Your biotech portfolio is growing—congratulations! But what clinical operations capabilities, systems, and external providers do you need to prioritize first to support this growth? What are the best parts of big pharma that you can adopt, but without the bureaucracy, big prices, and lack of flexibility? And how do you project and strengthen the culture that made your company successful?

Regardless, if a small biopharma has an outsourcing operational model or not, they will need a conscientious strategic operational plan that encapsulates effective communication, bolstered by robust vendor management, cultural alignment, and ongoing monitoring. They will need to either have internal staff or leverage a service provider that will assist in overseeing the CRO or study activities. Small bioPharma may need to rely on external professional services to staff quickly with the appropriate profiles to adjust workload around study needs. Technology for small BioPharma may be more challenging due to the high cost of systems, infrastructure, and resources to manage clinical systems. Regardless, the core business of BioPharma is drug development and not software development leading to a buy strategy versus a build. However, clinical operation teams need to at least have the capabilities to visualize data, and capability should be an in-house function. If the operational strategy is to outsource study conduct and clinical systems are with the CRO, then it is essential that all data, whether clinical operational data or patient data should be under the control of the Biopharma. This means regular ingestion of data from CRO to sponsor and/or direct access to the data allowing for the quick analysis for decision-making. This as well allows BioPharma to compare the performance of CROs should they have more than one. Therefore, establishing metrics is a must to be able to monitor CROs and address issues sooner rather than later. Any organization should always have data at their fingertips to allow for quick decision-making.

Discover strategies for managing clinical trials effectively in small biopharmaceutical companies. Learn to foster transparency and oversight with integrated project teams, define your role in ensuring trial success, and make informed decisions about in-house expertise and technology integration. Navigate challenges for a successful trial journey.

For small biotechnology companies, ensuring that the appropriate vendor partners are engaged is of particular importance, as not only is there a greater dependence on the success of each of the clinical trials, but the viability of the company itself is at stake. This presentation will provide a framework for selection, partnership, and management of the various vendors toward successful set-up and execution of clinical program trials.

Expanding the internal Clinical Operations team while partnering with a CRO can be successful, but choosing the right roles at the right time while adequately developing a CRO oversight process/plan that fosters teamwork, partnership, and collaboration can have its challenges. This session will provide an overview of how one company worked through this internal growth, which included site monitoring, medical monitoring, data management, study management, the TMF, and pharmacovigilance while running six global Phase III trials and two Phase I trials that successfully met each study's critical milestones.

The topic includes strategies and key considerations to implement operational success for clinical studies with outsourced teams. Operational success in clinical trials is attributed to robust study planning and diligent oversight when outsourcing. We will review study planning strategies: Highlighting resources, processes, and systems to adequately support study activities and identify risks. We will also review best practices for study oversight: highlighting quality and milestone management to ensure operational success.

Per ICH E6 (R2), the sponsor is responsible for ensuring that the clinical study is conducted in accordance with the protocol, GCP, and applicable regulatory requirements. The sponsor must implement a system (or process) to manage quality throughout all stages of the trial. However, there are minimal guidance available to confirm minimum oversight requirements to ensure adequate sponsor oversight. The Bioresearch Monitoring Program Information (BIMO) provides comprehensive information on site and data audits but does not list activities, tasks, or processes the sponsor should oversee to ensure a CRO, a central lab or any other vendor partners are meeting quality standards. Oversight tasks if not done correctly can be cumbersome and pose additional financial and resource burden on the sponsors. With multiple vendor partners, a requirement for sponsor oversight and a burden to maintain quality pose an immediate need to identify oversight approach that is feasible, flexible, and manageable. What should the sponsor oversee & how to document the oversight are some of the questions many sponsors are asked to address. This presentation will focus on a risk-based approach to oversee vendor partners.

This presentation will be focused on how to evaluate the outsourcing needs and select "fit for purpose" outsourcing model to complement small biotech infrastructure. Speaker will share best practices and considerations for assessing and selecting clinical vendors, as well as understanding the budget and scope before contract is signed. Special focus will be given to building successful partnership with the CROs from the start and building A-team for the trial.

One of the challenges of a small biopharma is linked to high clinical development costs. To circumvent these barriers, small biopharma companies tend to seek partnerships outside the U.S., e.g., Eastern Europe or India, to manage their clinical trials. Balancing the cost efficiency of running trials in the region(s) with the extra work needed to ensure compliance will be discussed.

Teams no longer have the luxury of taking their time to learn how to get the best from each other. Our world is less certain, more challenging, and change is accelerating. You are facing white-water change. Too slow to adapt and you risk getting stuck on the rocks; or worse, ceasing to be relevant and getting swept away by your faster, nimbler competitors. To adequately navigate these challenges, teams need to learn and evolve at pace, continuously experimenting and growing their capabilities to maximise their performance. There is no certainty about anything any more. To succeed in this harsh environment, teams need to discard old ways of thinking that are limiting what they can achieve. Instead, they need to form more useful mindsets and sustainable habits, changing their behaviours and discovering more effective ways of working. In other words, to navigate constant change and accelerate performance in today’s fast-moving world, teams need to be emergent.

Recently updated regulatory guidance for clinical trial planning has become more complex. We will discuss an overview of ICH E8 (R1) and ICH E6 (R3), including the proactive planning of clinical studies using Quality by Design and Critical to Quality Factors Assessments. The aim is to ensure trial operational feasibility, subject safety, and quality data for submissions from a multi-stakeholder lens. This involves input from critical stakeholders and the definition of risks during the protocol design phase and throughout the product life cycle. 

With the FDA accelerating pathways in rare disease, oncology, infectious disease and other indications using gene therapy, implications on study start-up and feasibility for sites exist to conduct these trials. This discussion will highlight regulatory and practical feasibility questions.

In large pharmaceutical companies, the opportunities for advancement may be limited due to the availability of leadership positions, corporate siloing, and competition. In addition, exposure to the drug development process may be limited by function. Small biotech may offer an opportunity to use large pharma drug development and functional experience to gain further knowledge and expertise across functional areas leading to enhanced development and leadership opportunities. There is risk and a transition period when taking this leap. This presentation will focus on the differences between the work experience at a large pharma vs a small biotech, what to expect during the transition, and how to plan for success. Topics will include infrastructure, choosing a CRO, relationships, technology, culture, recruitment, hiring for success, and training and development of team members.

Clinical study success depends on three “C” or core elements: communication, collaboration, and cooperation from all participating individuals. When it comes to working on rare diseases, the chances of outsourcing to a CRO or vendor with prior experience in that particular indication are often nonexistent or quite limited. This presentation will focus on how Rezolute took a more direct, hands-on approach to executing a rare pediatric pivotal Phase 3 Global Program. How we removed divisions in vendor communication lines and instead led or joined the lines which helped facilitate site and vendor relationships, ultimately delivering faster outcomes and creating stronger and more cohesive study teams.

Running trials nimbly—utilizing in-house talent and managing a trial without a CRO. How to evaluate if this is the right model for you and look at the pros and cons for your team/organization. Which vendors and consultants will you need and which resources can be used from the company? Which processes and plans will need to be developed and which lessons learned?

Discover strategies for diverse clinical trial participation by developing inclusive protocol designs, applying data-driven site identification, and proactively customizing outreach and support for diverse populations. Attendees will learn strategies for determining trial-specific benchmarks and measuring success to enhance their ability to contribute to equitable and representative clinical trials.

This presentation on "Collaborative Partnerships" provides a glimpse into the exploration of collaborative partnership as a strategic avenue for operationalizing Diversity, Equity, and Inclusion (DEI) initiatives within organizations and even our healthcare system. The focus is on forging inclusive alliances that contribute to the effective implementation and integration of DEI efforts. We can approach this from case studies, best practices, and practical insights, which this presentation seeks to shed light on the transformative potential of collaborative partnerships in creating a more diverse, equitable and inclusive organizational culture and environment. This brief presentation will attempt to delve into key considerations, challenges, and success factors in establishing and nurturing these alliances, emphasizing the role of outsourcing and external partnerships in advancing DEI goals. Ultimately the goal is to provide a fair understanding of how organizations, such as sponsors, CROs, and clinical trial research centers can leverage collaborative partnerships as a powerful tool for operationalizing DEI initiatives and fostering sustainable positive change as we work together to better the lives of all citizens, regardless of race, religion, or ethnicity.