FAQs

November 17 to 19, 2026, in Boston, MA.

Wyndham Beacon Hill - Boston, MA.

To benchmark your MIDD strategy against peers from big pharma, biotech, and regulatory agencies, and to work through practical challenges like AI integration and regulatory credibility with people facing the same problems.

Boston sits within one of the highest concentrations of pharma, biotech, and academic MIDD talent in the US, keeping travel easy for most of the audience.

Three days total: one Workshop Day followed by two Conference Days.

Between 60 and 80 senior MIDD practitioners, kept intentionally small for depth of conversation.

MIDD has moved from a supportive, dose-optimisation tool to a discipline that is actively shaping decisions across discovery, translational science, clinical development, and regulatory science. Regulatory guidance, including the recently harmonised ICH M15 guideline, has clarified how modelling and simulation can support submissions, dose selection, and trial design, and FDA's Project Optimus has reinforced this shift, particularly in oncology.

In 2026, several factors are pushing MIDD leaders to act:

• Regulatory clarity has increased, with some in the field arguing model-informed evidence should carry comparable weight to traditional clinical data in specific circumstances
• AI and machine learning are being integrated into MIDD workflows faster than most teams can validate, raising real questions about credibility and regulatory acceptance
• Data limitations remain the biggest practical constraint, particularly in early-phase development where clinical data is scarce
• MIDD groups are growing across big pharma, and biopharma organisations are under pressure to standardise and scale their use of modelling rather than treat it as an afterthought
• Bridging data and models across therapeutic areas and modalities (small molecules, ADCs, T-cell engagers, multispecifics) is becoming a shared challenge rather than a niche one

The 2nd MIDD Summit is built to address these questions directly, with a strategy and implementation focus rather than a "what is MIDD" introduction.

This summit is designed for senior practitioners who use quantitative models to inform real development decisions. Attendees typically include:

• Vice Presidents, Directors, and Heads of Pharmacometrics
• Modelling and Simulation, Simulation Engineering, and Quantitative Pharmacology leaders
• Quantitative Systems Pharmacology (QSP) specialists
• Clinical Pharmacology and Population Pharmacokinetics leaders
• PBPK modelling specialists
• Translational Science and Preclinical MIDD leaders
• Bioinformatics leaders working across MIDD platforms
• Regulatory scientists with a focus on model-informed evidence

This is not an introductory or academic meeting. Attendees come to benchmark strategy and troubleshoot implementation, which is what keeps the room focused and the conversations at depth.

The summit draws on the full MIDD ecosystem across big pharma, biotech, and regulatory agencies. Confirmed speaker faculty for 2026 includes teams from US FDA, AbbVie, Astellas Pharma, Biogen, BMS, Eli Lilly, EMD Serono, Genmab, Gilead Sciences, GSK, Health Canada, Novartis, Sanofi, Vertex Pharmaceuticals, Bicycle Therapeutics, and the Clinical Trials Transformative Initiative.

The summit runs across three days:

• Workshop Day, with two three-hour, expert-led workshops running in parallel, each capped for in-depth, interactive discussion
• Conference Day 1 and Day 2, featuring case study presentations, panel discussions, and structured networking throughout

This is a modality-agnostic, indication-agnostic programme. Content spans oncology, autoimmune, and other therapeutic areas, since practitioners in pharmacometrics and clinical pharmacology rarely work in a single modality and value shared cross-disease learning.

MIDD sits within a busy conference landscape, including ACOP, PAGE, ASCPT, and the Certara QSP Summit. The MIDD Summit is positioned differently:

• Depth over scale: with 60 to 80 senior practitioners in the room, this is a fraction of the size of ACOP, or ASCPT which allows for genuine, sustained conversation rather than a packed technical schedule
• Strategy-led, not purely technical: sessions are built around how and why MIDD has been used to accelerate programmes and support regulatory submissions, not foundational "what is MIDD" content
• Seniority-first: the audience is deliberately Director level and above, so conversations start from a shared baseline of expertise
• Cross-functional by design: pharmacometricians, clinical pharmacologists, QSP scientists, and translational leaders are in the same room, reflecting how MIDD actually operates inside organisations
• Full ecosystem, not a single sub-discipline: the MIDD Summit spans pharmacometrics, PBPK, QSP, and population PK together

The Workshop Day runs the day before the main conference and offers two three-hour, expert-led sessions running in parallel, each limited to a small group to support genuine problem-solving.

Planned 2026 workshop themes include:

• Building MIDD strategies from discovery through to first-in-human, when clinical data is limited
• Integrating AI, real-world evidence, and quantitative models to strengthen regulatory confidence

Each workshop is built around at least two presenting speakers to ensure the content is distinct from the main conference programme.

The Workshop Day is available as part of a Full Package alongside the two conference days, or the conference can be attended on its own. Delegates who take the Full Package get a deeper programme and more time with peers working on similar challenges.

Networking is central to the value of this summit. With 60 to 80 delegates in the room across three days, most attendees will get to know each other by name, something that is not possible at larger association meetings.

Opportunities include:

• Extended breaks and refreshments throughout the Workshop Day and both Conference Days
• Structured networking sessions built into the agenda
• Full lunches on all three days
• Access to the exhibition area, where MIDD-specific modelling and simulation providers are on hand for informal conversation

Both, though the programme places particular weight on translational and clinical-stage MIDD, which reflects where the majority of the audience sits. Some organisations run separate preclinical MIDD groups that work independently before collaborating closely with clinical teams once a candidate is selected, and the agenda reflects that reality with dedicated preclinical content alongside the primarily translational and clinical focus.

Yes. AI integration is one of the most active areas of discussion in the field right now, and the programme addresses it directly, including how AI is changing modelling workflows, where the current gaps and limitations are, and how to use AI without creating black-box models that regulators will not accept. This sits alongside the FDA and EMA's Guiding Principles of Good AI Practice in Drug Development and the current regulatory direction on AI-assisted submissions.

Yes. With ICH M15 now finalised, sessions will look at what this means in practice, including how MIDD evidence is weighted alongside clinical data, model-informed labelling, and how model credibility is demonstrated to regulators. FDA and Health Canada perspectives are represented directly in the faculty.

The summit is built for practitioners actively working in MIDD, not those exploring the discipline for the first time. Sessions assume familiarity with pharmacometric and modelling concepts and are pitched at Director level and above. If your MIDD group is newly established or scaling up, the peer access alone, with senior practitioners from big pharma, biotech, and regulatory bodies in one room, is one of the fastest ways to benchmark where your team stands.

The 2nd MIDD Summit takes place in Boston, MA. Boston sits within one of the highest concentrations of pharma, biotech, and academic MIDD talent in the US, which keeps travel friction low for the majority of the audience while remaining accessible to international delegates.

Group discounts are available for teams attending together. Early registration discounts may be available for your team, and given the capped, intimate format of this summit, registering early is recommended.

For registration enquiries and speaking opportunities, please contact info@hansonwade.com.

For sponsorship and exhibition enquiries, please contact sponsor@hansonwade.com.