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About this podcast: Recorded at DPHARM 2025, Bayer's Dr Bernhard Glombitza reports on the development, implementation and early impact of their clinical operations reorgnization. He describes how shifting from a traditional hierarchical model to a network of highly empowered teams reduced management layers, broadening the scope of work and changed cross-country operations monitoring.  Dr Glombitza details the results of the change thus far, including significant increases in efficiency and reduction in cost, maintaining quality levels and study targets, and improving employee job satisfaction. 

About this podcast: In this keynote from Patients as Partners in Clinical Research 2025, Amicus Therapeutics' Chief Patient Advocate, Jayne Gershkowitz, shares how their organization established and embedded patient advocacy into their core structure for lasting impact. More specifically, Ms Gershkowitz focuses on: Defining role standards and recruiting the right talent Co-creatin research with patient communities and developing patient-centered outcomesGenerating metrics that demonstrate the impact on R&D

When designing clinical trials, CMOs aim to answer meaningful questions for a plethora of stakeholders. Inherently, this results in study protocols with more measures, biomarkers and data collection that both provides a platform for strategic decision-making but also impacts patient burden, operational foot-print, timelines and cost. In this panel discussion from the 2025 Chief Medical Officer Summit 360°, CMOs address how to develop a balanced strategy that takes into account the ambition to answer these questions with the realities of complicated clinical trials. More specifically:Prioritizing data collection strategy to answer key scientific questions while avoiding overcomplicationDesigning trials around real patients rather than ideal patientsBetter understanding the objectives of the study and asking the questions that achieve those objectivesBetter partnering with patients and PIsTo learn more about the Chief Medical Officer Summit 360°, please visit CMO360.org.

Investing in developing a durable platform and strategy early leads to fewer delays throughout development. Locking requirements in early and educating teams to approach combination product development holistically lowers the time to development dramatically. In this panel discussion from the 2025 PODD: Partnership Opportunities in Drug Delivery Conference, pharma executives and drug delivery experts discuss how they used platform devices in concert with an internal engagement strategy to speed up development. Specifically, they address:  Advantages and disadvantages to platform approaches for device developmentOpportunities to overcome technical limitationsApproaches to bring a platform into multiple product design history filesRegulatory hurdlesAssessing business case and getting organizational buy-in To learn more about the PODD Conference, please visit Drug-Delivery.org.

About this podcast: Recorded at the 2025 DPHARM conference, this state of the union panel convenes site, technology and pharma to discuss:  Different models and the pros and cons of the deployment modelsWhat makes a great patient matching solutionPredicting what the future growth of this segment looks likeThe role of AI in this space

About this podcast:  Recorded at the 2025 IO360º Summit, this podcast addresses how Project Optimus is reshaping dose selection from maximum tolerated dose to a balance of efficacy and safety. More specifically, this panel addresses FDA objectives for multi-dose selection, alternative dose-selection strategies with imaging, biomarkers and tumor burden analysis, the higher costs and longer timelines, and financial impacts for early-phase oncology companies.  For more information, go to IO360summit.com.

About this podcast:  Recorded at the 2025 CRAACO meeting, UNC Lineberger’s Comprehensive Cancer Center shares  an initiative to allow local HCPs to still provide clinical care to patients but decentralized research elements to the university system, following the FDA’s change in guidance on Form FDA 1572, which stopped requiring local healthcare professionals (HCPs) involved in DCTs to be listed if they’re only performing standard-of-care.  Dr J Kaitlin Morrison talks about the process from an initial pilot of two sites to more than 23 today, providing cancer patients across the state the opportunity to access clinical trials. Specifically: How they are managing relationships with sitesHow they’re monitoring research elementsGoals, next steps and thoughts for industry sponsors

About this podcast: This podcast, recorded at the 2025 Patients as Partners Europe meeting, addresses how Novo Nordisk is consolidating patient insights to ensure greater knowledge-sharing, data integrity and traceability, addressing the unmet needs of patients, aligning product outcomes with patient expectations, and more.  For more information, go to theconferenceforum.org. 

In this podcast, Kate Woda, Conference Director of the Patients as Partners in Clinical Research conference discusses what attendees can expect at the 13th annual event, including key topic areas, session highlights, presenting companies and more. For more information about the upcoming event, full agenda and speakers, visit patientsaspartnersconference.com.

In this podcast, featuring a panel discussion from the 2025 Chief Medical Officer Summit 360°, CMOs with recent M&A and partnership experience share those experiences as well as how CMOs of other small to midsize emerging biotech companies can support the conversations and operations that take place throughout the process of business development. Specifically: Different kinds of BD deals to be aware ofHow the CMO fits into various phases of transactionsAppreciating how different c-suite colleagues and direct reports experience these transactionsThe different pharma teams CMOs will interact withWhat happens after the acquisitionTo learn more about the Chief Medical Officer Summit 360°, please visit CMO360.org.

In this panel discussion from the 2025 PODD: Partnership Opportunities in Drug Delivery Conference, pharma executives and drug delivery experts discuss conjugation and bioconjugation approaches to make ASOs and small molecules more tolerable while improving targeting. Technologies discussed include ADCs, PDCs, SMDCs, VDCs, RDCs and AOCs. Specifically they address: Biological and chemical challenges for these therapiesBuilding out scalable manufacturing and a regulatory strategyHurdles to overcome to get products to marketTo learn more about the PODD Conference, please visit Drug-Delivery.org.

This podcast features a panel discussion from the 2025 Chief Medical Officer Summit 360° about how to strategically approach hiring FTEs, insourcing, outsourcing and contracting to be appropriately prepared for the different stages of a biotech companies development from preclinical to early stage to late stage trials to commercialization. Specifically: Balancing the mix of hires and outsourcingHiring for skillsets to enable efficiency without overhiringReactive vs proactive hiringBuilding in a stage appropriate way but also hiring in time for later stagesTo learn more about the Chief Medical Officer Summit 360°, please visit CMO360.org.

While lipid nanoparticles are the most clinically advanced drug delivery system for nucleic acid therapeutics, they are only one tool in a toolbox of potential delivery vehicles. In this panel discussion from the 2025 PODD: Partnership Opportunities in Drug Delivery Conference, pharma executives and drug delivery experts discuss additional tools, including polymeric nanoparticles, protein-based nanoparticles and extracellular vesicles with a focus on: Where LNPs potentially fall shortWhere different tools can enable therapeutic deliveryChallenges to achieving meaningful clinical impact for these different vehiclesBuilding out a portfolio of delivery vehicles To learn more about the PODD Conference, please visit Drug-Delivery.org.

About this podcast:  This podcast comes from the DPHARM 2025 meeting. Pfizer details how they jointly co-designed and implemented an EDC/CDMS platform that’s fit for purpose, and analysis data set. This session focuses on:Engaging all stakeholders in designing the platformThe evolution of the platform focus: the transition from the majority of data coming from EDC to 3/4 of the data from third party sourcesImpact of the advanced data analysis capabilities for risk managementReview of impact on initial studies now using the platform For more information, go to DPHARMconference.com. 

About this podcast:  Preliminary survey results conducted by the Tufts CSDD focus on the strategic and structural growth of new trial sites and partnerships in bringing trials directly to the local communities. The preliminary survey findings also shed light on the strategic and structural growth of these new trial sites and partnerships, offering valuable insights into the evolving global clinical trial landscape. The significant shift towards bringing clinical trials directly to local communities through various innovative models is noteworthy. Many new clinical trial execution models have been introduced during the past decade including site staff embedded within clinical care settings, remote sites, retail pharmacies, urgent care facilities, and mobile units going directly into local communities.  This session comes from the 2025 Partnerships with Sites Summit.