Small biopharma clinical trials have doubled in the past five years, with higher overall success rates than larger companies. They have sponsored more than 3,300 clinical trials since 2021, nearly double since 2016. Yet filings for these companies are not always smooth. Even in the face of challenges, small biopharmas are embracing innovation, with shorter trial durations on average than larger companies and greater ‘white space’ between research phases. The session will offer data and insights on clinical ops and the importance of innovation to small biopharma.

Clinical trials face many challenges on the path to success. Scientific advances in disease biology and technology enable discovery of new targets and therapies but increase the complexity and number of choices, especially for smaller companies with limited resources. Trial design is foundational for solving these challenges. We will identify principles and best practices for clinical trial design to optimize success, based on analysis of the literature and practical experience.  We will engage the audience in understanding the challenges, and the value of potential solutions (modeling, simulation, adaptive designs, real-world data, decentralized trials, etc.) that increase success at lower cost.

Since 2019, our industry’s work has shifted as a result of COVID-19 limitations. Creating and maintaining a corporate culture with a geographically-dispersed team can prove very challenging to the delivery of complex clinical trial goals. Current practices to support virtual teams will be summarized. Members of the clinical trial operations industry were surveyed for primary pain points and benefits of the new virtual working model, to inform how to sustain and support high-performance virtual teams. A critical focus must be placed on sustaining collaboration, trust, and communication within a virtual world.

Remember, the buck stops with the sponsor! So, effective oversight, particularly for a lean organization, begins with the realization that vendor resources are an integral part of a clinical operations team. The ability to oversee vendor activities to ensure optimal performance and minimal risk requires a well-thought-out vendor oversight plan - one that is realistic and feasible. We need to maximize the return on outsourcing investment.

Building a vendor management capability within an operations organization can be puzzling in determining scope and right size. Kara will share some insight into her experience of building a vendor management process and team that is fit for purpose, serving the needs of the organization to provide proper oversight of vendor activities, while building a relationship that brings value to both parties.

Driven by a race to proof-of-concept and bogged down by an ever-growing list of vendors and their resourcing hurdles, small biotechs are turning to innovative solutions to bolster their in-house clinical operations capabilities within study start-up as a means of getting to FPI on time. In this presentation, Daniel will demonstrate how sponsors of any size can reduce start-up timelines drastically while strengthening the partnership with key sites. All without hiring a team or procuring yet another vendor to manage.

Small biopharma organizations running lean clinical trials, more than ever, need to ensure they are validating their performance benchmarks in order to more accurately forecast clinical trial completion. This session will highlight key steps to better estimate performance based on past analogues, how to leverage internal data assets, and approaches for choosing the best modeling method for your trial.

University-based incubators assist start-up company access to CORE facilities, simulated test environments, clinical trial units, interns, and an array of experts to serve as advisory board members, protocol reviewers, and principal Investigators. Review how biotech incubators serve small businesses and faculty innovators with clinical program needs through resource matching, PI and site selection assistance, regulatory education, scoping of funding sources, mentorship alignment, coordinated use of university infrastructure, and workforce needs.

Allows small internal teams to review global data sets and maintain quality and oversight, as well as subjective quality indicators such as participant and site feedback gathered from our patient advocacy group.

The growth of gene, cell & RNA-based therapies places an increasing challenge on study start-up activities.  This is due to additional complexities including regulatory site level requirements for Institutional Biosafety Committee (IBC) risk assessment reviews in the US, Canada, Australia, and GMO reviews in the United Kingdom. This talk will educate pharma on these additional regulatory requirements, the impact on study start-ups, and strategies to mitigate. Clinical Operations Executives will leave with a greater understanding of these specialized biologics trials require for start-up and ongoing maintenance from a regulatory perspective.

As with any treatment modality, cell and gene therapy therapeutic clinical trials have several unique considerations, including the way that they are manufactured, stored, and administered. In addition, there are specific study design requirements to comply with regulations and manage safety. The purpose of this discussion is to review some of the differentiating characteristics of a cell and gene therapy trial.

The focus during set-up for trials of cell and gene therapies is often on navigating the regulatory complexities. However, as we develop more advanced therapies for novel indications, this presents unchartered territory for sites and participants, requiring early engagement of both groups for a successful clinical operations strategy. This talk will share ideas of how to develop and implement a plan to engage site staff and patients, prior to regulatory submission, to positively impact trial timelines, recruitment, and retention.

There are thousands of publications, service offerings, and software solutions related to clinical site selection. Many of these solutions add tactical and operational value yet none address site selection strategy - a vitally important component of trial success and commercial adoption. We will discuss site selection strategy from a different perspective.

This presentation covers how Bayer's External Relationship Governance model adds value to the business ensuring a reliable partnership and complements the Sourcing & Procurement Functions, sharing current trends on procurement roles and the necessity to have an operational perspective in sight, with different approaches from different business necessities and how to best manage CMOs, 3PLs and Clinical Trials partners.