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<?xml version="1.0" encoding="UTF-8"?><rss version="2.0" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:wfw="http://wellformedweb.org/CommentAPI/" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:sy="http://purl.org/rss/1.0/modules/syndication/" xmlns:slash="http://purl.org/rss/1.0/modules/slash/" xmlns:media="http://search.yahoo.com/mrss/" xmlns:georss="http://www.georss.org/georss" xmlns:geo="http://www.w3.org/2003/01/geo/wgs84_pos#" > <channel> <title>Samedan</title> <atom:link href="https://www.samedanltd.com/feed/" rel="self" type="application/rss+xml" /> <link>https://www.samedanltd.com</link> <description>Samedan Ltd</description> <lastBuildDate>Tue, 20 Jun 2023 23:00:00 +0000</lastBuildDate> <language>en-GB</language> <sy:updatePeriod> hourly </sy:updatePeriod> <sy:updateFrequency> 1 </sy:updateFrequency> <image> <url>https://www.samedanltd.com/wp-content/uploads/2023/07/Samedan-icon-large.png</url> <title>Samedan</title> <link>https://www.samedanltd.com</link> <width>32</width> <height>32</height> </image> <site xmlns="com-wordpress:feed-additions:1">214882480</site> <item> <title>Lubrizol Licenses Award-Winning Apisolex Excipient to Welton Pharma to Develop a Novel Cancer Therapeutic</title> <link>https://www.samedanltd.com/2023/06/21/lubrizol-licenses-award-winning-apisolex-excipient-to-welton-pharma-to-develop-a-novel-cancer-therapeutic/</link> <dc:creator><![CDATA[Samedan Ltd]]></dc:creator> <pubDate>Tue, 20 Jun 2023 23:00:00 +0000</pubDate> <category><![CDATA[Uncategorized]]></category> <guid isPermaLink="false">https://www.samedanltd.com/2023/06/21/lubrizol-licenses-award-winning-apisolex-excipient-to-welton-pharma-to-develop-a-novel-cancer-therapeutic/</guid> <description><![CDATA[CLEVELAND, US - 21 June 2023 - The Lubrizol Corporation announces the licensing of its novel excipient polymer technology, Apisolex excipient, to Welton Pharma (Welton). The license allows Welton to use the Apisolex excipient worldwide to develop and commercialise a novel formulation of SN-38 to treat colorectal and associated gastro-intestinal cancers.]]></description> <content:encoded><![CDATA[<hr /> <div> </div> <div><b>CLEVELAND, US – 21 June 2023 –</b> The Lubrizol Corporation announces the licensing of its novel excipient polymer technology, Apisolex excipient, to Welton Pharma (Welton). The license allows Welton to use the Apisolex excipient worldwide to develop and commercialise a novel formulation of SN-38 to treat colorectal and associated gastro-intestinal cancers. </p> <p> </div> <div> </div> <div>Introduced to the market last year, the patented Apisolex excipient is a polyamino-acid polymer designed for parenteral applications. The use of the Apisolex excipient has been proven to increase the solubility of active pharmaceutical ingredients (APIs) by as much as 50,000-fold with the goal of increasing the API’s efficacy in the body. Lubrizol continues to invest in expanding the reach of the Apisolex excipient in the market and nurturing relationships with drug product manufacturers that are facing insoluble API challenges. </p> <p> </div> <div> </div> <div>Kevin Song, PhD Global Marketing Director, Lubrizol Life Science Health said, “We are continuously innovating to solve challenges for our customers and partners. By delivering differentiated solubility-enhancing solutions to the market, we enable the acceleration of life changing drug products to patients who need them.” </p> <p> </div> <div> </div> <div>Welton is looking to bring life-saving solutions for the treatment of colorectal cancer that impacts 1.9 million people worldwide (2020). Combining Welton’s formulation expertise and Lubrizol’s Apisolex excipient, Welton plans to develop a novel formulation of SN-38 to overcome its solubility challenges in water, which has hindered its clinical development. Welton seeks to develop a stable, ready-to-use formulation having higher bioavailability and shorter infusion time to enhance the clinical outcome for cancer patients. In the next 12 months, Welton will focus on advancing their lead formulation with the Apisolex excipient into nonclinical testing and developing plans for the first in-human studies. </p> <p> </div> <div> </div> <div>Kevin Sill, PhD, Welton CEO and cofounder, “We are thrilled to have access to both this critical excipient and the expertise of Lubrizol. We will be relying on the strong patent protection of the Apisolex么 excipient, coupled with supply and supporting data as we advance our product.” </p> <p> </div> <div> </div> <div>Request a sample of the Apisolex excipient today by visiting<a href="www.apisolex.com" title="www.apisolex.com"> www.apisolex.com</a>.</p> <p> </div> ]]></content:encoded> <post-id xmlns="com-wordpress:feed-additions:1">2155</post-id> </item> <item> <title>Allucent Selects THREAD to Power Patient Direct Trials Offering</title> <link>https://www.samedanltd.com/2023/06/20/allucent-selects-thread-to-power-patient-direct-trials-offering/</link> <dc:creator><![CDATA[Samedan Ltd]]></dc:creator> <pubDate>Mon, 19 Jun 2023 23:00:00 +0000</pubDate> <category><![CDATA[Uncategorized]]></category> <guid isPermaLink="false">https://www.samedanltd.com/2023/06/20/allucent-selects-thread-to-power-patient-direct-trials-offering/</guid> <description><![CDATA[Cary, US - 20 June 2023 - Global biopharmaceutical services provider Allucent has partnered with THREAD, an innovative decentralised clinical trial (DCT) and electronic clinical outcomes assessment (eCOA) technology provider, to launch Allucent Patient Direct Trials. The new offering brings advanced technologies and development and regulatory expertise to small and emerging biotechnology companies to support them in designing and overseeing customised decentralised clinical trial approaches.]]></description> <content:encoded><![CDATA[<hr /> <div><b><br /> <br /></b> </div> <div><b>Cary, US – 20 June 2023 –</b> Global biopharmaceutical services provider Allucent has partnered with THREAD, an innovative decentralised clinical trial (DCT) and electronic clinical outcomes assessment (eCOA) technology provider, to launch Allucent Patient Direct Trials. The new offering brings advanced technologies and development and regulatory expertise to small and emerging biotechnology companies to support them in designing and overseeing customised decentralised clinical trial approaches. </p> <p> </div> <div> </div> <div>Allucent will preferentially leverage THREAD’s DCT and eCOA technology across its global clinical trial portfolio. The partnership is part of a broader strategic initiative within Allucent to transform its clinical trial delivery to center on the patient and drive leading recruitment and retention outcomes, with a key focus on its rare disease and oncology programs. This expanded, three-year enterprise partnership will power Allucent’s new Patient Direct Trials offering for its customers. </p> <p> </div> <div> </div> <div>Mark A Goldberg, MD, chairman and chief executive officer of Allucent, stated, “THREAD has a track record of success as a leading provider of decentralised and eCOA technologies for our customers. The company’s no-code technology platform gives us the confidence we need to deliver high quality and on-time studies for our customers.” </p> <p> </div> <div> </div> <div>THREAD offers a configurable and flexible platform to operationalize a variety of study phases and designs across Allucent’s clinical trial portfolio. Its unique and tailored CRO enablement model utilises THREAD’s expertise and embeds change management support to drive true trial modernization and patient-first clinical research. </p> <p> </div> <div> </div> <div>John Reites, co-founder and chief executive officer of THREAD, stated, “Allucent’s Patient Direct Trials offering will enable its customers to center clinical trial delivery on the patient from study design to final analysis. We are excited to be selected as Allucent’s multi-year enterprise partner. Its offering aligns with our mission of advancing research for everyone, everywhere.” </div> ]]></content:encoded> <post-id xmlns="com-wordpress:feed-additions:1">2154</post-id> </item> <item> <title>Veristat Acquires European Medical Writing Consultancy</title> <link>https://www.samedanltd.com/2023/06/12/veristat-acquires-european-medical-writing-consultancy/</link> <dc:creator><![CDATA[Samedan Ltd]]></dc:creator> <pubDate>Sun, 11 Jun 2023 23:00:00 +0000</pubDate> <category><![CDATA[Uncategorized]]></category> <guid isPermaLink="false">https://www.samedanltd.com/2023/06/12/veristat-acquires-european-medical-writing-consultancy/</guid> <description><![CDATA[Southborough, US - 12 June 12 2023 - Veristat, a scientific-minded global clinical research organization (CRO), has acquired Scinopsis, a European medical writing consultancy with a 17-year track record of delivering regulatory and medical communication documents of the highest quality to the biopharmaceutical industry. The acquisition strengthens Veristat铆s ability to meet growing client demand in one of its highest-valued service areas as the range of clinical trial content expands and the importance of regulatory documentation increases.]]></description> <content:encoded><![CDATA[<hr /> <div> </div> <div><b>Southborough, US – 12 June 12 2023 –</b> Veristat, a scientific-minded global clinical research organization (CRO), has acquired Scinopsis, a European medical writing consultancy with a 17-year track record of delivering regulatory and medical communication documents of the highest quality to the biopharmaceutical industry. The acquisition strengthens Veristat’s ability to meet growing client demand in one of its highest-valued service areas as the range of clinical trial content expands and the importance of regulatory documentation increases. </p> <p> </div> <div> </div> <div>Based in Fr脠jus, France with an office in Brighton, UK, Scinopsis brings synergistic competencies to Veristat’s existing medical writing team. Scinopsis writers are highly qualified scientists with most members of the team holding a PhD or MD degree. The team has extensive experience meeting the requirements of regulatory organizations in Europe and the United States, with mastery in reporting and filing documents including clinical trial and regulatory documents and medical communications, along with medical device plans, reports, publications, and patient-friendly communications. Many staff members have held previous roles in biopharmaceutical environments across clinical and pre-clinical research, medical writing, and project management. </p> <p> </div> <div> </div> <div>“Effective medical writing in the clinical and regulatory realm has always been important, yet with the increasing complexity of today’s diverse scientific solutions and novel therapeutics it is essential,” said Patrick Flanagan, Chief Executive Officer of Veristat. “Medical writing informs critical decisions being made during clinical research, regulatory approval, and post-marketing. Expanding our medical writing capabilities globally was a business imperative, and I am thrilled to have Scinopsis join with Veristat. Our strength continues to be the combined capabilities of our exceptional team.” </p> <p> </div> <div> </div> <div>Medical writing for rare diseases, particularly in gene and cell therapies, holds additional challenges when compared to medical writing requirements for treatments that address larger patient populations. Less common statistical methods, data from smaller patient populations, natural history data, real-world evidence, and various other non-traditional data types are some of the unique circumstances medical writers confront as they strive for content clarity, accuracy, and effectiveness. Both Veristat and Scinopsis have significant expertise supporting the development of complex therapies for rare diseases and oncology. </p> <p> </div> <div> </div> <div>“Quality medical writing is unquestionably key to having productive engagement no matter the therapeutic category, audience, or document type,” stated Dr. Sarah Hopwood, Chief Operating Officer of Scinopsis. “We have built our reputation on an unwavering commitment to quality. I am proud to work with a leadership team and global organization that shares our values. With Veristat’s extensive experience in strategic consulting, regulatory affairs and publishing, global clinical operations, biostatistics and programming, the joining of our organizations offers clients access to additional services while delivering confidence that the writing quality and collaborative support they have come to expect from our team will continue.” </p> <p> </div> <div> </div> <div>Dr Barbara Balser, Veristat’s Co-founder and Chief Scientific Officer, remarked, “I am delighted to welcome the Scinopsis team to Veristat. The combination of the Scinopsis team with our experienced medical writing team will provide our clients with a global approach to the complexities of successful regulatory writing.” </p> <p> </div> <div> </div> <div>More information on Veristat’s medical writing services can be found at <a href="https://www.veristat.com/services/regulatory-affairs/medical-writing" title="https://www.veristat.com/services/regulatory-affairs/medical-writing " target="_blank" rel="noopener">https://www.veristat.com/services/regulatory-affairs/medical-writing </a><br /> </div> ]]></content:encoded> <post-id xmlns="com-wordpress:feed-additions:1">2153</post-id> </item> </channel> </rss>