A conversation between Julie Howard, Ph.D. and Michael Geffner, M.D. on field medical deployment across Europe.
The Biggest Misconception
Julie: Michael, thank you for joining us. We’re exploring field medical deployment across Europe. Unlike the US, which is a single market under one set of rules, Europe is fragmented: thirty-plus markets, multiple compliance codes and guidance frameworks, and distinct KOL communities. From a US perspective, what’s the biggest misconception about field medical in Europe?
Michael: That you can just ship your US people over to handle Europe. Even setting aside the cost and the time spent flying people across the ocean, you miss out on local knowledge, local intelligence and the local language. There are tools that give you what looks like that information, but it’s no substitute for people who live and work there, know the hospitals and institutions, and have relationships with the KOLs, and can therefore best represent your science.
Julie: You’ve supported European markets from your base in the US. What surprised you most about the operational compliance realities?
Michael: That it’s not homogeneous. Every country has its own rules, and in some, Italy being a prime example, regions differ too. It can be as mundane as whether a trial can reimburse patient travel, or whether a patient can stay overnight in a hotel around an intensive PK draw: some parts of Italy allow it, others don’t. To avoid looking foolish in front of investigators and hospital staff, you need to come in with that knowledge, and the only way to have it is local colleagues on the ground.
Julie: Is that why you can’t simply drop the US playbook into Europe, or is there more to it?
Michael: There’s more to it. Sometimes the science itself differs: the background therapies available through the public health system, and whether private-pay options exist. Treatment guidelines differ between the US and Europe for many indications, and even where the same treatments exist, access through the public system may not be the same. All of that shapes how plans must be tailored for each market, and you won’t know it running things from the US.
Do It Sooner
Julie: Thinking back to the first time you built a team like that, what’s the one thing you’d go back and tell yourself?
Michael: Do it sooner. People equate medical affairs with the MSL role, working alongside commercial on products close to or already on the market. Get rid of that definition. Compliance still has to be taken seriously, but for a small company about to enter the clinic and wanting European sites, local field medical should help design the trial, not just execute it. They can use existing relationships to take your concept to KOLs before you finalise the protocol and submit to regulators, and test whether the study is executable and will deliver value in European markets, which isn’t always the same answer as for the US. Ignore that and you will fail miserably in enrolment, in investigator engagement, and in building the trust you’ll need for later-stage trials.
Julie: That’s something we’re keen on at Phoenix. The MSL role varies so much between companies and countries, and what it can do is vastly underestimated. That’s why we use the term “field medical consultant”: it better captures what experienced consultants can actually achieve.
Reducing Recruitment Delays
Julie: Recruitment delays can vastly increase budgets during clinical development. What can be done to reduce them?
Michael: It starts well before enrolment. A field medical team should go to the planned investigators, countries and sites and get feedback on executability and design before the protocol is finalised. I can’t count the times a global investigator meeting is the first time someone from Bulgaria raises their hand and says, “we can’t do X, Y, Z in Bulgaria.” You shouldn’t be discovering issues that prompt protocol amendments at an investigator meeting. Ken Getz and the Tufts Center for the Study of Drug Development have shown for decades that the number of protocol amendments keeps rising, and this is one of the causes. Field medical can get down to that level of detail with sites, not just the investigator but the site staff who do most of the work, to confirm the patients exist, the procedures can be done, and the design assumptions hold.
Once enrolment has started, and many companies go into rescue mode six to twelve months in, you need a base plan of sites and countries, overage built in, and a backup plan that’s actively managed, not sitting in the wings, so it can enter the trial seamlessly if needed. That requires local people who know how to communicate with sites. Nobody wants to hear they weren’t selected for the initial group but may be needed later. Said honestly and in the local language, it’s received well rather than offending and alienating highly skilled people.
Julie: How much of this problem is site-specific versus strategy or awareness?
Michael: Both. There are always politics. You might have three German sites in the main plan and several more as backups, and some of them don’t get along: they clashed on a guideline committee, or one got a promotion the other wanted. If you don’t know about that and manage it upfront, the company takes the brunt, and sites may undermine the trial simply because they don’t want to work with each other. I’ve seen it in every country, including the US. If someone tells you outright, you’re lucky. Usually you have to know, which means having local knowledge.
Field Medical and the CRO
Julie: What can field medical do to unblock issues like that, that a CRO alone can’t? We often hear, “our CRO identifies the sites, manages them and monitors the study.”
Michael: It’s a partnership; it’s additive. The CRO often wants to drive site selection because, with a good contract, they’re responsible for enrolment delays. But there has to be give and take, and the sponsor must have final review and approval. Above all, local field medical often knows interested, capable centres outside the CRO’s database. Sponsors should solicit that input, evaluate those sites through proper pre-study evaluations, and include them early in planning. Field medical will also look at a CRO list and say, “she’s great, but she has six trials in the same indication, her coordinator is about to quit with no handover plan, and her sub-investigator is moving across the country.” The CRO won’t know that level of detail. Taking the CRO’s list and running with it is a recipe for disaster.
Julie: In an ideal world, with no budget or decision-making constraints, what would your backup plan look like?
Michael: It depends on the indication and where the experts are. Many trialists see Europe in binary terms: the US starts first and Europe comes in six to nine months later to help bend the curve. But Europe isn’t one thing. Each country has its own start-up timeline, and some can get up as fast as the US, sometimes faster than US academic centres. You need realistic projections of what Europe can contribute and when, feeding into screening and enrolment forecasts, and you can’t have those without local intelligence. Field medical can also flag, for example, a site finishing a similar-indication trial in about six months: not right for the primary plan, but a good backup. Expanding within a country should come first, as you already have regulatory approval and infrastructure there; adding countries takes more time, money and resources.
Julie: If a trial is already behind, what’s the fastest lever a company can pull?
Michael: It depends on the sponsor’s current engagement with sites. Many small companies leave that relationship to the CRO, and that’s the number one thing to fix. However well you train the CRO, CRAs aren’t always science experts, and one may be covering four other countries and fifteen other trials, spending much of their time travelling. A local field medical team focused only on your study, spending its time at the sites, keeps your trial top of mind and, equally important, clears up miscommunications and concerns. Site staff make or break enrolment: if they think a trial is too burdensome, or have scientific concerns about your asset or its mechanism of action, and nobody addresses it, no one signs a consent form at that site. Field medical is very well placed to manage that.
Build Versus Borrow
Julie: Let’s turn to build versus borrow. Most biotechs reach a fork where they either hire a permanent field medical team or engage an external partner, and the wrong call either burns cash or costs time. If a biotech asked you which to choose, what would you ask first?
Michael: I’d want to understand their assumptions about what field medical is versus what it should be. If you accept, as I do, that you’d rarely make a mistake by developing field medical too early, then as a chief medical officer I can’t see a circumstance where I’d build my own team. I’d want a knowledgeable, cohesive group with infrastructure and people already in the right places, who can learn the asset and hit the ground running. Building, meaning hiring, training and staffing up, takes too long and is a huge financial risk early in development. People get hurt too: if your Phase 2 study reads out and the asset doesn’t move forward, unless the company has other assets, those people are gone. So there’s a people cost, a financial cost and a timing cost. If you believe field medical has an impact early, getting the protocol design right, picking the right sites and educating them so they’re excited to execute once regulatory approval is achieved, I see no reason not to borrow.
Julie: Does that advice change for a US team versus a European one?
Michael: It depends less on the US versus Europe than on the company’s stage: is this your only asset, do you have marketed products, what stage is the asset and indication? Those are what answer the question. My answer wouldn’t differ, but the benefits are magnified in Europe.
Julie: At Phoenix we see build versus borrow as rarely a binary decision. Many companies borrow to establish field medical and then build at commercialisation, and we’re looking at how we can support that transition from a borrowed team to a permanent one. Would that resonate with the industry?
Michael: Absolutely. Over the last ten years, fractional services (CRA, chief medical officer, MSL) have really taken off, because for many companies that’s all they need for a good while, and they couldn’t afford to hire permanently at the level of expertise they want. That’s where a model like Phoenix makes a lot of sense, and a provider that then helps the sponsor build out a permanent team adds real value.
Julie: That’s still quite a culture change for our industry. What’s the biggest pushback against the fractional model, and how would you counter it?
Michael: Concerns about dedication, and whether a fractional resource will “own” the outcome in the way an employee would, with deeper understanding of the company and financial ties to its success. But that concern is quickly dispelled when a high-quality provider shows that its success is tied to the sponsor’s, and that it’s there to drive the sponsor’s success, not to rack up billable hours. When that’s evident, the concern melts away.