, compliance, and executional rigor. -> Review ongoing clinical and operational data to identify emerging trends, support risk mitigation, and improve overall interpretability and quality of study conduct. -> Partner cross-functionally with site teams, monitors, data management, and vendors to ensure consistent execution across complex patient populations with psychiatric, behavioral, and cognitive symptoms.

-> Directed clinical operations across 6 multi-site psychiatry trials (N=420 total participants), coordinating 3 data analysts and 8 site coordinators while ensuring ICH-GCP compliance and delivery of decision-grade datasets for interim analyses. -> Led development of core clinical trial documents for MDD and PTSD programs, including synopses, protocols, CRFs, ICFs, monitoring plans, and CSR inputs, ensuring both scientific validity and operational feasibility. -> Established and managed safety monitoring systems for psychiatric trials, including comprehensive AE tracking, weekly C-SSRS assessments, crisis escalation workflows, and DSMB-ready safety reporting tailored to the risk profiles of MDD and PTSD populations. -> Reviewed ongoing blinded clinical and operational data to identify patient-level trends, data quality issues, and emerging study risks, supporting timely cross-functional decision-making and maintaining study interpretability. -> Coordinated cross-functionally across Clinical Operations, data science, biostatistics, and external vendors to implement wearable sensor outputs as digital endpoints, improving enrollment performance by 22% and data completeness by 18%. -> Trained sites and CRAs at investigator meetings across 6 sites, developed training materials and FAQ documentation, and maintained strong investigator relationships that supported 95%+ protocol adherence. -> Supported site execution and trial quality through close collaboration with investigators and study teams, helping maintain consistency in protocol implementation, safety processes, and endpoint collection across a multi-site neuropsychiatry portfolio. -> Contributed to execution of Phase II-III neuropsychiatric studies in MDD, PTSD, anxiety, balancing scientific rigor, patient safety, and operational delivery in complex CNS populations. -> Reviewed scientific literature to write clinical protocols for new psychiatric indications using the company's IP.

-> Led a Phase 2-scale interventional MDD program (N=200, 8 sites, $2.1M budget) evaluating biomarker-guided antidepressant treatment selection, with MADRS as the primary endpoint. -> Owned end-to-end protocol development, driving study design, endpoint strategy, regulatory positioning, and KOL advisory board setup in partnership with Clinical Operations and cross-functional stakeholders. -> Established central-only MADRS rating governance with Signant Health, including rater certification, inter-rater reliability controls, drift monitoring, and outlier surveillance, reducing site-to-site variance by 32%. -> Built a comprehensive psychiatric safety infrastructure, including Safety Monitoring Plan, AE/SAE medical review workflows, C-SSRS crisis pathways, and DSMB support, with zero safety-related protocol deviations. -> Partnered cross-functionally to deliver inspection-ready datasets and regulatory-grade safety documentation for a complex multi-site MDD study. -> Led vendor selection, contracting, and oversight for central rating, eCOA, and safety database providers across 8 sites, achieving 100% on-time deliverable completion over 18 months. -> Designed composite digital endpoints integrating wearable outputs with clinical scales, improving treatment response detection by 25% for an FDA 510(k)-targeted clinical decision support platform. -> Directed a biomarker-informed precision psychiatry strategy combining EEG digital phenotyping, pharmacogenomics, inflammatory biomarkers, and clinical data to support patient stratification and antidepressant selection in MDD. -> Contributed to DEI enrollment strategies, achieving 40% underrepresented minority enrollment, and supported publications on digital biomarker validation in diverse MDD populations. -> Supported broader clinical development through regulatory preparation, investor materials, KOL engagement, and clinical site partnership discussions.

-> Coordinated translational pathways from preclinical target biology to biomarker plans for first-in-human studies, establishing frameworks bridging animal model endpoints to clinical measurement strategies -> Collaborated with discovery neuroscience teams conducting preclinical MOA studies evaluating synaptic transmission, neural circuit function, and behavioral pharmacology -> Led protocol development and execution across 4 CNS programs, including PTSD and anxiety, managing $1.2M in funding and coordinating cross-functional analytical teams. -> Built translational biomarker and measurement strategies linking preclinical biology to clinically relevant hypotheses and first-in-human plans across neuropsychiatric programs. -> Supported 2 IND submissions and 3 annual reports with multi-function interactions, ensuring scientific quality and regulatory compliance. -> Drove collaborative CNS research across PTSD, anxiety, autism, and Alzheimer’s disease, including multimodal biomarker strategies using fluid markers, genotyping, digital cognition, and sleep signals. -> Secured $380K in grant funding, authored protocols, contributed to 8 international presentations, and implemented DEI recruitment strategies that increased minority enrollment by 35%.

-> Advisors: Dr. Joseph LeDoux and Dr. Christopher K. Cain. -> Developed a fundamental research program to study the neuromodulation of endogenous cannabinoids over neural plastic circuits that promote proactive coping during the recall of aversive memories. -> Initiated collaborative leverage of experimental and technological strategies to study neuronal circuits that underlie fear and anxiety, involving 11 laboratories in 4 different research centers, as well as a clinical collaboration to translate those findings into clinical therapies. -> Application of the knowledge of plastic emotional circuits to make a translational link to treat fear, anxiety, and symptoms of anorexia nervosa. -> Successfully obtained direct and indirect funding from different stakeholders. -> Co-organizer and Co-chair of an international virtual symposium in neuroscience (Leon levy Symposium 2021) -> Mentored 5-6 collaborators in experimental technologies.

-> Neuroscience Teaching Assistant in the course “Brain & Behavior” for undergraduate students, both pre-medical and non-premedical, non-scientific majors.

-> Conducted preclinical MOA neuroscience research in PTSD and Major Depressive Disorder, designing and executing rodent studies on behavioral pharmacology, neural circuit function, and mechanism-of-action endpoints. -> Translated preclinical findings into clinically relevant insights to support drug development strategy, therapeutic positioning, and translational research planning. -> Engaged with KOLs, clinical researchers, academic collaborators, and pharmaceutical partners through scientific presentations, advisory boards, investigator meetings, and peer-to-peer exchange. -> Supported broader scientific and medical strategy through literature surveillance, scientific materials development, data communication, and cross-functional collaboration across discovery biology, translational medicine, and clinical development.

-> Supported global multi-site clinical operations across 12 sites in Europe and the US, coordinating site activation timelines and cross-border regulatory activities across Switzerland, France, Germany, and the United States. -> Led biomarker strategy for the Dipraglurant (mGluR5 NAM) program, defining quantitative EEG endpoints, operational requirements, and quality standards that informed protocol design and regulatory discussions with Swissmedic and FDA. -> Authored biomarker protocol sections and operational plans aligned with ICH-GCP across 2 clinical programs, managing cross-functional timelines with Clinical Development, Data Management, Biostatistics, Clinical Operations, and external neuroimaging partners. -> Established standardized qEEG and neurophysiological data collection procedures across sites, trained site personnel on specialized assessments, and maintained quality oversight during study conduct. -> Collaborated with international investigators across 12 sites, supported clinical study reports, and drafted responses to competent authority questions across multiple regulatory jurisdictions. -> Contributed to translational and clinical development strategy in Fragile X syndrome, epilepsy, anxiety programs, helping bridge mechanism-based biomarker plans to clinically feasible study execution.

-> Supported an international translational biomarker research program in CNS and rare diseases, focused on neurodegeneration and clinically relevant biomarker development. -> Connected disease biology, biomarker discovery, and translational planning to support future target validation and clinical development opportunities. -> Secured grant funding for Alzheimer’s disease-related biomarker research and managed project execution across scientific and collaborative workstreams. -> Delivered scientific presentations at international meetings and supported disease-state communication in anxiety and Alzheimer’s disease for academic and clinical audiences. -> Established collaborative research networks and contributed to the translational foundation underlying future CNS and neuropsychiatric development programs.

-> Supported early-phase program design for neuropsychiatric assets relevant to AMPA-dependent synaptic plasticity and GABA-A modulation, contributing to biomarker selection, feasibility assessments, and eCRF specifications for programs under evaluation for Phase 2 advancement. -> Contributed to translational research activities across 3 neuroscience portfolio programs, including Balovaptan (V1a antagonist) and mGluR5-related programs, supporting biomarker integration strategies and clinical endpoint discussions with Clinical Development partners. -> Helped translate mechanism-of-action data and human biology insights into clinically relevant target engagement, patient stratification, and measurement strategies to support first-in-human through early proof-of-concept planning. -> Coordinated with Clinical Operations, Biostatistics, Data Science, and Regulatory Affairs across 6 drug lifecycle management meetings, supporting IND package development and broader clinical readiness assessments for the neuroscience pipeline. -> Contributed to cross-functional evaluation of glutamatergic plasticity-related and GABAergic approaches in neuropsychiatry, helping align translational biomarker plans with portfolio decision-making and development milestones.

-> Therapeutic area: Neuroscience | Neuropsychiatric disorders(PTSD, Major Depression) | Neurodevelopmental -> Advisor: Larry Young -> Performed fundamental research in neuroscience studying oxytocin regulation of affiliative behaviors (pair bonding) and their relationship with the immune system.

Learned competent clinical researcher topics through a unique educational experience of theoretical and practical approaches, consisting of clinical trial methodology, clinical data interpretation, medical writing, epidemiology and biostatistics, PK/PD analysis, FDA and IRB regulatory processes, as well as evidence-based healthcare.

Advisor: Ron Stoop I studied the neuromodulation of the neural circuits that underly fear and anxiety using oxytocin

Advisor: Genaro A Coria-Avila. I performed fundamental research about the neuromodulation exerted by dopamine and oxytocin to regulate socio-sexual behaviors in male rats.