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Future watch global biobanks_presentation

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Presentation of Future Watch: Growth opportunities in global biobanks market.

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Future watch global biobanks_presentation

  1. 1. 1 Growth Opportunities & Recommendations for Growth of Finnish Bio-bank Ecosystem The Growth Pipeline™ Company Powering clients to a future shaped by growth 27 May 2020 FUTURE WATCH
  2. 2. 2 ABOUT THE STUDY At Business Finland, we create new growth by supporting companies to go global, as well as funding innovations. Our top experts speed up the identification of business opportunities around the world and help transform them into global success stories. Future Watch is part of TF Market opportunities service and it provides actionable insights from our global network for Finnish businesses and stakeholders. More information at www.marketopportunities.fi Business Finland aims to provide early stage insight on trends that define future business opportunities. Emerging global bio-bank ecosystem has been acknowledged as undergoing significant changes in the near future and bringing major opportunities also for Finnish bio- bank ecosystem. In closer discussions with industry stakeholders there was a clearly identified need to understand the relative competitive positioning of the Finnish biobank ecosystem. To support in this process, Personalized health program initiated a Future Watch study on global bio-banking markets. In the study, we identify key trends and their respective drivers in order to validate future growth opportunities in bio-bank markets as well as study the areas for improving the positioning and value proposition of the Finnish biobank offer in global setting. The ultimate aim is to generate insights that will be strategically actionable for bio-bank stakeholders in Finland. FUTURE WATCH
  3. 3. 3 Introduction Key Growth Opportunities for Finnish Biobanks Best Practices Assessment End-User Assessment Recommendations Gap Analysis FOCUS POINTS – AGENDA
  4. 4. 4 ENABLING FINNISH BIOBANK ECOSYSTEM TO BECOME BEST IN CLASS BY DRIVING COMPETITIVENESS AND REVENUES FROM ASSETS • Project initiation and Stakeholder Introductions • Handover/Source of Finnish Biobank Competencies Assessment Market Assessment: Segment & Country Level Breakdown • Market Overview, Key Trends, Industry Challenges, Drivers & Restraints, Business Models, Growth Opportunities • Biobank Market Sizing by Country (Finland, UK, US, Denmark & Sweden), Key Segments (bio-fluids, tissue, DNA/RNA, data etc.) Competitive Assessment: Biobanks Competency Analysis • Infrastructure and Assets, Segments Served, Services • Unique Value proposition and Pricing Mechanisms Operational Assessment: Pharma Customers Needs Analysis • Expectations from Pharma Players by Biobank Segments • Key Selection Criteria for Partnerships and Commercial Relationships Market Alignment Workshop • Clients Services, Partnerships • Competencies and Best Practices • End-User Perception of leading Biobanks • Biobank Services in the Pharma Sector: 5-10 year horizon
  5. 5. 5 THE TOTAL BIOBANKING MARKET WILL REACH $54.71 BN IN 2020 AND GROW AT A CAGR OF 4.5% BETWEEN 2020-2026 TO REACH $71.22 BN IN 2026. Application CAGR (2019-2026) Research 4.3% Therapeutics 5.0% Sample Type CAGR (2019-2026) Bio-Fluids 3.9% Tissue Cells 6.1% DNA/RNA 2.6% Stem Cells 4.6% Global Biobank Market (Application and Sample) Therapeutic Applications for Biobanks are Likely to Increase with a Focus on Biomarkers, Oncology, Chronic Therapies Biobank Market Trends • Increase in Genome based research projects leveraging large collections of bio-data • Increase in R&D activities using biospecimens in precision oncology, stem cell research, cell and gene therapies, etc. • Increase in Chronic Diseases utilizing the large population based data of biobanks • Utilization of sample data for research; Data monetization is the next key value driver for the biobanks • Legal and Ethical Challenges remain high • High operational costs for biobanks • Lack of standardization, lengthy procedures and processes • Insufficient awareness about Biobanking activities Drivers Barriers The sole purpose of samples is to produce Biodata enabling patient stratification for precision medicine and the Biobanks can make use multiple business models for data monetization: 1. Research Providers 2. Data Owners 3. Service Providers 67% 33% Biobank Market by Application (2019) Research Therapeutics 40% 26% 15% 5% 14% Biobank Market by Sample (2019)Bio-fluids Human Tissue/Tumor Cells Stem Cells DNA/RNA Growth will be Driven by Human Tissue/Tumor Cells and Stem Cells due to their Novel Therapeutic Applications in rare diseases, regenerative medicines, targeted therapies, which are the focus of commercial and academic research globally Research providers Utilizing Samples and Sample Data for research projects Data Owners Access to Sample Data is the core offering. Service Providers Utilizing sample data and technology to provide additional services.
  6. 6. 6 KEY GROWTH OPPORTUNITIES FOR FINNISH BIOBANKS FUTURE WATCH
  7. 7. 7 KEY AREAS THAT WILL DRIVE THE FUTURE GROWTH FOR THE FINNISH BIOBANKS Biobanks have evolved from sample repository centers to active research partners in personalized medicine applications Companion Diagnostics Co- Development Large-Scale Genome Sequencing Projects Oncology Clinical Development Digital Pathology and Imaging Services The global companion diagnostics market is expected to reach $8.1 billion by 2023 with a CAGR of 21.2% between 2017- 2023. By therapeutic area the oncology segment is expected to account for highest growth rate. The European next generation genome sequencing services market is forecast to grow at a CAGR of 15.4% from 2016 to 2023 to reach $605.0 million by 2023. Bioinformatics and application based services to provide competitive edge Immuno-oncology therapies are key application area in the oncology therapeutic category. The overall market for such therapies is expected to reach a revenue of $3.9 billion in 2022. With increasing need for digital workflow and technology for biospecimen assessment in pathology cases, digital information technologies offer the possibility to track the entire life cycle of a biosample The RWE market has witnessed a number of partnership and acquisition activities as companies aim to improve their technical expertise. The focus areas in RWE solutions include use of OMICS data, cloud computing, real time diagnostics, among others Real World Evidence Studies
  8. 8. 8 BEST PRACTICES ASSESSMENT
  9. 9. 9 EVALUATION OF THE BIOBANKS GLOBALLY WILL ENABLE THE FINNISH COUNTERPARTS TO HAVE AN OVERVIEW ON THE BEST PRACTICES • The Biobanks were shortlisted based on their services provided in any of the five application areas viz. Companion Diagnostics, Genome Sequencing, Oncology Clinical development, RWE Studies and Digital Pathology • The Interviews were conducted on telephone and based on a structured questionnaire that had both qualitative and quantitative responses. • A screening criteria was developed to only include those stakeholders from the Biobank who who were directly involved in finalization of deals with the end-users • The interview transcripts will be kept confidential • The interviews in the table above are the optimum sample size considering the time constraint • The discussion with the Biobanks was to evaluate their competencies on a large number of parameters including their operational capabilities, service capabilities, engagement types, pricing model preferences, customer types, marketing activities, application areas, sample and data value chain, cost drivers, virtual portals and digitization, network participation, regulatory scenario, and collaborations USA • All of US Biobank • NCI Biobank • UMMC biobank • Biome Biobank • Kaiser Permanente Research Bank UK • UK Biobank • CIGMR Biobank Sweden • Biobank Vast • Uppsala Biobank • KI Biobank • SMB Biobank Iceland • Decode Genetics France • IARC Biobank Denmark • Danish National Biobank • Danish Cancer Biobank • RBGB Biobank Austria • Biobank Graz
  10. 10. 10 A SUSTAINABLE BIOBANK BUSINESS MODEL SHOULD BE OPERATIONALLY EFFICIENT, SOCIALLY ACCEPTABLE, AND FINANCIALLY VIABLE TO MEET MARKET NEEDS Service Scope Biobank Sustainability • Biobanks must identify ways to collaborate with existing customers and potential means to reach out to new customers. • Dedicated Marketing Efforts to acquire potential customers would be significant to make an outreach • Biobanks long term operational sustainability could be based on: – Financial aspects – Social Aspects – Operational Aspects • Biobanks must identify levers for long term sustainable operations in the market. • Prepare robust business planning • The companies must assess the current state of the biobanking sustainable levers and the future potential of the same. • Diversify offering and funding sources . • Biobanks should aim for acting as one stop shop solution providers for the customers. • Based on expertise in services offered biobanks must identify ways to partner to enhance services. Customer Acquisition
  11. 11. 11 A STRATEGIC FIT, WELL DEFINED ENGAGEMENT MODELS AND ROBUST MARKETING OUTREACH CAN STRENGTHEN CUSTOMER PARTNERSHIPS Marketing Outreach • Biobanks have a dedicated marketing team to promote about their activities in various forums • There is a small budgetary allocation for marketing related activities of the Biobank. While active participation in conferences is the most prominent marketing activity by the Biobanks, print media, social media, etc. are emerging as new frontiers • The key focus of the biobanks is to spread awareness about their activities and areas of expertise, identify the key areas of collaboration in terms of samples requirement, data requirement and open a communication channel for ongoing outreach Commercial Partners • Biobanks globally have struggled to have robust commercial partnerships especially with Pharma. Key factors include limited marketing outreach for the customers and lack of defined engagement models • Identification of areas of collaboration as a strategic fit is a key factor to initiate partnerships • Research area focus such as genomic medicine can be a focus for a Pharma company where the Biobank can act as a partner • The focus can also be in advancing treatment and diagnostic in a specific therapeutic area such as Oncology. • Strategic Partnership is a preferred model for the Biobanks to collaborate with the commercial partners with long term engagement and flexibility in terms and conditions Academic Partners • The focus is on advancing medical research in one or more disease areas such as on Oncology, Neurology, Cardiovascular and also scientific expertise in terms of skilled staff and budgets for research based activities 2-3% 70% 15% 15% Number of Projects (2019) Academic Institutions Pharmaceuticals Others (Biotech, Healthtech, CSO, etc. ) Uppsala Biobank engages in 3 different models with the end-users • Pfizer entered into a partnership with Olink proteomics and KI Biobank for Biomarker based study to identify genetic mechanisms that control the production of protein • The goal was to map those proteins which play an active role in cardiovascular diseases Customer Acquisition
  12. 12. 12 HIGH OPERATIONAL COSTS AND A SMALL COST RECOVERY UNDERPIN THE FINANCIAL CHALLENGES FOR BIOBANKS; DIVERSE FUNDING SOURCES AND FEE FOR SERVICE MODELS ARE KEY SUCCESS FACTORS Operational Sustainability • Majority of the Biobanks consider providing both sample and data based services to the end-users • Biobanks can differentiate at each step of the sample value chain by expanding the volume and variety of biospecimens, state of the art infrastructure for sample storage and processing , etc. • Utilization of the data services for end users will increase and ease of access to samples, catalogue of biospecimens, direct contact to the research team, less turnaround time are some of the key advantages for such virtual access. Financial Sustainability • Financial sustainability is a challenge for a large majority of the Biobanks • Risk mitigation plans of such biobanks include expanding biospecimen portfolio, increasing quality, improving campaigning strategies to target new customers, profit based pricing models, long term partnerships with end-users for sustained biospecimen utilization Social Sustainability • Majority of the biobanks consider the participation in networks or collaborations a key source of differentiation • Therapy specific networks, regional and international cooperatives, bioresources repository, etc. are some of these networks. Access to resources, opportunity to reach out to large clientele, sharing of sample and data and keeping abreast of the latest trends are major attributes UK Tissue Directory is the UK’s register of sample collections covering multiple diseases. UK Biobank has a highly diverse set of funding sources. Funding includes core funding for sample storage and management and project based funding such as in genotyping, imaging studies, and biochemical markers Biobank Sustainability
  13. 13. 13 TARGETED THERAPIES AND ACTIONABLE GENE MUTATIONS ARE KEY FOCUS AREAS FOR ONCOLOGY DRUG DEVELOPMENT AND GENOMIC STUDIES Oncology Clinical Development • Increase in research and therapeutic applications in Oncology is a demand driver for the biospecimens. • It can be a key source for commercial partnerships with the Pharma as the immuno oncology pipelines for the Pharma is dominated by T-Cell therapies, checkpoint inhibitors, TNF receptors, etc. which increases the possibility of sample utilization, particularly the tissue samples. Genome Sequencing • Genome sequencing applications that utilize the genomic data have helped spur the advent of precision medicine. • Disease areas such as Oncology, cardiovascular, rare diseases, neurology, are major therapy areas for genomic applications. • Furthermore recent progress in NGS has enabled identification of genetic mutations and development of targeted drugs. For example for patients with GC, anti-vascular endothelial growth factor (VEGF)- and anti-human epidermal growth factor receptor 2 (HER2)-targeted therapies have become a standard therapeutic Digital Pathology Applications • Digital pathology applications are mainly driven by the increase in the diagnostic tests of all major sample types and increasing need for digital workflows technology for biospecimen assessment • Imaging biobanks linked to biological samples and patients’ clinical information can be considered as a potential area in biobanking. Biobank Graz is a partner to CBMed, the Center for Biomarker Research in Medicine Real World Evidence studies Utilization of samples and data for RWE study is not yet mature for the global Biobanks • RWE studies although currently lesser utilized in terms of partnerships will grow driven by increase in data sources and Biobanks competencies on data based engagements. • The type of data sources may include Biobank Sample data, population based cohorts, clinical and disease registry data, claims data and surveys, genomic data Service Scope
  14. 14. 14 END-USER ASSESSMENT
  15. 15. 15 THE SHIFTING INDUSTRY PARADIGM TOWARDS COMMERCIAL PARTNERSHIPS WITH PHARMA, BIOTECH, CROS, CDMOS AND DIGITAL SOLUTION PROVIDERS IS EXPECTED TO TRIGGER MARKET GROWTH Stakeholder Organizations Inclusion Criteria Stakeholders Country (Headquarters) Pharmaceutical Companies Mid-Size Pharma Senior Medical Director USA (New York City) Large Pharma Head of Clinical Ops UK (Cambridge) Large Pharma Head of Research and Development USA (Cambridge) Biotech Companies RNA interference therapeutics Head of Regulatory USA (Cambridge) Focus on Neurological disorders Head of Research and Development France (Lille) Focus on GI therapeutics Senior Medical Director USA (Cambridge) Healthtech Companies Diagnostics (Digital Pathology) Head of Diagnostics Germany (Nussloch) Drug Discovery Solutions Medical Director Poland (Krakow) Real World Evidence studies Chief Scientific Officer Switzerland (Basel) Drug Discovery Solutions Head of Research and Development USA (New York City) Diagnostics Chief Scientific Officer France (Marcy I-E’toile) Real World Evidence studies Chief Scientific Officer USA (Virginia) Precision Medicine Applications Medical Director UK (Cambridge) Contract Services Organizations Contract Research Organization Head of Clinical Ops Ireland (Dublin) Contract Research Organization Head of Regulatory Austria (Vienna) Contract Development and Manufacturing Organization Director USA (Durham)
  16. 16. 16 END-USERS ASSESSMENT OF BIOBANKS WAS DONE ON THREE KEY PARAMETERS- SERVICE ALIGNMENT, CRITERIA FOR SELECTION AND PARTNERSHIP FIT Source: Frost and Sullivan Analysis • This section covers the end users requirement of services from the biobanks • Service alignment of the end- users with the biobanks in terms of sample and services utilization, application areas, data utilization, is discussed Service Alignment • This section covers the assessment of the biobanks by the end-users • Capability assessment specifies the key selection criteria of the end-users to assess the biobanks for a potential partnership Selection Criteria • This section covers various factors that contribute to partnership between the end- users and the biobanks. • Assessment fit is analyzed based on business and pricing model fit as well as key stakeholder involvement Partnership Fit
  17. 17. 17 STRATEGIC ENGAGEMENT IS A PREFERRED CHOICE FOR ALL END-USERS AND HEAD OF R&D EMERGED AS A KEY STAKEHOLDER Source: Frost and Sullivan Analysis Type/Topic Pharma Biotech Healthtech CSO Service Utilization Biomarker Profiling, Genomic Applications, Targeted Therapies development Genomic Applications, Biomarker studies, Targeted therapies development Genomic applications, Biomarker, Diagnostics/Digital Pathology DNA/RNA applications, Biomarker studies, Targeted therapies Data Utilization OMICS, Clinical, Exogenous, Remote Care OMICS, Clinical OMICS, Exogenous, Remote Care Clinical Key Selection Criteria Scientific Record, Accreditation, Population Base, Data integration Scientific Record, Accreditation, Therapeutic expertise, Data integration Scientific Record, Accreditation, Population Base, Data integration Scientific Record, Accreditation, Therapeutic Expertise, Regulatory Support Engagement Models Research Provider Service Provider Data Rent Service Provider Pricing Models Value based pricing, Bundled Payments Value based pricing Fee for service, Bundled payment Milestone based pricing, Revenue sharing Stakeholder Mapping Decision Maker: Head of R&D, Procurement Influencer: Medial Director, Marketing Decision Maker: Head of R&D, Head of Procurement, Influencer: Head of Regulatory Decision Maker: Head of R&D, Head of Procurement, Head of Diagnostics Influencer: Chief Scientific Officer, Head of Clinical Ops Decision Maker: Head of Clinical Research, Head of Procurement Influencer: Chief Financial Officer, Clinical Operations Director Marketing Outreach Conferences/Symposiums, print Media- Brochures Conferences/Symposiums, Email Marketing Conferences/Symposiums, Email Marketing, Print Media Conferences/Symposiums, Print Media- Brochures
  18. 18. 18 GAP ANALYSIS
  19. 19. 19 WHILE SAMPLE UTILIZATION OF THE FINNISH BIOBANKS IS AT PAR WITH GLOBAL STANDARDS; IMPROVEMENTS TO CUSTOMER ACQUISITION STRATEGIES ARE NEEDED Customer Acquisition Working with a diverse customer type Well defined engagement models Robust Marketing and business development activities Service Scope High Utilization of Samples Balanced between disease and population based studies Balance between research and therapeutic based studies Balance between Academic and Industry based studies Strong Moderate WeakBest practices Finland UK USA Sweden Denmark Source: Frost and Sullivan Analysis
  20. 20. 20 Service Scope Companion Diagnostics Oncology Clinical Development Genome Sequencing RWE Studies Digital Pathology RWE STUDIES CAN ACT AS A COMPETITIVE ADVANTAGE FOR FINNISH BIOBANKS WHILE STRENGTHENING CAPABILITIES IN DIGITAL PATHOLOGY AND COMPANION DIAGNOSTICS Source: Frost and Sullivan Analysis Finland UK USA Sweden Denmark Strong Moderate WeakBest practices
  21. 21. 21 Financial Sustainability Availability of diverse funding sources Well defined pricing models Operational Sustainability Highly developed facilities for sample management Highly proficient data services to end-users Digitization capabilities One-Stop Shop solutions FINNISH BIOBANKS ARE WELL POSITIONED AS ONE STOP SHOP PROVIDERS HOWEVER THERE IS A NEED TO WORK WITH WELL DEFINED PRICING MODELS FOR FINANCIAL SUSTAINABILITY Source: Frost and Sullivan Analysis Finland UK USA Sweden Denmark Strong Moderate WeakBest practices
  22. 22. 22 Social Sustainability Regulatory Scenario Favorable Government Policies Participation in regional and international networks GOVERNMENT POLICY AND REGULATORY STRUCTURE ARE KEY STRENGTH FOR FINNISH BIOBANKS; GREATER PARTICIPATION IN REGIONAL AND INTERNATIONAL NETWORKS WILL ENHANCE THEIR COMPETITIVE STANDING Source: Frost and Sullivan Analysis Strong Moderate WeakBest practices Finland UK USA Sweden Denmark
  23. 23. 23 RECOMMENDATIONS
  24. 24. 24 FINNISH BIOBANKS CAN FOCUS ON SIX KEY RECOMMENDATIONS AS A PART OF THE TRANSFORMATION PROCESS Source: Frost and Sullivan Analysis 04 01 02 03 05 06 Developing Brand Finland: Leverage the core competencies of the Finnish Healthcare landscape to distinctively communicate the brand Finland for Biobanking activities Enabling Digitization and Data Services Strengthen the capabilities in data services offerings to the end-users and access through digital platforms Create sustainable revenue streams: Finnish Biobanks must look for opportunities to reduce dependence on short term funding models and seek means to have continuous funding structures Increase linkages between biobanks and industry Finnish Biobanks must look out for opportunities and increase visibility to engage more with the commercial partners and stand out ahead of the competition Capacity Expansion Finnish Biobanks can focus on expanding sample variety, sample management services and Ease of doing Business: Regulatory and Policy measures to improve the initiation and execution of biobanking collaborations in Finland
  25. 25. 25 BIOBANKS SHOULD INVEST IN TRACKING TRENDS AND IMPROVE WEB PRESENCE; MARKETING BUDGET SHOULD RANGE BETWEEN 2-3% OF TOTAL REVENUES Source: Frost and Sullivan Analysis FINBB, Biobanks MEDIUM TERM (1-2 years) Devise Engaging Communication Strategies • Employ Dedicated marketing personnel for sales promotion and commission a budget for marketing activities (~2-3% of the total) • Develop metrics to track trends and run targeted marketing campaigns. Trends such as the tracking of sample usage, solicit feedback from customers, community engagement, shipping trends, distribution trends, and so on • Adopt multi-channel marketing approach. Leverage print media such as brochures, flyers, newsletters, social media, email marketing, SEO, Adwords • Highlight the key strengths in the marketing pitch. Biobank infrastructure and case examples of past end-user experience can be leveraged in the marketing materials Improve Web presence • Create interest and showcase service offerings on the web. Features can include list of projects handled, details of service offerings, sample information, infrastructure details, number of visitors to sites, key contacts, etc. 1 Marketing and Business Development activities Developing Brand Finland Responsible Stakeholders Expected Timelines NEAR TERM (6-12 months)
  26. 26. 26 HIGHLIGHT THE KEY STRENGTHS OF FINNISH HEALTH LANDSCAPE THROUGH AN INNOVATION PLAYBOOK Source: Frost and Sullivan Analysis FINBB MEDIUM TERM (1-2 years) Create a comprehensive repository highlighting Finnish Competencies • Highlight key competencies in the area of digital health, data assets, population cohorts, scientific resources, country vision and policies, research infrastructure, key contacts in health industry and so on. • Feature interviews, anecdotes, case examples that demonstrate the proficiency of the Finland in healthcare innovation • Update annually with the key insights and research in healthcare activities in Finland that leverage the Finnish competencies and provide an overview of the latest activities in healthcare research • Showcase and distribute through conferences, electronic media such as mails, and snippets can be communicated through online platforms such as Twitter, LinkedIn to generate interest about the content in the audience. 2 Health Innovation Playbook Developing Brand Finland Responsible Stakeholders Expected Timelines
  27. 27. 27 TARGETING THE RIGHT DECISION MAKER, ENGAGING THE INFLUENCERS AND INCREASING VISIBILITY ON COMMUNICATION CHANNELS WILL BE KEY TO SUCCESSFULLY ENGAGE WITH COMMERCIAL PARTNERS Source: Frost and Sullivan Analysis Biobanks MEDIUM TERM (1-2 years) Target the right stakeholders • Commercial organizations have different levels of decision makers and influencers that guide the biobank selection process – Research/Pharma- Head of R&D and Head of Procurement are key decision makers. Influencers include Head of Clinical Ops, Medical Directors, Head of Marketing – Biotech- Head of R&D and Head of Procurement are key decision makers. Influencers include Head of Regulatory, Medical Directors – Healthtech- Head of R&D, Head of Procurement and Head of Diagnostics are key decision makers. Influencers include Chief Scientific Officer, Medical Director, Head of Clinical Ops – Contract Development Organizations- Head of Clinical Research and Procurement are key decision makers. Influencers include Commercial and Financial stakeholders Increase visibility on communication channels • Participate in major exhibitor conferences where commercial stakeholders participation is high. For example Biobanking and Regenerative Medicine Congress, ISBER Annual meetings, etc. • Utilize media channels as per the preference of the end-users, such as print media and exhibitor conferences (Pharma), exhibitor conferences, e-mail marketing, print media (Biotech, Healthtech and CSO) 1 Stakeholder outreach Increase linkages between biobanks and industry Responsible Stakeholders Expected Timelines NEAR TERM (6-12 months)
  28. 28. 28 ENGAGING WITH CSOS AS STRATEGIC PARTNERS, PHARMA & HEALTHTECH AS CUSTOMERS AND PARTICIPATION IN NETWORKS WILL BE THE WAY FORWARD Increase Participation in regional and international networks • Network with global biobanks, share learnings and best practices in focused areas, samples & data sharing, reach out to industry stakeholders, and market the capabilities of the Finnish biobanks • Prioritize such networks based on the complimentary fit of the Finnish Biobank capabilities with the objectives of the network. For example EuroBioBank is a partnership of more than 25 Biobanks globally in the area of rare diseases, BCNet is primarily into cohort building and network, p3g is a non profit consortium dedicated to research in the area of human population genomics. Biobanks MEDIUM TERM (1-2 years) FINBB LONG TERM (2-3 years) Lay out the terms of engagement • Identify small to mid-tier pharma emerging in Europe due to high clinical trial volumes and assess alignment with Finnish capabilities in niche therapeutic areas • Collaborate with CROs and CDMOs as strategic partners because Biotech/Pharma outsource cell bank activities to CROs and CMOs for meeting timelines and advanced technology requirements • Enhance strategic partnerships with informatics solution providers to provide XaaS. Identify Healthtech companies (Drug discovery, RWE, etc. ) based on data utilization • Define the engagement models for all the projects with commercial or academic partners. Models can be based on the length of partnership, service requirements (sample and data), and internal resources of biobanks utilized 2 Engagement model with end-users 3 International Collaborations Increase linkages between biobanks and industry Responsible Stakeholders Expected Timelines
  29. 29. 29 LEVERAGE FINGEN STUDY TO OFFER PERSONALIZED & TARGETED SERVICE OFFERINGS TO DIVERSIFY FUNDING SOURCES AND CREATE CUSTOMIZED PRICING MODELS Source: Frost and Sullivan Analysis Develop well defined pricing models • Finnish Biobanks need to move beyond arbitrary pricing of samples and data and need to adopt different pricing models; value based pricing, fee for service, bundled payment, revenue sharing and milestone based pricing • Allocate prices based on the market demand for the samples, rarity of the samples, severity of the disease and timely availability to end-users. Additional services such as consulting, regulatory support, etc. can also be priced as a part of the whole offering FINBB, Biobanks MEDIUM TERM (1-2 years) FINBB, Biobanks MEDIUM TERM (1-2 years) Diversify the sources of funding • Adopt learning's from the global best practices such as UK Biobank to expand on funding sources and reducing dependency on short term academic funding or sole commercial partners • The potential sources are: commercialization of research results, products, and services (e.g. intellectual property royalties, consultancy fees, assay and tool development, sample analysis), Private funding (e.g. pharmaceutical companies), Public funding (e.g. national government, research grants), donations etc. • Leverage the Finngen study to gauge the requirements of end-users for sample and data services; generate projects with partners for biomarker studies, patient recall studies, targeted therapies, among others as an extension to the national initiative 1 Multiple Funding Sources 2 Pricing Models with the end-users Create Sustainable Revenue Streams Responsible Stakeholders Expected Timelines
  30. 30. 30 FINNISH BIOBANKS CAN INCREASE THE VARIETY OF DATA SUBTYPES NAMELY EXOGENOUS & REMOTE CARE; UTILIZATION OF DATA SERVICES HAS HIGH COMMERCIAL POTENTIAL Source: Frost and Sullivan Analysis Strengthen the One-Stop services through Fingenius portal • Enhance the features of the portal such as easy login details, lesser complexity in access of sample information and data, less complicated navigation for additional features, contact details of the Biobank personnel, frequent updates of the Finnish Biobank activities and so on. • Identify a data sharing network for repository hosting of biomedical data based on several performance attributes like de-identification, data quality control, application of meta-data and identifiers, flexibility of access and long term preservation • Identify clinical research aggregation platforms which host health data originating in a non- research context including clinical trial registries, databanks, peer-reviewed medical journal, and omics directories . This shall enable Fingenius to offer data driven value added services Biobanks MEDIUM TERM (1-2 years) FINBB, Biobanks NEAR TERM (6-12 months) Increase the data variety • Expand the data collection from the donors and increase the variety of data types viz. Exogenous data, Clinical/Dx data, OMICS data and remote care data. Data collection can be done from a variety of sources such as patient questionnaire, physical activity monitoring, environmental measures, health outcomes studies, imaging data, genotyping data and so on. • Explore the data rent model under which the Biobank can grant temporary access to data to the end-users while keeping the ownership of the data with themselves. Utilization of data services is high for the Pharma and the Healthtech segment. 1 Expand data services 2 Enhance digitization capabilities Enabling Digitization and Data Services Responsible Stakeholders Expected Timelines
  31. 31. 31 FINNISH BIOBANKS CAN INCORPORATE TOOLS FOR EFFECTIVE NETWORKING AND RESOURCE SHARING IN MAJOR THERAPY AREAS SUCH AS ONCOLOGY OR GENOMICS Source: Frost and Sullivan Analysis Biobanks MEDIUM TERM (1-2 years) Develop capabilities in Oncology, Genomics and RWE • Oncology Clinical Development: Focus on precision oncology areas such as molecular signature, mutation pattern analysis, immunotherapy, etc. Furthermore the Biobanks can also look for expanding areas in Oncology such as molecular and genetic epidemiology (cancer causation), molecular pathology, and pharmacogenomics/pharmacoproteomics. Biobanks can also leverage their expertise in Oncology by incorporating tools for effective networking and resource sharing between biobanks. Examples include Minimum Information about Biobank Data Sharing Model (MIABIS 1.0/2.0), European Committee for Standardization (CEN) norms and Sample PREanalytical Code (SPREC) • Genomics: Next generation sequencing (NGS) will remain a key focus area however Biobanks should leverage participation in networks such as European Bioinformatics Institute (EMBL-EBI). Other potential research areas for Biobanks to explore include but not limited to single cell transcriptome analysis , tumor neoantigens from NGS data, among others. • RWE is a potential opportunity for the Finnish Biobanks however the utilization of biosamples and biodata for such studies is currently low and likely to grow further. Finnish Biobanks can position themselves as leaders in the category due to existing robust data infrastructure such as registries, population cohorts, patient records, and digitization of data. • Cdx presents a host of opportunities for the Finnish Biobank to develop capabilities especially in areas such as immunohistochemistry, in-situ hybridization, RT-PCR, gene sequencing, etc. 1 Focus on identifying the levers in growth opportunities Capacity Expansion Responsible Stakeholders Expected Timelines
  32. 32. 32 BIOBANKS NEED TO CONSIDER CONTINUOUS UP-GRADATION OF EXISTING SAMPLE MANAGEMENT SOLUTIONS TO HANDLE NEXT GENERATION HIGH-VALUE, LOW-VOLUME PERSONALIZED THERAPIES Source: Frost and Sullivan Analysis Invest in strengthening sample management infrastructure • Investing in state of the art equipment for next generation therapies that require cold chain handling, traceability, on-site storage and handling, and workflow coordination. • Adopting best practices for Automated sample handling, tube-scanning, cryopreservation units, LIMS data management systems, temperature controlled freezers, liquid nitrogen storage systems, track and trace technologies, remote monitoring of samples, DNA/RNA aliquoting Biobanks MEDIUM TERM (1-2 years) Biobanks LONG TERM (2-3 years) • Utilization of AI based technologies is a key to seize growth opportunity within the Digital pathology segment. The use of whole slide imaging technology has further increased the use of AI and ML tools in digital pathology. Key growth levers that propel use of AI in digital pathology include diagnostic pathology, deep learning system applications, and integration of advanced algorithms & computer aided diagnostic techniques (CADx/CADe). • Collaborate with key digital pathology companies in Europe such as Philips, Symex, Inspirata, Leica Biosystems, Perkin Elmer, etc. and participation in major events such as Digital pathology Congress 2 Automation in handling various sample types Capacity Expansion Responsible Stakeholders Expected Timelines
  33. 33. 33 FINNISH BIOBANKS NEED TO INVEST IN HUMAN CAPITAL TO ENHANCE LEGAL, SCIENTIFIC AND DATA SCIENCE EXPERTISE ENABLING COMMERCIAL PARTNERSHIPS Source: Frost and Sullivan Analysis Biobanks MEDIUM TERM (1-2 years) Invest in building human capital in Biobanks • Invest in hiring and retaining talent for managing activities in operations and for marketing and promotion. This includes marketing mangers and personnel with prior experience of working with commercial partners • Include a board of management with highly skilled and scientific resources as members or advisors who act as subject matter experts in the areas of data management and analysis • Hiring of legal experts in order to manage the contracts with the partners, conversant with the legal implications of the regulatory frameworks in both Finland and international • Hiring of data scientists who can act as data guardians to ensure privacy and data security , and manage functions that include but not limited to data standardization, use of analytical tools such as NLP, etc. for biospecimen annotation 3 Increasing human capital Capacity Expansion Responsible Stakeholders Expected Timelines
  34. 34. 34 Draft a robust project management plan • Develop a robust project management plan and standard operating procedures (SOPs) with details of activities, stakeholder responsibility for the activities, delivery timelines, current status, work breakdown structure (WBS). • Having established Ongoing communication with the end-users and updates about the project status are of importance to the end-users. FINBB, Biobanks MEDIUM TERM (1-2 years) Biobanks NEAR TERM (6-12 months) EASE OF INTERPRETATIONS OF LAWS SUCH AS ACT OF SECONDARY USE AND BIOBANK ACT AND USE OF SOPS, WBS IN PROJECT MANAGEMENT WILL ENHANCE BUSINESS EFFECTIVENESS OF THE FINNISH BIOBANKS Source: Frost and Sullivan Analysis Simplification and ease of interpretation of laws • Although the current Biobank Act is unique to Finland to provide a set of guidelines to govern the Biobanking activities, there is a need for better dissemination of laws in the area of broad consent, sample procurement and data sharing by the Biobanks • The introduction of Act of Secondary use of Data and laws related to national genome strategy, will enable researchers and service providers to collect, process data from different Finnish registries for broader use in Health such as personalized medicine, public health programs, etc. • In order to ease the interpretation of these laws , the Biobanks and FINBB can focus on ways to reach out to the research partners with knowledge modules, courses, hold seminars or webinars with FAQs on data access and application in research in context of the laws applicable 1 Regulations and Policies 2 Project Management Ease of doing Business Responsible Stakeholders Expected Timelines

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