Psychiatry has long been considered one of the most complex and least understood areas of medicine. While other therapeutic fields have advanced rapidly with clear biomarkers and objective endpoints, mental health has remained rooted in subjective assessments and decades-old treatment approaches.


In this episode, Brandon Li speaks with Ken Kramer, PhD, Vice President and Head of Neuropsychiatry Medical Affairs at Bristol Myers Squibb, about why psychiatry has historically lagged behind and why the field is now entering a new phase of innovation.


Kramer explains how schizophrenia treatment has relied on dopamine receptor-blocking antipsychotics for over 70 years, often forcing patients to trade symptom relief for serious tolerability and safety challenges. He walks through how a new class of treatments, targeting muscarinic acetylcholine receptors, represents a fundamentally different approach, one that may reduce these trade-offs while addressing a broader range of symptoms.


The conversation also explores the structural challenges that have made psychiatric drug development so difficult, from subjective clinical endpoints and high placebo responses to the lack of reliable biomarkers. These barriers pushed many large pharmaceutical companies out of psychiatry for decades.


Now, that trend is reversing. With better scientific understanding, improved trial design, and new mechanisms of action, pharma is re-entering the space with renewed confidence.


Brandon and Ken also discuss the real-world challenges of launching novel treatments, including clinical inertia, physician adoption, and the importance of medical affairs in bridging the gap between approval and actual patient impact.


This episode covers where psychiatry has been, what’s changing, and what it will take to deliver better outcomes for patients living with serious mental illness. 


What You’ll Learn:

• Why psychiatry has lagged behind other therapeutic areas in innovation
• How dopamine-based antipsychotics shaped schizophrenia treatment for decades
• The trade-offs patients face with current standard-of-care therapies
• How muscarinic receptor-targeting drugs offer a new approach
• Why psychiatric clinical trials are uniquely difficult to design and execute
• How subjective endpoints and placebo effects impact drug development
• Why pharma companies exited psychiatry and why they’re returning now
• The role of medical affairs in driving the adoption of new treatments
• How clinical inertia affects real-world patient outcomes
  
  

About the Guest:

Ken Kramer has a PhD and Vice President and Head of Neuropsychiatry Medical Affairs at Bristol Myers Squibb. He has spent his entire career focused on psychiatry and neuroscience, with a deep commitment to advancing treatment options for serious mental illness and addressing the stigma associated with these conditions. At BMS, he leads efforts to translate scientific innovation into real-world patient impact across neuropsychiatric disorders.



Episode Resources:

• Ken Kramer on LinkedIn
• Brandon Li on LinkedIn
• Bristol Myers Squibb Website
  
  

Power to the Patients is handcrafted by our friends over at: fame.so

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Kidney disease affects 37 million people and is now the ninth leading cause of death globally. Yet despite its scale and severity, it has largely been absent from the precision medicine revolution that reshaped oncology.


In this episode of Power to the Patients, Jason Coloma, CEO of Maze Therapeutics, explains how his team is applying genetics-driven precision medicine to kidney disease by moving beyond statistical associations to true mechanistic understanding.


Jason describes the limits of genome-wide association studies when they stop at correlation, and why understanding the functional impact of specific gene variants is essential for successful drug discovery. At Maze, this approach led to uncovering the pathogenic mechanism behind APOL1-mediated kidney disease, a condition that disproportionately affects Black communities, presents earlier in life, progresses more aggressively, and does not respond to current standard therapies.


Finally, Jason addresses the current state of AI in biotech, where natural language processing and structure-prediction tools accelerate workflows but do not replace cryo-EM, x-ray crystallography, or experienced drug hunters.


What You’ll Learn:

• 
  Why most genetic associations fail to translate into medicines
• How variant functionalization enables mechanism-driven drug discovery
• The biological mechanism behind APOL1-mediated kidney disease
• Why dialysis outcomes highlight the urgency for disease-modifying therapies
• How to identify which diseases are suitable for genetics-driven platforms
• The operational infrastructure required to implement precision nephrology
• Where AI meaningfully improves drug discovery workflows and where it does not
  
  

About the Guest:
Jason Coloma is Chief Executive Officer of Maze Therapeutics, where he leads the company’s mission to transform drug discovery through genetics-driven precision medicine. A trained scientist with deep experience in drug discovery, Jason previously held leadership roles at Genentech and Roche, including Head of Business Development focused on oncology and research technology platforms.


He later served as a venture partner at Third Rock Ventures, where he worked on early-stage biotech formation before building Maze Therapeutics. Under his leadership, Maze has developed a platform centered on variant functionalization to generate mechanism-based therapies for genetically defined diseases.



Episode Resources:

• Jason Coloma on LinkedIn
• Brandon Li on LinkedIn

Power to the Patients is handcrafted by our friends over at: fame.so

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In this episode of Power to the Patients, Brandon Li speaks with Dr. Ken Sharlin, a neurologist and principal investigator with decades of experience across clinical practice, functional medicine, and clinical research. Dr. Sharlin shares his journey from traditional academic neurology to a systems-based, precision medicine approach that focuses on restoring homeostasis rather than treating diagnoses in isolation.


The conversation explores why lifestyle, environment, and behavioral change play a central role in neurodegenerative disease and how advances in biomarkers, prognostics, and AI-driven diagnostics are transforming how clinicians understand and manage conditions like multiple sclerosis, Alzheimer’s disease, and Parkinson’s. Dr. Sharlin explains how tools such as blood-based biomarkers, disease activity scores, and predictive testing can help tailor therapies to the individual rather than relying on trial-and-error prescribing.


Brandon and Dr. Sharlin also dive into the realities of running clinical trials in a crowded therapeutic landscape, the challenges of patient recruitment when effective treatments already exist, and why sponsors must rethink timelines, communication, and study design. 

What You'll Learn:- Why most neurodegenerative diseases are driven by lifestyle and environmental factors - not just genetics


- How restoring biological homeostasis can lead to symptom improvement and potential disease reversal


- The difference between diagnostic, prognostic, and predictive biomarkers and why all three matter


- How precision medicine is changing treatment selection in multiple sclerosis and beyond


- Why behavioral change is foundational to functional and integrative neurology


- The role of emerging technologies like neuromodulation, photobiomodulation, sound, and electromagnetic therapies


- What sponsors often underestimate when designing and launching clinical trials


- Why patient recruitment is becoming harder in MS despite therapeutic advances


- How AI and biomarker-driven tools can accelerate drug development and trial execution


- Dr. Sharlin’s vision for the next 10 years of neurological care and research


About the Guest:
Dr. Ken Sharlin is a board-certified neurologist, clinical researcher, and leader in neurological disease reversal. With over 25 years of experience, his peer-reviewed research shows that cognitive decline and early Alzheimer’s disease can be improved and in some cases reversed through personalized, systems-based care.


He integrates conventional neurology, precision medicine, functional medicine, and regenerative therapies to treat conditions including Alzheimer’s, multiple sclerosis, Parkinson’s disease, ALS, epilepsy, and chronic migraine. Dr. Sharlin is the founder of the Sharlin Health Neuroscience Research Center, where he leads Phase II–IV clinical trials for next-generation neurotherapeutics, and the creator of the Brain Tune Up! Protocol.


His work focuses on improving brain health, resilience, and quality of life by addressing neurological disease at its root causes.

Power to the Patients is handcrafted by our friends over at: fame.so

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Psychiatric drug development may be overcomplicating progress while overlooking effective treatments. Brandon Li speaks with Dr. Jacob Jacobsen, neuroscientist and CEO of Evecxia Therapeutics, about why clinical outcomes should matter more than novel mechanisms.


Jacobsen argues that the field’s fixation on discovering entirely new mechanisms has distracted from the real goal: delivering treatments that produce better clinical outcomes for patients. Drawing on decades of human clinical data, he explains how serotonin synthesis amplification builds on well-established biology to enhance the effectiveness of existing antidepressant approaches, rather than replacing them.


The conversation explores why oral, scalable treatments are essential for addressing the massive unmet need in treatment-resistant depression, especially when costly clinic-based therapies reach only a fraction of patients. Jacobsen also breaks down why OCD presents a smarter initial indication for development, with lower placebo response rates, better patient selection, and a clear regulatory gap for next-line therapies.


Brandon and Dr. Jacobsen take a candid look at the structural failures in psychiatric research, including the continued reliance on animal behavioral models that have repeatedly failed to predict human outcomes. Instead,Dr. Jacobsen advocates for a return to human biology, biomarker research, and clinically grounded trial design, approaches that prioritize real-world impact over theoretical elegance.

What You'll Learn:- Why clinical novelty matters more than mechanistic novelty in psychiatric drug development


- How serotonin synthesis amplification can improve outcomes beyond traditional SSRIs


- The scalability advantages of oral treatments compared to clinic-based therapies like ketamine


- Why OCD is a strategically stronger indication than depression for early clinical development


- How placebo response rates distort psychiatric trial outcomes and how to reduce them


- Why animal models have repeatedly failed psychiatry and continue to slow innovation


- The importance of prioritizing human biology, biomarkers, and real-world clinical data


- How smarter trial design can reduce risk while increasing the likelihood of meaningful results

About the Guest:
Dr. Jacob Jacobsen is a neuroscientist, inventor, and CEO of Evecxia Therapeutics. He is the originator of the serotonin synthesis amplification pharmacological concept and has led seminal cross-disciplinary research in this area. Prior to Evecxia, Jacobsen held research positions at Duke University and Duke–National University of Singapore and spent eight years in pharma-biotech at NeuroSearch and Lundbeck, working on drug discovery and target validation.
Dr. Jacobsen is widely published in leading psychiatry journals, is an inventor on multiple issued and pending patents, and holds a PhD in Neuropharmacology from the University of Copenhagen.


Episode Resources:

• Jacob Jacobsen on LinkedIn 
• Brandon Li on LinkedIn
• Company Website:
  • Evecxia 

Power to the Patients is handcrafted by our friends over at: fame.so

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In this episode of Power to the Patients, Brandon Li speaks with Dr. Lara Shirikjian, board-certified psychiatrist and Medical Director at CenExel, about what it truly takes to build effective, ethical, and scalable psychiatric research programs.


Drawing on over 20 years of clinical and research experience, Dr. Shirikjian shares how operational rigor, deep protocol understanding, consistent site execution, and proactive communication directly impacts study quality, placebo response, and patient retention. She explains why schizophrenia trials, in particular, demand thoughtful wraparound support, strong community provider relationships, and clear boundaries between therapeutic care and research participation.


The conversation also explores the often-overlooked operational realities sponsors face, from protocol complexity to CRO bottlenecks, and why direct PI-to-sponsor communication can dramatically accelerate problem-solving. Throughout the episode, Dr. Shirikjian emphasizes that while technology and innovation matter, human judgment, site culture, and ethical responsibility remain irreplaceable in psychiatric research.

What You'll Learn:- Why operational consistency plays a critical role in minimizing placebo response in psychiatric trials


- How a protocol-first mindset reduces complexity and improves study execution


- Why direct communication between sponsors and principal investigators speeds up issue resolution


- How wraparound services improve retention in schizophrenia research without compromising study integrity


- The importance of planning for post-study patient restabilization before enrollment begins


- How research sites can build trust with community providers and unlock sustainable referral networks


- Why human judgment and site leadership remain essential despite advances in technology and AI


- What sponsors often underestimate about running high-quality psychiatry and CNS trials


About the Guest:
Dr. Lara Shirikjian is a board-certified adult psychiatrist with over two decades of clinical and research experience specializing in schizophrenia, postpartum depression, mood and anxiety disorders, trauma-related conditions, and women’s mental health. She currently serves as Medical Director and Principal Investigator at CenExel CNS / Collaborative Neuroscience Research, where she leads Phase I–IV clinical trials in partnership with global pharmaceutical sponsors.

Dr. Shirikjian has contributed to pivotal research on treatments such as zuranolone for postpartum depression and maintains an active private psychiatry practice. She also serves as Volunteer Clinical Faculty at Harbor UCLA Medical Center, mentoring psychiatry residents and supporting academic training.


Episode Resources:

• Lara Shirikjian on LinkedIn 
• Brandon Li on LinkedIn
• Company Website:
  • CenExel

Power to the Patients is handcrafted by our friends over at: fame.so

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In this episode of Power to the Patients, host Brandon Li speaks with Sonia Prashar, Founder and CEO of AIM Trials, about the future of psychiatry research and why patient-centric innovation is no longer optional. Drawing on more than 18 years of clinical research experience across multiple therapeutic areas, Sonia explains how hybrid and decentralized trial designs are expanding access to underserved communities, improving retention, and generating cleaner, more representative data.
Sonia also opens up about her own journey through postpartum depression and cultural stigma, revealing how her lived experience pushed her to build research models that treat patients as people first, not data points. 


What You'll Learn:- How hybrid and decentralized trial designs reduce patient burden while improving retention and data quality


- Why patient experience and psychological safety are essential to accurate psychiatry data collection


- How lived experience - including postpartum depression and stigma can fuel meaningful research innovation


- Why rural and underserved populations are critical to building diverse and representative study cohorts


- The operational challenges sponsors often overlook when designing protocols


- How AI tools and telehealth can enhance research without replacing human connection


- The role of informed consent conversations in managing placebo response and encouraging honest reporting


- Why failures and setbacks often teach site leaders more than their biggest wins


About the Guest:
Sonia Prashar is the Founder and CEO of AIM Trials, a leading clinical research site specializing in mental health studies across pediatric, adult, and geriatric populations. With more than 18 years of experience spanning drug and medical device research, Sonia has built a reputation for advancing patient-centered, hybrid, and decentralized trial models that expand access, improve retention, and generate more representative data. Her work integrates clinical research, regulatory excellence, and innovative technologies to modernize psychiatry research while reducing patient burden and stigma. 

Power to the Patients is handcrafted by our friends over at: fame.so

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What if the most effective way to treat some of the most devastating brain disorders isn’t by targeting symptoms in isolation, but by repairing the brain’s most fundamental unit of communication itself?

In this episode of Power to the Patients, host Brandon Li sits down with Dr. Craig Erickson, Research Director and Research Endowed Professor at Cincinnati Children’s and Chief Medical Advisor at Spinogenix, to explore how synaptic dysfunction serves as a unifying biological thread across conditions as diverse as Fragile X Syndrome, autism, schizophrenia, ALS, and Alzheimer’s disease.


Dr. Erickson shares how decades of failed large-scale neuroscience trials led him to rethink the drug development playbook - shifting from subjective clinical scales to objective, quantitative biomarkers like EEG and computer-based cognitive testing. Through his work with Spinogenix, he explains how early-phase trials can now detect true brain target engagement in small patient populations, dramatically reducing placebo effects, timelines, and patient burden.


The conversation dives deep into breakthrough Fragile X data, where a single dose of a synapse-targeting therapy normalized pathological brain activity - an effect stronger than anything previously observed in early trials. Dr. Erickson also unpacks why restoring synaptic connectivity can unlock functional gains that truly matter to patients and families, from reduced anxiety to greater independence and improved quality of life.

Whether you're a patient, caregiver, clinician, or investor seeking to understand the future of brain-targeted medicine, this conversation reveals how precision neuroscience is delivering hope where traditional approaches have failed.
What You'll Learn:- Why synaptic dysfunction is a common biological endpoint across neurodevelopmental, neurodegenerative, and psychiatric disorders, despite vastly different underlying causes


- How objective biomarkers like EEG and computer-based testing can derisk early-phase clinical trials and outperform subjective symptom scales


- Why a single-dose normalization of gamma band activity in Fragile X represents one of the strongest early target engagement signals ever observed


- How patient stratification and biological enrichment dramatically improve signal detection in heterogeneous conditions like Fragile X and autism


- The difference between using biomarkers for trial derisking and inclusion criteria versus FDA-approvable endpoints and why that distinction matters


- How Spinogenix’s platform uniquely restores synaptic spine morphology, not just neurotransmitter signaling, enabling neurons to regain mature connections


- Why smaller, faster, highly quantitative trials may be the future of neuroscience drug development


- What patients, caregivers, and clinicians should watch for next as synapse-restoring therapies move into chronic dosing and later-stage studies



About the Guest:
Dr. Craig Erickson is a Research Director and Research Endowed Professor at Cincinnati Children’s and Chief Medical Advisor at Spinogenix. For more than 20 years, he has led translational research in neurodevelopmental disorders, focusing on early detection of brain target engagement and patient-specific treatment response in human drug trials. Dr. Erickson holds multiple investigator-initiated INDs, is an inventor on several therapeutic patents, and has received extensive support from the NIH, CDC, U.S. Department of Defense, foundations, and global biotechnology partners.






Episode Resources:

• Dr. Craig Erickson on LinkedIn
• Brandon Li on LinkedIn
• Company Website:
  • Spinogenix

Power to the Patients is handcrafted by our friends over at: fame.so

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A groundbreaking approach to treating schizophrenia emerges through innovative drug development that addresses both efficacy and safety concerns in long-term treatment.
In this episode of Power to the Patients, host Brandon Li speaks with Dr. Laxminarayan Bhat, founder and CEO of Reviva Pharmaceuticals, about their revolutionary approach to developing new treatments for schizophrenia, focusing on their lead compound bileroxazine and its promising clinical trial results.
What You'll Learn:- Why current schizophrenia treatments fall short and how next-generation drugs can better serve patients' lifelong needs
- How rational drug design led to a breakthrough in addressing both serotonin-dopamine signaling and neuroinflammation
- The significance of achieving a 35% discontinuation rate compared to 60-70% with current treatments
- Why targeting multiple symptom domains (positive, negative, and cognitive) is crucial for effective schizophrenia treatment
- How improved drug absorption and metabolism profiles can enhance long-term treatment success
- The role of biomarkers and digital tools in advancing precision psychiatry for schizophrenia
- Why balancing commercial viability with precision medicine remains a key challenge in psychiatric drug development
- How addressing off-target effects can significantly improve drug safety and efficacy profiles


About the Guest:
Dr. Laxminarayan Bhat is the Founder and CEO of Reviva Pharmaceuticals, a pioneering pharmaceutical company focused on developing innovative treatments for psychiatric disorders. With over 25 years of experience in drug discovery and development, Dr. Bhat is a distinguished translational scientist with a PhD in medicinal chemistry and holds over 80 granted patents. He is the inventor of bileroxazine, a breakthrough treatment for schizophrenia that has shown promising results in clinical trials, treating over 1,000 patients with improved efficacy and reduced side effects compared to existing treatments. Under his leadership, Reviva has raised $150 million in funding and developed a novel approach to addressing both the core symptoms of schizophrenia and associated neuroinflammation. His work represents a significant advancement in psychiatric medicine, particularly in developing treatments that offer better patient adherence and reduced discontinuation rates compared to current standards of care.


Episode Resources:

• Dr. Laxminarayan Bhat on LinkedIn
• Brandon Li on LinkedIn
• Company Website:
  • Reviva Pharmaceuticals

Power to the Patients is handcrafted by our friends over at: fame.so

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What if treating Alzheimer’s, Parkinson’s, and other neurodegenerative diseases requires rethinking the problem entirely - not removing plaques or correcting neurotransmitter deficits, but reactivating the brain’s built-in ability to focus, remember, and repair itself?


In this episode of Power to the Patients, host Brandon Li sits down with Dr. Gabriel Vargas, Chief Medical Officer at CuraSen Therapeutics, to explore how adrenergic system modulators could offer both symptomatic relief and potential disease-modifying effects for neurodegenerative and psychiatric conditions - challenging the dominance of amyloid-focused approaches in Alzheimer's research.


So, whether you're navigating a neurodegenerative diagnosis, curious about innovative drug development, or wondering why current treatments fall short, this conversation is packed with cutting-edge science and hard-won clinical insights. 


What You'll Learn:- How translational medicine bridges preclinical science and human trials and why it’s essential for determining real-world therapeutic viability


- Why the adrenergic system may unlock both symptomatic improvement and long-term disease-modifying potential for neurodegenerative disorders


- How pairing beta-2 agonists with peripheral beta-blockers enables brain-selective targeting while reducing systemic side effects


- Why direct agonist therapies may succeed where SSRIs and amyloid-focused drugs fall short, especially in severe neurodegenerative states


- The clinical difference between symptomatic relief and true disease modification, and why both matter to patients and caregivers


- How PTRS (Probability of Technical & Regulatory Success) guides strategic decisions, regulatory alignment, and investment in new drug development


About the Guest:
Dr. Gabriel Vargas is Chief Medical Officer at CuraSen Therapeutics and a physician-scientist with over 20 years of experience in early-stage drug development, with particular expertise in neurology and psychiatry. Holding an MD/PhD from UC Irvine, Dr. Vargas has led translational medicine initiatives at industry leaders including Hoffmann-La Roche and Amgen, where he spearheaded the development of Erenumab for migraine - a breakthrough therapy approved by the FDA in 2018. 



Episode Resources:

• Dr. Gabriel Vargas on LinkedIn
• Brandon Li on LinkedIn
• Company Website:
  • CuraSen Therapeutics 

Power to the Patients is handcrafted by our friends over at: fame.so

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In this episode, host Brandon Li speaks with Cuong Do, CEO of BioVie, to explore the intersection of inflammation and neurodegenerative diseases. Drawing from his remarkable journey from Vietnam to McKinsey to biotech entrepreneurship, Do shares insights on drug development, clinical trials, and the future of CNS therapeutics.
What You'll Learn:- Why inflammation may be the hidden link between Alzheimer's, Parkinson's, and Long COVID
- How to design effective clinical trials by minimizing variability and selecting objective endpoints
- The critical advantage of small molecules that can cross the blood-brain barrier
- Why the amyloid hypothesis dominated Alzheimer's research and what we've learned since
- How biotech funding challenges are creating a pipeline problem for future drug development
- The "What Does Success Look Like" framework for maintaining focus on transformative outcomes in drug development
- Why continuous infusion delivery systems can improve safety profiles of existing drugs
- How to evaluate and acquire promising biotech assets through scientific due diligence
- Why Parkinson's trials can be more cost-effective than Alzheimer's studies
- The emerging technologies reshaping CNS drug development, from BBB crossing to personalized oncology
About the Guest:
Cuong Do is the CEO of BioVie, a clinical-stage biopharmaceutical company developing innovative therapies for neurological and inflammatory conditions. With over 17 years as a Senior Partner at McKinsey & Company and executive roles at Samsung, Lenovo, and Merck, he brings extensive leadership experience across healthcare and technology sectors. His journey from conducting medical research at the age of 14 to founding multiple successful biotechnology companies showcases his deep commitment to advancing medical science.


Episode Resources:

• Cuong Do on LinkedIn
• Brandon Li on LinkedIn
• Company Website:
  • BioVie

Power to the Patients is handcrafted by our friends over at: fame.so

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