Biotech Outsourcing Strategies Manchester 2022

16th & 17th NovemberManchester, UK

Introducing the BOS Manchester 2022 Programme

The scope of BOS MANCHESTER 2022 will be pharmaceutical Discovery Outsourcing and pharmaceutical CMC Outsourcing (primarily development phase). Both small molecules and biologics are included in this scope.

New for 2022 we will consolidate the programme into a single, high-quality track which will include the following components:

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 - 16th November 2022

Time	BOS Manchester Programme
08:45 - 10:00	Registration & Speedy Partnering (10 min Partnering Slots)
10:00 - 12:00	Outsourcing Process & Strategies Chair: Dr Joan Herbert, Senior Director, Business Development, Medicines for Malaria Venture
10:00 - 10:30	Harnessing Innovation in Pharmaceutical Development & Manufacture Dr Elizabeth Collins, Executive Director, Pharmaceutical Sciences, Pfizer About the speaker Full Speaker profile
10:30 - 11:00	Challenges and Opportunities with External Data Management Mr Mike Hindson, Scientific Externalisation SME, Partnership Governance and Process Excellence dept, Strategic External Development, GSK R&D, 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
11:00 - 11:30	Building Analytical Outsourcing Process for New Modality Therapeutics Dr David Allcock, Group Leader, Evox Therapeutics About the speaker I'm a Group Leader in the Analytical Development group for CMC. At Evox we're developing next generation therapeutics using Exosomes either directly as a therapeutic or as a delivery mechanism. We're excited to be investing in new technologies to allow us to overcome the challenges of working with a novel and complex biological therapeutic. Full Speaker profile
11:30 - 11:45	Manufacturing of Small Batches of Oral Drug Products On Demand Dr Mirko Gabriele, Innovation Director, Catalent About the speaker Mirko is Innovation Director in Catalent and his work is focused on new delivery technologies scouting and introduction. He is mainly focused on early phase drug development and is responsible for new way to overcome challenges in development and scale-up of small and large molecules programs. Mirko has 18 years of experience in the contract manufacturing space, he covered several roles of increasing responsibilities from R&D, quality and operations to innovation and strategy definition and deployment. He holds a bachelor’s in pharmaceutical chemistry from University of Rome, a PhD in Biomolecular and Pharmaceutical Science and an Executive MBA in Pharma Administration. Full Speaker profile
11:45 - 12:00	The Future of CMC Outsourcing Mr Tom Dexter, Senior Vice President, Scientist.com About the speaker Tom joined Scientist.com in 2017, bringing with him 20 years of experience leading global Procurement / Outsourcing teams at Rolls-Royce and AstraZeneca. Having developed and delivered strategic innovation initiatives within Pharma Research, he now helps new clients re-define and successfully implement their R&D outsourcing strategy through Scientist.com. Full Speaker profile
12:00 - 13:30	Lunch & 1-to-1 Partnering Meetings
13:30 - 15:30	Technical Operations Module Chair: Dr Suzanne Dilly, CEO, ValiRx PLC
13:30 - 14:00	Optimised Virtual Sourcing for SMEs: Building a Robust Supplier Network to Drive Drug Discovery & Early Development Valérie Reader, VP Scientific Operations, NodThera About the speaker I have over 25 years experience in the pharmaceutical industry, originally as a medicinal chemist in SmithKline Beecham before joining a small entrepreneurial provider of high-throughput chemistry services in Cambridge, UK. I have since worked in a number of companies, large and small, with increasing responsibility for outsourcing a wide variety of services in drug discovery, development and clinical. I have gathered insights from working on both sides of the CRO industry and enjoy successful collaborations with researchers worldwide. Full Speaker profile
14:00 - 14:30	Trends Shaping Early Chemical Development & How Outsourcing Partnerships Can Adapt to Meet the Challenges Dr Jeremy Parker, Head of Early Chemical Developmemt, AstraZeneca About the speaker Jeremy Parker is the Head of Early Chemical Development, a World-Class CMC department with responsibility for early phase Drug Substance. The department’s responsibilities span from early engagement with Discovery Chemistry groups to manufacture of Phase II Clinical material, and its key skill areas include Analytical Chemistry, Crystallisation, Isotope Chemistry, Large-Scale Laboratory (Kilo-Lab) Manufacturing, Process Chemistry, Process Design, Process Engineering, Route Design and Separation Science. Jeremy is a member of the Pharmaceutical Sciences Leadership Team, and also the Global Chemistry Leadership Team within AstraZeneca. External to AstraZeneca, Jeremy is a member of the Editorial Advisory Board of Organic Process Research and Development, Chairman of the Centre for Biocatalytic Manufacture of New Modalities Prosperity Partnership at the University of Manchester, and a Trustee of the Society of Chemical Industry. Full Speaker profile
14:30 - 15:00	Designing a Robust Manufacturing Strategy for Personalised Vaccines Dr Patrick Merky, Senior CMC Project Manager, Nykode Therapeutics About the speaker Patrick currently works as CMC project lead for the personalised plasmid DNA cancer vaccine programme at Nykode Therapeutics, located in Oslo, Norway. During his four years at Nykode (former Vaccibody), Patrick contributed to setting up and managing the supply chain for patient-specific manufacture. This also involved preparation of quality documentation and interaction with regulatory authorities to define a suitable manufacturing strategy. Prior to Nykode, Patrick was part of the analytical department at the CDMO Cobra Biologics, Södertälje, Sweden, supporting and coordinating development of protein-based drugs in pre-clinical and clinical phase for various international customers. He holds a master’s in integrative biology from the ETH Zurich, Switzerland and PhD in medical sciences within the area of autoimmunity and T cell immunology from the Karolinska Institute in Stockholm, Sweden. Full Speaker profile
15:00 - 15:15	Parenteral Formulations: Tackling Development and Scalability Challenges of Ever-Increasing Formulation Complexity Dr Lisa McIntosh, Formulation Scientist, Curia About the speaker Ten years in pharmaceutical development working across different dosage forms. Worked at Curia (formally AMRI) for the past three years specialising in lyophilisation and liquid parenteral formulation development. Ph.D. in Pharmaceutical Sciences and Master of Research in Biomedical sciences (Drug Delivery) from University of Strathclyde, Glasgow UK. Full Speaker profile
15:15 - 15:30	Seamless formulation and manufacturing into hybrid First In Human studies Mrs Ellen Verhavert, Head Production Facility-Qualified Person, SGS Belgium About the speaker Ellen graduated in 1998 as a Pharmacist. In 2001 she finished my Master Hospital Pharmacy and worked as a Hospital pharmacist in the Imelda hospital and was responsible for clinical trials, central sterilization department and quality assurance in the pharmacy (ISO9001-2015) and hospital (NIAZ). In 2016 she began my role as Head Pharmacy for SGS LS where she was responsible for the quality of prepared and produced IMP in the CPU Pharmacy and the IMP manangent. In 2020 she finished her master Industrial pharmacy to obtain the title of Qualified Person and her role in SGS changed to that of Head Production Facility -Qualified Person leading the quality department of the CPU production facility. Full Speaker profile
15:30 - 16:00	Coffee Break & 1-to-1 Partnering
16:00 - 17:00	Pharma Outsourcing Perspectives & Case Studies Chair: Dr Stella James, Executive Director Business Development, Bionow
16:00 - 16:20	Developing New Formulations for Respiratory Disease Peter Spargo, Senior Vice President, CMC, Verona Pharma plc About the speaker Dr Spargo has PhD in organic chemistry from Cambridge University and has been involved in pharmaceutical research and development throughout an international career spanning 25 years, embracing all aspects of research and development, including working on a number of commercialized drugs. Prior to joining Verona Pharma as Vice President of Chemistry, Manufacturing and Controls (CMC), Dr Spargo held similar roles at Creabilis (UK/Italy) and at Novexel (France) where he played an important role in the $500 million acquisition by AstraZeneca in 2010. Previously Dr Spargo was head of Chemical Process R&D for Pfizer in Europe responsible for the design, development and delivery of commercially viable synthetic routes to drug development candidates, supplying Active Pharmaceutical Ingredient (API) to meet the demands of toxicology, clinical and formulation development programmes and generating knowledge to underpin regulatory filings and transfer to commercial manufacturing. During his time at Pfizer, as well as his process chemistry responsibilities, Dr Spargo also lead Pharmaceutical Sciences development teams, embracing formulation and analytical activities, as well as leading a variety of multi-disciplinary human health development candidate project teams and being responsible for the company's Worldwide Pharmaceutical Sciences Veterinary Medicines portfolio. Dr Spargo also spent a period at Scientific Update, providing consultancy and CMC management services to a wide range of pharmaceutical and biotech companies. He continues to provide independent consultancy services as time permits. Full Speaker profile
16:20 - 16:40	Sourcing of New and Ad Hoc Services – Tools and Strategies to Find, Qualify, De-risk Dr Andy McElroy, CEO, TRN - The Research Network Ltd. About the speaker Andy graduated from Churchill College Cambridge in 1980 with a first class degree in Natural Sciences and completed a PhD in synthetic organic chemistry before joining Glaxo as a medicinal chemist in 1983. He spent seven years at the Ware and Greenford sites working on CNS targets and then three years at the Research Triangle Park in North Carolina as the lead chemist on Cardiovascular projects. Andy joined Pfizer in Sandwich in 1993 as a manager in the Medicinal Chemistry department. He became Therapeutic Area Lead for Cardiovascular and Neurodegeneration Research, and later on Tissue Repair managing a portfolio of projects up to First in Human. He had his first taste of process improvement at Glaxo building strong relationships with IT and operational groups and advancing a range of continuous improvement initiatives. This interest blossomed over the years at Pfizer and in 2005, lead to him having global responsibilities for coordinating the continuous improvement of research processes and workflow. Andy gained a qualification as an Agile process facilitator during this period. At the start of 2009 he became site lead at the Sandwich Site for External Research Solutions group, leading a multidisciplinary team focusing on optimising external research and in 2011 founded TRN – The Research Network Ltd, an associate network of drug discovery consultants focused on enabling drug discovery and development. Expertise Chemistry-Medicinal, CNS, CVMD, Dermatology, Pain, Small Molecule, UK, Neurodegeneration, Cardiovascular, Outsourcing, Drug Discovery Strategy, Drug Development Strategy, Funding, Networking, Team Building, Project leadership. Full Speaker profile
16:40 - 17:00	Hurdles to Develop a Parenteral Nanosuspension Formulation for Early Clinical Phase Dr Yogeshwar Bachhav, Associate 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
17:00 - 19:00	Drinks Reception & Canapés

Time	BOS Manchester Programme
08:00 - 09:00	Coffee & 1-to-1 Partnering
09:00 - 11:00	Technical Operations Outsourcing Module - chaired by Dr Brian Cox Emeritus Professor of Pharmaceutical Chemistry, B Cox Consulting Ltd
09:00 - 09:30	Outsourcing highly potent molecules – big challenges for small deliveries! Dr William Goundry, Principal Scientist, AstraZeneca UK Ltd About the speaker Dr Goundry is a leading scientist in the synthesis and manufacture of active pharmaceutical ingredients. Following his D.Phil in organic synthesis at Oxford University and Post Doc at Indiana University Will joined AZ at Macclesfield in 2006. He has developed a strong track record in process design and scale up working from grams to tonnes, including biocatalysis and flow chemistry. Will is currently AstraZeneca’s scientific lead for New Modalities in the early phase. In this role he supports the development and manufacture of antibody drug conjugates (ADC), peptides and oligonucleotide drugs for clinical trials. He is an Honorary Lecturer at the University of Manchester in the Division of Pharmacy, and an industrial lead for both the Centre for Biocatalytic Manufacture of New Modalities and the Centre for Doctoral training (CDT) in integrated catalysis. Full Speaker profile
09:30 - 10:00	Transitioning towards a Virtual CMC Operation for the Sourcing of API and Drug Products, Showcasing Highly Collaborative Outsourcing Partnerships Dr Craig Harris, Head of Small Molecule Development & Scientific Advisor, Galderma About the speaker Craig currently leads the small molecule development for Galderma, operating out of the offices of Lausanne, Switzerland. During his 9 years at Galderma, Craig has contributed to the delivery of 10 development candidates on a variety of targets linked to skin diseases such as psoriasis, acne, skin cancer, atopic dermatitis and in the aesthetic and corrective field. Prior to joining Galderma, Craig was responsible for driving the synthesis for the Oncology iMed in Reims, AstraZeneca, France where he contributed to many discovery programs including 3 clinical candidates as well as to several continuous improvement projects. Full Speaker profile
10:00 - 10:30	B2B+Me Kirsty Keith, Director of Manufacturing & Outsourcing, Immunocore About the speaker Kirsty is Director of Manufacturing and Outsourcing at Immunocore. She is responsible for execution and oversight of outsourced manufacturing of GMP products for clinical trials and commercial supply. Immunocore is a pioneering T Cell receptor biotechnology company, developing a new generation of transformative medicines addressing unmet needs in cancer, infection and autoimmune disease. Prior to Immunocore Kirsty spent over 20 years at GSK in small molecule pharmaceutical manufacturing and supply. 15 of those years were spent leading various manufacturing operations, after which she joined GSK's External Supply Organisation to lead the European region. At the beginning of this year Kirsty joined Immunocore to expand her experience in the Biopharmaceuticals arena. Kirsty is also a certified executive coach and is currently studying for an Executive MBA at Bayes Business School in London. Full Speaker profile
10:30 - 10:45	Enzymes: Biocatalysts for innovative small molecule production Greg Holgate, Biocatalysis Chemist, Sterling Pharma Solutions Ltd About the speaker Born in Frankfurt am Main, Germany to British/Russian parents. He moved to Gateshead, North East England at a young age. There he grew up, and developed a passion for natural sciences. Subsequently, he would be accepted into Newcastle University to study for a Masters degree in Chemistry with Medicinal Chemistry. During this time, he experienced a year working in industry at AkzoNobel, where he developed non-biocidal antifouling coatings for large ships and vessels. After graduating, he joined Sterling Pharma Solutions as a Knowledge Transfer Partnership (KTP) associate within of the Innovate UK programme. Alongside Northumbria University, he worked to knowledge transfer the use of enzymes for API manufacture to site; where he would go on to build a small scale enzyme screening laboratory. He would eventually join Sterling permanently as a Biocatalysis Chemist, working on chemoenzymatic synthesis of pharmaceuticals and enzymatic process development, in a role he continues to work in today. Full Speaker profile
11:00 - 11:30	Coffee Break & 1-to-1 Partnering
11:30 - 12:30	SME Outsourcing Perspectives Chair: Mr Duncan Judd, Managing Director, Awridian Ltd
11:30 - 11:50	CMC Strategy for Orphan and Rare Disease Indications and the Importance of Achieving Successful and Productive Vendor Partnerships Helen Barker, VP, CMC, Reneo Pharma About the speaker With a diverse background in large pharma and biotech companies, Helen leads the successful technical and strategic development of novel compounds, devices, and businesses. Helen is the Vice President of CMC at Reneo Pharma Ltd., a clinical-stage company focused on the development and commercialisation of therapies for patients with rare, genetic, mitochondrial diseases. She is also the founder and managing director of Project-ion Ltd, which advances the development of small and large molecules with biotech organisations. She has a proven track record in developing innovative project strategies and their delivery to critical milestones. A leader of global, multidisciplinary teams in CMC, diagnostics, clinical research, and across R&D. She enjoyed a range of positions within Pfizer, Bristol-Myers Squibb, multiple start-up companies, and the University of Oxford, enabled by degrees in Chemical and Pharmaceutical Science and an MBA. She was Head of Pharmaceutical Development at Ziarco, which Novartis acquired in 2017. Helen is a Faculty Fellow of the Royal Pharmaceutical Society, a Chartered Chemist, Chartered Scientist and a Fellow of the Royal Society of Chemistry. Areas of particular expertise include rare and orphan, infectious, and respiratory diseases. Further interests include business strategy development, supporting emerging pharmaceutical scientist leaders, and patient and public involvement in research. Full Speaker profile
11:50 - 12:10	Strategic Partnerships: The Future of Outsourcing? Mr Paul Martin, Business Development Manager, Intertek Melbourn About the speaker Paul Martin is a Business Development Manager at Intertek and has held several commercial positions within the pharmaceutical industry over the last 9 years. He joined Intertek in 2019 and is responsible for business development and managing new and existing partnerships. As part of his role, Paul routinely works with global companies to design tailored outsourcing solutions to meet their technical and commercial needs. Full Speaker profile
12:10 - 12:30	BIA – Supporting the UK Manufacturing Industry George Caterer, BD & Membership Manager, BIA About the speaker Full Speaker profile
12:30 - 14:00	Lunch & 1-to-1 Partnering Meetings with Speedy Partnering 10 min slots 13.00 to 14.00
14:00 - 15:00	Trends Shaping Pharmaceutical Outsourcing (Panel Session) Chair: Dr Joan Herbert, Senior Director, Business Development, Medicines for Malaria Venture Dr Sue Coote, Head, Non-Clinical R&D Procurement, GSK Neil Jones, Chief Commercial Officer, Aenova Sales International GmbH Dr Stewart Mitchell, EVP & Site Head Deeside, Sterling Pharma Solutions Ltd Dr Suzanne Dilly, CEO, ValiRx PLC About the speakers About the speaker Sue Coote is the head of Non-Clinical Procurement in Research and Development at GSK. Sue leads a global team that delivers the supply chain to support GSK’s new product portfolio of small molecules, biopharmaceuticals and Vaccines. Her extensive supply chain experience reflects a career spanning over 25 years within GSK and legacy organisations. Sue has a Masters in Chemistry from the University of Oxford and an MBA from Warwick Business School. Full Speaker profile About the speaker Responsible for all Commercial (Sales & Marketing) Activities for the Aenova Group. Neil joined the Aenova Group mid of July 2022 as Chief Commercial Officer. Neil has a deep experience in the Pharmaceutical / Biotechnology product and services industries and a great reputation for driving significant growth in the CDMO market. Before joining Aenova, he was CEO and CBO at VMIC. Full Speaker profile About the speaker Stewart is EVP and Site Head at the Deeside facility, and is responsible for leading Sterling’s bioconjugation and ADC services. His main focus is to grow capacity and capabilities within this area of the business, as well as integrate Sterling’s High Potency API offering within its ADC services. Bringing more than 25 years of industry experience to Sterling, Stewart previously managed sites in the UK and US for companies including Rhodia, Shasun, Piramal and Thermo Fisher. He joined Sterling in 2021 from CMAC, University of Strathclyde, where he managed multiple technology industrial collaborative projects within advanced pharmaceutical research, manufacturing and training. Full Speaker profile About the speaker Dr Suzanne Dilly is an experienced entrepreneurial scientist. After commercialising her Chemical Biology post-doctoral research in the University of Warwick spin-out, a2sp Limited, Suzanne was awarded a prestigious Royal Society of Edinburgh Enterprise Fellowship, during which formal commercial and entrepreneurial training completed her transition from lab to boardroom. Completing commercial transactions to progress projects through multiple companies, Suzanne has been working in small company virtual biotechs since 2006 Full Speaker profile
15:00 - 16:00	Drinks Reception to Close BOS Manchester 2022!