In Pharma value chain, PBMs manage to benefit

As 2020 Democratic presidential aspirants lean into their game of one-upsmanship on policies that would slow medical progress and undermine the U.S. biopharmaceutical industry, it’s a relief to see the Senate convene a hearing Tuesday on the self-dealing middlemen in the drug delivery system whose profits are largest when a drug’s list price is highest. Pharmacy benefit managers (PBM) help determine which medications get placed on insurance formularies and how much patients pay out of pocket for drugs they often can’t live without. However, PBMs are not primarily concerned with negotiating lower drug prices on behalf of patients, no matter what their press releases say. Their allegiance is to their shareholders and the health insurers who hire or own them. PBMs were originally conceived to help employers and insurers negotiate the best prices on prescription drugs, a fine idea in a market-based health care system like ours. But massive industry consolidation has fundamentally changed the way they do business. In private, PBMs ask biopharma companies to preserve high list prices and write them larger rebate checks in exchange for prime formulary placement. In public, these middlemen castigate drug companies for high prices while laughing all the way to the bank.

Spotlight

Harvest Healthcare Ltd

Harvest Healthcare Ltd is the leading manufacturer and distributor of quality healthcare equipment to the NHS, Care Home and Community markets, throughout the UK and internationally. We are continually developing our range of products to deliver a complete solution for all modern care environments. Focused on meeting the ever-evolving needs of patients, Harvest deliver quality and value for money.

OTHER ARTICLES
Medical

Data Analytics: A Groundbreaking Technology in Biotech

Article | July 14, 2022

Biotechnology is a vast discipline of biology that employs diverse biological systems to create solutions that can significantly alter the ways in which they operate across various domains. That said, biotechnology is not a new notion. It has existed for millennia, with ancient civilizations using its earliest incarnations to cultivate crops and create alcoholic beverages. Today, the biotechnology industry has developed by leaps and bounds and has amassed a vast quantity of scientific data through study and research. Given the importance of data in the biotechnology business, it is not difficult to understand why biotech companies utilize data analytics. Modern data analytics tools have made it possible for researchers in the biotech industry to build predictive analytics models and gain knowledge about the most efficient approaches to accomplish their desired goals and objectives. Data analytics is increasingly being adopted by biotech businesses to better understand their industry and foresee any problems down the road. How is Data Analytics Revolutionizing Fields in Biotechnology? Today's business and scientific fields greatly benefit from data. Without the analysis of vast information libraries that provide new insights and enable new innovations, no industry can really advance. Being highly reliant on big data analytics, biotech is not an exception in this regard. With the tools and methods that help scientists systematize their findings and speed up their research for better and safer results, data analytics is making deeper inroads into the biotechnology industry. It is emerging as a crucial link between knowledge and information and is extensively being used for purposes other than just examining the information that is already available. The following are a few of the cutting-edge biotechnology applications of data analytics Genomics and Disease Treatment Pharmaceutical Drug Discovery Drug Recycling and Safety Agriculture and Agri-products Environmental Damage Mitigation Data Analytics Possibilities in Biotechnology With data analytics becoming an integral part of how biotech businesses operate, biotechnologists and related stakeholders need to understand its emergence and crucial role. Data analytics has opened new frontiers in the realm of biotechnology. Thanks to developments in data analytics, research and development activities that once took years may now be accomplished in a matter of months. Also, now scientists have access to biological, social, and environmental insights that can be exploited to create more effective and sustainable products. By understanding the importance of data-related tools and techniques applications, biotech companies are aiming to invest in the popularizing technology to stay updated in the fast-paced biotechnology industry.

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MedTech

AI and Biotechnology: The Future of Healthcare Industry

Article | October 7, 2022

Artificial intelligence has grasped the foundation in biotech. It can have the most innovative impact on biotechnology. AI has already established its presence in our day-to-day life. AI has made the existence of self-driving cars possible. Likewise, the benefits and quality that it can contribute to biotech can also be felt. With AI, bio technicians will be able to enhance virtual screening, overlook preliminary datasets from clinics, and decipher an enormous amount of information. It can also help in improving the medication process by gathering and analyzing every bit of information. The Significance of AI in Biotechnology In the past few years, the application of artificial intelligence in the biotechnology industry has shifted from being sci-fi to sci-fact. A vast number of biotech companies like Deep Genomics are adopting AI for making data-driven decisions and use analytics tools to work efficiently. Unlike the AI robots in sci-fi that are ready to take over the world. AI designed for biotech has been designed to solve certain problems or complete a bunch of tasks by using automated algorithms. The aim of AI technology for biotech is to collect insights along with hidden patterns from large amounts of data. All the different industries of biotech including agriculture, animal, medical, industrial, and bioinformatics are gradually being affected by artificial intelligence. Moreover, the biotech industry is realizing that AI enables them some of the important strength to their business, including: Expanding accessibility Cost-effectiveness Critical predictions Efficient decision-making Research centers like PwC have also estimated output of $15.7 trillion by 2030 solely with AI contribution in industries. A survey revealed that about 44% of life science experts are using AI for R&D activities, as well. Use of AI in Biotechnology Altering Biomedical and Clinical Data So far the most developed use of AI is its ability to read voluminous data records and interpret them. It can prove to be a life-save for bio technicians who would have to examine that much data from research publications by themselves for the validation of their hypothesis. With the help of AI, clinical studies of patients will also become easier as all the examination reports and prescriptions will be stored in one place for cross-reference. Furthermore, it will also help in blending and fetching data into usable formats for analysis. Test Result Prediction Through trial and error, AI along with machine learning can help in predicting the response of the patient to certain drugs to provide more effective outcomes. Drug Design & Discovery AI plays a vital role whether it’s designing a new molecule or identifying new biological targets. It helps in identifying and validating drugs. It reduces the cost and time spent on the entire drug trial process and reaches the market. Personalized Medications for Rare Diseases With the combination of body scan results, patients’ body and analytics, AI can also help in detecting dangerous diseases at an early stage. Improving Process of Manufacturing To improve the process of manufacturing in biotechnology, AI offers a wide range of opportunities. It controls quality, reduces wastage, improves useability, and minimizes the designing time. Moving Towards AI-Enhanced Biotech Future Ever since the concept of artificial intelligence has arrived, being curious by nature, humans have started working towards achieving this goal. It has been growing at a fast pace while showing unbelievable growth and achievements at times. In comparison to the traditional methods used in the biotechnology industry, AI-based methods seem more reliable and accurate. In the upcoming years, it will show its success by improving the quality of health people have. You can also develop your AI-based application or know more about it by taking IT consultations.

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MedTech

How to Choose a Reliable Biotech Clinical Trial Management System?

Article | September 22, 2022

Introduction The medical and life-science industries are experiencing a robust transformation with the increasing prevalence of various types of diseases, including infectious diseases, chronic disorders, and acute conditions around the world. As a result, a significant rise in demand for more effective therapeutic drugs and bionics is being witnessed, leading to a swift increase in the number of clinical trials. For a successful trial, it is important for biotech companies to ensure the data submitted to regulatory bodies regarding clinical trials is accurate, reliable, and definitive from an ethical point of view. A reliable clinical trial management system plays a vital role in collecting, monitoring, and managing clinical data. The availability of high-quality clinical data also helps clinical research institutions make efficient treatment decisions and provide proper patient care. Hence, a number of biotech companies and research organizations are focusing on leveraging innovative clinical trial management solutions to handle a large amount of data, particularly in multi-center trials, and generate reliable, high-quality, and statistically sound data from clinical trials. However, selecting the most appropriate and reliable clinical trial management system is vital for the clinical trial's success. Let's see some of the steps that will assist these firms in choosing the right CTMS. Key Steps for Selecting Right Biotech Clinical Trial Management System Prioritize Study Needs Considering and prioritizing study needs is a crucial step in choosing the most reliable clinical trial management system for biotech companies. Prioritizing helps them to identify a solution that improves the study's quality and removes uncertainty for researchers when faced with difficult choices. Hence, biotech and life-science organizations should choose a clinical trial system that is simple to use, well-organized, and suitably designed to minimize the number of clicks required to complete a task. Select CTMS with Multiple Integrations Integrated clinical trial management systems provide the best value for the companies’ funds as they guarantee the smooth functioning of research protocols. In addition, integrations are necessary to fully understand the importance and advantages of clinical trial management software for ensuring smooth transitions between site management and data collection. Biotech and clinical research should look for CTMS platforms that can integrate with electronic medical record (EMR) platforms and clinical research process content (CRPC) billing grids. This will allow them to use the same billing designations and ensure compliance while minimizing the need for duplicate processes. Ensure System Compliance and Security Clinical research organizations need to adhere to a plethora of complex regulations in order to ensure compliance with one of the most challenging environments of principles, which is information security and privacy. Security and system compliance are vital aspects of choosing the right CTMS solutions for biotech firms as they assist in building trust and form a part of the system’s duties. While selecting CTMS systems, it is essential for companies engaged in clinical research to ensure that these platforms are able to configure both, group and individual permissions, along with having a data backup and recovery plan for hosted systems. This will allow companies to assess the privacy and security implications of research and anticipate complications that may arise in each phase of the project. Assess the Scalability Choosing a scalable CTMS that can accommodate various types of fluctuations and expansions enables biotech and clinical firms to quickly adapt to fast-changing trends and demand spikes while reducing maintenance costs and enhancing user agility. As scalability also means secure and expanded data storage, these businesses should instead use SaaS solutions than manually manage an ever-growing collection of hard drives. The right CTMS ensures accommodating the firm’s availability requirements without incurring the capital costs associated with expanding a physical infrastructure. The Closing Thought A well-executed and successful clinical trial involves multiple stages and processes. Several quality controls and stringent adherence to regulations are essential for the steps, along with efficient cross-departmental processes and procedures. Incorporating the right CTMS paves the way for paperless data collection, regulatory filing, and fiscal management tools for biotech researchers and administrative personnel.

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MedTech

Biotech in 2022

Article | July 11, 2022

The robust global channel of more than, 800 gene and cell curatives presently in trials will produce clinical readouts in 2022, revealing what lies ahead for advanced curatives. The impact will be felt in 2022, no matter how you slice it. Eventually, how well industry and non-supervisory bodies unite to produce new frameworks for advanced therapies will shape the year 2022 and further. Pacific Northwest talent will continue to contribute to the advancement of gene and cell curatives in both the short and long term, thanks to its deep pool of ground-breaking scientific developers, entrepreneurial directorial leadership, largely skilled translational scientists, and endured bio manufacturing technicians. We may see continued on-life science fund withdrawal from biotech in 2021, but this can be anticipated as a strong comeback in 2022 by biotech industry, backed by deep-pocketed life science investors who are committed to this sector. A similar investment, combined with pharma's cash-heavy coffers, can result in increased junction and acquisition activity, which will be a challenge for some but an occasion for others. Over the last five years, investment interest in Seattle and the Pacific Northwest has grown exponentially, from Vancouver, British Columbia, to Oregon. The region's explosive portfolio of new biotech companies, innovated out of academic centres, demonstrates the region's growing recognition of scientific invention. This created a belief that continued, especially because Seattle's start-ups and biotech enterprises are delivering on their pledge of clinical and patient impact. Talent and staffing will continue to be difficult to find. It's a CEO's market, but many of these funds' return, and are not rising in proportion to the exorbitant prices they're paying to enter deals. This schism has become particularly pronounced in 2021. Hence, everyone in biotech is concerned about reclamation and retention.

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Spotlight

Harvest Healthcare Ltd

Harvest Healthcare Ltd is the leading manufacturer and distributor of quality healthcare equipment to the NHS, Care Home and Community markets, throughout the UK and internationally. We are continually developing our range of products to deliver a complete solution for all modern care environments. Focused on meeting the ever-evolving needs of patients, Harvest deliver quality and value for money.

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Research, Diagnostics

ADOCIA Announces the Availability of a Prospectus for its Capital Increase and Convertible Bond Issue

Businesswire | July 28, 2023

Adocia (Euronext Paris: FR0011184241 – ADOC), a clinical-stage biopharmaceutical Company focused on the research and development of innovative therapeutic solutions for the treatment of diabetes and obesity (the “Company”), announces today the availability of an amendment to its 2022 Universal Registration Document, filed by the Company with the Autorité des Marchés Financiers ("AMF") on July 26, 2023, under number D.23-0346-A01, and an admission Prospectus approved by the AMF on July 26, 2023, under number 23-329, in connection with its reserved capital increase of around 5 million euros and the issue of convertible bonds subscribed for around 5 million euros. The Prospectus comprises: the 2022 Universal Registration Document filed by the Company with the AMF on April 26, 2023, under number D.23-0346; the amendment to the 2022 Universal Registration Document filed by the Company with the AMF on July 26, 2023 under number D.23-0346-A01; the Securities Note; and the Prospectus summary (included in the Securities Note). These documents can also be consulted on the Company's website (www.adocia.com) and on the AMF website (www.amf-France.org). About Adocia Adocia is a biotechnology Company specializing in the discovery and development of therapeutic solutions in the field of metabolic diseases, primarily diabetes and obesity. The Company has a broad portfolio of drug candidates based on four proprietary technology platforms: 1) The BioChaperone® technology for the development of new generation insulins and products combining insulins with other classes of hormones; 2) AdOral®, an oral peptide delivery technology; 3) AdoShell®, an immunoprotective biomaterial for cell transplantation, with a first application in pancreatic cells transplantation; 4) AdoGel®, a long-acting drug delivery platform. Adocia holds more than 25 patent families. Based in Lyon, the Company has about 100 employees. Adocia is listed on the regulated market of EuronextTM Paris (Euronext: ADOC; ISIN: FR0011184241).

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Research

Skye Bioscience Establishes New Cannabinoid Pharmaceutical Innovation Program

Skye Bioscience, Inc. | October 13, 2021

Skye Bioscience, Inc. (“Skye” or the “Company”), a biopharmaceutical company developing proprietary, synthetic cannabinoid-derived molecules to treat glaucoma and other diseases with significant unmet need, has formed a new exclusive sponsored research agreement with Emerald Health Biotechnology Espana SLU (“EHBE”), focused on developing and characterizing novel molecules that can affect the endocannabinoid system (ECS) for therapeutic benefit. The research initiative, referred to as the Cannabinoid Pharmaceutical Innovation Program (CPIP), will focus on targeting important signaling pathways in the endocannabinoid system to realize therapeutically beneficial effects. The CPIP reflects the company’s continued commitment to expand its leadership in cannabinoid-based science and cutting-edge research that can be commercialized through new and existing technologies. It leverages R&D initiatives with key opinion leaders with specialized research centers in the US and internationally, such as the University of Mississippi, University of Cordoba, and University of Eastern Piedmont. This agreement deepens the commitment of Drs. Munoz and Appendino, who will be the principal investigators and continue to lead Skye’s scientific advisory board. The CPIP is driven by the focus on investing in key value-creating pillars for the Company - ophthalmology applications, clinical development, pipeline expansion and people - to achieve the vision of creating a world-class cannabinoid pharmaceutical company. "As the world comes to appreciate the broad and dynamic role of the endocannabinoid system in humans and animal health, the pharmaceutical potential of cannabinoids to modulate this system is just starting to be understood. While the anecdotal evidence of the health benefits of cannabinoids dates back millenia, modern science has barely scratched the surface to validate the benefits of the ECS in preventing and treating diseases. Skye’s ambition is to play a leading role in effecting important therapeutic outcomes by influencing the endocannabinoid system. We want to continue to make strategic investments that can further bring value to all stakeholders, and our clear focus in this initiative is to achieve novel discoveries that achieve important clinical utility with commercial value. These overarching priorities will guide our strategy, project initiatives, and investments." Punit Dhillon, Chief Executive Officer and Chair of Skye Bioscience Under the terms of the agreement: Skye will approve and fund designated projects and have exclusive rights to all data and products, and any intellectual property resulting from this research collaboration will be owned by Skye Research will be broad and encompass novel molecules that modulate the ECS to treat or prevent human or animal diseases EHBE will receive a single digit royalty on all licensing revenue or other consideration paid to Skye by a third-party licensee, assignee or purchaser related to any product commercialized as part of a Skye Project Skye will pay EHBE a retainer of $200,000 per year. “Having worked with cannabinoids and the endocannabinoid system for over 25 years, it is clear that there are tremendous opportunities to discover and create cannabinoid-derived molecules with potential to beneficially interact with the ECS for positive medical outcomes. With the launch of Skye’s new Cannabinoid Pharmaceutical Innovation Program with our research team in Cordoba, Spain, our efforts will focus on preclinical development of CBDVHS, R&D of CB1 modulators involved in pain, inflammatory diseases, neurological diseases, fibrotic diseases and metabolic diseases, and drug discovery relating to modulators of the cannabinoid receptors CB2 and GPR55. We aim to generate a wide portfolio of proprietary products and IP around molecules with commercial potential.” Eduardo Munoz, Managing Director of Emerald Health Biotechnology Espana About Emerald Health Biotechnology Espana SLU Emerald Health Biotechnology España SLU (EHBE) is a preclinical-stage drug development research company focused on new cannabinoid derivatives to treat severe life-threatening conditions and other pathologies. Led by cannabinoid research experts and scientific advisors to Skye, Drs. Eduardo Munoz and Giovanni Appendino, EHBE is a pioneer in developing chemical cannabinoid derivatives that improve the therapeutic properties of the natural compounds. About Skye Bioscience Skye Bioscience Inc. is a biopharmaceutical company unlocking the pharmaceutical potential of cannabinoids through the development of its proprietary, cannabinoid-derived molecules to treat diseases with significant unmet needs. The company’s lead program, THCVHS, is focused on treating glaucoma, a disease with no cure and the world’s leading cause of irreversible blindness. For more information, please visit: www.skyebioscience.com

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Diagnostics

MacroGenics Uses Genedata Profiler to Improve Immunotherapy Development

MacroGenics, Genedata | April 20, 2021

Genedata, the leading supplier of enterprise software solutions for biopharmaceutical R&D, revealed today a long-term collaboration agreement with MacroGenics, a biopharmaceutical firm and emerging pioneer in discovering and commercializing innovative immune-oncology therapeutics. The agreement provides MacroGenics access to Genedata Profiler® as well as consulting services to aid in the platform's accelerated adoption and integration into MacroGenics' R&D infrastructure. The use of Genedata Profiler improves MacroGenics' ability to generate new hypotheses from combined databases from both proprietary and public sources, assisting in the interpretation of biomarker data and the design of clinical trials. The Genedata Profiler software provides MacroGenics with a comprehensive solution that solves a variety of problems while also presenting new possibilities, such as: • Aggregation and curation of dispersed clinical and non-clinical research data, in a central repository, to create an institutional memory; • Self-service access to data and easy-to-use analytical tools empowers data scientists and clinicians to run complex analyses in a controlled and secure environment; • Cross-study and cross-technology data integration and analysis unlock actionable insights and facilitate informed decision-making; and • Automated workflows for data harmonization, integration, and analytics streamlines and standardizes analytical processes, while ensuring data reproducibility. MacroGenics profits from Genedata's technical domain experience in data analytics and interpretation, IT support, and scientific consulting in addition to software while retaining sole ownership of its proprietary data. The MacroGenics science team is collaborating closely with Genedata experts to unlock the potential of their data and advance their translational and clinical research programs. MacroGenics will be able to produce new scientific insights and hypotheses due to the streamlined, data-driven approach provided by Genedata Profiler. • Accelerate the discovery and development of predictive biomarkers indicative of therapy response to define the best subpopulation of patients to benefit from their immunotherapies, • Identify drugs’ specific indications to improve clinical trials inclusion criteria, • Determine the therapeutic mechanism of action (pharmacodynamics) to strengthen the rationale of the treatment regimen. Genedata Profiler, which is already in operation, has advanced MacroGenics' internal data organization and formatting. Data integration workflows and applied analytics conducted within the system have enhanced many existing translational/clinical trials and resulted in findings for presentations at international conferences (ASCO, ASH). MacroGenics will continue to work with Genedata to improve their analytical capability to help forward and reverse translational studies. About Genedata Genedata transforms data into intelligence with innovative software solutions and domain-specific consulting services that automate complex, large-scale experimental processes and enable organizations to maximize the ROI in their R&D, spanning early discovery to the clinic. Founded in 1997, Genedata is headquartered in Switzerland with additional offices in Germany, Japan, Singapore, the UK, and the US.

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Research, Diagnostics

ADOCIA Announces the Availability of a Prospectus for its Capital Increase and Convertible Bond Issue

Businesswire | July 28, 2023

Adocia (Euronext Paris: FR0011184241 – ADOC), a clinical-stage biopharmaceutical Company focused on the research and development of innovative therapeutic solutions for the treatment of diabetes and obesity (the “Company”), announces today the availability of an amendment to its 2022 Universal Registration Document, filed by the Company with the Autorité des Marchés Financiers ("AMF") on July 26, 2023, under number D.23-0346-A01, and an admission Prospectus approved by the AMF on July 26, 2023, under number 23-329, in connection with its reserved capital increase of around 5 million euros and the issue of convertible bonds subscribed for around 5 million euros. The Prospectus comprises: the 2022 Universal Registration Document filed by the Company with the AMF on April 26, 2023, under number D.23-0346; the amendment to the 2022 Universal Registration Document filed by the Company with the AMF on July 26, 2023 under number D.23-0346-A01; the Securities Note; and the Prospectus summary (included in the Securities Note). These documents can also be consulted on the Company's website (www.adocia.com) and on the AMF website (www.amf-France.org). About Adocia Adocia is a biotechnology Company specializing in the discovery and development of therapeutic solutions in the field of metabolic diseases, primarily diabetes and obesity. The Company has a broad portfolio of drug candidates based on four proprietary technology platforms: 1) The BioChaperone® technology for the development of new generation insulins and products combining insulins with other classes of hormones; 2) AdOral®, an oral peptide delivery technology; 3) AdoShell®, an immunoprotective biomaterial for cell transplantation, with a first application in pancreatic cells transplantation; 4) AdoGel®, a long-acting drug delivery platform. Adocia holds more than 25 patent families. Based in Lyon, the Company has about 100 employees. Adocia is listed on the regulated market of EuronextTM Paris (Euronext: ADOC; ISIN: FR0011184241).

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Research

Skye Bioscience Establishes New Cannabinoid Pharmaceutical Innovation Program

Skye Bioscience, Inc. | October 13, 2021

Skye Bioscience, Inc. (“Skye” or the “Company”), a biopharmaceutical company developing proprietary, synthetic cannabinoid-derived molecules to treat glaucoma and other diseases with significant unmet need, has formed a new exclusive sponsored research agreement with Emerald Health Biotechnology Espana SLU (“EHBE”), focused on developing and characterizing novel molecules that can affect the endocannabinoid system (ECS) for therapeutic benefit. The research initiative, referred to as the Cannabinoid Pharmaceutical Innovation Program (CPIP), will focus on targeting important signaling pathways in the endocannabinoid system to realize therapeutically beneficial effects. The CPIP reflects the company’s continued commitment to expand its leadership in cannabinoid-based science and cutting-edge research that can be commercialized through new and existing technologies. It leverages R&D initiatives with key opinion leaders with specialized research centers in the US and internationally, such as the University of Mississippi, University of Cordoba, and University of Eastern Piedmont. This agreement deepens the commitment of Drs. Munoz and Appendino, who will be the principal investigators and continue to lead Skye’s scientific advisory board. The CPIP is driven by the focus on investing in key value-creating pillars for the Company - ophthalmology applications, clinical development, pipeline expansion and people - to achieve the vision of creating a world-class cannabinoid pharmaceutical company. "As the world comes to appreciate the broad and dynamic role of the endocannabinoid system in humans and animal health, the pharmaceutical potential of cannabinoids to modulate this system is just starting to be understood. While the anecdotal evidence of the health benefits of cannabinoids dates back millenia, modern science has barely scratched the surface to validate the benefits of the ECS in preventing and treating diseases. Skye’s ambition is to play a leading role in effecting important therapeutic outcomes by influencing the endocannabinoid system. We want to continue to make strategic investments that can further bring value to all stakeholders, and our clear focus in this initiative is to achieve novel discoveries that achieve important clinical utility with commercial value. These overarching priorities will guide our strategy, project initiatives, and investments." Punit Dhillon, Chief Executive Officer and Chair of Skye Bioscience Under the terms of the agreement: Skye will approve and fund designated projects and have exclusive rights to all data and products, and any intellectual property resulting from this research collaboration will be owned by Skye Research will be broad and encompass novel molecules that modulate the ECS to treat or prevent human or animal diseases EHBE will receive a single digit royalty on all licensing revenue or other consideration paid to Skye by a third-party licensee, assignee or purchaser related to any product commercialized as part of a Skye Project Skye will pay EHBE a retainer of $200,000 per year. “Having worked with cannabinoids and the endocannabinoid system for over 25 years, it is clear that there are tremendous opportunities to discover and create cannabinoid-derived molecules with potential to beneficially interact with the ECS for positive medical outcomes. With the launch of Skye’s new Cannabinoid Pharmaceutical Innovation Program with our research team in Cordoba, Spain, our efforts will focus on preclinical development of CBDVHS, R&D of CB1 modulators involved in pain, inflammatory diseases, neurological diseases, fibrotic diseases and metabolic diseases, and drug discovery relating to modulators of the cannabinoid receptors CB2 and GPR55. We aim to generate a wide portfolio of proprietary products and IP around molecules with commercial potential.” Eduardo Munoz, Managing Director of Emerald Health Biotechnology Espana About Emerald Health Biotechnology Espana SLU Emerald Health Biotechnology España SLU (EHBE) is a preclinical-stage drug development research company focused on new cannabinoid derivatives to treat severe life-threatening conditions and other pathologies. Led by cannabinoid research experts and scientific advisors to Skye, Drs. Eduardo Munoz and Giovanni Appendino, EHBE is a pioneer in developing chemical cannabinoid derivatives that improve the therapeutic properties of the natural compounds. About Skye Bioscience Skye Bioscience Inc. is a biopharmaceutical company unlocking the pharmaceutical potential of cannabinoids through the development of its proprietary, cannabinoid-derived molecules to treat diseases with significant unmet needs. The company’s lead program, THCVHS, is focused on treating glaucoma, a disease with no cure and the world’s leading cause of irreversible blindness. For more information, please visit: www.skyebioscience.com

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Diagnostics

MacroGenics Uses Genedata Profiler to Improve Immunotherapy Development

MacroGenics, Genedata | April 20, 2021

Genedata, the leading supplier of enterprise software solutions for biopharmaceutical R&D, revealed today a long-term collaboration agreement with MacroGenics, a biopharmaceutical firm and emerging pioneer in discovering and commercializing innovative immune-oncology therapeutics. The agreement provides MacroGenics access to Genedata Profiler® as well as consulting services to aid in the platform's accelerated adoption and integration into MacroGenics' R&D infrastructure. The use of Genedata Profiler improves MacroGenics' ability to generate new hypotheses from combined databases from both proprietary and public sources, assisting in the interpretation of biomarker data and the design of clinical trials. The Genedata Profiler software provides MacroGenics with a comprehensive solution that solves a variety of problems while also presenting new possibilities, such as: • Aggregation and curation of dispersed clinical and non-clinical research data, in a central repository, to create an institutional memory; • Self-service access to data and easy-to-use analytical tools empowers data scientists and clinicians to run complex analyses in a controlled and secure environment; • Cross-study and cross-technology data integration and analysis unlock actionable insights and facilitate informed decision-making; and • Automated workflows for data harmonization, integration, and analytics streamlines and standardizes analytical processes, while ensuring data reproducibility. MacroGenics profits from Genedata's technical domain experience in data analytics and interpretation, IT support, and scientific consulting in addition to software while retaining sole ownership of its proprietary data. The MacroGenics science team is collaborating closely with Genedata experts to unlock the potential of their data and advance their translational and clinical research programs. MacroGenics will be able to produce new scientific insights and hypotheses due to the streamlined, data-driven approach provided by Genedata Profiler. • Accelerate the discovery and development of predictive biomarkers indicative of therapy response to define the best subpopulation of patients to benefit from their immunotherapies, • Identify drugs’ specific indications to improve clinical trials inclusion criteria, • Determine the therapeutic mechanism of action (pharmacodynamics) to strengthen the rationale of the treatment regimen. Genedata Profiler, which is already in operation, has advanced MacroGenics' internal data organization and formatting. Data integration workflows and applied analytics conducted within the system have enhanced many existing translational/clinical trials and resulted in findings for presentations at international conferences (ASCO, ASH). MacroGenics will continue to work with Genedata to improve their analytical capability to help forward and reverse translational studies. About Genedata Genedata transforms data into intelligence with innovative software solutions and domain-specific consulting services that automate complex, large-scale experimental processes and enable organizations to maximize the ROI in their R&D, spanning early discovery to the clinic. Founded in 1997, Genedata is headquartered in Switzerland with additional offices in Germany, Japan, Singapore, the UK, and the US.

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