Custom Data Collection System to Improve Health Disparity Research

Managed Healthcare Executive | September 18, 2019

An innovative web-based data collection platform used in public health research with multilingual older Chinese Americans and their family caregivers is the focus of a new article published in the Journal of the American Geriatrics Society. Researchers at Rutgers developed the platform, which has been in use since 2011 for the PINE Study, or the Population Study of Chinese Elderly, a longitudinal cohort study of more than 3,000 Chinese Americans aged 60 years and older living in the Greater Chicago area. Using the innovative data collection system, we were able to collect community- and individual-level health data of Chinese older adults with culturally and linguistically appropriate measures, says XinQi Dong, director of Rutgers University's Institute for Health, Health Care Policy and Aging Research and the lead researcher of the PINE Study.

Spotlight

The publication of the IOM report To Err is Human in 2000 served as a catalyst for a growing interest in improving the safety of health care. Yet despite decades of attention, activity and investment, improvement has been glacially slow. Although the rate of harm seems stable, increasing demand for health services, and the increasing intensity and complexity of those services (people are living longer, with more complex co-morbidities, and expecting higher levels of more advanced care) imply that the number of patients harmed while receiving care will only increase, unless we find new and better ways to improve safety.


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HEALTH TECHNOLOGY

Antengene Announces ATG-101 Granted Orphan Drug Designation by the U.S. FDA

Antengene Corporation Limited | September 19, 2022

Antengene Corporation Limited a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, announced that ATG-101, the company's in-house developed novel PD-L1/4-1BB bispecific antibody, has been granted an Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This ODD will help Antengene facilitate regulatory communication with the FDA, accelerate the clinical development and the future registration of ATG-101. At present, no PD-L1/4-1BB bispecific antibody has been approved for the treatment of pancreatic cancer worldwide. Orphan Drugs, also known as Rare Disease Drugs, refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. Orphan Drug Designations by the U.S. FDA are meant to support the development of drug candidates that could potentially bring substantial therapeutic benefits to patients with rare diseases and to provide incentives to the subsequent development, registration and commercialization to designated drugs. Those incentives include tax credit on expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, and 7-year market exclusivity in the U.S. regardless of the patent status of the designated drug. Pancreatic cancer is a highly malignant type of gastrointestinal cancer. According to the statistics by the World Health Organization (WHO), pancreatic cancer was ranked 13th and 7th globally by its incidence and mortality rates in 2012. In 2018, the U.S. reported over 55,000 newly- diagnosed pancreatic cancer cases and 44,330 related deaths. Whereas still defined as an orphan disease currently, it is projected that by 2030, pancreatic cancer will become the second most common cause of cancer-related deaths. ATG-101 is a novel PD-L1/4-1BB bispecific antibody that was designed to block the binding of immunosuppressive PD-1/PD-L1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, while delivering enhanced anti-tumor activity, with an improved safety profile. In preclinical studies, ATG-101 demonstrated significant anti-tumor activity in animal models of resistant tumors as well as those that had progressed on anti-PD-1/L1 treatment. Furthermore, ATG-101 has also shown an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies. ATG-101 is the first PD-L1/4-1BB bispecific antibody entering clinical development in Australia and is currently being evaluated in clinical studies in Australia, China, and the U.S. "We are very encouraged by this Orphan Drug Designation from the U.S. FDA and are hopeful that ATG-101 will offer a novel therapeutic to patients with pancreatic cancer. As Antengene's first in-house developed asset with global rights, ATG-101 has already entered clinical development in Australia, China, and the U.S. We will strive to accelerate the global clinical development of ATG-101 in efforts to provide a new treatment option to patients around the world." Dr. Bo Shan, Antengene's Chief Scientific Officer About Antengene Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders". Since 2017, Antengene has built a broad and expanding pipeline of 15 clinical and preclinical assets, of which 10 are global rights assets, and 5 came with rights for Asia Pacific markets including the Greater China region. To date, Antengene has obtained 24 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® already approved in mainland China, South Korea, Singapore and Australia.

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HEALTH TECHNOLOGY

Aktana Welcomes New Medical Affairs Lead from IBM Watson Health (Now Merative)

Aktana | September 28, 2022

Aktana, the leader in intelligent customer engagement for the global life sciences industry, welcomes Deepak Patil as its new senior director of medical strategy. Patil comes to Aktana after leadership roles at IBM Watson Health, IQVIA, and Sun Pharma Industries where he managed medical affairs in conjunction with six key product launches and developed lasting relationships with key opinion leaders in targeted therapeutic areas. At Aktana, Patil will lead the company’s medical affairs program, initially helping to build modern, data-driven solutions for medical science liaisons but over time, also expand to other areas within medical affairs. Medical Affairs is the “third strategic pillar of the pharmaceutical organization alongside R&D and commercial, as science and data merge,” according to a McKinsey report. Business models are starting to evolve both around and beyond the “product” to encompass the wider therapeutic context, while organizations seek to explain and contextualize the ever more complex medical science to a diverse range of stakeholders. In outreach efforts, MSLs and commercial teams can unintentionally overlap, causing major compliance issues and frustrating doctors. Aktana’s intelligence solutions will not only help medical affairs improve key opinion leader relationships but also better orchestrate outreach to the physician community in compliance with regional engagement regulations. “Deepak brings a unique blend of medical experience – he received his medical degree in India – plus data science and operational expertise from IQVIA and IBM. As we prioritize new, AI-driven solutions for medical affairs teams, Deepak will help expertly shape our new offerings while building a powerhouse team focused on this increasingly important area of life sciences.” Clay Hausmann, chief revenue officer at Aktana Aktana has also announced a strategic partnership with Envision Pharma Group, a global, technology-enabled scientific communications company operating across many areas of medical affairs. Envision and Aktana will combine their offerings to help MSLs address HCP demands for personalized scientific content and coordinated omnichannel engagement. “Aktana is committed to enabling the medical affairs organization in a new era, and I’m excited to serve in a leadership role as part of this endeavor,” said Deepak Patil. “The real-world data is there. With the right technology, we have the power to improve the generation and dissemination of scientific insights to physicians, leading to better treatment decisions and outcomes for their patients.” With more than 300 deployments across 50+ use cases, Aktana has been refining its commercial life sciences intelligence platform for more than a decade. More than half of the world's top-20 pharmaceutical companies rely on Aktana to coordinate and optimize personalized omnichannel engagement with HCPs. Aktana’s Contextual Intelligence 360 platform is powered by the company’s next-generation Contextual Intelligence Engine, which uses AI-driven optimization to predict the value of all potential customer experiences, then prioritize and recommend Next Best Engagements that will deliver the highest ROI. About Aktana Aktana is the category creator and leader of intelligent engagement in the global life sciences industry. By ensuring that every customer experience is tailored to individual preferences and needs, Aktana helps life science companies strengthen their relationships with healthcare providers to inspire better patient care. Today, commercial and medical teams from more than 300 brands use Aktana’s AI-enabled Contextual Intelligence Engine to coordinate and optimize personalized omnichannel engagement at scale. More than half of the top-20 global pharmaceutical companies are Aktana customers. Headquartered in San Francisco, Aktana has offices in every major biopharma region around the world.

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HEALTH TECHNOLOGY

PointClickCare Launches Integrated Virtual Health Solution for Long-Term and Post-Acute Care Providers

PointClickCare | October 11, 2022

PointClickCare Technologies, a leading healthcare technology platform enabling meaningful collaboration and access to real‐time insights announced the launch of its Virtual Health offering – an integrated telemedicine solution to the Skilled Nursing Facilities market. With the help of partner Sound Physicians, this technology is currently being implemented in more than half of the states across the U.S. Over the next two days at the AHCA/NCAL Convention and Expo, PointClickCare will be showcasing the innovative ways providers can better achieve quality care and reach the full potential of virtual health in the post‐acute setting. According to the Forrester U.S. Tech Outlook, 2022 Report, investment in virtual health, remote monitoring, and hospital-at-home, are spending priorities in 2022. Forrester analysts have confirmed that these technologies have the power to reduce the cost of administrative complexity, which is currently $265 billion. Recent data from the US Department of Health & Human Services explains that the share of Medicare visits conducted through telehealth rose to 52.7 million in 2020, from approximately 840,000 in 2019. Knowing that telehealth has become an increasingly important, yet sometimes complicated component of healthcare, PointClickCare has developed an alternative to traditional telehealth by applying technological improvements to offer an integrated solution. “Telehealth is no longer a futuristic concept in long-term care, it’s table stakes. Our customers continue to navigate between care settings and our team has sought to innovate and push the envelope on providing virtual care. We’re proud to announce this technology that has been specifically designed to meet the mission‐critical needs of post‐acute providers to improve clinical care and reduce healthcare costs, consistently driving down hospital readmissions by 30%.” Travis Palmquist, Senior Vice President and General Manager of Senior Care at PointClickCare With PointClickCare’s Virtual Health offering, providers can now Improve patient care & staff satisfaction: By streamlining operations through a sophisticated level of integration into existing workflows, care teams have access to shared patient records, and can cut down on administrative tasks and can focus on what matters most – patient care. Reduce healthcare service costs: With the ability to “treat in place,” facilities experience stabilized occupancy rates and can reduce the need for after-hours readmissions or emergency room department transfers, ultimately lowering overall costs. “The ongoing staffing crisis has created a new level of pressure for our staff. With PointClickCare’s Virtual Health solution, our care teams can access an on-shift physician with just one click, streamlining operations and cutting down on a lot of the administrative burdens we are faced with, all while ensuring our patients are getting the best quality of care, any time,” said Kevin Baxter, Vice President of Operations at Health Services Management. About PointClickCare PointClickCare is a leading healthcare technology platform enabling meaningful collaboration and access to real‐time insights at any stage of a patient’s healthcare journey. PointClickCare’s single platform spans the care continuum, fostering proactive, holistic decision‐making and improved outcomes for all. Over 27,000 long‐term post‐acute care providers, and 2,700 hospitals use PointClickCare today, enabling care collaboration and value‐based care delivery for millions of lives across North America.

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HEALTHTECH SECURITY

Tivic Health to Acquire Assets of Reliefband

Tivic Health | October 18, 2022

Tivic Health® Systems, Inc. a commercial-phase health technology company focused on bioelectronic medicine, announced it has entered into a definitive agreement to acquire the Reliefband product line for nausea treatment and all related assets from Reliefband Technologies, LLC. Reliefband has been an innovator in wearable, FDA-cleared electronic therapeutics for treatment of nausea and vomiting. Reliefband has multiple products available both over-the-counter and by prescription. “We are incredibly excited to add the full suite of Reliefband products to our commercial portfolio. The Reliefband team successfully pioneered a direct-to-consumer business model for medical products. This acquisition, when combined with our growing direct-to-consumer sales of ClearUP, will significantly accelerate Tivic’s revenue opportunities.” Jennifer Ernst, CEO of Tivic Health Recurring nausea impacts approximately 1 in 6 US adults. According to QY Research, nausea treatment is a $2.4B market in the US and $5.5B globally, growing at 6.5% CAGR. Reliefband’s wrist-worn electronic nerve stimulators have been FDA-cleared for treatment of nausea associated with seven independent clinical indications, including nausea from motion sickness, pregnancy, migraines, anxiety, chemotherapy, various medications and hangovers. The patented products are backed by 40 peer-reviewed clinical studies and have generated over 3500 Amazon reviews averaging 4+ stars. Both Reliefband and ClearUP products offer consumers ways to manage health-related conditions without the issues and side effects often associated with medication use. Both are FDA-cleared, highly effective, fast-acting, convenient, and drug-free. Both currently are sold primarily online, and both have received CE Marks allowing international expansion. In addition to the Reliefband direct-to-consumer branded products, Tivic will also acquire Reliefband’s Reletex-branded prescription nausea treatments. Reletex products are currently distributed by hospitals and medical professionals and are reimbursed under HCPCS code E0765 for certain conditions. “We look forward to growing Tivic with the addition of clinically proven, revenue-producing bioelectronic products that have seen strong customer adoption and growth,” continued Ernst. Consideration to be provided by Tivic consists of up to $33.5 million, of which up to $1.5 million can be paid, at the election of Tivic, in restricted common stock of Tivic. Consideration is subject to working capital adjustments, less Reliefband transaction expenses and any indebtedness of Reliefband at closing. The transaction is expected to be consummated in the fourth quarter of 2022 or first quarter of 2023 after the satisfaction of certain customary closing conditions, including but not limited to securing the financing necessary to pay the purchase price. Additional information on the transaction can be found in a Current Report on Form 8-K filed by Tivic with the Securities and Exchange Commission (SEC).

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Spotlight

The publication of the IOM report To Err is Human in 2000 served as a catalyst for a growing interest in improving the safety of health care. Yet despite decades of attention, activity and investment, improvement has been glacially slow. Although the rate of harm seems stable, increasing demand for health services, and the increasing intensity and complexity of those services (people are living longer, with more complex co-morbidities, and expecting higher levels of more advanced care) imply that the number of patients harmed while receiving care will only increase, unless we find new and better ways to improve safety.

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