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UNOS Plan Reimagines Governance of US Transplant System to Best Serve Patients

United Network for Organ Sharing

United Network for Organ Sharing (UNOS) officially submitted a plan to the Health Resources and Services Administration (HRSA) that would establish a new governance structure for the OPTN in order to strengthen public trust and oversight and accountability. UNOS is the mission-driven, non-profit organization that serves as the nation’s organ donation and transplant system—the Organ Procurement and Transplantation Network (OPTN)— under contract with and overseen by HRSA. The OPTN Independence Plan, which HRSA requested through a contract modification in May 2023, outlines how best to establish an OPTN Board that is legally independent from the OPTN contractor’s board, with no overlap in membership and with distinct obligations. Creating an independent OPTN Board would require the incorporation of the OPTN as an independent, nonprofit organization. The plan represents the culmination of a multi-year effort. UNOS first requested HRSA engagement in May 2021 to create an independent OPTN Board. In January 2023, UNOS sent a follow-up letter to HRSA Administrator Carole Johnson, advocating for a contract modification that would allow UNOS to submit a roadmap detailing concrete steps to advance board independence. “The roadmap that we submitted is a critical step forward for the nation’s organ donation and transplant system and the patients and families who depend on it,” said UNOS CEO Maureen McBride, Ph.D. “Transplant patients will be best served if the OPTN and its Board are given greater independence. Our plan increases accountability, transparency and good governance, which will lead to greater public trust in the national system.” Since the formation of the OPTN, the OPTN and UNOS have used a unitary board approach, where the UNOS Board also serves as the OPTN Board. This has been done in compliance with the National Organ Transplant Act (NOTA), the OPTN Final Rule and the current OPTN contract held by UNOS. Efforts to reform and improve the national system, however, require a collaborative reimagining of this structure. UNOS’ plan will accomplish several critical goals of UNOS, HRSA, Congress and federal partners. It will provide the continuity of services on which patients rely while ensuring the OPTN’s independence from any current or future OPTN contractors. “The OPTN Independence Plan also promotes competition for the upcoming OPTN contract, eliminating any potential or perceived conflict of interest,” UNOS Board President Dianne LaPointe Rudow, APN-BC, DNP, FAAN said. Creating a legally independent OPTN corporation is a key pillar of UNOS’ Action Agenda and was endorsed by the Senate Finance Committee in its August 2022 report. The proposed plan is subject to HRSA approval. “We are committed to working with HRSA to ensure the successful and timely implementation of any OPTN governance restructuring plan by March 31, 2024,” McBride continued. “It is imperative that we pursue reforms as a unified community, and I am proud of the cooperation at all levels that has resulted in this plan.” About UNOS United Network for Organ Sharing (UNOS) is a non-profit, charitable organization that serves as the Organ Procurement and Transplantation Network (OPTN) under contract with the federal government. The OPTN helps create and define organ allocation and distribution policies that make the best use of donated organs. This process involves continuously evaluating new advances and discoveries so policies can be adapted to best serve patients waiting for transplants. All transplant programs and organ procurement organizations throughout the country are OPTN members and are obligated to follow the policies the OPTN creates for allocating organs. Contact Details United Network for Organ Sharing Anne Paschke +1 804-782-4730 anne.paschke@unos.org Company Website https://unos.org

August 02, 2023 01:50 PM Eastern Daylight Time

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Back to School Tips for Healthy Eyes

YourUpdateTV

With the back-to-school season underway, it’s time to take an important look at your child’s eye health. Recently, the President of the American Optometric Association, Dr. Ronald L. Benner, participated in a nationwide satellite media tour to discuss back-to-school eye safety tips and the importance of having in-person, comprehensive eye exams with a doctor of optometry. A video accompanying this announcement is available at: https://youtu.be/_wkZ4uuCvmg Since the pandemic, children have spent more hours using computers and digital devices for remote learning. This increase in screen time can be extremely taxing on the visual system and have long-term consequences for vision and learning. It also increases the likelihood of developing myopia (nearsightedness), eye coordination issues, eyestrain, dry eye, and exacerbated existing eye conditions. Eye and vision disorders can lead to problems in a child’s normal development, school performance, social interactions, engagement in athletics, and self-esteem. Vision disorders that occur in childhood may manifest as problems well into adulthood, affecting an individual’s level of education, employment opportunities, and social interactions. In addition, undiagnosed vision issues are sometimes misdiagnosed as learning disorders. Vision screenings, such as those performed in schools or pediatrician’s offices,are not a substitute for comprehensive eye exams performed by an optometrist. Annual in-person, comprehensive eye exams are one of the most important, preventative ways to preserve vision and overall health. Optometrists are America’s primary eye health care providers, and are on the frontline of eye and vision care. They examine, diagnose, treat and manage diseases and disorders of the eye. In addition to providing eye and vision care, they play a major role in an individual’s overall health and well-being by detecting systemic diseases, such as diabetes and hypertension. Eye exams safeguard overall health by enabling doctors to detect more than 270 serious health conditions including diabetes, high blood pressure, autoimmune diseases and cancers. Eye Deserve More is a multi-faceted national campaign to take a stand that every American deserves in-person comprehensive care from an AOA doctor of optometry as part of their eye health and overall health and wellbeing. As part of the campaign, to further combat serious eye conditions, AOA developed Blink Land, a single-player mobile game that educates gamers through engaging mini-games and interesting trivia to empower them to focus on their eye health. Download Blink Land on Apple App Store and Google Play Store. For more information, visit aoa.org/eyedeservemore About Dr. Benner Ronald L. Benner, O.D., was elected to the American Optometric Association Board of Trustees at the 118th Annual AOA Congress & 45th Annual AOSA Conference: Optometry's Meeting® in June 2015 and elected to the office of President during the 126th Annual AOA Congress & 55th Annual AOSA Conference: Optometry's Meeting in June 2023. In addition to his duties as President, Dr. Benner serves as chair of the Executive Committee, Agenda Committee, and 401(k) Committee. Dr. Benner is also the liaison trustee to the American Academy of Optometry, the AOA Political Action Committee and the National Optometric Leadership Conference. His board assignments also include the Advocacy Committee, the Meetings & Member Experiences Committee, the Faculty & Student Membership Liaisons Committee, the Future Practice Education Task Force and the Advocacy Roundtable Committee. He also serves as a liaison to affiliate associations in Idaho, Illinois, Indiana, Iowa, Michigan and Wisconsin and is the trustee liaison to optometry schools including Chicago College of Optometry, Illinois College of Optometry, Indiana School of Optometry and Michigan College of Optometry—Ferris State University. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

August 01, 2023 10:21 AM Eastern Daylight Time

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Doceree collaborates with global marketing experts in an industry-first talk show ‘The Next Marketing with HJ’

Doceree Inc

Doceree, the leading global platform for HCP programmatic marketing, today launches the first season of its brand-new talk show- ‘The Next Marketing with HJ’, a refreshing knowledge-first series for potential and practising pharma marketers. Demystifying the global best practices in healthcare marketing, Doceree aims to provide informative and engaging content to the young marketers in the most candid and intelligible form. The launch of The Next Marketing with HJ series coincides with the rise of unprecedented innovation and competition in the marketing world today. As new-age marketers strive each day to achieve the most from their sought-after and captivating marketing campaigns, the show arrives just in time to provide them with the secrets of successful marketing. Released today on Doceree’s YouTube channel, The Next Marketing with HJ features Harshit Jain MD as the show host, fostering dialogue and knowledge-exchange with global experts who share exceptional insights and experiences from their marketing journeys, engaging in compelling discussions that can potentially captivate young audience and provide a holistic view of the multi-faceted advertising and pharma marketing industry. Harshit Jain being a healthcare innovator himself, has been actively driving transformation across the globe with his life-changing, creative and sustainable marketing ideas. He is a celebrated global marketer, an inspiring entrepreneur, an international speaker, and a published author who recently launched his book ‘ The Next Marketing-To Healthcare Professionals ’. Harshit’s passion for going beyond the creative thresholds and redefining marketing campaigns to augment global healthcare outcomes, makes him the perfect host for the show. Speaking on the launch of the show, Harshit Jain says, “Being interviewed multiple times myself, it fills me with excitement to now sit on the other side. I am extremely excited to exchange experiences with some of the most skilful and seasoned personalities from the healthcare and marketing ecosystem. The brand-new knowledge-exchange series not only promises to deliver empowering conversations around pharmaceutical marketing, but also narrates some extremely interesting untold stories that marketers can relate with and gain greatly from.” As renowned marketing stalwarts from across the world grace the show, Harjot Singh, Global Chief Strategy Officer, McCann Worldgroup, talks about his experience of being on the show and says, “ Shows like this expand our understanding of the industry and provide a unique perspective. I have really enjoyed being part of it.” Another expert, Ritesh Patel, Senior Partner - Global Digital Health, FINN Partners expresses, “ My interaction with Harshit is not only refreshing in terms of knowledge sharing but also insightful for those who want to have an in-depth understanding of pharmaceutical marketing ”. With an interesting content palette--ranging from Creative Innovation in marketing to Digital Literacy and the use of Data & Analytics in advertising, to adoption of Point-of-Care Messaging and Omni-channel Marketing —the show brings to light some new-age tips and tricks for marketers from experts like Nancy Phelan, Omnichannel Activation Lead, Indegene, George C.D Griffith, Executive Vice President-Omnichannel Strategy, Relevate Health, among others. The first episode of the show, featuring Harjot Singh, Global Chief Strategy Officer, McCann Worldgroup, disentangles the dichotomy between ‘Magic & Maths’ and further reveals the value of ‘authenticity’ for brands to stay relevant in today’s digital age. The show takes some hilarious twists with the guest sharing funny anecdotes about their marketing journey, thereby giving the marketers of today an opportunity to witness the industry from an unfiltered lens. Episode 01 I The Next Marketing With HJ: https://youtu.be/frJ4y4CfaNs Show Teaser: https://www.youtube.com/watch?v=ARXWFOu4y64&ab_channel=Doceree About Harshit Jain MD: A marketer, an entrepreneur, and a doctor- Harshit Jain MD, has been working towards introducing creative and innovative ways for pharmaceutical brands to reach Healthcare Professionals globally through his venture Doceree, and has established himself as a successful storyteller and change-maker through creative campaigns- The Immunity Charm, Noon Assembly, Blouse Door, etc. Opening doors into a new world marketing, Jain recently authored a book ‘ The Next Marketing-To Healthcare Professionals’ on Point-of-Care Marketing, and is now ready to build a new home for industry best learnings and conversations on the Future of Marketing through his show- ‘The Next Marketing with HJ'. About Doceree: Doceree is a global platform building unprecedented solutions for healthcare professional (HCP) programmatic marketing with proprietary data tools. It facilitates messaging between life sciences brands and HCPs through an extensive global network of digital endemic and point-of-care platforms to programmatically deliver personalized communications to HCPs and transparent marketing campaign metrics at scale. To learn more, visit www.doceree.com. Contact Details Doceree Inc Tanya Singh +91 70420 89805 tanya.singh@doceree.com Company Website https://doceree.com/us/

August 01, 2023 08:56 AM Eastern Daylight Time

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xCures to Contribute Data to Support Aetion®'s Collaboration with FDA

xCures

In a step forward for healthcare research, xCures is pleased to announce that it will support Aetion®'s collaboration with the US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE). As part of this partnership, xCures will provide Aetion with data to support their research collaboration agreement with OCE which centers on using real-world data (RWD) to assess real-world oncology endpoints and measure and address health disparities. As part of the collaboration with OCE, Aetion’s comprehensive fit-for-purpose data assessment identified xCures’ real-time, regulatory-grade data platform to be an appropriate fit for this research study, particularly its ability to integrate clinical data with patient pathology, radiology reports, and imaging assessments. “Aetion is proud to embark on this partnership with xCures to help OCE conduct pivotal research to advance the use of real-world evidence, including in measuring and understanding vulnerable and underrepresented populations,” said Liz Garry, Head of Scientific Research, Aetion. “This work furthers our mission to power critical decisions in healthcare with data science-driven technology and brings us one step closer to achieving health equity.” xCures’ CEO, Mika Newton, explains, "Our platform's automated organization and structuring of aggregated, continuous data result in complete, source-verifiable, and fully longitudinal clinical data sets. This rich dataset can offer unprecedented insight into the real-world patient experience." The contribution of robust RWD from xCures will play an integral role in this endeavor, aiming to fill knowledge gaps and facilitate advancements in healthcare research. For more information about real-time, regulatory-grade clinical data, please visit www.xcures.com/solutions. About Aetion® Aetion is a healthcare analytics company that delivers real-world evidence for the manufacturers, purchasers, and regulators of medical treatments and technologies. Aetion Evidence Platform® analyzes data from the real world to produce transparent, rapid, and scientifically validated answers on safety, effectiveness, and value. Founded by Harvard Medical School faculty members with decades of experience in epidemiology and health outcomes research, Aetion informs healthcare’s most critical decisions—what works best, for whom, and when—to guide product development, commercialization, and payment innovation. Learn more at aetion.com and follow us on LinkedIn. About xCures xCures Inc. operates an AI-assisted platform that automatically retrieves medical records from all sites of care. The (unstructured) data is aggregated and organized into a powerful, always up-to-date care summary that helps cancer patients get the right therapy at the right time. The platform's portals, xINFORM for patients and xDECIDE for providers, facilitate treatment option decisions. The research portal, xUTILITY, generates Real-time, Regulatory-grade, Clinical data (RRC) for studies and decentralized trials. For more information, contact info@xcures.com or visit http://www.xcures.com. Contact Details xCures Inc Patrick van der Valk pvandervalk@xcures.com Company Website https://xcures.com

August 01, 2023 08:45 AM Eastern Daylight Time

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Proactive Analyst expects "some good news over the next 1-2 months" from Tiziana Life Sciences

Tiziana Life Sciences PLC

Proactive Research Analyst Robin Davidson talks to Thomas Warner about his new research note on Tiziana Life Sciences Ltd, which focuses on what he expects from the clinical-stage biopharmaceutical company over the next few months. He says Tiziana is approaching a significant milestone with the initiation of a planned study for its lead agent, Foralumab in non-active secondary progressive MS. Meanwhile, data from the existing expanded access protocol study of the same drug is expected to be revealed next month. Additionally, there's a possibility of scientific data being published at what he describes as the "main MS meeting globally" ECTRIMS scheduled to take place in Milan in October. He goes on to say that Foralumab is also in development for other indications, including Alzheimer's disease, where they are seeking grant funding from a philanthropic source to potentially conduct a study in 2024. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 01, 2023 08:00 AM Eastern Daylight Time

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MGC Pharmaceuticals receives permission to import psilocybin mushrooms into Europe

MGC Pharmaceuticals Ltd

MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) CEO and managing director Roby Zomer speaks to Thomas Warner from Proactive after the Europe-based plant-inspired medicine company announced it has secured permission to import 200g of psilocybin mushrooms into Slovenia for analysis. The news is significant because its the first time the company has been granted permission to import the naturally-occurring psychedelic compound into the country. Zomer explains that MGC Pharma has been contracted by a pharmaceutical company based in Southern Africa to import psilocybin mushrooms grown in the region to MGC's facility in Slovenia. As a certified pharmaceutical company in Europe, MGC Pharma will provide the necessary support and infrastructure to help their partner gather essential data for obtaining marketing approval for the product in other countries. Despite this new collaboration, Zoma emphasized that MGC Pharma's primary focus remains on their existing treatments for refractory epilepsy and immune modulation. However, they recognise the potential of psilocybin as an innovative medicine for the future, particularly in palliative care and post-traumatic treatments. MGC Pharma aims to stay at the forefront of this emerging sector and provide services to other companies interested in exploring psilocybin-based therapies. Looking ahead, MGC Pharmaceuticals awaits the arrival of the imported mushrooms in Slovenia with a view to commencing the testing and development processes. Additionally, updates are expected on their cannabinoid treatments in the UK, as well as their relations and expansion in America. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 01, 2023 04:14 AM Eastern Daylight Time

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Proactive Research Analyst says Shield Therapeutics' commercialisation drive "going well"

Shield Therapeutics PLC

Proactive Research Analyst Robin Davison speaks to Thomas Warner after publishing a new research note on Shield Therapeutics PLC, following the release of new prescription data from the commercial-stage specialty pharmaceutical company for its iron deficiency treatment Accrufer/Feraccru. The key highlight from the analysis is the significant increase of 50% in prescriptions during the second quarter, specifically for Accrufer. The number of doctors prescribing the drug for the first time has also shown a positive trend, with a considerable proportion of those doctors continuing to prescribe it in the following quarter. Davison says that the company's efforts in commercialising the product are "going well", with more benefit expected to come following the expansion of their sales force in June. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 01, 2023 03:45 AM Eastern Daylight Time

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Syntekabio and Metaclipse sign MOU for Joint Research on Personalized Immunotherapy for Cancer

Syntekabio, Inc.

Syntekabio (KOSDAQ: 226330), an Artificial Intelligence (AI) based drug development company, announced that it has signed a MOU with Metaclipse Therapeutics, an Atlanata, GA USA based biotechnology company developing immunotherapies for cancer and vaccines for infectious disease, for joint research on development of a personalized immunotherapy for cancer. Through this MOU, Syntekabio plans to support Metaclipse in conducting research on neoantigen identification for its Membrex TM personalized cancer vaccine platform. Metaclipse’s Membrex™ vaccine is a personalized immunotherapy for solid tumors comprising a patient tumor antigen source combined with the company’s proprietary membrane-linked biological adjuvants. The company has received approval from US FDA to proceed with a phase 1 clinical trial and will work with Syntekabio to leverage its proprietary NEO-ARS® platform to identify neoantigen candidates that generate patient-specific anti-tumor immune responses. Michael Coleman, CEO of Metaclipse, said, “The TMV-based cancer vaccine has the advantage of presenting a broad array of potential neoantigens derived from the patient’s tumor, thereby providing a personalized immunotherapy for cancer. With this MOU agreement, we plan to identify neoantigen candidates, which play a critical role in activating the patient’s immune system and provide the potential for tailoring patient-specific booster doses and developing off-the-shelf Membrex TM therapies with broad application.” Jongsun Jung, CEO of Syntekabio, said, “We are delighted to conduct joint research with Metaclipse, a cancer vaccine specialist in the clinical development stage. We are open to collaboration with companies specializing in the development of cancer vaccines and immunotherapies and will contribute in various ways so that domestic and foreign vaccine manufacturers in clinical stages can achieve positive results.” The Phase 1 clinical trial is to verify the safety and immunological activity of Metaclipse’s tumor membrane vesicle-based vaccine, termed Membrex TM. Syntekabio will contribute to the clinical trial by analyzing genomic data from tumor sample of clinical trial subjects and identifying personalized cancer neoantigens using NEO-ARS®, a neoantigen prediction AI platform. Metaclipse's cancer vaccine incorporates a broad array of tumor antigens in the form of tumor membrane vesicles prepared from the patient's own tumor. This type of vaccine has the advantage of providing a broad array of antigen candidates minimizing selection bias that is present in some other approaches. Through the joint research, the two companies expect to be able to identify the most immunologically relevant antigens by utilizing Syntekabio's NEO-ARS® platform. After this agreement, the two companies plan to comprehensively analyze Syntekabio's neoantigen prediction results and Metaclipse's clinical trial results to evaluate the correlation between the neoantigen profile and treatment response and to conduct joint research to identify potent individual neoantigens that demonstrate high immunogenicity among the many antigens loaded in the Membrex TM vaccine. For more information about Syntekabio and its offering, please visit http://www.syntekabio.com/. Contact Details WMSG | Syntekabio USA +1 201-402-1400 wgroup@wmedical.org Company Website http://www.syntekabio.com/

July 31, 2023 02:58 PM Eastern Daylight Time

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Neural Therapeutics gets go-ahead from Peruvian Government to work with San Pedro Cactus

Neural Therapeutics Inc.

Neural Therapeutics CEO Ian Campbell joined Steve Darling from Proactive to share the news that after 11 months of rigorous review, the company has received permission from Peru's Ministry of Agriculture to access genetic resources and their derivatives for the evaluation of the mescaline-containing cactus species of the Echinopsis genus, commonly known as San Pedro or Huachuma, for possible medicinal purposes. The company's plan is to develop intellectual property that will pave the way for drug development using mescaline. Mescaline is a chemical compound classified as a psychedelic and has shown potential medicinal and therapeutic applications. It is derived from the Peyote and San Pedro cacti. Neural Therapeutics is committed to sustainable practices throughout its exploration and development of mescaline-containing cacti. This includes replanting, donating samples for genetic preservation, and publishing biomarker data to aid in the preservation of wild stands of these cacti species. The access to genetic resources and derivatives of the San Pedro cactus will enable Neural Therapeutics to further explore the potential medicinal benefits of mescaline. The company's efforts could lead to the development of novel therapeutic options and potentially expand treatment options for various medical conditions. As the research progresses, Neural Therapeutics aims to ensure responsible and sustainable practices to safeguard the preservation of these valuable plant species. This approach aligns with the growing interest in harnessing the potential of natural compounds for therapeutic purposes while respecting the environment and preserving biodiversity. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

July 31, 2023 11:29 AM Eastern Daylight Time

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