Episodit
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In this episode, Ayesha spoke with Sarah Averill Lott, MPH, CPH, Research Lead at Digital Medicine Society (DiMe) and Diane Stephenson, PhD, Executive Director at the Critical Path for Parkinson (CPP) at the Critical Path Institute.
DiMe is a global non-profit and a professional home for digital medicine that aims to drive the broad adoption of digital approaches to advance medicine and public health. DiMe convened a working group to identify barriers to greater utilization of digital measures in Alzheimer's research and subsequently developed resources to help researchers and clinicians more quickly adopt digital measures in this area.
Sarah Averill Lott is a program lead at DiMe where she supports programs and resources that promote the safe, effective and equitable use of digital health technologies to advance clinical research and improve outcomes for patients. She has degrees in neuroscience and public health.
Diane Stephenson is a neuroscientist by training with 35 years combined experience in academic neuroscience and drug discovery. Dr Stephenson joined Critical Path Institute in 2011 and presently leads the Neurology programs centered around Critical Path for Parkinson’s (CPP) and Critical Path for Alzheimer’s Disease (CPAD), with the goal of accelerating drug development tools for neurodegenerative diseases. Dr. Stephenson received her PhD in Medical Neurobiology from Indiana University.
Tune into the episode to hear about the adoption of digital measures in Alzheimer’s research and care, including the collaboration between DiMe and the Critical Path Institute.
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In this episode, Ayesha spoke with Amit Etkin, Founder, President and CEO of Alto Neuroscience, a company developing precision treatments for neuropsychiatric conditions.
Alto Neuroscience is focused on designing candidates that target core brain processes in patient populations not adequately treated by currently available medications. Alto is currently pursuing candidates in major depressive disorder (MDD), bipolar depression and schizophrenia.
Mental health disorders are a leading cause of disability globally. In the US alone, 1 in 5 people are living with a mental health disorder, with an estimated $280 billion spent on mental health services in the country in 2020. Despite significant need, the current standard of care consists of treatments that are ineffective for many patients.
Dr. Amit Etkin founded Alto in 2019 and is the president, CEO and serves as chair of the company’s board of directors. Prior to founding Alto, Dr. Etkin was a tenured professor of psychiatry and behavioral sciences at Stanford University, where he held multiple leading roles.
His research contributions during his tenure at Stanford led to Dr. Etkin being awarded the National Institutes of Health (NIH) Director’s Pioneer Award, the most competitive and prestigious NIH grant, and the first in history to be awarded in clinical psychiatry. He also received an Entrepreneur of the Year (EY) award.
Tune into the episode to hear from Dr. Etkin about innovations in treatments for neuropsychiatric disorders at Alto Neuroscience.
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In this episode, Vera spoke with Dr. Robert Den, Chief Medical Officer (CMO) of Alpha Tau Medical, a company developing cancer treatment with its highly potent alpha radiation technology.
Dr. Den shared his journey to becoming CMO at Alpha Tau Medical and discussed the company’s mission to bring innovative cancer therapies to patients worldwide.
Learn how Alpha Tau’s technology differs from traditional radiation therapies, the types of cancers it has shown promise in treating and the impact this novel, investigational approach could have on patient care.
With his expertise in radiation oncology and his role as an Associate Professor and Clinical Practitioner at Jefferson University, Dr. Den also provided insights into the challenges in the field and shared his vision for the future of cancer treatment.
Don’t miss this episode to hear about Alpha Tau Medical’s recent advancements and Dr. Den’s advice for aspiring leaders in the biotech and medical industries.
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In this episode, Ayesha spoke with Judy Chou, PhD, CEO, President and Board member of AltruBio, a company developing first-in-class immunomodulators to target diseases of the immune system.
AltruBio’s pipeline includes compounds being investigated for indications such as ulcerative colitis, psoriatic arthritis and acute graft vs. host disease.
Prior to joining AltruBio, Dr. Chou headed the global Biotech organization at Bayer Pharmaceuticals overseeing the development, manufacturing and distribution of Bayer’s biotechnology pipeline, product portfolio & more than 2,000 employees.
Before Bayer, Dr. Chou held various leadership roles at biopharmaceutical companies such as Pfizer/Medivation, Tanvex Biopharma, Genentech, Pfizer (Wyeth) and AbbVie (Abbott).
Dr. Chou has extensive experience in biologics development with multiple filings of BLAs, NDAs and INDs of novel products. She is well recognized by the biomedical industry for her leadership and received the Most Influential Women in Business Award in 2018 by San Francisco Business Times.
Currently, Dr. Chou also serves as the Board of Directors of Akero Therapeutics, the California Institute of Regenerative Medicines (CIRM); and the Advisory Board members of UC Berkeley Engineering School and Silicon Valley Women in Engineering. Before joining the industry, Dr. Chou was a research faculty member at Harvard University Medical School.
Dr. Chou obtained her PhD from Yale University and completed her post-doctoral training at Max-Planck Institute in Germany.
Tune into the episode to learn about AltruBio’s innovative solutions targeting diseases of inflammation.
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In this episode, Ayesha spoke with Jonathan Rigby, MBA, CEO of Sernova, a Canadian biotech company developing innovative cell therapy-based approaches for the management of type 1 diabetes.
The company’s lead innovation is an implantable bio-hybrid organ pouch, which is currently in an ongoing Phase I/II clinical trial.
An estimated 537 million people are currently living with diabetes globally and this number is projected to reach 643 million by 2030, making it a pressing health issue in need of new, effective solutions.
Jonathan has held leaderships positions at several biopharmaceutical companies over his career. Prior to heading Sernova as its CEO, Jonathan served as President and CEO of Revolo Biotherapeutics where he took the company through multiple financings and two Phase II clinical trials. He also served as Chairman and Chief Business Officer of BIOS Acquisition Corporation, with an oversold IPO.
He also currently serves on the Board of Directors of cancer therapy company Oncolytics Biotech Inc. and IM Therapeutics, which is developing therapies for type 1 diabetes.
Tune into the episode to learn about Sernovo’s innovative cell-based approaches for the development of type 1 diabetes treatments.
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In this episode, Ayesha had a conversation with Lewis Bender, MBA, Founder, Chairman and CEO of Intensity Therapeutics, a biotech company developing first-in-class immune-based intratumorally injected cancer therapies.
Intensity’s lead product candidate, INT230-6, is currently in human clinical studies for the treatment of refractory solid tumors, including metastatic soft tissue sarcoma and breast cancer.
Lewis Bender has almost three decades (28 years) of biopharmaceutical leadership experience and has helped take innovative new products from discovery through to product approval.
Lewis has held various leadership roles at biopharmaceutical companies including Interleukin Genetics and Emisphere Technologies. During his career, Lewis has partnered with several major pharmaceutical and biotech companies, with success raising capital from institutional investors through multiple types of transactions.
Tune into the episode, to hear more about the work Lewis is heading at Intensity Therapeutics to bring innovative, targeted intratumoral cancer therapies to patients.
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In this episode, Ayesha spoke with John Yu, MD, CEO of Kairos Pharma, a company advancing therapies to overcome challenges in cancer drug resistance and immune suppression.
Kairos is developing therapeutics that reverse cancer drug resistance in cancers such as prostate and lung cancer. The company’s lead candidate, ENV105, is an antibody targeting CD105, which is implicated in cancer cell resistance to various treatments. By inhibiting CD105, ENV105 seeks to restore the effectiveness of standard therapies across multiple cancer types.
Dr. Yu is also Professor and Clinical Chief of Neurosurgery, Director of the Brain Tumor Center at Cedars Sinai Medical Center.
He has developed numerous immunotherapies and nanotechnologies from his National Institutes of Health (NIH) funded laboratory. This includes eight new investigational drugs with the US Food and Drug Administration. Dr. Yu has also led numerous clinical trials.
Dr. Yu served in leadership roles at several biotechs, including ImmunoCellular Therapeutics and most recently served as CEO and Chairman of AcTcell and Director of Enviro Therapeutics.
Dr. Yu has an MD from Harvard Medical School and MIT, and completed an Immunology Fellowship at the Institut Pasteur, Paris.
Tune into the episode, to hear more about the work Dr. Yu is leading at Kairos Pharma to address cancer drug resistance.
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In this episode, Ayesha spoke with Thomas Heineman, MD, PhD, Chief Medical Officer at Oncolytics Biotech, a company developing an oncolytic virus cancer therapeutic that is currently in clinical trials for indications including metastatic breast cancer and pancreatic cancer.
Oncolytics is developing a first-in-class, nonpathogenic oncolytic virus administered intravenously that activates, recruits and trains immune cells to identify and destroy cancer cells. Simultaneously, it remodels the tumor microenvironment, improving immune cell infiltration and access.
Prior to joining Oncolytics, Dr. Heineman held leadership roles at Denovo Biopharma, Genocea Biosciences and Halozyme Therapeutics.
Dr. Heineman’s experience extends to big pharma and academia, as he previously worked as Senior Director, Global Clinical Research and Development at GlaxoSmithKline and as an Associate Professor at the Saint Louis University School of Medicine. Dr. Heineman has co-authored over 60 peer-reviewed publications and is board certified in Internal Medicine and Infectious Diseases.
To hear more about the work Dr. Heineman is leading at Oncolytics Biotech in the development of oncolytic virus therapy, tune into the episode.
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In this episode, Ayesha spoke with AnnMarie Hipsley, DPT, PhD, CEO and founder of Ace Vision Group, an ophthalmic laser device company that is bringing touchless eye laser therapy to patients with age-related vision loss.
Dr. Hipsley is a vision scientist, inventor, entrepreneur, author and speaker on ocular biomechanics and the biomechanical rejuvenation of the aging eye.
She invented an innovative touchless laser system and a laser microporation system for the treatment of presbyopia.
Presbyopia is an age-related condition in which the eye gradually loses its ability to focus on close objects due to natural aging of the lens inside the eye. It typically begins to affect individuals around the age of 40 and continues to progress until around age 65.
Dr. Hipsley is passionate about educating the health care space on the global burden of uncorrected presbyopia, particularly the socioeconomic and quality of life implications of the condition.
Over the past 25 years, she has trained more than 100 ophthalmic surgeons worldwide in using near-infrared lasers for tissue microporation.
Tune into the episode to hear more about Dr. Hipsley and Ace Vision Group’s innovative solutions for presbyopia.
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In this episode, Ayesha spoke with Shaheen Lakhan, MD, PhD, Chief Medical and Scientific Officer, Click Therapeutics, a company focused on developing software as prescription medical treatments for people with unmet medical needs.
Click Therapeutics is specifically developing Digital Therapeutics, which involve the delivery of prescription treatments to patient’s smartphones. These are being developed for indications in psychiatry, neurology, oncology, immunology and cardiometabolic diseases.
In collaboration with Otsuka, Click Therapeutics most recently developed the first prescription digital therapeutic authorized by the FDA for the adjunctive treatment of major depressive disorder symptoms.
Dr. Lakhan, is an inventive entrepreneurial physician-scientist who is board-certified in neurology and pain medicine with over 20 years of industry experience. As Chief Medical and Scientific Officer at Click Therapeutics and a Board Director at SpineThera, he spearheads AI-enabled clinical development and drug-delivery platforms.
Tune in to the episode to hear more the cutting-edge new field of digital therapeutics and how they are shaping the industry.
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In this episode, Ayesha spoke with Brent Lucas, CEO of Envoy Medical.
Envoy Medical is a medical device company focused on providing cutting-edge technologies across the hearing loss spectrum.
According to the National Institute of Deafness and Other Communication Disorders, 13 percent of people in the US 12 years of age and older have hearing loss in both ears, underscoring the importance of developing solutions to help this population.
Brent Lucas has been the CEO of Envoy Medical Corporation for the last seven years. Brent is a lawyer by training and as a Medical Devices Executive, he has extensive experience leading across enterprise functions. He has over 15 years of experience in active implantables in the hearing health industry. Brent has a Bachelor’s Degree from the University of St. Thomas and JD from the Mitchell Hamline School of Law.
Tune into the episode to hear more about the innovative hearing solutions Envoy Medical currently offers and some of the ones under development. Also hear more about hearing health, including guidance on how to protect hearing, where the industry may be headed in the next few years, as well as the Hearing Device Coverage Clarification Act and where it currently stands.
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In this episode, Ayesha spoke with Robert Perkins, MD, Vice President, US Medical Affairs/Renal and Cardiovascular at Bayer who spoke about recent advancements in the heart failure (HF) treatment landscape.
This includes new Phase III trial data for Kerendia (finerenone) in patients with heart failure that was presented recently at this year’s European Society of Cardiology (ESC) Congress 2024.
At Bayer, Dr. Perkins leads a team of medical directors and field team members working to advance the care of patients with kidney disease and heart failure. Dr. Perkins has also led the development and implementation of innovative digital educational outreach campaigns for primary care physicians. Prior to joining Bayer, Dr. Perkins held leadership roles with Novartis and AstraZeneca. He obtained an MD at the University of Pittsburgh Medical School, a Masters of Public Health at Johns Hopkins University, Bloomberg School of Public Health, and a Bachelor of Arts in English Literature from Harvard University.
Tune into the episode to hear more about the latest trial data for finerenone in heart failure and the landscape of heart failure research.
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In this episode, Vera spoke with Morgan Hanger, Executive Director of the Clinical Trials Transformation Initiative (CTTI). CTTI is a public-private partnership dedicated to improving the quality and efficiency of clinical trials, aiming to transform the industry by 2030.
Hanger shares her career journey, from her roles at PatientsLikeMe and Memorial Sloan Kettering Cancer Center, to leading CTTI. She explains how her patient-centered focus has shaped CTTI’s approach to its Transforming Trials 2030 initiative.
Hanger addresses the major challenges in clinical trials today, including regulatory complexities and the need for better data transparency. She explains how CTTI is tackling these issues through collaboration and innovative trial designs, like decentralized and adaptive trials, which aim to improve efficiency and inclusivity.
Hanger encourages new clinical trial professionals to embrace innovation and stay patient-focused. She hopes her work at CTTI will influence the development of a clinical trial system that is more efficient, inclusive and better aligned with patient needs.
Tune in to learn how CTTI is leading efforts to reshape clinical trials.
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In this episode, Vera spoke with Dr. Sam Lee, Co-Chief Executive Officer and President of Cocrystal Pharma, a clinical-stage biotech company focusing on antiviral drug development with a unique structure-based drug discovery platform.
With over 25 years of experience in anti-infective drug discovery, Dr. Lee brings a wealth of knowledge to the discussion on the urgent need for innovative antiviral therapies.
The conversation begins with Dr. Lee sharing insights on the mission of Cocrystal Pharma, which leverages Nobel Prize-winning expertise in the development of antiviral drugs.
Vera and Dr. Lee then discuss the recent emergence of a new strain of Avian flu, examining the potential risks and the current state of flu vaccines in providing protection against both seasonal and pandemic strains.
Dr. Lee delves into the challenges of pandemic preparedness and explains how broad-spectrum antivirals could offer a valuable tool in combating influenza outbreaks. He provides an overview of Cocrystal Pharma’s approach, particularly their focus on targeting viral replication proteins, which sets their platform apart from traditional antiviral discovery methods.
The discussion also covers the limitations of current antiviral treatments and highlights the unmet medical needs in influenza care.
As the conversation wraps up, Dr. Lee discusses his excitement for the future of antiviral drug development.
Tune in to gain an understanding of the evolving landscape of antiviral research and the cutting-edge innovations that could redefine treatment options for viral infections.
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In this episode, Vera spoke with Tim Culp, PhD, Vice President of Research and Development at Interius BioTherapeutics, a Philadelphia-based biotech company.
Their lead program focuses on an intravenous CAR therapy for B cell lymphomas. Additionally, the company is advancing a second program aimed at treating autoimmune diseases.
Dr. Culp joined Interius following a distinguished 14-year career with Merck Research Laboratories where he supported vaccine and oncolytic virus program development as a Senior Principal Scientist. His experience includes leadership of both early and late-stage development teams responsible for all Chemistry, Manufacturing and Controls (CMC) deliverables needed for clinical programs.
Dr. Culp completed a PhD from the Pennsylvania State University, College of Medicine for his research on human papillomaviruses. He then completed post-doctoral studies at Penn State developing chimeric papillomavirus vaccines. Dr. Culp holds a BS in Biology/Secondary Education from Christian Heritage College and had a 15-year high school teaching career prior to his graduate studies.
Tune into the episode to learn more about the promise of in vivo CAR T therapy and novel advancements in the field.
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In this episode, Ayesha spoke with James E. Brown, DVM, co-founder, President and CEO of DURECT.
DURECT is pioneering a therapeutic strategy by leveraging the potential of epigenetic modulation to alter the trajectory of severe and life-threatening conditions like acute organ injury and cancer.
The company is specifically focused on the development of an epigenetic modulator, larsucosterol (DUR-928) for the treatment of alcohol-associated hepatitis (AH). The therapeutic has shown promising results in human studies, including a Phase IIb trial in AH patients.
Dr. Brown co-founded DURECT in February 1998 and has served as President, CEO and a Director since June 1998. Dr. Brown has worked in various leadership positions, including as Vice President of Biopharmaceutical and Implant Research and Development at ALZA Corporation from 1995 to 1998 and various leadership roles at Syntex Corporation, now Roche. Dr. Brown holds a Doctor of Veterinary Medicine (DVM) from the University of California, Davis, where he also conducted postgraduate work in pharmacology and toxicology.
Tune into the episode to learn more about the promise of next generation epigenic modulators, including DURECT’s innovative epigenetic therapeutic approach.
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In this episode, Vera spoke with Carsten Rudolph, PhD, CEO of Ethris.
Ethris was founded by Dr. Rudolph and Professor Christian Plank with the goal of establishing messenger RNA (mRNA) as a novel drug modality for lung diseases such as asthma and rare pulmonary conditions like primary ciliary dyskinesia (PCD) and pulmonary alveolar proteinosis.
Ethris leverages its proprietary SNIM® RNA platform and lipidoid nanoparticle (LNP) delivery technology for versatile, multi-route therapeutic applications.
As mRNA therapies gain global traction, Dr. Rudolph sees opportunities for Ethris to make an impact.
Tune into the episode to explore the promise of nasal delivery of mRNA therapeutics as an innovative approach to treating lung diseases like asthma and beyond.
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In this episode, Ayesha spoke with Kirk Brown, PhD, Vice President of Research at Alnylam Pharmaceuticals.
Alnylam is focused on developing RNAi medicines to transform the way diseases like cardiovascular and neurological diseases are treated.
Dr. Brown’s preclinical work combining stable siRNA designs with alternative conjugation strategies has enabled potent, long-lasting silencing across the CNS following a single intrathecal administration.
In addition to driving RNAi platform innovations, Dr. Brown leads a team of CNS target biologists at Alnylam and serves as the research lead for ALN-APP, the first clinical CNS RNAi program.
In this episode, Dr. Brown discusses the promise and evolving landscape of RNAi therapeutics across various therapeutic areas and Alnylam’s approach to developing innovative RNAi medicines.
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In this episode, Ayesha spoke with Jennifer Gudeman, Pharm D, Senior Vice President, Medical and Clinical Affairs, Avadel Pharmaceuticals plc, a biopharmaceutical company working on innovative solutions to the development of medications that disrupt treatment paradigms and address unmet needs. The company is currently focused on developing treatments for narcolepsy, a complex chronic neurological sleep disorder.
Dr. Gudeman joined Avadel in 2020. This was a critical time for the company as the team had submitted an NDA for a treatment that had the potential to improve the standard of care in narcolepsy. Dr. Gudeman helped continue the clinical development of Lumryz (sodium oxybate) through to its approval, which was approved last May and is the first and only FDA approved once-at-bedtime oxybate for individuals living with narcolepsy.
Narcolepsy affects the brain’s ability to regulate sleep-wake cycles. People with narcolepsy experience excessive daytime sleepiness (EDS) and sudden episodes of falling asleep during the day, which can be uncontrollable and occur at inappropriate times.
Tune into the episode to learn more about the unmet needs in narcolepsy, the clinical development and approval of Lumryz and where the science is heading in the sleep disorder space.
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In this episode, Ayesha spoke with Steffen-Sebastian Bolz, MD, PhD, a scientist, physician and entrepreneur. He is a Co-Founder of Aphaia Pharma AG and Founder and Chief Scientific and Medical Officer at Qanatpharma AG. Dr. Bolz holds a full professorship at the University of Toronto, is a Principal Investigator at the Ted Rogers Centre for Heart Research and Director of the Toronto Centre for Microvascular Medicine.
Aphaia Pharma is developing innovative, non-hormonal treatments for metabolic conditions like diabetes and obesity. The company is focused on restoring a normal metabolic food response through natural and safe treatment alternatives that can be applied to broad populations and enable long-term use.
To learn more about Aphaia’s innovative approach to treating metabolic conditions like obesity by turning to the body’s natural physiology, tune into the episode with Dr. Bolz.
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