Agenda

MaxPotent Pharma Summit 2027 Programme

Two days, four themed sessions, two keynotes and two industry panels. 21–22 April 2027, Rome, Italy.

Home Agenda
08:15
Registration & Networking Coffee
09:00
Chairperson’s Welcome & Opening RemarksEster Lovsin Barle, Global Head Product Sustainability and Stewardship, Takeda
09:10
Opening Keynote: Challenges and Opportunities in Setting HBELs for New Modalities in the Age of AI KeynoteEster Lovsin Barle, Global Head Product Sustainability and Stewardship, Takeda
09:40
Global Regulatory Expectations for HPAPIs: EMA, FDA, PIC/S and Annex 1 Updates
10:10
Developing Robust Occupational Exposure Limits (OELs), HBELs and PDEs for Next-Generation Molecules
10:40
Networking Coffee Break
Session 1: Manufacturing & Scale-Up
11:25
Scaling HPAPIs from Clinical Development to Commercial Manufacturing: Lessons Learned
11:55
Technology Transfer Challenges Between Pharma and CDMOs
12:25
ADC Payload Manufacturing: Containment, Safety and Commercial Readiness
12:55
Networking Lunch
Session 2: CDMO & Outsourcing Excellence
13:55
Selecting the Right HPAPI CDMO Partner: What Pharma Companies Really Look ForLuiz Alberto Barberini, Head, External Manufacturing, Latin America, Bayer
14:25
Building Flexible Facilities for Multi-Product HPAPI Manufacturing
14:55
Digital Transformation in HPAPI Facilities: AI, MES, LIMS and Data Integrity
15:25
Networking Refreshment Break
16:00
Engineering Challenges in OEB-5 to OEB-7 Manufacturing Environments
16:30
Panel Discussion: The Future CDMO Model: How Pharma and Manufacturing Partners Can Accelerate Speed, Quality and Innovation PanelPanellist: Luiz Alberto Barberini, Head, External Manufacturing, Latin America, Bayer
17:15
Chairperson’s Closing Remarks
17:20
Drinks Reception and Networking
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5 more sessions on Day 1

The rest of the 3rd Annual programme, including every talk title, is available on request. Add your details below to unlock both days.

    We will send the PDF agenda across as well.

    Key highlights

    Ten Themes Across the Two Days

    01

    Evolving EU Regulatory Frameworks

    Adapting to the latest EMA and ECHA requirements to ensure compliance in HPAPI production.

    02

    Innovative Containment Technologies

    Designing next-generation facilities with advanced isolators and fully closed systems.

    03

    Building Supply Chain Resilience

    Addressing challenges in sourcing, logistics, and cross-border disruptions affecting HPAPIs.

    04

    Harnessing AI and Machine Learning

    Driving precision manufacturing through real-time analytics and process analytical technologies (PAT).

    05

    Protecting Workforce & Operations

    Applying robust risk assessment methods to safeguard operators and minimise exposure risks.

    06

    Sustainability in HPAPI Manufacturing

    Reducing environmental impact through waste management and alignment with EU Green Deal goals.

    07

    Continuous Processing & Automation

    Leveraging modular platforms, robotics, and automation to enable scalable, cost-efficient production.

    08

    CDMO/CMO Collaboration Models

    Enhancing partnerships for seamless tech transfers and accelerated drug development.

    09

    Frontiers in ADCs and Novel Therapies

    Exploring advances in antibody-drug conjugates and other innovative therapeutic modalities.

    10

    Digitalization for Operational Excellence

    Deploying digital twins, AI-driven simulations, and real-time monitoring to optimise manufacturing.

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