Episodes
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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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Missing episodes?
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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.
For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/Follow Us on Social Media
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In this episode, Ayesha spoke with Alessio Travaglia, PhD, neuroscientist and Director Neuroscience at the Foundation for the National Institutes of Health (FNIH) and Suzanne Schindler, MD, PhD, Associate Professor of Neurology at Washington University.
Results from a head-to-head study led by the FNIH Biomarkers Consortium, with data analysis led by Dr. Schindler, have shown that some commercial diagnostic blood tests are accurate enough for clinical use and could replace cerebrospinal fluid (CSF) tests and PET scans in the near future for the diagnosis of Alzheimer’s disease. This would save patients the cost and pain associated with these traditional diagnostic approaches. The findings were presented at the Alzheimer’s Association International Conference (AAIC) in Philadelphia recently.
The findings could improve clinical diagnosis and speed future drug development by helping researchers select optimal clinical trial participants.
Tune into the episode to hear from Dr. Schindler and Dr. Travaglia about the promise of the blood tests for Alzheimer’s diagnosis.
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In this episode, Ayesha spoke with Matthew Martinez, MD, a board-certified cardiologist and nationally recognized expert in hypertrophic cardiomyopathy (HCM). He serves as director of Atlantic Health System Sports Cardiology and the director of the Chanin T. Mast Center for Hypertrophic Cardiomyopathy.
Dr. Martinez is the Chair of ACC online “LEARNHCM” platform, which educates clinicians about HCM patient care. Dr. Martinez also serves as a cardiology consultant for elite and professional athletes including acting as the League cardiologist for Major League Soccer, team cardiologist for the New York Jets and cardiac consultant for the NFL and NHL.
The American Heart Association (AHA)/American College of Cardiology (ACC) Joint Committee on Clinical Practice Guidelines recently published a new clinical guideline for the evaluation and management of people with hypertrophic cardiomyopathy (HCM), which Dr. Martinez co-authored.
The guidelines now recommend CAMZYOS (mavacamten), the first and only FDA approved cardiac myosin inhibitor, as a Class 1 Level B-R therapy for the treatment of adults with obstructive HCM who have persistent symptoms after first-line therapy.
Tune into the episode to hear Dr. Martinez’s expert insights on the significance of the updated guidelines, the firsthand and real-world application of CAMZYOS in clinical practice and HCM care for everyday individuals to high level athletes.
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In this episode, Ayesha spoke with Lawreen Asuncion, a patient advocate who works to raise awareness for the rare disease Usher syndrome.
Lawreen has worked professionally in the biotech and life science markets for over 25 years. She provides input and perspectives for rare genetic disease programs and clinical trials sponsored by biotech and pharma companies.
Lawreen is a dedicated patient advocate for Usher syndrome, a rare genetic disorder that causes both hearing and vision loss in most individuals, and also balance for some. As someone living with Usher syndrome type 2c, Lawreen brings a deeply personal perspective to her advocacy work, sharing her experiences and challenges to raise awareness and educate others about the condition. Her advocacy extends to supporting research initiatives and promoting accessibility and inclusion for individuals with sensory impairments.
Tune into the episode to hear Lawreen’s perspectives as both a life sciences professional and rare disease patient advocate.
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In this episode, Ayesha spoke with Moreno Perugini, President of Active & Medical Nutrition, US & President of Global Pharmaceutical Therapies at Nestlé Health Science US.
As President of Global Pharmaceutical Therapies, Moreno and his team actively shape the healthcare system through innovative approaches and a strong commitment to delivering pharmaceutical products with a human-centered focus.
Throughout his career spanning over two decades, he has held leadership positions at pharmaceutical companies like AbbVie and Novartis. Notably, he has been instrumental in bringing multiple pharmaceutical technologies to market, across different therapeutic areas guided by his unwavering commitment to prioritizing patients and expanding access to treatment.
Moreno holds a master's degree in Pharmacoeconomics/Pharmaceutical Economics from Universität Pompeu Fabra – IDEC and an MBA from Bocconi.
Last year, Nestlé Health Science won FDA approval for Vowst (Ser-109) for the prevention of recurrent C. difficile infections. Moreno discusses the significance of the approval given the difficulty of treating the recurrent infections, which are usually acquired during hospital stays.
Tune into the episode to hear more about the work Moreno is leading at Nestlé Health Science, which includes both nutrition- and pharmaceutical-based treatments for GI conditions and gut health.
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In this episode, Ayesha spoke with Jerry McLaughlin, chief executive officer and board member of Life Biosciences, a company advancing innovative cellular rejuvenation platforms to reverse diseases of aging.
Life Biosciences is developing a gene therapy for primary open-angle glaucoma (POAG) and non-arteritic anterior ischemic optic neuropathy (NAION), two types of optic neuropathies with significant unmet needs. The company is developing innovative therapies for these indications that are based on innovative partial epigenetic reprogramming and chaperone-mediated autophagy technologies.
Jerry McLaughlin has over 30 years of experience in the biopharmaceutical industry and has been involved in the discovery, clinical development and global commercialization of more than a dozen FDA-approved drugs with multiple successful exits. Jerry began his career at Merck and was extensively involved in multiple blockbuster product launches. Most recently, Jerry was President and CEO for Neos Therapeutics, Inc., a commercial stage pharmaceutical company. He holds a BA in economics from Dickinson College and an MBA from the Villanova School of Business.
Tune into the episode to learn more about the work Jerry is leading at Life Biosciences to better understand and target the biology of aging through innovative therapeutics for aging-related diseases with critical unmet medical needs.
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In this episode, Ayesha spoke with Karen S. Ho, PhD, Vice President, Translational Medicine at Clene Nanomedicine, a biopharmaceutical company focused on developing treatments for neurodegenerative diseases to restore and protect neuronal health and function.
Clene Nanomedicine is developing nanotherapeutics that target cellular energy impairments common to neurodegenerative and many other diseases. Specifically, the company’s lead asset is based on leveraging the catalytic therapeutic activities of gold when engineered as clean-surfaced faceted nanocrystals.
At Clene Nanomedicine, Dr. Ho directs the translation of preclinical successes of Clene’s lead drug assets into high clinical value with applicability to multiple disease areas. Dr. Ho has a PhD in Developmental Biology from Stanford and completed her postdoctoral training as a National Sleep Foundation Pickwick Scholar and Howard Hughes Medical Institute Postdoctoral Fellow at University of Pennsylvania in the Department of Neuroscience. Dr. Ho serves on several rare disease group Scientific Advisory Boards and holds a concurrent position as adjunct faculty at the University of Utah School of Medicine in the Department of Pediatrics, Division of Medical Genetics.
Tune into the episode to learn about Clene Nanomedicines’ innovative gold nanocrystal technology and how Dr. Ho is leading its development in diseases like ALS and Multiple Sclerosis. Also hear about Dr. Ho’s journey in the biopharmaceutical industry, including a touching personal story.
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In this episode, Ayesha spoke with Marci English, Vice President and Head of BioPharma Development at Astellas Pharma about a groundbreaking new treatment that addresses the underlying mechanisms of menopause symptoms.
In May 2023, Astellas received FDA approval for fezolinetant (commercial name Veozah) for the treatment of moderate to severe vasomotor symptoms due to menopause. The therapy is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat vasomotor symptoms associated with menopause, which include hot flashes and night sweats.
Tune into the episode to learn about the latest on fezolinetant one year after its approval, including its reception from healthcare providers and patients.
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In this episode, Ayesha spoke with Lawrence Blatt, PhD, MBA, Chairman and CEO of Aligos Therapeutics, a company developing targeted therapies for liver diseases like MASH (metabolic dysfunction-associated steatohepatitis) and viral diseases to address important unmet medical needs.
Prior to co-founding Aligos Therapeutics, Dr. Blatt served as the Global Head of Infectious Diseases and Vaccines at Janssen Pharmaceutical Companies of Johnson & Johnson from 2014 to 2018. He also co-founded several biotech companies, including Alios BioPharma, which was acquired by Janssen in November 2014. Dr. Blatt previously served on the board of directors of companies including ReViral Ltd. and Alveo Technologies, Inc., which he co-founded in 2014, and Meissa Vaccines, Inc. Dr. Blatt received an MBA from California State University, Northridge, and a PhD in Public Health Administration from the University of La Verne.
In March, Aligos announced the dosing of its first patient in its Phase IIa trial for a novel thyroid hormone receptor-beta agonist (ALG-055009) designed to address the root fibrosis of MASH. The drug is in the same class as Rezdiffra, which was approved this year as the first treatment for MASH.
Aligos also shared positive data at the European Association for the Study of the Liver (EASL) Congress last month in Milan, Italy for one of its candidate therapeutics for chronic hepatitis B (CHB).
Tune into the episode to learn more about the work Dr. Blatt is leading at Aligos Therapeutics in chronic liver disease and viral diseases.
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In this episode, Ayesha spoke with Alessio Travaglia, PhD, Director Neuroscience at the Foundation for the National Institutes of Health (FNIH) who also manages FNIH’s new Accelerating Medicines Partnership in Amyotrophic Lateral Sclerosis (AMP ALS) program, and Nadia Sethi, DDS, an ALS patient advocate who formerly served as Director of Community Outreach and Engagement at the ALS Therapy Development Institute.
Dr. Travaglia has 15 years of experience in basic and translational neuroscience in academia, non-profit, management consulting and venture philanthropy. Dr. Sethi is a patient advocate with strong leadership skills, experienced in patient outreach and representing advocacy organizations. She was a caregiver to her late husband who had ALS.
Last month, the FNIH launched a new AMP ALS research program designed to accelerate the discovery and development of treatment and diagnostics for ALS. The goals of the initiative include the faster identification of biomarkers and clinical outcome assessments that will may aid in earlier diagnosis and help accelerate drug development.
ALS is a neurologic disease with severely limited treatment options, none of which halt or reverse the progression of the fatal condition.
To learn more about the FNIH’s new AMP ALS program, including the continuing importance of patient advocacy and inclusion of the patient and caregiver voice in ALS research, tune into the discussion with Dr. Travaglia and Dr. Sethi.
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