Xtalks Life Science Podcast

Off the Shelf Cell Therapies for Bone Marrow Transplantation with Ossium Health’s Kevin Caldwell

In this week’s episode of the Xtalks Life Science Podcast, host Ayesha Rashid, Senior Life Science Journalist at Xtalks, spoke with Kevin Caldwell, CEO, Co-Founder & President of Ossium Health, a biotechnology company advancing the first off-the-shelf bone marrow therapy derived from deceased organ donors. The treatment is designed to address longstanding clinical and logistical challenges in allogeneic bone marrow transplantation.
Kevin Caldwell has led Ossium Health in building more than 50 strategic partnerships with biopharmaceutical companies and helped secure a transformative federal contract with BARDA (Biomedical Advanced Research and Development Authority).
Prior to founding Ossium, Kevin served as an Engagement Manager at McKinsey’s San Francisco office where he advised clients in the biotechnology and healthcare sectors, and prior to that, served as a Senior Investment Associate at Bridgewater Associates where he did quantitative research for the firm’s global macro investments. Kevin holds degrees in Physics and Economics from MIT and a JD from Harvard Law School.
Tune in to learn about how about the landscape of cell therapy and allogeneic transplantation, including the translation of off-the-shelf cellular therapies into clinical practice and how emerging models could reshape bone marrow transplantation workflows.
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Scalable Biologics Production Trends: Featuring Omar Wahab of Lonza

In this episode of the Xtalks Life Science Podcast, part of the Breakthrough with Dr. Corey Stanton series, host Dr. Corey Stanton sits down with Dr. Omar Wahab, Vice President of Bioprocessing at Lonza, to explore the increasingly strategic role of cell culture media in enabling scalable biologics manufacturing.
As biologics pipelines continue to expand across therapeutic areas such as oncology, immunology and advanced therapies, upstream development decisions are taking on new importance in determining manufacturing readiness, supply resilience and long-term commercial viability.
Drawing on more than two decades of experience spanning research, manufacturing, MSAT and commercial leadership, Dr. Wahab discusses how early formulation choices can shape downstream productivity, influence product quality attributes and ultimately impact cost of goods.
He underscores why media development should be viewed not as a routine procurement decision but as a core element of process design. This is particularly important as intensified production platforms and higher cell densities increase sensitivity to raw material variability and operational conditions.
The conversation examines the operational pressures facing today’s bioprocessing teams, including the need to advance clinical programs rapidly while maintaining confidence in scalability and regulatory expectations.
Dr. Wahab highlights how structured experimentation frameworks, such as Design of Experiments, are helping organizations generate more actionable data and move beyond traditional trial-and-error approaches.
He also points to the importance of aligning upstream innovation with real-world manufacturing considerations, from large-scale process feasibility to globally sustainable material sourcing strategies.
Listeners will also gain insight into how non-GMP and GMP manufacturing stages function as critical transition points between early development insights and regulated commercial production. When formulation strategies are developed with downstream execution in mind, companies can reduce late-stage comparability challenges and strengthen supply continuity across global manufacturing networks.
Dr. Wahab further discusses the growing role of digital tools and structured data environments in improving process visibility and enabling more coordinated decision-making across development and production teams.
Looking ahead, Dr. Wahab shares his perspective on the trends set to define the next phase of upstream bioprocessing, including tighter integration between development and manufacturing functions and the rising strategic significance of regional biologics hubs such as Singapore.
He notes that future success in biologics manufacturing will depend not only on scientific excellence but also on cross-functional alignment and a systems-level understanding of how early upstream decisions influence performance at commercial scale.
Tune in to learn how structured media development strategies help life sciences organizations accelerate timelines, reduce technical risk and strengthen confidence as programs move toward commercial biologics production.
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Novel Therapeutic and Trial Approaches for Lysosomal Storage Disorders with Polaryx’s Alex Yang

In this week’s episode of the Xtalks Life Science Podcast, host Ayesha Rashid, Senior Life Science Journalist at Xtalks, spoke with Alex Yang, JD, LLM, CEO of Polaryx, a company focused on developing disease-modifying small molecule therapies for rare, pediatric lysosomal storage disorders.
Alex is a biotech executive and investor with over 25 years of experience spanning law, private equity, cross-border fund formation and strategic leadership across the biopharmaceutical sector. He currently serves investment and risk committee member roles for various regional and country-focused private equity funds. Alex was formerly a managing partner at Kim & Chang and a partner at the Ernst & Young Hong Kong office leading regional financial services practice, including banking and capital markets, asset management and insurance.
Alex graduated from New York University School of Law with both Juris Doctor (JD) and Master of Laws (LLM) degrees and a bar with the State of New York and received an undergraduate degree from Binghamton University in Economics.
Tune in to learn about how Polaryx is aiming to accelerate treatment options for patients with urgent unmet needs using robust therapeutic and flexible clinical trial designs.
 
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Psilocybin Treatments for Treatment-Resistant Depression with Compass Pathways’ Dr. Steve Levine

In this week’s episode of the Xtalks Life Science Podcast, host Ayesha Rashid, Senior Life Science Journalist at Xtalks, spoke with Steve Levine, MD, Chief Patient Officer at Compass Pathways, a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health.
One of the areas that Compass Pathways is working in is the development of psilocybin-based treatments for treatment-resistant depression (TRD).
Dr. Levine is a board-certified psychiatrist who has spent his career working across multiple facets of the healthcare system to improve people’s lives through creating access to innovation. Dr. Levine completed an internship and residency in psychiatry at New York – Presbyterian Hospital/Weill Cornell Medical Center, followed by fellowship subspecialty training in psychosomatic medicine/psycho-oncology at Memorial Sloan Kettering Cancer Center/New York – Presbyterian Hospital.
Prior to Compass Pathways, Dr. Levine led Actify Neurotherapies, a company he founded in 2010 that built new models of care delivery across the US for interventional psychiatry treatments. He has published extensively in both peer-reviewed journals and popular media, presented to both professional and lay audiences around the world, served in leadership roles for professional societies and not-for-profit entities and received numerous awards for leadership and service.
Tune in to hear about innovations and unmet needs in the mental health space and the development of science-driven psilocybin-based treatments for depression.
 
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First Surrogate Endpoint in Osteoporosis Drug Trials with FNIH’s Dr. Tania Kamphaus

In this week’s episode of the Xtalks Life Science Podcast, host Ayesha Rashid, Senior Life Science Journalist at Xtalks, spoke with Tania Nayak Kamphaus, PhD, Associate VP of Science Partnerships at the Foundation for the National Institutes of Health (FNIH).
In December 2025, the FDA qualified bone density DXA scans as the first surrogate endpoint for bone fractures in clinical trials of anti-osteoporosis drugs in post-menopausal women at risk for osteoporosis fracture.
The surrogate endpoint will allow for measuring change in bone mineral density, rather than fracture occurrence, promising to speed the development of new drugs to treat osteoporosis. The decision was based on FNIH’s request for qualification through the work of the FNIH Biomarkers Consortium.
Dr. Kamphaus leads patient engagement at FNIH and oversees programs across its Metabolic Disorders, Inflammation and Immunity and Women’s Health portfolios. She develops multi-stakeholder public-private partnerships involving NIH, FDA, non-profits and life sciences companies, and oversees target validation efforts within the Accelerating Medicines Partnership (AMP), as well as biomarker qualification initiatives in areas including preeclampsia and osteoporosis.
Dr. Kamphaus conducted her postdoctoral fellowship at Columbia University and has a PhD in Molecular Genetics from The Ohio State University.
Tune in to hear Dr. Kamphaus discuss the FDA’s decision on the new surrogate endpoint for bone fractures, the science behind the biomarker and the real-world impact it will have on the speed and cost of osteoporosis drug development.
 
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From Insights to Impact: Rare Disease Therapies with UCB’s Dr. Kim Moran

In this week’s episode of the Xtalks Life Science Podcast, host Ayesha Rashid, Senior Life Science Journalist at Xtalks, spoke with Kim Moran, PhD, Senior Vice President & Head, Rare Diseases US, UCB, a company focused on neurological and immune-mediated inflammatory diseases, as well as developing therapies for rare genetic disorders such as the mitochondrial disease thymidine kinase 2 deficiency (TK2d).
Dr. Moran has been at UCB for over 17 years where she has led US digital business transformation and most recently served as Head of Insights to Impact, a role she originated to translate patient insights into strategic and operational impact. She has held multiple leadership roles across neurology and epilepsy strategy, and led lifecycle and medical affairs initiatives for key products.
Dr. Moran has received multiple leadership awards, including HBA Rising Star, a PM360 Pharma Choice Award and recognition by Medical Marketing + Media as a Woman to Watch (2019) and Woman of Distinction (2024). She is a CHIEF member, a Women in Bio Boardroom Ready alumna and serves on the board of Nile AI. She holds an Executive Global MBA from INSEAD, a PhD in Neuroscience and Physiology from New York University and a Bachelor of Science (BS) in Biochemistry and Molecular Biology from Penn State University.
Tune in to hear Dr. Moran discuss the evolving rare disease landscape, how patient insights are shaping strategy and what it takes to bring innovative therapies to underserved populations.
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Rare Disease Day Insight: Epilepsy Care Gaps in Pregnancy with UCB’s Andrea Wilkinson

In this week’s episode of the Xtalks Life Science Podcast, host Ayesha Rashid, Senior Life Science Journalist at Xtalks, spoke with Andrea Wilkinson, Global Head of Patient Engagement & Advocacy, Epilepsy & Neuromuscular at UCB, a company dedicated to developing solutions for autoimmune and neurological conditions, including epilepsy. The company has a growing commitment to addressing unmet needs in rare neurological diseases and underserved patient populations.
With fewer than 5% of clinical trials including pregnant women, major knowledge gaps persist, particularly for women with epilepsy. In this episode, we look at new research that used social media listening across several countries to uncover treatment fears, uncertainty and barriers women face during pregnancy and motherhood, and what must change to better support informed decision-making.
While epilepsy is not considered a rare disease, epilepsy in pregnancy represents a small, clinically complex population that faces unique risks and persistent care gaps.
Andrea is a biotech and health tech executive who has led strategic product launches for over 30 breakthrough biopharmaceutical therapies. Focused on improving outcomes for patients, particularly in rare diseases, she has worked with early- to late-stage launch teams at AstraZeneca/MedImmune, Takeda and Sanofi Pasteur. She develops platform tools, stakeholder roadmaps and patient-centered advocacy campaigns to support first-in-class medicines and address access, reimbursement, regulatory and commercial barriers. Andrea is also an angel investor with Pipeline Angels and serves on the boards of Project Open Hand and the HBA Pacific Region. She holds a BA from Louisiana Tech University.
Tune in to learn more about the unmet needs, challenges and advancements in the rare disease and epilepsy spaces.
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Anti-Aging Gene Therapy in Alzheimer’s and ALS with Klotho Neurosciences’ Dr. Joseph Sinkule

In this week’s episode of the Xtalks Life Science Podcast, host Ayesha Rashid, Senior Life Science Journalist at Xtalks, spoke with Joseph Sinkule, CEO, Founder and the Chairman of the Board of Directors at Klotho Neurosciences, a biogenetics company developing cell and gene therapies using a patented, secreted form of the “anti-aging” human α-Klotho gene for the treatment of neurodegenerative, age-related disorders such as Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease and others.
Dr. Sinkule has over 40 years of drug, biologic and medical device R&D and commercialization experience. He has managed over eight drug and biotech products successfully through FDA approval to market, as well as five medical devices and eight in vitro diagnostics.
After serving in academics and then in industry, Dr. Sinkule has evolved into a successful businessman and entrepreneur. He has led teams of all sizes, managed CROs and CDMOs, serves on two company boards and regularly advises venture capital firms, investment banks and pharmaceutical and biotech companies at all stages.
Tune in to learn more about targeting pathways of aging in diseases like Alzheimer’s and ALS.
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Translating Nerve Growth Factor Biology into Ocular Disease Therapies with Dompé’s Dr. Ahmed Enayetallah

In this week’s episode of the Xtalks Life Science Podcast, host Ayesha Rashid, Senior Life Science Journalist at Xtalks, spoke with Ahmed Enayetallah, PhD, MBBCh, Chief Development Officer at Dompé Farmaceutici, a company founded as the first compounding pharmacy in Milan, Italy, which has grown into a global biopharmaceutical company over 130 years.
Currently, the company has a therapeutic pipeline focused on nerve growth factor (NGF)-based therapeutics in ocular diseases, including non-arteritic anterior ischemic optic neuropathy (NAION). Dompé has been a pioneer in translating NGF biology into medicine, building on decades of research by Nobel laureate Dr. Rita Levi-Montalcini.
Dr. Enayetallah has a robust background in clinical research and deep expertise in drug development. His career has spanned several high-profile leading roles at pharmaceutical and biotechnology companies such as Amgen, Biogen, Pfizer and Alexion. He has led efforts in personalized medicine and oversaw multiple successful clinical programs that brought novel therapies to patients with high unmet needs. Prior to joining Dompé, he led the development organization at BlueRock Therapeutics.
Dr. Enayetallah earned his medical degree from the University of Cairo and completed his PhD in Pharmacology and Toxicology at the University of Connecticut.
Tune in to learn more about NGF biology and how it is being leveraged therapeutically in ocular diseases with high unmet need.
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Innovative Approaches to Regenerative Therapies in Wound Care with BioStem CEO Jason Matuszewski

In this week’s episode of the Xtalks Life Science Podcast, host Ayesha Rashid, Senior Life Science Journalist at Xtalks, spoke with Jason Matuszewski, chairman, CEO and co-founder of BioStem Technologies, a company developing perinatal tissue allografts for regenerative therapies.
The applications of the allografts, developed using the company’s proprietary processing method, include wound care, limb saving in conditions like diabetic foot ulcers and treating wounds and amputations of veterans.
After beginning his career as a technical engineer at SC Johnson and later leading process and quality initiatives at companies like ATI Ladish Forging, Nemak and HUSCO International, Jason’s work with the Juvenile Diabetes Research Foundation inspired his move into biotech. At BioStem, he’s overseen optimized tissue sourcing, the build-out of a 6,000-square-foot, fully FDA- and AATB-compliant tissue processing facility and the growth of a high-performing team.
Jason has a Bachelor of Science (BS) in Mechanical Engineering Technology, is a Six Sigma Black Belt and serves on the AATB Processing and Distribution Council and BioFlorida’s Government Affairs Committee.
Tune in to learn more about cutting edge developments in regenerative medicine and wound care.
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