13 - 15 November, 2018 | Hilton London Kensington, London, United Kingdom

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

  • 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

9:50 am - 10:20 am Panel Discussion: Industry Challenges Deep Dive

  • 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.

10:20 am - 11:00 am Industrial Purification Platform of Adeno Associated Virus

  • 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 - 12:10 pm Can we Afford a Cure? Payers Perspective on Drug Leasing & Innovative Reimbursement for Curative Medicines

  • 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

12:10 pm - 12:45 pm Panel Discussion: Understanding the Global Regulatory Climate for CGT Production

  • Discuss the current European and US regulatory landscape, and the key differences for manufacturers to be aware of.
  • Harmonisation – fact or fiction? Look at the European requirements post 2008, assessing where they fall short of industry requirements and demand
  • Plan for the future by predicting further guidelines to emerge and how this will challenge ‘being GMP compliant’
  • The Brexit effect! Discuss how the political landscape and changes such as Brexit will alter the GMP requirements

12:45 pm - 1:45 pm Networking Lunch

1:45 pm - 2:25 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

2:25 pm - 3:05 pm Case Study: The Balancing Act: Quality Assurance and Scalability for Efficient CAR T Production

  • 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

3:05 pm - 3:45 pm Process Development Goes Viral

  • 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

3:45 pm - 4:15 pm Afternoon Coffee Break

4:15 pm - 4:55 pm Case Study: Ensuring Viable and Precise Production of Autologous TCR-T Cells

  • 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

4:55 pm - 5:35 pm Implementing Process Change and Comparability for Autologous Product Production

  • 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

5:35 pm - 5:45 pm Chairman's Summary of Day One