Discover how early engagement with key opinion leaders transforms clinical trial outsourcing decisions, reduces program risk, and optimizes clinical operations for higher-impact trial outcomes.

1. Thierry Schulmann, Senior Director, Medical Affairs Strategy, Sumitomo Pharma (LinkedIn)

This episode—recorded live at COG Europe—features Thierry Schulmann, Senior Director, Medical Affairs Strategy at Sumitomo Pharma, in a highly practical session focused on the operational value of engaging key opinion leaders (KOLs) early in clinical research.

Listeners will gain a clear framework for involving KOLs at each stage of clinical trial outsourcing, from initial design and feasibility to trial execution and market access. Drawing from real-world case studies, Thierry Schulmann illustrates how underestimating KOL input can lead to misalignment on endpoints, failed market launches, or unmet regulatory expectations—even in otherwise well-executed trials.

The discussion covers:

1. Why CRO selection should account for KOL expertise and therapeutic alignment
2. How to use KOL engagement to build patient-centered protocols and enhance feasibility, recruitment, and retention
3. The impact of KOLs on regulatory strategy, payer acceptance, guideline inclusion, and real-world implementation

For clinical operations professionals, outsourcing leads, and vendor managers, the episode provides actionable strategies to protect trial value, avoid program pitfalls, and ensure the commercial relevance of new therapies through smarter stakeholder engagement and clinical study optimization.

00:02:10 – Framing the risks: Why approved products still fail to launch due to misaligned trial endpoints and weak stakeholder input

00:03:13 – Case study: The commercial impact of not localizing active comparators for European market expectations

00:04:58 – Why strategic KOL engagement is a form of "outsourcing" critical expertise beyond CRO selection

00:07:13 – Clinical operations best practice: Focusing on endpoints that drive real-world adoption, not just statistical significance

00:09:28 – Bridging gaps: KOLs as operational connectors between academic protocols, regulatory requirements, and patient needs

00:10:40 – Regulatory navigation: How global KOL networks inform region-specific trial design and submission strategies

00:13:19 – Leveraging KOL and patient group relationships for evidence generation in rare and serious diseases

00:14:47 – Ensuring real-world effectiveness: The role of KOLs in validating trial design beyond controlled settings

00:18:30 – Lessons learned: When missed KOL input on comparator choice, unmet need assessment, or side effect profiles led to program failures

00:21:36 – When to engage KOLs: Practical recommendations for biotech and pharma, starting as early as Phase 1

1. Proactive KOL engagement in early trial design is essential for successful clinical trial outsourcing and market access—don't wait until later phases to bring real-world and regulatory perspectives into protocol development.
2. Aligning clinical study endpoints and comparators with both therapeutic practice and payer requirements optimizes trial relevance and supports smoother regulatory acceptance—a key consideration...

Learn how small biotech’s can streamline clinical trial outsourcing, optimize CRO selection, and establish truly patient-centered operations for rare disease studies—while maintaining high data quality and speed.

1. Jurate Lasiene, VP Clinical Operations, North Sea Therapeutics
2. LinkedIn: Jurate Lasiene

This episode of The COG Review: Building Better Clinical Studies is recorded live at COG Europe in Amsterdam. Jurate Lasiene, VP Clinical Operations at North Sea Therapeutics, shares firsthand insights from managing a first-in-human, early-phase rare disease trial with a small, agile biotech team. The session explores critical decision points and real-world solutions in clinical trial outsourcing, CRO selection, and effective sponsor–vendor collaboration.

Key topics include designing adaptive, patient-first protocols for challenging rare disease populations, the shift from traditional full outsourcing models to targeted FSP (Functional Service Provider) or hybrid approaches, and optimizing budget, speed, and quality by retaining operational control in-house where it matters most. Jurate Lasiene offers a practical breakdown of site and partner selection, early regulatory and KOL engagement, and hands-on clinical operations best practices.

This episode equips clinical research professionals in biotech, pharma, and CROs with actionable frameworks for clinical study optimization—especially useful for those navigating complex trials with lean teams and limited resources. Listeners gain concrete guidance on the sponsor-side leadership choices and process refinements that reduce common failure points and accelerate study timelines.

00:01:40 – The unique operational challenges of rare disease trials: small, dispersed patient populations and high rates of trial discontinuation

00:03:41 – Why small biotech’s are driving the majority of clinical trial starts and how their outsourcing strategies have evolved

00:04:31 – Clinical trial protocol design: avoiding rigid endpoints and restrictive eligibility to improve enrollment and retention

00:05:16 – The necessity of integrating patient and caregiver input early for truly patient-centered clinical trials

00:06:45 – How to select clinical trial sites: speed, fit, and operational capacity versus academic prestige

00:08:31 – Practical cost-savings from targeted FSP models: 30% budget reduction by outsourcing only specialty capabilities

00:10:23 – Engaging KOLs and patient advocacy groups at the protocol development stage for better outcomes

00:11:41 – Keeping oversight in-house with dedicated monitors/PMs: advantages for quality and site engagement

00:13:27 – Building a “meshwork” of specialist partners to keep small teams agile, responsive, and in control

00:16:46 – Simulating the patient journey to optimize protocol, logistics, and site operations for clinical study optimization

1. Early and deep integration of clinical operations into trial and protocol design is essential for avoiding downstream roadblocks—making this a core clinical operations best practice.
2. Targeted outsourcing and deliberate CRO selection (favoring fit and flexibility over scale alone) enables small teams to maintain control, ensure sponsor oversight, and optimize budgets.
3. Mapping the exact patient (and caregiver) journey—through direct simulation and advocacy group...

Discover operational strategies to move beyond traditional clinical trial outsourcing—learn how the clinical mesh approach can optimize study speed, oversight, and cost efficiency for today’s clinical operations leaders.

1. Maria Expósito Lorido (LinkedIn)
2. Venture Partner, Vu Venture Partners
3. Extensive experience in clinical development, clinical trial outsourcing, and operational leadership within pharma/biotech

This live session from COG Europe in Amsterdam features Maria Expósito Lorido, a leading venture partner with hands-on experience designing and implementing innovative clinical outsourcing strategies. Maria offers a compelling presentation shifting the conversation from conventional CRO selection and outsourcing models to a new paradigm: sponsor-led orchestration through the clinical mesh playbook.

Listeners gain practical guidance on clinical operations best practices by contrasting traditional outsourcing with platform and ecosystem-based models. Maria reveals why most studies fall short on recruitment, what it costs, and how an orchestrated mesh of specialized partners can reduce delays and increase value for sponsors and patients alike.

Specific areas covered include how to tailor sourcing architecture to your study’s needs, which operational components to retain or externalize, and ways to apply clinical study optimization principles for faster, more flexible trial delivery. The episode also addresses implementation steps, measurable KPIs, and critical sponsor responsibilities in this emerging model.

Ideal for clinical operations, outsourcing managers, and vendor strategy professionals seeking to future-proof their approach to CRO selection and clinical trial outsourcing.

00:03:00 – Why 80% of clinical studies miss recruitment targets and the financial impact of delays

00:05:00 – Comparing small, agile biotech teams vs large pharma R&D models for clinical trial delivery

00:06:55 – The Nvidia platform analogy: platform business models vs linear development pipelines

00:07:10 – Introduction to the “clinical mesh” model: moving from fixed structures to reconfigurable networks

00:08:33 – Three sourcing architecture types—full-service CRO, functional service provider, and clinical mesh—and when each works best

00:11:23 – Governance challenges and sponsor responsibilities under the mesh model

00:14:04 – Early-stage oncology case study: cost, timelines, and screen failure rate compared across outsourcing models

00:16:27 – Quality management, risk, and safety oversight: what sponsors must own when orchestrating a clinical mesh

00:18:57 – KPIs for clinical study optimization: measuring cost per qualified patient, time to first contact, and more

00:19:43 – 90-day roadmap for piloting a clinical mesh approach with stepwise best practices

1. Orchestrate, don’t just outsource: Sponsors retain strategy, quality, and data oversight even when leveraging a network of specialized vendors—this increases flexibility and operational control compared to traditional outsourcing.
2. Match sourcing architecture to study needs: Evaluate each study to determine the best-fitting sourcing model (full-service CRO, hybrid/FSP, or clinical mesh), rather than defaulting to a single approach for all trials.

Navigating Global Clinical Trial Outsourcing: Risk, Strategy & CRO Partnerships in a Changing World

Gain operational clarity on the evolving landscape of clinical trial outsourcing—discover the risk factors, partnership models, and geographic strategies reshaping CRO selection and clinical operations.

1. Heike Schoen, CEO, Loomis International (LinkedIn)
2. 20+ years in clinical operations, global trial strategy, and vendor management
3. Bart Scheerder, Host
4. Authority in European clinical operations and outsourcing trends
5. David Jones, Head of Content, The PBC Group

Recorded live at COG Europe, Amsterdam.

This episode of The COG Review: Building Better Clinical Studies features Heike Schoen, CEO of Loomis International, in a keynote session from COG Europe. The discussion centers on the global shift in clinical trial outsourcing, with a sharp focus on how sponsors and CROs are adapting to rapid changes in regulation, geopolitics, and technological innovation.

Heike Schoen explores the evolution of sponsor–CRO partnerships, from transactional service agreements to nuanced hybrid models, where flexibility and deep therapeutic expertise are essential for success. Practical examples from Novartis–PPD and Moderna–Medidata illustrate both functional service partnerships and the impact of digital, decentralized trials.

Key areas include CRO selection strategies for emerging markets, navigating regulatory changes, and building operational agility in the face of supply chain fragility and geopolitical risk. Insights are tailored for professionals involved in clinical operations best practices, outsourcing decisions, and those seeking to optimize clinical studies through smarter partnerships and technology use.

The session closes with real-world challenges and live audience questions on how to structure outsourcing models, respond to regulatory shifts, and future-proof location choices for clinical trials.

00:03:37 – Global clinical trial outsourcing market growth and drivers

00:04:45 – The rise of hybrid CRO partnerships: strategic alliances vs. modular models

00:06:06 – Digital platforms and AI: boosting operational efficiency in decentralized trials

00:07:00 – CROs must demonstrate deep therapeutic expertise and flexible service models

00:08:15 – Geographic diversification: assessing emerging markets for clinical study optimization

00:10:06 – AI’s impact on CRO value pools: standardization and resource allocation

00:12:09 – Comparative advantages of clinical outsourcing in the US, Asia-Pacific, Europe, Latin America, Africa, and the Middle East

00:14:24 – Geopolitical risks in outsourcing: contingency planning for disruption and instability

00:16:08 – Supply chain fragility and cross-border data management: lessons for clinical operations best practices

00:18:10 – Key drivers for outsourcing strategy: cost pressure, patient diversity, regulatory speed

00:19:49 – Location strategy essentials and what sponsors should expect from CROs

00:24:29 – Guidance for small biotechs on engaging CROs and designing flexible outsourcing models

1. Hybrid CRO partnership models are becoming standard—sponsors should seek partners who can offer both full-service and functional...

Pipeline Strategy: Balancing Science, Feasibility, and ROI in Clinical Development Decisions

What does it take to make confident, cross-functional pipeline decisions that drive approval speed and sustainable value for companies in today’s clinical research landscape?

Moderated by Emily Roberts-Thomson, Development Operations Leader

Featuring:

• Raj Patel, Chief Operating Officer, ReacX Pharmaceuticals

• Nikhil Dube, Lifecycle Management Strategy Lead, Biogen

• Mukhtar Ahmed, Director, Project and Portfolio Strategy, Greenstone Biosciences

Recorded live at COG Bay Area, this candid panel brings together executive decision-makers from biotech and pharma to break down how leaders navigate real-world portfolio strategy. The episode centers on operational and strategic considerations behind advancing programs through clinical development, highlighting the balance between scientific conviction, development feasibility, market opportunity, and the resource reality facing large and small organizations.

Across the discussion, guests confront the hard questions: How do companies form pipeline priorities when there’s no single formula and risk is high? How is cross-functional alignment reached amid competing perspectives from research, clinical, and business stakeholders? What happens when market forces or funding landscapes suddenly shift, and clinical priorities must adapt in real time?

The conversation offers practical takeaways for leadership teams, study managers, and anyone responsible for portfolio and governance in clinical operations. Listeners will hear direct examples and best practices in portfolio rationalization, aligning R&D and commercial goals, preparing for investor scrutiny, and maintaining flexibility as science, funding, and the therapeutic landscape evolve.

00:03:22 – The critical variables in pipeline decision-making: time to approval, cost, risk profile, and investor priorities in smaller companies.

00:04:45 – Defining the three pillars of commercial portfolio review: scientific rigor, development feasibility, and commercial opportunity.

00:06:14 – Smaller company perspectives: building agility with scientific depth, setting translational feasibility as a practical filter.

00:08:02 – Balancing scientific conviction and commercial realities: frameworks for vetting high-risk, high-potential targets and business discipline in early-stage programs.

00:10:12 – When to deprioritize mechanistically elegant targets that lack translational or commercial plausibility.

00:12:00 – How individual leadership mindsets shift from discovery focus to financial pragmatism with career progression.

00:13:28 – The real challenges of cross-functional alignment: gaining buy-in when teams or investors disagree on program value.

00:16:22 – The unpredictable journey: case example where ‘unexpected’ surviving candidates emerge as portfolio winners.

00:17:05 – The influence of investors and boards - how market timing and external conditions force rapid portfolio shifts.

00:19:03 – Best practices in large-company collaboration: integrating collective baselining and focused scenario-building across commercial and scientific domains.

00:21:38 – Running transparent, non-siloed portfolio processes in smaller biotech - connecting scientific and business data, KOL feedback, and investor imperatives to rapid cycle decisions.

1. Successful portfolio prioritization demands a rigorous cross-functional lens -combining scientific rationale, operational feasibility, and realistic assessments of funding and market drivers.
2. Transparent discussions and alignment between R&D, clinical, and commercial functions are critical...

AI Integration in Clinical Outsourcing: Real-World Applications and Next Steps

Discover actionable guidance for integrating AI into clinical trial outsourcing, with a focus on operational efficiency, quality, and oversight from an experienced biotech leader.

Featuring:

Paulius Ojeras, Head of Clinical Operations, Perceive Biotherapeutics (LinkedIn), keynote speaker at COG Bay Area

Recorded live at COG Bay Area, this session features an in-depth presentation from Paulius Ojeras, who brings more than 18 years directing clinical programs in biotech and CRO environments. With a candid, technical perspective, he explores the evolving adoption of AI agents and automation in clinical operations - cutting through industry hype to share what’s working, where the risks lie, and how to implement with minimal disruption.

Paulius Ojeras addresses the practical realities of AI adoption, from early-stage automation through to “agentic AI” capable of acting as operational teammates. He details the case study of deploying AI for Trial Master File (TMF) management at Perceive Biotherapeutics, outlining the specific gains in error reduction, scalability, and process speed. The discussion goes beyond technology, offering a framework for selecting solutions, evaluating vendors, and anchoring AI initiatives in robust human oversight and process redesign.

This episode is tailored for clinical operations leaders, vendor managers, and outsourcing strategists seeking a best-practice, risk-mitigated approach to AI - filled with hard-won lessons, practical questions for suppliers, and clear indicators of what “good” looks like in this emerging space.

00:02:37 – The ‘AIQ’ (Augmented Intelligence Coefficient): Why most clinical operations teams score near zero today - and what that means for competitive advantage.

00:04:53 – The five levels of AI in clinical trials: From basic automation to fully autonomous agents.

00:06:28 – “Agentic AI” explained: Where AI can become a real teammate, not just a tool, and which activities are best suited for this shift.

00:09:51 – A live case study: How Perceive Biotherapeutics integrated AI teammates into TMF management, what triggered the decision, and how results compared with traditional CRO models.

00:13:02 – AI vs. human performance: How AI reduced TMF filing errors by 25% compared to QC-checked human work, with clear examples of operational improvements.

00:15:10 – Real-time quality by design: Automated document reconciliation, instant issue flagging, and the move away from labor-intensive QC.

00:18:06 – Key vendor selection criteria: Questions to ask, red flags to watch for, and why 95% of AI companies may not survive.

00:21:26 – Consistency, transparency, and validation: Guardrails for ensuring reliability and compliance in regulated trial environments.

00:25:05 – Change management and team education: Why AI literacy, prompt engineering, and cross-functional buy-in matter for sustainable implementation.

00:26:47 – The end game: How AI should amplify - not complicate - operations, freeing teams to focus on patient and protocol quality.

1. Think beyond automation - strategically redesign processes for “agentic” AI, ensuring humans focus on oversight and exception handling, not repetitive tasks.
2. Assess vendors the way you’d assess a new CRO: demand proof of real deployment, robust oversight, and clear accountability, not just a slick demo.
3. Invest in AI literacy across your team - garbage in means garbage out, so prompt design and...

Discover actionable frameworks to incorporate the patient voice throughout clinical trials and ensure study design delivers both regulatory value and real-world outcomes.

Guest: Lisa Lea – Director of Patient Insights, Merck

LinkedIn: Lisa Lea

With over 20 years in biotech and clinical development – 18 of those in pulmonary arterial hypertension – Lisa leads global strategies to embed patient perspectives into every phase of research at Merck.

Clinical trial success increasingly depends on moving beyond tokenistic patient engagement towards approaches that deliver measurable value. Recorded live at COG Bay Area, this session features Lisa Lea, Director of Patient Insights at Merck, as she shares operational frameworks and firsthand experiences for integrating patient perspectives early and often throughout study development.

Lisa draws on decades of clinical and industry leadership to clarify what meaningful patient engagement really looks like, why regulators and payers now expect it, and how study teams can systematise input to improve trial design, recruitment, and data integrity. Real-world vignettes underline how adapting protocols – even small adjustments – can avert site and patient loss, while strategic engagement with advocacy groups transforms both design and recruitment outcomes.

Key themes include trends in regulatory expectations, practical avenues to gather patient feedback, and tools to quantify the impact of engagement. Whether you oversee protocol development, feasibility, or operations, you’ll come away with a concrete checklist to embed patient insight across study endpoints and execution.

00:03:09 – “Nothing about us, without us”: Why early patient involvement sets the foundation for relevance, retention, and success in clinical trials.

00:04:49 – 80% of clinical trials miss recruitment goals, with preventable patient burden as a key factor – the case for patient-driven protocol design.

00:05:58 – The evolution of patient engagement post-HIV/AIDS activism and how regulatory expectations have transformed over the past three decades.

00:07:03 – Practical definition of patient-focused drug development and the FDA’s systematic approaches for capturing patient and caregiver input.

00:08:00 – Concrete benefits: Patient engagement improves recruitment speed, retention, data relevance, diversity, and streamlines protocol amendments.

00:10:42 – How and where to embed patient voice, from prioritizing advocacy partnerships to pragmatic steps during protocol development and feasibility assessments.

00:12:43 – Examples from site operations: The operational consequences of burdensome visit schedules and how patient input can safeguard enrollment.

00:15:40 – “Beyond tokenism”: Strategies for feedback loops that demonstrate value to patients and foster true partnership.

00:17:01 – Common operational challenges – cultural resistance, lack of structure, and compliance concerns – and proven solutions to address them.

1. Engage patients early and often – feedback at protocol development and feasibility planning stages is critical to avoid costly amendments and study delays.
2. Use advocacy partnerships, patient advisory boards, and real-world data sources to identify barriers and needs that might otherwise be overlooked.
3. Create clear, structured feedback loops and share outcomes so patients see how their input drives tangible improvements in studies.

Discover practical strategies for building cross-functional alignment and trust to ensure faster, more efficient completion of clinical trials.

Featuring: Kimberly Guedes, VP Clinical Operations, Intensity Therapeutics (LinkedIn), keynote speaker at COG Bay Area

Recorded live at COG Bay Area, this episode delivers a candid, operationally focused keynote from Kimberly Guedes, drawing on over 30 years in drug development, global clinical operations, and vendor oversight. David Jones guides the conversation, foregrounding challenges and solutions for anyone directing clinical study delivery in pharma, biotech, or contract research settings.

The discussion homes in on one of the biggest practical challenges for clinical leaders: how to foster true stakeholder engagement across sponsors, CROs, sites, vendors, and trial participants. Kimberly Guedes shares grounded advice for aligning incentives, clarifying roles, and maintaining continuity even when teams and vendors change throughout a study’s lifecycle. Several specific pain points are unpacked, from failures in upfront communication to the morale impacts of frequent rework, with actionable steps for improving transparency, collaboration, and operational efficiency.

00:02:23 – Defining stakeholder engagement: why it matters for timelines and data quality.

00:04:56 – The risk of mismatched priorities: sponsors, CROs, vendors, and site perspectives.

00:05:40 – How honest, early communication reduces uncertainty and costly rework.

00:06:54 – Downside of poor engagement: delays, low morale, and repeated mistakes.

00:08:08 – Laying the groundwork: best practices for planning, joint training, and truly collaborative kick-off meetings.

00:10:03 – Building mutual respect: recognising expertise and encouraging transparent conversations.

00:12:07 – Establishing clear governance and efficient escalation paths for faster decisions.

00:13:43 – Keeping roles and responsibilities up to date as teams change.

00:17:38 – The power of inclusivity: making every partner and participant feel ownership of the project.

00:18:16 – Active listening and seeking out what isn’t being said – practical tips for better meetings, both remote and in-person.

00:24:23 – Top reasons for trial delays: lack of key conversations up front, underestimating contracting and operational constraints, and not integrating practical site or CRO input before protocol finalisation.

1. Initiate honest conversations early with all operational partners – from contracting and CROs to sites – to surface constraints and align expectations before finalizing protocols and timelines.
2. Prioritize continuity and regular communication, especially when teams change, through real-time updates of responsibilities and direct outreach beyond the project core.
3. Foster an environment of active listening, transparency, and personal connection – even in remote or hybrid teams. Clarity, engagement, and recognition of expertise drive better outcomes.

Intensity Therapeutics

Kimberly Guedes on LinkedIn

“If you don’t know the constraints of your partners, the timelines that they can do things in, then you have failed already.”

“We build more...