Biotech Outsourcing Strategies Basel 2023

Our BOS Basel 2023 Programme

BOS Basel 2023 scope is primarily development stage CMC outsourcing for both Small Molecules and Biologics and also 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.

Trends in Pharmaceutical Outsourcing
Following our popular closing panel sessions at BOS Events 2022 we will be honing in on a specific topic that came to light and taking a deeper dive... stay tuned for further details.

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Day 1 - 4th July 2023

Time	BOS Basel Programme
08:00 - 09:00	Registration & Partnering
09:00 - 10:30	Outsourcing Process and Strategy Chair: Dr Tarita Qveflander, Head of Strategic Sourcing and Direct Procurement, Swedish Orphan Biovitrum AB
09:00 - 09:30	Revolutionising Procurement: Go from Reactive to Proactive Mr Matthew McLoughlin, Senior Vice President, Scientist.com About the speaker Matt is Senior Vice President of Compliance and Categories at Scientist.com. Matt has been involved in drug research and discovery for over 20 years. Prior to his role in Scientist.com he was a senior research scientist at AstraZeneca before moving to procurement as a global category manager supporting pre-clinical research and human biological sample acquisition. He joined Scientist.com over 7 years ago, and is now responsible for compliance and our category strategy. Since joining Scientist.com he has developed our third party vendor risk management solution, which is now widely accepted across the industry, as well as our award winning COMPLi(r) platform and new on-site pre-assessment program VERIF.i(r). Using his knowledge of the industry he has supported the creation of our category approaches to HBS, In Vivo, CMC, Biomarkers and many more to ensure the platform provides enhanced functionality and benefits to our users both within Clients and Suppliers. Full Speaker profile
09:30 - 10:00	Biotherapeutics Development and Production at Outsourcing Partners – How to Best Manage the Partnerships 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
10:00 - 10:30	Partnerships Powering a Patient-led Biotech Start Up: Treeway 10 Years On Dr Ronald van der Geest, CDO, Treeway & Managing Partner, 3d PharmXchange About the speaker A PhD-level clinical pharmacologist and drug delivery expert. Besides being a serial entrepreneur in the life sciences sector, he currently fulfills development leader roles within several biotech companies. Full Speaker profile
10:30 - 11:00	Coffee and Partnering
11:00 - 12:00	Outsourcing Case Studies Chair: Dr Rudolf Hausmann, Partner/Consultant, Viopas Venture Consulting
11:00 - 11:20	Dasiglucagon: The Journey from Compound to Commercial Product Dr Frederik Barfoed Beck, Senior Outsourcing Manager, Zealand Pharma About the speaker Frederik Barfoed Beck is the Senior Outsourcing Manager at Zealand Pharma A/S. Dr. Frederik Beck has more than 25 years of experience from pharmaceutical and biotech companies. He is the Senior Outsourcing Manager at Zealand Pharma and has held this position for the past twelve years and has successfully completed 2 IMPD s for two new chemical entities as well as been part of bringing Zegalogue, Zealand Pharma’s product for treatment of severe acute hypoglycemia to market. As Senior Outsourcing Manager Dr. Beck is responsible for the outsourcing of all activities relating to clinical trials, both DS, DP and medical device. Prior to joining Zealand Pharma Dr. Beck worked for CMC Biologics as Project Director and as scientist/ project manager at Hexal. Dr. Beck received a Master of Chemical Engineering in 1992 from the Technical University of Denmark and an industrial Ph.D. from the University of Copenhagen in collaboration with DAKO A/S. Dr. Beck is a member of the Board of Directors at Zealand Pharma. Full Speaker profile
11:20 - 11:40	I Don't Care Polymorphism 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
11:40 - 12:00	Viral Vectors Manufacturing Challenges: AAV Case Studies Dr Eduard Ayuso, CEO, DINAMIQS About the speaker • Doctor in Veterinary Medicine, Autonomous University of Barcelona • PhD in Biochemistry and Molecular Biology, Autonomous University of Barcelona • INSERM Researcher, Head of Innovative Vectorology, University of Nantes • Scientific director of the Translational Vector Core, University of Nantes • > 50 publications in international journals • 20+ years experience in gene therapy, including vectorology, translational medicine and viral vector manufacturing Full Speaker profile
12:00 - 13:30	Lunch Break
13:30 - 15:30	Technical Operations Outsourcing Chair: Dr Kai Rossen, Editor-in-Chief, ACS
13:30 - 14:00	Continuous Processing for Oligonucleotide Building Blocks - Harnessing CMO Expertise and Capabilities Dr Heena Panchal, Associate Director, AstraZeneca About the speaker - PhD in Organic Chemistry (focussed on Nickel Catalysis) - Associate Director - leading a team to deliver process improvements to complex APIs - Experienced working with new modalities in late stage development - Lead for numerous process design and development projects with external partners Full Speaker profile
14:30 - 15:00	Biotech Startup Goes to Product Launch : How Partnerships Impact ? Dr Alain Bernard, CTO, VECTIVBIO About the speaker Dr. Alain Bernard is currently Chief Technical Officer at Vectivbio AG. Prior to that role, he was Vice-President, Biopharmaceutical Process Sciences at UCB, overseeing process developments for new chemical and new biological entities as well as for life-cycle management of marketed products. He joined UCB in 2006, from Serono where he was Director of Process Development. He had joined Serono in 1998 and was formerly responsible for the biotechnology department in the R&D function. Prior to that move, he had been working at the Glaxo-Wellcome Institute of Molecular Biology. He holds a PhD in biochemical engineering and worked both in the US and Europe on process/product development and reactor design for a variety of biotechnological processes. He has authored or co-authored many publications in biotechnology. Full Speaker profile
14:30 - 15:00	Setting up a Sourcing Strategy for Combination Products and Injection Systems Dr Andrea Calenne, Associate Director, Global Strategic Sourcing, Biogen International GmbH About the speaker Employed as Associate Director Global Strategic Sourcing at Biogen International, Andrea is Drug Product category leader for the outsourced manufacture of injectable products (Biologicals and Oligonucleotides) as well as oral solid dosage forms. A wide and solid network in the CMO space, understanding of manufacturing processes, together with strong negotiation skills contribute to the success of Andrea's role in Biogen Sourcing organization. Over the past 20 years Andrea worked in External Manufacturing and QA roles for CSL Behring, Bayer Healthcare and Biogen, managing a relevant number of manufacturing sites and a product portfolio including plasma derivatives, biologicals, as well as non-sterile pharmaceuticals distributed globally. Starting his career in Corporate Quality Management within a Japanese automotive company (Bridgestone), Andrea developed his professional identity in an environment where outsourcing is key to product compliance as well as to the performance of the supply process. Andrea holds a M.Sc. in Organic Chemistry from University La Sapienza in Rome, after graduation he completed a Master in Intellectual Property at the Italian Patent and Trade Mark Office. Andrea speaks Italian, English, Spanish, French and German. Born 1972 in Rome (Italy) Andrea lives in Switzerland with his family since 2005. Andrea is Italian and Swiss national. Full Speaker profile
15:00 - 15:15	Electrochemistry: a Viable & Sustainable Tool for API Manufacturing Dr David Cantillo, Scientific Advisory Board Member, Axplora About the speaker David Cantillo obtained his PhD in organic chemistry from the University of Extremadura, Spain, in 2011. Then, he moved to the University of Graz as a postdoctoral researcher under the supervision of C. Oliver Kappe, where he gained experience in continuous flow chemistry. David Cantillo is currently an Area Leader at the Research Center Pharmaceutical Engineering and in 2018 joined the faculty of University of Graz, where he leads the electroorganic synthesis research group. As of 2023, David is a member of the Scientific Advisory Board of Axplora. Full Speaker profile
15:15 - 15:30	Developing High Potency Oral Solid Formulations – Maintaining Operator Safety Requirements Without Compromising Flexibility and Quality Carolina Bonifacio, R&D Head, Siegfried About the speaker Carolina Bonifacio is a pharmaceutical consolidated professional with over 20 years of experience in the sector, both sterilized and oral solid dosage forms, with extensive experience in handling of highly potent compounds. Currently leading the Development team at both Spanish finish product Siegfried sites, Barberà del Vallès and El Masnou. Prior to joining Siegfried, Carolina held different positions of increasing responsibility in technology transfer and scale up at Novartis. She has a Pharmacy Degree at Salamanca University, Spain and a Pharmaceutical Technology and industrial Pharmacy Master in the University of Barcelona. Full Speaker profile
15:30 - 16:00	Coffee and Partnering
16:00 - 17:00	Outsourcing Case Studies Chair: Prof Brian Cox, Emeritus Professor of Pharmaceutical Chemistry, University of Sussex
16:00 - 16:20	Creating the Optimal Environment for Sponsor and Supplier Partnerships to Thrive & Prosper Dr Miranda de Jager, Head of CMC Hybridize Therapeutics & Owner, M3 Pharma Consultancy About the speaker Miranda works as Head of CMC at Hybridize Therapeutics. As owner of M3 Pharma Consultancy she also supports development activities of other companies, on a parttime consultancy basis. Hybridize Therapeutics is an innovative Dutch biotech company that was founded in 2019 as a spin-out from Leiden University Medical Center. The company’s main focus is the development of RNA therapies for untreated kidney diseases. Miranda has more than 18 years of experience in the pharmaceutical industry. She worked for large “big pharma” companies as well as for small and virtual start-ups, both as an employee and as a consultant. She enjoys pioneering and working on complex projects in an international and multidisciplinary environment. Miranda has acted as CMC leader of multiple early to late stage development projects. Over the years she collaborated with a wide range of academic and industrial partners for CMC, drug delivery and nonclinical related activities. Being responsible for delivering project objectives at high quality and within agreed budget and timelines, finding creative solutions for challenges that pop up along the way and being able to collaborate with many dedicated internal and external colleagues is what gives her energy and drives her every day. Full Speaker profile
16:20 - 16:40	Nanoforming - the Patient and Planet Centric Approach From Increasing Bioavailability to Enabling Sustained Drug Delivery Christian Jones, Chief Commercial Officer, Nanoform About the speaker Mr. Jones is the Chief Commercial Officer for Nanoform Finland Plc and a member of the Management Team. He oversees all commercial activities for the company and leads a strong and talented sales, marketing and business intelligence team across US and Europe. Since joining Nanoform at the end of 2018 the company has grown from 18 to approximately 150 people, established commercial relationships with 10 of the top 20 pharma and biotech companies globally, become a listed public company on NASDAQ First North Premier in Finland and Sweden and raised approximately 150m Euros to support the technology development and commercialization in Europe and US. Prior to joining Nanoform he has served as Commercial Director, Innovator Pharma Products and Solutions at Johnson Matthey Plc and was a member of the Senior Leadership Team for the Global Health Sector. Prior to this he was Head of Asia Pacific Sales and member of the Senior Leadership Team at Dr. Reddy’s Global Custom Pharma Solutions business after holding the roles of Associate Director and Manager of Sales and Business Development, Europe. His first commercial role was at Prosonix Ltd, where he led global business development for their proprietary particle engineering technology. Prosonix was later sold to Circassia for £100M. Mr Jones has extensive experience in understanding the value between Drug Substance and Drug Product development and the critical importance particle engineering and solid form can play to deliver value for patients. Full Speaker profile
16:40 - 17:00	Developing a Document System Solution for a Manufacturing Platform Approach to Optimize Sponsor and CMO Partnership: A case study Mr Philipp Andre, Manager - Process Science & Technical Services, Hookipa Pharma About the speaker Philipp Andre works as a Manager at the Process Science and Technical Services department of Hookipa Biotech GmbH. HOOKIPA is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies to fight cancer and chronic infectious disease utilizing a proprietary arenavirus platform technology to develop therapies that are designed to reprogram the body’s immune system and to induce robust and durable antigen-specific T cell responses and pathogen-neutralizing antibodies to fight cancer and infectious diseases. Philipp has a background as biotechnological process engineer with more than 7 years of experience in viral vector process development, process transfer and manufacturing support. He transferred HOOKIPAs manufacturing platform process to multiple contract manufacturing organizations. In this time, he got valuable real-world insights from Person-in-Plant visits he conducted. With this he also developed a deep understanding of technical documentation needs for a prolonged and enhanced customer-client collaboration, utilizing the advantages of a manufacturing and documentation platform. He further supported preparations of source and submission documents for multiple successful clinical trial applications. Full Speaker profile
17:00 - 19:00	Drinks Reception

Time	BOS Basel Programme
08:00 - 09:00	Refreshments & Partnering
09:00 - 11:00	Technical Operations Outsourcing Chair: Dr Alexander Bausch, ceo, kinarus ag
09:00 - 09:30	Chemical Development of Adafosbuvir Dr Simon Wagschal, Senior Scientist External R&D, Janssen Pharmaceuticals About the speaker Simon Wagschal earned his Ph.D. in 2010 from École Polytechnique, Paris, France, under the supervision of Prof. El Kaïm and Prof. Grimaud. He then delved in organometallic chemistry during his postdoctoral stay with the Kündig group in Geneva, Switzerland. In 2013, he joined Janssen’s Chemical Process R&D group and have been involved in a dozen late-stage projects, developing and introducing new processes in the pilot and production plants. He received the Vice Presidents' Research Award for Outstanding Technical Achievement in 2020. In 2021, Simon joined the Janssen External R&D team, focusing on compounds in early development and delivering GxP batches at CRO partners. Full Speaker profile
09:30 - 10:00	Deploying Appropriate Spending on Analytical Testing To Avoid Wasting Resources? Dr Gerald Gellermann, Associate Director, Novartis About the speaker A senior professional with extensive experience and expertise in biotechnological drug development. Cultivates a pro-active “can-do” mentality and entrepreneurial spirit. Able to liaise with many different groups and customers as well as work towards a common company goal/strategy. Gained significant experience through interactions with health authorities and preparation of source and submission documents for clinical trial and license application. Excellent understanding of enhanced development approaches aligning on ICH Q8 to upcoming ICH Q12. Full Speaker profile
10:00 - 10:30	Analytical Strategies for Novel Therapeutic Entities - Considerations When Evaluating Outsourcing Models and CRO Partners - Case study: Personalised Vaccine Perspective Cathrine McCoig, Clinical Supply Manager, Nykode Therapeutics About the speaker Clinical Supply Manager in Nykode Therapeutics ASA. I work in clinical supply with our personalised cancer vaccine clinical trial (VB10.Neo). I will be sharing our experiences with outsourcing multiple steps of a complex supply chain in a personalised cancer vaccine clinical trial. Full Speaker profile
10:30 - 10:45	Crystallising a Challenging API – a Pragmatic Approach for Phase 1 Dr Julian Northen, Solid State Manager, Onyx Scientific Limited About the speaker Jules graduated from the University of Newcastle upon Tyne with a 1st Class Honours degree and subsequently a PhD in Medicinal Chemistry and Anti-cancer Drug Design. This was followed by two post-doctoral positions, before a move from academia to Onyx. He has over 20 years of industrial experience in PR and D as Research Manager and is currently Solid State Manager at Onyx and is responsible for all solid form development and preformulation activities. Full Speaker profile
10:45 - 11:00	Utilisation of Crystallisation Kinetics to Preferentially Isolate a Meta-Stable Form – Pyrimethanil 3-Nitrobenzoic Acid Salt as a Case Study Dr Daniel Rixson, Scientist II, Veranova About the speaker Scientist specialising in the area of solid form and particle engineering with a back ground in solid state characterisation and crystallography. Full Speaker profile
11:00 - 11:30	Coffee and Partnering
11:30 - 12:30	Outsourcing Case Studies Chair: Dr Yogeshwar Bachhav, Associate Director (Consultant), AiCuris Anti-infective Cures AG
11:30 - 11:50	Managing Complexity in ADC Supply Chain Dr Jan-Oliver Schwabe, Senior Site Manager, F. Hoffmann-La Roche Ltd About the speaker Over 20 years of experience in Research, Engineering & Construction, CAPEX investments, Biotech Manufacturing and Contract Manufacturing Operations. Managing external collaborations for commercial supply of products with a primary focus on oncology indications. 10 years of experience in managing supply chains of antibody drug conjugates. Full Speaker profile
11:50 - 12:10	Formulation Strategies to Improve the Bioavailability of APIs with BCS Classification II and IV Dr Dave Seghers, Head of Sales Pharm Division, Ardena Holding NV About the speaker Dave Seghers is a seasoned professional with 20 years of experience in the pharmaceutical industry, supporting many new drugs in their path to clinical trials. As a bio-engineer and after completing his PhD in Applied Biological Sciences from Ghent University, he joined Pharmavize (now Ardena) in 2004. He has extensive knowledge in CMC writing, drug product formulation and analytical development, GMP production for early an late phase clinical trials, and CMC development. Dave currently serves as the Head of Sales of the Pharmaceutical Division at Ardena. Full Speaker profile
12:10 - 12:30	Development and Supply of Personalized ATMPs – A Global Challenge Diego Möckli, Head of Supply Chain, Tigen Pharma AG About the speaker Diego Möckli is Head of Supply Chain at Tigen Pharma, where he leads the manufacturing platform initiative to make CGT therapies faster, cheaper, more accessible and more sustainable. Before Tigen, he successfully held various leading supply chain positions in different industries, most recently at Novartis as Head of Logistics and Supply Chain. He has been instrumental in various key product launches and successfully introduced new operational standards and integrated business planning (IBP) locally and globally. Diego holds an engineering degree from ETH Zurich. Full Speaker profile
12:30 - 14:00	Lunch & Partnering
14:00 - 15:00	Sustainability in Pharmaceutical Outsourcing (Panel Session) Chair: Dr Joan Herbert, Senior Director, Business Development, Medicines for Malaria Venture Mrs Cecilia NORD, Global Head of Sustainability, SOBI AB Mrs Marianne Spaene, CBO, Siegfried Holding AG Dr Hanns-Christian Mahler, CEO, ten23 health Mr Rathish Ravindrakumar, Director Business Development, CDMO, Novartis About the speakers About the speaker Global Head of Sustainability at Swedish Orphan Biovitrum AB, Sobi AB, since September 2021. M Sc Industrial Engineering. Working with environmental and sustainability management for over twentyfive years in several industries. Focus on crafting and driving sustainability strategies and other improvement programs within global organizations and supply chains. Full Speaker profile About the speaker For more than 30 Years in the pharmaceutical business in different leading positions as Divison Head of Drug Product, heading Project Management and Regulatory Affairs, as well as Marketing, Sales and Business Development and for 13 Years in the Executive Commmittee of Siegfried. Full Speaker profile About the speaker Dr. Mahler is Founder, CEO and Board Member at ten23 health AG, the human-centric and sustainable pharmaceutical development partner. Previously, Dr. Mahler has been leading the Drug Product Services Business Unit at Lonza AG, leading Pharmaceutical Development & Supplies Biologics at Roche (Basel), and as Principal Scientist & CMC Team leader Erbitux at Merck KGaA. He is also adjunct faculty at the Universities of Frankfurt (Germany) and Basel (Switzerland), serves as Scientifc Expert (Ph.Eur.) at EDQM and as Board Member for Bionter & KriyaBio. He studied Pharmacy & holds in Ph.D. in Toxicology from the University of Mainz. Full Speaker profile About the speaker A passionate, curious and joyful person in the quest of unleashing human potential to the fullest. Over 13 Years of industry experience in Biotech sector with increasing role of responsibilities in Manufacturing, process development and Business development. Currently in the Novartis contract manufacturing unit representing business development leadership team in this event. I love to network and enjoy meeting new people. Full Speaker profile
15:00 - 16:00	Conference Close & Drinks Reception