Name: 8th Annual MarketsandMarkets High Potent Medicines Conference
Start: 2023-05-24
End: 2023-05-26
Location: Duo Milan Porta Nuova, Via Gerolamo Cardano, 1, 20124 Milano MI, Italy.

EVENT OVERVIEW

Looking and the current market scenario, many companies are outsourcing the manufacture of their highly potent compounds for various reasons, mainly marketing. The escalation in the High Potent drug market is subjected to a variety of aspects such as the diversification of pharmaceutical manufacturers towards precision medicines such as HPAPI, increasing demand for oncology drugs & antibody-drug conjugates, and advancements in HPAPI manufacturing technologies.

We are delighted to announce our 8th Annual MarketsandMarkets High Potent Medicines Conference, scheduled to be on 24th -26th May 2023, in Italy. This conference will evidence the presence of some great minds in the Medical and Pharmaceutical industry bringing you the solutions to the challenges faced in advanced High Potent Medicines. Grab the opportunity to interact with them, 10+ hours of dedicated networking for two days in a row and meet your potential targets to create target revenue.

Process Development and scale up of HPAPI’s
Strategies for effective outsourcing partnership
Containment and Handling Strategies
Validation of cleaning procedures to avoid cross contamination
Regulatory Landscape
Hazard Assessment Classifications

Utilizing the best practices to ensure safe and efficient production of high potent medicines
Training sessions on complex high potent compounds handling and containment issues
Understanding the updated regulatory guidelines in the HPAPI process
Implementing response plans to react to an unplanned event
Knowing the outsourcing strategies to effectively build a reliable supply chain

From pharmaceutical and Biopharmaceutical manufacturing:

Chief executives, VP’s, Directors, Heads, Leaders, Senior Managers, Principal Scientists, Principal Toxicologists, Toxicologists, Fellows, Investigators working in:

Research & Development
Manufacturing/Operations/Production
Maintenance
Engineering
Risk Assessments
Laboratory Services/Analytical
New Technologies
Process Development/Technical transfer

CONFERENCE AGENDA

Registration	08:15 - 09:00
Welcome note from MarketsandMarkets	09:00 - 09:05
Opening Remarks from the Chairman Dean Calhoun , President, CEO, Affygility Soultions, USA	09:05 - 09:10
Keynote Presentation: Revolutionizing Pharmaceutical Manufacturing: Harnessing the Power of Artificial Intelligence and In Silico Tools Dean Calhoun , President, CEO, Affygility Soultions, USA	09:10 - 09:40
Process Development and Scale up
Cryogenic Milling and cleaning Processes under GMP conditions Hermann Schmidt, Operations Director, Pharma & Lab Division, Hosokawa Alpine AG	09:40 - 10:10
Morning Refreshments and Poster Presentation \| One-to-One Networking Meetings	10:10 - 11:00
From lab to commercial production -How to combat challenges in OSD High potency products development Carolina Bonifacio, Siegfried, Head, Drug Product Development	11:00 - 11:30
High Containment Kilolab Plant: From Design to Process Validation Helena Camps, R&D Director, MOEHS Fine Chemicals	11:30 - 12:00
Outsourcing High Potent OSD Late Stage Development: CDMO Insights David O’Connell, Director, Scientific Affairs, PCI Pharma Services, UK	12:00 - 12:30
Manufacturing of Oncological Products by a CDMO Fabio Zenobi, EHS Director, BSP Pharmaceuticals, Italy	12:30 - 13:00
Lunch and Poster Presentation \| One-to-One Networking Meetings	13:00 - 14:00
Containment and Handling
Efficient Handling of high-potent APIs – a CDMO perspective Martina Breuer, Head, Operations, Aenova Group	14:00 - 14:30
Large Scale HPAPI Micronization Andrew Lemaire, Global Director Containment & Micronization, DEC Group	14:30 - 15:05
HPAPI Milling and Micronization contained system Stefano Butti , Sales Director, FPS	15:00 - 15:30
Afternoon Refreshments and Poster Presentation \| One-to-One Networking Meetings	15:30 - 16:15
Engineering of containment in a OEB5 facility Pietro Virgilio , Process Design Containment, Exyte, Italy	16:15 - 16:45
Verification and Monitoring of Containment Performance Tara Dennis, Occupational Hygiene Manager, SafeBridge	16:45 - 17:05
Closing Remarks from the Chairman Dean Calhoun , President, CEO, Affygility Soultions, USA	17:05 - 17:10
Drinks Reception & Networking	17:10 - 17:10
End of Day 1	17:10 - 17:10

Registration	08:15 - 09:00
Welcome note from MarketsandMarkets	09:00 - 09:05
Opening Remarks from the Chairman Dean Calhoun , President, CEO, Affygility Soultions, USA	09:05 - 09:10
Keynote Presentation: Strategic Elements within HPAPI Projects Justin Mason-Home, Director, HPAPI Services	09:10 - 09:40
Containment and Handling
Technology transfer – more than a check list Anna Kulesza, Director, Pharmaceutical Development, Clovis Oncology	09:40 - 10:10
Morning Refreshments and Poster Presentation \| One-to-One Networking Meeting	10:10 - 11:00
CMO selection and partnership Filippo Saleri, Subject Matter Expert CMO, Ferring Pharmaceuticals	11:00 - 11:30
Isolator Technology – the most proper solution for HPAPI handling Marco Alberio, Engineering Director, Pharmaprocess	11:30 - 12:00
Potent European regulation requests about high containment Giorgio Mari, Senior Process Engineer, Exyte	12:00 - 12:30
Campoverde: an Abbvie plant for containment production Giorgia Scoppa, NPI Program Manager, AbbVie	12:30 - 13:00
Cleaning Validation and Risk Mitigation
Lunch and Poster Presentation \| One-to-One Networking Meetings	13:00 - 14:00
Sources of uncertainty in toxicological risk assessment Martin Kohan, Senior Occupational Toxicologist, SafeBridge	14:00 - 14:30
Cleaning Validation for shared equipment in manufacturing of highly potent APIs Stefania Vergura, Validation Expert, Novartis	14:30 - 15:00
Closing remarks from the Chairman Dean Calhoun , President, CEO, Affygility Soultions, USA	15:00 - 15:05
End of Conference	15:05 - 15:05

Transfer from Hotel to FPS factory	08:00 - 10:00
Registration and coffee break	10:00 - 10:15
Welcome introduction	10:15 - 10:30
SESSION 1: Process equipment integration into containment systems	10:30 - 11:15
Q&A	11:15 - 11:30
SESSION 2: Containment performance verification	11:30 - 12:15
Q&A	12:15 - 12:30
Lunch break / buffet	12:30 - 14:00
SESSION 3: Guided Company Tour	14:00 - 15:00
SESSION 4: LIVE DEMO - Q&A Shailendra Singh (Shelly), Board Member, MarketsandMarkets	15:00 - 16:00
Final notes	16:00 - 16:15
Transfer from Hotel / Linate Airport	16:15 - 16:15