Beyond Biotech - the podcast from Labiotech

Disease X, a concept shrouded in mystery, represents the unknown pathogens that could unleash future epidemics or pandemics. In the wake of recent global health crises, our understanding of the profound impact of those pandemics has deepened. On this week’s podcast, we have a conversation with Hamilton Bennett, who led Moderna’s mRNA-1273 COVID-19 vaccine development program team to the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic. Bennett is Moderna’s senior director of vaccine access and partnerships, and has unparalleled insights into the world of infectious diseases. In this in-depth discussion, Bennett talks about the origins of Disease X, the role of mRNA technology in tackling pandemics, and the importance of preparedness.Disease X was intended to be a placeholder name; it was adopted by the World Health Organization (WHO) in February 2018 on their shortlist of blueprint priority diseases to represent a hypothetical, unknown pathogen that could cause a future epidemic.

Despite the huge commercial success of PD-1 inhibitors and widespread use of checkpoint inhibitors such as anti-PD-1 or anti-CTLA4, 70 to 80% of patients still experience limited or no response to existing therapies.  In response to this critical challenge, Portage Biotech is on a mission to expand the number of patients who derive long-term benefits from immunotherapies.  Portage Biotech is advancing a portfolio of novel precision immuno-oncology therapies, including invariant natural killer T-cell (iNKT) engagers, designed to correct the tumor microenvironment and enable the body to recognize and attack tumors, and next-generation adenosine inhibitors for a variety of cancers, with better potency, selectivity and durability. Heading this pioneering endeavor is Dr. Ian Walters, Portage's CEO, who brings decades of experience in the immuno-oncology space. With a unique background as a physician with a business degree, Dr. Walters has been deeply involved in academia and large pharmaceutical companies. He played a pivotal role in the development of some of the first checkpoint inhibitors and has supported the approval of five oncology drugs.  In this conversation, Walters tells Labiotech about Portage's unique approach to targeting known checkpoint resistant pathways and the company's strategy to revolutionize immunotherapy research and drug development.

This week’s podcast is sponsored by Vetter.On this week’s episode, we have a conversation with Steve Worland, CEO of eFFECTOR Therapeutics.eFFECTOR is a clinical-stage biopharmaceutical company pioneering the development of a new class of oncology drugs referred to as STRIs (selective translation regulation inhibitors). eFFECTOR’s STRI product candidates target the eIF4F complex and its activating kinase, mitogen-activated protein kinase interacting kinase (MNK). The eIF4F complex is a central node where two of the most frequently mutated signaling pathways in cancer, the PI3K-AKT and RAS-MEK pathways, converge to activate the translation of select mRNA into proteins that are frequent culprits in key disease-driving processes. The company’s product candidates are designed to act on a single protein that drives the expression of a network of functionally related proteins, including oncoproteins and immunosuppressive proteins in T cells, that together control tumor growth, survival and immune evasion. The lead product candidate, tomivosertib, is an MNK inhibitor currently being evaluated in KICKSTART, a randomized, double-blind, placebo-controlled phase 2b trial of tomivosertib in combination with pembrolizumab in patients with metastatic non-small cell lung cancer (NSCLC). Zotatifin, eFFECTOR’s inhibitor of eIF4A, is currently being evaluated in phase 2a expansion cohorts in certain biomarker-positive solid tumors, including ER+ breast cancer and KRAS-mutant NSCLC. eFFECTOR has a global collaboration with Pfizer to develop inhibitors of a third target, eIF4E.

As September 8 is Stand Up To Cancer Day, one area of promising research lies in cytokine-based drugs, which have the potential to activate T cells against tumors. Historically, toxicity from systemic cytokine treatment has remained a challenge, prompting several companies to explore ways to “engineer” drugs with modified cytokine molecules like interleukin 2 (IL-2) for targeted and safer delivery.  Cue Biopharma is a standout in this field, harnessing nature’s ‘cues’ to selectively activate the immune system against cancer. Their approach overcomes IL-2’s narrow therapeutic window by directing IL-2 delivery specifically to cancer cells, targeting only disease-specific T cells.  Cue Biopharma is a Boston, U.S., based clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT (Selective Targeting and Alteration of T cells) and biologics are designed to harness the body’s intrinsic immune system as T cell engagers without the need for ex vivo manipulation or broad systemic immune modulation.Anish Suri, Cue’s chief scientific officer, spoke with us about Cue Biopharma’s platform and its approach in the evolution of immunotherapies. 

On this week’s podcast, to recognize Blood Cancer Awareness Month, we have a conversation with Affimed's CMO, Andreas Harstrick, to talk about blood cancers, and what Affimed is doing to tackle blood cancers.One of the main challenges in treating blood cancers is the limited options for therapeutic intervention. Treatment relies primarily on chemotherapy, which is often associated with high toxicity and limited duration of response. Most other approaches to treating hematologic tumors target the adaptive immune system, neglecting the importance of innate immunity. However, harnessing the body’s first line of response could be an important gateway to treating these cancers, which could drastically lower side effects and overcome immune evasion by cancers, especially in refractory or relapsed patients. Approaches based on the innate immune system mainly utilize NK (natural killer) cells. Innate Pharma, Dragonfly Therapeutics, and Affimed are among the biotech companies directing NK cells to tumors with the help of bi- or multi-specific antibodies. Affimed has completed a phase 2 trial with its innate cell engager (ICE), AFM13. To address the fact that cancer patients often lack a functional immune system, Affimed has combined its ICE approach with PD-1 inhibitors or allogeneic cord blood-derived NK cells to further increase the potential success of its treatments. Initial results from an exploratory study together with MD Anderson have already provided encouraging data with relapsed or refractory patients that previously exhausted all treatment options showing a complete response rate of 71% when treated with AFM13 precomplexed with cord blood-derived NK cells.

On this week’s podcast, we have a conversation with Dr Jack Scannell, CEO of Etheros Pharmaceuticals Corp. Scannell recently co-authored a paper on the expenses related to clinical research and the factors that underly the translational failure of inhibitors of the insulin-like growth factor-1 receptor (IGF-1R) in oncology.Costs and Causes of Oncology Drug Attrition With the Example of Insulin-Like Growth Factor-1 Receptor Inhibitors, published in Jama Network Open, looked at 16 inhibitors of IGF-1R, in 183 clinical trials involving more than 12,000 patients. None of the agents received approval for clinical use in oncology practice and the trials were estimated to have had expenses of greater than $1.6 billion. Half of the published in vivo preclinical data analyzed showed less than a 50% inhibition of tumor growth by IGF-1R inhibitors.The authors stated that failed drug development in oncology incurs substantial expense. At an industry level, an estimated $50 billion to $60 billion is spent annually on failed oncology trials. Improved target validation and more appropriate preclinical models are required to reduce attrition, with more attention paid to decision-making before launching clinical trials. A more appropriate use of resources may better reduce cancer mortality, the authors argued.

Since its inception in 2012, World Lung Cancer Day has been observed every year on August 1 in order to raise awareness of lung cancer issues and magnify the need for more lung cancer research funding.Around a quarter of a million people in the US alone will be diagnosed with some form of lung cancer in 2023. And more than 125,000 people in the US will die from the disease. And another pretty awful stat is that one in 16 men and one in 17 women will be diagnosed with lung cancer, which kills three times as many people as breast cancer or prostate cancer. However, there are some positive trends. The number of new lung cancer diagnoses is declining steadily. Since 2006, the incidence rate decreased by 2.6% per year in men and 1.1% per year in women. Mortality rates are declining even faster, because of advances in treatment and early detection.This week’s guest is Prof. Iris Barshack, Head of the Pathology Institute at Sheba Medical Center, to talk about a new diagnostic tool for lung cancer.Sheba Medical Center’s new AI cancer diagnostics platform reduces diagnosis timeSheba Medical Center, Israel’s largest medical center, has announced the deployment of a new accelerated, AI-powered cancer diagnostics research platform to improve patient diagnosis,  treatment and outcomes. The platform enables the integration of AI technology developed by Sheba in addition to solutions created by innovative digital health startups.One of the first AI solutions to be deployed was developed by Imagene, an emerging leader in AI-based precision oncology, incorporating an algorithm to identify actionable biomarkers of non-small cell lung cancer. The algorithm is directly applied to a digitized image of a conventionally stained pathology slide and can then, within minutes, identify the presence of actionable biomarkers in the tumor, thus providing crucial information for diagnostic and therapeutic decisions. The solution essentially shortens diagnostic time from three weeks to minutes, enabling patients to begin treatment earlier. “We have reached another significant milestone in digital pathology with this ability to detect biomarkers by AI. The use of deep learning algorithms is changing the world of diagnosis, and in certain cases can drastically shorten the cost and time to treatment. I am excited to hear about the growing number of patients who were able to receive rapid diagnoses and treatment using our new service,” said Prof. Iris Barshack, Head of the Pathology Institute at Sheba Medical Center.This latest advancement in cancer diagnostics builds on the progress Sheba’s Pathology Institute has made in recent years. In 2019, the pathology lab at the hospital went fully digital, using computer screens for diagnosis instead of microscopes. Once the lab turned fully digital, the team worked with Imagene who developed a rapid AI-based molecular profiling algorithm to identify actionable biomarkers from the digital biopsy image alone.        “We are very proud to be part of this incredibly important initiative by Prof. Barshack to facilitate an accelerated program for rapid diagnosis of cancer patients,” said Dean Bitan, co-founder and CEO of Imagene. “It takes an innovative approach and openness to new and advanced technologies to drive cancer research and advanced cancer care. We believe this program will showcase the importance of rapid molecular profiling within the clinical workflow.” 

To learn about pepteins, we had a conversation with Christian Schwarz, CEO and co-founder of Numaferm.  Numaferm is a German biotech company, specializing in the production of pepteins, which are an underdeveloped class of molecules located between peptides and proteins (with a length of 30-300 amino acids). Pepteins are non-structured and complex posing a challenge for manufacturing, yet exert a high biological activity, wherefore they play an increasing role as innovative molecules in a range of industries, including animal and human health.  To date, peptein production via chemical synthesis or recombinant approaches is cumbersome, leading to time and resource-intensive development programs. This, in combination with high production costs, limits promising peptein applications. The proprietary high-titer expression platform Numaswitch changes this situation and enables the access to pepteins within weeks. The company and Zoetis, an animal health company, recently signed a licensing agreement for the development and production of defined veterinary therapeutics.  

2:02 Labiotech.eu news2:51 MinervaX To recognize International Group B Strep Awareness Month in July, we had a conversation with MinervaX CEO, Per Fischer. MinervaX is a privately-held Danish biotechnology company developing a novel prophylactic vaccine against Group B streptococcus (GBS), with two phase II clinical trials ongoing in pregnant women and a phase I clinical trial ongoing in older adults. Due to the global burden and no current mechanism for preventing this invasive GBS disease available. There is an urgent need for a vaccine to prevent GBS which has a well-recognized morbidity and mortality rate. MinervaX’s GBS vaccine has been granted Fast Track regulatory status by the US Food and Drug Administration. The process is designed to facilitate the development of investigational treatments that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions.  This follows the European Medicines Agency’s decision to award Priority Medicine (PRIME) status to the vaccine.

2;00  Labiotech news3:36  BaseLaunchIn today's episode, we have a conversation with Stephan Emmerth, director business development and operations at biotech startup incubator BaseLaunch, and Sai Reddy, an entrepreneur well versed in the highs and lows of the biotech startup journey. The discussion includes BaseLaunch’s approach to empowering early-stage biotech entrepreneurs with not just financing, but also the necessary tools for success, from team-building to IP licensing. Emmerth and Reddy offer their perspectives on the realities of building a biotech startup, the perfect time to transition from a lab to a new venture uncover the significance of choosing the right team making this episode a must-listen for anyone looking to navigate the biotech landscape successfully. 

1:54  Labiotech news3:48  NodTheraThis week, we’re talking about inflammasome inhibitors with Alan Watt, CEO of NodThera.The company recently announced it is the first to show a reduction in neuroinflammation with an inflammasome inhibitor.​​NodThera announced positive initial data from four subjects in the elderly volunteer stage of its phase Ib/IIa study evaluating the effects of its lead candidate NT-0796 on inflammatory and disease-specific biomarkers in the blood and cerebrospinal fluid (CSF).NodThera is a clinical-stage biotech developing brain-penetrant NLRP3 inflammasome inhibitors to treat chronic inflammatory diseases.Initial data from the ongoing study confirm earlier findings from the completed first-in-human and preclinical studies with NT-0796 showing excellent pharmacokinetics with a novel capsule formulation.Subjects in the study were cannulated and CSF-sampled on day one (pre-dose) and day seven following daily NT-0796 dosing. CSF drug levels were confirmed as consistent with previous observations and a range of inflammatory CSF biomarkers demonstrated meaningful reductions.Neurofilament light chain (NfL), exclusively synthesized in the central nervous system (CNS), decreased by approximately 25% over seven days in the most inflamed subject and by 13% on average. NfL is now recognised by the U.S. Food and Drug Administration (FDA) as a key biomarker of neuroaxonal damage and neurodegeneration.

1:24  Labiotech news3:45  TolerogenixXTolerogenixX GmbH, a biopharmaceutical company developing personalized cellular therapies aimed at achieving sustained immune tolerance to combat organ rejection and autoimmune diseases, has announced that its phase IIb study in renal transplant patients has received the green light to initiate the B arm of the study. MIC treatment is a personalized cell therapy approach modulating the immune system via a novel mode of action to achieve a specific and sustained immune tolerance. It can not only be applied to transplant recipients, but also to patients with autoimmune diseases such as systemic lupus erythematosus and multiple sclerosis. TolerogenixX has already reported positive results from the one- and three-year follow-up of 10 transplant recipients of its TOL-1 phase I trial initiated at Heidelberg University Hospital. All patients who had received MIC infusions prior to kidney transplantation in the TOL-1 clinical trial had a favorable clinical course three years after surgery. 

2:55  Labiotech news4:27  Mablink BioscienceOn the podcast this week, we have a conversation about antibody-drug conjugates with Pejvack Motlagh, who was recently announced as the chief medical officer at Mablink Bioscience. Mablink Bioscience Mablink Bioscience is a biotechnology company developing the next generation of an emerging class of cancer drugs, antibody-drug conjugates (ADCs). Mablink’s patented hydrophilic drug-linker technology, PSARLink, enables the design of homogeneous, plasma-stable, next generation ADCs with high DAR (drug-to-antibody ratio) while maintaining pharmacological properties and tolerability.The company recently announced the appointment of Dr. Pejvack Motlagh as chief medical officer. “We are very pleased to welcome Dr. Pejvack Motlagh as our chief medical officer. His experience in managing oncology portfolios, especially in the immuno-oncology and large molecules’ space, will be a great asset to take Mablink’s pipeline of innovative therapies to the next level,” said Jean-Guillaume Lafay, CEO of Mablink. “As MBK-103 enters the last preclinical phases, Pejvack’s appointment is a very important step in making Mablink’s clinical ambitions a reality.”We spoke with Motlagh about his work, Mablink, and antibody-drug conjugates.

2:38  Labiotech news4:23  APSFA20:59 University of MichiganJune is Antiphospholipid Syndrome (APS) Awareness Month. APS is a rare autoimmune disorder in which the body recognizes certain normal components of blood and/or cell membranes as foreign substances and produces antibodies against them. There are two known forms. APS may occur in people with systemic lupus erythematosus, other autoimmune disease, or in otherwise healthy individuals.APS is also referred to as APLS or APLA in the U.S., and formerly Hughes Syndrome or Sticky Blood in the U.K.On the podcast this week, we spoke with Tina Pohlman, who suffers from APS, and who is president of the APSFA, about the disease and the organization.The APS Foundation of America, Inc. (APSFA) was founded in 2005, and is the only U.S. nonprofit health agency dedicated to bringing national awareness to APS, a major cause of multiple miscarriages, thrombosis, young strokes and heart attacks. The APSFA’s Medical Advisory Team includes nationally & internationally recognized experts on Antiphospholipid Syndrome.We also had a conversation with APS researcher Dr Jason Knight, Marvin and Betty Danto Research Professor of Connective Tissue Research and Associate Professor, Division of Rheumatology at the University of Michigan.Current APS trialsThere are currently several clinical trials being undertaken with respect to APS. University Hospital, Clermont-Ferrand, France, is looking to assess the effect of injectable anticoagulants (unfractionated heparin (UFH), low molecular weight heparins (LMWH), fondaparinux, danaparoid, and argatroban) on lupus anticoagulant testing assays over broad anti-Xa activity ranges and to establish their potential for causing false-positive or false-negative results.David Ware Branch, from the University of Utah, is also undertaking a trial with results expected in 2024. The treatment trial is evaluating the addition of an anti-tumor necrosis factor-alpha drug,certolizumab, compared to the usual treatment (a heparin agent and low-dose aspirin) in pregnant women with APS and repeatedly positive tests for lupus anticoagulant (LAC) to determine if this regimen will improve pregnancy outcomes. All enrolled patients will receive certolizumab, and pregnancy outcomes will be compared to those of women with APS and repeatedly positive tests for LAC enrolled in a previous study by the investigators.Another study, in China, also with results anticipated in 2024, is being run by Zhang Lei. The study aims to evaluate the safety and efficacy of zanubrutinib in the treatment of APS with secondary thrombocytopenia in 10 patients.The University of Turin in Italy is sponsoring BLAST (belimumab antiphospholipid syndrome trial), which is expecting to see results in 2025. BLAST aims to evaluate the safety and tolerability of belimumab for up to 24 months in patients with persistent aPL positivity and clinical features attributable to aPL that are resistant to warfarin and/or heparin.

1:13  Labiotech news3:09  Lund Spring Symposium27:36 SapientSapientSapient is an end-to-end biomarker discovery organization dedicated to accelerating the mapping of circulating chemistries in humans through rapid, large-scale small molecule biomarker profiling. Its platform combines next-generation mass spectrometry technologies capable of assaying tens of thousands of small molecule biomarkers in human biosamples, advanced biocomputational learning, and a proprietary Human Biology Database with extensive data from several hundred thousand biosamples. Together these approaches enable rapid discovery and validation of circulating biomarkers of health, disease, and drug responsiveness at unprecedented speed and scale.We spoke with founder and CEO of Sapient, Mo Jain. Lund Spring SymposiumThe inaugural Lund Spring Symposium held in Lund, Sweden from May 24 to 26. It was an impressive forum where an exceptional set of international and national top researchers, entrepreneurs, and business leaders gathered around the subject of ‘Enabling Novel Therapeutic Principles,’ with examples of actual treatment breakthroughs, as well as novel modalities across therapeutic areas ranging from cancer, COVID-19 to neuroscience.Six researchers were awarded for their groundbreaking discoveries and outstanding achievements: Craig Crews Yale University; Brian Kobilka, Stanford University; Robert Langer, MIT; Jude Samulski, University of North Carolina; Sarah Tabrizi, University College London; and Drew Weissman, University of Pennsylvania.The symposium also featured two other Nobel Prize laureates, David Julius, from the University of California San Francisco, who gave a presentation, and Bengt Samuelsson, after whom one of the awards was named.The organizer, Lars Grundemar, Lund University and AGB Pharma, decided together with Mikael Dolsten, Lund University, and chief scientific officer, president R&D, Pfizer, and Claes Wahlestedt, Lund University and University of Miami Miller School of Medicine, to create the event featuring high-profile international and local researchers at a symposium in Lund to raise the profile of pharmacology as a cross-functional discipline in the 21st century, and to provide a forum to facilitate collaborations across academia and industry.“This event was designed to reflect the importance of combining basic research with clinical applications and entrepreneurship in successful development of novel therapeutic principles,” Grundemar said. The symposium was intended for scientists and entrepreneurs to be an engaging and interactive forum to broaden the participants’ horizons of cutting-edge science.The Lund Spring Symposium will be held biannually, with the next event taking place in 2025.

2:45  Labiotech news4:58  Orgenesis22:35 CellProthera38:22 Terumo Blood and Cell Technologies52:02 BioSenicThe International Society for Cell & Gene Therapy (ISCT), the global society of more than 3,000 members dedicated to the translation of cell and gene therapies (CGT) into safe and effective treatments to improve patient lives, recently hosted the largest translation-focused event connecting academic, regulatory and industry experts from around the world to collaborate and find tangible solutions to the most critical issues affecting the development of advanced therapies.The event took place in Paris, France.The ISCT 2023 Translational Pathway Program featured plenary and concurrent sessions designed to address and overcome barriers at each stage of development across a full range of modalities such as CAR T, iPSC, and a dedicated half-day program on unlocking the potential of exosomes (EVs). In this week’s podcast, we look into two of the sessions: ‘Will allogeneic cell therapy replace autologous when it comes down to patient access?’ and ‘Have exosomes replaced MSCs?’ Our guests to talk about these subjects are Carole Nicco, CSO at BioSenic; Dalip Sethi, director of scientific affairs, Terumo Blood and Cell Technologies; Matthieu de Kalbermatten, CEO of CellProthera; and Vered Caplan, CEO of Orgenesis. 

1:24  Labiotech news3:40  BC PlatformsA conversation about precision medicine with Tero Silvola, CEO at BC Platforms. We also discuss the acquisition of 4Pharma.The acquisition expands BCP’s global service offering for accelerating the translation of innovations into clinical practice. In addition, 4Pharma customers will benefit from additional services in the field of RWD through the BC Platform technology.4Pharma (HQ Turku, Finland and Lund, Sweden) was founded more than 20 years ago, and has collaborations with around 70 clients in the Nordics, Central Europe, and the U.S. The company has developed expertise in a range of therapeutic areas including oncology, neurology, ophthalmology, musculoskeletal, respiratory diseases, infectious diseases, and gynecology. The company provides medical research services in several areas: high-quality and cost-effective solutions for the management and delivery of clinical trial data, including real world data; medical writing; patient safety data collection, analysis, and reporting including data visualization; trial design & interpretation; health technology assessment; global regulatory submissions to the FDA (U.S.), EMA (Europe) and PMDA (Japan); and risk-based patient monitoring. With this acquisition BCP bolsters its capabilities in these areas for drug development and clinical research, which further diversifies its service portfolio for pharma and biotech clients.Tero Silvola, CEO at BC Platforms, said: “This exciting acquisition of the excellent 4Pharma brings impressive healthcare data intelligence expertise. It aligns with our vision to build a world leading analytics platform to enable the pharmaceutical industry’s advancement of precision medicine, improving the efficiency of drug development and patient outcomes. This expands our service offering to healthcare and lifesciences customers, as well as connecting data partners in a global, interoperable federated network. We combine omics and clinical data assets around the world, without compromising data privacy and security. This enables our customers to conduct novel research and discover fascinating new insights to advance healthcare which are fundamental to helping patients receive better treatments and care.”

1:18  Labiotech news3:37  BioInventBioInvent International AB, a Swedish biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, and Transgene, a biotech company that designs and develops virus-based immunotherapeutics against cancer, recently announced positive phase 1a data on the oncolytic virus BT-001 for the treatment of solid tumors.BioInvent currently has four drug candidates in five ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors, respectively. The company's validated, proprietary F.I.R.S.T technology platform identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the company's own clinical development pipeline and providing licensing and partnering opportunities.BioInvent generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the company's fully integrated manufacturing unit.We spoke with CEO Martin Welschof and Cecilia Hofvander, senior director investor relations.

1:33  Labiotech news3:31  Daiichi Sankyo/AstraZenecaThe companies Daiichi Sankyo and AstraZeneca have worked together for several years.This week’s podcast is sponsored by Daiichi Sankyo and AstraZeneca.On this week’s podcast, we have a conversation with Markus Kosch, the head of Oncology Europe and Canada for Daiichi Sankyo, and Greg Rossi, Senior Vice President, Oncology, Europe and Canada, from AstraZeneca, who are joining forces to bring new oncology medicines into clinical practice. In March 2019, AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialize health technologies worldwide. Their collaboration is designed to leverage strengths and combine efforts to improve patient care.

4:26  Labiotech news6:36  Medidata21:43 Bill & Melinda Gates Research InstituteThis week’s podcast is sponsored by Jubilant Biosys.May 20 is International Clinical Trials Day.ECRIN,  the European Clinical Research Infrastructure Network, is a not-for-profit organization that supports the conduct of multinational clinical trials in Europe. Based in Paris, France, the organization launched International Clinical Trials Day (ICTD) in 2005 to commemorate the day when James Lind started his clinical trial on scurvy in 1747, on May 20.ECRIN is hosting an event, both in-person and online, on Monday, May 23, called Decentralised Clinical Trials: challenges and opportunities. While the physical event in Warsaw, Poland, is full, online registration can be found here.International Clinical Trials Day is also supported and promoted by a range of charities, companies and organizations, such as the 13,000-member Association of Clinical Research Professionals (ACRP), which is the only non-profit organization solely dedicated to representing, supporting, and advocating for clinical research professionals.To celebrate the day, we have two interviews about the importance of the event and clinical trials in general. We have conversations with Dr. Michael Dunne, head of development and chief medical officer of the Bill & Melinda Gates Medical Research Institute, and Kelly McKee, vice president, decentralized clinical trials (DCT) and patient registries at Medidata.