Enough hubbub about HHS Truvada patents, Gilead says. We are challenging them at the PTO

FiercePharma | August 22, 2019

Drugmakers have often lambasted the U.S. Patent and Trademark Offices (PTOs) inter partes review system, but now Gilead Sciences is hoping to use it to its advantage. The drugmaker is taking on the U.S. government, arguing the Department of Health and Human Services patents covering preventive uses of its HIV drug Truvada are invalid. Gilead says it stronglybelieves HHS pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) patents for Truvada granted since 2015 are invalid. It's asking the PTO to review and invalidate them accordingly. The company hasn't acted on that belief until now, but Gilead says that “well before” HHS claims to have invented PrEP and PEP, “others had conceived of using an antiretroviral therapy” such as Truvada for “both forms of prophylaxis.” The company pointed to unspecified 2004 guidelines recommending combo antitretrovirals for “high risk” individuals before HIV exposure. Centers for Disease Control and Prevention guidelines in 2005 recommended Truvada for prophylaxis immediately after exposure, the company says. Government patents covering Gilead’s Truvada have made the rounds in the press lately, and the company figures the ongoing debate is “a distraction from the important work being done by Gilead and its many community partners to reduce barriers to PrEP."

Spotlight

The rise of performance-based managed care contracts is requiring pharma companies to demonstrate drug value in producing health outcomes and/or health economic benefits.1 While performance-based contracts are currently still relatively rare, even without these contracts, managed care plans are making decisions on formulates based on evidence of value. They are also looking to guidelines and the treatment pathways being adopted by providers which are also driven by evidence of outcomes and value.

Spotlight

The rise of performance-based managed care contracts is requiring pharma companies to demonstrate drug value in producing health outcomes and/or health economic benefits.1 While performance-based contracts are currently still relatively rare, even without these contracts, managed care plans are making decisions on formulates based on evidence of value. They are also looking to guidelines and the treatment pathways being adopted by providers which are also driven by evidence of outcomes and value.

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PHARMA TECH

BlackRock and QLS Advisors Partner Through BlackRock Systematic to Invest in Biomedical Innovation

BlackRock and QLS Advisors | July 19, 2022

BlackRock and QLS Advisors LLC, a life sciences technology and advisory firm, have announced a partnership through BlackRock Systematic to develop data-driven investment solutions to help accelerate biomedical innovation. The partnership will leverage the firms’ combined Research and Development and investment experience, directing funding toward public and private companies that have the potential to create transformative therapies while seeking to earn attractive investment returns for clients. Biomedicine is at an inflection point: breakthrough therapies—with the potential to extend longevity and improve quality of life—are emerging at an ever-increasing pace. Funding these therapeutic development programs has the potential to deliver attractive investment returns, but as biomedicine has grown more complex, so have the risks to investors. QLS has developed proprietary technology for estimating the probability of success of clinical trials, a key driver of financial performance, and systematically incorporating these forecasts into fundamental valuation models and portfolio construction algorithms. Their approach applies machine learning techniques to a multitude of predictive factors including therapeutic characteristics, clinical trial design features, disease-specific characteristics, and drug company track records. This methodology, coupled with BlackRock Systematic’s global platform, proprietary analytics, and more than 35 years1 of data-driven investment experience, presents a differentiated approach to investing in life sciences companies. “BlackRock’s partnership with QLS applies sophisticated quantitative investment technologies to the intersection of finance, academia, and life sciences. QLS brings an industry-leading approach to investing in life sciences that complements the work that BlackRock Systematic is doing in our actively managed portfolios. We expect this will create compelling, differentiated solutions that can deliver attractive returns for our clients while providing funding for life-changing therapies.” Rich Kushel, Head of the Portfolio Management Group BlackRock Andrew Lo, QLS Co-founder and Professor of Finance at the MIT Sloan School of Management commented: “We founded QLS to improve the way financial resources are allocated to emerging therapies, with the goal of lowering the cost of capital in this important sector. With BlackRock, we gain a partner who is a recognized leader in data-driven investing and shares our passion for delivering investment returns with positive outcomes for society. We’re thrilled and honored to join forces with a firm that has such a strong and trusted global brand, broad network, and access to world-class investment resources.” BlackRock and QLS have also assembled a Scientific Advisory Council comprising renowned academics, medical doctors, and inventors. The Council will support sourcing, due diligence, and value creation through the members’ vast networks and decades of experience as industry leaders in their respective fields. The Council is expected to include Dr. Robert Langer, Institute Professor, MIT Department of Chemical Engineering, and founder of over 40 biotechnology companies including Moderna. Ms. Lita Nelsen, retired director of the MIT Technology Licensing Office; now consultant in technology licensing. Dr. Larry Norton, Senior Vice President, Norna S. Sarofim Chair in Clinical Oncology and Medical Director of the Evelyn H. Lauder Breast Center at Memorial Sloan Kettering Cancer Center, Past President of the American Society of Clinical Oncology, ASCO David Karnofsky Awardee, FASCO, FAACR. Dr. Richard H. Scheller, Chairman of Research and Development BridgeBio. Board of Directors BridgeBio, Alector, 23andMe, DICE and others. Former Executive Vice President Research and Early Development Genentech and former HHMI Investigator and Professor Stanford University Medical School. Dr. Phillip A. Sharp, Institute Professor, MIT Department of Biology, geneticist and molecular biologist who co-discovered RNA splicing, co-founded Biogen and Alnylam, and the recipient of the 1993 Nobel Prize in Physiology or Medicine. About BlackRock Systematic BlackRock’s systematic investment platform brings together BlackRock’s community of systematic investors across equity, fixed income, and factor-based strategies. Systematic portfolios combine cutting-edge technology, scientific research, and human insight in the relentless pursuit of investment performance. With over 35 years of experience and nearly 200 professionals across the globe managing over US$200 bn in client assets as of March 31, 2022, BlackRock Systematic partners with clients to deliver quantitative alpha-seeking and factor-based investment solutions for the whole portfolio. About QLS Advisors LLC QLS Advisors LLC is a life sciences technology and advisory company based in Cambridge, MA, dedicated to fostering biomedical innovation. QLS employs a unique blend of fundamental and quantitative tools to help clients manage risk, assess reward, and develop investment and financing strategies for portfolios of healthcare-related assets.

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BUSINESS INSIGHTS

Labcorp Enhances Clinical Trial and Drug Development Capabilities Through Real World Data Collaboration With HealthVerity

Labcorp® | June 23, 2022

Labcorp® a leading global life sciences company, announced a new collaboration with HealthVerity, Inc., the leader in Identity, Privacy, Governance, and Exchange (IPGE) for real-world data that will expand Labcorp’s comprehensive, end-to-end drug development and clinical trial programs. HealthVerity’s IPGE platform, an integrated technology and RWD infrastructure, enables Labcorp Drug Development and other participating companies to access fully interoperable, HIPAA-compliant data from the U.S.’s largest ecosystem1 of health care and consumer data. “This collaboration allows Labcorp to expand existing end-to-end solutions for drug and diagnostics development, commercialization and clinical trial efforts to include large-scale access to real-world data for research applications. By applying advanced analytics, Labcorp can help its clients improve their processes and reach better outcomes. Our substantial repository of test results can also help study sponsors more quickly and accurately assess patient eligibility for clinical trials, enroll patients faster and accelerate the availability of new medicines.” Dr. Paul Kirchgraber, CEO of Labcorp Drug Development Now more than ever, study sponsors are seeing the potential of RWD to yield longitudinal patient insights before, during and after trials. With more predictive analytics and artificial intelligence applications requiring comprehensive and fully interoperable RWD, Labcorp can align de-identified patient data with ten times greater accuracy2 than industry alternatives by using the HealthVerity IPGE platform. In addition, access to HealthVerity’s RWD with on-demand de-identification and data linkage capabilities reinforces Labcorp’s ability to be a trusted source of information for its clients. "Fragmentation of patient data is at an all-time high, and the goal is no longer just connecting this data," said Andrew Kress, CEO of HealthVerity. "Rather, the goal is making data more accessible and useful for gaining a detailed understanding of patient journeys. With analytics and applications requiring more frictionless access to the data itself, the HealthVerity IPGE platform stands alone in offering the ability to combine transaction-level patient data in a de-identified, fully interoperable manner, and delivering it directly into the client's applications of choice." About Labcorp Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. With over 75,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $16 billion in FY2021. About HealthVerity Pharmaceutical manufacturers, payers, and government organizations have partnered with HealthVerity to solve some of their most complicated use cases through transformative technologies and real-world data infrastructure. The HealthVerity IPGE platform, based on the foundational elements of Identity, Privacy, Governance, and Exchange, enables the discovery of real-world data across the broadest healthcare data ecosystem, the building of more complete and accurate patient journeys and the ability to power best-in-class analytics and applications with flexibility and ease. Together with our partners, HealthVerity has built the modern way to data for the health insights economy.

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PHARMACY MARKET

BC Platforms Drives Data Enablement and Collaboration to Accelerate Precision Medicine in Asia

BC Platforms | June 07, 2022

BC Platforms a leading provider of data and technology platforms for personalized medicine and drug development, will host a key, day-long, Precision Medicine and Data Science Conference in Singapore on 7 June 2022 to discuss how stakeholders can securely collaborate and enable the use of federated data at scale to empower precision medicine, population health, and preventive care initiatives in the region. The event features preeminent local and international experts from healthcare, government, and academia, including Professor Patrick Tan, Executive Director of the Genome Institute of Singapore, Associate Professor Neerja Karnani, BioInformatics Institute A*STAR and Dr Shay Ben-Shachar, Director of Precision Medicine and Genomics at Clalit Research Institute, Israel. It is part of BCP's efforts to support the growth of precision medicine activities in Asia Pacific. "Access to connected, secure data is a key pillar in overall healthcare development. High quality clinical and genomics information is foundational to predictive and preventive clinical care as well as drug development. Today, real-world data generated from Asian countries is not represented well enough and data diversity is key to solving the most pressing research questions. At BC Platforms we recognize that Asian countries continue to remain under-represented in global life science research; so it is important for healthcare systems in the region to collaborate, build highly secure, enabling technologies and ensure local legislation is supportive of real-world data initiatives. It will allow the whole ecosystem to stay in front of the development, and our vision focuses on personalized care models for patients in this region." Mr Tero Silvola, Chief Executive Officer of BC Platforms The company had expanded its R&D operations in Singapore earlier this year and partnered with SingHealth, Singapore's largest public healthcare group. Parties aim to build a series of research projects and by doing so accelerate relevant clinical research with pressing targets on diseases prevalent in the Asian population, including but not limited to cancer and cardiovascular diseases. This highly visible partnership is part of BC Platforms' rapidly growing data partner network for secure and regulatory compliant sharing of real-world data. The BCRQUEST.com global partner network now comprises 33 million patient lives from 37 data partners on five continents. While BC Platforms has been active in Singapore since 2019, it plans to ramp up activities and continue to build its presence in the region as it continues to develop and deploy safe and secure infrastructure for healthcare data. The company is also focusing on partnerships with local and regional healthcare and research institutions to strengthen translational research capabilities in Asia Pacific and improve care outcomes for patients in the region. About BC Platforms BC Platforms is a global leader in providing a powerful data and technology platform for personalised medicine and drug development, accelerating the translation of insights into clinical practice. Our technology drives the infinite loop between personalised care and research discoveries, leveraging latest science, deep technical expertise, strategic partnerships, and harmonized, diverse data collections. Our high performing genomic data discovery and analytics platform enables flexible data integration, secure analysis, and interpretation of molecular and clinical information.

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