Category Archives: Pharmacogenomics

Supporting and enhancing the evolving role of MSLs

By Jill Padgett, EdD

Medical science liaisons (MSLs) play an essential and prominent role in the pharmaceutical industry. They form a link between pharmaceutical companies and the medical community, working to ensure that information about new drugs and treatments is disseminated accurately and effectively.

The pace of medical research that were experiencing currently will lead to increased frequency of product launches, more multi-indication brands, and a strong focus on rare disease and specialty care. As a result, the market landscape and corresponding needs of HCPs are becoming increasingly complex. Indeed, in cases such as those involving rare diseases where there may be only a small number of specialists HCPs will place greater reliance on MSLs as a primary resource with respect to innovative therapies.

The landscape is changing in other ways, too. The pandemic has only accelerated the already sizable shift to digital communications. And with the increasingly fast-paced nature of society in general, time-crunched HCPs can be more difficult to engage.

To support the various market changes, the scope of the average MSL function will expand. This article explores the evolving role of MSLs and their value for biopharmaceutical companies, and examines how best to utilize their expertise.

The impact of rare disease on MSLs

A key driver of change is the escalation of therapies in the field of rare diseases. This is accompanied by accelerated timelines as companies rush to get products to market. The increased complexity and urgency can lead to knowledge and communication gaps that MSLs are uniquely poised to bridge. They act as trusted sources for KOLs and HCPs who are facing a range of challenges, including inconsistencies in, and approaches to, care.

Additionally, when it comes to rare disease, there is often minimal data available and few KOLs to consult. This is an area where the MSL role has expanded. They now play a key part in helping to cultivate KOL influencers. There are also other players that MSLs will need to identify because oftentimes, different stakeholders or experts are involved in a patients treatment. The MSLs role now involves understanding what each of those different stakeholders provides in the patient journey, what they need based on their own knowledge of the disease, and their insights and perspectives on the patients care.

MSLs must be able to identify major influencers and handle diverse conversations with each stakeholder. They need to simultaneously take on a holistic and micro view of issues, and be able to draw key insights that are most important for the pharmaceutical company.

Another trend driven by the prevalence of rare disease treatments is the need for MSLs to be well-versed in pharmacogenomics, which studies the impact of genetics on patients response to medications. This can affect small populations, and knowledge of pharmacogenomics can help MSLs personalize conversations with HCPs and increase confidence in a particular therapy based on how patients are expected to respond.

Typically, pharmacogenomics is not a part of an MSL training curriculum, depending on what therapeutic areas theyre working in. However, in rare diseases, it is a critical component of MSL development. In addition to learning about pharmacogenomics, MSLs must also become knowledgeable in personalized medicine, pharmacoeconomics, and evidence-based medicine. With fewer KOLs, they play an important role in educating HCPs and providing in-depth knowledge on these topics.

Building connections that make better health happen

The MSL role is changing from a practical standpoint, too. HCPs, KOLs, and other stakeholders in the field are rapidly shifting toward digital communications. MSLs need to adapt their approach to avoid missing out on timely and effective collaboration opportunities. This might involve an expanded suite of digital tools, increased personalization, or testing various hybrid communication methods.

Post-pandemic, many KOLs have grown accustomed to the virtual environment, some still prefer in-person meetings, while others favor a mixture. To communicate effectively, MSLs must be more versatile, technically savvy, and armed with the necessary digital assets. One way to help MSLs navigate new communication methods is for pharmaceutical companies to ensure they have all the digital tools (e.g., slide decks and digital brochures) and corresponding training necessary to carry out their jobs effectively.

Whats more, many stakeholders today are multidisciplinary as the integration of commercial, medical, and market access teams continue to proliferate within biopharma companies. This means MSLs must tailor their approach to consider multiple viewpoints within the same conversation. In the same vein, MSLs are becoming more closely involved in understanding unmet patient needs.

Determining influential KOL networks is critical, especially in rare disease. MSLs need to undertake a great deal more research in advance to find out the influencer in these networks, for example, to help determine the patient journey and how these patients are finding experts. The new MSL model involves a patient-centric approach to care since there is a larger network of stakeholders who have shifted to focusing on the patient journey rather than the drug.

How biopharmaceutical companies can support the evolving role of MSLs

To support MSLs in their changing roles, there are measures that biopharmaceutical companies can take. The following are our four recommendations.

Most of the existing MSL training programs focus on clinical aspects and knowledge acquisition. Formalizing these cohort, peer-to-peer types of learning activities within their training plan will enhance the application part of their learning experience, which is often missing.

Supporting the evolution of the MSL

Theres no denying that the role of MSLs is evolving, in particular, due to the industrys increased focus on rare disease and specialty care. MSLs are having more specialized conversations with a dynamic group of stakeholders, bringing crucial insights back to pharmaceutical companies, and playing a pivotal role in the development process.

As more new drugs targeting rare disease enter the market, the MSL function will continue to expand. Companies can support MSLs in this new landscape by providing the tools and training they need to carry out their roles effectively. This should include mapping out dedicated training plans that include peer-based learning, an emphasis on enhancing their emotional intelligence skills, and providing the digital assets needed to enhance important conversations.

With the right training in place, MSLs can play an optimal role in educating and engaging key stakeholders, ultimately leading to improved patient outcomes.

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Supporting and enhancing the evolving role of MSLs PharmaLive - PharmaLive

The Precision Medicine and Functional Genomics (PMFG) 2022 conference is all set to take place from September 23 to 26 at St Regis Doha, bringing together researchers, healthcare professionals, policymakers, and community members from different countries.Precision Medicine takes individual variations in genetics, pharmacogenomics, proteomics, microbiome, environmental, lifestyle factors, and others into account, allowing healthcare providers to improve the efficiency and effectiveness of disease prevention, diagnosis, and treatment, Sidra Medicines chief research officer Dr Khalid Fakhro said in a statement.The sixth edition of the annual event, which will be preceded by a pre-symposium Biotech Forum tomorrow (September 22) at Sidra Medicines hospital auditorium, aims to explore the latest developments and innovations in biomedical research and how they translate into precision medicine solutions.According to the organisers, the four-day in-person symposium has pre-and post-conference workshops, as well as a satellite half-day meeting focusing on two major themes: How cellular, organoid, and animal models are being used to facilitate the discovery of basic disease mechanisms and potential cures; and The development of advanced therapies to treat diseases.Over the years, the PMFG series has grown significantly in topics and diversity with a wide range of speakers and a growing audience worldwide. As part of its National Vision 2030, Qatar is committed to building a knowledge-based economy in the biomedical and health sciences. Sidra Medicine supports this goal by actively engaging clinical and scientific expertise to establish a leading model for Precision Medicine in the region, Dr Fakhro said. He noted that the conference also aims to discover how personalised medicine can move from vision to practice and to draft with us the roadmap for a personalised health data ecosystem.Organisers noted that the conference provides an opportunity for participants to: Learn about co-ordinated efforts to develop precision medicine around the world and specifically in the Middle Eastern region, best practices for conducting successful precision medicine clinical trials, learn how advanced diagnostics and personalised treatments improve the quality of care for children with rare and chronic diseases (i.e. immune deficiency, hemoglobinopathy, cancer, etc), understand the value of using cell, organoid, and animals as disease models in biomedical research and learn about modelling of human tissues and diseases and how large-scale data resources, genome sequencing and novel technologies are driving precision medicine.

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Top experts to attend Precision Medicine and Functional Genomics conference - Gulf Times

LONDON, May 9, 2022 /PRNewswire/ -- Datar Cancer Genetics ("Datar"), a world-leading cancer research corporation today announced a $250 million contract with Artemis DNA, a leading USA-based diagnostic laboratory company that provides proprietary Next Generation Sequencing (NGS) genetic testing and diagnostic laboratory services for a wide variety of medical specialties, including cardiology, oncology, immunology, neurology, reproductive health and pharmacogenomics. Under the 5 years exclusive agreement, Artemis DNA will provide Datar's pioneering cancer detection Liquid Biopsies in the USA and Vietnam markets.

Trucheck_Pragma_CancerTrack

The deal covers two solutions from Datar's cancer screening and diagnostic portfolio - Trucheck Pragma and Cancertrack. Trucheck Pragma is a non-invasive, blood-based screening test for Lung, Stomach, Colon, Pancreas, Prostate, Breast, and Ovarian cancers. Cancertrack is for the evaluation of response/resistance/recurrence during the management of cancer. The solutions will be presently offered as Laboratory Developed Tests (LDTs) in the USA.

In addition, Artemis DNA will provide Datar with high-complexity CLIA certified, CAP-accredited testing facilities in Texas and California to enable the commercial launch of various cancer screening and diagnostic tests developed by Datar.

"We are extremely delighted to offer our highly accurate cancer detection technology for the benefit of patients in the USA and Vietnam in partnership with Artemis DNA. Their marketing strength and experience will enable a seamless roll-out of our innovative, game-changing, life-saving Liquid Biopsies," commented Mr. Rajan Datar, Chairman of Datar Cancer Genetics. "We will continue to expand our offerings in the USA and European markets with high standards of accuracy and quality of service," he added.

"We are so excited to be able to offer the ground-breaking technologies to patients in the USA and Vietnam," commented Ms. Emylee Thai, Founder and CEO of Artemis DNA. "Datar Cancer Genetics continues to innovate and push the boundaries on what people thought was impossible when it comes to cancer screening, diagnosis and management. Artemis DNA is proud to be part of the pioneers to help change the landscape of early screening and diagnosis, as well as management of cancer, which will improve and save lives."

Story continues

Datar Cancer Genetics is a global oncology research and applications company specializing in non-invasive technologies for improved detection, treatment, and management of cancer. Datar's state-of-the-art facility is ISO, CAP-accredited and CLIA certified. Datar's tests for early detection of Breast and Prostate cancer have been granted 'Breakthrough Designation' by the US FDA. The Company serves cancer patients and suspected cases in the UK, European Union, United States, GCC, and India. The Company has already established an advanced research and testing facility at Guildford, UK, and is pursuing large clinical studies across various geographies to cover multiple cancers where there is a potential for cure with early detection. The Company also proposes to roll out multiple test centers globally.

CONTACT: Dr. Vineet Dattadrvineetdatta@datarpgx.com

Website: trucheck360.com

Image: https://mma.prnewswire.com/media/1813311/Trucheck_Pragma_CancerTrack.jpgLogo: https://mma.prnewswire.com/media/1572835/Datar_Cancer_Genetics_Logo.jpg

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Cision

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SOURCE Datar Cancer Genetics

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DATAR CANCER GENETICS ANNOUNCES FORAY INTO THE UNITED STATES WITH A $250M CONTRACT TO OFFER PIONEERING CANCER DETECTION LIQUID BIOPSIES - Yahoo...

Past research links the health of the gut microbiome to various diseases, including inflammatory bowel disease, Alzheimers disease, and kidney disease.

Researchers from the Dr. Israel Fernndez Cadenas (PI) Group Stroke Pharmacogenomics and Genetics Laboratory have uncovered a link between certain bacteria in the gut microbiome associated with more severe stroke and negatively affecting post-stroke recovery.

Researchers presented the study on May 4, 2022, at the 2022 European Stroke Organisation Conference (ESOC).

What is the gut microbiome?

The gut microbiome refers to the trillions of bacteria and other microorganisms living within the intestinal tract of humans. Research shows these good bacteria play an important role in the bodys overall health, including boosting immunity and helping with digestion.

If the gut microbiome becomes unbalanced, it can harm the body. Stress, bad eating habits, and antibiotics can disrupt the gut microbiome. When this happens, the body becomes vulnerable to diseases, including those related to inflammation, such as rheumatoid arthritis and heart disease.

A stroke happens when blood is not able to reach the brain. If blood flow to the brain becomes blocked, oxygen and vital nutrients cannot get to the brain, which can cause brain cells to die.

Data shows that about 13 million people globally experience a stroke each year, and about 5.5 million people die from strokes.

There are two main types of strokes:

In this new study presented at the 2022 European Stroke Organisation Conference, a research team led by Miquel Lleds, lead researcher and Ph.D. student from the Stroke Pharmacogenomics and Genetics Laboratory Group at the Sant Pau Research Institute in Barcelona, Spain, studied fecal samples from 89 ischemic stroke patients.

The influence of the gut microbiome is a modifiable risk factor associated with the risk of stroke and with post-stroke neurological outcomes, Lleds explains. However, most research has previously been done in animal models. In this study, we took (fecal) samples the first samples taken after the event from 89 humans whod suffered an (ischemic) stroke. (Compared) with a control group, we were able to identify multiple groups of bacteria that were associated with a higher risk of (ischemic) stroke.

From their research, scientists identified multiple types of bacteria associated with an increased risk for ischemic stroke, including the bacteria Fusobacterium and Lactobacillus. They also found the bacteria Negativibacillus and Lentisphaeria were associated with a more severe stroke in the acute phase. And the bacteria Acidaminococcus led to poor post-stroke recovery after three months.

Acidaminococcus is an opportunistic pathogen, and this genus has already been related to a higher risk of stroke, Lleds told Medical News Today when asked why Acidaminococcus associates with poor functional outcomes at three months. He added that Acidaminococcus is a member of the family Veillonellaceae, known for producing succinate a compound linked to increased risk factors for cardiovascular disease.

Based on his teams research, Dr. Lleds said research on gut microbiota could have direct and simple applicability in the clinical field. If the evolution of patients with stroke is associated with the presence of a certain type of microbial flora, we could carry out clinical trials varying this microbial composition, he explained.

In other pathologies, clinical trials are being carried out in which researchers replace the intestinal flora through dietary changes or fecal transplantation from healthy individuals much more consistent in the long term, he continued. One way to do that is by using lyophilized compounds of microorganisms in capsules that are easy to ingest and that modify the intestinal flora.

And in regards to post-stroke recovery, Dr. Lleds said there are currently no specific neuroprotective treatments to prevent neurological worsening after stroke. The use of new therapies, such as changes in the microbiome through nutritional changes or fecal transplantation, could be useful to improve post-stroke evolution, he added.

MNT also spoke about this study with Dr. Reza Shahripour, a board certified vascular neurologist at Providence Saint Johns Health Center in Santa Monica, CA. He says the label cryptogenic stroke is used for 30 to 35 percent of stroke cases where there is no known cause for the condition.

We dont know whats the etiology and the patient doesnt have any atherosclerosis disease, no cardioembolic source, he explained. If we believe that inflammation of these kinds of microbes in the gut could be the source of inflammation, we have a reason for that type of stroke.

Additionally, Dr. Shahripour said there are recurrent stroke cases in people taking antiplatelet or anticoagulant drugs.

If there is a risk factor of (the) microbiome in the gut, if we can address it before another stroke, we can decrease the (recurrence) of stroke in the future, he added.

Link:
Gut bacteria and stroke: What is the link? - Medical News Today

According to a new report published by Grand View Research, increasing prevalence of chronic diseases and rising awareness among health-conscious population have fueled the growth of the global clinical laboratory tests industry.

Clinical Laboratory Tests Industry Overview

The global clinical laboratory tests market size was valued at USD 176.7 billion in 2019 and is expected to reach USD 304.9 billion by 2027, registering a CAGR of 7.1% over the forecast period. Increasing prevalence of chronic diseases and rising awareness among health-conscious population have fueled the growth of the overall market.

The demand for clinical laboratory tests is driven by growing investments in diagnosing target diseases such as cardiovascular disorders, tuberculosis, and diabetes. Clinical laboratory tests help diagnose diabetes mellitus. According to an article published by the International Diabetes Federation in 2019, around 463 million adults were living with diabetes, and by 2045 it is estimated to reach 700 million globally.

Gather more insights about the market drivers, restrains and growth of the Global Clinical Laboratory Tests Market

Increasing geriatric population is anticipated to drive the overall market for clinical laboratory tests. According to the data published by the World Population Prospects: the 2019 Revision, around one in 11 people were aged over 65 years in 2019, and by 2050, it is estimated that approximately one in 6 people in the world will be aged 65 years and above. Clinical laboratory tests are increasingly used to diagnose age-related diseases.

Moreover, growing rate of insufficient exercise, consumption of unhealthy food, and the subsequent rise in cases of obesity are expected to increase the prevalence of various chronic diseases. Rising awareness of the necessity of regular body profiling among healthcare professionals and patients globally is expected to increase the demand for clinical laboratory tests.

Clinical Laboratory Tests Market Segmentation

Based on the Type Insights, the market is segmented into Complete blood count, HGB/HCT, Basic metabolic panel, BUN creatinine tests, Electrolytes testing, HbA1c tests, Comprehensive metabolic panel, Liver panel, Renal panel, Lipid panel.

Based on the End-use Insights, the market is segmented Central Laboratories and Primary Clinics.

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

Browse through Grand View Researchs Clinical Diagnostics IndustryResearch Reports.

Market Share Insights

Key Companies Profile:

Key companies are focusing on strategic partnerships, mergers, and acquisitions to increase their presence in the market for clinical laboratory tests.

Order a free sample PDF of the Clinical Laboratory Tests 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/clinical-laboratory-tests-market

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Clinical Laboratory Tests Market To Witness Revenue Surge Reaching $304.9 Billion By 2027, Driven By Rising Investments in Diagnosing Target Diseases...

The partnership will address some critical issues in pharmacogenetic assay through sequencing workflows improvement SINGAPORE - Media OutReach - 21 April 2022 - MGI , a company committed to being a world-leading life science innovator, today announced a partnership with Nalagenetics (NALA) to co-develop low coverage whole genome sequencing for risk prediction and pharmacogenomics through optimizing Next Generation Sequencing (NGS) workflow based on MGI's sequencing devices and products*.

The collaboration aims to use NALA' Clinical Decision Support, a software medical device, to be able to analyze whole genome sequencing data sets generated by MGI's DNBSEQTM sequencing platform*, and generate clinical-grade reports for pharmacogenomics and polygenic risk scores. Although NGS has been known to be an effective way to capture a large amount of genomic information to guide and tailor clinical management and treatment,[1] NGS workflows are complicated and not trivial to adopt in clinical settings. NALA is dedicated to help implement clinical genetic testing in Southeast Asia with strong expertise in pharmacogenetics, assay development, and AI-linked genetics analysis for pharmacological phenotypes and risk prediction.

"We see more and more hospitals adopting sequencing for personalization of medicine in oncology, cardiovascular conditions, and others. One of the biggest challenges is recommending follow up action that makes sense for the local market, for example list of alternative therapies and screening procedures that lead to cost-effectiveness. We are glad to work with MGI to co-develop products and offer services to answer local needs," said Levana Sani, CEO of Nalagenetics.

[1] Gagan and Van Allen Genome Medicine (2015) 7:80 DOI 10.1186/s13073-015-0203-x. Accessed at https://genomemedicine.biomedcentral.com/track/pdf/10.1186/s13073-015-0203-x.pdf

MGI Tech Co., Ltd. (MGI), an affiliate of BGI Group, is committed to building core tools and technology to lead life science through intelligent innovation. Based on its proprietary technology, MGI focuses on research & development, production and sales of sequencing instruments*, reagents*, and related products to support life science research, agriculture, precision medicine and healthcare. MGI's mission is to develop and promote advanced life science tools for future healthcare. As of December 2020, MGI has a footprint that spans across more than 70 countries and regions, serves over 1,000 international users and employs more than 1,700 professionals globally, around 33% of which are R&D personnel. For more information, please visit the MGI website or connect on Twitter , LinkedIn or YouTube .

*Unless otherwise informed, StandardMPS and CoolMPS sequencing reagents, and sequencers for use with such reagents are not available in Germany, USA, Spain, UK, Hong Kong, Sweden, Belgium, Italy, Finland, Czech Republic, Switzerland and Portugal.

#MGI

Nalagenetics is a biotechnology technology company focusing on personalized screening and intervention. Nalagenetics aims to provide affordable and actionable end-to-end genetic testing that is relevant to local populations by working with hospitals and labs. The company's main product, Clinical Decision Support, allows providers to generate clinical-grade genetic reports from raw genetic data files and clinical input. Nalagenetics has presence in Southeast Asia and Europe. For more information, please visit http://www.nalagenetics.com .

#Nalagenetics

The issuer is solely responsible for the content of this announcement.

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MGI announces partnership with Nalagenetics to advance pharmacogenomics in Singapore and Indonesia - AsiaOne