8th Annual MarketsandMarkets

High Potent Medicines Conference

24th - 26th May 2023

Duo Milan Porta Nuova, Via Gerolamo Cardano, 1, 20124 Milano MI, Italy.

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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.

WHAT TO EXPECT

  • 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

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

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

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

Carolina Bonifacio, Siegfried, Head, Drug Product Development

 11:00 - 11:30

High Containment Kilolab Plant: From Design to Process Validation

Helena Camps

Helena Camps, R&D Director, MOEHS Fine Chemicals

 11:30 - 12:00

Outsourcing High Potent OSD Late Stage Development: CDMO Insights

David O’Connell

David O’Connell, Director, Scientific Affairs, PCI Pharma Services, UK

 12:00 - 12:30

Manufacturing of Oncological Products by a CDMO

Fabio Zenobi

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

Martina Breuer, Head, Operations, Aenova Group

 14:00 - 14:30

Large Scale HPAPI Micronization

Andrew Lemaire

Andrew Lemaire, Global Director Containment & Micronization, DEC Group

 14:30 - 15:05

HPAPI Milling and Micronization contained system

Stefano Butti

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

Pietro Virgilio , Process Design Containment, Exyte, Italy

 16:15 - 16:45

Verification and Monitoring of Containment Performance

Tara Dennis

Tara Dennis, Occupational Hygiene Manager, SafeBridge

 16:45 - 17:05

Closing Remarks from the Chairman

Dean Calhoun

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

Dean Calhoun , President, CEO, Affygility Soultions, USA

 09:05 - 09:10

Keynote Presentation: Strategic Elements within HPAPI Projects

Justin Mason-Home

Justin Mason-Home, Director, HPAPI Services

 09:10 - 09:40

Containment and Handling

Technology transfer – more than a check list

Anna Kulesza

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

Filippo Saleri, Subject Matter Expert CMO, Ferring Pharmaceuticals

 11:00 - 11:30

Isolator Technology – the most proper solution for HPAPI handling

Marco Alberio

Marco Alberio, Engineering Director, Pharmaprocess

 11:30 - 12:00

Potent European regulation requests about high containment

Giorgio Mari

Giorgio Mari, Senior Process Engineer, Exyte

 12:00 - 12:30

Campoverde: an Abbvie plant for containment production

Giorgia Scoppa

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

Martin Kohan, Senior Occupational Toxicologist, SafeBridge

 14:00 - 14:30

Cleaning Validation for shared equipment in manufacturing of highly potent APIs

Stefania Vergura

Stefania Vergura, Validation Expert, Novartis

 14:30 - 15:00

Closing remarks from the Chairman

Dean Calhoun

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)

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

SPEAKERS

Pietro Virgilio

Pietro Virgilio

Process Design Containment, Exyte, Italy

Giorgio Mari

Giorgio Mari

Senior Process Engineer, Exyte

Stefano Butti

Stefano Butti

Sales Director, FPS

Justin Mason-Home

Justin Mason-Home

Director, HPAPI Services

Dean Calhoun

Dean Calhoun

President, CEO, Affygility Soultions, USA

Andrew Lemaire

Andrew Lemaire

Global Director Containment & Micronization, DEC Group

Carolina Bonifacio

Carolina Bonifacio

Siegfried, Head, Drug Product Development

Hermann Schmidt

Hermann Schmidt

Operations Director, Pharma & Lab Division, Hosokawa Alpine AG

Fabio Zenobi

Fabio Zenobi

EHS Director, BSP Pharmaceuticals, Italy

Martina Breuer

Martina Breuer

Head, Operations, Aenova Group

Martin Kohan

Martin Kohan

Senior Occupational Toxicologist, SafeBridge

Tara Dennis

Tara Dennis

Occupational Hygiene Manager, SafeBridge

Helena Camps

Helena Camps

R&D Director, MOEHS Fine Chemicals

Ronnie Miranda

Ronnie Miranda

Process Chemist, MOEHS Fine Chemicals

Stefania Vergura

Stefania Vergura

Validation Expert, Novartis

Filippo Saleri

Filippo Saleri

Subject Matter Expert CMO, Ferring Pharmaceuticals

Marco Alberio

Marco Alberio

Engineering Director, Pharmaprocess

Anna Kulesza

Anna Kulesza

Director, Pharmaceutical Development, Clovis Oncology

Giorgia Scoppa

Giorgia Scoppa

NPI Program Manager, AbbVie

Salvatore Sorrentino

Salvatore Sorrentino

EHS & LPA Supervisor, AbbVie

David O’Connell

David O’Connell

Director, Scientific Affairs, PCI Pharma Services, UK

ENQUIRE NOW

SPONSORS

FPS
PCI Pharma Services
Dec Group
Hosokawa Alpine
BSP Pharmaceuticals
Siegfried AG
Moehs Group
Aenova Group
CTS Europe Ltd Design
Lugaia AG Containment Solutions
Angelini Pharma
Almac Pharma Services
Munit
CSV Containment
BEA Technologies
International Business Development

PARTNERS

IoT Global Network
The Enterprise World
This Week in Digital Health

LOCATION

Venue

Duo Milan Porta Nuova, Via Gerolamo Cardano, 1, 20124 Milano MI, Italy.

PAST EVENT GALLERY

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