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 Chair: Dr Hayley Binch, Head of Medicinal Chemistry, Hoffmann-La Roche
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	Macro Factors Shaping the Ongoing CMO Sourcing Strategy for an SME in the Orphan Diseases Space 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 Mr Gabriele Sassi, Head of Global R&D Procurement, Chiesi Farmaceutici S.p.A Mrs Elena Bosi, Global Category Lead - Technical Development, Chiesi Farmaceutici S.p.A. About the speaker Full Speaker profile
10:30 - 11:00	Coffee and Partnering
11:00 - 12:00	Outsourcing Case Studies Chair: Dr Miranda de Jager, Owner/Principal Consultant CMC, M3 Pharma Consultancy
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 - 11:35	How the origin of the crude drives preparative chromatography to produce high-purity APIs Ms Pauline Oster, R&D Engineer, Novasep About the speaker Pauline has a double background of pharmacist and engineer in biotechnologies, obtained in 2012 at the University of Pharmacy and ENSAIA (Nancy). She joined the CDMO Novasep-Axplora as R&D engineer in 2012, to develop industrial purification processes of API, from bench scale to pilot and production scale, under GMP conditions. She has then gained experience in various types of chromatography, from low downstream processes applied to recombinant proteins or mAbs, to chiral separations in SFC or continuous processes like SMB, or HPLC on plant extracts and small molecules Full Speaker profile
11:35 - 11:50	Application of Innovative Platform Technologies as sources of novel treatments for malaria Dr Joseph O'Sullivan, Director Business Development, Medicine for Malaria Venture About the speaker Full Speaker profile
11:50 - 12:05	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
12:00 - 13:30	Lunch and Partnering
13:30 - 15:30	Technical Operations Outsourcing Chair: Dr Reinhard Karge, Executive President, RCJ unlimited - Karge consulting
13:30 - 14:00	Chemical Development of Remibrutinib Dr Lucie Lovelle, Associate Director, Science and Technology, Novartis About the speaker Lucie Lovelle is an Associate Director, Science and Technology in the Chemical and Analytical Development organization of Novartis. Lucie earned her PhD in Organic Chemistry from the University of Montreal (Canada), where she worked, under the supervision of Prof. André B. Charette, on the diastereo- and enantioselective synthesis of 1,2,3-trisubstituted cyclopropanes. In 2010, she moved to ETH Zürich (Switzerland) to complete her post-doctoral studies in the group of Prof. Ryan Gilmour, leveraging from the gauche effect to design and synthesize various fluorinated organocatalysts. Lucie was recruited a year later by Janssen, pharmaceutical companies of Johnson & Johnson (Schaffhausen, Switzerland) to work on, among other projects, the development of bedaquiline, an approved marketed drug to treat multi-drug-resistant tuberculosis (MDR-TB). Since 2015, Lucie is working at Novartis in process research & development for drug candidates across indications and phases of clinical development. Full Speaker profile
14:00 - 14:30	Trends Shaping the Design and Synthesis of New Synthetic Modalities 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 and CMC development aspects, I have a proven track record of bringing radiopharmaceuticals from concept to market. 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 I am French, born in Normandy in 1977. I hold a master's degree in organic chemistry (1999) and defended my PhD thesis in physics, thermodynamics of heterogeneous equilibria applied to crystallization of small molecules, in 2004. Under contract with a dozen of pharma company during this period, I founded Holodiag right after my PhD. And as everyone knows (I hope so !) Holodiag is a CRO dedicated to solid state and crystallization of small molecules since 2006. Full Speaker profile
15:15 - 15:30	Process Development and Commercialization of Highly Potent APIs Dr Rob Abbenhuis, CHEM Division Manager, Ardena About the speaker Obtained a PhD in metal-mediated organic synthesis from Utrecht University in 1997 and started his industrial career in Process Development and Commercialization of small molecule API’s. Rob headed a chemical pilot plant and has been Director Process R&D on Steroids & Heterocyclic molecules. After two years in Biotech (upstream and downstream processing), he worked for six years as Director Operations in a commercial sterile Fill & Finish plant. He joined Ardena in 2018, initially as Director Process R&D & Manufacturing and in 2020 he transitioned into the role of Business Unit Director of Ardena Oss. In July 2022 he was appointed CHEM Division Manager of Ardena. In his current role, Rob is responsible for Ardena’s drug substance activities at the sites in Oss (The Netherlands) and Sodertalje (Sweden). Rob brings experience in working with API’s in highly potent DS and DP facilities. Full Speaker profile
15:30 - 16:00	Coffee and Partnering
16:00 - 17:00	Outsourcing Case Studies Chair: Dr Rudolf Hausmann, Partner/Consultant, Viopas Venture Consulting
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 Yogeshwar Bachhav is a pharmacist by training and has PhD in advanced drug-delivery systems from ICT, Mumbai (India). He has around 16 years of post-PhD experience in Europe in the field of pharmaceutical development of investigational drugs. He has contributed to the success of the clinical candidates ranging from preclinical to phase 1, 2, and 3 trials followed by commercial launch. Yogesh has worked as a Research Scientist for around four years on a collaborative project between Pantec Biosolutions AG (Lichtenstein) and University of Geneva, Switzerland. After this, he has worked as a Formulation Manager at Debiopharm Group, Lausanne, Switzerland, for around four years in the capacity of a lab head, where he successfully developed preclinical and clinical formulations for oncology indication. Currently Yogesh is working as a Associate Director (Consultant) at AiCuris Anti-infective Cures AG Germany and responsible for pharmaceutical development of investigational drugs in the domain of innovative anti-viral and anti-bacterial drugs. Yogesh’s expertise in the field of advanced drug-delivery system comprises pre-formulation, formulation development of small molecules and/or peptides for oral, dermal, and parenteral applications. Also, he has exposure to in-house development and outsourcing these novel dosage forms. Besides several publications in the targeted formulation field, Yogesh is a well-known expert with over 30 conference proceedings and has been named Wiley-VCH in the same book series titled Innovative Dosage Forms: Design and Development at Early Stage. He is also serving as visiting faculty at reputed Pharmacy Schools in India. 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, Founder / 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, 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 Vice 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. 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 Chair: Dr Firelli Alonso, Founder / Consultant, ConsultFi Biologics, LLC
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. Currently an external partnership lead (supplier relationship manager) for GSK ensuring delivery of a portfolio of assets with our analytical strategic business partners Full Speaker profile
10:00 - 10:30	Agile Outsourcing: Designing a Biologics Sourcing Strategy To Speed Development & Maximize Quality Mr Jay Howlett, Director, External Operations, Vir Biotechnology About the speaker Jay Howlett is the 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 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). Full Speaker profile
10:30 - 10:45	Numaswitch: A Revolutionary Platform for Peptide, Peptein, and Protein Production Dr Roxann Guerrette, Director, Numaferm About the speaker Full Speaker profile
10:45 - 11:00	Enabling Robust Impurity Rejection and Form Control in the Crystallization of a Small Molecule API by Switching from Batch to Continuous Processing Dr Brendan Roche, Senior Process Development Scientist, APC Ltd
11:00 - 11:30	Coffee and Partnering
11:30 - 12:30	Outsourcing Case Studies Chair: Dr Harald Hufsky, MBA, Sr. Pharma Consultant, Dr. Harald Hufsky Pharma Consulting
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	The Growing Complexity of Sterile Formulation Dr Iain MacGilp, Senior Director, Curia Scotland Ltd About the speaker Summary 25 year plus pharmaceutical development knowledge spanning chemical development, drug substance development, external collaboration/outsourcing oversight and aseptic drug product development/manufacturing. Broad understanding of CMC development strategies and regulatory requirements in highly controlled processing environments. Detail/CV Degree and PhD in Chemistry from University of Strathclyde in Glasgow and 11 years at GSK in chemical development and CMC project outsourcing. 18 years at Curia Scotland, principally in role leading GMP operations. Direct responsibility for aseptic GMP manufacturing programmes at the site as well as member of site leadership team. Work in partnership with business development colleagues in new project opportunities to the Curia Scotland site as well as technical transfer of maturing programmes to our commercial sites. Full Speaker profile
12:10 - 12:30	Atypical topical application - ushering an endolysin product through development Dr Joris Schillemans, CMC expert and Co-founder, NovoSere About the speaker PhD in Pharmaceutics with +10y of accumulated experience in formulation and process development in the pharmaceutical industry. Fields of expertise include advanced drug delivery and complex injectables, pharmaceutics, DoE, QbD, continuous improvement, scale up, tech transfer, and GMP manufacturing. Previously worked for OctoPlus, Dr. Reddy’s and Micreos Pharma. 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 Prof Claire Thompson, CEO, Agility Life Sciences 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 I have been working for over 20 years on building paths to success, together with customers and partners. I had the pleasure to navigate different industries including specialty chemicals and nutraceuticals, to allow me to find a real passion for healthcare, in particular CDMO. Working with a large portfolio of exciting programs in different clinical phases and serving different patient’ needs is what drives me every day. Together with Lonza I share a vision to enable a healthier world. In my current role at Lonza I am able to provide fully integrated CDMO services, from drug discovery to market supply, from drug substance to drug product, bringing any new therapy to life. 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 About the speaker Claire is a multi-award winning scientist, entrepreneur, NED and philanthropist with more than 20 years’ experience in the Pharmaceutical Industry. She is CEO of Agility Life Sciences, an award-winning formulation development CDMO which uses its “Futureproof Formulations Fast” approach to give its Clients’ molecules the best chance of success in preclinical studies, and enable them to be accelerated to clinic or commercialisation. A former footballer, Claire has launched and fully funds the Girls In Football Teams (GIFT) Grants, which support >30 girls’ and women’s teams across the UK. Full Speaker profile
15:00 - 16:00	Conference Close and Drinks Reception