Category Archives: Transhuman News

By Tom Piombino

For the cell and gene therapy (CGT) sector, recent years have been nothing less than phenomenal. For example, according to the Alliance for Regenerative Medicine, the sector has witnessed skyrocketing investment. The $7.5 billion raised in 2017 was more than tripled by the $22.7 billion raised in 2021.

Besides creating opportunities for CGT companies, such funding is creating a crunch for both real estate and talent. For example, in San Francisco, more than half a billion square feet of manufacturing space has been acquired by CGT companies in the past year. In Philadelphia, where academia is generating intellectual property in the CGT space at a torrid pace, more than one million square feet of new laboratory space is in development.

In North Carolinas Research Triangle regionwhere vacancy rates have kept per-square-foot development in the $30s range (as opposed to downtown Bostons $100/square foot)the competition for resources has placed a premium on selection and planning, as CGT programs shift from R&D, which occurs in science clusters, to manufacturing, which occurs in attractive suburban markets.

This shift is a huge challenge for CGT companies. The transition from research and preclinical development to process development and clinical manufacturing is rough. Some stakeholders underestimate the difficulties of taking their businesses to the manufacturing phase, and they end up treading water in a sea of limited options. While the pandemic significantly impacted the office market, many of the available and proposed building conversions cannot provide the rigor or meet the cost expectations of a manufacturing facility.

Site selection in todays market goes beyond engineering and real estate. It requires bringing knowledge and talent to appreciate the perspectives of more diverse workforces and company cultures while sustaining market growth, promotion, and compliance. From an organizations project inception, unity of the resources early in a planning process offers owners the perspectives needed to make the right decisions for their businesses while focusing on the big picture of bringing groundbreaking therapies to market. All too often, these decisions are predicated on immediate needs (2 years out) or currently available resources, instead of a vision of technological progress (10 years out).

Site selection can be daunting for the most seasoned real estate professionals, and even more so for people whose expertise is outside of the field. Selecting an attractive siteone with the proper structural capacity, heights, utilities, workforce availability, access to transportation, access to parking, and amenitiescan quickly become an all-consuming task for an operating company. Additionally, predicting the needs and wants of a workforce in a transitionary state, post-pandemic, adds another dimension of complexity for peoples whose day job is attending to developing science.

Much like an engineering design process, the building out of early-stage GCT facilities requires a deliberate approach with input from experts whose knowledge in various fields benefits the project as a whole. It must start at the business case inception, utilizing a well-rounded team that can streamline the process and thoroughly explore solutions while addressing needs and challenges across the organization. While speed is incredibly important at this stage, attempts at seeing this inceptionary process as a transaction often result in a misrepresentation of the required outcome.

Using applied experience and several iterations, an experienced project team with an understanding of the business case can recognize trends, similarities, and the opportunities to quickly adapt the solutions that can be acted upon in weeks rather than months. If this approach is taken from the inception of a project, owners can realize considerable benefits and avoid distractions from their day jobs.

First, it brings into focus a clear multiyear plan addressing the operational needs of the organization: Who will need to be hired for research, quality control, manufacturing, maintenance, packaging, and shipping, among other positions? How can an organization build its culture during the growth period? What kinds of efficiencies are needed in the facility? What impact will the operational costs have on funding resources? How does residual value of the asset impact the investor appetite in a facility?

Second, it brings more value to the effort by helping owners explore costs and schedules from the outset. If owners begin months later, during conceptual design, they may belatedly discover that they could have been better positioned to seize growth opportunities.

Planning for companies in a fast-growth period can be daunting, especially in a real estate environment as competitive as the one that currently exists. Company leaders versed in other aspects of the business such as R&D may not have a sense of how much space will be needed in the long term, or of how much effort will be needed to ensure a space meets requirements such as staying up to code.

Onboarding the project team early on can be key to making a project successful because it streamlines the iterative process. By working closely with owners at the inception of the project, team members learn what works for organizations and what does not, building upon the plan as it progresses.

It also develops trust and confidencetwo elements that are especially valuable when the team needs to be flexible in the exploratory phase of project planning. Not only do these elements empower team members to present multiple options, including unconventional options, it gives them the space to learn from feedback and converge on the right solution.

When evaluating options, organizations have to focus on important factors for each element of the plan:

Site: This is about more than the location of the facility. The site plays a key role in meeting the organizations current goals and serves its future growth. With those near-term and long-term goals prioritized, the team can address details such as the need to include multi-floor manufacturing facilities or loading docks capable of accommodating particular types of vehicles.

Also, not to be overlooked in site selection is customer access. Ensuring that an organizations key audience can easily access these facilitieswhether they are in urban areas, which may present traffic and parking difficulties, or in smaller markets, which may not be as easily accessible by commercial transportationwill be a factor in the decision-making process.

Space: The rapid growth in the CGT market puts space at the forefront of planning for small companies. How big does a new facility need to be? What features will need to be included? Can the current building stock in a market serve an organizations needs, or will a greenfield development be required? Much of the real estate market is developer-driven rather than company-driven, which has both benefits and challenges.

In a developer-driven project, a facility may be fitted out to serve as a manufacturing nexus for cell therapies, gene therapies, and biologics. Alternatively, a facility may meet a particular manufacturing need, once the developer determines the appropriate scale reviews a few solutions. While there are few standard solutions that fit all CGT companies, by taking standard ideas and measuring the options to the needs, organizations can streamline the process by tailoring elements to their requirements.

Brand: More than being about aesthetics, a facilitys appearance has the ability to tell an organizations story, from its culture to its future plans. While a warehouse can serve a company like Amazon quite effectively, for growing CGT companies wanting to attract top talent and top funders, the impression that a facility presents impacts the mission of the company as well as how an organization can differentiate itself from other companies in a competitive marketplace.

Expectations: There are a lot of companies that can get derailed early on in the process, as their expectations can deviate from reality.

For owners coming out of institutions that are not well placed, moving to a central location might put them in greater proximity to talent. It also could come with significant extra costs in rent, construction, and operations. Rents within regions, not justbetween regions, can swing significantly.

However, organizations also must be honest when considering the costs. For example, is $22/square foot for rent in the suburbs more cost effective compared to $55/square foot near a city core if it means sacrificing the ability to recruit talented people who refuse to work in the suburbs?

In addition, with space at a premium, can an organization live with a real estate strategy that might require a stepped approach to growth? In the rapidly expanding CGT markets, many companies moving from research to trials to manufacturing have compromised on facilities that are too small or in the wrong location, putting growth strategies at risk.

The demands on CGT companies are different from those on other companies. Even as biopharma players have moved into the market, the competition has only increased the difficulty of coping with the markets growth.

The move from research to preclinical trials to clinical manufacturing is occurring at such a pace that it is leaving some companies waiting at a crossroads without a complete strategy on moving forward. By engaging technical and subject matter experts as part of a project team early in the process, organizational leaders can make decisions that will position their organizations for years of growth.

Tom Piombino (tpiombino@ipsdb.com) is managing director of the Americas for IPSIntegrated Project Services. For more information on the Inceptioneering process, please visit http://www.ipsdb.com/expertise/services/inceptioneering.

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Overcoming the Challenges of Cell and Gene Therapy Facilities - Genetic Engineering & Biotechnology News

Arrested Development: A brain organoid derived from the skin cells of a child with Pitt-Hopkins syndrome (right) is smaller and has fewer neurons than that derived from a child without the syndrome (left).

Tiny balls of cultured human brain cells reveal how genetic mutations linked to Pitt-Hopkins syndrome, a profound form of autism, disrupt brain development, according to a new study. These balls of cells called brain organoids also reveal how gene therapies might help lessen the mutations effects.

The data offers hope that a future clinical application with gene therapy might actually benefit certain autism spectrum disorder patients, says co-lead investigator Alysson Muotri, professor of pediatrics and of cellular and molecular medicine, and director of the stem cell program, at the University of California, San Diego. Our research is focused on profound autism spectrum disorder subtypes individuals that really need help and medical support to achieve their full potential.

Pitt-Hopkins syndrome is caused by de novo mutations in TCF4, a gene that controls when other genes are turned on or off in the embryo and is essential for brain development. Children with Pitt-Hopkins syndrome have severe cognitive and motor disabilities and typically are nonverbal.

There is a rough estimate that Pitt-Hopkins syndrome affects 1 in every 30,000 individuals, but this is an underestimate, because genetic diagnostic testing is not available in most countries, says co-lead investigator Fabio Papes, associate professor of genetics, evolution, microbiology and immunology at the University of Campinas in So Paulo, Brazil.

Papes has a relative with Pitt-Hopkins syndrome, which spurred him to study how TCF4 mutations impair brain development. He and Muotri turned to organoids because mouse models of the condition are limited: The animals display some Pitt-Hopkins syndrome-like traits, such as impairments in social interactions and memory, but fail to mimic the severe traits seen in people.

The new results highlight once more, the need for human models in order to fully understand the genetics of neurodevelopmental disorders, says Jrgen Knoblich, scientific director of the Institute of Molecular Biotechnology at the Austrian Academy of Sciences in Vienna, Austria, who did not take part in this research. It represents nice and useful progress for the field of neurodevelopmental disorders.

Muotri, Papes and their colleagues generated brain organoids using skin cells from five children with Pitt-Hopkins syndrome and five controls.

After four weeks, organoids with TCF4 mutations were significantly smaller than those without, and many of their cells had not developed into neurons from precursor cells called neural progenitors.

The neural progenitors exhibited arrested development, likely due to a disruption in a cell signaling pathway called WNT and then reduced expression of a gene called SOX, the scientists found. Compared with controls, the progenitors yielded fewer cortical neurons, which power thinking, memory, speech and other cognitive abilities. And the neurons they did produce showed impaired electrical activity and tended to cluster together instead of self-organizing into neural circuits. The findings appeared in Nature Communications in May.

It is surprising to see such significant effects on neural progenitor cells, because the obvious traits of Pitt-Hopkins syndrome, such as microcephaly, or a small head, usually develop after birth, says Ben Philpot, professor of cell biology and physiology at the University of North Carolina at Chapel Hill, who did not work on this study. This suggests that their organoid model was highly sensitive and has great value for screening potential therapeutics, he says.

The scientists also tested two different virus-based gene therapies on the organoids. One encodes molecules that boost levels of TCF4 protein, whereas the other delivers a functional copy of the gene to the cells. Both techniques resulted in organoids that resembled the controls.

We could rescue molecular, cellular and neural network alterations by just restoring the expression of the corrected gene, Muotri says.

In an unrelated study published in eLife in May, Philpot and his colleagues tested a very similar gene therapy strategy in mouse models, Papes says. Both papers complement each other very nicely, providing very solid evidence, in patient-derived human cells and in animals, that gene therapy is possible for this form of profound autism.

Muotri, Papes and their colleagues have partnered with a pharmaceutical company specializing in gene therapy to use these new findings to design a clinical trial. The clinical potential is huge, Muotri says. We will start with TCF4, but our strategy allows us to test other genes implicated in autism spectrum disorder.

The scientists caution that these findings may not translate for people with Pitt-Hopkins syndrome. A brain organoid is not a mini-brain, Muotri says. These are really small structures when compared to the human brain. Also, they are mimicking developmental stages rather than a more mature human brain.

In addition, children enrolled in a clinical trial would receive the gene therapies a few years after the prenatal stage of brain development in which the therapies were tested. Our gene therapy approach may not correct all characteristics, especially those changes that cannot be reverted once the cells and brain tissue have already been altered, Papes cautions.

Before clinical trials can ever happen, we need to be absolutely convinced that our methods will cause no harm and will be effective, Muotri says. Thus, we have a lot of work to do in the following years.

Cite this article: https://doi.org/10.53053/FQVM6681

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Organoids test gene therapies for Pitt-Hopkins syndrome - Spectrum

A new gene therapy that inhibits targeted nerve cell signaling effectively reduced neuropathic pain in mice with spinal cord or peripheral nerve injuries with no detectable side effects.

An international team of researchers led by scientists at the University of California San Diego School of Medicine reported that a gene therapy that inhibits targeted nerve cell signaling effectively reduced neuropathic pain in mice with spinal cord or peripheral nerve injuries with no detectable side effects.

The results, which were published in the online edition of Molecular Therapy on May 5, 2022, suggest a possible new treatment option for a condition that may affect more than half of individuals with spinal cord injuries. Neuropathy involves damage or dysfunction in nerves elsewhere in the body, typically resulting in chronic or debilitating numbness, tingling, muscle weakness, and pain.

There are no singularly effective remedies for neuropathy. Pharmaceutical therapy, for example, may need sophisticated, continuous medication administration and is linked with adverse side effects such as drowsiness and motor weakness. Opioids may be effective, but they can also develop tolerance and raise the risk of overuse or addiction.

Because physicians and researchers are able to pinpoint the precise location of a spinal cord injury and the origin of neuropathic pain, there has been much effort to develop treatments that selectively target impaired or damaged neurons in the affected spinal segments.

In recent years, gene therapy has proven an increasingly attractive possibility. In the latest study, researchers injected a harmless adeno-associated virus carrying a pair of transgenes that encode for gamma-aminobutyric acid or GABA into mice with sciatic nerve injuries and consequential neuropathic pain. GABA is a neurotransmitter that blocks impulses between nerve cells; in this case, pain signals.

The delivery and expression of the transgenes GAD65 and VGAT were restricted to the area of sciatic nerve injury in the mice and, as a result, there were no detectable side effects, such as motor weakness or loss of normal sensation. The production of GABA by the transgenes resulted in measurable inhibition of pain-signaling neurons in the mice, which persisted for at least 2.5 months after treatment.

Senior study author Martin Marsala, MD, is a professor in the Department of Anesthesiology at UC San Diego School of Medicine. Credit: UC San Diego Health Sciences

One of the prerequisites of a clinically acceptable antinociceptive (pain-blocking) therapy is minimal or no side effects like muscle weakness, general sedation or development of tolerance for the treatment, said senior author Martin Marsala, MD, professor in the Department of Anesthesiology in the UC San Diego School of Medicine.

A single treatment invention that provides long-lasting therapeutic effect is also highly desirable. These findings suggest a path forward on both.

Reference: Precision spinal gene delivery-induced functional switch in nociceptive neurons reverses neuropathic pain by Takahiro Tadokoro, Mariana Bravo-Hernandez, Kirill Agashkov, Yoshiomi Kobayashi, Oleksandr Platoshyn, Michael Navarro, Silvia Marsala, Atsushi Miyanohara, Tetsuya Yoshizumi, Michiko Shigyo, Volodymyr Krotov, Stefan Juhas, Jana Juhasova, Duong Nguyen, Helena Kupcova Skalnikova, Jan Motlik, Hana Studenovska, Vladimir Proks, Rajiv Reddy, Shawn P. Driscoll, Thomas D. Glenn, Taratorn Kemthong, Suchinda Malaivijitnond, Zoltan Tomori, Ivo Vanicky, Manabu Kakinohana, Samuel L. Pfaff, Joseph Ciacci, Pavel Belan and Martin Marsala, 5 May 2022, Molecular Therapy.DOI: 10.1016/j.ymthe.2022.04.023

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Gene Therapy Successfully Treats Spinal Cord Injuries Without Side Effects - SciTechDaily

image:In comparing the gene expression patterns of 26 species with diverse lifespans, University of Rochester biologists found that the characteristics of the different genes were controlled by circadian or pluripotency networks. view more

Credit: University of Rochester illustration / Julia Joshpe

Natural selection has produced mammals that age at dramatically different rates. Take, for example, naked mole rats and mice; the former can live up to 41 years, nearly ten times as long as similar-size rodents such as mice.

What accounts for longer lifespan? According to new research from biologists at theUniversity of Rochester, a key piece of the puzzle lies in the mechanisms that regulate gene expression.

In a paper published inCell Metabolism, the researchers, includingVera Gorbunova, the Doris Johns Cherry professor of biology and medicine;Andrei Seluanov, professor of biology and medicine; and Jinlong Lu, a postdoctoral research associate in Gorbunovas lab and the first author of the paper, investigated genes connected to lifespan. Their research uncovered specific characteristics of these genes and revealed that two regulatory systems controlling gene expressioncircadian and pluripotency networksare critical to longevity. The findings have implications both in understanding how longevity evolves and in providing new targets to combat aging and age-related diseases.

The researchers compared the gene expression patterns of 26 mammalian species with diverse maximum lifespans, from two years (shrews) to 41 years (naked mole rats). They identified thousands of genes related to a species maximum lifespan that were either positively or negatively correlated with longevity.

They found that long-lived species tend to have low expression of genes involved in energy metabolism and inflammation; and high expression of genes involved in DNA repair, RNA transport, and organization of cellular skeleton (or microtubules). Previous research by Gorbunova and Seluanov has shown that features such asmore efficient DNA repairand aweaker inflammatory responseare characteristic of mammals with long lifespans.

The opposite was true for short-lived species, which tended to have high expression of genes involved in energy metabolism and inflammation and low expression of genes involved in DNA repair, RNA transport, and microtubule organization.

When the researchers analyzed the mechanisms that regulate expression of these genes, they found two major systems at play. The negative lifespan genesthose involved in energy metabolism and inflammationare controlled by circadian networks. That is, their expression is limited to a particular time of day, which may help limit the overall expression of the genes in long-lived species.

This means we can exercise at least some control over the negative lifespan genes.

To live longer, we have to maintain healthy sleep schedules and avoid exposure to light at night as it may increase the expression of the negative lifespan genes, Gorbunova says.

On the other hand, positive lifespan genesthose involved in DNA repair, RNA transport, and microtubulesare controlled by what is called the pluripotency network. The pluripotency network is involved in reprogramming somatic cellsany cells that are not reproductive cellsinto embryonic cells, which can more readily rejuvenate and regenerate, by repackaging DNA that becomes disorganized as we age.

We discovered that evolution has activated the pluripotency network to achieve longer lifespan, Gorbunova says.

The pluripotency network and its relationship to positive lifespan genes is therefore an important finding for understanding how longevity evolves, Seluanov says. Furthermore, it can pave the way for new antiaging interventions that activate the key positive lifespan genes. We would expect that successful antiaging interventions would include increasing the expression of the positive lifespan genes and decreasing the expression of negative lifespan genes.

Comparative transcriptomics reveals circadian and pluripotency networks as two pillars of longevity regulation

16-May-2022

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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The secret to a longer lifespan? Gene regulation holds a clue - EurekAlert

BURLINGTON, N.C.--(BUSINESS WIRE)--Labcorp (NYSE: LH), a leading global life sciences company, understands the important and growing role of precision medicine and is working to ensure more people have access to targeted and personalized treatments. As part of this effort, the company is announcing a new sponsored testing program aimed at helping advanced non-small cell lung (NSCLC) cancer patients and their physicians make informed treatment and care management decisions through comprehensive genomic insights.

The new program is sponsored by Eli Lilly and Company, a global health care leader dedicated to developing and delivering innovative new medicines to make a meaningful difference in the lives of cancer patients. The program will use Labcorps OmniSeq INSIGHTSM test, a pan-cancer, tissue-based sequencing test, to provide comprehensive genomic and immune profiling for cases that meet eligibility criteria. The program is designed to increase awareness of and provide enhanced access to more comprehensive testing options for eligible NSCLC patients in order to encompass all indicated guideline-directed genes and biomarkers.

Comprehensive genomic and immune profiling allows for a much more extensive investigation into biomarkers that can lead to more effective treatment options, access to new clinical trials, and better patient outcomes, said Prasanth Reddy, M.D., MPH, senior vice president and oncology head at Labcorp. With OmniSeq INSIGHT testing, people across the country living with lung cancer may be able to receive therapies or be informed of clinical trials that otherwise may not have been available because their specific biomarkers or gene mutations were not found in a single gene test. By equipping oncologists, health care systems and pharmaceutical developers with data-driven insights we are bringing the promise of precision medicine within reach for all.

Comprehensive genomic profiling (CGP) allows physicians to test for all actionable biomarkers that may be present in patients with NSCLC, rather than one or a few biomarkers that can be found using single gene testing. Comprehensive immune profiling tests for immune-related genes to provide novel, differentiating insights into the tumor microenvironment by testing for immune-related genes. These insights help identify potential immunotherapy eligibility. Test results from both genomic and immune profiling are used to help inform oncologists of the most appropriate targeted therapy for their patients.

Comprehensive genomic profiling helps identify treatment options for patients to better inform targeted therapy selection, said Anthony (Nino) Sireci, M.D., vice president clinical biomarker and diagnostics development, Loxo Oncology at Lilly. Our collaboration with Labcorp in their efforts to deliver OmniSeq INSIGHT tests to more patients further demonstrates the value of precision medicine and our commitment to making a difference.

Labcorp Oncology is committed to pioneering scientific breakthroughs that make a difference in cancer care through investments in innovative programs such as OmniSeq INSIGHT. OmniSeq INSIGHT is a pan-cancer, solid tumor test that combines two different treatment paradigmsgenomic and immune profiling. The test enhances the characterization of the unique genomic biomarkers in a patients tumor enabling clinicians to make more informed decisions about personalized treatment approaches that can be more effective and may have fewer side effects, in addition to identifying clinical trials for which patients may be eligible.

Click here to learn more.

About Labcorp

Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. With more than 75,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $16 billion in FY2021. Learn about Labcorp at http://www.Labcorp.com, or follow us on LinkedIn and Twitter @Labcorp.

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Labcorp Expands Access to Comprehensive Genomic Testing Through New Lung Cancer Program - Business Wire

According to a new report published by Grand View Research, Recent advancements in biological therapies have resulted in a gradual shift in preference toward personalized medicinal strategies over the conventional treatment approach. This has resulted in rising R&D activities in the regenerative medicine arena for the development of novel regenerative therapies.

Regenerative Medicine Industry Overview

The global regenerative medicine market size was valued at USD 27.29 billion in 2020 and is expected to reach USD 57.08 billion by 2027, growing at a CAGR of 11.27% over the forecast period. The emergence of gene therapy coupled with the developments in stem cell and tissue engineering are expected to fuel the market growth. In addition, increasing regulatory approvals for advanced therapy medicinal products have propelled the market growth. The ongoing COVID-19 pandemic created lucrative opportunities for the operating players owing to the urgent need for the development of new therapies against SARS-COV-2. Several initiatives are being implemented in the cell and gene therapy manufacturing industry, including the T-cell therapy space.

For instance, based on the previous research insights, Singapore-based Duke-NUS medical schools emerging infectious diseases research program demonstrated the utility of these immunotherapies in treating patients with COVID-19 infection. The presence of several programs and continuous investments by government and private agencies to support R&D also accelerate the industrys progress. Like National Institutes of Health (NIH) supports the scientific research community through NIH Regenerative Medicine Program, NIH Stem Cell Libraries & Projects, NIH Stem Cell Unit, and others. Similarly, initiatives adopted by market players to raise finance for the R&D of regenerative medicine support the market progression.

Gather more insights about the market drivers, restrains and growth of the Global Regenerative Medicine market

In addition, companies are collaborating to strengthen their R&D capabilities to develop and commercialize innovative therapies to ensure their availability to their customers locally or worldwide. For instance, in July 2021, Pharming Group N.V. and Orchard Therapeutics collaborated for the development and commercialization of OTL-105, an investigational ex vivo autologous Hematopoietic Stem Cell (HSC) gene therapy for the treatment of Hereditary Angioedema (HAE).

Moreover, technological advancements in stem cell-based therapies have revolutionized the perspective of researchers toward regenerative medicine. Advances in stem cell therapy have accelerated the developments in regenerative medicine. For instance, haematogenic stem cells currently are being used to treat leukemia and blood disorders. Also, nanotechnology is a powerful tool for engineering stem cells and regenerative medicine. With the introduction of new technology, nanofabrication techniques can now allow researchers to develop nanofiber scaffolds.

Regenerative Medicine Market Segmentation

Based on the Product Insights, the market is segmented into Therapeutics, Tools, Banks, and Services.

Based on the Therapeutic Category Insights, the market is segmented into Dermatology, Musculoskeletal, Immunology & Inflammation, Oncology, Cardiovascular, Ophthalmology, and Others.

Based on the Regenerative Medicine Regional Insights, the market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

Market Share Insights:

Key Companies Profile:

Key companies invest heavily in the development of regenerative therapies to meet the demand for unmet clinical needs. The market is highly competitive as the companies are focusing on the introduction of therapies for oncology & age-related degenerative disorders.

Some of the prominent companies in the global regenerative medicine market are:

Order a free sample PDF of the Regenerative Medicine Market Intelligence Study, published by Grand View Research.

About Grand View Research

Grand View Research is a full-time market research and consulting company registered in San Francisco, California. The company fully offers market reports, both customized and syndicates, based on intense data analysis. It also offers consulting services to business communities and academic institutions and helps them understand the global and business scenario to a significant extent. The company operates across multitude of domains such as Chemicals, Materials, Food and Beverages, Consumer Goods, Healthcare, and Information Technology to offer consulting services.

Web: https://www.grandviewresearch.com

Media ContactCompany Name: Grand View Research, Inc.Contact Person: Sherry James, Corporate Sales Specialist U.S.A.Email: Send EmailPhone: 1888202951Address:Grand View Research, Inc. 201 Spear Street 1100 San Francisco, CA 94105, United StatesCity: San FranciscoState: CaliforniaCountry: United StatesWebsite: https://www.grandviewresearch.com/industry-analysis/regenerative-medicine-market

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Regenerative Medicine Market To Grow At A CAGR Of 11.27% By 2027, Due To Advancements In Cell Biology, Genomics Research, And Gene-Editing Technology...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced its participation in a neoadjuvant screening trial in partnership with the Lung Cancer Research Foundation (LCRF) and Lung Cancer Mutation Consortium (LCMC). This screening trial, entitled LCMC4 Evaluation of Actionable Drivers in EaRly Stage Lung Cancer (LEADER), is the fourth study conducted through the LCMC and is a collaborative effort involving numerous academic study sites and pharmaceutical supporters. Foundation Medicine will be the sole provider of comprehensive genomic profiling (CGP) in the LEADER trial, which will utilize both of Foundation Medicines FDA-approved CGP tests: the tissue-based FoundationOneCDx and the blood-based FoundationOneLiquid CDx.

The LEADER trial is utilizing an umbrella trial design to screen for 11 actionable driver mutations in 1,000 patients with high-risk, resectable non-small cell lung cancer (NSCLC). These patients are candidates for neoadjuvant therapy, which is treatment given as a first step to shrink a tumor before the main treatment, often surgery. By identifying patients with biomarker-positive tumors for enrollment to several matched therapeutic trials, the LEADER trial aims to develop essential data that can be used to support oncologists in their personalized treatment planning for cancer patients prior to such patients undergoing surgery.

The neoadjuvant setting is a rapidly evolving space for the development of precision treatment options in lung cancer. Enabling trials in this setting will continue to help us understand the impact of targeted therapies in the curative treatment of NSCLC, says Dr. Geoff Oxnard, Foundation Medicines VP, Head of Clinical Development. At Foundation Medicine, we are committed to being an engaged collaborator in the pivotal research needed to shape the future of cancer care for patients at all stages, so that patients can get on the right therapy at the right time for their specific cancer.

The results from both FoundationOne CDx and FoundationOne LiquidCDx will be used by LEADER trial sites to screen patients for actionable driver mutations. While circulating tumor DNA (ctDNA) shed is often lower in early disease, the goal of using both tests in the LEADER trial is to help researchers understand how blood-based CGP testing can complement tissue-based CGP testing to inform targeted treatment in resectable NSCLC.

In the past two years, the FDA has granted approvals for the first tyrosine kinase inhibitor and checkpoint inhibitor, respectively, for the adjuvant treatment of resected NSCLC, each requiring testing for precision biomarkers. The FDA has also recently granted approval for neoadjuvant immunotherapy for resectable NSCLC, as well as the first-and-only immunotherapy-based treatment for neoadjuvant use in NSCLC, reinforcing the value of targeted therapies as a component of curative lung cancer. These FDA approvals could better position early-stage NSCLC patients, like those who are enrolled in the LEADER trial, to become potential candidates for these personalized treatment approaches.

The LEADER trial is now open to enrollment and will include participation from trial sites and investigators across the oncology community, including MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, Dana Farber Cancer Institute, Yale Cancer Center/Smilow Cancer Hospital and many others.

In a new Trial in Progress abstract being presented at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting from June 3-7, Boris Sepesi, M.D., associate professor of Thoracic and Cardiovascular Surgery at The University of Texas MD Anderson Cancer Center, and principal investigator of the LEADER Trial, and Mark Kris, M.D., Attending Physician, Thoracic Oncology Service, Department of Medicine at Memorial Sloan Kettering Cancer Center will detail LEADERs primary objective of determining the proportion of resectable NSCLC patients within the trial who possess actionable oncogenic drivers. Results from Foundation Medicine CGP testing will inform the LEADER trial sites on their selection of neoadjuvant therapy and enrollment onto independent therapeutic trials with genomically matched neoadjuvant treatment, standard therapies or other trials if no driver is detected. Read more on ASCO.org, and visit Foundation Medicine at Booth #13019 to learn more. Follow along on Twitter and LinkedIn for more details about Foundation Medicines data being presented at ASCO22.

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on http://www.FoundationMedicine.com and follow us on Twitter and LinkedIn.

About FoundationOneCDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.

About FoundationOneLiquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit http://www.F1LCDxLabel.com.

Foundation Medicine and FoundationOne are registered trademarks of Foundation Medicine, Inc.

Source: Foundation Medicine

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