CROs Add Value to Drug Discovery Strategy During a Recession?
When the bottom line is top of mind, it’s time to maximize your partnership with your CRO. Here’s how.
How your CRO serves you and delivers value during a recession economy demonstrates its commitment to partnership and your success.
Many biopharmaceutical and biotechnology companies today are taking a closer look at their drug development strategy in relation to spending and risk. The economic realities of untamed inflation, limited funding and supply chain pressures may mire growth plans — although there are reasons for hope, as our biotech experts recently noted.
Prior analyses indicate that recessions can affect drug demand for myriad reasons, including lower utilization of patented biologics and branded drugs, as well as an uptick in utilization of biosimilars and generics.
Biotech and biopharma companies with a dependable contract research organization (CRO) partner will derive strong value across all business cycles — ensuring project delivery excellence and continued speed to market.
Here are five questions to ask yourself to assess the value of your CRO during a recession, in order to ensure expertise in asset optimization and risk strategy.
1. Is your CRO partner strategic when looking after your most valuable resources?
As some drug development organizations right-size their workforces, a strong CRO partner will optimize your drug development strategy by rehiring your talent — avoiding destabilization of your clinical research — via rebadging through functional service provider (FSP) engagements. Through rebadging, biotech and biopharma companies shift human resource expenses from fixed to variable, and tried-and-true staff continue in the same roles as before under the CRO’s umbrella.
The staff transfer team at the PPD™ clinical research business of Thermo Fisher Scientific provides transfer success rates that average nearly 90% for FSP engagements and are experts in Acquired Rights Directive laws and regulations. As such, our customers’ staff experience little or no downtime as they’re assured secure employment, either as a contractor or in new positions. We further prioritize developing staff knowledge and skill sets, resulting in an enriching environment that propels study continuity through each phase. This strategy reduces the overhead for sponsors’ studies by offering business continuity, flexibility and potential cost savings.
Go deeper with our experts on rebadging advantages and best practices in this Applied Clinical Trials article.
2. Are your CRO’s services flexible and easily scaled to your needs?
With funding and overhead in flux, providers should be able to easily scale and adjust their outsourcing models with their CRO. In fact, experts say outsourcing puts you in a better position to handle the demands placed on your business by a recession.
It’s little surprise that our 2022 report on the FSP landscape showed that three-quarters of drug developers rely on an FSP model now, and that hybrid models will continue expanding and optimizing their drug development strategy. A strong FSP partner providing services like our PPD™ Functional Service Partnership solutions can easily customize its portfolio to your fluctuating needs — offering a plan for stability and dependability as a salve for uncertainty.
- Mix and match: With the flexibility of FSPs, adjust your mix of services and resources for a clinical product, marketing product or a diverse portfolio of assets, whether you need to fill small gaps in services or support large-scale programs with dedicated capacity management across functions.
- Adapt to your needs: FSP includes an adaptable combination of systems, processes, oversight and facilities, and accommodates various contract structures, from full-time equivalent to unit-based, outputs-based, time and materials, and hybrid models.
- Your innovative process or ours? FSP models enable a CRO to embed its staff within your workforce; tailor deliveries using your systems or processes; or take the work fully in-house leveraging the CRO’s own innovations and technologies to design the best drug development process possible.
Considering how to choose the best outsourcing model for your needs? We have you covered in our comprehensive overview of outsourced clinical trial models.
3. Does your CRO have a pulse on the issues within drug development?
The drug development industry is undoubtedly in a season of change. Has your CRO demonstrated it keeps up with industry trends — and its preparedness to partner with you on progress?
Our recent industry trends report found that the top three innovations drug developers are pursuing are adaptive trial design, digitalization and greater use of real-world data/evidence, which are especially important for addressing one of drug developers’ biggest challenges: patient diversity. Your CRO should be all in to deploy these new technologies with you, as well as demonstrate success stories. For example, we have seen that sponsors that adopt adaptive trial designs see reduced costs and streamlined drug development processes — critical for drug developers looking to dial up efficiency and success rates for their clinical programs.
Likewise, and particularly since partnering with Moderna on the development of its COVID-19 vaccine, we know that novel therapeutic platforms will continue to hold strong potential for priority therapeutic areas. We worked through the complexities and regulatory hurdles of mRNA vaccine trials early — and enable end-to-end delivery including manufacturing — so that our customers can lean on our track record of success and hit the ground running in their first 100 days.
Make sure your CRO stays ahead of the curve. Check out our industry predictions for 2023 to see our thinking on what’s ahead.
4. Does your CRO leverage data-backed intelligence to accelerate your clinical development plan?
Not every asset gets the green light in a down economy, which is why data is imperative to illuminate which of your assets have the strongest chance of moving forward. Couple that intelligence with expertise on how to keep these assets moving forward — such as planning upfront for regulatory designation, determining the most effective evidence strategy, and implementing early pharmacokinetic modeling to inform optimal dosing and trial design modifications for cost and time savings.
A strong CRO partner will also talk through your holistic data strategy early, pinpointing milestones at which data could expedite development and approval. For example, drug developers have historically not pursued integration of real-world data (RWD) into their studies until they know their assets are moving forward. But today, the paradigm has shifted as both regulators, like the U.S. Food and Drug Administration (FDA), and payers seek relevant RWD, and delaying its integration could set you steps behind. Accordingly, make sure your CRO fosters the use of data so that you’re poised for market access early in the game. Data provides the plot; a good CRO turns it into a winning narrative for you.
Familiarize yourself with these six trends influencing the future of real-world evidence.
5. Is your CRO a true partner to you — or just another vendor?
Evaluating whether your CRO is going to be an invested business partner and not just a vendor that delivers a study will be something that rewards your team for years to come. Even during a recession economy, a CRO partner makes space for your clinical trials amid a busy landscape and enables you to smartly navigate resources and supply challenges.
We encourage our customers to consider multiple values in selecting their CRO partner, including:
- Integrated global capabilities
- Agility and a proactive approach
- Experience and proven expertise
- Diversity
- Investment in staff
- Collaborative engagement, including personal attention
Think back to your most recent conversation with your CRO. Which bucket did it fall into?
| Vendor | Transformative Partner |
|---|---|
| Transactional | Collaborative |
| Reactive approach | Proactive approach |
| 3- to 6-month engagement runway, often project-based | 6- to 12-month engagement runway that co-creates solutions aligned with your goals |
| Financial/operational incongruity (business value gaps) | Business and values alignment |
| Oversight viewed as administrative burden | Governance and executive oversight, as well as a support-led model |
| Client holds risks | CRO shares risks |
| Staff motivation challenges (high turnover) | Magnet for talent — deep expertise in both established and emerging therapeutic areas |
| CRO selection is high burden | CRO selection is low burden |
We recognize that drug developers have a fast-paced, passionate mindset that requires responsiveness, acceleration and a hands-on project team. Your CRO should have a robust drug development strategy and deliver certainty across every phase and milestone, proactively anticipating your needs.
Dig deeper on the path to selecting an equally devoted CRO partner.
Bonus: Can your CRO singlehandedly advance your molecule from discovery to market?
A single CDMO-CRO vendor drives time and cost efficiencies through product continuity and reduces the administrative headache of cobbling together study components across vendors. Thermo Fisher Scientific, for example, creates economies of scale for pharmaceutical organizations by powering their clinical programs from research/discovery through each phase and commercialization/production, all under one roof. Our approach and expertise enable us to anticipate downstream roadblocks and proactively respond — driving operational efficiency that minimizes downtime in our clients’ drug development programs.
Economic downturns are a reality of doing business.
Maximize your partnership with your CRO to ensure downturns don’t slow down your drug development. A strong CRO partner will add value by:
- Looking after your workforce to ensure project delivery excellence
- Flexing its comprehensive services as your needs evolve
- Staying ahead of the curve to navigate industry shifts
- Leveraging data to accelerate your drug development strategy
- Collaboratively engaging as an invested partner
- Bending the time and cost curve by coalescing CDMO and CRO services
A CRO that demonstrates a shared commitment to value, quality and your bottom line and accelerates your momentum is a vital tool for pharmaceutical and biotech companies.
Dig deeper on the growing role of CROs in clinical trials.
The need to demonstrate asset value and ROI was reported as a top challenge facing nearly one in three (30%) respondents of our 2023 report, The Pulse: Global R&D Insights in Pharmaceuticals.