Business, Divergent CRO, Drugs and Pharmaceuticals, Product Launches

Divergent CRO Announces Launch of New Contract Research Organization

ATLANTA, Ga. -- Divergent CRO, a leading provider of clinical services to biotech and device companies, is pleased to announce the official launch of its new Contract Research Organization (CRO). This new venture aims to revolutionize the research and development process by offering comprehensive and tailored clinical services to meet the unique needs of the biotech and device industries.

With an unwavering commitment to excellence, Divergent CRO provides a wide range of services, including clinical trial management, regulatory affairs, data management, biostatistics, and medical writing. By leveraging our extensive expertise, we are dedicated to helping our clients accelerate the development of innovative biopharmaceuticals and medical devices.

Our team of highly skilled professionals, including experienced clinical researchers, project managers, and regulatory specialists, is dedicated to delivering the highest standards of quality and efficiency throughout each stage of the clinical trial process. We understand the challenges faced by biotech and device companies and are committed to providing flexible and cost-effective solutions to meet their specific needs.

Divergent CRO is equipped with cutting-edge technology and infrastructure to ensure the smooth execution of clinical trials. Our advanced data management systems and secure facilities ensure the confidentiality and integrity of study data, while our robust quality assurance processes guarantee compliance with regulatory requirements.

"We are thrilled to launch our new Contract Research Organization and partner with biotech and device companies to advance the development of life-changing therapies," said Divergent CRO's Owner-Partners. "Our team is dedicated to delivering exceptional results and providing the highest level of service to our clients. With our expertise and commitment to excellence, we are confident that we can make a significant impact on the success of their clinical programs."

Divergent CRO is now accepting inquiries and is available to discuss collaboration opportunities with biotech and device companies seeking to enhance their clinical research capabilities.

For more information, please visit Divergentcro.com or contact our business development team at Customerservice@divergentcro.com or (888) 342-1447.

About Divergent CRO:

Divergent CRO is a leading provider of clinical services to biotech and device companies. With a focus on innovation and quality, we strive to accelerate the development of life-changing therapies through our comprehensive and tailored clinical services. We thrive on leaving our clients and patients satisfied by improving human health and wellness. Our team of experts is dedicated to delivering exceptional results and providing the highest level of service to our clients. At Divergent CRO, we don't just manage clinical trials; we craft personalized solutions, striving to be the difference by transforming challenges into triumphs in the pursuit of groundbreaking healthcare innovation.

Learn more at: https://divergentcro.com/

Social Links:

LinkedIn Page: https://www.linkedin.com/company/divergentcro/

Instagram: https://www.instagram.com/divergent.cro/

TikTok: https://www.tiktok.com/@divergentcro1

YouTube: https://www.youtube.com/@DivergentCRO

Featured Podcasts:

The Jali Podcast - Melyssa Barrett/DivergentCRO - https://melyssabarrett.com/the-jali-podcast/

Episode Thirty-one - AMY HUTTO, PRODUCTIVITY COACH - https://amyhutto.com/podcast/s1ep30

Related link: https://divergentcro.com/

This news story was published by the Neotrope® News Network - all rights reserved. ID:NEO2022

Business, Drugs and Pharmaceuticals, Free News Articles, Insurance, Reports and Studies

Trends in Drug Benefit Design Report Released by Pharmaceutical Strategies Group (PSG)

DALLAS, Texas -- Pharmaceutical Strategies Group (PSG), an EPIC company, is pleased to announce the launch of its Trends in Drug Benefit Design Report. The report delivers innovative research on the latest trends in the traditional (non-specialty) drug benefit. Sponsored by Rx Savings Solutions, it outlines the complexities of designing and managing the drug benefit and the cost challenges faced by consumers and plan sponsors alike.

KEY HIGHLIGHTS OF THE FINDINGS INCLUDE:

* Plan sponsors are grappling with the potential cost of weight loss drugs.

With respondents divided on weight loss as a lifestyle or chronic condition, 43% cover FDA-approved weight loss medications, and 28% may do so in the next 1-2 years.

"Employers are concerned about affordability, as well as the long-term side effects resulting from chronic use," commented Michael Medel, PharmD, Senior Vice President and Practice Lead Plan Sponsors. "While there is recognition of the positive health benefits of weight loss, the data is lacking today to support any significant cost-offset of those benefits."

* Most plans use more than one type of trend and utilization management program, such as prior authorization and refill too soon limits, but these programs can present challenges.

Growing percentages of respondents cited cost and cumbersomeness as barriers to utilization management programs. Two-thirds of respondents wanted more transparency and accountability in these programs, and over half expressed interest in new offerings for tracking and controlling utilization.

* Major advancements have been made in gene and cell therapies over the past 5 years, and as the pace of change increases, interest in financial protection products is growing.

Nearly all (91%) respondents have heard of gene therapy financial protection products. While just 7% currently use these products, nearly half are considering it.

"With a robust cell and gene therapy pipeline, plan sponsors are seeking ways to mitigate the financial risk these expensive therapies present while also ensuring access for their members. Although few are currently using cell and gene therapy financial protection products, many are considering it. This will be an interesting trend to watch in the coming years," noted Morgan Lee, PhD, MPH, CPH, Senior Director, Research & Strategy, PSG.

* Plan sponsors recognize the need to reduce wasteful drug spend.

A little over half of plans (53%) take steps to identify and reduce wasteful spend in the formulary; that percent rising to 75% when isolating the data to health plans. Blocks, exclusions, and use of programs and reporting from their PBM are among the most common steps they take to address this problem.

* The monetary impact of cost-sharing strategies on consumers has spurred a focus on transparency.

The promotion of cost-sharing transparency tools to help members manage expenses continues to rise, from 28% in 2018 to 63% in 2023.

"We are honored to once again sponsor this insightful report, which highlights the importance for plan sponsors to evolve the pharmacy benefit," said Michael Rea, PharmD, Founder and CEO of Rx Savings Solutions (RxSS). "This year, there is a noticeable undercurrent of change in the market. Consumers and patients whose share of prescription drug costs continue to grow are searching for relief and turning to sources both within and outside of the traditional drug benefit. It's a goal all of us in the pharmacy benefit ecosystem to help advance the benefit in ways that produce greater access and affordability, all while controlling spend."

Since the inception of this report, the drug benefit has become more intricate to design and manage. With many new drugs coming to market, decisions around program structure, formulary design, cost sharing, and trend management become increasingly challenging and important. This report helps benefit leaders identify trends and future possibilities so they can adjust as appropriate around these factors and more.

Download the "Trends in Drug Benefit Design" Report: Trends in Rx Benefit Design | Rx Savings Solutions (rxss.com): https://rxss.com/benefit-design-report-2023/

About the 2023 Trends in Drug Benefit Design Report:

The Trends in Drug Benefit Design Report provides in-depth insights into traditional (non-specialty) drug benefit trends and strategies and focuses on drug benefit design for the 2023 benefit year among employers, union/Taft-Hartley, and health plan respondents. The survey sample informing this report included 180 benefits leaders. Issues specific to specialty drugs are included in a separate report - Trends in Specialty Drug Benefits. This report as well as prior annual reports conducted by PSG can be found at https://www.psgconsults.com/research.

About Pharmaceutical Strategies Group (PSG):

Pharmaceutical Strategies Group, an EPIC company, relentlessly advocates for clients as they navigate complex and ever-changing drug cost management challenges. PSG functions as a strategic partner through industry-leading intelligence and technologies to realize billions of dollars in drug cost savings for clients every year. Learn more: https://www.psgconsults.com/

About Rx Savings Solutions - Report Sponsor:

Rx Savings Solutions ("RxSS"), part of McKesson Corporation, works on behalf of everyone who takes prescription drugs and the health plans and employers who cover them. Founded by a former retail pharmacist, RxSS helps members reduce out-of-pocket prescription costs and a health plan's pharmacy spend. The solution layers on top of an existing pharmacy benefit and analyzes individual claims to identify and present cost-saving alternatives to each member. Our member engagement platform notifies members proactively anytime they have prescription savings available. Visit https://rxss.com for more information.

Related link: https://www.psgconsults.com/

This news story was published by the Neotrope® News Network - all rights reserved. ID:NEO2022

Business, Drugs and Pharmaceuticals, Free News Articles, Reports and Studies

PSG Announces Release of Highly Anticipated ‘Trends in Specialty Drug Benefits Report’

DALLAS, Texas -- Pharmaceutical Strategies Group (PSG), an EPIC company, is pleased to announce the release of its annual Trends in Specialty Drug Benefits report. Delivering visibility into the complexity of the specialty drug landscape, it offers detailed intelligence through proprietary research.

Specialty drug costs have continued to push the boundaries in terms of complexity and affordability. The complicated landscape must consider many variables, such as multiple dispensing channels, dual payment methods, and site of care. This report takes a detailed look into what plan sponsors are facing as they make decisions relative to specialty drug benefit plan design.

Alternative funding continues to be a hot topic as plans explore strategies to help offset the high cost of specialty drugs.

"As plans continue to seek ways to offset specialty drug costs, the market is divided as to whether alternative funding is a positive option or a detriment," commented Michael Lonergan, RPh, PSG President. "Affordability of specialty drugs for plans and members is driving this interest, while there is a concern about sustainability in these models."

Integrated pharmacy and medical claims data for managing specialty drugs remains essential.

"Total cost of care is a key concern, and payers rely on reporting that details how well specialty drugs are performing through the insights of integrated data. However, the challenge is in tracking clinical efficacy," observed Morgan Lee, PhD, MPH, CPH, Senior Director, Research and Strategy.

Affordability of cell and gene therapies will likely be a significant payer challenge in coming years.

"As the cost of specialty drugs continues to increase, some health plans and fewer employers have explored the use of value-based contracting (VBC), a performance-based reimbursement agreement. Rare disease treatments that are being targeted by cell and gene therapies will drive future spending," noted Renee Rayburg, RPh, Vice President, Specialty at PSG. "VBCs represent an effort into finding strategies for keeping costly specialty drugs accessible and affordable."

KEY FINDINGS FROM THE REPORT INCLUDE:

* Gene Therapies: While just 24% of respondents have had a gene therapy patient, 81% expect affordability of gene therapies to be a moderate or major challenge in the next 2-3 years.

* Alternative Funding: 14% of employers and 7% of health plans use alternative funding models, and 14% of employers and 33% of health plans are exploring their use. However, 68% of respondents viewed these models as not at all or slightly sustainable.

* Value-based Contracting: Only 12% of respondents report using value-based contracting for specialty drugs. The need for additional evidence, difficulty agreeing on and tracking outcomes, and lack of resources and buy-in were all cited as key barriers to adoption.

* Specialty Rebates: Nearly all plans receive specialty drug rebates under the pharmacy benefit, but health plans are more likely than employers to receive rebates under the medical benefit (66% vs. 27%).

Additional topics covered in the report include increasing usage of new-to-market formulary blocks, interest in site of care programs, prior authorization tracking and reporting, and use of strategies related to biosimilars.

Download the Trends in Specialty Drug Benefits Report and register for the 5/10/23 webinar here: https://www.psgconsults.com/2023specialtybdr-webinar

About the Trends in Specialty Drug Benefits Report

PSG has been researching and reporting on drug benefit design for over 10 years. The report takes an in-depth look at trends and best practices in specialty drug benefit design through the lens of comprehensive questions and responses from over 180 employers, health plans, and labor unions.

About Pharmaceutical Strategies Group (PSG)

Pharmaceutical Strategies Group, an EPIC company, relentlessly advocates for clients as they navigate complex and ever-changing drug cost management challenges. PSG's innovative drug management solutions, including Artemetrx(R) - PSG's proprietary industry-leading software for integrated drug management, deliver actionable insights with exceptional financial and clinical value. PSG functions as a strategic partner through industry-leading intelligence and technologies to realize billions of dollars in drug cost savings for clients every year. Learn more: https://www.psgconsults.com/

Related link: https://www.psgconsults.com/

This news story was published by the Neotrope® News Network - all rights reserved. ID:NEO2022

Business, Drugs and Pharmaceuticals, Free News Articles, Product Launches, Software

NEW PRODUCT LAUNCH: Pharmaceutical Strategies Group (PSG) Announces Artemetrx Extend – Revolutionary Drug Management Reporting Tool Offers Powerful User Insights

DALLAS, Texas -- Artemetrx®, the industry's most preeminent platform for integrated drug cost management, is now even more robust with the launch of its new module, Artemetrx Extend™. With greater insights and analytics, Artemetrx Extend is a custom reporting tool that provides unparalleled data access through its user-friendly platform.

"Artemetrx delivers swift and easy access to valuable drug management insights. With Artemetrx Extend, our clients will be able to further tap into the rich integrated dataset of the Artemetrx platform," said Libby Johnson, PSG Chief Data and Analytics Officer. "Artemetrx Extend continues our long legacy of client advocacy and innovation, as the industry's best keeps getting better."

Can your organization quickly get its data-driven questions answered? Most plans get bogged down waiting for custom analytics when Artemetrx can respond in seconds. The major capabilities now available within Artemetrx Extend, through powerful filtering and drill downs, include the ability to:

* Determine how many members have medical claims associated with a diagnosis for a specific group

* Analyze the specific diagnoses that a particular drug is prescribed to treat for a population based on claims history

* Model the financial impact of switching from one preferred medication to another

* View spend and trend statistics on all drugs (specialty/non-specialty, medical/pharmacy) or search based on National Drug Code, Healthcare Common Procedure Coding System, or drug name

There are two versions of Artemetrx Extend available: Base Access is available for all users, and Power User Access is optional, allowing for custom report and dashboard building and the ability to save and share reports.

Artemetrx is a proprietary industry-leading web-based software for integrated drug management developed by Pharmaceutical Strategies Group. Artemetrx Extend is the latest in a series of innovations on the Artemetrx platform.

Learn more about how Artemetrx Extend: https://link.psgconsults.com/Artemetrx.Extend

About Artemetrx®

Artemetrx is a proprietary SaaS platform developed by Pharmaceutical Strategies Group (PSG), an EPIC company. As one of the first technology solutions in the market to integrate pharmacy and medical claims data for specialty drug cost management, Artemetrx continues to provide market-leading specialty drug insights to payers. It delivers unparalleled intelligence and line-of-sight into serious challenges perpetuating out-of-control drug costs and compromised patient outcomes.

More information: https://www.psgconsults.com/discoverartemetrx

About Pharmaceutical Strategies Group (PSG)

Pharmaceutical Strategies Group, an EPIC company, relentlessly advocates for clients as they navigate complex and ever-changing drug cost management challenges. PSG's innovative drug management solutions, including Artemetrx®, deliver actionable insights with exceptional financial and clinical value. PSG functions as a strategic partner through industry-leading intelligence and technologies to realize billions of dollars in drug cost savings for clients every year.

More information: https://www.psgconsults.com/

Related link: https://www.psgconsults.com/

This news story was published by the Neotrope® News Network - all rights reserved. ID:NEO2022

Business, Drugs and Pharmaceuticals, Free News Articles

Kalyagen Announces Attendance and Speaking Engagement at 8th Annual Biohacking Conference

AUSTIN, Texas -- Kalyagen is pleased to announce that it will be attending and its founder, Christian Drapeau, will be speaking at the upcoming 8th Annual Biohacking Conference. The conference, which is completely sold out, will be held September 15-17 at The Beverly Hilton in Beverly Hills, California.

"The Biohacking Conference will be an ideal opportunity to introduce STEMREGEN directly to an audience whose core focus is to tap into the body's innate ability to repair," said Christian Drapeau. "We are eager to meet and collaborate with the leaders of the biohacking movement."

STEMREGEN® is a unique and patent-pending blend of proprietary plant-based extracts documented to increase the number of circulating stem cells by stimulating Endogenous Stem Cell Mobilization (ESCM). Ingredients in STEMREGEN® have been investigated in more than eight studies for their effect on stem cell function, of which five were randomized, double-blind, placebo-controlled human clinical trials. STEMREGEN® has wide application in anti-aging and overall health maintenance.

"The link between a lower number of circulating stem cells and the development of age-related diseases has been well studied with numerous degenerative conditions, including diabetes, cardiovascular diseases, atherosclerosis, Alzheimer's disease, rheumatoid arthritis, pulmonary diseases, erectile dysfunction, and kidney disease," continued Mr. Drapeau. "From a therapeutic standpoint, increasing the number of circulating stem cells has been documented to enhance tissue repair or improve the course of disease formation in many degenerative conditions and overall health and well-being."

About Kalyagen:

Austin-based Kalyagen® was founded by Christian Drapeau, author of the bestseller Cracking the Stem Cell Code. Kalyagen® is a leader in the research and development of natural products aimed at supporting stem cell function of the body. Stem cells constitute the natural repair system of the body, and stem cell enhancers have been documented to strongly contribute to improving health and quality of life. STEMREGEN® is the first stem cell enhancer product developed by Kalyagen®. STEMREGEN® is a unique blend of proprietary plant-based extracts documented to support Endogenous Stem Cell Mobilization and provide other health benefits.

For more information, please visit our website: https://www.kalyagen.com/

CONTACT:

Biomics, LLC (dba Kalyagen®)

Herbert Dogan, Chief Marketing Officer (310-433-8072)

hgd@kalyagen.com

Social media: @kalyagen #kalyagen #christiandrapeau #stemcellchristian #stemregen #stemcells #stemregeneffect #stemthetideoftime #stemthetide #biohacking

Disclaimer: None of the statements contained in this press release have been evaluated by the U.S. Food and Drug Administration. The products and information in the release are not intended to diagnose, treat, cure or prevent any disease.

Related link: https://www.kalyagen.com/

This news story was published by the Neotrope® News Network - all rights reserved. ID:NEO2022

Business, Drugs and Pharmaceuticals, Free News Articles, Product Launches

Zeteo Biomedical Introduces OrionMRQ™ Nasal Delivery Device for Vaccines

PFLUGERVILLE, Texas -- Zeteo Biomedical LLC announced today the availability of the ZEOx1 OrionMRQ™ nasal drug and vaccine delivery device. Zeteo's latest innovative delivery device provides pharmaceutical and biotech companies developing drugs, peptides, proteins, monoclonal antibodies and vaccines with precise, metered unit dose systemic delivery via the nasal route.

Nasal administration provides needle free, rapid systemic uptake into the body via the nose. Nasal delivery of vaccines can invoke a fast local immune response in the respiratory track, which is frequently the primary route of infection for contagious pathogens such as pandemic flu or coronavirus. The ZEOx1 OrionMRQ™ device is intuitive to use, enabling either patient self-administration or administration by caregivers with configurations available for both adults and children.

The OrionMRQ reloadable nasal delivery device has the capability to store up to four unit doses in the on-board storage compartment. The device is compact making it easy to carry in a pocket or purse. Zeteo intranasal delivery devices incorporate novel packaging technology utilizing a Form Fill Seal (FFS) flexible foil, packaging the drug or vaccine in a unit dose blister reducing the cost and eliminating the supply chain constraints of glass vials.

ZEOx1™ blister packaging provides exceptional barrier properties to protect the drug or vaccine during storage and transport and can be stored at room temperature, refrigerated or frozen storage conditions. The ZEOx1™ packaging technology is commercially scalable to produce millions of doses per day; a critically important requirement for rapid, cost effective deployment of vaccines and medical countermeasures to global populations.

About Zeteo Biomedical LLC:

Zeteo Biomedical™ is a biomedical device technology company based in Austin, Texas. Zeteo provides patient-centric delivery device technology, drug/device combination product development services and fill/finish packaging technology for pharmaceuticals, biopharmaceuticals, biologics and botanicals for intranasal, nose-to-brain, ophthalmic, sublingual, and animal care product applications.

For more information, please visit the Zeteo website at: https://www.zeteobiomed.com/

Related link: https://www.zeteobiomed.com/

This news story was published by the Neotrope® News Network - all rights reserved.

Business, Drugs and Pharmaceuticals, Free News Articles

Oral Vaccine Boosts COVID Immunity: study conducted on nonhuman primates is published in the journal Vaccine

ROCHESTER, Minn. -- Vyriad, Inc., a clinical-stage biotechnology company developing oncolytic virus therapies to treat a wide range of cancers, today announced results confirming the activity of an oral vaccine formulation for boosting immunity against SARS-CoV-2. The full study conducted on nonhuman primates is published in the journal Vaccine accessible at http: https://www.sciencedirect.com/science/article/pii/S0264410X21016716

The article describes the evaluation of an oral COVID-19 vaccine built on the vesicular stomatitis virus (VSV) platform. Oral administration of the VSV based vaccine induced antibodies that could neutralize SARS-CoV-2, the virus that causes COVID-19. More importantly, the novel oral formulation powerfully boosted the levels of neutralizing antibodies against SARS-COV-2 in previously vaccinated monkeys. The oral vaccine was shown to be safe and did not cause clinically significant adverse effects.

"By tweaking the way we generate the VSV-SARS vaccine, we created a new oral formulation that worked remarkably well to boost virus neutralizing antibody titers when administered into the cheek pouches of cynomolgus macaques whose immunity was waning after they had been primed with an intramuscular vaccine," stated Kah-Whye Peng, Ph.D., Chief Technical Officer of Vyriad, and first author of this publication. "Oral dosing is convenient and more likely to be accepted by people who are reluctant to receive yet another intramuscular injection to boost their immunity."

The COVID-19 pandemic is not over and there is a continued need to deliver vaccines to a much of the world's population. An effective oral vaccine/booster has the potential to dramatically improve vaccine uptake rates by addressing some of the key barriers to effective deployment such as logistics of distribution to remote populations, fear of needles, and administration to young children.

"We are excited by these groundbreaking findings. Vyriad has cGMP manufacturing capabilities and is running clinical trials using an engineered VSV for cancer therapy. We are therefore actively seeking partnership to help bring this promising platform to human testing," stated Stephen J Russell, M.D., Ph.D., Chief Executive Officer of Vyriad.

The publication is a collaboration between researchers at Vyriad, Imanis Life Sciences, Regeneron Pharmaceuticals, and the University of Minnesota.

About Vyriad, Inc.

Vyriad is a clinical-stage company developing virus-based therapeutics, focusing initially on proprietary oncolytic virus therapies for the treatment of cancers with significant unmet needs. Founded by scientists at Mayo Clinic and the University of Miami, Vyriad is working with VSV, measles and picornavirus platforms, programming their viruses to selectively attack cancer cells, thereby igniting antitumor immune responses that can complete the process of tumor destruction and prevent disease recurrence.

Our lead platform, derived from vesicular stomatitis virus (VSV), is being evaluated in ongoing Phase 1-2 clinical trials addressing multiple cancer types. Vyriad and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) have a well-established broad-based strategic agreement for the discovery and development of new oncolytic virus treatments for cancer leveraging Vyriad's VSV platform and Regeneron's PD-1 inhibitor Libtayo® (cemiplimab-rwic) as well as its unmatched antibody discovery capabilities. Vyriad is a privately held company based in Rochester, Minnesota.

For more information, visit https://vyriad.com/.

Related link: https://vyriad.com/

This news story was published by the Neotrope® News Network - all rights reserved.

Alliances and Partnerships, Business, Drugs and Pharmaceuticals, Free News Articles

Myrio Therapeutics and Pure MHC, LLC Announce Research Collaboration to Develop Novel, Targeted Antibody-Based Cancer Therapies

OKLAHOMA CITY, Okla. -- Pure MHC, LLC and Myrio Therapeutics Pty Ltd (Myrio) today announced a collaboration to develop new antibody-based oncology therapeutics. The companies will combine Pure MHC's proprietary offering of MHC peptide targets for oncology with Myrio's revolutionary Retained Display(tm) (ReD) antibody discovery process to initially create up to three novel therapies based on targets distinct to tumors across multiple types of cancer.

The cancer therapies resulting from this collaboration will represent a unique synergism: Myrio's ReD platform is differentiated in its ability to routinely identify antibodies that bind to peptides from intracellular proteins presented on the cell surface by major histocompatibility complex (MHC), and Pure MHC is a world-leader in the identification and validation of peptide/MHC (pMHC) targets. Antibodies to next generation pMHC oncology targets may provide more efficacious therapies, particularly for solid tumors, while minimizing off-target effects for patients.

Researchers at both companies expressed excitement at the prospect of combining these innovative approaches:

"The speed and flexibility of Myrio's ReD platform enables the generation of robust antibody-based therapies against challenging targets like pMHC with high affinity and specificity," said Myrio's CEO Pete Smith. "Pure MHC's curated pMHC targets are an excellent fit for our platform and substantially de-risk downstream development."

Pure MHC's Chief Scientist, William Hildebrand, PhD shared this enthusiasm, "Pure MHC is dedicated to the identification of pMHC complexes distinct to cancer and absent from healthy tissues. Peptide/MHC complexes for several oncology indications have been identified by Pure MHC as present on tumors yet absent from healthy tissue, and we are excited for Myrio to deploy their cutting-edge technology to engineer antibodies that recognize our targets with great specificity."

From a business perspective, these therapeutic candidates will bolster Myrio's existing portfolio of in-house assets while providing Pure MHC access to a powerful antibody platform that enables multiple therapeutic pipelines.

"Myrio's platform is not just an outstanding scientific fit, the collaboration represents a unique and exciting way for Pure MHC to deploy its novel target assets strategically," said Kris Looney, President of Pure MHC. "As we continue to provide targets from our pipeline to the market via more traditional partner licensing models, we felt the time was right to also establish our own therapeutic pipeline and have found exactly the collaborator we need in Myrio."

Pete Smith agreed, "With the close alignment of both scientific and business objectives between our two companies, a partnership between Myrio and Pure MHC just makes so much sense. We are excited about its potential."

The companies expect the collaboration to yield therapeutic candidates within the next twelve months.

About Myrio Therapeutics

Myrio Therapeutics is driving a new frontier of antibody-based therapies as the company's Retained Display(tm) (ReD) antibody platform offers identification of highly specific human antibodies that bind to peptide-MHC complexes. Myrio's antibodies can readily be converted into multispecific, CAR-T or other formats, dramatically increasing the target landscape for these modalities. Visit: http://www.myriotx.com/

About Pure MHC

Pure MHC, LLC is a platform technology company funded and managed by Emergent Technologies, Inc. with expertise in disease-specific target identification and validation as well as immunotherapeutic drug development for cancer, infectious disease, and autoimmune diseases. The Pure MHC target discovery technology was developed by Chief Scientist William Hildebrand, Ph.D., of the University of Oklahoma Health Science Center. For more information, visit: https://puremhc.com/

About Emergent Technologies

Emergent Technologies, Inc. is an innovation solutions and technology commercialization leader headquartered in Austin, Texas. Visit: http://www.etibio.com/

Related link: https://puremhc.com/

This news story was published by the Neotrope® News Network - all rights reserved.

Business, Drugs and Pharmaceuticals, Free News Articles, Product Launches, Software

Geminid Systems Unveils Pharmalite CRM to Boost Remote Engagement of Pharma Field Teams

REDWOOD CITY, Calif. -- Geminid Systems, Inc. today announced the global rollout of a SaaS super-app that aims to improve pharmaceutical operations by helping field teams easily overcome challenges arising from the ongoing COVID pandemic.

In conjunction with the product's worldwide release, subscriptions to the app are available at discounted pricing through Jan. 31, 2022.

"Pharmalite CRM is an all-in-one app that enables pharma sales and medical field teams to much more effectively perform, track, and analyze the complex tasks involved in working with existing and prospective healthcare providers," said Guru Karur, VP Product Strategy.

"It's essential for pharma companies," Karur continued, "to have field teams that can communicate better, faster, and more impactfully with providers by use of digital transformation technologies. Companies are finding it difficult now in this pandemic environment to meet patient needs, satisfy regulatory compliance requirements, and reach business objectives."

Karl Gunst, senior product lead, agreed. "The pandemic is making it difficult to build effective field teams. It's more difficult because the environment has changed from face-to-face to remote interactions. Existing solutions have failed to meet the new remote needs."

According to Karur, a potent attribute of Pharmalite CRM is its ability to create fully regulatory-compliant recordings and paper-trails for each interaction between the field teams and health care providers, whether remote or otherwise.

Gunst added that Pharmalite CRM eliminates the need to use as many as a dozen separate apps to cover all the bases. "Pharmalite CRM consolidates within a single app the functionalities to permit training, compliance, analytics, compensation, and more," he said.

"Most CRM solutions lack built-in analytics and advanced insights," Karur said. "Pharmalite CRM fills this gap with excellent support for startup, midlife, and fully mature pharmaceutical companies alike-especially those that urgently need to become more agile."

Pharmalite CRM was in development and beta testing for three years prior to today's debut, but the super-app already is in use by a number of pharmaceutical companies, Gunst revealed.

Company officials predict Pharmalite CRM will quickly emerge as a formidable rival to the industry's current top-selling CRM products.

Said Karur: "We in fact believe Pharmalite CRM will eventually overtake the competition as more and more pharmaceutical teams subscribe to our solution and discover its advanced capabilities and actionable AI-driven insights, which are made possible by highest compliance, performance, and scalability features."

To learn more about Pharmalite CRM, please visit https://www.pharmalitecrm.com/.

ABOUT GEMINID SYSTEMS

Redwood City, California-based Geminid Systems, Inc. is the maker of Pharmalite CRM, currently the only all-in-one pharma SaaS product with applications for sales, medical, market access, as well as management and executive teams. In developing Pharmalite CRM, Geminid harnessed mobile and web technologies to its extensive cloud technologies experience, thereby permitting creation of a fully integrated package of productivity-enhancing, process-simplifying tools designed for unparalleled ease of use.

Related link: https://geminidsystems.com/

This news story was published by the Neotrope® News Network - all rights reserved.

Business, Drugs and Pharmaceuticals, Free News Articles, Reports and Studies

iCell Gene Therapeutics Announces cCAR-T Clinical Publication in the Stem Cell Reviews and Reports Journal

STONY BROOK, N.Y. -- iCell Gene Therapeutics, a clinical stage biopharmaceutical company focused on immunotherapies for hematologic malignancies, solid tumors, organ rejections and autoimmune disorders, today announced the publication of their clinical study utilizing cCAR T-cell immunotherapy to successfully treat a patient with lupus. Their CAR is directed against CD19 and BCMA surface proteins generating a cCAR with dual expression of CD19 and BCMA CAR molecules. Their cCAR is one of a kind in the family of engineered CAR T-cells researchers are studying.

Their report "Treatment of Systemic Lupus Erythematosus Using BCMA-CD19 Compound CAR" published on August 30, 2021, shows the clinical success of cCAR in treating a patient with Systemic Lupus Erythematosus (SLE).

According to Dr. Yupo Ma, founder of iCell Gene Therapeutics, "After a single infusion of CD19-BCMA cCAR the patient achieved undetectable levels of autoantibodies that mediate SLE, successfully treating the patient's SLE for 2 years without the need for additional medications."

The publication is available online at https://doi.org/10.1007/s12015-021-10251-6.

About SLE

Systemic lupus erythematosus (SLE) is an antibody-mediated autoimmune disease, in which autoantibodies attack its own tissues, resulting in widespread tissue damage in the affected organs including kidneys, lungs, joints, brain and blood vessels. According to the Lupus Foundation of America, it estimates that 1.5 million Americans, and at least five million people worldwide, have a form of lupus.

About CD19-BCMA cCAR Therapy

iCell has developed a novel compound Chimeric Antigen Receptor (cCAR)approach. In this approach, the cCAR T cells express two distinct and fully functional CAR molecules, one that targets the molecule CD19 present on B cells and one that targets BCMA, which is present on plasma cells. In their recently published paper, researchers have shown that this cCAR led to rapid and dramatic decreases in B cell levels and levels of "autoantibodies" (antibodies that attack the body's own cells) in a patient with SLE.

As B cells are part of the normal immune system, it is preferable that the elimination of B cells be temporary. After 9 months of B cell depletion, the patient's B cells returned to normal. Importantly, the levels of autoantibodies remained undetectable. Based on these results, the researchers concluded that cCAR effectively "reset" the antibody-producing populations. In this "reset," the problematic cell populations were removed, leaving behind a fresh, clean slate. From this, new B cells and plasma cells were eventually formed, which did not have the same autoantibody-producing properties. Because of this, the patient has not had further lupus symptoms despite receiving no additional medications for over 2 years.

Given the prevalence of antibody-mediated disorders, this cCAR may prove useful for a variety of different medical conditions.

Sjögren's Syndrome, autoimmune hemolytic anemia, neuromyelitis optica spectrum disorder, celiac disease, type 1 diabetes, inflammatory bowel disease, rheumatoid arthritis, psoriasis, and multiple sclerosis all incorporate autoantibody formation in disease pathogenesis. Additionally, organ rejection following transplantation may be mediated by antibodies. By "resetting" the immune system prior to organ transplantation, this antibody-mediated rejection may be avoided. More research is needed on the long-term efficacy and safety of this treatment, but future applications of cCAR has a large window of opportunity.

About iCell Gene Therapeutics

iCell Gene Therapeutics, located in Stony Brook, New York, is a clinical-stage biopharmaceutical company developing first-in-class chimeric antigen receptor engineered cells. Their main focuses are on autoimmune disorders, AML, and T-cell malignancies. Their current clinical trials utilize their CARvac, T-cell targeted CARs, cCARs and non-gene edited universal CARs engineered as treatments for cancer, organ rejections and autoimmune diseases. These studies are ongoing in the US and China for their use.

For more information, please visit http://icellgene.com/

CONTACT:
Media and Investors
Kevin Pinz
Tel: (631) 538-6218
Kevin.pinz@icellgene.com

RELATED LINKS:

https://www.lupus.org/resources/how-many-people-have-lupus-in-the-united-states

https://www.lupus.org/resources/what-is-lupus

Related link: http://icellgene.com/

This news story was published by the Neotrope® News Network - all rights reserved.