Regulatory Guidance

By Asad KhanThere's a particular kind of energy at the World Vaccine Congress that's hard to describe unless you've been in it. Hundreds of scientists, executives, policymakers, pharma leaders, CRO teams, and site networks, all in one convention centre, all sitting with the same fundamental tension. We know how to make vaccines that save lives. So why does getting them to patients still take so long?I spent three days in Washington this week as part of the Medable team. Washington in late March meant that the cherry blossoms were just past their peak but still stunning, and catching them along the Tidal Basin between sessions was one of those small, unexpected gifts that a busy conference week doesn't always make room for.For the conference, I came in with a clear intention. I wanted to reconnect with partners I respect, listen more than I talk, and have honest conversations about where this industry is and where it needs to go. What I didn't fully anticipate was how much the week would reinforce something I already believed but needed reminding of.The urgency is real. And it's shared.The mood in the roomThe congress opened with a keynote from senior US government leadership on federal strategy for public health and pandemic preparedness. The fact that the speaker lineup was still being confirmed close to the event said something in itself. The policy ground under the vaccine industry is shifting, and nobody in that opening session pretended otherwise.Nicole Lurie from CEPI was direct about it during the pandemic preparedness plenary. "We have a long way to go to rebuild trust, not just in the US but globally." That landed with weight in the room. Because the trust deficit isn't just about public perception of vaccines. It runs deeper, into data sharing, into international cooperation, into whether countries will report surveillance information when there are real social and economic consequences for doing so. No platform fixes that. It's a human problem before it's a technology problem.What I kept noticing alongside all of that was a stubborn determination to keep going. Scientists presenting new data, site networks sharing what's working, regulatory specialists wrestling with AI governance frameworks in real time. Nobody was waiting for the policy environment to sort itself out. That resilience is one of the things I find most compelling about this community.The AI conversation nobody's fully figured out yetThomas Waite, Deputy Chief Medical Officer at the UK Department of Health, said something that hasn't left me. "Maintaining public trust when deploying AI surveillance agents is challenging." He also raised the point that if you're training AI on datasets where certain populations are over or underrepresented, you risk making existing inequalities worse. It's not just about what AI can do. It's about how you do it and who it serves.In almost every conversation I had at the congress, excitement about AI's potential existed right alongside genuine uncertainty about whether it can be trusted and governed responsibly. I think both of those things are true at the same time. The potential is real. So is the responsibility. The companies that'll matter in five years are the ones holding both of those thoughts without letting one crowd out the other.The question the whole congress was really askingCristina Cassetti from CEPI and WHO framed something that stuck with me. "How do we weave all responsibilities into one unit? When there's an outbreak, it's always chaotic." The argument from the main stage was that you can't build rapid response infrastructure in the middle of a crisis. It has to already exist.That felt directly relevant to everything I think about in my day job. The systems, processes, and partnerships that let trials move at the speed the science demands have to be in place before the pressure arrives. You can't retrofit speed into something built that is slow.COVID proved that when urgency is real and barriers are genuinely removed, trials can move at a pace nobody thought possible. The question I came to Medable to work on is why that should require a global emergency to unlock. Every unnecessary delay in trial startup or enrollment or conduct is a delay in patient access to therapies that could genuinely change or save lives. That's not a commercial point. It's a human one.What we shared over dinnerOn Tuesday evening Medable hosted an intimate dinner at Ocean Prime for a group of vaccine development leaders. There were small tables, honest exchanges, no polished presentation competing with the actual conversation.Our guests came from right across the clinical trial ecosystem, pharma, biotech, site networks, and CROs. Chief executives, chief medical officers, regulatory leaders, portfolio directors, and clinical operations specialists. People who design trials and people who run them at scale and people who are responsible for the vaccines themselves. The whole ecosystem around one table.I shared Medable's 1:1:1 vision, one day to start a study, one day to open enrollment, one year to complete study conduct. Not as a pitch. As an honest articulation of what we're genuinely building toward and why it matters.What surprised me was how it landed. The response wasn't just polite interest. It was recognition. Immediate and consistent, regardless of where people sat in the ecosystem. Every person in that room had felt that friction from their own angle.My colleague Toai then gave a live demonstration of some of the technology behind that vision. Watching the room engage with it, the questions people asked, the connections they drew to their own programmes, reminded me why showing something real matters so much more than describing it. One result I shared made that concrete in a way no slide ever could. A recent vaccine megatrial we supported delivered 100% cohort enrollment within five days, at a scale where weeks or months would've been completely normal. That study became a blueprint, that blueprint became a programme, and three additional vaccine trials launched immediately after. Nobody needed me to explain what that meant. They'd all lived the alternative.The conversation that mattered mostHowever, the most memorable part of the evening came up naturally around the table and it's stayed with me more than anything else from the week.The people in that room care deeply about what they do. They're genuinely invested in vaccine development, they live the science,and they want to get safe and effective vaccines to the people who need them. That passion was unmistakable.Yet, almost every person there described being held back by the same things. Manual processes. Paper. Operational friction that really shouldn't exist in 2026. Systems designed around how trials used to run rather than how they need to run now.What came through just as strongly was a real fatigue with vendors. Not with technology. With a particular kind of vendor relationship where someone sells you a solution without ever truly understanding your problem, where the pitch is confident but the partnership is thin. Where you end up feeling like a number rather than a partner.That hit me hard, because I think it's the most honest thing the industry is trying to communicate to technology companies right now. Better tools aren't enough on their own. Real partnership combined with the right technology is what'll actually shift the status quo. You can't have one without the other. It's also the standard I try to hold myself to, and a conversation like that one is a reminder of why it matters.What I'm taking awayThe policy environment is genuinely uncertain and the congress didn't try to dress that up. The questions around AI governance and trust are real and unresolved. But what I felt most strongly across the whole week was something much simpler. The people in this industry are committed to getting it right. The challenge isn't will or capability. It's the infrastructure and the processes and the weight of how things have always been done.The work is urgent. The community doing it is serious. And what'll move it forward isn't technology on its own. It's technology in the hands of people who've taken the time to genuinely understand the problem they're there to solve.That's why I do this. A week in Washington reminded me not to take it for granted.‍‍

From the Congress floor to the dinner table: A Week in Washington that reminded me why this work matters

6 min

There's a particular kind of energy at the World Vaccine Congress that's hard to describe unless you've been in it. Hundreds of scientists, executives, policymakers, pharma leaders, CRO teams, and site networks, all in one convention centre, all sitting with the same fundamental tension. We know how to make vaccines that save lives. So why does getting them to patients still take so long?

I spent three days in Washington this week as part of the Medable team. Washington in late March meant that the cherry blossoms were just past their peak but still stunning, and catching them along the Tidal Basin between sessions was one of those small, unexpected gifts that a busy conference week doesn't always make room for.

For the conference, I came in with a clear intention. I wanted to reconnect with partners I respect, listen more than I talk, and have honest conversations about where this industry is and where it needs to go. What I didn't fully anticipate was how much the week would reinforce something I already believed but needed reminding of.

The urgency is real. And it's shared.

‍

Speakers

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Access

Adherence

Advarra

Artificial intelligence

Artificial Intelligence

Cell and Gene Therapy

Change Management

Cindy Howry

Clinical IT

clinical research associate (CRA)

Clinical trial platform

Decentralized Clinical Trials

device delivery

DHTs

DIA

Digital Health Technology

digital measures

DiMe

Diversity in Clinical Trials

electronic data capture

Electronic informed consent

Future of Clinical Research

Back to basics: How the FDA's diversity requirements impact clinical trial treatments

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6 min

The FDA is taking steps to ensure that clinical trials are more representative of the diverse populations they aim to serve. This comes after the industry and the FDA's long-term recognition that clinical trials have often excluded underrepresented groups, leading to health disparities across the United States and the world.

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Medable's analysis on DCT and digital trial elements

White Papers, Case Studies, Reports

Evidence & Insights: A Data-Driven Exploration of Decentralized Elements and Digital Trial Technologies

evidence generation

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Blog posts

Key Insights from the FDA's DHT Guidance

DHTs

6 min

On December 23, 2023, the FDA released guidance for the industry on how digital health technologies (DHTs) should be used in clinical trials.

DHTs, which the FDA defined in their “Framework for the Use of DHTs in Clinical Trials,” are “technologies such as wearable, implantable, ingestible, and environmental sensors and software applications on mobile phones, among others.”

DHTs can be used to collect data from clinical trial participants more efficiently and objectively than traditional methods. For example, DHTs can collect data on participants' activity levels, sleep patterns, and medication adherence. This data can be collected electronically, which can reduce the burden on participants and improve the accuracy of the data

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Medable Petitions Comments on ICHE6(R3) Draft Guidance

Decentralized Clinical Trials

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When technology enters a regulated environment, early adopters often cite regulatory uncertainty as a hurdle. In fact, a 2021 Clinical Trials Transformation Initiative (CTTI) survey showed that regulatory uncertainty and lack of harmonization were the top reasons that hindered adoption of elements of decentralized clinical trials (DCTs).

During the COVID-19 pandemic, the increased adoption of decentralized methodologies was guided by temporary guidances put out by many regulators such as FDA’s March 2020 “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency” and the corresponding EMA guidance, which explicitly mentioned it would expire at the end of the designated Public Health Emergency.

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eConsent

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Camila Matheny, EVP of DCT Offerings at Medable and Caroline Beaufour, PharmD, Ph.D., Innovation Lead, Clinical Development Support at Servier, dive into the intricacies of implementing electronic informed consent (eConsent) in clinical trials within the complex regulatory landscape of European countries.

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Medable perspective: Key takeaways of recent FDA DCT Draft Guidance

FDA

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Medable perspective: Three points on FDA eCOA guidance

Regulatory Guidance

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At the beginning of April 2023, the FDA published a draft of the fourth in a series of Guidance Documents entitled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments (COA) Into Endpoints For Regulatory Decision-Making”. Once finalized these four documents will be combined and will replace the 2009 Guidance, “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims”. Part 3, which was released in draft in June 2022, provides advice around the development and validation of new COA (including the modification of existing COA).

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Podcast: Michelle Longmire and David Fajgenbaum of EveryCure join the PharmaExec podcast

Future of Clinical Research

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Medable CEO Michelle Longmire and Dr. David Fajgenbaum, co-founder of EveryCure, join Pharmaceutical Executive podcast to talk about their partnership adn navigating the regulatory landscape.

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