Biotech Outsourcing Strategies Basel 2024

BOS Basel 2024 Programme

BOS Basel 2024's scope is primarily development-stage CMC outsourcing for both Small Molecules and Biologics, as well as covering Novel Therapeutic Entities.

We have a single-track programme consisting of high-quality presentations and drawing from the diverse organisation types in the community including multinational pharmaceutical companies, speciality pharma, SME biotech, CRO/CMO and Consultants. Our programme consists of the following modules:

Outsourcing Business Process
Exploring strategies and processes driving sourcing and procurement of R&D services

Technical Operations
Exploring the technical elements of outsourcing discovery R&D, Drug Substance Outsourcing, Analytical Development Outsourcing, Drug Product Outsourcing for Biologics and Small Molecules.

Outsourcing Case Studies
Building on the Technical Operations sessions, demonstrating outsourcing approaches to real life scenarios.

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Day 1 - 19th June 2024

Time	BOS Basel Programme
08:00 - 09:00	Registration and Partnering
09:00 - 10:30	Outsourcing Process and Strategy
09:00 - 09:30	Designing a Scalable Biologics Outsourcing Strategy for a Fast Growing International Biotech Company Mr Jesper Valbjørn, SVP, Global CMC Operations, Genmab A/S About the speaker Full Speaker profile
09:30 - 10:00	AI - The Future of the Outsourcing Partnerships? Dr Tarita Qveflander, Head of Strategic Sourcing and Direct Procurement, Swedish Orphan Biovitrum AB About the speaker Tarita Qveflander is the Head of Strategic Sourcing and Direct Procurement at Sobi – Swedish Orphan Biovitrum AB. Tarita has 18+ years of pharmaceutical operations, supply chain, and procurement experience. She also has extensive knowledge of global API/drug substance, drug product, and finished goods supply chain, including hands-on technical expertise and a deep understanding of quality and GMP regulations. Full Speaker profile
10:00 - 10:30	Managing the Transition to a Sustainable Sourcing Strategy: Gabrielle Sassi, Head of Sustainable and Global Research and Technical Development Outsourcing Management & Elena Bosi, Global CMC Outsourcing Manager, Chiesi
10:30 - 11:00	Coffee and Partnering
11:00 - 12:00	Outsourcing Case Studies
11:00 - 11:20	In-house Manufacture or External Sourcing of Gene Editing Reagents to Support the Growing Cell and Gene Therapy Business Dr Ulrich Rümenapp, Senior Program Lead, Bayer AG About the speaker Dr. Rümenapp is based in Wuppertal, Germany and working within the Product Supply Biotech organization of Bayer AG, where he is responsible for the transfer of Bayer’s pipeline candidates (antibodies and antibody-drug-conjugates) to external manufacturing partners and regulatory submission and launch preparations. Prior to working in Development, Dr. Rümenapp was Head of Biotech Projects in Product Supply Biotech at Bayer, where he was responsible for contract manufacturing partnerships in the field of biotechnological drug substances and drug products and interdisciplinary project management with the goal to ensure market supply. Before it was acquired by Bayer, Dr. Rümenapp hold a similar position at Schering AG, and before that, he worked in the Production & Logistics department of Schering, where he was responsible for production aspects of in- and out-licensing deals, due diligences, and product acquisitions of small molecule products and biologics.Dr. Rümenapp studied chemistry and holds a Ph.D. in biosciences. He worked several years in academic research in the field of signal transduction and as an assistant teacher in the field of general pharmacology.Today, Dr. Rümenapp area of expertise is the set-up and management of external relationships for the development and supply of bio-pharmaceutical products. He has more than 20 years of experience in the bio-pharmaceutical industry.To correspond with Dr. Rümenapp, please contact him at [email protected]. Full Speaker profile
11:20 - 11:40	Gold Sponsor : Axplora - Presentation Title to be Confirmed
11:40 - 12:00	Presentation Title to be Confirmed
12:00 - 13:30	Lunch and Partnering
13:30 - 15:30	Technical Operations Outsourcing
13:30 - 14:00	Chemical Development of Remibrutinib Dr Lucie Lovelle, Associate Director, Science and Technology, Novartis About the speaker Full Speaker profile
14:00 - 14:30	Presentation Title to be Confirmed Dr Werngard Czechtizky, Head Medicinal Chemistry, AstraZeneca About the speaker Werngard Czechtizky obtained her PhD at ETH Zürich. After a postdoctoral stay at Harvard University, she worked on GPCR lead generation in a global Chemical Biology platform at Aventis. At Sanofi, from 2005, she moved into a parallel synthesis team working in the fields of CNS and CV diseases. In 2010, she became leader of a Medicinal Chemistry section working on Diabetes programs. In 2014, she was appointed Head of Chemistry at Sanofi R&D Germany, with therapeutic focus on Diabetes, pain and inflammatory indications. Since 2017, she is Head of Medicinal Chemistry, Respiratory, Inflammation and Autoimmunity, at AstraZeneca in Sweden. Full Speaker profile
14:30 - 15:00	Sourcing Radiopharmaceutical Manufacturing Expertise Mr Dimitrios Mantzilas, CTO, Precirix About the speaker Passionate about advancing healthcare through radiopharmaceuticals As a dedicated professional and pioneer in the field of radiopharmaceuticals, I bring a wealth of experience and expertise in the dynamic intersection of nuclear medicine and pharmaceuticals. My mission is to contribute to the advancement of healthcare by leveraging the power of radiopharmaceuticals to diagnose and treat diseases. Over the years, I have been at the forefront of cutting-edge research, development, and production of radiopharmaceuticals that play a pivotal role in personalized medicine. I thrive on the challenges of innovating within a rapidly evolving industry, always seeking novel solutions to enhance diagnostic accuracy and therapeutic efficacy. Having successfully navigated the complexities of regulatory frameworks, I have a proven track record of bringing radiopharmaceuticals from concept to market. My commitment to excellence extends beyond the laboratory, as I actively engage in industry conferences, share insights, and collaborate with professionals to stay ahead of the curve. Let's connect to explore opportunities for collaboration, knowledge exchange, and mutually beneficial partnerships. Together, let's drive innovation in radiopharmaceuticals to make a lasting impact on patient outcomes and contribute to the future of healthcare. Full Speaker profile
15:00 - 15:15	Where are the polymorph reference samples ? Dr Pierric Marchand, CEO, Holodiag About the speaker Full Speaker profile
15:15 - 15:30	Phase-Appropriate API Development Strategies Miss Christina Dreher, Business Development Director, Ardena About the speaker Full Speaker profile
15:30 - 16:00	Coffee and Partnering
16:00 - 17:00	Outsourcing Case Studies
16:00 - 16:20	Outsourcing of API and Formulation Manufacturing of a Compound with Segregation Needs. Dr Yogeshwar Bachhav, Director (Consultant), AiCuris Anti-infective Cures AG About the speaker Full Speaker profile
16:20 - 16:40	A Novel Series of Ivosidenib-Polymer Cocrystals Dr Adam Patterson, Senior Scientist I, Veranova About the speaker Adam Patterson is an experienced research scientist with a demonstrated history of working in the pharmaceutical industry. Since joining Veranova in July 2016, Adam has both undertaken and led projects applying his expertise in solid state science to numerous active pharmaceutical ingredients. His work at Veranova covers polymorph screening, salt and cocrystal selection and crystallization development. Adam leads Veranova’s efforts in Raman spectroscopy with expertise in Raman mapping of drug products and also applies his skillset to the single crystal X-ray diffraction group, focusing on the structure solution of different solid forms of active pharmaceutical ingredients. Adam gained his PhD in Inorganic Chemistry from Trinity College Dublin, Ireland and an MChem from Durham University. Full Speaker profile
16:40 - 17:00	Acquiring ADC Manufacturing Capacities and Capabilities: Insights from an Outsourcing Career Dr Firelli Alonso, Consultant, ConsultFi Biologics, LLC About the speaker 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, 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 Vice President of the Atlanta Orchid Society and has been an active American Orchid Society Student Judge at the Atlanta Judging Center for three years. Dr. Alonso's judging experience includes judging at various orchid shows across different states, showcasing her passion for orchids. Full Speaker profile
17:00 - 19:00	Drinks Reception

Time	BOS Basel Programme
08:00 - 09:00	Refreshments and Partnering
09:00 - 11:00	Technical Operations Outsourcing
09:00 - 09:30	Development of a Scalable Route toward an Alkylated 1,2,4-Triazol Dr Raffael Davenport, Director, Team Leader Process Chemistry, Idorsia Pharmaceuticals Ltd. About the speaker Full Speaker profile
09:30 - 10:00	External Data Management Challenges and Strategies Mr Mike Hindson, Scientific Externalisation SME, GSK About the speaker I have worked within the pharmaceutical industry for over 30 years in R&D and previously manufacturing. A time-served analytical chemist who has been externalising development projects for over 20 years. Externalisation Subject Matter Expert with evolving expertise in Data Integrity with particular application in risk assessment of third party systems. Experience in technical delivery of pharma development projects from a diversity of global suppliers. Increasingly interested in using technology solutions to achieve efficient data transfer mechanisms and to deliver dynamic data from the supplier. Full Speaker profile
10:00 - 10:30	Agile Outsourcing: Designing a Biologics Sourcing Strategy To Speed Development & Maximise Quality - Jay Howlett, Director, External Manufacturing at Vir Biotechnology, Inc.
10:30 - 10:45	Numaswitch: A Revolutionary Platform for Peptide, Peptein, and Protein Production Dr Roxann Guerrette, Director, Numaferm
10:45 - 11:00	Continuous Crystallization Development: Abhishek Mysore Srikant, APC
11:00 - 11:30	Coffee and Partnering
11:30 - 12:30	Outsourcing Case Studies
11:30 - 11:50	Developing Novel siRNA Therapeutics and the Importance of Building Productive C(D)MO Partnerships Dr Ioannis Giannios, Project Manager, Silence Therapeutics About the speaker Ioannis Giannios is a Project Manager at Silence Therapeutics. Ioannis has worked for the last years as Project Manager in the biopharmaceutical area, focusing on development of Oligonucleotides as Drug Substance and Drug Product. He has extensive experience on management of late-stage and commercial projects, selection and establishment of CMO relationships and deep understanding of quality and GMP regulations. Full Speaker profile
11:50 - 12:10	Gold Sponsor : Curia
12:10 - 12:30	Navigating the Complexity of Cell and Gene Therapy Development and Outsourcing Dr Grace Lee, Founder and Consultant, Elevalue Consulting LLC About the speaker Dr. Grace Lee is a founder and consultant of Elevalue Consulting LLC. She brings over 20 years of experience in research, technical development, quality, and regulatory, with a focus on analytical development and quality control for Cell and Gene Therapies, and Biologics. Her extensive scientific background in academia is complemented by her industry expertise in CMC and GxP disciplines in big pharma and start up, enriching her unique strategic, business-oriented approach to drug development. Previously, Dr. Lee was a senior director of analytical development at Kyverna Therapeutics and served in various roles at Genentech supporting >10 biologics and cell therapy products from pre-clinical, clinical, to commercialization for potency assay development and other QC release and characterization assays. Dr. Lee holds a Ph.D. in Chemistry from Stanford University and finished her postdoctoral fellowship under Professor Jennifer Doudna at UC Berkeley. She has a prolific record of peer-reviewed publications in leading scientific journals and active participation in prominent industry conferences and consortiums such as PDA, US-TAG ISO/TC276, ASGCT, BioPhorum, and ARM. Dr. Lee has contributed to several white papers and guidance documents, sharing her expertise and insights. Dr. Lee serves as PDA Biopharmaceutical Advisory Board Member since 2021. Her dedication to addressing high-impact, challenging issues continues to advance the fields of pharmaceutical science and biotechnology. Full Speaker profile
12:30 - 14:00	Lunch and Partnering
14:00 - 15:00	Panel Session: New Technologies Shaping External Manufacturing Chair: Dr Joan Herbert, Vice President, Business Development, Medicines for Malaria Venture Dr Christoph Becker, CEO and Partner, NegotiumBio GmbH Mr Andre Unglert, Director Commercial Development Bioconjugates, Lonza AG Dr Samanta Cimitan, CEO, Celonic Group, Celonic Group About the speakers About the speaker Starting out as PhD biochemist, Christoph’s 25-year track record in the pharmaceutical, CMO and chemical industry includes global companies such as Novartis, Lonza and Siegfried as well as consulting work with biotech start-ups. Christoph's main areas of expertise are custom-made APIs & intermediates (chemical and biologics), lean manufacturing, and building partnerships with providers of complex drug conjugates. An additional focus is the consulting service NegotiumBio offers to clients who want to expand into new therapeutic areas as an investment opportunity. Full Speaker profile About the speaker Full Speaker profile About the speaker Samanta Cimitan PhD has been Chief Executive Officer at Celonic Group, a Pure Play Mammalian Biologics CDMO since August 2023. Sam has nearly 2 decades of experience in the specialty chemicals and life science industry, having worked for global organizations such as Ciba Specialty Chemicals, BASF and 13 years for Lonza. Prior to joining Celonic, she was Vice President at Lonza Pharma and Biotech Technical Operations. Full Speaker profile
15:00 - 16:00	Conference Close and Drinks Reception