In Pharma value chain, PBMs manage to benefit

JIM GREENWOOD | April 8, 2019 | 11 views

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.

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Consociate Health

Consociate Health partners with employers to provide professional employee benefits administrative services. With plan members in 48 states and an unmatched access to a wide variety of analytical, educational and human resource tools, Consociate has proven solutions for employer sponsored benefit programs. Consociate administers traditional self-funded programs, captive health insurance programs, association health plans, multi employer welfare associations (Taft-Hartley), FSA's, HSA's, COBRA and many other employee benefits.

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DIAGNOSTICS

Advancement in Genomics Accelerating its Penetration into Precision Health

Article | April 20, 2021

Genomics is an interdisciplinary field of biology emphasizing the structure, editing, evolution, function, and mapping of genomes. It is creating deeper inroads across the precision health domain with the increasing introduction of advanced technologies such as quantum simulation, next-generation sequencing (NGS), and precise genome manipulation. As precision health focuses on providing the proper intervention to the right patient at the right time, genomics increasingly finds applications in human and pathogen genome sequencing in clinical and research spaces. Rising Hereditary Diseases Burden Paving the Way for Genomics in Precision Health In the last few years, a significant surge in the prevalence of diseases and ailments such as diabetes, obesity, baldness, and others has been witnessed across the globe. A history of family members with chronic diseases, such as cancer, diabetes, high blood pressure, hearing issues, and heart disease, can sometimes continue into the next generation. Hence, the study of genes is extensively being conducted for predicting health risks and early treatment of these diseases. It also finds use in CRISPR-based diagnostics and the preparation of precision medication for the individual. In addition, ongoing advancements in genomics are making it possible to identify different genetic traits that persuade people to more widespread diseases and health problems. The Emergence of Genomics Improves Disease Understanding Genomics refers to the study of the complete genetic makeup of a cell or organism. Increasing scientific research in the area substantially contributes to increasing knowledge about the human genome and assists in improving the ability to understand disease etiology, risk, diagnosis, treatment, and prevention. On account of these improvements, innovative genomic technologies and tools are being developed to enable better precision health not only for the individual but for various regional populations as well. The Way Forward With growing preference for personalized medicine and an increasing need for more accurate pathogen detection and diagnostics, genomics is gaining huge popularity across the precision health domain. Also, increasing research activities for developing novel high-precision therapeutics and rising importance of gene study in the prevention, diagnosis, and management of infectious and genetic diseases will further pave the way for genomics in the forthcoming years.

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MEDICAL

Top 10 biotech IPOs in 2019

Article | August 2, 2021

The big question at the start of 2019 was whether the IPO window would stay open for biotech companies, particularly those seeking to pull off ever-larger IPOs at increasingly earlier stages of development. The short answer is yes—kind of. Here’s the long answer: In the words of Renaissance Capital, the IPO market had “a mostly good year.” The total number of deals fell to 159 from 192 the year before, but technology and healthcare companies were standout performers. The latter—which include biotech, medtech and diagnostics companies—led the pack, making up 43% of all IPOs in 2019. By Renaissance’s count, seven companies went public at valuations exceeding $1 billion, up from five the year before

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Cell Out? Lysate-Based Expression an Option for Personalized Meds

Article | April 17, 2020

Cell-free expression (CFE) is the practice of making a protein without using a living cell. In contrast with cell line-based methods, production is achieved using a fluid containing biological components extracted from a cell, i.e., a lysate. CFE offers potential advantages for biopharma according to Philip Probert, PhD, a senior scientist at the Centre for Process Innovation in the U.K.

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Closing bacterial genomes from the human gut microbiome using long-read sequencing

Article | February 12, 2020

In our lab, we focus on the impact of the gut microbiome on human health and disease. To evaluate this relationship, it’s important to understand the particular functions that different bacteria have. As bacteria are able to exchange, duplicate, and rearrange their genes in ways that directly affect their phenotypes, complete bacterial genomes assembled directly from human samples are essential to understand the strain variation and potential functions of the bacteria we host. Advances in the microbiome space have allowed for the de novo assembly of microbial genomes directly from metagenomes via short-read sequencing, assembly of reads into contigs, and binning of contigs into putative genome drafts. This is advantageous because it allows us to discover microbes without culturing them, directly from human samples and without reference databases. In the past year, there have been a number of tour de force efforts to broadly characterize the human gut microbiota through the creation of such metagenome-assembled genomes (MAGs)[1–4]. These works have produced hundreds of thousands of microbial genomes that vastly increase our understanding of the human gut. However, challenges in the assembly of short reads has limited our ability to correctly assemble repeated genomic elements and place them into genomic context. Thus, existing MAGs are often fragmented and do not include mobile genetic elements, 16S rRNA sequences, and other elements that are repeated or have high identity within and across bacterial genomes.

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Spotlight

Consociate Health

Consociate Health partners with employers to provide professional employee benefits administrative services. With plan members in 48 states and an unmatched access to a wide variety of analytical, educational and human resource tools, Consociate has proven solutions for employer sponsored benefit programs. Consociate administers traditional self-funded programs, captive health insurance programs, association health plans, multi employer welfare associations (Taft-Hartley), FSA's, HSA's, COBRA and many other employee benefits.

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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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AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis

pipelinereview | April 24, 2019

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved SKYRIZI™ (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.3 In clinical trials, SKYRIZI produced high rates of durable skin clearance – most people (82 and 81 percent) treated with SKYRIZI achieved 90 percent skin clearance (PASI 90) at one year, with the majority (56 and 60 percent) achieving complete skin clearance (PASI 100).1 "The complex nature of psoriasis and the variability or loss of treatment response over time can prevent some patients from achieving their treatment goals," said Kenneth B. Gordon, M.D., a principal investigator for the ultIMMa-1 pivotal trial and professor and chair of dermatology at the Medical College of Wisconsin. "In clinical trials, risankizumab demonstrated high levels of skin clearance that persisted through one year. I'm pleased the dermatology community now has a new option that can help patients achieve and maintain a high level of treatment response."

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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.

Read More

AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis

pipelinereview | April 24, 2019

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved SKYRIZI™ (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.3 In clinical trials, SKYRIZI produced high rates of durable skin clearance – most people (82 and 81 percent) treated with SKYRIZI achieved 90 percent skin clearance (PASI 90) at one year, with the majority (56 and 60 percent) achieving complete skin clearance (PASI 100).1 "The complex nature of psoriasis and the variability or loss of treatment response over time can prevent some patients from achieving their treatment goals," said Kenneth B. Gordon, M.D., a principal investigator for the ultIMMa-1 pivotal trial and professor and chair of dermatology at the Medical College of Wisconsin. "In clinical trials, risankizumab demonstrated high levels of skin clearance that persisted through one year. I'm pleased the dermatology community now has a new option that can help patients achieve and maintain a high level of treatment response."

Read More

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