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

9:10 am - 9:30 am People Bingo: Interactive Speed Networking

A highlight of Pharma IQ events, now at the
Cell and Gene Therapy Manufacturing Forum. Be
ready to meet your peers and share best
practices. You will have several two minute
conversations so you can introduce yourself to
your peers and build your contact pool. There is
a prize in it for the winner so get networking.

Please Share:
1. Who you are
2. The scope of your job role
3. What you plan to achieve from attending this event
4. Your most important challenge

9:30 am - 10:05 am The UCL Translational Model And Its Impact On Developmental Partnerships Across The Pharma And Academic Spheres

Pamela Tranter - Head of Translational Research Group, UCL
- Hear how UCL has created a translational model to identify and drive stronger therapeutic development across the CGT industry
- Examine the impact of successful academic translation on industry development
- Discuss how the private sector can contribute to the efficient translation of academic developments
- Analyse how we can maximise the relationship between the academic and private sectors to facilitate the commercialisation of viable treatment candidates

Pamela Tranter

Head of Translational Research Group

10:05 am - 10:35 am Integrated CGT Manufacturing Planning

Joachim Lasoen - Head of Product, Bluecrux
Use case how we implemented integrated planning in a CGT plant:
- translating the CRM plan to an End-to-end sequence of CGT manufacturing/QA/QC activities,
- scheduling the different functions considering detailed competences and availabilities,
- capacity planning to support upscaling business decisions,
- optimise efficiency & release using visual management tools.

Joachim Lasoen

Head of Product

10:35 am - 11:10 am Ensuring Process Comparability And Effective Manufacturing Strategy Validation To Avoid Unexpected Surprises

- Discuss how Pluristem have incorporated process comparability requirements as part of their process development
- Debate the critical success factors to be considered in your manufacturing strategy validation to ensure that you are asking the right questions!
- Implement a flexible manufacturing strategy to ensure that your process can react to market demand and manufacturing pressures

11:10 am - 11:40 am Morning Coffee Break

11:40 am - 12:10 pm ATMP Manufacture: From Bench to Bedside

Matthew Cobb - Clinical Account Manager, Miltenyi Biotech
- Map the evolution of ATMPs within the pharmaceutical industry
- Examine the importance of strong research foundations
- Discuss the critical success factors for a smooth transition towards clinical environments

Matthew Cobb

Clinical Account Manager
Miltenyi Biotech

12:10 pm - 12:45 pm The Inspection Perspective: Understanding GMP Requirements Across Your Product Life Cycle

Kevin Page - Senior GMDP Inspector - Inspection, Enforcement and Standards, MHRA
- Analyse the current EU and MHRA perspective on GMP inspections
- Discuss strategies to prepare for inspections at all stages of your product life cycle in advance to avoid process disruption
- Examine key takeaways and lessons learned from a series of real life inspection case studies to ensure your site is prepared for the next inspection

Kevin Page

Senior GMDP Inspector - Inspection, Enforcement and Standards

12:45 pm - 1:20 pm From Stem Cells To GMP Products: Paving The Way For Clinical Applications

Elsa Abranches - Director, Stem Cell Bank and Lead, Stem Cell Biology, NIBSC - A Division of MHRA
- Examine the ramifications of 2017 EU guidelines for the compliant manufacture of ATMP-based products
- Analyse the impact of the 2018 implementation on current industry process and how these guidelines prepare for industry harmonisation
- Discuss whether these guidelines provide the clarity and guidance necessary for efficient standardisation of therapeutic development

Elsa Abranches

Director, Stem Cell Bank and Lead, Stem Cell Biology
NIBSC - A Division of MHRA

1:20 pm - 2:20 pm Networking Lunch

2:20 pm - 2:55 pm How To Apply A Risk-Based Approach To Effectively Manage Raw Material During CAR-T Clinical Development

Emilie Gauthy - Industrialization Manager, Celyad
- Examine the main challenges and opportunities regarding raw material selection for cell-based therapies
- Discuss the interest of applying risk-based approach to evaluate critical raw materials supply, quality and cost
- Pros and cons of implementing raw material changes early in your product development.

Emilie Gauthy

Industrialization Manager

2:55 pm - 3:30 pm Case Study: Stem Cell Raw Material Qualification At Novo Nordisk

Pernille Linnert Jensen - Development Scientist - Stem Cell Process Development, Novo Nordisk
- Examine the Novo Nordisk paradigm shift from API production raw material selection
- Analyse the balance of considerations between high level of quality versus achieving fast to FHD
- Discuss phase appropriate considerations and efforts to identify your critical success factors

Pernille Linnert Jensen

Development Scientist - Stem Cell Process Development
Novo Nordisk

3:30 pm - 4:00 pm Afternoon Coffee Break

4:00 pm - 4:35 pm The 4cs Of Process Planning: Building Your Manufacturing Process With Commercialization In Mind From Day One

- Examine how and why QbD can be applied to the cell and gene therapy industry
- Discuss the application and benefits of QbD in ATMP-based manufacturing processes
- Identify opportunities for process improvement and standardisation based on a QbD approach

4:35 pm - 5:50 pm Interactive Think Tank Focus Sessions

Use this opportunity to discuss with your peers the key topics disrupting the cell and gene manufacturing sector and brainstorm strategies to stay ahead of the game.
With a focus on looking beyond the HOW to address each problem, and focusing on the WHY we are even trying – these interactive discussion groups will give you a thorough grounding in the process development necessary to advance your solutions internally.
Each think-tank will last for 30 minutes with the opportunity to rotate to a second think-tank in the next session.

1. Managing The Development Of New Site Facilities: Technology, Scalability And Project Management Concerns
Facilitated by: Liam Whitnell, Engineering and Site Director, Site Lead, Johnson & Johnson

2. Ensuring Your Raw Material Selection Is Compliant And Cost Effective

3. Achieving GMP Compliance Without Breaking the Bank

4. Examining the Risks and Rise of APAC Markets For CGT Production

5. International standardisation efforts for accelerating the development and commercialisation of cell and gene therapy products

6. Preparing for transportation: Mitigating against temperature excursions to ensure product viability at the point of delivery

5:50 pm - 6:00 pm Chairman's Summary of Day One

6:00 pm - 8:00 pm COLLABORATION MIXER

In the spirit of enhancing collaboration between all stakeholders involved in the cell and gene therapy product development lifecycle, join us for a well-earned drink and informal networking to get to know your industry peers.