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TARA Biosystems Award Write Up

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TARA Biosystems receives Frost & Sullivan's 2018 Technology Innovation Award.

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TARA Biosystems Award Write Up

  1. 1. 2018 North American Heart-on-a-Chip Technology Innovation Award 2018
  2. 2. BEST PRACTICES RESEARCH © Frost & Sullivan 2018 2 “We Accelerate Growth” Contents Background and Company Performance ........................................................................3 Industry Challenges..............................................................................................3 Technology Attributes and Future Business Value .....................................................4 Conclusion...........................................................................................................6 Significance of Technology Innovation ..........................................................................7 Understanding Technology Innovation ..........................................................................7 Key Benchmarking Criteria ....................................................................................8 Best Practices Award Analysis for TARA Biosystems ........................................................8 Decision Support Scorecard ...................................................................................8 Technology Attributes ...........................................................................................9 Future Business Value...........................................................................................9 Decision Support Matrix ......................................................................................10 Best Practices Recognition: 10 Steps to Researching, Identifying, and Recognizing Best Practices .................................................................................................................11 The Intersection between 360-Degree Research and Best Practices Awards.....................12 Research Methodology ........................................................................................12 About Frost & Sullivan ..............................................................................................12
  3. 3. BEST PRACTICES RESEARCH © Frost & Sullivan 2018 3 “We Accelerate Growth” Background and Company Performance Industry Challenges Cardiovascular side effects are a persistent concern in biopharmaceutical drug development. To gauge the safety risk of drug compounds, regulatory authorities mandate cardiac testing of all biopharmaceutical drug candidates. These tests include the hERG test, an in vitro assay that studies a single protein involved in muscle contractility in isolation, and an electrocardiogram (ECG) assay wherein drug candidates are tested in animals. The hERG test, while amenable to screening large numbers of compounds, may not reflect the effects of a drug in the complex setting of the human heart. ECG studies in animals can ameliorate this concern; however, differences in physiology between animals and humans have often resulted in poor translation of animal results to humans. There is a growing consensus that the current paradigm, with its limitations, has had an outsized impact on new drug development. Approximately 60% of new molecular entities show hERG liability and are abandoned in early development. Doubts persist as to how many of these compounds would pose an unacceptable risk to humans. On the in vivo testing side, there has been a strong movement by regulators and industry to reduce animal testing for ethical reasons. In addition, late stage clinical development failures fuel the ongoing debate on the reliance on animal models as human proxies. Increasing regulation of animal testing has also increased the cost of performing animal studies. In this context, regulators and drug developers are keenly interested in identifying novel approaches for drug-induced cardiac toxicity testing that will overcome the limitations of the current paradigm. Heart Failure Drug Development Heart failure (HF) is a complex clinical syndrome in which heart muscle become damaged and cannot pump blood properly, resulting in insufficient supply of oxygen and nutrients to the body. The damage can result from a heart attack or long-term health issues like diabetes, high blood pressure and heart disease. HF can be caused by several conditions including heart attack, coronary artery disease, thyroid, kidney disease and cardiomyopathy. HF has been recognized as a global pandemic, affecting 26 million people worldwide. Mortality and morbidity rates are high and quality of life is poor for patients suffering from HF. Currently 5.7 million people in the United States (US) have HF, growing to more than 8 million by 2030, accounting for a 46% increase in prevalence.
  4. 4. BEST PRACTICES RESEARCH © Frost & Sullivan 2018 4 “We Accelerate Growth” In 2012, HF was responsible for an estimated health expenditure of approximately $31 billion. These costs are expected to increase by 127% between 2012 and 2030. Global trends mirror the US experience. Currently, there is no cure for heart failure in any of its forms, only therapies that alleviate symptoms or seek to slow disease progression. The lack of effective treatment options in the context of the growing prevalence and associated economic burden of HF highlights the urgency for new HF treatment approaches. To-date, therapeutic drug development for HF has been challenging and slow, stymied by the lack of physiologically-relevant preclinical models. Current state-of-the-art involves extensive use of 2D cell culture assays. While amenable to high-throughput screening, 2D systems are widely recognized as inadequate to investigate mechanisms of drug action. Technological advances at the interface of stem cell biology, engineering and materials science have fueled a rich pipeline of research giving rise to sophisticated organ-on-a-chip platforms. Organ-on-a-chip platforms produce functional human organoids or tissues in a controlled, microphysiological environment. A major limitation in the commercial scale-up of many organ-on-a-chip models stems from their reliance on primary cells for seeding. While primary cells possess an innate ability to replicate functionality, these cells are also difficult to maintain due to their relatively short period of homeostasis and their low differentiation ability, which is required to form functional organoids or tissues. Specifically, as it relates to cardiac, commercial-grade human iPSC-derived cardiomyocytes are now available through several suppliers, making the development of robust, 3D heart- on-a-chip models now possible. Those models which can demonstrate physiologically- relevant performance, mimicking the characteristics of adult human cardiac tissue, will be poised to propel the discovery and development of safe, effective, and much-needed HF therapies. Technology Attributes and Future Business Value Industry and Product Impact of Heart-on-a-Chip Platform TARA Biosystems, a human heart-on-a-chip company headquartered in New York, has developed a proprietary platform for engineering human-relevant cardiac tissues. The company offers a variety of services and solutions for evaluating the safety and efficacy of biopharmaceutical drugs. Biowire™ II is TARA Biosystems’ showcase platform. Frost & Sullivan identified TARA’s in vitro human heart-on-a-chip model as a tremendous enabling innovation in the development of the next generation of medicines for cardiovascular diseases. Tissues engineered from the Biowire™ II platform have been shown to mimic functional human
  5. 5. BEST PRACTICES RESEARCH © Frost & Sullivan 2018 5 “We Accelerate Growth” heart muscle with a high degree of fidelity to human biology, thereby providing a robust platform for predicting drug-induced side effects and therapeutic efficacy. Biowire™ II can not only accelerate the drug discovery and development process but can also decrease associated costs by providing better human translation data than existing assays and animal model studies. The platform can also help weed out drugs that have unacceptable levels of cardiotoxicity earlier in the drug discovery process and highlight the contributing factors which could, in turn, help in the design of better drugs. Robust Microphysiological System with Predictive Power TARA Biosystems uses induced pluripotent stem cells (iPSCs) to generate cardiac tissues on the Biowire™ II platform, biomimetically exercising the immature tissue until it exhibits the characteristic hallmarks of adult human cardiac muscle tissue. Using these engineered replicas of adult human heart muscle, the effects of a drug candidate can be observed without the need for human testing. Some of the unique maturity hallmarks of the Biowire™ II platform cardiac tissues are positive force-frequency, inotropic response, improved post-rest potentiation, decrease in spontaneous beating, improved structural alignment, and adult-like action potential. The Biowire™ II platform employs a multi-well cell culture plate. iPSC-derived cardiomyocytes along with a small population of fibroblasts are seeded in the wells. The cardiac tissues assemble and attach to polymer wires that are suspended across each well. Via embedded electrodes that deliver electrical stimulation in accordance with specific protocols, the Biowire™ II platform simulates the natural pacing of the heart. The resultant contraction and relaxation of the suspended tissues is captured by the deflection of the polymer wires which can be non-invasively imaged in real time. Biowire™ II is capable of measuring important metrics of human cardiac physiology such as maximum force, rates of contraction and relaxation, calcium handling, electrophysiology, gene expression and structure. These established functional metrics empower the heart-on-a-chip platform with the ability to determine whether a new drug is disrupting the normal pumping mechanism, and also to provide in-depth information clarifying whether the disruption is due to the heart not filling up or the heart’s inability to distribute blood. Applicability to Disease Phenotypes, Precision Cardiology and Other Tissue Types The Biowire™ II platform can also be used to engineer tissues which accurately mimic specific human heart failure phenotypes. These diseased tissue constructs can be used for both discovery and development of novel medicines to treat heart failure phenotypes. They can also be used for toxicology studies. Biowire™ II can also be used to engineer customized models for precision medicine via patient-derived iPSC-derived cardiomyocyte cell lines.
  6. 6. BEST PRACTICES RESEARCH © Frost & Sullivan 2018 6 “We Accelerate Growth” Unlike most organ-on-a-chip companies that develop multi-organ chips or several single organ-on-a-chip platforms, TARA Biosystems singularly focuses on the development of heart-on-a-chip technology. Frost & Sullivan believes this better equips the company to deliver comprehensive insights across cardiac safety and mechanistic studies. That said, the Biowire™ II platform is capable of producing 3D skeletal muscle as a future growth direction. Conclusion Frost & Sullivan recognizes the excellence of TARA Biosystems’ groundbreaking Biowire™ II heart-on-a-chip platform, which produces mature engineered cardiac tissues and has numerous functional metrics that could serve as an accurate predictive tool for cardiac drug discovery and development. The Biowire™ II platform represents the next logical step in the evolution of preclinical testing platforms, from cell assays and animal models to a better predictive and human- relevant model. Biowire™ II also has the potential to contribute to precision care, catering to individuals who do not respond to traditional treatments. Frost & Sullivan believes that TARA Biosystems’ Biowire™ II heart-on-a-chip platform is set to revolutionize drug discovery and development and, ultimately, to enable safer and more effective therapies for patients. With a strong emphasis in replicating the fidelity of human cardiac biology and a strong overall performance in terms of application of technology, science, engineering, and vision, TARA Biosystems has earned Frost & Sullivan’s 2018 Technology Innovation Award.
  7. 7. BEST PRACTICES RESEARCH © Frost & Sullivan 2018 7 “We Accelerate Growth” Significance of Technology Innovation Ultimately, growth in any organization depends upon finding new ways to excite the market and upon maintaining a long-term commitment to innovation. At its core, technology innovation, or any other type of innovation, can only be sustained with leadership in three key areas: understanding demand, nurturing the brand, and differentiating from the competition. Understanding Technology Innovation Technology innovation begins with a spark of creativity that is systematically pursued, developed, and commercialized. That spark can result from a successful partnership, a productive in-house innovation group, or a bright-minded individual. Regardless of the source, the success of any new technology is ultimately determined by its innovativeness and its impact on the business as a whole.
  8. 8. BEST PRACTICES RESEARCH © Frost & Sullivan 2018 8 “We Accelerate Growth” Key Benchmarking Criteria For the Technology Innovation Award, Frost & Sullivan analysts independently evaluated two key factors—Technology Attributes and Future Business Value—according to the criteria identified below. Technology Attributes Criterion 1: Industry Impact Criterion 2: Product Impact Criterion 3: Scalability Criterion 4: Visionary Innovation Criterion 5: Application Diversity Future Business Value Criterion 1: Financial Performance Criterion 2: Customer Acquisition Criterion 3: Technology Licensing Criterion 4: Brand Loyalty Criterion 5: Human Capital Best Practices Award Analysis for TARA Biosystems Decision Support Scorecard To support its evaluation of best practices across multiple business performance categories, Frost & Sullivan employs a customized Decision Support Scorecard. This tool allows our research and consulting teams to objectively analyze performance, according to the key benchmarking criteria listed in the previous section, and to assign ratings on that basis. The tool follows a 10-point scale that allows for nuances in performance evaluation. Ratings guidelines are illustrated below. RATINGS GUIDELINES The Decision Support Scorecard is organized by Technology Attributes and Future Business Value (i.e., these are the overarching categories for all 10 benchmarking criteria; the definitions for each criterion are provided beneath the scorecard.). The research team confirms the veracity of this weighted scorecard through sensitivity analysis, which confirms that small changes to the ratings for a specific criterion do not lead to a significant change in the overall relative rankings of the companies.
  9. 9. BEST PRACTICES RESEARCH © Frost & Sullivan 2018 9 “We Accelerate Growth” The results of this analysis are shown below. To remain unbiased and to protect the interests of all organizations reviewed, we have chosen to refer to the other key participants as Competitor 2 and Competitor 3. Measurement of 1–10 (1 = poor; 10 = excellent) Technology Innovation Technology Attributes Future Business Value Average Rating TARA Biosystems Inc. 9 9 9 Competitor 2 7.5 8.5 8 Competitor 3 8 7 7.5 Technology Attributes Criterion 1: Industry Impact Requirement: Technology enables the pursuit of groundbreaking ideas, contributing to the betterment of the entire industry. Criterion 2: Product Impact Requirement: Specific technology helps enhance features and functionalities of the entire product line for the company. Criterion 3: Scalability Requirement: Technology is scalable, enabling new generations of products over time, with increasing levels of quality and functionality. Criterion 4: Visionary Innovation Requirement: Specific new technology represents true innovation based on a deep understanding of future needs and applications. Criterion 5: Application Diversity Requirement: New technology serves multiple products, multiple applications, and multiple user environments. Future Business Value Criterion 1: Financial Performance Requirement: Potential is high for strong financial performance in terms of revenues, operating margins, and other relevant financial metrics. Criterion 2: Customer Acquisition Requirement: Specific technology enables acquisition of new customers, even as it enhances value to current customers. Criterion 3: Technology Licensing Requirement: New technology displays great potential to be licensed across many sectors and applications, thereby driving incremental revenue streams.
  10. 10. BEST PRACTICES RESEARCH © Frost & Sullivan 2018 10 “We Accelerate Growth” Criterion 4: Brand Loyalty Requirement: New technology enhances the company’s brand, creating and/or nurturing brand loyalty. Criterion 5: Human Capital Requirement: Customer impact is enhanced through the leverage of specific technology, translating into positive impact on employee morale and retention. Decision Support Matrix Once all companies have been evaluated according to the Decision Support Scorecard, analysts then position the candidates on the matrix shown below, enabling them to visualize which companies are truly breakthrough and which ones are not yet operating at best-in-class levels. High Low Low High FutureBusinessValue Technology Attributes Competitor 2 Competitor 3 TARA Biosystems Inc.
  11. 11. BEST PRACTICES RESEARCH © Frost & Sullivan 2018 11 “We Accelerate Growth” Best Practices Recognition: 10 Steps to Researching, Identifying, and Recognizing Best Practices Frost & Sullivan analysts follow a 10-step process to evaluate Award candidates and assess their fit with select best practice criteria. The reputation and integrity of the Awards are based on close adherence to this process. STEP OBJECTIVE KEY ACTIVITIES OUTPUT 1 Monitor, target, and screen Identify Award recipient candidates from around the globe  Conduct in-depth industry research  Identify emerging sectors  Scan multiple geographies Pipeline of candidates who potentially meet all best- practice criteria 2 Perform 360-degree research Perform comprehensive, 360-degree research on all candidates in the pipeline  Interview thought leaders and industry practitioners  Assess candidates’ fit with best-practice criteria  Rank all candidates Matrix positioning of all candidates’ performance relative to one another 3 Invite thought leadership in best practices Perform in-depth examination of all candidates  Confirm best-practice criteria  Examine eligibility of all candidates  Identify any information gaps Detailed profiles of all ranked candidates 4 Initiate research director review Conduct an unbiased evaluation of all candidate profiles  Brainstorm ranking options  Invite multiple perspectives on candidates’ performance  Update candidate profiles Final prioritization of all eligible candidates and companion best-practice positioning paper 5 Assemble panel of industry experts Present findings to an expert panel of industry thought leaders  Share findings  Strengthen cases for candidate eligibility  Prioritize candidates Refined list of prioritized Award candidates 6 Conduct global industry review Build consensus on Award candidates’ eligibility  Hold global team meeting to review all candidates  Pressure-test fit with criteria  Confirm inclusion of all eligible candidates Final list of eligible Award candidates, representing success stories worldwide 7 Perform quality check Develop official Award consideration materials  Perform final performance benchmarking activities  Write nominations  Perform quality review High-quality, accurate, and creative presentation of nominees’ successes 8 Reconnect with panel of industry experts Finalize the selection of the best-practice Award recipient  Review analysis with panel  Build consensus  Select recipient Decision on which company performs best against all best-practice criteria 9 Communicate recognition Inform Award recipient of Award recognition  Present Award to the CEO  Inspire the organization for continued success  Celebrate the recipient’s performance Announcement of Award and plan for how recipient can use the Award to enhance the brand 10 Take strategic action Upon licensing, company is able to share Award news with stakeholders and customers  Coordinate media outreach  Design a marketing plan  Assess Award’s role in future strategic planning Widespread awareness of recipient’s Award status among investors, media personnel, and employees
  12. 12. BEST PRACTICES RESEARCH © Frost & Sullivan 2018 12 “We Accelerate Growth” The Intersection between 360-Degree Research and Best Practices Awards Research Methodology Frost & Sullivan’s 360-degree research methodology represents the analytical rigor of our research process. It offers a 360-degree-view of industry challenges, trends, and issues by integrating all 7 of Frost & Sullivan's research methodologies. Too often companies make important growth decisions based on a narrow understanding of their environment, leading to errors of both omission and commission. Successful growth strategies are founded on a thorough understanding of market, technical, economic, financial, customer, best practices, and demographic analyses. The integration of these research disciplines into the 360-degree research methodology provides an evaluation platform for benchmarking industry participants and for identifying those performing at best-in-class levels. About Frost & Sullivan Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth and achieve best-in-class positions in growth, innovation and leadership. The company's Growth Partnership Service provides the CEO and the CEO's Growth Team with disciplined research and best practice models to drive the generation, evaluation and implementation of powerful growth strategies. Frost & Sullivan leverages more than 50 years of experience in partnering with Global 1000 companies, emerging businesses, and the investment community from 45 offices on six continents. To join our Growth Partnership, please visit http://www.frost.com. 360-DEGREE RESEARCH: SEEING ORDER IN THE CHAOS

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