As we begin a new year, a singular message rings true across all pockets of the life science industry – we must ‘do more with less.’ This message was echoed during the recent JP Morgan Healthcare Conference and will continue to resonate throughout the year.
The macroeconomic conditions facing our industry include reduced headcounts, reduced funding opportunities, and reduced budgets, and yet, despite the headwinds, science and innovation continue to press forward to improve human health. The industry environment is at a different pace than what was experienced in the last couple of years when funding was more accessible, resources were rising rapidly, and drug development was expedited in many ways.
Our current environment is quite different. As we face this ‘year of correction,’ we are called upon to ‘do more with less.’ But what does this mean, and how should our industry prepare for these challenges and opportunities?
Halloran believes there are six critical recommendations to maximize the year ahead, stay resilient in the face of obstacles, and continue to propel clinical development forward.
1. Maximize Collaboration with the FDA
In 2022, the U.S. Food and Drug Administration (FDA) approved fewer marketing applications than in previous years. For example, there was a significant decline in FDA’s Center for Drug Evaluation and Research (CDER) approvals for novel drugs compared to prior years because of inadequate applications.
We also saw FDA under increased scrutiny around the Accelerated Approval (AA) process, as numerous drugs cleared haven’t been confirmed to benefit patients in follow-up testing. Additionally, the Food and Drug Omninus Reform Act (FDORA), signed by President Biden on December 29, 2022, now requires that confirmatory studies be initiated before a sponsor receives AA designation. The confirmatory study is a topic of high interest as clinical trial sponsors must verify trial results from their pivotal study in a Phase III or Phase IV study. In the past, many trial sponsors have ignored FDA’s expectation that the confirmatory study must be well underway, if not fully enrolled, at the time of a developer’s AA. FDORA has now given FDA the power to require that confirmatory studies be initiated before a sponsor receives AA.
The bottom line is this – it is critical for sponsors to discuss AA with FDA early and frequently during the drug development process, including the agreement on the trial design of the confirmatory study, which should be ongoing by the time of a product’s AA.
It’s crucial to build and maintain collaborative partnerships with FDA and other Regulatory Agencies throughout development. Building the right development strategy, based on regulatory knowledge and experience, while obtaining buy-in every step of the way, will pave the way for an efficient and successful development and commercialization approach. Without this collaboration, companies run the risk of delaying timelines and spending additional funding on more studies and program-related activities.
2. Be Partner and Deal Ready
Merger and acquisition (M&A) activity and overall deal flow are predicted to ramp up sharply in 2023, so it’s critical to be partner-ready with vetted and credible development strategies for your program(s). An integrated development plan is a useful way to highlight the asset strategy and target product profile (TPP), key cross-functional program activities, program risks and mitigations, budgets, and timelines. Integrated development plans enable teams to streamline development strategy, highlight efficient development pathways, optimize the speed and efficiency of asset development, and outpace competitors.
A clear and well-thought-through integrated development plan brings credibility to diligence activities and data room(s) and provides potential partners with the right level of insight into development approaches and strategies. It also serves as a key source for timeline and budget-related discussions. An optimal strategy, based on technical insight, experience, and precedent, will accelerate the progress of development programs. Leveraging the right expertise and experience driving these activities is also critical.
3. Adopt the Right Patient-Centric Approaches to Trial Design
It’s time to design trials in ways that work for patients and caregivers, in addition to sponsors. The first step in this approach is to incorporate patient feedback into trial design from the planning stage and to continue to listen to the patient voice throughout the entire duration of the study.
Questions we often ask clients, include:
Listening to the patient voice is key to designing studies that are feasible and less burdensome for trial participants. Additionally, supporting enrolled patients with clinical research and study-related education and communication will help enrolled patients feel engaged, connected, and appreciated for their involvement. Combining the right approaches will ensure efficient and on-time trial enrollment, visit completion, and will ultimately support high-quality data, bringing meaningful readouts for patients, companies, and shareholders.
4. Be Inspection Ready throughout the Entire Development Lifecycle
Post-COVID inspections are expected to occur at rapid rates, though they may look different than they have in the past. The use of remote regulatory assessments (RRAs) is here to stay, beyond the COVID-19 pandemic, and it’s critical to be inspection ready and prepared for either setting.
Understanding global regulations and maintaining an inspection-ready state throughout the course of development is vital to the long-term success and approvability of an asset. Ongoing management and maintenance will ease the burden as a development program nears the inspection stage. Patient safety and data integrity will be top of mind for inspectors, and we can expect to see a focus on systems, especially those that collect data, on the trial master file (TMF), and processes around vendor selection and oversight, monitoring, protocol writing, and site performance. Understanding expectations and regulations and carrying an inspection preparedness mindset throughout all stages of development will prevent costly activities and delays.
5. Take the Time to Assess Operational Efficiency
Business process stabilization and transformation can drive powerful and sustainable changes throughout any organization. As corporate priorities and financial situations shift, it’s important to assess existing structures and processes to measure operational performance and determine areas that would benefit from optimization.
Examining opportunities for operational efficiencies throughout an organization can highlight key areas in need of new approaches, processes, and roles and responsibilities to support the attainment of corporate goals and objectives. With so many innovative new approaches across our industry, it’s easy to find new ways to leverage people, processes, data, and technology to support faster timelines and decreased spending.
6. Expect Gaps Across Development Roles and Teams
We witnessed hundreds of biopharma companies impacted by layoffs in 2022, with the trend continuing into 2023. Rightsizing may help to control operating costs, but it can negatively impact the ability to set proper development strategies and execute those plans in real-time.
Experienced consultants, used on a fractional basis to fill existing gaps in development teams, can be a useful approach during these times to set strategy, execute plans, and fill key functional gaps. Outsourcing key deliverables or roles is a lean and capitally efficient operating model that can scale up or down, depending on the needs of a company, asset, or pipeline.
Conclusion
Don’t let the current environment derail your 2023 key milestones and objectives. At Halloran, our collaborative development teams of specialized experts who possess deep bench strength across multiple disciplines can give you a leg up to maintain or propel your asset(s) and your organization. Our technical expertise coupled with a team of subject matter experts delivers a tailored approach to each engagement. We are focused on partnering with you to provide efficient, scalable models to accelerate growth and achieve a faster return on investment.
Want to learn more? Reach out to Katie McCarthy, Chief Innovation Officer, to schedule a meeting.