Biotech Outsourcing Strategies Manchester 2023

Introducing the BOS Manchester 2023 Programme

BOS Manchester 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 - 28th November 2023

Time	BOS Manchester Programme
08:45 - 10:00	Registration & Speedy Partnering (10 min Partnering Slots from 08.00 to 09.00)
10:00 - 12:00	Outsourcing Process and Strategy Chair: Dr Joan Herbert, Vice President, Business Development, Medicines for Malaria Venture
10:00 - 10:30	Driving Sustainability Improvements from Outsourcing Partnerships Mr Calum Cook, Lead Technical Outsourcing Manager, AstraZeneca About the speaker Full Speaker profile
10:30 - 11:00	Challenges in developing an effective CDMO operating model, as the organisation grows in size and complexity Dr Colm Campbell, Senior Director, Chemical Development & Manufacturing, BioMarin About the speaker After completing a PhD in synthetic chemistry in the Royal College of Surgeons, Dublin, Colm took up a postdoctoral position in the Leiden Institute of Chemistry, modelling metalloenzymes. Following this, since late 1997, Colm has been working in the pharma industry, in chemical development and manufacturing roles, across big pharma and CDMOs, before joining BioMarin in 2010, where he now leads drug substance development and manufacturing, for early phase (toxicology to P3) synthetic molecules. Colm is a seasoned manufacturing development chemist, leading groups, often through organisational change, to deliver synthetic molecule strategies, in alignment with corporate goals and requirement. Full Speaker profile
11:00 - 11:30	Navigating a Pathway to New CRO Launch Dr Suzanne Dilly, CEO, ValiRx PLC 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. Full Speaker profile
11:30 - 11:45	How to Develop a Safe Process with Hazardous Chemistry? Dr Jan Haller, R&D-Chemist, Axplora About the speaker Full Speaker profile
11:45 - 12:00	Leveraging Developability Assessments to Accelerate and De-risk Formulation Development Dr Mark Lawlor, Vice-President, Product Development, Pharmaron About the speaker Full Speaker profile
12:00 - 13:30	Lunch Break
13:30 - 15:30	Technical Operations Outsourcing Chair: Dr Paul Madeley, Managing Director, Synth-Isis Limited
13:30 - 14:00	Harnessing Innovative External Capabilities to Expedite Early Chemical Development Mr Andrew Stark, Senior Scientist, Astrazeneca About the speaker I grew up in Scotland and studied chemistry at the University of Strathclyde (with 1 year spent in Alnwick at Sanofi-Synthelabo as an placement student). Upon graduation in 2002 I joined AstraZeneca’s Process R&D department as a scientist where I contributed to and eventually led teams to make numerous small molecule APIs working on mg scale to 250 Kg scale. I joined the technical outsourcing team in 2016 and have been working with numerous CDMO's across the world to deliver early phase projects. Outside of working I enjoy getting out into the Peak District and exploring the countryside with the dog / family. Full Speaker profile
14:00 - 14:30	CMO/CRO Selection for an Early Stage Biologics Company, Process and Challenges Dr Paul Varley, SVP CMC Development, Alchemab About the speaker A leader in Biotechnology, Biopharmaceutical and Manufacturing Development, experienced at leading teams in across the R&D process through to commercialisation. Strong Pre-clinical Development, Bio-manufacturing, DMPK, Pharmaceutics and general development background with significant management experience within the life sciences sector. Proven experience of building, leading and working with international cross-function al groups. Broad range of skills including innovative product development and project leadership across Biotechnology and Pharma. Full Speaker profile
14:30 - 15:00	Lipophilicity - Current Drug Discovery Landscape and Chromatographic Methods for its Determination. Dr Magdalena Kierkowicz, Senior Scientist, UCB Pharma Ltd About the speaker Full Speaker profile
15:00 - 15:15	Addressing the growing complexity of sterile product development Dr Iain MacGilp, Senior Director, Curia Scotland Ltd About the speaker 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. Degree and PhD in Chemistry from University of Strathclyde in Glasgow and 11 years at GSK in chemical development and CMC project outsourcing. 17 years at Curia Scotland. Responsible for aseptic GMP manufacturing programmes at the site as well as member of site leadership team. Engage in new project opportunities and technical transfer of maturing programmes to our commercial sites. Full Speaker profile
15:15 - 15:30	Use of Modelling to Improve Process Understanding and Facilitate Project Delivery Mr George Taylor, Chemistry Team Leader, Sai Life Sciences Limited About the speaker 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, B Cox Consulting Ltd
16:00 - 16:20	Optimizing Program Delivery Through Contract Research Organizations and Their Sub-Contractors Mr Stephane Hauduc, Senior CMC Project and IP Manager, Destiny Pharma plc About the speaker Full Speaker profile
16:20 - 16:40	Utilising advanced technologies to support product development through to commercial success Dr Scott Wharry, Custom and Flow Chemistry Manager, Almac About the speaker Custom and Flow Chemistry Manager in Almac Sciences responsible for technical leadership and delivery on a range of multidisciplinary projects. Over 20 years’ experience in the Pharmaceutical industry, gaining expertise in a number of disciplines including process R&D and tech transfer, cGMP manufacture, biocatalysis and enzyme immobilisation. More recently responsible for overseeing Almac’s entry into the continuous processing landscape and leading the integration of technology driven solutions into our customers' products and processes. Full Speaker profile
16:40 - 17:00	Highly Collaborative Work to Support Marketed Products Dr Craig S. Harris, CEO and Founder, CMC Innov Consulting About the speaker 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 and trouble-shooting marketed products (eg., OOS, OOT) resulting in several success stories, avoiding market recalls and costly re-processing through sound science. 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 (>100 scientific communications) 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
17:00 - 19:00	Drinks Reception

Time	BOS Manchester Programme
08:00 - 09:00	Coffee and Partnering
09:00 - 10:00	Technical Operations Outsourcing Chair: Dr Stella James, Executive Director Business Development, Bionow
09:00 - 09:30	Harnessing AI To Expedite Antimalarial Drug Discovery Dr Paul Willis, Senior Director, MMV Dr Thorsten Nowak, VP, Medicinal Chemistry, Exscientia About the speaker I joined MMV in 2011. Before that, I was a Drug Discovery Project Leader and Medicinal Chemistry Team Leader with AstraZeneca. I have over 20 years’ experience in drug discovery and have worked as a member of teams that have successfully delivered clinical candidates in a number of therapeutic areas. I have a doctorate in Chemistry from the University of Southampton. Full Speaker profile About the speaker Full Speaker profile
09:30 - 10:00	Sustainable Manufacturing of BMS-986278 Leveraging an ERED/KRED Biocatalytic Cascade Dr Shane McKenna, Principal Scientist, Bristol-Myers Squibb About the speaker Shane completed his chemistry undergraduate study at University College Cork, Ireland in 2011 before earning his PhD at the University of Liverpool. He initially gained experience with transition metal catalysed allylic alkylations before moving to the area of biocatalysis. Following completion of his Ph. D, Shane held a post doctoral position funded by Innovate UK where he applied his biocatalysts methodology to the synthesis of building block chemicals derived from biomass. Shane started his industrial career at Merck Sharpe & Dohme (MSD), Ballydine, Ireland as a Senior Specialist in Engineering, where he supported the piloting and launch of new global products and provided technical support for the GMP manufacture of APIs on site. Shane is now part of Bristol Myers Squibb’s, Chemical process development (CPD) department and currently leads the BMS UK Moreton Chemistry group. The UK group work as part of a global matrixed team with their sister sites in New Brunswick and Summit, New Jersey to develop safe, innovative and sustainable chemical routes to APIs. In addition, Shane leads the Biocatalysis strategy for CPD. Full Speaker profile
10:00 - 10:20	Development of Phase Appropriate Drug Products and Management of the CMC Minefield in an Outsourced Environment Dr Kreshnik Hoxha, Director of 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
10:20 - 10:35	An introduction to CRAMSN: A One-Stop-Shop CRO & CDMO solutions Partner for your Chemistry Needs Mr Donald Charles Ross, Life Sciences Leader, CRAMSN Research Park Private Limited Dr Vijayavitthal Mathad, Chief Operating Officer, CRAMSN Research Park Private Limited About the speaker Life Sciences Leader Full Speaker profile About the speaker Dr. Vijayavitthal T. Mathad. M.Sc, Ph.D(Med. Chem)- Chief Operating Officer Dr. Mathad is leading the world’s biggest CRO and CDMO pharmaceutical operations and development center with 500 plus scientific people providing End-To-End Integrated R&D and Manufacturing solutions to accelerate the delivery of innovative medicines. Extensive experience in setting up and executing the business plan with local board members to ensure continued high compliance with GMP regulations and Quality standards to generate organic growth faster than the market – short and long term. Dr. Mathad has over 90+ research publications in national and international journals, and over 100+ patents to his credit. He was actively involved in the development of novel, efficient, economical, scalable, green, production-friendly chemical processes for more than 120 pharmaceutical products. Full Speaker profile
10:35 - 11:00	The Spinout Journey from Drug Repurposing to Clinical Trials for Diagnosing and Treating Alzheimer's Disease Dr Farid Khan, CEO, Pharmakure Ltd About the speaker Dr Farid Khan is a co-founder of PharmaKure, a company dedicated to early stage diagnosis and treatment for Alzheimer's Disease. Full Speaker profile
11:00 - 11:30	Coffee Break
11:30 - 12:30	Outsourcing Case Studies Chair: Mr Duncan Judd, Director, Awridian Ltd
11:30 - 11:50	ENHANCE: Scaling Up Development of Novel Mergo® Formulations via Optimised Synthesis and High-Throughput Strategies Dr Aleksandra Singh, R&D Oligonucleotide Synthesis Team Leader, Sixfold Bioscience About the speaker Full Speaker profile
11:50 - 12:10	Novel Bicyclic Drug Product Development and Sterile Manufacture Dr Jenifer Mains, Director Formulation Science, Bicycle Therapeutics About the speaker Full Speaker profile
12:10 - 12:30	Manufacturing KNS366 from Spinout to First in Human Studies Prof Scott Webster, Chief Technology Officer, Kynos Therapeutics Ltd About the speaker Scott is founder and Chief Technology Officer of Kynos Therapeutics and Professor of Medicines Discovery at the University of Edinburgh. Following a period working in biotech he joined the Centre for Cardiovascular Science at the University of Edinburgh where he built a drug discovery team and led its first project from inception through to Phase I studies and out-licensing. With his university colleague, Damian Mole, his team was also part of a fruitful Discovery Partnerships with Academia collaboration (DPAc) with GSK to identify small molecule inhibitors of KMO for the treatment of acute pancreatitis. Following a strategic decision by GSK to close all DPAc programmes he and Damian formed Kynos Therapeutics where they are developing their portfolio of KMO inhibitors for the treatment of a range of acute and chronic inflammatory conditions. Full Speaker profile
12:30 - 14:00	Lunch Break
14:00 - 15:00	Sustainability in Pharmaceutical Outsourcing - Chair: Dr Joan Herbert, VP of Business Development, Medicines for Malaria Venture Anthony Fuller, Head of Global Sourcing, Mitsubishi Tanabe Dr Shane McKenna, Principal Scientist, Bristol Myers Squibb. Alissa Chair: Dr Joan Herbert, Vice President, Business Development, Medicines for Malaria Venture Mr Anthony Fuller, Global Head of Sourcing, Mitsubishi Tanabe Dr Shane McKenna, Principal Scientist, Bristol-Myers Squibb Miss Alissa Monk, Sustainability Lead, ten23 health About the speakers About the speaker Passionate sustainability and procurement leader with the mission to put ESG at the heart of all supplier relationships. 15+ years' senior level experience, driving strategic partnerships and embedding sustainability goals into supply network. Collaboration catalyst, initiative builder, and speaker, I put responsible sourcing front and center in business and procurement strategy. Full Speaker profile About the speaker Shane completed his chemistry undergraduate study at University College Cork, Ireland in 2011 before earning his PhD at the University of Liverpool. He initially gained experience with transition metal catalysed allylic alkylations before moving to the area of biocatalysis. Following completion of his Ph. D, Shane held a post doctoral position funded by Innovate UK where he applied his biocatalysts methodology to the synthesis of building block chemicals derived from biomass. Shane started his industrial career at Merck Sharpe & Dohme (MSD), Ballydine, Ireland as a Senior Specialist in Engineering, where he supported the piloting and launch of new global products and provided technical support for the GMP manufacture of APIs on site. Shane is now part of Bristol Myers Squibb’s, Chemical process development (CPD) department and currently leads the BMS UK Moreton Chemistry group. The UK group work as part of a global matrixed team with their sister sites in New Brunswick and Summit, New Jersey to develop safe, innovative and sustainable chemical routes to APIs. In addition, Shane leads the Biocatalysis strategy for CPD. Full Speaker profile About the speaker Alissa is currently working as a Sustainability Lead at ten23 health and was previously an Environmental Sustainability Lead in the research department at Novartis. She is an executive member of ‘Go Circular in Life Sciences’ and a steering committee member for My Green Lab. She has a background as an environmental scientist, more specifically ecotoxicology. She pushes for collaborative action to address systemic issues. She is passionate about understanding and measuring environmental impact, and helping create tools and automated processes to help accelerate sustainable action. Full Speaker profile
15:00 - 16:00	Drinks Reception to Close BOS Manchester 2023 !