MaxPotent Pharma Summit 2026

Welcome to the 2nd Annual MaxPotent Pharma Summit – a leading international platform bringing together senior executives, regulatory authorities, technology providers, and pharmaceutical innovators dedicated to advancing the future of Highly Potent Active Pharmaceutical Ingredients (HPAPIs).

This year’s edition builds on the strong foundation of our inaugural summit, with an expanded agenda designed to address the critical challenges and opportunities across the HPAPI value chain. Over two intensive days, the conference will highlight the latest developments in EU and global regulatory frameworks, emerging containment and isolation technologies, and state-of-the-art automation and process engineering that are transforming manufacturing practices.

about

Delegates will gain actionable insights from real-world case studies, panel discussions, and technical presentations covering occupational health and safety standards, scaling-up strategies, risk-based exposure assessments, and supply chain resilience. Particular emphasis will be placed on partnership models with CDMOs/CMOs, sustainability in high-potency operations, and the integration of digital tools and data-driven decision-making in pharma manufacturing.

By convening experts from across the globe, the MaxPotent Pharma Summit fosters meaningful dialogue, collaborative learning, and knowledge exchange. Whether you are a pharmaceutical manufacturer, regulatory specialist, technology innovator, or solution provider, this event offers a unique opportunity to connect with peers, strengthen professional networks, and explore pioneering solutions that are shaping the next generation of high-potency drug development.

Join us in Milan, Italy to connect with thought leaders, gain actionable insights, and contribute to the advancement of HPAPI manufacturing.

Key Highlights

  • Evolving EU Regulatory Frameworks – Adapting to the latest EMA and ECHA requirements to ensure compliance in HPAPI production.
  • Innovative Containment Technologies – Designing next-generation facilities with advanced isolators and fully closed systems.
  • Building Supply Chain Resilience – Addressing challenges in sourcing, logistics, and cross-border disruptions affecting HPAPIs.
  • Harnessing AI and Machine Learning – Driving precision manufacturing through real-time analytics and process analytical technologies (PAT).
  • Protecting Workforce & Operations – Applying robust risk assessment methods to safeguard operators and minimize exposure risks.
  • Sustainability in HPAPI Manufacturing – Reducing environmental impact through waste management and alignment with EU Green Deal goals.
  • Continuous Processing & Automation – Leveraging modular platforms, robotics, and automation to enable scalable, cost-efficient production.
  • CDMO/CMO Collaboration Models – Enhancing partnerships for seamless tech transfers and accelerated drug development.
  • Frontiers in ADCs and Novel Therapies – Exploring advances in antibody-drug conjugates and other innovative therapeutic modalities.
  • Digitalization for Operational Excellence – Deploying digital twins, AI-driven simulations, and real-time monitoring to optimize manufacturing.

20+

Industry Expert Speakers

150+

Attendees Across Pharma, Biopharma, CMOs/CDMOs

What makes our Program Unique?

Expert Speaker Panel 2026

Esmaeil Ektefaie
Quality Validation Expert
Takeda
William Hawkins
Senior Managing Toxicologist
Safebridge Europe Ltd
Neha Mehta
Regulatory CMC Facilitator
Novartis
Jihene Elkhal
Validation Lead
Octapharma
Michael Schweizer
Head of Sales
Lugaia AG Containment Solutions
Justin Mason-Home
Director
HPAPI Project Services, UK
Dean Calhoun
CEO
Affygility Solutions, USA
Tara Dennis
Occupational Hygiene Manager
SafeBridge Europe, UK
TBA
TBA
Senior Representative
Telstar
Fabio Zenobi
EHS Director
BSP Pharmaceuticals S.p.A
Sean Codling
Managing Director
CTS Europe Limited
Cedric Gysel
Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability
Johnson & Johnson
Manuela Dubacher
Senior Process Modelling Lead
Takeda
TBA
Head of GQA-Chemical API
Bayer AG
Ezequiel Blanco
CAR-T Cells Specialist & Growth Manager
GMP Check

Past Speakers

Stefano Butti
Technical Sales Director
FPS Pharma
Andrew Lemaire
Technical Director - Containment & Micronization Technologies
Dec Group
Fabio Zenobi
EHS Director
BSP Pharmaceuticals
Dean Calhoun
CEO
Affygility Solutions, USA
William Hawkins
Senior Managing Toxicologist
SafeBridge Europe, Ltd
Justin Mason-Home
Director
HPAPI Project Services, UK
Martin Kohan
Managing Toxicologist
SafeBridge Europe, UK
Richard Hall Hall
Mechanical Engineer
RATTIINOX S.R.L.
Andreas Schreiner
Global Validation Leader
Novartis
Milena Gjorgjieva
Validation Manager
Boehringer Ingelheim
Mahfoud Zerarka
Procurement Manager
Sanofi
Daniel Hurni
Director Manufacturing Network Strategy and Business Intelligence
Bristol Myers Squibb
Dr. Ildikó Ziegler
Director of Quality
Hunazine Biotech
David Cragin
Senior Director - Occupational & Environmental Health Sciences, EHS & Sustainability
Teva Pharmaceuticals
Adam Burgol
Process engineer
AstraZeneca
Angéline MPEMBA BONI
Stability Specialist
Bristol Myers Squibb
Jack Brown
Senior Principal Scientist
Boehringer Ingelheim
Manuela Dubacher
Senior Manufacturing Scientist Digital & Data Manufacturing Sciences
Takeda
Giorgio Mari
Senior Process Engineer
Exyte
Andrea Weiss
International Business Strategist
AM Instruments
Matteo Alaria
Former Head of Sustainability
Sartorius
GastónAriel Estruch
Technical Director
GENTEC Pharmaceutical Group Pharmanoid Site

Sponsors & Partners 2026

Gold Sponsors

Silver Sponsors

Exhibitors

Speaking Partner

Visiting Partners

Media Partners

Delegates

Who Should Attend?
From Pharmaceutical, Biopharmaceutical, and Contract Manufacturing:

Senior Managers, Principal Scientists, Principal Toxicologists, Fellows, Investigators, Chief Executives, Vice Presidents, Directors, Heads, Leaders

Why Attend?
  • Implementing best practices for the safe and efficient production of high-potent medicines
  • Navigating updated regulatory guidelines in HPAPI manufacturing
  • Specialized training on handling and containment of complex high-potent compounds
  • Developing effective response plans for unplanned incidents
  • Optimizing outsourcing strategies to build a robust and reliable supply chain
Key Departments:
  • Validation
  • Manufacturing/Operations/Production
  • Occupational Toxicology
  • Process Development/Technical Transfer
  • Environmental, Health & Safety (HSE)
  • Risk Assessments
  • Product Quality
  • Engineering
  • Regulatory Affairs
  • Formulation Development
  • New Products
  • Research & Development
  • Industrial Hygiene
  • Laboratory Services/Analytical
  • New Technologies
  • Maintenance
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Testimonials

Join us at the MaxPotent Pharma
Summit 2026!