DSCSA and Blockchain Study Exploring the use of blockchain technology within Healthcare 9/30/2016
The Purpose of this Study There has been much discussion regarding the use of blockchain technology within healthcare. HDA will have a session in their November Traceability Seminar ONC recently had a Blockchain and Its Emerging Role in Healthcare and Health-related Research whitepaper challenge numerous blogs have asked the question of whether blockchain could address some of the Internet of Medical Things (IOMT) security issues. Speculation on whether it could be applied to the Drug Supply Chain Security Act (DSCSA) needs This study will: 1. Seek to understand blockchain technology in context of the DSCSA law 2. Create ReferenceModels or simulations that demonstrate blockchain's use 3. Examine various funding models 4. Define future phases that may extend the exploration of blockchain for: Exchange of regulatory documents Clinical Trials Medical Devices 2
Today s Speakers Darryl Glover, Pharm.D, MBA is a Principal and Chief Clinical Officer (CCO) of isolve. As CCO, Darryl creates the connections between the advantages of Advanced Digital Ledger Technology and the needs of the Biopharma and Healthcare Industries. He has been a frontline provider, manager, and worked internationally in marketing and served as COO and CEO. He has co-founded and served as COO for two tech startups focused on healthcare and general recruiting. Darryl has authored or co-authored 10 publications and published a children s book. Bob Celeste Is the Founder of the Center for Supply Chain Studies. Bob s has in-depth knowledge of and experience in the healthcare supply chain, including current standards and technologies. His ability to harness this expertise to innovate around complex challenges has made him a trusted partner to industry in its ongoing efforts to implement track & trace, serialization and regulations. As he has done for over 20 years, Bob continues to implement strategic simulation processes to address the industry s ever-growing challenges and demands that face all stakeholders in the supply chain. Prior to founding the Center, Mr. Celeste was Senior Director at GS1 US where he lead the industry to develop the pharma supply chain guideline for DSCSA. 3
Antitrust Statement The Center for Supply Chain Studies (the Center) is nonprofit organization that serves as a forum for free and open discussion of diverse opinions without in any way attempting to encourage or sanction any particular business practice. During the course of any Center activity, discussions involving pricing, sales terms, territories, production or other aspects of competition, must be avoided. In the event any person feels that statements or actions in meetings are headed into such an area, attendees should raise the issue immediately so that further discussion of such matters can be suspended pending receipt advice satisfactory that questionable topics do not give rise to antitrust problems. The Center recognizes the severity of the potential penalties that might be imposed in the event that certain conduct is found to violate the antitrust laws. Should the Center or its cooperative participants be involved in any violation of federal/state antitrust laws, such violation may involve both civil and criminal penalties that may include imprisonment, as well as fines and/or attorney fees. This policy statement unequivocally supports the policy of competition served by the antitrust laws. Given this, the Center intends to take all necessary and proper measures to ensure that violations of the antitrust laws do not occur. 4
NonProfit Serves Industry: Exploration, ReferenceModel Library and Education 5
2016 2017 Studies 6
How a Study is initiated Study Proposal Prospectus/Charter Pre-Launch Study Publish Draft Goals and definition Goals, Metrics and Scenarios Detailed Goals, metrics and Scenarios Final Scope Publish ReferenceModels White Paper RoadMap Socialize With Community Agreement Anti-Trust Funding Develop /execute Scenarios Education Module 7
Agenda Welcome and Intro of speakers Blockchain discussion DSCSA Discussion Why the interest in Blockchain for DSCSA? The Study Next steps 8
Today s Speakers Darryl Glover, Pharm.D, MBA is a Principal and Chief Clinical Officer (CCO) of isolve. As CCO, Darryl creates the connections between the advantages of Advanced Digital Ledger Technology and the needs of the Biopharma and Healthcare Industries. He has been a frontline provider, manager, and worked internationally in marketing and served as COO and CEO. He has co-founded and served as COO for two tech startups focused on healthcare and general recruiting. Darryl has authored or co-authored 10 publications and published a children s book. Bob Celeste Is the Founder of the Center for Supply Chain Studies. Bob s has in-depth knowledge of and experience in the healthcare supply chain, including current standards and technologies. His ability to harness this expertise to innovate around complex challenges has made him a trusted partner to industry in its ongoing efforts to implement track & trace, serialization and regulations. As he has done for over 20 years, Bob continues to implement strategic simulation processes to address the industry s ever-growing challenges and demands that face all stakeholders in the supply chain. Prior to founding the Center, Mr. Celeste was Senior Director at GS1 US where he lead the industry to develop the pharma supply chain guideline for DSCSA. 9
Agenda Welcome and Intro of speakers Blockchain discussion DSCSA Discussion Why the interest in Blockchain for DSCSA? The Study Next steps 10
Advanced Digital Ledger Technology The Bridge to Innovation
History of ADLT ERA Year Cryptography 1945 Public/Private Keys 1970 Bitcoin Blockchain Jan 2009 Applications: Digital Currencies, Financial Services, Provenance 2009-2014 ADLT /Blockchain 2.0 April 2014 Ethereum/MultiChain July 2015 to Date Smart Contracts, DAOs
What is ADLT? ADLT provides a Secure and Distributed solution, that integrates with legacy systems and allows information to be controlled and passed in a bidirectional manner from Manufacturer to Consumer to better understand Consumer Behavior, Inventory and Product Traceability.
What is Centralized vs Distributed? Most systems utilize a Centralized Client Server Model requiring participants to trust the server as the single source of truth. ADLT is based on a Decentralized and Distributed Model allowing information to be secure but transparent to other trusted participants without a single point of failure or a single source of truth. All participants maintain a local copy of the ADLT working from the same source to validate the legitimacy of the data. The fully transparent data is available for viewing to any one in the network on a Need To See Basis.
What are the Benefits? Auditable, Traceable, Transparent Decentralized System that can be deployed globally Integrates with Legacy Systems and Smart Devices (IoMT) Incentive Models for Patients and Manufactures Directly provides information on Compliance, Outcomes and Drug Utilization Provides Real-time Phase IV Data Gathers a wide range of patient information to detect unmet needs and help direct pharma s research efforts
The Essence of ADLT /Blockchain Technology Immutable, Transparent, & Auditable Ledger Secure method to Transfer Data between trusted partners Creates bidirectional communication and visibility across the supply chain Data becomes an asset under the Organizations Control
Agenda Welcome and Intro of speakers Blockchain discussion DSCSA Discussion Why the interest in Blockchain for DSCSA? The Study Next steps 17
DSCSA Time Line Wholesalers Cannot purchase medicines unless TI, TH,TS are provided Jan 1 Manufacturers Pass "TI, TH, TS" at Lot level Jan 1 Dispenser Receives DSCSA "TI, TH, TS" May 1 Manufacturers Provide GTIN (NDC), Serial No, Lot No and Exp Date in 2D Barcode on Medicines Nov 27 Whosalers can only purchase Serialized Medicines Nov 27 Dispensers must receive TI, TS and retrieve past TI's electronicall y Nov 27 Whosalers must receive and pass TI, TS electronicall y Nov 27 Manufactur ers Provide (TI, TS) at Item Level Nov 27 2015 2015 2016 2017 2018 2019 2020 2021 2022 2023 2023 Today 18
DSCSA Discussion Effective November 2023, the DSCSA law reads: ``(E) The systems and processes necessary to promptly facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer, as applicable, shall be required-- ``(i) in the event of a request by the Secretary (or other appropriate Federal or State official), on account of a recall or for the purposes of investigating a suspect product or an illegitimate product; or ``(ii) in the event of a request by an authorized trading partner, in a secure manner that ensures the protection of confidential commercial information and trade secrets, for purposes of investigating a suspect product or assisting the Secretary (or other appropriate Federal or State official) with a request described in clause (i). Still some debate in the industry as to exactly what this means. Manufacturer TI 1 TI 2 TI 3 TI 1 1 st Wholesaler 2 nd Wholesaler Hospital TI 2 TI 3 FDA, DEA, State BoP 19
DSCSA Discussion Effective November 2023, the DSCSA law requires that, trading partners share information (called Transaction Information, or TI ) regarding the exchange of pharmaceutical products. Upon request of an authorized body (FDA, State Board of Pharmacy, DEA, etc.) a trading partner must produce the immediate TI as well as collect and produce all TI data going back to the drug manufacturer or repackager (via an electronic, interoperable system). Manufacturer TI 1 TI 2 TI 3 TI 1 1 st Wholesaler 2 nd Wholesaler Hospital TI 2 TI 3 FDA, DEA, State BoP 20
DSCSA Discussion The Challenge Trading Partners may not have the means to collect the previous TIs (ex: Hospital #2 must collect TI 1, TI 2, TI 3 ). Each supply chain participant may not have pre-established an electronic connection with all previous participants in the supply chain leading back to the drug manufacturer or repackager. The current prevailing solution within the industry is to use a large database or system of databases to provide a single connection point for all trading partners in the supply chain. This would provide a single point of entry, unfortunately, it also potentially creates a single point for attack as well as a series of complicated data governance issues to be resolved. In order for a supply chain participant to provide the TI n information to another company, they first must be assured that the asking party: Is a legitimate (valid licensed) trading partner in the Supply Chain actually possess, or have had possessed the drug package in question. Manufacturer TI 1 TI 2 TI 3 TI 1 1 st Wholesaler 2 nd Wholesaler Hospital TI 2 TI 3 FDA, DEA, State BoP 21
DSCSA Discussion Some Options Discovery Service Manufactur er TI 1 1 st TI 2 2 nd TI 3 TI 1 Wholesaler Wholesaler Hospital TI 2 TI 3 FDA, DEA, State BoP Checking Service Manufactur er TI 1 1 st TI 2 2 nd TI 3 TI 1 Wholesaler Wholesaler Hospital TI 2 TI 3 FDA, DEA, State BoP 22
DSCSA Discussion Some Options Blockchain? Manufactur er TI 1 1 st TI 2 2 nd TI 3 TI 1 Wholesaler Wholesaler Hospital TI 2 TI 3 FDA, DEA, State BoP 23
Agenda Welcome and Intro of speakers Blockchain discussion DSCSA Discussion Why the interest in Blockchain for DSCSA? The Study Next steps 24
Why the interest in Blockchain We need help: Establishing trust Verifying parties in the transaction With clearing and settlement of transactions With recordkeeping We traditionally turn to middlemen or intermediaries: Discovery Service Checking Service ONS 25
Why the interest in Blockchain Centralized entities are vulnerable to: Hacking, Attack, Failure They also: Tax the system (who pays for it?) Exclude certain # of people from using the service (can t afford it) May slow things down 26
Why the interest in Blockchain? Trust is established by: Mass collaboration Clever Code and Cryptography 27
Why the interest in Blockchain? Advantages Two or more parties need not know or trust one another to transact or do business Interesting for DSCSA use Interesting for future uses Clinical Trial information Regulatory Documents 28
Agenda Welcome and Intro of speakers Blockchain discussion DSCSA Discussion Why the interest in Blockchain for DSCSA? The Study Next steps 29
How a Study is initiated Study Proposal Prospectus/Charter Pre-Launch Study Publish Draft Goals and definition Goals, Metrics and Scenarios Detailed Goals, metrics and Scenarios Final Scope Publish ReferenceModels White Paper RoadMap Socialize With Community Agreement Anti-Trust Funding Develop /execute Scenarios Education Module 30
How we will work together 1. Stakeholder Questionaires and Calls 2. Weekly Calls 1. Bi-Weekly Reviews of ReferenceModels 2. Running the ReferenceModules 1. Stakeholder input Parameters 2. Group agreed input Parameters 3. Results comparisons 31
Respecting Your Time Reduce the number of technical calls: Individual calls with SPs to develop a number of Product, Entity/Location, and DSCSA data scenarios to plug into the Study Scenarios. Spend more time running the ReferenceModels. Weekly Agendas Attend calls that interest you. Monthly Updates Keep in touch with the team s work and why it s important Specific review periods for Whitepaper, EducationModule and ReferenceModules 32
Demo: Sample ReferenceModel 33
DSCSA and Blockchain Study Goals The overall objective of this Study is to examine various blockchain configurations through the use of ReferenceModels (simulations) in light of the DSCSA law. Specific goals are: 1. Provide clear examples of blockchain technology. 2. Determine if blockchain technology could work for DSCSA purposes. 3. Demonstrate a number of blockchain technologies or uses via simulations 4. Identify metrics and compare blockchain solutions with other potential solutions. 5. Provide Thought Leadership to the Industry on the feasibility of using blockchain technology. 6. Demonstrate possible funding models 7. Identify future phases of study (ex: blockchain and authentication at point of dispense, blockchain use for securing regulatory documents, clinical trials, etc.) 34
Study Goal Use a simulation (or ReferenceModel) to demonstrate Blockchain technology being used for the purposes of DSCSA. Concerns: Response time Data attributes needed Can we develop a set of simulations to show the differences between a distributed Blockchain model and a centralized relational database model 35
Agenda Welcome and Intro of speakers Blockchain discussion DSCSA Discussion Why the interest in Blockchain for DSCSA? The Study Next steps 36
Next Steps Study Proposal Prospectus/Charter Pre-Launch Study Publish Draft Goals and definition Goals, Metrics and Scenarios Detailed Goals, metrics and Scenarios Final Scope Publish ReferenceModels White Paper RoadMap Socialize With Community Agreement Anti-Trust Funding Develop /execute Scenarios Education Module 37
Next Steps This presentation will be published on the Center s Website You will receive: This presentation DSCSA and Blockchain Study Information sheet DSCSA and Blockchain Study Proposal Invite to the Pre-Launch Calls Questions to be addresses Scenarios Metrics Instructions on how to join the Study Pre-Launch calls start: 10/7/2016 (break for 10/14/2016 FDA Workshop) Kickoff Call: 11/4/2016 38
Questions / Discussion 39
Today s Speakers Darryl Glover, Pharm.D, MBA Chief Clinical Officer isolve 510-599-2608 (Mobile) dglover@isolve.io www.isolve.io Bob Celeste Founder Center for Supply Chain Studies 215-584-7374 rceleste@c4scs.org www.c4scs.org 40