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.
Time | BOS Manchester Programme |
---|---|
08:45 - 10:00 |
Registration & Speedy Partnering (10 min Partnering) |
10:00 - 12:00 |
Outsourcing Process and Strategy Chair: Dr Joan Herbert, Executive Vice President, Business Development, Medicines for Malaria Venture |
10:00 - 10:30 |
Observations and Challenges in Global Registration of a New
Anti-Cancer Drug. |
10:30 - 11:00 |
Developing a Blueprint for Effective Data Management Between Sponsor and Vendor |
11:00 - 11:30 |
Process Development for the Manufacture of a Topical Pan-Trk Inhibitor Incorporating Decarboxylative Sp2-Sp3 Cross-Coupling. |
11:30 - 11:45 |
Solubility Enhancing Technologies for APIs |
11:45 - 12:00 |
An Integrated CMC Approach to Expedite Early Phase Drug Product Development |
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 |
14:00 - 14:30 |
Acceleration to Malaria Elimination - Developing Long-Acting Injectable Formulations for Chemoprevention |
14:30 - 15:00 |
Developing Mutually Productive Outsourcing Partnerships - Pharma View . |
15:00 - 15:15 |
Formulation and PK Integration: A Fast-Track to Drug Development Success |
15:15 - 15:30 |
Case Studies in Enabling Robust & Sustainable Cures to Life |
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 - 16:20 |
CMC Insights into the Development of a Personalised Neoantigen Peptide Cancer Vaccine |
16:20 - 16:40 |
Integrated Formulation Development & Manufacture of Complex Sterile Drug Product |
16:40 - 17:00 |
Expediting Drug Product Development in an SME Organisation |
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 |
Presentation Title to be Decided |
09:30 - 10:00 |
Early Chemical Development and Optimization of A Novel Macrocyclic PKC Theta Inhibitor |
10:00 - 10:30 |
Optimising the Outsourcing of a Oral Solid Dosage Form Programme – a Biotech Perspective. |
10:30 - 10:45 |
An Accelerator™ Drug Development Case Study: How Thermo Fisher aligns CRO and CDMO Activities to Meet an Urgent Clinical Milestone |
10:45 - 11:30 |
Coffee Break |
11:30 - 12:30 |
Outsourcing Case Studies Chair: Mr Duncan Judd, Director, Awridian Ltd |
11:30 - 11:50 |
Development of the First Sumatriptan Buccal Film: From Concept to Market Approval |
11:50 - 12:10 |
Feasibility of Developing Topical Formulation: Concept to Advanced Clinical Phase |
12:10 - 12:30 |
Building "Solid" Foundations: Drug Product and API polymorphism |
12:30 - 14:00 |
Lunch and Partnering |
14:00 - 15:00 |
Panel Session : Selecting The Optimal Outsourcing Model For Your Organisation Chair: Dr Joan Herbert, Executive Vice President, Business Development, Medicines for Malaria Venture Miss Shilpi Ghosh, CDMO Chapter Lead, Roche 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 About the speakersAbout the speakerShilpi Ghosh is an External Manufacturing (CDMO) Chapter Lead within Roche Pharmaceuticals. In this capacity Shilpi manages a portfolio of Roches External Manufacturers with her Team and is also responsible for establishing strategic External Manufacturing Relationships. About the speakerFor 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. About the speakerA growth-oriented and dedicated procurement leader with 15+ years of experience in transforming procurement operations. About the speakerWe 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. |