Optimizing Drug Management: Leveraging Technology for Enhanced Supply Chain Efficiency

1. Utilization of Drug Pooling to Optimize Complex Drug Management Kevin Collier, Sr. Director Product, Rave RTSM kcollier@medidata.com Blair Grimes, Manager Supply Chain, Dermavant blair.grimes@dermavant.com

2. Agenda • Trends of interest • What is drug pooling? • Benefits of pooling? • How can technology help overcome opposition? • Case Studies • Summary of Benefits

3. Broader Trends in Clinical Studies Cost of bringing new drugs to market continues to increase • Companies continue to search for efficiency gains in all aspects of R&D • Timelines continue to be a challenge and Sponsors are looking for ways to shorten these • Reduce Costs; Maintain Quality! • Truly global studies are growing in scope and breadth • Study complexity increasing (combining phases, planned changes) • Logistics are becoming more complex • Increasingly focused on biologics • Expensive to manufacture • Often limited in supply • Oncology is predominant therapeutic area; higher failure rates, (especially in Ph3) • Increase interest to better plan clinical supply needs through forecasting, improved utilization, more efficient supply chain

4. Study 1 Study 2 Study 3 What is “pooled supplies?” Depot 1 Depot 2 Depot 3 Lot 1 Lot 2 Lot 3 Sharing the same lot across multiple trials Site 1 Site 2 Site 3 Depot 2 Non-Sharing Study Supplies are associated to a trial at the time a packlist is uploaded Site Pooled Group Supplies are associated to a trial at time of dispensation Sites Subjects 15 Non-sharing study Depot Pooled Group Site 1 Subj 1 Depot 1 Study 1 Study 2 Study 3 Depot 1 Study 1 Study 2 Study 3 Site 2 Subj 2 Depot Pooled Group Supplies are associated to a trial at time of shipping Lot 1 Lot 1 Site 3 Subj 3 Site Pooled Group Site 1

5. Benefits of Pooling 4 trials in a program Manufacture 1000 kits for each trial Total manufactured (4x1000 = 4000) Wasted kits (30% x 4) = 1200 Average Supply overage in studies today ~30% per trial Program with pooling Program without pooling If running simultaneously: • Forecasted need = 2800 kits • Spread supply buffer across all trials • 3700 manufactured (2800 + 30% = 3640) • 300 less kits and reduction in waste If running concurrently: • 1000 manufactured for first trial • Roll over 300 left-over, etc…

6. Let’s look at technology in action!

7. Remove Technology as a Barrier Technology can help foster adoption Operational and Regulatory Oppositions New Technology Paradigm • Foreknowledge of trials • Cost and effort of pooling systems • Drug Accountability • Labeling (US vs ex-US) • Ability to map sites across trials • Lack of transparency to inventory levels • Un-numbered supplies work around? • Pooling benefits determined after trial/program start • Configurable solution instead of customized • Site’s drug accountability activities are transparent across trials • Share at the lot level rather than the study level • Inventory transparency in system and through robust reporting • Platform allows for program and portfolio level metadata

8. Logistical Challenges and Solutions Technology can help mitigate challenges Solution via Pooling at Site Challenges Burden for the site • Receive multiple shipments of drug into different databases Burden for depots • Pick, pack and ship multiple shipments all going to same destination Burden for sponsor • Pay for multiple shipments instead of one: increase drug overage for each database: increase in drug waste? Solution for the site • Receive one shipment Solution for depot • Pick, pack and ship one combined shipment to the site Solution for sponsor • Run multiple indication databases with less inventory • Decrease costs by sharing supplies across studies and sites 8

9. Case Study: Mid-sized biotech with innovative immuno-oncology treatment Challenges Clinical Strategy • Early stages of development, not sure what indications benefit the most • Needs to simultaneously investigate 5 tumor types • Treatment schedules varied • Data collection varied • Large molecule: scarce and expensive to manufacture • Sites included many ‘megacenters’ enrolling across multiple patient groups • Part I dose finding escalation • Part II investigation of multiple tumor types at MTD • Many unknowns and changes occurring throughout the life of the study • Execute in manner that preserved the science while optimizing the timeline and budget The best approach from a scientific perspective brought operational challenges • How to handle tumor specific changes and addition of cohorts in the quickest fashion? • Multiple databases being used simultaneously at the sites to study the same treatment - inherently inefficient from a supply perspective 9

10. Case Study Outcomes: Pooled Supplies Mid-sized biotech with innovative immuno-oncology treatment Agile constantly changing trial design and stable supply management • Sponsor estimates 39% less package waste and a 34% reduction in shipping costs by applying the pooling strategy • Achieved without making compromises to the (complicated) study design and clinical objectives dose finding escalation • Study is ongoing and operating smoothly. 10

11. Here is another Sponsor perspective Blair Grimes Manager Supply Chain, Dermavant blair.grimes@dermavant.com

12. Study Details: • 2x Identical Phase III Studies rolling into a single long-term extension study • Psoriasis • Topical Formulation • US and Canada • Single Label across all 3 studies Dermavant Use Case Pooled supplies allows for a single label Phase III Study: Protocol #1 Long-Term Extension: Protocol #3 Phase III Study: Protocol #2 Pooling all supplies for two identical Phase III studies and a long-term extension allows for a single label

13. Unique Challenges for Topical Formulation • Study drug estimates are based on average Body Surface Area Percentages (BSA%) • Number of tubes must be rounded-up to nearest full tube • Overages are applied based on a high BSA% and full tubes Disease Severity Determination for BSA% Study Overages Average Tubes per Patient per week: 1.3 Tubes Individual Study Overages Minimum 3 Studies Maximum Study Drug Calculation (tube per patient per week): 2 Tubes

14. Why Drug Pooling with Medidata’s RTSM? Benefits Impact • No need for separate supplies for each study • No need to re-seed sites for the extension study • Easier to manage supply with a single source of drug supply across all studies • Flexibility to move IP from one study to another without re-labeling if there is a need in the future (non-enrolling sites, over supplied sites) • Hope to gain back rounding errors and reduce total amount of tubes required to supply the study • Expect to reduce the need for final packaging run/ manufacture addition drug product batch • Expected Cost Savings from reduced packaging runs (reduced number of batch records and total number of kits) • Expected Cost Savings with reduced shipments • Reduce study overage requirements (hoping to apply to future studies to reduce upfront manufacturing) 14

15. What is Dermavant looking to achieve? • Make the best use of the supply • Achieve maximum flexibility with current inventory • Reduce study drug overages • Reduce cost of packaging and labeling

16. Summary Let’s move Drug Pooling from a concept to a substantive usage rate • There are added challenges yet inherent value to pooling the supplies – especially as IP becomes more expensive and innovative approaches are applied to trial design. • Advancements in IRT/RTSM technology can reduce operational complexities, allowing sponsors to realize the value of implementing pooling strategies. Challenge to audience: • Shift from tactical/incremental improvements - Push boundaries and bring strategic innovation to trial supply management. 16

17. Questions? For more information: Kevin Collier, Sr. Director Product, Rave RTSM kcollier@medidata.com Blair Grimes, Manager Supply Chain, Dermavant blair.grimes@dermavant.com

18. Thank you

19. Sources Clinical Development Success Rates 2006-2015 Tufts Center for Study of Drug Development Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B