Halloran’s Ecosystem Gathers to Improve Clinical Development Operations

Clinical development and operations executives and life science leaders recently gathered at CORE West – a Clinical Operations Retreat for Executives produced by Halloran Consulting Group – to discuss and solve for pressing industry challenges.

The event is designed to foster in-depth, off-the-record conversations to ignite a roadmap for industry transformation. Attendees and speakers engage in three days of discussions and interactive workshops, resulting in an accumulation of feedback to bring back to their organizations.

Each year, the retreat is centered around multiple themes. For 2023, diversity and modernization of clinical trials, propelling patient-centric approaches to trial design, and recent policy inciting long-term change were the three resonating themes.

These discussions left me, in particular, with a strong belief that we will collectively drive our industry forward to a better place. Here is a summary of the three main themes.

FDORA’s Intent – Diversify and Modernize Clinical Research

The Food and Drug Omnibus Reform Act (FDORA) created an inflection point for clinical researchers to revise, reinvent, and rethink the way clinical trials as a healthcare option are more inclusive and representative of more populations. FDORA, in particular, mandates a modernization of clinical research by improving access and enabling research to reflect the populations it intends to serve while leaving a positive footprint. Just one of those modernization components is the Diversity Action Plan – an important part of a sponsor’s development plan that defines actionable goals for underrepresented racial and ethnic research participants.

The panel centered around this topic discussed the importance of making a difference through actionable strategies to propel the intent of FDORA and the Diversity Action Plan.

For smaller biopharma companies, implementation of FDORA may seem to be a barrier in clinical study design, but the panelists shared actionable steps, including:

• Set a mission and goal within your organization to become dedicated to the diversification of clinical trials. This initiative must start from the top, and requires a commitment within your organization to make appropriate shifts in product development
• Plan early in the development phase by identifying your patient profile. FDORA requires a plan by end of Phase 2, but start earlier
• Build partnerships with investigators, patients, and communities early on to build trust that goes beyond study participation
• Include the patient’s voice by engaging with patients early and often within the trial process
• Adjust site feasibility questionnaires to include demographic and site recruitment strategies
• Train your clinical team to discuss diverse recruitment strategies with sites throughout every stage of the trial
• Industry must share their successes and failures so we can learn from each other to enable positive industry change

“FDORA is important legislation because the industry can no longer make excuses and continue to overlook underrepresented populations. The time is now to make considerable changes on how we develop products in this country and this legislation is a great start.” – Rashida Challenger, Senior Consultant, Clinical Operations, Halloran Consulting Group.

Click here to learn more about the components and timeline considerations for the Diversity Action Plan.

Building Trust and Propelling Patient-Centric Approaches into Trial Design

One key question proposed at the retreat was, “how do we take the patient’s voice and carry it through the entire clinical trial process?” since patients are part of the solution and lead positive change.

To get to that patients-as-partners mindset, trust must be built. This is not a new concept, yet somehow, our industry still faces challenges. There are four key questions that every patient considers, verbally or not, that sponsors must keep top of mind as they develop their clinical trial protocol:

• Can I trust you?
• Are you committed to excellence?
• Do you care about me?
• Is there hope?

The components of sponsors’ clinical development plans, protocols, and actions should reflect tactics that would enable patients to respond positively to these questions. Opportunities are available to tap into the patient voice, including engaging with patient advocacy groups, and families of patients, and being vulnerable with what you don’t know about patient needs in order to find the right answers.

Recent Policy Inciting Long-Term Change – the IRA Impact

The major policy impact discussed at the retreat, in addition to FDORA, was the Inflation Reduction Act (IRA) that was signed into law in December 2022. The act includes some major drug-pricing provisions. While these measures are intended to curb drug costs for patients, biopharma executives and investors indicate they are having unintended development and fundraising consequences.

Industry leaders, investors, and policymakers believe the new drug price measures will disincentivize the development of small-molecule drugs unless companies make other trade-offs like going after a large patient population early in development to maximize revenue post-approval.

An unfortunate result of this policy may be a stifling of innovation based on a trifecta of a tradeoff – development costs, drug pricing impact, and investment trends.

To stay engaged and informed about the IRA, connect with local trade organizations like Biocom and subscribe to their informative industry newsletters. Trade organizations – like Biocom – advocate on behalf of life science companies to policymakers in their geographical regions. Engaging with trade organizations enables companies to have their voices heard where it matters most.

The biggest takeaway is this – don’t assume the IRA won’t apply to your organization. There is a big impact felt by the IRA and its chilling impact on drug development choices and corresponding fundraising opportunities. Connect and engage with your local trade organizations.

Save the Date for CORE East 2023

Halloran will be producing and hosting CORE East, just like CORE West, held in Chatham, Massachusetts from October 4– October 6, 2023. Attendees will be building upon the themes discussed during the latest retreat and will be participating in a workshop-style forum to map out new methodologies to collectively move from idea generation to action to propel our industry forward in meaningful ways.

Save the date! We hope to see you there.

About Halloran Consulting Group

Halloran Consulting Group is a life science consulting firm providing strategic development, regulatory, quality, clinical, and organizational support to industry leaders in the pharmaceutical, biotechnology, and medical device sectors.

Halloran consultants are Subject Matter Experts who deliver a tailored approach to each engagement, successfully propelling clients to their next inflection point. Halloran takes an integrated approach to help clients position their pipelines and companies for success by offering a full range of development and commercialization services.

Contact our team today to discuss your clinical development goals and clinical operations challenges. We’re ready when you are.