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—your fast track to the latest insights in clinical research operations. In under three minutes, we’ll recap top stories, highlight expert interviews, and keep you current on what’s moving the industry. Let’s get into it.

On this episode, we’re spotlighting our three most-viewed articles from the past week—covering regulatory shifts, vaccine funding changes, and the future of digital transformation in clinical trials.

Recent Complete Response Letters to Replimune and Capricor

 are sending a clear signal: the FDA is turning up the heat on clinical trial design. In both cases, the agency cited inadequate or incomplete trial structures—surprising the sponsors despite earlier communications. Industry leaders warn this marks a shift toward heightened oversight that could impact everything from patient recruitment to timelines. The FDA’s own transparency push, including publishing over 200 CRLs from recent years, reinforces the message: tighten your study designs, document every interaction, and expect less leniency in late-stage approvals.

the US Department of Health and Human Services is winding down mRNA vaccine work under BARDA

, canceling 22 contracts worth $500 million. The move shifts funding toward vaccine platforms that officials say are safer and more resilient to viral mutations. Programs at Emory University, Tiba Biotech, and several industry partners are being terminated or scaled back, with some late-stage projects allowed to finish. The decision also halts funding for Moderna’s H5N1 bird flu vaccine, despite positive early trial results. Critics warn the cuts could slow progress in critical vaccine research and disproportionately impact trials involving minority populations.

digital tools and AI are rapidly transforming clinical research

—accelerating data collection, streamlining processes, and expanding patient engagement options. But with innovation comes complexity. The author of this article highlights five priorities for navigating this shift: strengthening data governance, creating trusted AI frameworks, implementing risk-based processes, upskilling clinical teams, and fostering cross-industry collaboration. The takeaway: technology should enable better science, not dictate it.

For more on this and other developments in clinical research, visit us at 

Podcasts

In this episode of the Applied Clinical Trials Brief, we recap our three most-viewed stories of the previous week with a look into the FDA’s heightened scrutiny of trial design, the wind-down of federal mRNA vaccine programs, and how digital innovation is reshaping the clinical research landscape.

ACT Brief Episode 2: FDA Oversight, Vaccine Funding Cuts, and the Digital Future of Clinical Trials

, tackling a topic that’s resurfacing in troubling ways: placebo-controlled vaccine trials.

Secretary of Health and Human Services, Robert F. Kennedy Jr., is pushing for more placebo-controlled vaccine trials—framing it as a return to scientific rigor. But as the authors explain, that framing ignores both medical ethics and history.

Once a vaccine has been proven safe and effective, it is no longer ethical to withhold it in a clinical trial setting. Giving participants a placebo when a working vaccine exists isn’t just unnecessary—it’s dangerous. That principle is embedded in both the Common Rule and FDA regulations, which require minimizing risk and maximizing benefit in human studies.

The idea of withholding treatment in the name of science has a dark past in the US—most notoriously, the Tuskegee syphilis study. That wasn’t just unethical. It was lethal.

Kennedy’s recent “Make America Healthy Again” report suggests bringing back placebo arms even for standard childhood vaccines. If implemented, this would violate long-established protections for research subjects and open the door to trials where participants—especially children—are knowingly exposed to preventable illness.

Alarmingly, this isn’t just hypothetical. In May, the FDA approved a Phase IIII placebo-controlled trial for Novavax’s COVID-19 vaccine in low-risk adults. That’s a trial in a population where safe vaccines already exist. It’s a shift away from science-driven ethics and toward politically motivated disruption.

The deeper danger? A chilling effect on vaccine innovation. Once trial participants understand they may receive no protection against disease, enrollment will plummet. And if children are involved, expect outrage.

This isn’t transparency. It’s regression. And in clinical operations, we know: ethical trial design isn’t a barrier to good science—it is good science.

In this pilot episode of the Applied Clinical Trials Brief, we examine the renewed push for placebo-controlled vaccine trials in the US, why experts warn it violates core ethical standards, and how these proposals could jeopardize both participant safety and future innovation.

ACT Brief Episode 1: Placebos, Politics, and the Ethics of Vaccine Trials

David Nickerson, head of clinical quality management at EMD Serono, executive sponsor of TransCelerate's ICH E6(R3) Initiative & PhRMA topic lead on the ICH E6(R3) Expert Working Group; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, and ACRO member participating in the ICH E6(R3) Initiative with TransCelerate, discuss:

Industry collaboration through TransCelerate and ACRO's partnership 

Tools to help stakeholders better understand the latest GCP guidelines

Their own recommendations for best practices in risk management and data governance

In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.

Unifying Industry to Better Understand GCP Guidance

Breakthrough Therapy Designation was based on results from the Phase II IDeate-Lung01 trial (NCT05280470), which demonstrated clinically meaningful benefits in patients with extensive-stage small cell lung cancer treated with ifinatamab deruxtecan. 

Phase II Trial Data Lead to FDA Breakthrough Therapy Designation for Ifinatamab Deruxtecan in Extensive-Stage Small Cell Lung Cancer

Ron Lanton, partner, Lanton Law, explains how shifts in policy and government guidance could reduce public participation and complicate the design and recruitment of future vaccine trials.

How Policy Changes Could Impact Vaccine Trials and Public Participation

In this Q&A, Rohit Nambisan, CEO of Lokavant, and Jonathan Crowther, head of predictive analytics, Pfizer, explore how AI is transforming study feasibility, regulatory review, and trial execution.

Q&A: How AI Is Reshaping Clinical Operations and Study Feasibility

A unified technology approach improves study efficiency and data collection.

AI-Powered Non-Interventional Research Delivers What DCTs Promised

As clinical trials become more complex, success depends on early collaboration, thoughtful protocol design, and practical strategies to manage risk, reduce delays, and support patients.

Navigating Complexity: Strategies to Accelerate Modern Clinical Trials

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, shares practical ways clinical teams can strengthen trial protocols for expedited programs—such as incorporating control groups where possible, leveraging synthetic and real-world data, and adopting adaptive trial designs to reduce regulatory risk.

Future-Proofing Trial Protocols to Avoid CRLs

, Meri Beckwith, Co-CEO, Lindus Health, discussed the evolving perception of breakthrough designation amid the FDA’s recent 

 issued to Replimune and Capricor. He emphasized that breakthrough designation does not necessarily guarantee approval, but offers quicker decision access and investor signaling. Beckwith also stressed the importance of agility in trial design, advocating for adaptive trials and control groups where ethical. To mitigate regulatory unpredictability and avoid costly CRLs, he highlighted the need for future-proofing trial protocols with adaptive randomization and synthetic control groups.

ACT: What changes would you recommend clinical teams make now to future-proof trial protocols—especially when pursuing expedited programs—to avoid costly CRLs down the line?

It's pretty obvious, just given the FDA’s comments here, but control groups where possible. Now, obviously, I do believe that a control group in Replimune’s case would have been unethical, and I think you'd struggle to get an IRB or an ethics committee to sign off on anything like a kind of a conventional RCT with a one-to-one randomization ratio. Now, there are constantly-improving kinds of options around match placebo controls often using AI to create synthetic data, or using a growing trove of real-world evidence to create that match control. I don't believe Replimune included that. That is a relatively low-cost option to try and include, so that is something that sponsors could look into, but it's very different in a space like cardio metabolic or type 2 diabetes, a more chronic condition, it would be very appropriate to include a control group. But again, there are also options which technology enables for us now, like adaptive trials, where you could have an adaptive randomization ratio and start with a one-to-one ratio, and as you notice an effect on the control group, reduce the number of participants who are randomized onto a placebo. Using technology now, you can do that without unblinding the study teams to the results, so those options do exist. Again, relatively low-cost ways of ensuring or preventing these CRL letters. If I were a clinops leader, I'd look into them. It's something that we've been doing for some of our sponsors now. Certainly, we hope that in the near future, every clinical trial will be adaptive by default, and I think there's really no reason not to.

Videos

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, discusses whether recent trial design rejections signal a broader shift in FDA expectations or simply reflect changes in individual reviewers, emphasizing that current unpredictability may be more situational than systemic.

Is FDA Trial Design Scrutiny Increasing or Just Less Predictable?

ACT: Do you think the growing scrutiny around trial design is a sign of regulatory unpredictability, or are we seeing more transparent expectations from the FDA that just haven’t been operationalized effectively yet?

I’m not sureI'd quite say that there is more scrutiny, or there's a pattern of more scrutiny, on trial design. I do think in this case, it just seems to be kind of like a personally driven issue with a few kind of personalities inside the FDA. Having said that though, maybe over the next year or two, there's a pretty consistent pattern of the FDA rejecting more studies that aren't controlled or insisting on more robust results, more carefully scrutinizing sample sizes, those kinds of things, remains to be seen. My view is that these decisions, it's just kind of unpredictability, the result of one set of reviewers, maybe transitioning off or out of the FDA, and then a different set of reviewers with a different perspective coming in. That does make me hopeful that this will be an isolated case of just regulatory unpredictability rather than a sort of raising of the bar, but it remains to be seen.

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, explains why sponsors pursuing breakthrough or priority review designations must maintain rigorous trial design while building organizational agility.

Balancing Speed and Rigor in Accelerated Trial Pathways

ACT: How should clinops leaders balance trial design for accelerated pathways like breakthrough or priority review, while still meeting the FDA’s rising bar for adequate and well-controlled studies?

 I'd go back and say just because you have a breakthrough designation doesn't mean you should treat the trial design process, or approach the trial with any less rigor. I think most people are on board with that. I think that the best thing that sponsors can do in these times of uncertainty with the FDA is to cultivate agility. If the worst happens, and the FDA effectively moves the goal posts on you, and you need to generate more data, cultivate agility in your organization to be able to generate that data or even an entire new study, worst case at a reasonable cost. I think the way I've observed a lot of the industry operates is it's in a very kind of waterfall fashion, where you specify a study design, you agree on it with the FDA, you gold plate it by trying to throw every conceivable mitigation at it, and that makes these studies lengthy and expensive. This is things like 100% SDV, extra-long follow up periods, many, many secondary and exploratory endpoints, and so on. What I think some sponsors could be better served by, is cultivating the agility necessary to be confident in a study design, but then be ready to generate additional data, and do that quickly if need be without this very laborious gold plating process. Ultimately, it's about more shots on goal. I think that's the best way to insulate yourself against the uncertainty.

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, discusses recent Complete Response Letters issued to Replimune and Capricor, explaining how shifts in FDA reviewers can affect single-arm trial acceptance, especially in oncology settings where control groups may be deemed unethical.

FDA Review Changes and the Impact on Trial Design

ACT: With both Replimune and Capricor expressing surprise at receiving CRLs, what operational red flags should clinical teams be watching for earlier in the design or submission process?

Yeah, this is a tricky one. I think particularly in Replimune’s case, the FDA seemed to take issue with the fact that it was an uncontrolled study. I've got to say that that's pretty unfortunate, given, obviously the FDA were involved, and Replimune would have cleared that with them. I mean, it's also super common in this space, i.e., non-responders in oncology to run an uncontrolled study, because, arguably, having a control group would be, would be unethical because these people are going to die without treatment. I'm not really sure the clinical operations folks are really at fault here. I know a bit more about the Replimune case than I do Capricor, but in Replimune’s case, the study design had been approved by the FDA. Running a single-arm design is such a fundamental part of the study design, that there's no way that wouldn't have been carefully scrutinized by the FDA at the point at which they discussed the study design with them. I think they more just fell afoul of shifting internal politics at the FDA, and I'd say it's as simple as, with the change in administration, a lot of reviewers have changed. They went from a set of reviewers who were very comfortable with that approach to a different set of reviewers who are less comfortable. I think it's as simple as that. I don't think it's part of a grander shift in policy at the FDA. I think it's just a changing of the guard, and the new guard have a slightly different take on things, and unfortunately, Replimune has fallen foul of that.

Understanding FDA and EMA Guidance on AI and Digital Twin Applications in Trials

, Jon Walsh, founder and chief scientific officer of Unlearn, discussed how AI-designed therapies and digital twin technologies are reshaping the clinical trial landscape. While the fundamental principles of clinical testing remain consistent, Walsh explained that AI-discovered drugs often warrant deeper attention to specific biomarkers and safety signals in early development. He also highlighted how digital twins—virtual models of trial participants—can significantly improve trial efficiency, reduce control group sizes, and enhance the precision of treatment effect estimates. As regulatory agencies like the FDA and EMA begin to offer clear frameworks for integrating AI into drug development, Walsh emphasized the importance of transparency, reproducibility, and interpretability in model design and implementation.

ACT: What are the regulatory implications of using AI-generated data or digital twins in trials?

Regulators have been very clear in their positions and guidance on how to use AI in drug development more safely, effectively, and in line with their expectations. For example, the FDA released guidance earlier this year outlining a seven-step process for applying AI in this context. Similarly, EMA has been developing frameworks, such as its 2024 reflection paper, which emphasize the importance of context of use.

Sponsors need to clearly specify how a model will be used in drug development, identify potential risks and impacts to the study, quantify those risks, and have a plan to address them by evaluating the model under defined conditions.

So far, the primary way we use digital twins in randomized controlled trials has been fully aligned with regulatory guidance. From the outset, we designed our approach to help randomized trials achieve higher statistical power, in a manner consistent with both EMA and FDA expectations. We have received positive feedback from both agencies—through EMA qualification programs and open discussions with the FDA, where we’ve even published their comments.

When it comes to other trial designs, such as open-label studies—where there is more risk and obtaining a control group is often not feasible—there are still clear ways to use digital twins within the FDA’s framework. These methods allow regulators to assess the risks and interpret evidence appropriately, even in these more challenging contexts.

 AI-designed therapies can present unique characteristics in clinical trials compared to traditionally developed treatments, often requiring closer scrutiny of biomarker signals and safety data early on. However, the fundamental process of clinical testing remains consistent. Digital twin technology helps make these trials more efficient and insightful by modeling individual trial participants under standard of care, offering a virtual comparator without needing additional enrollees.

Digital twins work by creating a probabilistic model of how a specific patient would respond to standard treatments over time. Rather than enrolling new participants, sponsors gain deeper insights into existing ones, improving the precision of treatment effect estimates and boosting trial power. In randomized controlled trials, this added statistical confidence can reduce participant numbers or accelerate timelines. In open-label studies, digital twins can serve as virtual control arms, allowing meaningful comparisons when a real control group is not feasible.

Regulatory agencies like the FDA and EMA are providing clear guidance on the use of AI and digital twins in drug development. They emphasize defining the model’s context of use, evaluating its risks, and proving its reliability. The companies building digital twins must ensure model development is transparent, reproducible, and interpretable—tracking how models were built, and which data were used, while safeguarding against unblinding.

Looking ahead, digital twins are expected to become a foundational part of the clinical trial landscape, particularly in neuroscience and CNS trials. They offer the promise of more adaptive, efficient, and patient-centric designs that can accelerate drug development and reduce reliance on traditional control groups, while maintaining—or even improving—the quality and reliability of clinical evidence. As adoption grows, digital twins could reshape how sponsors design trials and regulators evaluate new therapies.

Jon Walsh, founder, chief scientific officer, Unlearn, explains how regulators are clarifying best practices for integrating AI and digital twins into clinical research.

Video Series

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, examines how recent developments with Complete Response Letters have shifted industry perceptions of FDA breakthrough designation—highlighting that it offers faster review timelines and investor visibility, but not a higher likelihood of final approval.

Rethinking the Value of FDA Breakthrough Designation

ACT: How has the industry’s perception of breakthrough designation evolved, and do you think it’s led some sponsors to over-prioritize speed to designation over the rigor required for final approval?

 The industry's confidence, or perceived value of a breakthrough designation, has definitely taken a hit after the last few weeks. However, if you dig under the surface, the breakthrough designation was never about, if you receive a breakthrough designation, it doesn't mean your drug is more likely to be approved. The FDA has always been super clear about drugs with the breakthrough designation being subject to the same rigorous level of review as those without a breakthrough designation. It really is just about access to a slightly quicker decision. I think that is what it is. I also think perhaps that companies pursue it, not just because of the timeline benefits, but also because of the signaling to investors. Beyond just that shortened review timeline, it does have a certain kind of cache, it gets your company better visibility with investors. If you're listed, it's a great news flow item to put out. I think there's a few reasons companies pursue it, but I don't think anyone really sees it as something that's more likely to make your therapy approved.

In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, discusses how integrated systems and data transparency enable sponsors to meet evolving regulatory expectations and streamline FDA inspections through enhanced operational readiness.

How Integrated Systems Help Biotechs Stay Inspection-Ready

, Luke Wilson, senior director, biotech, pharma services, Thermo Fisher Scientific, discussed the role of data visibility in clinical trials, emphasizing the need for actionable data to meet aggressive timelines and budgets. Remote monitoring is crucial for quick decision-making and patient safety, reducing site burdens and leveraging advanced technology. Integrated systems help study sponsors meet evolving regulatory expectations by removing data silos and streamlining inspection processes. Barriers to real-time trial oversight include data silos and the need for integrated systems. Best practices for decentralized trials include unified data management, clear SOPs, and governance pathways to ensure operational alignment and regulatory compliance.

ACT: What role do integrated systems play in helping sponsors stay inspection-ready and meet evolving regulatory expectations?

 You mentioned regulatory. I think the market is changing rapidly in front of us. If you think about how data is captured, how data is managed within certain regions and even therapeutic areas, it’s really important that we remove some of those silos to enable data to be captured and logged in an appropriate way that then can be provided to the sponsor. We actually had a recent example with a customer, they were a small biotech, and they were about to have an FDA inspection, and they commented on how some of our teams at Thermo Fisher Scientific captured the data, how we provided it to them. It really helped streamline the process of that FDA inspection, and resulted in a very successful inspection for them, which is critical. You imagine biotechs, they've got to have partners who can enable them to be inspection ready to your question, and it's really important that we support them on that journey with our expertise within Thermo Fisher Scientific.

In this video interview, Michael Miller, chief operating officer at Quanterix, discusses how biopharma companies—especially smaller biotechs—can leverage platform trials and biomarker-driven accelerated approvals to remain efficient and competitive amid shifting public-private funding dynamics.

Adapting to a Changing Research Funding Landscape

, Michael Miller, chief operating officer, Quanterix, discussed how the clinical research industry is increasingly integrating biomarkers. Biomarkers are particularly beneficial in neurology, where advancements in imaging and blood tests have improved trial outcomes, and in oncology, where multiomic approaches and protein tissue imaging aid in matching therapies to mutations. Synopsis professionals should focus on the biomarker's purpose, technical requirements, and regulatory compliance. Platform trials and biomarkers are also driving accelerated drug approvals. These advancements are crucial for biopharma companies navigating the shift between private and government-funded research.

ACT: With a shift in balance occurring between private and government-funded clinical research, what are some opportunities for biopharma companies moving forward as they navigate this new, challenging landscape?

I can think of a couple areas. One is, in terms of, let's say biotechs or smaller companies, probably not so much large pharma, but participating in platform trials as a way of having a more efficient clinical trial approach. A platform trial is where a particular institution or different institutions will pull money together to be able to recruit patients within a particular disease area. Sometimes it's rare diseases because they're less available and harder to recruit, and then multiple drug companies can come and access that population and do subsets of that population, give them drugs, track their outputs, and the infrastructure is put together by the platform so each company doesn't have to do that lift. That's one example I can think of that can help people be more efficient given the times, and do things like that.

The other relates back to one of the main themes of this discussion, which is biomarkers. In the example I'll cite here is that biomarkers have allowed people to get accelerated approval for drugs that have a breakthrough designation. One example in the neurology area was a blood test for neurofilament light that was used to gain accelerated approval for an ALS drug, so that's an example. That's a technology that Quanterix was involved in, neurofilament light, making that commercializing that assay, but that's a huge gain to where now you have a rare disease, it's very difficult to track clinical outcomes, and here's a biomarker that can show efficacy by giving you a signal of lower levels of neurodegeneration that then can speed going to getting regulatory approval. Again, accelerated regulatory approval, nonetheless, it allows them to get them to market faster and advance the drug.

In this video interview, Michael Miller, chief operating officer at Quanterix, outlines key technical and regulatory considerations for clinical operations professionals integrating biomarkers into studies, stressing the importance of clarity on biomarker purpose and working with qualified assay partners.

What Clinical Ops Teams Must Know About Biomarkers in Trials

ACT: What should clinical operations professionals have top of mind when utilizing biomarkers in trials they’re managing?

I think that the first most important thing to think about in terms of when including biomarkers in a clinical trial is what is the purpose of the biomarker, and the reason why I say that is that that's fundamental to then understanding what are the technical requirements of, let's say, an assay or a technique to measure that biomarker, and then also what are the regulatory requirements around the use of that biomarker. I'll give you an example. We've done some work for customers where we'll be measuring a blood biomarker to help understand who should be enrolled in a clinical trial, and when you use a blood biomarker to decide who might be excluded from a trial, that's considered a medical decision, so this is up to the pharmaceutical companies or the clinops people to decide whether this applies or not, but I'm just giving you an example. That then puts a higher level of regulatory requirement on the validation of the assay, the evidence behind the assay, and its use. A vendor like Quanterix, we routinely do that within our accelerator lab for customers, and so the clinops people should think carefully about, ‘Hey, what is the purpose? How's this going to be used?’ because there may be regulatory requirements. I think you had mentioned earlier about hesitancy. I think this is where it can cause some hesitancy because it sounds complicated, but there's plenty of people who can help customers through that process, as I mentioned, we've done it.

Further that relates to where I've talked about purpose that gets to technical requirements. What's the sensitivity of the assay? How is it validated, the regulatory requirements? Then that then leads you to, ‘Hey, who should I partner with to help me measure this biomarker?’ and again, the regulatory and the technical requirements will help with that selection, because then you're like, ‘Oh, here's what I need to measure. Here's the regulatory framework you need to operate under the quality system, for example.’ If you want to submit your results to the FDA, you need to have custody of sample, data integrity, and auditability of the results, so you want to work with a partner who can provide you that. As I said, Quanterix is one of those partners.

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, advises clinical research organizations to assess their portfolios, diversify funding sources, and strengthen industry-academic partnerships to maintain compliance and continuity amid shifting federal priorities.

How Research Institutions Can Future-Proof Compliance Programs

, Kate Gallin Heffernan, life sciences attorney, Epstein Becker Green, discussed the challenges clinical research teams face with compliance due to evolving executive orders and federal funding policies. She highlighted the confusion and increased scrutiny on research projects, particularly those involving diverse populations. Practical risks include potential legal scrutiny and funding agency actions. Heffernan also emphasized the importance of accurate reporting and careful documentation to avoid false claims. Future-proofing compliance involves thorough portfolio assessments, diversifying funding sources, and strengthening partnerships between academia and industry to support early-stage research and innovation.

ACT: What is your top piece of advice for clinical research organizations that want to future-proof their compliance programs in an increasingly politicized funding environment?

I think the main advice that I would give people is, is a pretty obvious one, which is what people, I think, have been doing since January: do a thorough assessment of your research portfolio, look at the areas that your organization really wants to focus on. What are the areas that align most with your mission, your patient population, the potential for IP development and commercialization for your organization, the ultimate financial impact ways in which your organization can supplement funding for certain efforts and maybe not others. I think ultimately, diversification of funding sources is going to really be key for all parties involved going forward, and a point that I think is sometimes overlooked, but really important to note is that these cuts to federal funds are not only impacting the academic sector, so the pharmaceutical industry and a lot of the other industry players have been and continue to be in strong partnership with academic hospitals, medical centers, universities, with respect to that early-stage investment time, so the cuts to this early-stage funding that we're seeing are also going to have downstream impact on the ability of pharmaceutical companies to have access to important early-stage ideas that they can then evaluate and decide whether to license and how to possibly partner with respect to the commercialization. I think we're going to have to see a new commitment by both industry and academia to a renewed partnership around how we go from bench to bedside with these new early-stage concepts and innovations because that missing bridge funding that we get, normally, from the federal government to help determine what's worth bringing to market is something we're going to see, obviously, severely reduced. I think for our academic and institutional and other research clients, using your innovation offices, your clinical trial offices, for increased outreach to the private sector for these types of early-stage collaboration agreements and collaboration arrangements to try and supplement that bench science research funding, I think, is something that we're going to have to see our clients focusing on in the near future.

Regulatory

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