Tag Archives: Interim

How pharma teams are adding senior medical cover without adding headcount

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Across pharma and biotech teams, the conversation is shifting.

The challenge is no longer only how to respond once pressure becomes visible. It is how to build enough senior medical capacity into the model before review timelines start to slip, signatory responsibility becomes too concentrated or regional coverage becomes harder to sustain.

In many teams, the issue is not a lack of expertise. It is that the expertise exists in too narrow a bandwidth.

That is where delivery starts to feel fragile.

What is changing

Over recent months, we have seen a clearer pattern emerge across client conversations and active engagements.

Teams are becoming more deliberate about how they access senior medical expertise. Not only through permanent hires, but through interim, fractional and specialist support that can be introduced at the point where continuity matters most.

That shift is showing up in three places in particular.

1. Interim medical cover is becoming more strategic

Interim support used to be viewed mainly as a short-term solution.

Increasingly, it is being used more deliberately.

For many organisations, permanent headcount cannot move quickly enough to absorb sudden peaks in review demand, launch activity, congress preparation or programme expansion. Waiting until the pressure becomes obvious often means the delay is already under way.

The teams managing this well are using flexible senior medical support earlier, as a way to protect continuity rather than recover it.

2. Signatory pressure is harder to absorb

One of the clearest pressure points remains signatory and senior review capacity.

In theory, workflow may look manageable. In practice, the strain often sits with a very small number of people carrying responsibility for final medical judgement, approval and escalation.

That concentration creates risk quickly.

Review timelines become less predictable. Decisions take longer to land. Work begins queueing behind a handful of senior individuals whose capacity is already stretched.

In our experience, this is one of the areas where fractional or interim support can make the most immediate difference, particularly when demand rises faster than internal structures were built to handle.

3. Regional expertise is being added more flexibly

As programmes expand across Europe, APAC and beyond, medical delivery becomes more complex.

What looks manageable from a global planning perspective can become much harder to sustain at regional level when medical affairs, regulatory interpretation and local execution all need timely senior input.

We are seeing more teams look for flexible regional support rather than waiting for permanent structures to catch up.

That is especially true where timelines are moving quickly, local nuance matters and there is limited tolerance for delay.

Where we are seeing demand for senior medical cover most often

The practical need is usually showing up in familiar areas:

  • Peak MLR review demand and final signatory cover
  • Interim and fractional Medical Affairs support
  • Medical monitoring reinforcement during active programme phases
  • Regional medical input across Europe and APAC
  • Flexible senior input around launch, submission and milestone pressure

These are not isolated issues. They are often connected.

When one part of the model becomes too dependent on a small number of senior people, the knock-on effect is felt across the wider programme.

What usually prompts teams to act

By the time support is being actively explored, the early signs are often already visible:

  • Review timelines becoming less predictable
  • Signatory work concentrating in too few people
  • Regional medical input becoming harder to maintain
  • Milestones putting visible strain on existing medical resource
  • Teams becoming increasingly dependent on one or two senior decision-makers

Usually, none of these issues looks dramatic in isolation.

Together, they are a strong signal that continuity needs strengthening.

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How MMD is responding

This April, My Medical Department marked 12 years of supporting pharmaceutical, biotech and life sciences teams with physician-led medical expertise.

Over that time, our role has remained consistent. We help clients access senior medical support when quality, continuity and timely decision-making matter most.

We have also recently strengthened our UK Medical Affairs capability with the appointment of Linnea Lindqvist-Brown, whose background includes AstraZeneca, Eisai, Roche and Pfizer, alongside ABPI Final Signatory experience.

That addition reflects something we are seeing clearly in the market. Clients increasingly need experienced support that can be deployed quickly, credibly and in a way that fits the realities of modern medical delivery.

A final thought

The most resilient teams are not always the ones with the largest structures.

They are often the ones that think earlier about continuity, senior decision-making capacity and how specialist expertise can be added without slowing everything else down.

That is where interim and fractional medical support is becoming more strategic.

And it is why more organisations are treating flexible senior medical cover not as a backup plan, but as part of how delivery is protected in the first place.

If your team is reviewing how to strengthen medical capacity without adding permanent headcount too quickly, we would be very happy to compare notes. Contact us at enquiries@mymedicaldepartment.com or visit www.mymedicaldepartment.com.

Where Pharmaceutical Programmes Start to Slow Down

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Executive Briefing · March 2026

Where Pharmaceutical Programmes Start to Slow Down

Across clinical development, medical affairs and global programme delivery, one issue is showing up more consistently right now. It is rarely a lack of expertise. More often, it is a lack of alignment — and by the time it becomes visible, it is usually already affecting timelines.

Clinical, medical, regulatory and commercial teams can all be doing strong work individually and still create delay collectively. Not because people are underperforming, but because they are moving at different speeds, under different pressures and without enough structural overlap to catch the gaps before they become bottlenecks.

“The bottleneck is not capability. It is the moment when throughput increases but capacity does not adjust in the same way.”

That usually becomes visible at predictable pressure points — conference periods, team transitions, key milestones, holiday cover and launch preparation. By the time the problem is obvious, it is often already affecting timelines.

Why Australia Is Becoming a Stronger Option for Early-Phase Trials

One of the clearest shifts we are seeing is the continued growth of early-phase and exploratory trial activity in Australia. The reasons are practical.

Speed

Study start-up can be faster than in the US and much of Europe

Regulatory clarity

The regulatory pathway is well understood, particularly for Phase I and II

Cost efficiency

The cost profile can be attractive, particularly in earlier development phases

Site quality

Strong site and investigator capability across the country

From a development strategy perspective, the case is clear. The part that is easier to underestimate is the operating model around it.

Once programmes are spread across regions, time zones and governance frameworks, execution becomes more demanding. The strategic decision may be sound, but the supporting structure does not always evolve at the same pace. That is often where delay begins.

Considering Australia for your next early-phase programme? We work with sponsors navigating this exact challenge across clinical development and regulatory strategy.

Talk to our team about your programme →

Where Bottlenecks Usually Appear in Clinical and Medical Affairs Teams

There are three places where we see this most consistently.

1. Medical Affairs and MLR Review

During high-volume periods, review processes come under pressure quickly. Materials arrive not fully ready. Signatory responsibility is concentrated in too few people. Workflows begin to fragment.

The result is predictable — delays increase, timelines become less reliable and pressure builds between teams at exactly the point when speed matters most.

2. Clinical Development and Medical Monitoring

As programmes scale, safety data is generated continuously. Oversight structures do not always scale with it. Signal interpretation slows. Escalation pathways become less clear across regions. Decision-making latency starts to creep in.

This is rarely dramatic at first. It is usually gradual — but it becomes very obvious once the programme is under pressure.

3. Global and Local Execution

As soon as work needs to move across markets, global strategy has to stay aligned with local requirements, local codes and local expectations. If that alignment is weak, teams end up dealing with inconsistent interpretation, slower approvals and avoidable compliance risk.

Zero

substantiated code complaints relating to MMD-approved materials in over 12 years. Compliance is not a constraint on speed — it is a condition for it.

What High-Performing Pharmaceutical Teams Do Differently

The strongest teams do not simply add more people when pressure appears. They make structural adjustments earlier.

  • Scaling review and signatory capacity before peak periods rather than during them
  • Embedding medical input earlier so materials arrive for review genuinely ready
  • Ensuring medical monitoring models keep pace with data flow rather than lagging behind it
  • Aligning global and local regulatory thinking before regional differences become execution blockers

In other words, they do not wait for friction to become visible before addressing it.

Early Warning Signs of a Misaligned Programme

A Quick Check

If any of these sound familiar, it is usually a sign that alignment is starting to break down — and worth addressing before timelines tighten further:

  • Review timelines are becoming less predictable
  • Increasing back-and-forth between medical and marketing teams
  • Materials requiring multiple review cycles before reaching approval
  • Delays linked to limited signatory or senior medical capacity
  • Bottlenecks appearing during periods that should have been manageable

These issues rarely resolve themselves. They tend to compound as timelines tighten.

“Since partnering with MMD we have found that our materials no longer reach a bottleneck in the copy process. I would recommend them as an agency for companies looking for effective and proactive solution providers.”

Dr Tim Patel

Medical Director UK, Astellas

How My Medical Department Supports Global Programmes

My Medical Department is a physician-led global medical consultancy supporting pharmaceutical and biotech organisations across clinical development, medical affairs and regulatory strategy. Our teams are based in Australia, the UK and Latin America, with project support delivered globally.

We are currently supporting organisations with:

  • Managing peak MLR review demand and signatory capacity
  • Implementing continuous medical monitoring in clinical programmes
  • Strengthening global-to-local regulatory alignment across regions
  • Strategic consultancy across clinical development, medical affairs and market access
Australia United Kingdom Latin America

Where timelines are already under pressure, small structural changes can make a material difference to delivery. If these are challenges your team is currently facing, get in touch to discuss how others are approaching them in practice.

Let us talk about what you are seeing

We support global programmes with teams in Australia, the UK and Latin America. If timelines are already under pressure, the right time to address it is now.

Talk it through with our team →

No commitment. Just a conversation.

Kwesi Ackah is Global Director of Strategic Development at My Medical Department, a physician-led medical consultancy operating across Australia, the United Kingdom and Latin America. Connect on LinkedIn · mymedicaldepartment.com

© My Medical Department 2026. Executive Briefing series.

Tackling Peak Conference Demands in Pharma: How MMD Can Support

Congresses/Conferences

Every year, major UK and European medical conferences such as ESMO, EURETINA, ERS and BSH bring an incredible opportunity for pharmaceutical companies to engage with HCPs and showcase their latest scientific data.

But with these opportunities come challenges for medical and marketing teams:

  • Workload spikes as symposia, booth activities and HCP engagements occur simultaneously within a short period
  • International colleagues often play a key role in event delivery but may require dedicated support to navigate ABPI Code requirements
  • Compressed timelines for the review and approval of congress materials
  • Overlapping leave and escalating demands can place considerable strain on internal medical resources

Why Conference Season Creates Bottlenecks

When conference season hits, internal medical teams are expected to:

  • Review and approve various materials, including slides, posters and booth content
  • Respond to real-time medical enquiries and healthcare stakeholder engagements
  • Maintain compliance oversight, ensuring all activities meet ABPI standards

These demands can quickly outpace available internal resources. Without additional support, the combination of time pressure and increasing workload often leads to bottlenecks, delayed approvals and increased compliance risk.


How My Medical Department Provides Overflow Support

At MMD, we act as an extension of your medical affairs team during peak periods, helping you stay compliant and efficient, while easing the workload.

Among the services we offer:

  • ABPI-compliant medical review and approval of all congress materials
  • Overflow and leave cover, so work continues seamlessly
  • Rapid turnaround, even during busy conference seasons
  • Guidance for international teams, ensuring local compliance for UK and EU activities

By stepping in as flexible medical support, MMD allows your core team to focus on high-value HCP engagement, knowing that all materials are handled accurately and on time.


Congresses/Conferences

Ready for a Smoother Conference Season?

When internal teams are stretched, MMD steps in with specialist support that’s fast, flexible and fully ABPI-compliant. Whether it’s last-minute content reviews or strategic overflow coverage, we help you stay ahead—so your team can focus on delivering scientific excellence where it matters most.

Let’s talk about how we can support your next conference season.

📩 Email us at enquiries@mymedicaldepartment.com
🌐 Visit www.mymedicaldepartment.com

Pharmaceutical Medical Expertise. Anytime. Anywhere.

Regulatory Roundup – May 2025

Regulatory Round Up

Welcome to the May 2025 edition of our Regulatory Roundup! This month, we bring you the latest updates from key regulatory bodies worldwide, including the Therapeutic Goods Administration (TGA) in Australia, the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA).

These updates highlight significant strides in medical regulation, from consultations on in vitro diagnostic (IVD) medical device classifications to advancements in artificial intelligence integration within regulatory processes. Additionally, we provide expert tips to streamline your copy approval processes, ensuring efficiency and compliance.

Stay informed about the latest regulatory changes and how they might impact your work and industry.

🇦🇺 Therapeutic Goods Administration (TGA)

IVD Classification Consultation: The TGA actively seeks stakeholder feedback on proposed changes to in vitro diagnostic (IVD) medical device classifications and definitions. This initiative aims to align Australia’s regulations with the European Regulation 2017/746. Stakeholders have until 23 May 2025 to submit their feedback.

Nitrosamine Impurities Update: On 30 April 2025, the TGA updated its guidelines regarding acceptable intake levels for nitrosamine impurities in medicines. This update aligns with recent changes made by the European Medicines Agency (EMA), ensuring consistency in safety standards.

🇺🇸 U.S. Food and Drug Administration (FDA)

AI Integration in Reviews: The FDA has announced a significant step forward in its regulatory processes by integrating artificial intelligence tools across all its centres. Full integration is expected by 30 June 2025, following a successful generative AI pilot to streamline the drug approval process.

COVID-19 Vaccine Advisory Meeting: An advisory committee meeting is scheduled for 22 May 2025 to discuss and make recommendations on selecting the 2025–2026 formula for COVID-19 vaccines in the U.S. This meeting will play a crucial role in shaping the upcoming vaccination strategy.

🇪🇺 European Medicines Agency (EMA)

Advanced Therapies GMP Revision: On 8 May 2025, the EMA published a concept paper proposing revisions to Part IV guidelines on good manufacturing practice (GMP) specific to advanced therapy medicinal products. This revision aims to enhance the regulatory framework for these innovative therapies.

Data and AI Workplan: In collaboration with the Heads of Medicine Agencies, the EMA has released a joint work plan titled “Data and AI in medicines regulation to 2028.” This strategic document outlines plans to leverage data and artificial intelligence to improve regulatory processes and outcomes.

As we navigate the evolving landscape of medical regulation, it is crucial to stay informed about the latest updates from key regulatory bodies. The May 2025 Regulatory Roundup has highlighted significant TGA, FDA, and EMA developments, showcasing efforts to enhance regulatory frameworks and integrate advanced technologies.

We hope this roundup provides valuable insights and helps you stay ahead in your field. Look for future updates, and don’t hesitate to share your thoughts or questions. Together, we can continue to drive progress and innovation in medical regulation.

Thank you for reading, and stay tuned for next month’s roundup!

The Crucial Role of Final Signatories in the Pharmaceutical Industry (UK)

My Medical Department Strategy Consulting

Final signatories are crucial in markets operating under strict regulatory frameworks.

The pharmaceutical industry operates under strict regulatory frameworks to ensure that medicines and healthcare products meet the highest standards of safety, efficacy, and compliance. One key role in maintaining these standards is that of the final signatory, a professional who bears the ultimate responsibility for approving promotional materials, ensuring compliance with industry regulations, and safeguarding public health. However, final signatories constantly face competing interests that make their role uniquely challenging.

The Balancing Act of Final Signatories.

While final signatories are required to apply the strictest possible compliance standards, they are also frequently challenged by:

  1. Brand Messaging vs. Compliance – Companies push for the strongest possible messaging to differentiate their brands, but signatories must ensure this remains within legal and ethical boundaries.
  2. International Regulatory Variability – Messaging consistency across different countries is difficult when regulations vary widely. The UK is often perceived as one of the most restrictive environments, making global alignment a challenge.
  3. Rapidly Advancing Technology – Innovations like AI chatbots for answering customer queries evolve faster than regulations can keep up, leaving signatories navigating grey areas in compliance.
  4. Social Media Complexities – Companies seek engagement on platforms like LinkedIn, but social media interactions can inadvertently breach regulations. A significant number of complaints under industry codes arise from company personnel liking or reposting company announcements on publicly visible media.

Interpretation and Inconsistencies in Compliance.

The regulatory code is open to interpretation, and rulings by the Prescription Medicines Code of Practice Authority (PMCPA) can evolve and sometimes be inconsistent. This means that no two final signatories will necessarily assess a compliance challenge in exactly the same way, leading to frustration for companies that receive differing advice on similar issues.

The Multifaceted Expertise Required.

Final signatories must strike a balance between medical expertise, keeping up to date with the latest data and scientific advancements and skills typically associated with the legal profession. Unlike in the US, where compliance is managed through a Medical, Legal, and Regulatory (MLR) process, the UK often expects final signatories to perform all three functions themselves, adding to the role’s complexity.

The Importance of Support and Collaboration.

New final signatories need strong support to navigate these challenges effectively. This includes:

  • Guidance from experienced colleagues to help interpret complex and evolving regulations.
  • A robust compliance team to provide additional oversight and support.
  • Close cooperation with commercial and marketing colleagues to ensure that promotional materials are both impactful and compliant.
  • Alignment with international teams to manage regulatory variations while maintaining a consistent global brand presence.

Final signatories play an indispensable role in the pharmaceutical industry, balancing strict compliance with the evolving demands of marketing, technology, and international regulations. Their role requires a unique blend of medical, legal, and regulatory expertise, making collaboration and ongoing education essential. As the industry continues to evolve, the challenges faced by final signatories will only grow, reinforcing their critical position as guardians of responsible pharmaceutical communications.

If you would like to speak with our Final Signatory team to learn more or discuss your compliance needs, please get in touch with us today.