Biotech Outsourcing Strategies Manchester 2024

Introducing the BOS Manchester 2024 Programme

BOS Manchester 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 - 26th November 2024

Time	BOS Manchester Programme
08:45 - 10:00	Registration & Speedy Partnering (10 min Partnering)
10:00 - 12:00	Outsourcing Process and Strategy Chair: Dr Peter Tiffin, Consultant, PKMD Consulting
10:00 - 10:30	Observations and Challenges in Global Registration of a New Anti-Cancer Drug. Dr Yasunori Abe, Manager, Taiho Pharmaceutical Co., Ltd. Mr Yuji Kanamoto, Manager, TAIHO PHARMACEUTICAL CO., LTD. About the speaker Yasunori started his industrial career in 2009 at Kyorin Pharmaceutical Co., Ltd. During his early years at Kyorin, he made significant contributions to the process development department, engaging in process research, clinical API manufacturing, external manufacturing management, and supporting the launch of new drugs. In 2017, he transitioned to Taiho Pharmaceutical Co. Ltd. as a key member of the process development department, leading the development and commercialization of robust and sustainable processes for numerous small molecule API. His areas of expertise include process chemistry, quality engineering and statistics. Throughout his career, he has been dedicated to improving the efficiency and sustainability of API manufacturing processes. His work involves not only optimizing chemical routes for APIs production, but also ensuring that these processes meet stringent quality and regulatory standards. He is passionate about applying advanced statistical methods and quality engineering principles to solve complex challenges in APIs development and manufacturing. Full Speaker profile About the speaker Yuji has 15 years of experience in the pharmaceutical industry, during which he has continuously worked at Taiho Pharmaceutical Co., Ltd. At Taiho, he has been primarily involved in CMC-related tasks, including the development of analytical methods for drug products. He has successfully managed around ten approval applications for injectable and solid oral dosage forms, several of which were global products submitted in Japan, the U.S., Europe, and Asia. Additionally, he has collaborated with both domestic and international CMOs to set up and technical transfer analytical methods. This experience has allowed him to deepen his understanding of different cultures and regulations, enabling him to lead multinational projects to success. Recently, Yuji transferred to Taiho drug substance team where he leads the development of analytical methods and setting specifications for APIs for global development. This has further broadened his career, reinforcing the importance of analytical technology in ensuring product quality and safety. Full Speaker profile
10:30 - 11:00	Developing a Blueprint for Effective Data Management Between Sponsor and Vendor Ms Nessa Carson, Digital Champion, AstraZeneca About the speaker Full Speaker profile
11:00 - 11:30	Process Development for the Manufacture of a Topical Pan-Trk Inhibitor Incorporating Decarboxylative Sp2-Sp3 Cross-Coupling. Dr Neil Stevenson, CMC / Process Chemistry Manager, BenevolentAI Dr David Fengas, CMC Services Director, Concept life Sciences About the speaker Neil Stevenson is the CMC / Process Chemistry Lead at BenevolentAI, covering drug substance, drug product, and all associated CDMO partnerships. With 20 years of experience within the pharmaceutical industry, he has worked on projects throughout the drug development lifecycle, from candidate selection to Phase 3 and filing. Neil has extensive experience of process chemistry, genotoxin control, analytical chemistry and regulatory strategy, with a range of publications in these fields. Prior to BenevolentAI, Neil spent a number of years within Chemical Development at GSK, and received his PhD from the University of Sheffield, within Professor Harrity’s group. He has a keen passion for people leadership, coaching and continuous development. Full Speaker profile About the speaker Dr. David Fengas, a Fellow of the Royal Society of Chemistry (FRSC), joined Peakdale in 2010, which later merged into Concept Life Sciences in 2014. Currently serving as the CMC Services Director and Site Lead in Sandwich, David has emerged as a key influencer in Chemistry, particularly in advancing Chemistry, Manufacturing, and Controls (CMC) services. His leadership and vision have established him as a pivotal figure, overseeing crucial functions within his role. Throughout his distinguished career, David's relentless pursuit of knowledge and innovation earned him FRSC status, a prestigious recognition reflecting his outstanding contributions to the scientific community. As the Site Lead in Sandwich, his leadership style combines strategic thinking, technical acumen, and a deep understanding of CMC intricacies, fostering a collaborative work environment. Beyond his leadership role, David continues to contribute to the field through research, publications, and mentorship. His commitment to pushing scientific boundaries and inspiring others solidifies his legacy as a respected trailblazer in the world of CMC services. Full Speaker profile
11:30 - 11:45	Solubility Enhancing Technologies for APIs Dr Jonathan Loughrey, Associate Director, Almac Group About the speaker Technical head of of Physical Sciences and Isotope Chemistry for Almac Sciences. Contact for: - Material characterisation - Polymorph / salt / cocrystal screening enquiries - Crystallisation process development - Preformulation development for low solubility or challenging stability API - Excipient compatibility - ASD / SDD screening, development, & manufacture - PK-Tox liquid doses - SEDDS development - Milling & micronisation - C14 radiolabeling (non-GMP and GMP) Full Speaker profile
11:45 - 12:00	An Integrated CMC Approach to Expedite Early Phase Drug Product Development Dr Ziheng (Harry) Wang, Senior Director-DP Early Phase Development, WuXi STA About the speaker Ziheng (Harry) Wang serves as Senior Director in DP Early Phase Development Department at WuXi STA. He has more than 10-year experience in the fields of oral drug product development with the focus on oral peptide formulation development and lipid-based drug delivery system. He successfully led the development and commercialization of different drug products including one peptide with enhanced oral bioavailability. Before joining WuXi STA Pharmaceutical Co., Ltd., he served as director for oral formulation development at Qilu Pharmaceutical in China and formulation scientist at Thermo Fisher Scientific, Perrigo, and Catalent in the US and Canada. During the employment, he successfully developed several oral drug products that have been received FDA approval and added value to the product pipeline and business portfolio. Ziheng (Harry) Wang graduated from the University of Toronto with a Ph.D. Degree in chemical engineering in 2015. Full Speaker profile
12:00 - 13:30	Lunch Break
13:30 - 15:30	Technical Operations Outsourcing Chair: Dr Stella James, Executive Director Business Development, Bionow
13:30 - 14:00	Route Design and Scale-Up of a Topoisomerase I Inhibitor Antibody–Drug Conjugate Payload Dr William Goundry, Senior 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
14:00 - 14:30	Acceleration to Malaria Elimination - Developing Long-Acting Injectable Formulations for Chemoprevention Mr Laxman Cherkupally, Associate Director, MMV About the speaker Full Speaker profile
14:30 - 15:00	Expediting Drug Product Development in an SME Organisation Dr Sara Melief, Senior Consultant CMC, 3D-PharmXchange About the speaker Sarah obtained her PhD from Leiden University before joining Gadeta working in CMC roles culminating in being an Associate Director of CMC. Over the past 10 years she has been working on the process development and manufacturing of biologics in the treatment of immune related diseases. In recent years she has been a consultant in CMC biologics at 3-DPharmXchange Full Speaker profile
15:00 - 15:15	Formulation and PK Integration: A Fast-Track to Drug Development Success Mr Sanjeev Sood, Associate Director, Preformulation and Preclinical Services, Pharmaron UK Limited Mr Simon Taylor, VP, DMPK, Pharmaron UK Limited About the speaker Full Speaker profile About the speaker Full Speaker profile
15:15 - 15:30	Case Studies in Enabling Robust & Sustainable Cures to Life Dr Sharadsrikar Kotturi, Chief Scientific Officer, Neuland Laboratories Ltd About the speaker Dr. Kotturi holds a PhD in chemistry from Oklahoma State University (USA) and MSc (Tech) in Chemical Technology from UDCT, Bombay. Sharad brings over 20 years ofexperience in R&D across organizations such as Advinus Therapeutics Limited, GVK Biosciences Private Limited,Urikot Research, Durham, RTI International (USA), among others. His last role was with Piramal Pharma Limited,Mumbai where he was designated as Senior Vice President Operations and was responsible for the P&L of Discovery Services and Peptides Business. His area of expertise includes Discovery and development, Analytical R&D, conceptualization and development of sustainable chemistries for tech transfers of Agrochemicals (AI, AI intermediates), Electronic chemicals (OLED monomers), Flavors, Pharma (NCEs, Gx APIs, API intermediates, IND packages, Integrated Drug Discovery Programs, Peptide APIs, Perfumery, and Vitamins, Circular chemistries, business strategy. Full Speaker profile
15:30 - 16:00	Coffee Break
16:00 - 17:00	Outsourcing Case Studies Chair: Prof Brian Cox, Emeritus Professor of Pharmaceutical Chemistry, B Cox Consulting Ltd
16:00 - 16:30	CMC Insights into the Development of a Personalised Neoantigen Peptide Cancer Vaccine Dr Miranda de Jager, Owner/Principal Consultant CMC, M3 Pharma Consultancy About the speaker Miranda founded M3 Pharma Consultancy, a Dutch based company, in April 2022. She has almost 20 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 and finding creative solutions for challenges that pop up along the way is what gives her energy and drives her every day. • Transparent, motivated and reliable • Analytical, accurate, result- and quality-driven • Troubleshooting, out of the box thinking • Outgoing person with a dual orientation on tasks and people • Cross-functional collaboration on projects and/or root cause investigations Full Speaker profile
16:30 - 17:00	Integrated Formulation Development & Manufacture of Complex Sterile Drug Product Dr Jaclyn Raeburn, Manager, Formulation Development, Curia About the speaker I have 8+ years in pharmaceutical development working in the CDMO and CRO fields; including almost 4 years at Curia Scotland managing the formulation development team. Our primary focus is sterile injectables, which includes development of simple aqueous, organic and lyophilised product to more complex formulations such as viscous, suspension, emulsion and liposomal drug product. I have previous experience in drug substance solid state characterization and solid form screening at Cambrex, Edinburgh, UK. Prior to moving into industry, I completed a Ph.D. in chemistry from the University of Liverpool, focusing on the development of functionalised dipeptide hydrogels. My post-doctoral research was conducted at the University of Edinburgh working on oligonucleotide cross- linked polymer gel sensors. Full Speaker profile
17:00 - 19:00	Drinks Reception

Time	BOS Manchester Programme
08:00 - 09:00	Coffee and Partnering
09:00 - 10:45	Technical Operations Outsourcing Chair: Yogeshwar Bachhav, Director (Consultant), AiCuris Anti-infective Cures AG
09:00 - 09:30	Building "Solid" Foundations: Drug Product and API polymorphism Dr Kreshnik Hoxha, Director, CMC and Clinical Supply Chain, Grey Wolf Therapeutics About the speaker Kreshnik Hoxha works as Director of CMC and Clinical Supply Chain at Grey Wolf Therapeutics and leads the company’s CMC small molecule development activities in immuno-oncology. As part of his 13-year international experience with small molecules, Dr Hoxha has led the development of 20+ drug products for delivery to clinics worldwide. He holds a PhD in crystallography and crystal engineering (co-crystals and salts) from the University of Hull, United Kingdom. Kreshnik’s experience transcends all sides of the drug development model: in-house development, virtual biotechs and CDMOs. Previously, Dr Hoxha led the CMC operations at Healx, a Cambridge-based AI biotech company and was responsible for API and pharmaceutical development activities and clinical supply chain. He was also engaged in commercial manufacturing and technology transfers as part of Consilient Health, a London-based virtual pharma. Aside from his sponsor experience, he has also worked in the CDMO space as part of Patheon Thermo Fisher Scientific, where he provided technical leadership in formulation development and scale-up - partnering with biotech partners in the UK, Europe and North America. Kreshnik has also worked in a semi-virtual model with partial in-house development as part of Indivior developing solid oral dosage forms and nasal sprays. Full Speaker profile
09:30 - 10:00	Early Chemical Development and Optimization of A Novel Macrocyclic PKC Theta Inhibitor Dr Craig Harris, Founder and CEO, CMC Innov About the speaker In a nutshell, I am a NCE (new chemical entity) drug development leader and scientific advisor with more than 25 years’ experience in small molecule drug discovery & development working in big pharma alongside 5 years' experience in HA-based dermal filler R&D. Throughout my career, I have been priviledged to have driven excellent discovery and CMC teams on >20 small molecule drug NCE discovery and development projects resulting in 14 transitions including 6 clinical candidates in the Oncology, Dermatology and Aesthetic & Corrective fields. In the past 8 years, I also expanded my horizons to trouble-shooting established products (eg., impurity management strategy, second sourcing of APIs, route improvement while remaining in the scope of DMF, CEP etc) resulting in several success stories, avoiding market recalls through sound scientific position papers and costly re-processing. I am not afraid to innovate within the scope of the project or task in hand and have a strong track record of tangible creativity spanning from enabling access to hard-to-make design space in a drug discovery setting all the way to significantly improving established API routes permitting net commercial gain. Full Speaker profile
10:00 - 10:30	Optimising the Outsourcing of a Oral Solid Dosage Form Programme – a Biotech Perspective. Dr Serena Schiano, Associate Director, Kalvista About the speaker Serena Schiano works as Associate Director, CMC at KalVista, managing drug development from early stage to clinical trials, filing and commercialisation. She holds a Marie Curie PhD in Chemical and Process Engineering focused on material characterisation and process optimisation for solid dosage form from the University of Surrey in UK. During her studies she published several papers, presented to more than 10 international conferences worldwide and collaborated with numerous companies in UK, Europe and China. With more than a decade of experience Dr. Schiano development more than 20 drug products delivered for clinical trials worldwide. Serena has extensive expertise in formulation development, process optimisation and scale up and gained experience not onlK from the prospective of the sponsor but also worked in the CDMO space as part of Patheon Thermo Fisher Scientific, where she led the formulation development of products for several markets including UK and Europe. Serena also has experience from a business perspective due to her Manager role in Gamlen Tableting where she supported the business development team as SME in compaction and formulation optimisation during the early stage of her career. Full Speaker profile
10:30 - 10:45	An Accelerator™ Drug Development Case Study: How Thermo Fisher aligns CRO and CDMO Activities to Meet an Urgent Clinical Milestone Mr Jon Faulkes, Senior Manager, Sales Development, Thermo Fisher Scientific About the speaker Jon Faulkes has 30 years’ experience in the Pharma Industry, starting with an industrial placement at Glaxo Group Research as part of his degree in Applied Chemistry. Upon graduation, Jon worked for AstraZeneca for 16 years in various roles within the Medicine Development function before moving into a technical role with a leading Contract Development and Manufacturing organization. After a stint leading a cross-functional team, Jon moved into a Business Development role and has worked for several leading CDMO/CMOs in similar commercial roles before joining Thermo Fisher Scientific in 2019. Jon left Thermo Fisher for a year before returning earlier this year to lead the EMEA Oral Solid Dose Business Development team. Full Speaker profile
10:45 - 11:30	Coffee Break
11:30 - 12:30	Outsourcing Case Studies Chair: Mr Duncan Judd, Director, Awridian Ltd
11:30 - 11:55	Development of the First Sumatriptan Buccal Film: From Concept to Market Approval Dr Marc Willuhn, Managing Director, Willuhn Consulting AB About the speaker Marc is a senior CMC consultant with a broad and varied experience, covering projects from preclinical to commercial, from small molecules to biologics and ATMP, in various dosage forms. He mostly supports startup biotech companies as Head of CMC, developing strategies, identifying and engaging with external partners and CDMOs, executing projects to ensure drug supply and regulatory approval. Marc has worked in the pharmaceutical industry for more than 20 years and started his own consultancy in 2018. Previously, he was VP R&D at Fresenius Kabi and Head of the Innovation & Development Centre in Uppsala, Sweden, and Director of Process Development at Baxter Healthcare in Brussels, Belgium. Marc obtained his PhD in organic chemistry at the Max Planck Institute for Coal Research. Full Speaker profile
11:55 - 12:20	Feasibility of Developing Topical Formulation: Concept to Advanced Clinical Phase 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
12:30 - 14:00	Lunch and Partnering
14:00 - 15:00	Panel Session : Selecting The Optimal Outsourcing Model For Your Organisation - chaired by Sangeeta Bhagat of Medicines for Malaria Venture Chair: Ms Sangeeta Bhagat, Associate Director, Business Development, Medicines for Malaria Venture Dr Nathalie Huther, Associate VP Business Development, Sai Life Sciences Ltd Mr Mark Hollison, Former Head of R & D Procurement, invoX Pharma Prof Claire Thompson, CEO, Agility Life Sciences Mr Jerome Dubiez, Director of Technical Outsourcing, AstraZeneca About the speakers About the speaker For the last 15 years, Nathalie has held various leadership positions in both tactical and strategic marketing and, more recently, in sales and business development, successfully building/deploying territorial strategies to support revenue growth for companies offering discovery, development, manufacturing, nonclinical/clinical and commercial solutions for Biotech/Pharma innovators in Europe, the Middle East and Asia Pacific. She is also a Strategic Advisor Board member at BioNow and a career mentor for young science graduates with the Society of Chemical Industry (SCI). In 2020 and 2021, she was named one of the Northern Powerhouse Export champions for successfully building and deploying export strategies for a UK entity (Arcinova) leading to market penetration in new/unexplored territories. She holds an executive MBA with Entrepreneurship Specialism from Warwick Business School, BSc and MSc degrees in Chemistry from the University of Strasbourg (France) and a PhD in Organic Chemistry from the University of York. Full Speaker profile About the speaker A growth-oriented and dedicated procurement leader with 15+ years of experience in transforming procurement operations. Adept at establishing and leading procurement functions, implementing systems that streamline processes, and achieving significant savings. Proven track record in surpassing cost reduction targets and fostering stakeholder engagement through best practice procurement strategies. Recognised for spearheading procurement transformations that align with business objectives and contribute to organisational growth. Demonstrated leadership qualities in motivating and guiding teams. Expert in developing robust procurement strategies that deliver both financial and operational improvements, positioning companies for competitive advantage Specialties: Procurement, Strategic Sourcing, Negotiation, Category Management, R & D Procurement, Leadership, People Management, Transformational Leadership, Strategic Thinking, Learning & Development, Influencing, Negotiation, Communication, SRM, TPRM and Value Driven Change Management Full Speaker profile About the speaker We are an award-winning formulation development CDMO. We turn badly behaved molecules into smart formulations which give them the best chance of success in preclinical studies, and enable them to be accelerated to clinic and commercial. Our core expertise is in developing formulations for small molecules, peptides and proteins for a range of routes of administration including oral, ocular, IV, intranasal and topical. We develop and manufacture formulations to meet the needs of our clients including: - Overcoming solubility and permeability issues - Targeted drug delivery, including across the blood-brain barrier - Lipid nanoparticle and liposomal formulations - Immediate, controlled and sustained release - Formulations and analytical methods suitable for preclinical safety and efficacy studies, including GLP tox studies - Clinical and commercial prototypes - Reverse engineering of existing products Full Speaker profile About the speaker I lead the outsourcing of small molecules drug substances for Early Chemical Development. We cover AstraZeneca's outsourcing needs from GLP tox studies to the end of Phase 2 clinical trials. Full Speaker profile