Cell & Gene Therapies The logistics of providing life saving, industry changing treatments

Transcription

1 Cell & Gene Therapies The logistics of providing life saving, industry changing treatments PharmaInsight Briefings CPhI Europe Frankfurt, 25 th September 20187

2 Cell and Gene Therapy History Cell Therapy: originated in the 1950s (blood transfusions) Gene Therapy: conceptualized in the 1970s. Patient research began in the 1990s 16/11/2016 CONFIDENTIAL

3 Cell and gene therapies are biopharma products that utilize living cells and/ or genetic material to fight diseases 16/11/2016 CONFIDENTIAL

4 Current Cell & Gene Therapy Activity Sample of Current Cell & Gene Therapy Customer Locations +55% +55% Active Gene Therapy +45% +45% Active Cell Therapy 16/11/2016 CONFIDENTIAL

5 So, What s the big deal? 1 in 3 people will develop some form of cancer during their lifetime 1,500+ diseases are caused by a single defective gene EU approved first gene therapy treatment 90% Gene-based clinical trials have increased by almost 90% since 2009 By 2020, the global regenerative market is expected to reach over $67 billion 1. "Lifetime Risk of Developing or Dying From Cancer." Lifetime Risk of Developing or Dying From Cancer. American Cancer Society, 23 Mar Web. 04 May < 2. McCain, Jack. "The Future of Gene Therapy." Biotechnology Healthcare. BioCommunications LLC, n.d. Web. 04 May < 3. Moran, Nuala. "Glybera Gains Official EMA Nod as First Gene Therapy."BioWorld. N.p., Web. 04 May < 4. "Gene Therapy Clinical Trials Worldwide." Gene Therapy Clinical Trials Worldwide. John Wiley and Sons Ltd, Web. 04 May < 5. "MarketResearchReports.Com: Global Regenerative Medicine Market Is Expected to Reach $67.6 Billion by 2020, Reveals New Report." - Press Release. N.p., Web. 05 May < 5

6 Why this business is important to World Courier Clinical supply chain virtually same as commercial supply chain Unique requirements suited for specialty courier service Competitive landscape 16/11/2016 CONFIDENTIAL

7 How hard can it be? Complex criteria requirements include: Strict temperature ranges and qualification of transportation systems Extremely tight turnaround timelines typically 18 to 36 hours Short Lead Times, Collections and deliveries 24/7, weekends and holidays Unique logistics limitations such as inability to x-ray Cross border shipment challenges and regulations 7

8 Cell Therapy and the Circular Supply Chain 16/11/2016 CONFIDENTIAL

9 Types of shipment in the circular supply chain Apheresis samples: High importance, lifespan, temp control Finished product: Frozen (LN2 or dry ice) Tumor samples: Sent to a lab for storage, analysis QC samples: Sent to a lab for analysis 16/11/2016 CONFIDENTIAL

10 Important Service Factors Tight transit time requirements Chain of Custody Communication / Visibility Packaging 16/11/2016 CONFIDENTIAL

11 What could possibly go wrong? 11

12 How important is your shipment? 12

13 The World Courier Way Study Specific SOPs Training AT All Levels Technical & Quality SLAs Airline Buy In and Understanding Certificated Airports, Hand Searches Transport Plan Recommended airports and airlines use data including hours of operation, lockout and recovery and performance for analysis Latest pick up times Best transport mode

14 Cell Therapy Clinical Trial: Phase II months 245 shipments 63 patients 39 destination sites 2,066.4 KGs of materials transported 1 FDA fast track designation 14

15 39 Destinations. 24 Hours. 15

16 Packaging Preparation Transport System Shipping at 2 to 8 degrees Celsius (GTC size 4) Liquid nitrogen dry vapor shipper Vacuum insulated panel boxes with PCM Qualification Months of challenging packaging TiltWatch monitor stickers 80 percent of shippers pre-charged with liquid nitrogen by client 16

17 Plan, Anticipate, Manage, Repeat Study-specific SOPs Customer SOPs Quality Agreement Technical Agreement/Annex to Quality Agreement Training at 16 investigational sites Shipping manuals Weekly client teleconference calls, 5 minutes to 1 hour I am convinced World Courier is the best option in terms of temperature controlled transports over different borders. 17

18 Air Time, In Time Transport challenges and solutions: Non X-ray/Customs - Hand carry authorizations Short close out times - small/responsive regional airports vs. global hubs Import Regulations for Thermo Boxes. Russia and Ukraine -.e.g ensuring temporary imports to Russia and Ukraine World Courier did a great job reviewing all the airports that we needed for trial, checking the routing and X-ray exemption status. 18

19 Making a World of Difference Consultation Training Knowledge sharing Status communication Practical problem solving 19

20 World Courier = Peace of Mind

21 Contact me: Martin Pohle Branch Manager World Courier (Deutschland) GmbH An AmerisourceBergen Company