Bloomberg News

Initial collaborators in the new program to focus on molecular diagnostic development and decentralized testing to identify and track diseases in developing countries ALAMEDA, Calif. and DURBAN, South Africa, Sept. 26, 2024 /PRNewswire/ -- Alveo Technologies, Inc. (Alveo), a leader in molecular sensing and diagnostics with its proprietary IntelliSense molecular detection technology platform, today announced the launch of an academic arm of its partner program in collaboration with the Global Virus Network (GVN), along with faculty at the Johns Hopkins University's School of Public Health. The program now includes two new partnering approaches: a research use only (RUO) program focused on enabling innovative research through universities and academic partners and a deeper collaboration with Alveo that has the shared aim of commercializing tests in countries where there is a significant unmet need. Global Virus Network (GVN) and faculty at John's Hopkins University's Bloomberg School of Public Health are initially focused on equipping their network with access to Alveo's highly sensitive and easy-to-use platform to support the research and development of "in region, for region" testing. The primary goal of this effort is to enable institutions and developing countries with a highly sensitive and easy-to-use platform to proactively detect and track illness at the local level — and, ultimately, in the regional populations at large. Enabling testing at the point of need is paramount given the challenges of collecting and transporting samples to laboratories to provide results. GVN was instrumental in helping to conceive the academic partner program, and its participation was announced at the GVN's Annual Scientific Meeting in Durban, South Africa. "The world desperately needs accessible molecular tests for pathogens that afflict developing countries," said Dr. Sten Vermund, President of the GVN. "This partnership will enable accessible 'in-region, for-region' test development, manufacturing, and deployment for devastating, yet neglected infectious diseases. The ability to identify hotspots before they spread will help us as a global community to avoid future pandemics." The GVN and its 80+ scientific sites, which include Johns Hopkins School of Public Health, will help countries develop tests on Alveo's open platform, which is well suited for challenging environments thanks to the devices' ruggedness and portability. The platform provides precise results comparable to polymerase chain reaction (PCR) in terms of accuracy and sensitivity without requiring shipment of samples to a lab for processing. Alveo provides on-location results within 30-45 minutes or less. Alveo's rugged device continues to complete tests and produce accurate results despite extreme temperatures, high humidity, shaken, or even dropped. The platform can upload geotagged results to the cloud, providing researchers and authorities with near real-time information on a pathogens' spread, regardless of where in the world the test is run. Researchers can proactively collect, detect and track outcomes in Alveo's cloud-based software solution, so test results can be accessed and aggregated from anywhere in the world. "Many molecular testing platforms fall short in meeting the needs of remote and under-resourced regions worldwide, relying on expensive equipment, skilled and highly trained technicians and cumbersome sample transportation," said Erik Tyrrell-Knott, Chief Business and Strategy Officer at Alveo Technologies. "Alveo is focused on helping the molecular testing world catch up with the modern world – making testing fast, sensitive, easy to use, and affordable. This partner program, with GVN's member institutions, will enable scientists to take their cutting-edge research out of the lab and deliver it effectively to impacted populations." "I reached out to Alveo Technologies in our search for a diagnostics company that is open to rich, disruptive collaboration," observed Dr. Maggie Linn Bartlett, program director for the Global Virus Network and faculty at the John Hopkins Bloomberg School of Public Health. "Together, Alveo and GVN have created a Partner Development Kit that enables GVN members to independently develop tests on Alveo's be.well™ platform. Initial collaboration units have been placed with Professor Deborah Williamson of the MRC University of Glasgow Centre for Virus Research, Dr. Al Ozonoff of Broad Institute of MIT and Harvard and my lab at Johns Hopkins Bloomberg School of Public Health. I'm excited to finally solve a problem that has been unaddressed for far too long." For more information on the program visit: . About Alveo Technologies Alveo Technologies is the first company to make molecular detection and diagnostics universally accessible – on the farm, in the field, in the clinic, or in the manufacturing plant – helping prevent or significantly limit the destructive impact of viruses, fungi, bacteria, and other pathogens by detecting earlier at the Point of Need™. Alveo's rugged and portable, multiplex-capable diagnostic platform employs IntelliSense, it's patented method of direct electrical sensing of nucleic acid amplification to provide affordable, rapid, and accurate results. By enabling early pathogen detection, Alveo helps manage global health, food security, and supply chain resiliency by providing actionable insights at lightspeed. Know Sooner, Act Faster™ with Alveo. For more, visit: About the Global Virus Network GVN works to raise awareness and mobilize resources to meet critical needs in medical virology. To this end, GVN works with governments, multilateral institutions, private-sector groups, and non-profit organizations to improve virology worldwide, call attention to critical research and training needs, and provide science-driven information and perspectives related to preparing for—and responding to—viral threats, outbreaks, epidemics, and pandemics. Contact: Jeff Miller [email protected] 541-207-6413 SOURCE Alveo Technologies WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Monitoring daily activity patterns using a wrist-worn device may detect early warning signs of Alzheimer's disease, according to a new study. Monitoring daily activity patterns using a wrist-worn device may detect early warning signs of Alzheimer's disease, according to a new study led by researchers at the Johns Hopkins Bloomberg School of Public Health. The researchers analyzed movement data from wristwatch-like devices called actigraphs worn by 82 cognitively healthy older adults who were participants in a long-running study of aging. Some of the participants had detectable brain amyloid buildup as measured by PET scan. Buildup of the protein amyloid beta in the brain is a key feature of Alzheimer's disease. Using a sensitive statistical technique, the researchers found significant differences between this "amyloid-positive" group and "amyloid-negative" participants in mean activity in certain afternoon periods and differences in variability of activity across days in a broader range of time windows. The new study was published online February 21 in the journal SLEEP. "We need to replicate these findings in larger studies, but it is interesting that we've now seen a similar difference between amyloid-positive and amyloid-negative older adults in two independent studies," says Adam Spira, PhD, professor in the Department of Mental Health at the Bloomberg School. The new study's results partly confirm findings from an earlier study in a smaller sample, also led by Spira, and suggest that actigraphs someday could be a tool to help detect incipient Alzheimer's disease before significant cognitive impairment sets in. Data from the prior study came from participants in the Anti-Amyloid Treatment in Asymptomatic Alzheimer's (A4) and the Longitudinal Evaluation of Amyloid Risk and Neurodegeneration (LEARN) studies. For their new study, Spira and colleagues investigated the potential of actigraph-based monitoring in 82 community-dwelling individuals whose average age was about 76. Each participant had a PET scan to measure brain amyloid and wore an actigraph 24 hours per day for one week. Using a sensitive statistical technique called FOSR (function-on-scalar regression), the researchers found that the 25 amyloid-positive participants, compared to the 57 amyloid-negative participants, had higher mean activity during the early afternoon, 1:00 to 3:30 p.m., and less day-to-day variability in activity from 1:30 to 4:00 p.m. and 7:30 to 10:30 p.m. In more conservative analyses, some of these time windows with differences were no longer statistically significant. Nonetheless, the higher afternoon activity and lower afternoon variability echoed the investigators' prior findings. Alzheimer's disease, the leading cause of dementia, is estimated to affect more than 6 million older adults in the U.S. The Alzheimer's disease process is still not fully understood but is characterized by amyloid plaques and tangles in the brain, which typically begin to accumulate a decade or two before Alzheimer's is diagnosed. The only approved treatments that may slow the disease course are those that target amyloid beta and reduce the plaques. Many researchers believe that such treatments can be much more effective if given earlier in the disease course -- ideally, years before dementia becomes evident. Abnormal patterns of sleep and waking activity have been studied as potential early indicators of Alzheimer's. Alzheimer's patients typically have abnormal sleep-wake rhythms, and prior studies have found evidence that amyloid accumulation may disrupt sleep-wake rhythms relatively early in the disease process. There is also evidence that sleep loss promotes amyloid accumulation, suggesting a "vicious circle." Such findings hint at the possibility that older adults might someday, among other measures, wear wristwatch-like devices that would automatically track and analyze their sleep and waking activity. Individuals with anomalous activity patterns could then consult their physicians for more in-depth Alzheimer's screening. The individuals in the new study were participants in a long-running study, the Baltimore Longitudinal Study of Aging, which is conducted by the Intramural Research Program of the National Institute on Aging (NIA), part of the National Institutes of Health (NIH). Several members of the NIA team were co-authors of the study. Standard, non-FOSR statistical methods did not detect any significant differences in activity or sleep patterns, suggesting the methods may be less sensitive to amyloid deposition. In the earlier actigraphy study, the researchers, using FOSR-based analyses in a different sample of 59 participants, found increases in mean activity in afternoon hours and differences in variability, including lower variability in the afternoon, among amyloid-positive participants. The scientists don't know why amyloid buildup would trigger differences in activity patterns during these particular times of day. They note that there is a well-known phenomenon among individuals with Alzheimer's disease called "sundowning," in which agitation increases in the afternoon and early evening. "It's conceivable that the higher afternoon activity we observed is a signal of 'preclinical sundowning,'" Spira says. "At the same time, it's important to note that these findings represent averages among a small sample of older people over a short period of time. We can't predict whether an individual will develop amyloid plaques based on the timing of their activity. So, it would be premature for older people to be concerned because their fitness trackers say they are particularly active in the afternoon, for example." He and his colleagues plan to do larger studies of this kind. They also hope to do longer-term studies to see if daily activity-pattern changes are associated not only with brain amyloid but also with actual cognitive decline. Support for the research was provided by NIH (R01AG050507, HHSN-260-2004-00012C).

自2016年至今，同写意医药项目合作与交易论坛和估值班已举办多次，被业界誉为国内“医药BD黄埔军校”。应业界人士的要求，今年3月，同写意BD俱乐部将邀请专业导师、实战派总裁就医药BD交易与并购的新逻辑、新策略、新方法进行系统和全面分析与讲解。人的观点，总是取决于他的立场。对于美国药物的价格来说，不同的立场可能导致完全不同的态度。对于高药价最有切肤之痛的，当属公共医疗保健计划和雇主医疗保险计划的提供者，即美国联邦政府和州政府以及公司雇主，以及患者本身。而对于制定药物高价持欢迎态度的，应该是最大的利益既得者，即制药公司和相关产业链（包括生物技术公司、CDMO, CRO和一系列利益相关者）。处于生产与消费中间流通环节的机构，包括药物批发商、药房、药品福利管理者（PBM），他们的立场可能会更微妙一些，取决于他们具体的得益得失。1美国药品到底有多贵？根据Bloomberg数据，2020年美国药物平均费用约为每人每年1300美元，远高于对比国家（图1）。2021年美国新药的上市价格中位数为每年18万美元，而且最近几年药价的上涨中位数基本保持在5%左右（美国药物通常在每年1月和7月上涨）。虽然私人保险公司和政府项目承担了账单的最大份额，但羊毛还是出在患者和保户身上。美国患者的直接自掏腰包支付率（out-of-pocket costs）约占13%的处方药费用（图2）。在一项调查中，五分之一的美国成年人表示，由于费用原因，他们未能完成规定的疗程。在德国、加拿大和澳大利亚这些“ 对比国家”，这一数字仅为十分之一。图1. 2020年部分国家人均药品支出（单位为美元）图片来源：Bloomberg图2. 美国2021年按来源支付的零售处方药费用的百分比图片来源：Bloomberg美国药价如此之高的原因非常复杂，主要是一套独特的流通系统所决定的，中间存在PBM这样美国特色的药物流通中间人，以及随之衍生的非常不透明的药物折扣与回扣（图3），这一部分不是本文要讨论的内容。图3. 美国医药领域交易关系图图片来源：Americanprogress.org2高药价（光明）的另一面虽然高药价给患者群体、公共医疗保健计划和雇主医疗保险计划带来了巨大的经济压力，但如果换一个角度评价高药价的是非，人们也不应该完全忽略它给医药开发领域带来的积极因素，尽管站在少数人的立场上发表观点可能引发争议。从大的层面来讲，高药价可能产生的积极效果可以表现在以下几个方面：• 创新激励高药价可以作为一种激励机制，鼓励制药公司投入更多资源进行研发。制药公司需要投入大量资金和人力资源来开发新药物，并进行必要的临床试验，以获得审批并将药物推向市场。这种创新激励可能会导致更多创新的药物问世，从而改善医疗治疗和管理疾病的效果。例如，一些罕见病治疗药物可能没有足够的市场规模来吸引投资，但高药价可以使这些治疗变得更具吸引力。• 市场竞争高药价可能激发制药公司之间的竞争，以争取更大的市场份额。由于高价药物的利润空间较大，这可能会吸引更多的制药公司进入市场，推动创新，并提供更多的药物选择。竞争也可能促使制药公司降低价格或提高药物质量，以吸引更多的消费者和医疗保健提供者。• 投资回报高药价可以提供制药公司更高的投资回报，这可能会吸引更多的资金投入该行业。这些资金可以用于支持更多的研发项目和临床试验，从而推动医药科技的进步。对投资者而言，高回报率可能会鼓励他们将更多的资金投入医药行业，这有助于推动医药领域的创新和发展。• 经济增长和就业机会制药行业在美国是一个重要的经济支柱，高药价可能有助于促进该行业的发展，从而创造更多的就业机会。高药价也可能促进研发和生产相关的行业的增长，例如生物技术、医疗设备等领域，进一步推动经济增长。• 医疗保健服务行业高药价可能带动了医疗保健服务行业的增长，包括医院、诊所、医疗设备和医疗技术供应商等。这些行业可能会从制药行业的发展中受益，因为更多的药物需求意味着更多的医疗服务和设备需求。开发新药的费用最终会落在患者的肩上（从更大的范围来说是保户以及纳税人），首当其冲的是美国人，但他们也是最先的受益者。说一句比较残酷的话，如果付钱，患者就能获得新的挽救生命的药物。如果不付，很可能就得不到。而美国以外的患者，即便有支付能力可能也得不到最新的药物。3为什么美国市场最重要新药上市时间和数量对比分析为什么几乎所有的开发商在开发一款新药时，都不能忽略美国的市场？因为在那里存在着巨大的利润空间，而且患者群体也要大得多（这一点可以从最近非常火热的减肥药市场见微知著）。虽然FDA监管审批新药的流程严格，但新药批准的速度仍然较快。FDA去年批准了72款新药（CDER 55个，CBER 17个），这种监管姿态极大地激发了制药公司开发新产品的热情。虽然传统上不被视为自由市场，但美国的医药领域在定价方面具有相对的灵活性，能够保证新药在监管审批后用最快的时间上市。例如去年11月8日批准的礼来减肥药物Zepbound，12月5日就出现了在美国市场。而Zepbound今年2月中旬才在英国上市，比美国晚了一个多季度，而且这并不是极端案例。Wegovy在美国的上市时间为2021年6月（因为供应链推迟），但在英国上市的时间则是两年多之后的2023年9月。美国的上市时间之快确保了患者的利益。而在单一价格体系的市场中，新药在解决定价协议之前是很难上市的。高收益带来的回报表现在上市新药数量上，可以从图4（左）看出美国市场上的新药，在2018年（69款）至2022（287款）年全球数量（累计）的增长趋势。在此期间，美国每年花费在新药上的比例也明显高于26个对比国家（图4，右）。图4. 美国新药支出比例图片来源: RAND Health CareRAND Health Care的研究结果（图5）表明：图5. 截止2022年第四季度在美国和对比国家新药数量对照图片来源: RAND Health Care•　2018年至2022年在美国和其它“对比国家”上市的287种新药中，有164种（57%）同时在美国和其它对照国家（后者作为一个整体）上市。•　164种同时在两个板块上市的药物的支出，占美国所有新药支出的90%，占对照国家的93%。这组数据说明，最重要的新药在美国和对比国家均得到广泛的应用。•　有48款（17%）药物仅在美国市场上市，75种药物 (26%) 在至少一个对比国家/地区销售，但在美国不销售。•　在美国销售的新药中，近85%是首先在美国销售的，或者是与其它国家同一季度上市的。有超过一半的新药首先在美国上市，然后在其他国家上市。对照国家的上市时间平均要落后美国一年左右。•　在对比国家中，日本的上市速度仅次于美国，日本上市的平均滞后时间（相对于美国）约为三个季度。•　与其他国家相比，美国在新药总支出中的支出更高，并且持续增长：2022年，美国为12.8%，对比国家为6.9%。以德国为例：•　截至 2022年第四季度，在美国和对照国家共同销售的164种新药中，有129种（79%）在德国有售，有35种（21%）没有在德国销售。•　有48种新药仅在美国有售，这些药物自然也不存在于德国市场。•　到2022年第四季度，美国市场不存在的75种新药中，有20种（27%）在德国市场有售，其余55种（73%）则没有进入德国市场。对于那些只存在于美国市场之外的75款新药，在各自存在的市场中也并不显赫。没有登陆美国市场的这75种药物中，有47种在日本上市。与之对照的是，加拿大市场上的80种新药中，只有4款没有美国上市。在美国上市的212种新药中，有189种（84.9%）是率先在美国上市，或者与率先上市国家同一季度上市的。图6显示了新药上市时间名次（中位排名和平均排名）的排名。很显然，新药在美国上市时间最短，患者可以最快地获得它们。从图6显示的其它国家新药上市时间相对于美国的四分图来看，对照国家的新药上市中位数时间都要超出美国一年以上（日本约为三个季度）。图6. 七个国家新药上市时间相对于美国的四分图图片来源：RAND Health Care图6. 新药上市顺序排名图片来源: RAND Health Care— 总结 —  RAND Health Care的研究结果表明，超过一半的新药首先在美国上市，而且从数量上显著多于对照国家。从上市时间来看，如果新药在两个板块都上市的话，在美国市场出现的时间通常要早于对照国家一年以上。这种时间对比可能反映了监管审批的时间差异，以及其他国家对于药物经济评估要求上的差异（包括药物带来的利益能否超过经济成本）。美国以外的许多国家的监管机构要求对新药进行正式的经济评估。这些审查的具体要求各不相同，但可以包括成本效益分析、新药与现有疗法的比较，以及与其他国家的覆盖范围和定价决策相关的分析。这种经济评估要么与监管审查同时进行，要么在监管审查之后进行。这不仅可能导致新药上市时间缓慢，甚至有可能令新药因为成本问题无法上市。这种现象也解释了为什么大部分新药率先在美国上市的商业决策，开发商可以在其他国家制定受监管的上市价格之前自由设定定价。附表：受研国家2021，2022年新药占处方药支出比例数据来源：Rand Health Care参考文献：1.Langreth, R. Why Prescription Drug Prices in the US Are So High. Bloomberg. 19. 07. 2022.2.Zepbound™ (tirzepatide) is Now Available in U.S. Pharmacies for Adults Living with Obesity. Eli Lilly Press Release. 05. 12. 2023.3.Henderson, D.R. et al. Be Thankful for High Drug Prices. The Wall Street Journal. 04. 02. 2024.4.Mulcahy, A. Comparing New Prescription Drug Availability and Launch Timing in the United States and Other OECD Countries. Rand Health Care. 01. 02. 2024.更多优质内容，欢迎关注↓↓↓