Conference Day 1
8:30 am - 8:55 am Registration and Welcome Coffee
8:55 am - 9:00 am PharmaIQ Welcome
9:00 am - 9:10 am Chairman's Opening Address
9:00 am - 9:40 am Opening Keynote: Manufacturing Cell and Gene Therapy Products: Looking at the Potential and the Reality
Professor Brendon Noble - CSO & Director of Strategy, UK Stem Cell Foundation, The Royal Institution of Great Britain- Analyse the industry development trends of the past 6-12months; where the industry is now and what are the biggest barriers to further development?
- Discuss the importance of ‘Flexible’ and ‘Scalable’ Manufacturing processes – why do you need to worry about this now?
- Move to Market – Identify industry developments in cost efficiency of manufacturing
Professor Brendon Noble
CSO & Director of StrategyUK Stem Cell Foundation, The Royal Institution of Great Britain
9:50 am - 10:20 am Panel Discussion: Industry Challenges Deep Dive
Mark Woodyer - Technical Lead, Manufacturing Sciences & Technology, Oxford BiomedicaFatma Senkesen - Head of Market Insights - Cell & Gene Therapy, Lonza
Omar Ali - Visiting Lecturer Value Based Pricing and Former Advisor, University of Portsmouth and NICE
David Sourdive - Executive Vice President Technical Operations, Cellectis
Katy Spink - COO and Managing Partner, Dark Horse Consulting
Stephen Ward - Chief Manufacturing Officer, Cell and Gene Thearpy Catapult
- Discuss the realities of Cell and Gene Development, and the challenges our industry is currently facing, with valuable insights and feedback from our industry experts. Discussions will cover the realities of commercialising novel therapies without an established model, the challenges of scaling product development when working with such fragile and changeable materials and the difficulty in anticipating industry development and demand without established case studies as a basis.
Omar Ali
Visiting Lecturer Value Based Pricing and Former AdvisorUniversity of Portsmouth and NICE
10:20 am - 11:00 am Industrial Purification Platform of Adeno Associated Virus
Ales Strancar - Managing Director, BIA Separations- Discuss why adeno associated virus (AAV) is the leading vector of choice in the field of gene therapy.
- Analyse the effects of shear and concentration methods in promoting stable associations between virus’, DNA and proteins
- Examine the benefit of monolithic purification in increasing the speed of product capture, flow rates and column loading
- Highlight an exclusively monolithic purification platform that includes three chromatographic steps and is fully scalable and effective for all AAV serotypes evaluated to date
11:00 am - 11:30 am Morning Coffee Break
11:30 am - 12:05 pm Manufacturing At Scale, Requires More Than Just The Process
Stephen Ward - Chief Manufacturing Officer, Cell and Gene Thearpy Catapult· Fluid path challenges at scale
· Automation and QC challenges for a more integrated product release future
· Large systems development and the value of scalable test beds
12:05 pm - 1:05 pm Can we Afford a Cure? Payers Perspective on Drug Leasing & Innovative Reimbursement for Curative Medicines
Omar Ali - Visiting Lecturer Value Based Pricing and Former Advisor, University of Portsmouth and NICE- Analyse a fiscal overview of global healthcare payer landscape & medicines
- Discuss the difficulty of valuing innovation from a reimbursement perspective
- Utilise real world data to secure payer approval in conditional reimbursement models and the cancer drugs fund
- Examine the ground breaking drug leasing concept for CAR-T curative therapies – with reference to the original publication with Guy’s & St.Thomas Hospital
Omar Ali
Visiting Lecturer Value Based Pricing and Former AdvisorUniversity of Portsmouth and NICE
1:05 pm - 2:05 pm Networking Lunch
2:05 pm - 2:50 pm Interactive Round Tables
Choose from 3 different round table discussions to participate in and exchange industry best practice to drive your development forward
Round Table 1: Open and Closed System Processing – Same problem, new solutions!
Round Table 2: Identifying a Risk Based Strategy for Commercialising Cell and Gene Therapy Products
Round Table 3: Defining the Critical Quality Attributes for your Products
Round Table 4: Analysing the Global Regulatory Landscape you Need to Navigate on the Route to Market
2:50 pm - 3:25 pm Case Study: Rapid Development of a Scalable Process for a Neural Stem Cell Therapy
William Newell - Process Development Engineer, ReNeuron- Define the Critical Success Factors for stem cell production viability
- Reduce the risk of shortfall by proactively managing your production strategy to allow for the move towards off-the shelf models
- Future proof your development by discussing the application of QbD metrics as a means of defining your development pathway
3:25 pm - 4:00 pm Process Development Goes Viral
Eugenio Macchiarulo - Vector Development Associate Director, Adaptimmune Ltd- Discuss the importance of a good strategy to develop a viral vector process
- Evaluate the impact of GMP requirements on viral vector development
- Analyse the effect of access to multiple plans to supply GMP vector
4:00 pm - 4:30 pm Afternoon Coffee Break
4:30 pm - 5:05 pm Case Study: Ensuring Viable and Precise Production of Autologous TCR-T Cells
Arjan Roozen - CTO and Head of Manufacturing, Zelluna Immunotherapy- Discuss the challenges of scaling Autologous Cell Production with reference to viability and precision of treatment
- Analyse specialised manufacturing techniques to enhance natural production
- Cost vs Gain: looking at the reality of implementing new technology when demand is hard to forecast
5:05 pm - 5:40 pm Implementing Process Change and Comparability for Autologous Product Production
Nina Kotsopoulou - Head, Process Development, Autolus- Analyse the unique challenges presented by the CGT space with specific reference to CAR T Therapies
- Avoid the common manufacturing pain-points by identifying your manufacturing bottlenecks
- Prevent costly back-tracking by implementing a flexible process design to cope with unexpected situations
