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7:00am - 7:55am

Registration

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Showing of Streams
9:30am - 10:15am

Morning Coffee & Networking

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Showing of Streams
12:15pm - 1:30pm

Networking Luncheon in the Poster & Exhibition Hall

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Showing of Streams
3:00pm - 3:10pm

Chairperson's Closing Remarks

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3:10pm - 3:15pm
End of Conference

End of Conference

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7:00am - 7:55am 55 mins
Registration
7:55am - 8:00am 5 mins
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Chairperson's Opening Remarks
7:55am - 8:00am 5 mins
Cell and Gene Therapy Connect – Partnering Track
Chairperson's Opening Remarks
8:00am - 8:30am 30 mins
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Successful delivery to the patient– quality perspectives on manufacturability & the supply chain
8:00am - 8:45am 45 mins
Info
Cell and Gene Therapy Connect – Partnering Track
Evolving landscape of cell and gene therapies, a year in review

With the industry moving at an incredible rate, changes are frequent, and updates happen daily. 2018 and the first half of 2019 have brought both exciting news as well as challenges. Points to be discussed on this panel include (but are not limited to):

-Policy environment 2019
-Sector Technology 2019
-Clinical progress H1 2019
-Anticipated clinical data events 2019-2020
-Looking ahead: 2019 and beyond

8:30am - 9:00am 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Understanding customer needs: Surgeons, patients, payers and more

-What supply chain considerations need to be made when looking at all the key stakeholders in the supply chain?
-How do you best serve all your ‘customers’?

8:45am - 9:30am 45 mins
Info
Cell and Gene Therapy Connect – Partnering Track
Partnership and collaboration: Can more collaboration solve a multitude of problems?
  • Timothy Herpin - Chief Business Officer, Caribou Biosciences
  • Traditional models for development, R&D, manufacturing and commercialization may not produce the best results in the ever-evolving world of cell and gene therapies. Can collaboration between companies, academic institutions, patient advocacy groups and public (government and non-profit) organisations help solve the problem?
9:00am - 9:30am 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Spotlight Presentation

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Kristin Skahan; Email: kristin.skahan@knect365.com

 

9:30am - 10:15am 45 mins
Morning Coffee & Networking
10:15am - 10:45am 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Supply chain scale up – Working hand in hand with chain of compliance

-How does chain of compliance look in a commercial environment?
-Treatment centres and education
-How do you ensure a robust process?
-Electronic systems and feedback loops

10:15am - 11:15am 60 mins
Info
Cell and Gene Therapy Connect – Partnering Track
CMO landscapes for new product initiatives: Novel outsourcing models
  • Moderator Amanda Micklus - Principal Analyst, Datamonitor Healthcare
  • Panellist Wouter Van t’Hof - Cord Blood Bank Director, Cleveland Cord Blood Centre, USA
  • When looking forward to the successful manufacture and commercialization of cell and gene therapies, there is the age-old debate of what model is best when it comes to success. This panel will discuss what the most cost-effective models are, and how target therapeutic companies can form meaningful and engaging partnerships with CMO’s to produce commercial grade products.
10:45am - 11:15am 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Avoiding even more bottlenecks – strategies for apheresis
  • How are companies currently handling apheresis
  • Is everyone using apheresis, or do some use large blood draws?
  • What is the best strategy?
  • Possible centralised auditing systems?
11:15am - 11:45am 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Discussion panel: Supply chain automation – what and where can we automate?

Looking for 3- 5 panellists from suppliers and also manufacturers to discuss:

-When/how are manufacturers automating supply chain
-How early on in manufacturing does this need to be considered to avoid bottlenecks?
-What should be automated: storage, packaging, labelling, distribution?
-How can automation make supply chain a more cost-effective process?

11:15am - 12:15pm 60 mins
Info
Cell and Gene Therapy Connect – Partnering Track
When to make the decision to ‘spin out’?
  • It is common place to see emerging biotech’s spinning off from academic centres; and these academic centres harness a lot of exciting technology. This panel will address the issues surrounding how best to ‘spin out’. When is the right time? What are the expectations? And how best to tech transfer? How can these exciting new technologies leverage the experience of the larger more established players? And most importantly how and when to protect IP.
11:45am - 12:15pm 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Spotlight Presentation

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Kristin Skahan; Email: kristin.skahan@knect365.com

12:15pm - 1:30pm 75 mins
Networking Luncheon in the Poster & Exhibition Hall
1:30pm - 2:00pm 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Developing platforms to fulfil final fill operation needs

-How are companies meeting the needs for fill finish?
-What materials are being used?
-What do manufacturers need from suppliers to help them

1:30pm - 2:15pm 45 mins
Info
Cell and Gene Therapy Connect – Partnering Track
Pharmacoeconomic approaches to reimbursement
  • With the majority of cell and gene therapies being prices at hundreds of thousands of dollars per year, Pharmacoeconomics provides measures to help understand what acceptable and unacceptable drug price will be; cost benefit, cost effectiveness and cost utility. This panel will address what stage these should be taken into consideration as well as providing feedback on creative payment models
2:00pm - 2:30pm 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Best practise in establishing supply chain procedures in line with product shelf life

-Case study on best practise for establishing a supply chain that would enable you to get the product to the patient within the shelf life constraints (48hrs etc).

2:15pm - 3:00pm 45 mins
Info
Cell and Gene Therapy Connect – Partnering Track
Next generation therapies
  • Panellist David Smith - Chief Commercial Officer, Healios
  • Panellist Felicia Pagliuca - VP Cell Biology R&D, Semma Therapeuticsa
  • With all the exciting clinical results and new candidates rising up through product pipelines, CAR-T, gene therapies and CRISPR are seeing real advancements. What are some of the new advances in the field? And what will the ‘next generation’ or ‘CART 3.0’ therapies be?
2:30pm - 3:00pm 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Best practice for managing particulates and visible inspections

-Particulate issues with regards to large scale production
-Guidelines/regulatory expectations
-Filter capabilities
-Risk assessment approaches
-How does this link into COGs?

3:00pm - 3:10pm 10 mins
Chairperson's Closing Remarks
3:10pm - 3:15pm 5 mins
End of Conference