During the discussion, they unpack Phase 3 results from the ARTISTRY‑1 and ARTISTRY‑2 trials, which evaluate BIC/LEN, an investigational single‑tablet regimen that combines the guideline‑standard integrase inhibitor bictegravir with the long‑acting capsid inhibitor lenacapavir in virologically suppressed people living with HIV, including those on complex multi‑tablet regimens. 

The discussion examines what non‑inferiority to standard-of-care regimens, high rates of viral suppression, and favourable safety and satisfaction profiles could mean for an ageing, comorbid population that still struggles with pill burden, drug–drug interactions, and resistance.

Mike and Jared then turn to prevention, focusing on twice‑yearly lenacapavir for PrEP, marketed as Yeztugo in the US, and the broader PURPOSE program. They look at how strong efficacy signals across diverse populations, early real‑world launch experience, and rapid access efforts in high‑burden regions may expand the overall PrEP market rather than simply cannibalise oral options.

Finally, they discuss Gilead’s long‑acting pipeline vision—from weekly orals to potentially once‑yearly injectable PrEP—and how the company is balancing ambitious innovation with mounting pricing and policy headwinds while aiming to sustain HIV franchise growth into the 2030s. They also examine how access can be expanded so that people living with HIV can benefit from these medicines in both high-income and low-income countries.

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

Join us as Mike dissects the winners and losers reshaping pharma's landscape: Eli Lilly's historic ascent to a trillion-dollar market cap, driven by clinical superiority in the obesity space and revenues growing at 46 % year-to-date, versus Novo Nordisk's stunning $400 billion value destruction through clinical disappointments, patent losses, and execution failures.

Beyond the headline-grabbing giants, discover why China has transformed from a low-cost alternative to a global innovation powerhouse, now contributing 38 % of patents in cutting-edge protein degradation technology. Explore the strategic M&A moves reshaping the industry, including the transformational Metsera bidding war and the real deal-making in Chinese oncology assets. Understand the FDA's revolutionary "Plausible Mechanism Pathway", opening new regulatory opportunities in rare disease and how AI is finally moving from hype to robust commercial valuations.

This is essential listening for anyone seeking to understand the seismic shifts reshaping biopharma investment, innovation, and competitive positioning as the industry heads into 2026.

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

The two approaches are conceptually similar – each involves the isolation and modification of patients’ T-cells to recognise and kill tumour cells. The main difference lies in the types of antigens they can recognise. Whereas CAR-T therapies are currently confined to a handful of extracellular antigens expressed on the surface of malignant (and healthy) B-cells, TCR therapies can target a whole universe of intracellular antigens, fragments of which are presented on the cell surface as peptide fragments by major histocompatibility complex (MHC) molecules.

Ensuring these highly engineered cells can persist, expand and operate effectively within the immunosuppressive tumour microenvironment in patients has been a complex challenge. But the current generation of therapies is starting to show promising results.

In this episode of BioBiz Buzz, Elisa Kieback, co-founder and Chief Technology Officer at T-knife Therapeutics, joins your host Cormac Sheridan to discuss how TCR cell therapies work and what they can do, and how the founders of the Berlin-based company came up with its distinctive name.

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

In this episode, Tom joins your host Mike Ward to discuss the four critical barriers early-stage biotechs face (expertise gaps, data infrastructure challenges, execution risk, and capital inefficiency) and how Lilly's integrated platform of capital, expertise, and infrastructure is removing those barriers. 

Learn how the future of drug discovery isn't about companies innovating in isolation, it's about removing friction and accelerating the best science from wherever it exists toward patients.

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

In this episode of BioBiz Buzz, your host Mike Ward sits down with Antoine Papiernik, Managing Partner and Chairman of Sofinnova Partners, to unpack one of the most significant European life sciences venture capital announcements of the year.

Together, they explore why leading pharma companies, sovereign wealth funds, and top-tier institutional investors are doubling down on early-stage biotech and medtech when the broader VC market is under pressure. 

Moreover, they discuss Sofinnova's disciplined, science-driven investment strategy, the geographic and therapeutic opportunities driving Capital XI deployments, and what the €1.5 billion raised across Sofinnova's platform over the past year reveals about institutional confidence in healthcare innovation.

More importantly, what does Sofinnova's oversubscription mean for the future of early-stage healthcare ventures as they head into 2026?

Whether you're an entrepreneur seeking funding, an industry strategist tracking market dynamics, or an investor evaluating the early-stage healthcare landscape, this conversation provides critical insights into where the smart money is being invested and why. 

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

The conversation examines the devastating impact of ALS, a progressive neurodegenerative disease that typically leads to death within three to five years of symptom onset, and the profound unmet need for disease-modifying therapies. Dr. Salzmann explains how AP-101 was discovered using Neurimmune's proprietary Reverse Translational Medicine platform, which leverages human immune responses to identify antibodies that selectively bind misfolded and aggregated forms of SOD1 while sparing normally folded protein. Professor Genge discusses the intriguing evidence that misfolded SOD1 may play a role not only in familial ALS patients with SOD1 mutations but also in sporadic ALS patients without known genetic causes, potentially expanding the therapeutic opportunity to a much broader patient population.

The Phase 2 study enrolled 73 ALS patients, both sporadic and SOD1 mutation carriers, and met its co-primary safety and tolerability endpoints while demonstrating clinically meaningful changes in exploratory outcome measures, including survival, ventilation requirements, and neurofilament biomarkers after 12 months of treatment. The guests explore the unique collaborative ecosystem that enabled this progress, including the partnership between Neurimmune and TVM Capital Life Sciences, and discuss AP-101's Orphan Drug Designation from the FDA, EMA, and Swissmedic. 

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

US-based Vivani Medical, a clinical-stage biopharmaceutical company, is developing miniature implants which are designed to solve this problem. Once inserted, patients and caregivers can be confident that the intended medicine is being delivered throughout the once- or twice-yearly dosing interval.

In this episode of BioBiz Buzz, CEO and co-founder Dr. Adam Mendelsohn, discusses the company’s NanoPortal platform technology with your host Shani Alexander. The platform centers on vertically aligned titanium dioxide nanotubes, incredibly tiny, precise channels that are over 40 micrometers in length and attached to a titanium substrate. The key innovation lies in the pore sizing: when the pore is only slightly larger than the drug molecule, the system achieves near-constant, steady-rate medication delivery over many months.

With chronic disease management placing a huge burden on patients - remembering doses, managing side effects and making frequent visits to clinics, the NanoPortal platform is built around a fundamental principle: to maintain steady, consistent drug levels over extended periods, to guarantee adherence and potentially improve tolerability. 

Mendelsohn says that the company is reimagining how GLP-1s can be delivered. For him, the NanoPortal platform represents a fundamental shift from treatment management to treatment assurance. The technology could move the healthcare system toward a model where patients receive a simple procedure every few months and know they're getting optimal, consistent therapy, he argues.

Beyond individual patient outcomes, Mendelsohn believes the platform could have massive implications for healthcare economics. Poor medication adherence costs the US healthcare system hundreds of billions of dollars annually. He explains that if patients can get the full benefit of their prescribed therapies, this can lead to both better outcomes and significant cost savings.

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

This rapidly evolving field enables researchers to eliminate disease-causing proteins rather than merely inhibiting their function, offering unprecedented opportunities to tackle previously "undruggable" targets that have eluded conventional therapeutic approaches with the potential to revolutionize treatment paradigms across oncology, neurodegenerative disorders, and autoimmune diseases.

Swedish biotech Beactica Therapeutics is pioneering novel approaches to drug discovery through its proprietary Eclipsor™ platform, which combines allosteric modulation with targeted protein degradation to tackle previously "undruggable" targets. 

In this episode, CEO and co-founder Per Källblad discusses with BioBiz Buzz co-host Mike Ward how the company's dual-modality strategy addresses the fundamental limitations of traditional small molecule inhibitors, particularly for proteins lacking well-defined binding pockets or serving complex scaffolding functions. 

The conversation explores Beactica's lead programme BEA-17, a first-in-class LSD1-CoREST degrader that has received FDA Orphan Drug Designation for glioblastoma, a devastating cancer where median survival remains just 12-18 months. By degrading the entire LSD1-CoREST complex rather than merely inhibiting it, BEA-17 simultaneously restores antigen presentation, induces viral mimicry responses, and reprograms the tumour microenvironment to enable immune recognition. 

Källblad also discusses the company's TEAD degrader programme P65-047, which shows superior efficacy through its unique ability to eliminate resistance-mediating co-factors like VGLL3, and outlines Beactica's biomarker-driven clinical development strategy designed to maximize patient selection precision as the company advances toward Phase I trials.

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

In this episode of Biobiz Buzz, your host Shani Alexander is joined by two guests from Resitu Medical, Åsa Runnäs, CEO, and Elisabeth Liljensten, Chief Clinical Officer to discuss the company’s game-changing technology that has the potential to not only change the way breast cancer is diagnosed but also treated.

Runnäs and Liljensten reveals that their vacuum assisted, minimally invasive, ultrasound guided device uses diathermy to remove entire breast lesions, not just fragments, for histopathological examination. Unlike current methods that excise small tissue samples which may require follow up surgery if cancer is confirmed, the Resitu device can remove the entire lesion. The device works in outpatient settings, making it available to millions of women in countries where surgical theatres, anaesthesiologists etc. are lacking and it is unclear whether they will be diagnosed or treated.

This disruptive technology has the potential to eliminate the need for open surgery, as it offers a simpler, safer, faster and less invasive solution to remove the lesion and save the lives of millions of people around the world.

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

In this episode of BioBiz Buzz, your host Shani Alexander sits down with Christoffer Ekström, CEO of AI Medical Technology, a Swedish-based company which has developed the Dermalyser, a diagnostic decision support system to help healthcare professionals classify skin cancer, such as malignant melanoma, using image analysis combined with the company’s algorithm. All that is needed is a smartphone with the Dermalyser app, a compatible dermatoscope, and a clinical environment with trained healthcare staff.

Clinical validation studies have demonstrated the high diagnostic accuracy of the device with an AUC of 0.96 when both invasive and in-situ melanomas are included, and an even higher AUC of 0.988 when considering invasive melanomas only. For the combined group (invasive + in-situ), Dermalyser achieved a sensitivity of 95.2% and specificity of 84.5%. For invasive melanomas only, sensitivity reached 100% and specificity 92.6%.  

The Dermalyser is CE-marked under EU Medical Device Regulation (MDR) and can be used on patients with Fitzpatrick skin types I–IV.  AI Medical Technology is working on bringing Dermalyser to clinics across Europe and has an eye on the US market.

Ekström explains that the company’s innovation is more than a technological breakthrough; it represents a fundamental shift in how skin cancer is diagnosed. For patients, it means faster diagnosis, fewer unnecessary surgeries, and potentially life-saving decisions made sooner. 

This episode provides insights into a solution that offers hope and will bring peace of mind to the millions of people with a suspected skin lesion.

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

With no approved treatments available for ICH, a devastating condition that claims nearly 50% of patients within 30 days, Bioxodes' groundbreaking approach tackles both the inflammation and clotting that drive secondary brain damage, without increasing bleeding risk. Fresh from announcing their breakthrough Phase 2a trial results, where all treated patients experienced reduced brain bleeding and no deaths occurred over eight months of follow-up, Dechamps shares the remarkable journey from laboratory discovery to potential life-saving medicine.

Discover how millions of years of tick evolution led to this medical breakthrough, why traditional stroke treatments fall short in hemorrhagic cases, and what the promising clinical data means for the 3 million worldwide who suffer ICH annually.

As Bioxodes prepares to launch its €70 million Series B funding round and advance toward a potentially registrational Phase 2b trial, Dechamps reveals the challenges of developing treatments for neglected diseases and his vision for expanding this tick-derived platform to tackle broader thrombo-inflammatory conditions.

This episode offers exclusive insights into one of biotech's most compelling David-versus-Goliath stories, where innovative science meets urgent medical need in the race to bring hope to stroke patients who have had none.

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

In this episode of BioBiz Buzz, your host Mike Ward sits down with David Bejker, CEO of Swedish biotech Affibody, to explore how engineered protein platforms are systematically addressing the industry's most pressing challenges. With over 20 years of radioligand development experience and more than 200 patients dosed, Affibody has developed a unique solution: engineered proteins 25 times smaller than traditional antibodies that deliver targeted radiation with unprecedented precision while avoiding the toxicity issues that have historically limited therapeutic efficacy.

Bejker reveals how Affibody's platform overcomes critical industry bottlenecks — from manufacturing stability at extreme temperatures to rapid tissue penetration and optimized pharmacokinetics. The conversation delves into the company's HER2-targeting program, which addresses a huge market opportunity. It explores how their technology differentiates from the peptide and antibody approaches dominating current billion-dollar acquisitions by Bristol Myers Squibb, Eli Lilly, and AstraZeneca.

Beyond the technical innovations, this episode examines Affibody's strategic partnerships with industry giants, demonstrating how specialized biotechs can leverage established infrastructure to accelerate patient access while maintaining focus on core innovation. From bacterial production systems that slash manufacturing costs to companion diagnostics that enable personalized treatment selection, Bejker illustrates how thoughtful platform design can transform radioligand therapy from a niche treatment to a scalable healthcare solution.

Essential listening for biotech executives, investors, and industry professionals seeking to understand how the next generation of radioligand companies is solving the challenges that will determine which treatments reach patients—and which billion-dollar bets pay off.

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

In this episode of BioBiz Buzz, your host Mike Ward sits down with Dr. Matthias Wiedenfels, CEO of BioCopy, the Swiss-German biotech company that's completely rewriting the playbook for cancer drug development. Under Wiedenfels' visionary leadership, recognized by WirtschaftsWoche magazine as one of Germany's biotech pioneers of the coming decade, BioCopy has created an unprecedented AI-powered platform that's achieving what seemed impossible.

The numbers are staggering: BioCopy is slashing drug development timelines from three years to just 12 months and testing 25,000 drug candidates in parallel instead of the traditional 10-100. Its proprietary ValidaTe technology performs large-scale precision screening of cancer targets, while its end-to-end automated laboratory mimics industrial production processes from day one.

But BioCopy's true innovation lies deeper. While conventional approaches focus on surface cancer markers, BioCopy homes in on hidden internal targets that make up 75% of all potential targets, a virtually untapped treasure trove that promises unprecedented specificity and safety. Its AI-driven platform generates massive datasets of unmatched quality, enabling it to develop highly complex multi-specific biotherapeutics that directly connect immune cells to cancer cells with minimal risk to healthy tissue.

This episode exposes the brutal realities of traditional drug development and unveils how artificial intelligence, automation, and visionary leadership are converging to potentially save millions of lives. As cancer rates soar globally, discover how one company's radical approach could transform the fight against humanity's most persistent enemy.

Don't miss this essential conversation about the future of precision medicine, the power of AI in biotechnology, and why the next decade could mark a turning point in our battle against cancer.

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

ReproNovo is not a typical Series A company. It has secured rights to two clinical-stage assets that originated in large pharma companies. Novartis originally developed leflutrozole (RPN-001) before licensing the molecule to Mereo Biopharma. Merck originated nolasiban (RPN-002), which ObsEva took into phase 3 development. As well as having well-understood mechanisms of action and supportive clinical data, the two molecules address clear unmet medical needs and have significant commercial prospects. 

Although neither program went the full distance under their original developers, ReproNovo is now subtly repositioning them to optimise their potential. Leflutrozole, an aromatase inhibitor, is currently undergoing a phase 2 trial in the U.S. for the future indication of infertility in men with low serum testosterone. Nolasiban, an oxytocin receptor antagonist, is in preparation for two phase 2 studies next year. The company will evaluate its potential to improve the success rates of in vitro fertilisation procedures and to ameliorate adenomyosis, an under-recognised condition caused by tissue from the lining of the uterus growing into the muscular area of the uterus.

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

Werner explains why platform-based approaches, combining mass-spec diagnostics across multiple diseases, are capturing investors’ interest and how family offices are redefining “unicorn” potential through scalable, multi-use technologies. 

Learn why healthy, productive aging has become the mission-critical market, how Big Tech and global competitors are reshaping healthcare, and what emerging MedTech startups must do to secure funding in this high-stakes arena. 

Tune in now to unlock the roadmap for tomorrow’s intelligent devices. 

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

The conversation delves deep into PharmNovo's groundbreaking approach through their lead candidate PN6047, a selective delta-opioid receptor agonist that promises to deliver powerful pain relief without the addiction risks or sedation effects associated with conventional mu-opioid receptor targeting drugs. Von Mentzer explains how this innovative mechanism specifically addresses neuropathic pain - a particularly challenging condition caused by nerve damage that affects millions of patients with diabetes, chemotherapy side effects, and various injuries.

This episode offers hope for the future of pain management, suggesting that the next five to ten years will witness a fundamental shift toward safer, non-addictive treatments becoming the standard of care. The interview provides both scientific insight into delta-opioid receptor targeting and a realistic perspective on the challenges and opportunities in developing safer pain medications for millions of patients worldwide who desperately need effective alternatives to traditional opioids.

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

In this episode of BioBiz Buzz, host Mike Ward interviews Michael Altorfer, CEO of the Swiss Biotech Association, to discuss the findings and implications of the Swiss Biotech Report 2025. The conversation focuses on the report’s central theme, "The Power of International Alliances", and examines how cross-border collaborations have become a key factor in the success of the Swiss biotech industry, with 80% of patents originating from international partnerships.   

Listeners will hear a comprehensive discussion about the increasing divide between well-funded serial entrepreneurs and emerging innovators. It will explore the evolving strategies that Swiss companies are using to access capital and how the sector is responding to the stagnation in public markets. Additionally, the episode will address important questions regarding talent retention, the sustainability of employment growth in manufacturing, and the risks posed by rising global protectionism and regulatory challenges.

Altorfer shares insights on how Switzerland’s collaborative culture, regulatory harmonization efforts, and academic excellence have enabled the country to excel in global innovation rankings. The episode concludes with a candid discussion of the disruptive forces that could shape the future of Swiss biotech, including geopolitical shifts, trends in reshoring, and the sector’s preparedness for unforeseen events. Tune in to understand why Switzerland remains a global leader in biotech and what it must do to maintain its competitive edge in an increasingly complex world.

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

Cereno’s lead candidates, CS1 and CS014, leverage epigenetic modulation through histone deacetylase inhibition (HDACi) to address the root causes of diseases like pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF), aiming to reverse pathological remodeling and prevent thrombosis-without the bleeding risks of traditional therapies. 

Sörensen discusses the company’s strategic pivot to rare diseases, the science behind their innovative pipeline, and the impact of recent SEK250 million financing on accelerating clinical programs. The conversation also highlights Cereno’s approach to partnerships, regulatory milestones, and the transformative potential of targeting gene expression in cardiovascular drug development. 

Tune in for a deep dive into the future of disease-modifying therapies and the milestones shaping Cereno’s journey in 2025 

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

Your host Mike Ward interviews Elin Trampe, CEO of Dicot Pharma, who discusses the company’s innovative drug candidate, LIB-01. 

Unlike conventional therapies, LIB-01 introduces a novel mechanism of action and offers a significantly longer efficacy window, 28 days after a brief 3-day dosing according to exploratory data in the phase 1 trial, potentially transforming the standard of care for both ED and PE. 

Trampe shares insights on the drug’s clinical progress, the company’s strategic partnerships, and efforts to reduce the stigma surrounding sexual health. 

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn

Your host Mike Ward explores how Caszyme is expanding the boundaries of gene editing through novel enzyme discovery, delivery optimization, and strategic collaborations, enabling breakthroughs in therapeutics, diagnostics, and sustainable agriculture. 

Dr. Paule discusses Caszyme’s unique approach to engineering smaller, more versatile Cas enzymes, their impact on treating genetic diseases, and the challenges of translating cutting-edge science into clinical and commercial success. 

The conversation also addresses the importance of diversity in biotech leadership and Caszyme’s vision for a more inclusive and sustainable future, highlighting the transformative potential and ongoing challenges of the CRISPR revolution.

● Feedback

● Subscribe (Get notified when new episodes are available. NO marketing!)

● Disclaimer

● LinkedIn