3rd Annual MarketsandMarkets High Potent Medicines Conference | 28 - 29 May 2019

Exploring comprehensive strategies on containment, robustness, scalability & safety of highly potent compounds

Drug product development for highly potent APIs (HPAPIs) can be challenging. Complications with the interface between operations in drug substance and drug product handling can result in increased program complexity and cost. The growth in this market is driven by factors such as increasing demand for oncology drugs, growing demand for antibody-drug conjugates, increasing focus of leading pharmaceutical companies on HPAPIs, advancements in HPAPI manufacturing technologies, and growing focus on precision medicine. This year’s conference will focus on case studies related to development, rapid scaling, validation and commercial production of HPAPI drug substance, as well as integrated containment requirements for particle engineering and drug product.

The 2-day event will share the latest industry trends, advancements and future growth in the highly potent medicines market where leading industry experts will discuss the strategies for both pharma and CMO’s by presenting expert keynote presentations, live case studies and breakthrough panel sessions.

Expert keynote presentations, live case studies, and breakthrough panel sessions on Solutions to the challenges with regards to cleaning and validation in API Manufacturing and procedures to avoid cross-contamination.

Discussing strategies for effective management of high potent medicines supply chain, sessions on how to do a competent toxicological evaluation of HPAPI and Overview of the new ASTM E3106 Cleaning Standard

Process Development and Scale-up
Regulatory Landscape
Containment and Handling
Cleaning Validation and Industrial Hygiene

Containment and safety of pharmaceutical toxic powders
Managing cleaning validation in biologics
Overcoming regulatory challenges for ADC’s

Chief executives, VP’s, Directors, Heads, Leaders, Senior Managers from Pharma and BioPharma Companies Working in R&D, Risk Assessments, Validation and Product Quality

CONFERENCE AGENDA

Registration	08:15 - 08:55
Welcome note from MarketsandMarkets	08:55 - 09:00
Opening Remarks from the Chairman Richard Denk , Head Containment, SKAN AG, Switzerland	09:00 - 09:10
Process Development and Scale up
Keynote Presentation: State of the art potent solutions, drug development and manufacture Nicola Giubellina , Head, CRAMS Sales , Dishman Europe Ltd.	09:10 - 09:35
Manufacturing of Oncological Products by a CDMO Fabio Zenobi, EHS Director, BSP Pharmaceuticals, Italy	09:35 - 10:05
Sharing data Chris Seaman , Managing Toxicologist, SafeBridge, UK	10:05 - 10:35
Morning Refreshments and Poster Presentation \| One-to-One Networking Meetings	10:35 - 11:15
The development and manufacture of HPAPI drug products throughout the clinical phases David O Connell , Director, Scientific Affairs, PCI Services, UK	11:15 - 11:45
Aseptic meets high-potent - setting the stage for next level ADC processing Matthias Angelmaier , Product Manager Isolator Technology, Bosch	11:45 - 12:15
Consolidating IH programs and Potent Compound controls to enhance Process Safety Management effectiveness Pascal Michoux , Vice President, TAPI and BIO Global EHS, TEVA (TAPI and BIO division)	12:15 - 12:45
Lunch and Poster Presentation \| One-to-One Networking Meetings	12:45 - 13:45
HP APIs Engineering – key considerations in HP APIs facilities design Andrea Messori , Lead Process Engineer-Project & Engineering Manager, Process Service	13:45 - 14:15
Critical Elements in the Design, Implementation and Monitoring of Handling HPAPI Rudolf Bechter , Managing Director , Bechter Consulting GmbH, Switzerland	14:15 - 14:45
Regulatory Landscape
Health-Based Exposure Limits: How Do The EMA’s Q&As Compare with New and Upcoming ASTM Standards? Andrew Walsh , President , Centre for Pharmaceutical Cleaning Innovation, USA	14:45 - 15:45
Afternoon Refreshments and Poster Presentation \| One-to-One Networking Meetings	15:45 - 16:35
Ten common occupational health and safety audit findings from High Potency API facilities in the developing world Dean Calhoun , President, CEO, Affygility Soultions, USA	16:35 - 17:05
Break out session Richard Denk , Head Containment, SKAN AG, Switzerland	17:05 - 17:45
Closing Remarks from the Chairman	17:45 - 17:50
Drinks Reception & Networking	17:50 - 19:00

Registration	08:15 - 08:55
Welcome note from MarketsandMarkets	08:55 - 09:00
Opening Remarks from the Chairman Ester Lovsin Barle , Head, Product Stewardship and Health, Takeda, Switzerland	09:00 - 09:05
Keynote Presentation: “Selection of the right Exposure Control Banding system – a case study” Jennifer O'Leary, EHS Director , SK biotek Ireland	09:10 - 09:35
Containment and Handling
Trends in Containment and outlook Richard Denk , Head Containment, SKAN AG, Switzerland	09:35 - 10:05
Morning Refreshments and Poster Presentation \| One-to-One Networking Meetings	10:05 - 10:55
HPAPI handling and processing in Aseptic condition Stefano Butti , Sales Director, FPS	10:55 - 11:25
Laboratory Containment Case Study Sean Codling , Managing Director , CTS Europe	11:25 - 11:55
Cleaning Validation and Industrial Hygiene
Quality Risk Management in Cleaning Validation Kenneth Farrugia, Quality Assurance Manager , Natrix Sciences, Malta	11:55 - 12:25
Cleaning and Validation in API manufacturing; Challenges and Solutions Michel Crevoisier , Consultant, Ex-Novartis Consultant, Switzerland	12:25 - 12:55
Lunch and Poster Presentation \| One-to-One Networking Meetings	12:55 - 13:55
Cleaning Validation as one driver to prevent cross-contamination Andreas Schreiner , Head of Validation, Novartis, Switzerland	13:55 - 14:25
The sky is not the limit; HBELs are Ester Lovsin Barle , Head, Product Stewardship and Health, Takeda, Switzerland	14:25 - 14:55
Closing remarks from the Chairman	14:55 - 15:00
Afternoon Refreshments and Poster Presentation \| One-to-One Networking Meetings	15:00 - 16:00