Blockhain and Clinical Trials and an Innovative Clinical
Blockhain and Clinical Trials and an Innovative Clinical Trial Management & Financial System (CTMFS) to Accelerate Clinical Trials and Cut Costs October 24, 2019 1
Three Questions? • How many of you think drug costs are too high? • How many would like to own your Healthcare data and monetize it? • How many would like to see decreased healthcare costs? CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 2
Agenda • What is the problem? • Challenges in Pharma R&D • How can Blockchain help • Software enabled clinical trials • Bloqcube’s approach to accelerate trials • Other end uses of blockchains • Q&A CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 3
Rama K Rao • Mr. Rama K Rao is the CEO and Co-Founder of Bloqcube, a US-based company which pioneers blockchain based clinical research management systems. Rama is an alumnus of IIT Delhi ( B. Tech. ), IIM Calcutta and INSEAD, France ( MBAs). He has a certification on Blockchain from MIT, Cambridge. • He is a senior executive with 27 years of extensive experience in the pharmaceutical industry with Eli Lilly and Novartis. He worked in multiplicity of senior executive roles including being the Global Head for Clinical Development Finance for Novartis Oncology, Head of Clinical Development and Medical Affairs Novartis USA and the CFO of Novartis Pharma in Canada/Russia. • He has lived in eight countries and speaks four languages including French. He also is an Adjunct Professor of Finance at Fairleigh Dickinson Univ NJ currently teaching a course on Blockchains to MBAs CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 4
Moore’s Law… Most of you are aware how Moore’s law has operated in the world of computing The question is why has this not happened in the world of Health care CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 5
Some Reasons? • Complexity – Every human being is unique • Immature technology • Computing technologies • Lack of trust and the presence of multiple intermediaries • Health care has two segments • Prevention • WHO and other public health agencies tend to focus on this • Cure • Pharma and Biotech companies focus on drug development CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 6
Q&A To find a cure almost 10000 compounds may be reviewed “ CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 7
Pharma Discovery – Diminishing Returns Return on investment is directly linked to growth Decreasing supply of New Drugs Decreasing Revenue Growth Broken Business Model Decreasing Investment into R&D Decreasing Revenues R&D spending is limited as fixed % of sales …High Drug Costs Source: Evaluate Pharma, IRR analysis Source: “Pharma’s broken business model – an industry on the brink of terminal decline”; Scraping the barrel in drug discovery’; Kelvin Stott, Director R&D Portfolio Management; Nov 17, 2017 CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 8
Pharma Discovery – Diminishing Targets CONCLUSION: Use Technology to deliver process efficiencies in health care Source: “Pharma’s broken business model – an industry on the brink of terminal decline”; Scraping the barrel in drug discovery’; Kevin Stott, Director R&D Portfolio Management; Nov 17, 2017 CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 9
When should we use a blockchain based solution and when not to? Ethereum Hyperledger ™ Ethereum ERP systems CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED
Fraud Prevention. . . Data Is Immutable In Blockchains CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 11
Blockchain’s Distributed Nodes Avoid Centralized Vulnerability CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 12
access to shared data and tools to link data sets • Bloq – Enterprise grade technology • Guard Time – Data systems /security • Pokidok – Development platform • Iryo – Open sourced Open EHR platform • Bloq. Cube – Clinical Trials management systems • Blockchain Health – Health care data sharing • Block MD – Electronic Health Records • Bloqpharma – Drug sales tracking and counterfeiting • Factom – Medical records • Medical Chain – Healthcare records storage • Chronicled – Medical supply chains for traceability and accountability Consumer driven • Gem OS – Enterprise; secure Middle Ware Infrastructure Broad Categorization Of Blockchain Companies (not an exhaustive list) • Bowhead health – monitoring customer data to dispense medicines • Nebula Genomics – genomic data protections • Doc. ai – consumer controlled, blockchain based AI powered management of biological data • Patientory – patients track their medical history • Coral Health – platform for sharing medical records across various stakeholders • Encrypgen – Selling consumer DNA information for tokens Source: https: //www. beckershospitalreview. com/lists/25 -blockchain-companies-in-healthcare-to-know-2017. html; Laura Dyrda August 17, 2017; ‘The Medcial Futurist’ 27 Mar 2018 CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 13
CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 14
Source: CBI analyst reports, 2017 CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 15
Why Is Blockchain Superior To Existing Models? Integrated Immutable Cryptography Distributed Individualization CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 16
Why Is Blockchain Superior To Existing Models? Integrated silos Immutable Distributed • Integrates silos and multiples handling points present currently in the value chain • Compliant Data entered into a block creating a permanent, auditable record • Blocks replicated at the other nodes & distributed enhancing fraud detection / prevention; less vulnerable to centralized attacks Cryptography Individualization • Blocks are linked cryptographically • Fraud controls • Consumer records holders can own and monetize their data if needed CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 17
Big Picture: multiple silos and multiple systems CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 18
Software Enabled Clinical Trials Industry – Fierce, Fragmented, Strong Medidata New technology Clinical Ink Greenphire My. IRE Consilyx System 37 Flatiron IBM Watson Old Technology CRO Systems In House systems eg Parexel, Quintiles Bio Clinica Siloed Veeva Consilyx Bloqcube Apple? Google? Oracle Local systems? Integrated CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED Systems: PRO- Patient Recording of outcomes/Recruitment Protocol design review e. TMF- Electronic Trial EDC-Electronic Data Capture Drug supply Data management Site selection systems Financial Payment systems Financial accounting systems Financial planning systems Blockchain based companies 19
Bloqcube’s Focus Area is the Clinical Trial Process Our initial area of focus Define the Unmet Medical Need? External Advisory Board Clinical Development Plan Develop Protocol Pre-trial Preperation Patients Recruitment Visits/ Trial Execution CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED Trial Finalization Post Trial close 20
Financial Impact Of Clinical Trial Delays: ~$8 m/Day ** $2. 6 B* A new drug’s development cost Costs growing at a CAGR of 8. 5% p. a. Source* Page 23 No. 7 Mc. Kinsey : Accelerating studies by 18 months potentially delivers Source** Page 23 No. 4 $190 m more in NPV** Only 3 -6% of all cancer patients participate in clinical trials suggesting we need to take our trials via new technology to the patient and not have the patient come to the trial. *** Slide 23 #4 CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 21
Pain Points in Clinical Trials Siloed systems slowing processes and causing inefficiencies Data fidelity/fraud issues Delayed data including financial data; delayed decisions Delayed site/Physician payments- as late as 4 months exposing sites to financial jeopardy Multiple intermediaries – SDV* costs are approx. 26% Clinical trials are vital to the development of drugs but are slow and expensive Pharma companies spend upto $100 b/year*. The CTMS* market is~$10 b growing in double digits. **A day’s delay can cost upto $8 m Note: Patient recruitment is another key pain point that we may not address in our first phase *SDV- Source Data Verification ; Source: Page 23; # 5. Delayed Site Payments: Page 23#2; ** Page 23 #4 CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 22
Pain points? Solution? Impact: Mc. Kinsey research ‘Accelerating studies by 18 months potentially delivers $190 m more in NPV’. (*Source: Slide 1? #3) Pain points Solutions Siloed systems slowing processes and causing inefficiencies Integrated Trial management & Finance system Data fidelity/fraud/ownership issues Blockchain driven fraud reduction/data security enhancement Delayed data including financial data; delayed decisions Continuous clinical trial accounting; real time data; reconciliation reduction Delayed site/Physician payments- as late as 4 months exposing sites to financial jeopardy Peer to peer payments system with speedy payments – within days! Decreased need for reconciliations Multiple intermediaries – SDV* costs are approx. 26% Smart contracts driven automation to cut costs CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 23
How Do Clinical Trials Work? Filing Publishing & Record Keeping CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 24
How Do Clinical Trials Work? C 2 TA FDA Filing Publishing & Record Keeping CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED P 2 P Payments 25
The Bloq. Cube™ Solution We have developed a pioneering integrated Clinical Trial Management and Financial System (CTMFS) for accelerated, cost-effective clinical trials management system using blockchain and Ipads. Integrates multiple Meets regulatory systems including and governance needs financial payments & accounting Automates and streamlines major processes Real time view of patient activities and financial resources consumed Accelerates clinical trials and cut costs This innovative solution is simple, seamless and scalable. CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 26
Why Now? CTMS* Survey by Veeva™ 99% of respondents had issues with existing CTMS* systems 50% Top Drivers to Improve CTMS were: Better visibility e. TMF* Integration Proactive Risk Identification Ease of Use Better Study Analytics Improved governance/oversight Costs Savings EDC* integration had issues with Site/Study management reporting 25% had issues with financial management Source: https: //www. veeva. com/resources/industry-survey-shows-87 -of-clinicaloperations-leaders-taking-action-to-unify-clinical-processes/ *Note: CTMS- Clinical Trial Management Systems; e. TMF-Trial Master Forms’ EDC- Electronic Data Capture CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 27
Why Now… Blockchain technology for improving clinical research Trials quality Reproducibility, data sharing and patient enrolment in clinical trials are huge medical challenges for contemporary clinical research Ioannidis et al. estimated. . 80% non-reproducible studies. This rate may be related to several types of errors, misconduct or fraud Mehdi Benchoufi & Philippe Ravaud : Trials 2017 ; 18: 335 How blockchain will revolutionize clinical trials In addition to increased costs, today’s researchers face the challenges of accurately reproducing data, efficiently sharing data (including personal data), privacy concerns and patient enrollment strategies. …. technology that can provide solutions to all of these problems: blockchain. ” Gunjan Bhardwaj, CEO – Innoplexus, June 19, 2018 A Finance perspective Blockchain could enable the continuous, real-time auditing of accounts, with transaction history reported instantly. With transactions executed and automatically validated in real-time, investors and auditors would have an accurate snapshot of a company’s finances at any given moment…. . Jeanne Boillet and 10 Rule, Contributors “Blockchain: Should CFOs believe the hype”; CFO. com April 14, 2017 Boehringer Ingelheim and IBM link up for blockchainpowered clinical trials in Canada-based units of Boehringer Ingelheim and IBM will work together to employ blockchain recordkeeping technology in a clinical trial pilot project, in what they say will be a first in the country Conor Hale | Feb 12, 2019 ‘Fierce. Biotech’ CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 28
The Bloq. Cube™ Value Proposition Bloq. Cube™ deploys an Integrated Clinical Trial Management and Financial System (CTMFS) that 01 Innovatively integrates multiple systems from electronic data capture to Financial systems 02 Delivers immutable, distributed data, unlike existing legacy systems 03 Delivers patient activity and financial data in real time 04 For clinical development teams in life-science organizations to automate processes and accelerate trials for the benefit of patients CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 29
Clinical Trial Experts Testify Dr Stephen Cunningham Former CSO and Head of Clinical Development and Medical Affairs for Novartis in North America The system is unique, intuitive and fast; The clinical trial suite uses an integrated i. Pad-based system with a user-friendly front end. The proprietary C 2 TA™ system integrated with financial software gives real time transparency. For the first time this unique system unlocks the value of blockchain technology and distributed ledgers to drive real advantages for companies and investigators conducting clinical trials: Thomas Bock MD, MBA, ex-CEO, Herit. X Inc. ; ex- Global Medical Affairs Head for Celgene and Novartis Oncology Bloqcube’s system… covers the data typically collected across a broad range of disease fields…a one-stop-shop for all aspects of planning, implementation, resourcing and financially controlling clinical research. …this system is unique across the medical research landscape. It streamlines tasks, enhances speed, and importantly, leads to greater data accuracy and data security (innovative blockchain technology)…. . , thus facilitating an integrated team approach… Especially for a non-profit R&D organization like ours, the operational streamlining and cost savings are highly valuable, and I can highly recommend this system’s consideration when planning future studies- as I do. CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 30
A CTFMS that uses Blockchain Technology for Clinical Trials: The Bloq. Cube™ USP Blockchain Technology* has the potential to streamline the Clinical Trials process Blockchain Technology* ensures integrity of Clinical Trial Data Blockchain system* creates an immutable audit trail that makes it easy to spot any tampering with results CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED MOU with a recognized leader in global IT services Virtual R&D set up with NIST Washington DC to explore blockchain solutions for GPDR compliance in CTMS 31
Screen shots – Sponsors Dashboard 1/2 i. Pad based solution for electronic data capture and patient convenience First in class t o integrate financials Site progress tracking for remote monitnoring Real time picture of financial resources with drill down capabilities to ensure transparency at accounting levels 32
Real Time Data – Accounting Record/Data Export 2/2 33
Which System Would You Rather Use? Old Technology - Siloed Solutions New technology- Integrated Solutions CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 34
Summary Clinical trials are expensive due to delays • • Blockchain technology: A new, elegant solution Largely paper based • Distributed ledger • Cryptographic structures • Data immutability Multiple intermediaries Slow, untrustworthy and prone to fraud Inordinate trial and site payment delays, pushing sites to brink of financial insolvency By implementing An integrated i. Pad based blockchain solution Bloq. Cube’s value proposition A proprietary financial module C 2 TA ™ • • • A point of care solution Meets Regulatory needs Automates major processes Minimizes intermediaries using smart contracts A real time view of activity and financial expenses Savings and speeding up of clinical trials In an industry that spends up to $100 billion in Development spend depending on trials of which CTMS market is upto$10 b growing at ~13% p. a. CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 35
Other End Uses In Blockchains Driven Solutions • ILLINOIS BLOCKCHAIN INITIATIVE • Illinois is at the forefront of experimental blockchain in government with the Illinois Blockchain Initiative. The state-funded initiative has already put in place measures to use a distributed blockchain ledger to enhance the security of birth certificates, death certificates, voter registration cards, social security numbers and much more. • CIVIC • • Civic is a blockchain-based ecosystem that gives individuals insights into who has their information. The company’s users enter into smart contracts, where they decide who can share their personal information and how much. If the contract is broken or an unauthorized source tries to access private data, the individual is immediately alerted DHL • Shipping giant DHL is at the forefront of blockchain-backed logistics, using it to keep a digital ledger of shipments and maintain integrity of transactions. DHL has a major presence in the US and is one of the largest shipping companies to embrace blockchain. • MAERSK • Based in Denmark, but with offices all over the US, shipping giant Maersk has teamed up with tech giant IBM to infuse blockchain into global trade. The two companies will use blockchain to better understand supply chain and track goods digitally across international borders in real-time • PROPY • Propy is a global real estate marketplace with a decentralized title registry system. The online marketplace uses blockchain to make title issuance instantaneous and even offers properties that can be purchased using cryptocurrency • . Source: 25 BLOCKCHAIN APPLICATIONS & REAL-WORLD USE CASES DISRUPTING THE STATUS QUO; December 5, 2018; Updated: September 6, 2019; by Sam Daley. https: //builtin. com/blockchain-applications CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 36
Questions CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 37
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Sources 1. Society for Clinical Research Sites(SCRS) • ‘Why is clinical source data still collected on paper’ – May 2017’ White Paper; ‘Center. Watch, SCRS & Clinical Ink. Research Site Source Survey. December 2016. [n = 656]’ • (b)“ 90% of sites create study specific source forms…. Of those sites, 96% still use paper-based approaches when creating source forms and collecting source data”; Page 1 • “Site Payment” May 2016. White paper by SCRS Panel co chaired by Messrs. Kelly Cummings, Claire Grace, David Vulcano 2. In a survey conducted by SCRS in 2016 sites are reporting a profit margin of 13%. In addition to receiving payments well after they complete their work, holdbacks mean that more than the entire profit margin on a study may not be realized until months after the study end, unrealistic burden on the site to remain cash positive or even neutral. It is no wonder that guaranteed payment in 30 days is considered “very valuable” by 77% of research sites doing more than 5 studies per year. Yet only 28% of site payments are monthly 3. ‘The Road to Positive R&D returns’ David, Tramontin, Zemmel – Mck. Insy Quarterly Feb 2010 4. “$8 m revenue loss per day” – ‘Drug Development Technology’ www. drugdevelopment-technology. com/features/ ‘Clinical trial delays: America’s patient recruitment dilemma’ by Daniel Garrun 5. *Parexel Biopharmaceutical R&D statistical source book 2016/2017 Page 247 -250. ‘Clinical Trial Costs: An examination of costs by Phase, Therapeutic area and the key contributing factors’ Eastern Research Group July 2014 6. *https: //www. fda. gov/downloads/training/guidancewebinars/ucm 383657. pdf 7. Parexel Biopharmaceutical R&D Statistical Sourcebook 2016/17; Pg. 66 -67. ”A global CRO market model to 2018: A 2015 analysis”- UBS Investment Research; Jan 2015 CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 42
Safe Harbour Statement/Disclaimers Certain statements contained in this presentation, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond the control of Bloq. Cube Inc. (“Bloq. Cube”). Such risks include, but are not limited to, Blockchain software and the environment for its acceptance, the impact of general economic conditions, general conditions in the life sciences and pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which Bloq. Cube does business, stock market volatility, changes to the competitive environment, the risks of a new technology that is immature like blockchains, and other risks included in Bloq. Cube’s public and private disclosures. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance on the forward-looking statements included in this presentation. These statements speak only as of the date made and Bloq. Cube is under no obligation and disavows any intention to update or revise such statements as a result of any event, circumstances or otherwise. CONFIDENTIAL; VIEWS OF THE AUTHOR RAMA K RAO; NO COPYRIGHT INFRINGEMENT IS INTENDED 43
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