BOS Basel 2025

ADC Outsourcing,Technology Transfer,and CDMO-Client Relationship

June 10th, 9am, Hyperion Hotel, Basel

Details & Registration Form: please scroll to the bottom of this page to complete the form or click here

Please note that there there is a cost of £950.00 for this event. We will be in touch with you after registration to secure payment.

Executive Summary

This day has been designed for professionals working in biopharma outsourcing to improve their understanding about the processes involved in outsourced Antibody Drug Conjugates (ADCs).

The workshop will cover technical aspects such as the sourcing of the foundations of ADCs – antibodies, linkers and payload, as well as the conjugation process and other downstream processes that would be common to producing non-ADC drug products.

Those attending will gain invaluable ‘hands-on’ experience of the issues faced in an ADC outsourcing project and how to improve your own company’s processes and performance.
The workshop will be facilitated by highly experienced moderators from big pharma, biotech and CDMOs :

About Us:
Firelli Alonso, PhD, ConsultFi Biologics LLC; - Fi was Senior Director at Pfizer, Inc.,and led the BioTherapeutics and Vaccines Outsourcing group
Jay Howlett, Currently Head of External Manufacturing for Antibody CRO AbCellera and 20 years experience at Genentech and Vir Biotechnology
Jon Crate, Advantage Analytical LLC; Founder of Advantage Analytical LLC and President/Senior Chemist at FAI Materials Labs
Morten Munk holds a position as Senior Commercial Program Director at FUJIFILM Diosynth Biotechnologies
(FDB), supporting the strategic partnership collaboration with several FDB’s key partners.

Agenda Overview

• Learn about real-life biopharmaceutical projects developed successfully by the workshop instructors, who represent both the Client and the CDMO sides.
• In depth look at the key elements to develop a partnership between the parties, covering all phases, from the CDMO selection activity, technology transfer of processes and test methods, to production, testing, and delivery of Clinical Trial Materials (CTM).
• An interactive case study, offering the participants hands-on experience with different CDMO selection, risk assessment and mitigation, as well as vendor management tools developed to facilitate cost effective and successful transfer and development of biopharmaceuticals in partnership between the Client and the CDMO.

Who Should Attend?

This workshop is designed for anyone involved in outsourcing activities - either from the BioPharma or CDMO side, or even from Academia.

Relevant job functions include: Project Management, Process and Analytical Development, Production / Manufacturing, Sourcing, Procurement, Quality Assurance and Control, Business Development, and Senior Management.

Time	Leader	Topic
09.00 - 09.15	All	INTRODUCTIONS • Instructors & Participants
09.15 - 10.15	Firelli Alonso	CDMO selection process and performance management tools: • Selection process parameters • CDMO performance management metrics • Introduction to the CDMO selection exercise
10.15 - 10.45	All	Coffee / Networking / E-mail Break
10.45 - 12.00	All	GROUP BREAKOUT AND DISCUSSION I • CDMO selection process (60 min) • Justification of CDMO choice / Group presentations (15 min)
12.00 - 13.00	All	Lunch / Networking Break
13.00 - 13.45	Jay Howlett	Technology transfer and outsourcing tools – Part 1: • Process technology transfer • Risk assessment and FMEA
13.45 - 14.30	Jon Crate	Technology transfer and outsourcing tools – Part 2: • Analytical test methods transfer • Risk assessment and FMEA
14.30 - 15.00	All	Coffee / Networking / E-mail Break
15.00 - 16.15	All	GROUP BREAKOUT AND DISCUSSION II • Technology transfer FMEA (30 min) • Analytical methods transfer interactive exercise (30 min) • Discussion (15 min)
16.15 - 16.45	Jay Howlett	Production, testing, and delivery of Phase I CTM • Project execution and management
16.45 - 17.00	All	Closing Remarks • Lessons learned • Participants’ and instructors’ feedback
17.00	All	End of Workshop

Speakers

	Dr Firelli Alonso Founder / Consultant, ConsultFi Biologics LLC Dr. Firelli Alonso, a retired Senior Director at Pfizer, Inc., led the BioTherapeutics and Vaccines Outsourcing group in Worldwide Research and Development. With 40 years of experience in research, development, and cGMP production of biological products and vaccines, as well as 20 years in outsourcing, project management, and technology transfer, Dr. Alonso's expertise spans viral vectors, viral vaccine development, recombinant proteins, antibody-drug conjugates, and mAb process development and cGMP production. In March 2024, Dr. Alonso founded ConsultFi Biologics, LLC, offering consulting services aimed at optimizing the outsourcing process for biopharma companies and assisting in selecting suitable Contract Development & Manufacturing Organizations (CDMOs). Her services involve navigating the complexities of CDMOs, assessing capabilities and capacities, and ensuring compatibility with the requirements of Sponsors. Dr. Alonso supports clients throughout the technology transfer process and effectively manages contracts for successful biologics manufacturing and testing. She earned her Ph.D. in Microbiology/Virology from the University of Alabama in Birmingham and pursued postdoctoral research at esteemed institutions such as the U.S. Army Medical Research Institute for Infectious Diseases, Sloan-Kettering Institute for Cancer Research, and Rutgers University’s Center for Advanced Biotechnology and Medicine. Before her tenure at Wyeth/Pfizer starting in 1996, Dr. Alonso worked at The Salk Institute-Government Services Division, specializing in vaccine manufacturing for the U.S. Armed Forces. After nearly 28 years of service, she concluded her career at Pfizer in December 2023. Beyond her professional endeavors, Dr. Alonso is dedicated to orchid culture and judging. She currently serves as President of the Atlanta Orchid Society and has been an active American Orchid Society Certified Judge at the Atlanta Judging Center. Dr. Alonso's judging experience includes judging at various orchid shows across different states, showcasing her passion for orchids.
	Mr Jay Howlett Head External Manufacturing, AbCellera Jay Howlett is currently working for Abcellera Biologics (Vancouver Canada) as the Head of External Manufacturing. Previous to that role, he was Director of External Operations for the mAb platform at Vir Biotechnology in San Francisco, CA. He has worked in the biotechnology industry for over 20 years in the small biotech, innovator company and contract manufacturing spaces. Previous to Abcellera and Vir, Jay spent 15 years at Genentech/Roche where for 10 years he worked on commercial product transfers (DS, DP and packaging) to support both internal and external needs world-wide and then 5 years in the development space within external manufacturing supporting CMC teams. His contract manufacturing career started at DSM Biologics in Montreal, Canada for early and late stage DS biologics manufacturing. Jay holds an undergraduate degree in chemical engineering from the University of Waterloo (ON, Canada) and a Master of Science in Biology/Biotechnology from Carleton University (ON, Canada).
	Jon Crate President & CTO, Advantage Analytical LLC
	Morten Munk Senior Commercial Program Director Morten Munk's focus and success in making pharmaceutical products available for patients, is founded on more than 35 years of industry experience in biopharmaceutical development and manufacturing, which has made him a globally recognized technical expert in the field. One common denominator for his work has been to use his business and quality mindset in combination with a broad perspective on biomanufacturing, to support all stages of development and the full supply chain of high-quality pharmaceuticals. This includes experience in addressing the areas critical for commercial manufacturing during the process development and subsequent scale-up stages, as well as handling drug product operations and distribution aspects. Morten holds a position as Senior Commercial Program Director at FUJIFILM Diosynth Biotechnologies (FDB), supporting the strategic partnership collaboration with several FDB’s key partners. Before joining FDB in 2020, Morten worked at NNE as Global Technology Partner since 2015. In 2001 he co-founded CMC Biologics (now AGC Biologics), after working 14 years at Novo Nordisk. Morten is active in the biopharmaceutical community as member of scientific committees for various international conferences and as volunteer in international industry organizations such as PDA, ISPE and BPOG. Currently, Morten is member of the Board of Directors at PDA and member of the Advisory Board for Master studies at Copenhagen University.

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