Susan has recently been promoted to Global Head of Medical Affairs. She works for a small company that currently has one product launched in the US. The company is expanding to Europe and is opening offices in selected European locations. The company has no European footprint.

Susan likes her employer because she enjoys to drive things end to end. The upside is she is often in the driver’s seat. The downside? She must be creative with the budget she has, as headcount and budget is restricted.

What Susan did first:  Understand the market

When we last encountered Susan, she had just been promoted, and had started with making a list of things to consider as she identifies the best set-up for Medical Affairs in Europe.

Today we will dive deeper into Susan’s reality. Susan’s initial list took her three minutes to write. It includes the following points, I am sharing them here, so you don’t need to go look for my first post on Susan.

Susan’s List of Hard Facts She Needs to Know to Design EU Medical Affairs

• Commercial strategy, launch sequence and rationale
• Sales teams, co-marketing or will the company build its own team?
• What is the status of regulatory submission(s)?
• Competitor landscape and anticipated market entry.
• What data is available on the markets, physicians, healthcare systems, reimbursement and patient demographics and access?
• Who prescribes this medication in this indication? Different markets may have different approaches.
• Regulatory and compliance considerations.
• What conferences are critical for this indication in Europe?
• Can the US support the EU market? What setup does the US need to do this?
• What is the leanest but most effective setup she can put in place?
• What roles, responsibilities, IT systems and documentation will she need?
• Does she outsource or insource, and what are the rules governing this?

Note this is a first pass, but she will add many more items to her list.

When I introduced Susan, I said writing a list is like planning a hike looking at a map.  It looks easy on paper, but in reality it is tougher.

Comments on LinkedIn confirmed this – leading to a second list of factors Susan needs to consider:

Susan’s List of Additional Factors That Influence Medical Affairs Design Success

Face the rocks

I said planning a hike is easy. Felipe Navarrera MD. MBA. BCMAS said “Keeping the same analogy, the best thing to do is to be present in the ground full of rocks, instead of building nice AI slide decks in the office; expansions are full of assumptions meaning lot of mistakes. Growth mindset is a must as a requirement for the team to be hired”. Pretty slide kits are not enough, anything the global teams design needs to serve the teams at the pointy end of the business.

In the words of a senior executive at a Top 5 pharma company “Supporting local teams is the only reason global teams exist.”

Understand Interdependencies and Plan for Long Lead-times

The list is the just the start. Maaike Addicks, MD says: “I remember starting with a logical and simple list and ending with a complex spreadsheet full of landmines. I think one of the most challenging parts is interdependence. What may look like a small step could be the step that screws it all up if missing, especially if it is a step that has a long lead time and cannot be organized in a short period of time (as medical affairs activities often are)

And Dr Elsa Zekeng adds :  “Perhaps the real skill in building a Medical Affairs function is not creating the initial plan but recognizing how every decision reshapes the options that follow. The roadmap may fit on a page, but the organisation is built through hundreds of interconnected choices.”

Projects of this scale are challenging – don’t expect to get everything right

You cannot plan for everything, you will miss something, it is worth highlighting this early on. Even if you plan everything you still cannot anticipate every detail. Dorota Rajska comment illustrates this well “I don’t know about Medical Affairs, but in hiking, I’ve often over prepared, taking things I never used. … I don’t mean must haves in case of emergency like first aid and a rain jacket. I mean too much food, extra t-shirt, a book I never read while hiking. This has also happened in my software work. I tend to over engineer” which highlights you can put a lot of effort into anticipating every issue, but you may still not get it right.

I recommend planning well enough, starting and planning enough time for adaptations. You can never have enough time. Plan 25%  more than you anticipate needing.

Susan’s Situation is Unique – So is Yours

Nobody has done this before: Many companies have built Medical Affairs teams – but none have built Susan’s Medical Affairs set-up before, in this market, with this molecule, in this political environment. Naturally the tools in Susan’s toolbox will match the tools other Global Medical Affairs leaders have, but what she builds and how she builds it will depend on her unique situation and how much budget and other factors she has available. I share this because the question I am asked most often is “What is the gold standard in this situation?” and I say “It depends”

However there are some considerations that will help you:

• The indication, the molecule type, where and how it is administered.
• Is it an orphan indication, fast-track approval, or a “me-too” in primary care.
• Is the product meeting an unmet need?
• Will the product be used in in-patient settings or prescribed in clinical practice?
• Do doctors know the drug class or is it novel? (Remember:  biosimilars)
• Not established in the market – need experienced people
• Healthcare system models
• What does the future look like for this molecule.

Based on the answers to the above, who Susan hires, how senior they are, who they engage with and the types of activities they focus on will be dramatically different. Also, this is important:  Susan’s company is setting foot in a market for the first time, so her company cannot afford to get it wrong. This may mean engaging with local experts, who help guide.

Susan’s Additional Challenge – She Only Has 12 months to Launch

In addition to a challenge that is already significant, Susan has an additional challenge. She only has 12 months until the first launch. If all goes to plan.

Many small companies build their Medical Affairs team too late – ideally you start setting the up two years before launch

Susan works for an US-American company. While many team members have worked for bigger pharma companies, they have in previous roles been supported by established European teams and don’t really understand the challenges of the EU market. They are confident that the US approach can be adapted to the EU market.

This is why the Global Medical Affairs director was hired with 12 months to go before the first launch.

Despite her Leadership Teams confidence, Susan knows 12 months to launch is insufficient. She will start to identify how she wants to set-up her regional structure, plan the structure, hire the team and get them out in the field working with a focus on the first market: considering what activities must we do to get this right? She will focus to understand that market and those KOLs. She will try to lay the foundation for critical Medical Affairs activities like real-world evidence generation, investigator-initiated trials, or data generation and data capture.

She knows that absent existing KOL relationships, it will be a struggle to put a foundation in place. As Maaike Addicks said above some activities in Medical Affairs have long lead-times.

She also knows that If you have a footprint on the ground, relationships with Key Opinion Leaders, your brand is established etc. you are in a different situation to a company that is starting with nothing.

As Myriam Cherif, PhD writes in response to the question what looks simple on paper, but what might take longer in practice “I love the analogy Dr Isabelle for me KOL relationship is an example that looks simple on paper but takes months or years in reality”

So, what does Susan do next?

Susan performs a preliminary assessment of the materials at her disposal.

An often-underestimated activity but one you MUST do. She starts by taking stock of what’s already available to her, what data the company have in-house, what IT systems and documentation already exist, what materials and content have already been developed, and what relationships and market intelligence might already sit somewhere in the organisation, unused or forgotten.

She talks to IT. She asks for a data catalogue. She finds out that much of the information she needs is available in house.

Once she has an approximate size and shape of the challenge she faces

She maps out an approximate plan with interdependencies and identifies things that need to start happening now. Some of these are simple:

She looks ahead. As European headquarters and local websites go live, medical questions may start arriving before the product even reaches the market. Ensuring these questions are captured, catalogued and analyzed, and figuring out where those questions go, and setting up data analytics to track inbound traffic, needs to happen early, not once the product has launched.

The same is true for search visibility, having accurate information findable online before everything else is fully set up matters, because inbound interest doesn’t wait for internal readiness.

Then she talks extensively

She then talks to everyone in the organisation that has exposure to the markets she will be expanding into. She finds out what the planned local affiliate set-up is, what the commercial strategy is, what teams will be on the ground, whether a regional structure is envisioned, that will map to her own med affairs approach.

She finds out which markets have the greatest need and potential influence other markets. She finds out where the biggest KOLs in Europe  are and how they connect internationally. She finds out what they are famous for currently and how they were involved in developing the product or portfolio she is responsible for.

She makes sure everyone knows what she is considering and establishes and maintains open lines of contact.

She designs a preliminary plan and starts planning team members to support build

She starts considering what type of team she will need to put in place to build the structure and who needs to be on the team. She considers what IT systems she will need to manage KOL engagements, Medical Information enquiries, integrate with Pharmacovigilance teams, and enable data analytics and she considers how these systems will scale as the company expands beyond Europe (in truth Susan typically doesn’t do this, but it would be good if she did).

Susan knows she will need a team with cross-functional skill-sets to drive the project, as well as dedicated individuals who are responsible for the Eu market.

What she does next here depends on what team members are available at a global level who are specialized in KOL management, communications, medical excellence etc. and who she can engage as she designs her approach.

As Susan is US based, she feels that having a counterpart in the EU may be helpful.

Susan then gets help

Now she has the bones together she knows she cannot gather or build all this alone. What she does next depends largely on her budget and her timeline. She may pull together a small global team, tasking specialists to focus on specific markets. She may bring in outside consultant support to accelerate the parts she cannot resource internally fast enough. Often, it’s a combination of both.

Either way, the list she wrote in three minutes is now becoming an organisation, one interconnected decision at a time.

If you are in Susan’s shoes: be realistic, note that Medical Affairs planning ideally starts up to two years before launch. If you are in a in small companies, with limited headcount and stretched resources, it frequently starts far later, sometimes with only 12 months to go, sometimes less, prioritise ruthlessly. Know you can only do the best you can, and build a strong network of allies, both in your own company and across other companies, whose knowledge, strength and experience you can draw on.

If this resonates and would like to set-up a short 30-minute chat with me, bring your problem, and I will give you my take: here

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