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FDA gives MD Anderson the green light to test skin cancer treatment on humans – Houston Chronicle

Posted: August 22, 2022 at 3:01 am

MD Anderson Cancer Center and a Massachusetts biotechnology company received clearance from the Food and Drug Administration to begin testing a new cell therapy treatment on humans for metastatic melanoma, the most serious type of skin cancer. Clinical trials will begin next month.

The treatment, developed with Obsidian Therapeutics of Cambridge, Mass., aims to avoid life threatening complications associated with similar cell therapies.

It is a type of tumor infiltrating lymphocyte (TIL) therapy, in which doctors remove tissue from the tumor, isolate the cancer fighting T cells, and infuse in the patient to concentrate their attacks on the cancer cells and reduce the tumors. Typically, patients also receive an infusion of interleukin-2, which promotes the growth of those T cells, but can cause heart, lung and kidney dysfunction.

MD Anderson and Obsidian researchers hope they found a technique that is more effective without harsh side effects.

On HoustonChronicle.com: MD Anderson launches joint venture with biopharma manufacturer, creating a potential launching pad for Houstons biotech ambitions

The researchers modified the T cells to produce their own interleukin, but a slightly different version known as interleukin-15. They modified the T cells so they can be activated by a pill called Acetazolamide, which is used to treat a variety of diseases from from glaucoma to epilepsy.

If patients have adverse reactions to the treatment, they can be advised to stop taking the pill for a day or so. This wouldnt be the case with a one-time infusion.

It's an on-off switch, Dr. Rodabe Amaria, the lead researcher on the study said. Well be able to regulate the function of the T cell, which we really havent been able to do before in our T cell therapy.

Dr. Paul Wotton, chief executive officer of Obsidian Therapeutics, said he believes the therapy has the potential to significantly transform the treatment landscape for patients, bringing broader access to (tumor infiltrating lymphocyte therapy).

The cell therapies will be manufactured at CTMC, a joint venture between a San Diego biomanufacturer and MD Anderson to develop and manufacture cell therapies, aiming to build a niche in biologic treatments.

becca.carballo@chron.com

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Case Report of Long Term Complete Response in Hepatocellular Carcinoma to CARsgen’s GPC3 CAR T Cells (CT011) Published in Frontiers in Immunology – PR…

Posted: August 22, 2022 at 3:01 am

SHANGHAI, Aug. 18, 2022 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that a case report, titled "Long Term Complete Response of Advanced Hepatocellular Carcinoma to Glypican-3 Specific Chimeric Antigen Receptor T-Cells plus Sorafenib, A case report", has been published in Frontiers in Immunology (https://www.frontiersin.org/articles/10.3389/fimmu.2022.963031/full).

Hepatocellular carcinoma (HCC) is the most common histologic subtype of primary liver cancer, which is the sixth most common cancer type worldwide. Clinical efficacies of existing therapies for unresectable HCC are still unsatisfactory. CAR T-cell therapy has been approved for a variety of hematological tumors, but there are still great challenges for CAR T-cell therapies to treat solid tumors. We firstly reported GPC3 as a reasonable target for CAR T-cell therapy and thereafter advanced it into clinic.[1,2] In order to further enhance the efficacy of GPC3 CAR T cells, we proposed a new strategy by combining the GPC3 CAR T cells with sorafenib for the treatment of hepatocellular carcinoma[3]. To further validate this strategy in clinical setting, we conducted an investigator-initiated clinical trial at the First Affiliated Hospital of Wenzhou Medical University. The published case reported a patient with advanced HCC who achieved a complete response (CR) and a long survival period after the combination therapy of CAR-GPC3 T-cell plus sorafenib.

The case showed a 60-year-old Asian male patient with hepatitis B virus (HBV)-related HCC who underwent surgery in May 2018. In August 2018, the recurrence of liver cancer and pulmonary metastasis occurred after the operation, and then he received transarterial chemoembolization (TACE) to treat liver lesions and interventional ablation to treat pulmonary metastases. Two months later, he progressed and was enrolled into the clinical trial. After the enrollment, the patient underwent leukapheresis for CAR-GPC3 T-cell manufacturing. Seven days after leukapheresis, the patient started to receive 400 mg of sorafenib twice daily. The patient received 4 cycles of CAR-GPC3 T cells (CT011) treatment and each cycle was divided into two infusions. Prior to each cycle of CT011 treatment, lymphodepletion was performed. A total of 4109 CAR-GPC3 T cells were infused.

The CT011 plus sorafenib combination therapy was well tolerated. This patient obtained partial responses (PR) from the 3rd month and achieved CR in the 12th month after the first cycle of CT011 infusion. The tumor had no progression for more than 36 months and maintained the CR status for more than 24 months after the first infusion.

To the best of our knowledge, this is the first reported case with a CR after the combination therapy of CAR T cells with tyrosine kinase inhibitors. The clinical outcome demonstrated that the combination therapy of GPC3 CAR T-cell and Sorafenib may be a new promising approach for GPC3+ advanced HCC patients.

Dr. Zonghai Li, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, commented that, "There is great expectation for CAR T cells to provide curative potential in treating solid tumors. When enrolled into the clinical trial, the patient in this reported case had undergone local therapies such as TACE and interventional ablation but had not received systemic therapies such as anti-angiogenesis inhibitors. Based on the finding of our earlier preclinical research, we adopted the combination therapy of sorafenib and CT011 as treatment regimens. It was very encouraging to see that the patient achieved a complete response and a long survival period without recurrence for more than two years. While directly indicating that GPC3 CAR T may be used for early-line treatment of HCC, this case report also provides new evidence supporting the adoption of CAR T cells in the early-line treatment of other solid tumors."

About CT011

CT011 is an autologous CAR T-cell product candidate with proof-of-concept clinical data for the treatment of hepatocellular carcinoma (HCC) and has the potential to be the first-in-class globally. Dr. Zonghai Li Founder, Chairman of the Board, Chief Executive Officer and Chief Scientific Officer of CARsgen Therapeutics led the world's first successful effort in identifying, validating, and reporting GPC3 as a tumor-associated target for the development of CAR T-cell therapies to treat HCC. CARsgen has completed enrollment of a Phase I trial in China.

About CARsgen Therapeutics Holdings Limited

CARsgen is a biopharmaceutical company with operations in China and the U.S. and is focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. The Company has built an integrated cell therapy platform with in-house capabilities that span target discovery, antibody development, clinical trials, and commercial-scale manufacturing. CARsgen has internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR T-cell therapies, such as improving the safety profile, enhancing the efficacy in treating solid tumors and reducing treatment costs. The Company's vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable.

References

[1]. Gao H, et. al. Clin Cancer Res. 2014 Dec 15;20(24):6418-28

[2]. Shi D, et. al. Clin Cancer Res. 2020 Aug 1;26(15):3979-3989

[3]. Wu X, et. al. Mol Ther. 2019 Aug 7;27(8):1483-1494

For more information, please visit https://www.carsgen.com/

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Taking a Distinctive Path Reflections on the History of Gene Therapy Development – BioProcess Insider

Posted: August 22, 2022 at 3:01 am

Clearly, CGTs have not taken the same development path as MAbs, and those paths are unlikely to converge unless one of the modalities shows differentiated benefits for productivity, purity, and applicability. However, manufacturing processes have improved dramatically since production of the worlds first CGT products, as has industry and regulatory understanding about the safety profiles and characterization requirements for such products. But the CGT industry has much further to go.

The State of the CGT Industry

A major question that lingers along the development path is whether gene therapies will continue addressing monogenic targets or expand to multigenic indications. Despite efforts to match the productivity of processes for other biopharmaceuticals, improvements to CGT-process productivity have been stepwise rather than transformative, and such changes generally have not met expectations. One result is that after 20 years, CGTs largely remain focused on treating small patient populations with specific medical needs. Small production volumes also have led to high prices, which have been justifiable for early entrants to the CGT space but will be unsustainable in the long term.

Until the past few years, suppliers of raw materials, cell-culture media, and bioprocess equipment largely have ignored the CGT space. The market had been perceived as too small and unproven to provide profitable opportunities. Luckily, commercial success has driven most suppliers to recognize the CGT industry as a viable market that needs special attention. Today, equipment is designed solely for cell therapy applications or viral vector manufacturing. Raw materials such as plasmids have increased both in quality and availability. Most suppliers have awakened to the potential of CGT commercial success, especially considering that clinical timelines for most such products are condensed compared with those for MAbs and other biologics.

The Story of Oxford Biomedica

My employer, Oxford Biomedica, also has been involved in gene therapy production for over 25 years. Oxford Biomedica has been a biotechnology company for much of its history, and weve built lentiviral (LV) manufacturing technology to support in-house production of our products. Like many other candidate therapies, our lead programs did not progress through clinical studies, and weve moved on to other indications. But our hard work in gene-therapy development, manufacturing, analytics, quality control (QC), and regulatory affairs has paid off nicely because other companies have recognized the depth of our expertise. Weve forged licensing partnerships so that our technology can be used by multiple companies rather than just one.

We capitalized on that business model in January 2022 when we worked with Homology Medicines to form a new entity called Oxford Biomedica Solutions to focus on adenoassociated virus (AAV) development and manufacturing. The hard work that was put into developing AAV manufacturing expertise now is readily available to partner organizations rather than held closely within one company. The decision to form Oxford Biomedica Solutions speaks to the importance of sharing lessons learned from taking products from early clinical phases through commercial manufacturing with partner companies that want to benefit from such experience.

Personal Reflections on CGT Development

From a business perspective, CGT companies have needed to navigate a series of ups and downs. Such a process isnt for the faint of heart.

Early in my career, only academic centers, a few biotechnology companies, and a large pharmaceutical company or two engaged with gene-therapy technologies. In 1999, the tragic death of Jesse Gelsinger, the first person to die during a clinical trial for gene therapy, dropped the industry to its knees. Most large pharmaceutical companies stopped funding gene therapy projects, but a small number of true believers persisted with the technology, developing safer and better vector systems and improving clinical trial design and support.

It was only 10 years ago that two fundamental technologies were found to be effective for gene therapy: AAV vectors were found to be effective in delivering therapeutic genes for certain monogenic rare diseases, and patients treated with CAR-T products showed spectacularly improved rates of complete responses to blood cancers. Companies and investors started to take notice. In 2019, when AveXis/Novartis began commercializing Zolgensma (onasemnogene abeparvovec-xioi) as a treatment for spinal muscular atrophy (SMA), I was among many scientists who felt that the drugs regulatory approval was just the validation that the CGT industry needed.

My work in CGT is personal. My 21-year-old daughter suffers from Rett syndrome (RTS, cerebroatrophic hyperammonemia), a rare, monogenic neurological disease. Sadly, a cure is not yet available but developers are still trying. The challenges that my family has encountered while seeking out RTS treatments mirror some of the obstacles that face the CGT industry. Manufacturing processes remain small and fragmented, although they have moved largely to mammalian cell cultures in suspension bioreactors, which will provide scalability advantages. AAV vectors work best when the serotype used matches to a target organ, but results have been inconsistent. Increasingly, the US Food and Drug Administration (FDA) insists on characterization of AAV products, even for early phase clinical trials. A number of clinical holds have occurred for AAV-based gene therapies. Thus, Oxford Biomedica believes, as do many drug companies, that AAV needs to be manufactured using a scalable process that can deliver high levels of full, infectious particles; that qualified analytics should be established at the earliest possible stage; and that impurities, including empty capsids, must be closely monitored and reduced.

Guarded Optimism for the CGT Industry

Ive worked for both drug developers and service providers within the CGT industry, so I am in the novel position of having been on both sides of the table. The macrodynamics of outsourcing have changed dramatically over the past five years. What had been a largely underserved marketplace now has become inundated with large multinational pharmaceutical companies, specialty providers, and academic centers. Companies that suffered through 1824 months of waiting in a manufacturers queue have decided to build their own capacity. And the few manufacturing specialists with CGT capabilities have found themselves becoming critically important as the talent pool has thinned out among the industrys many offerings. This current situation, when combined with our uncertain economic environment, is putting internal and external manufacturing capacity under renewed focus.

I am hopeful but realistic about the next 10 years of the CGT industry. The COVID-19 pandemic has shown us that under certain circumstances, new technologies such as mRNA can be developed and scaled rapidly. Cell therapies are likely to improve in quality and scale through automation of production processes. Improvements also might come from transitions from autologous to allogeneic processes or from novel applications such as in vivo delivery of CAR T cells. I hope that gene therapies will move to even more scalable processes, with well-considered regulatory guidelines particularly for AAV-based therapies established to help minimize patient and manufacturing risks. And just maybe, we can treat not only rare diseases such as what my daughter has, but also larger indications. Doing so will support the future of the industry.

David Backer is chief commercial officer at Oxford Biomedica in Oxford, UK; d.backer@oxb.com; https://www.oxb.com.

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Insights on the Leukapheresis Global Market to 2027 – Leukapheresis for CAR or Adoptive Cell Therapy Presents Opportunities – ResearchAndMarkets.com -…

Posted: August 22, 2022 at 3:01 am

DUBLIN--(BUSINESS WIRE)--The "Leukapheresis Market Research Report by Type (Leukapheresis Devices and Leukapheresis Disposables), Application, End-user, Region (Americas, Asia-Pacific, and Europe, Middle East & Africa) - Global Forecast to 2027 - Cumulative Impact of COVID-19" report has been added to ResearchAndMarkets.com's offering.

The Global Leukapheresis Market size was estimated at USD 46.88 million in 2021, USD 51.30 million in 2022, and is projected to grow at a CAGR 9.61% to reach USD 81.31 million by 2027.

Competitive Strategic Window:

The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies to help the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. It describes the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth during a forecast period.

FPNV Positioning Matrix:

The FPNV Positioning Matrix evaluates and categorizes the vendors in the Leukapheresis Market based on Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.

Market Share Analysis:

The Market Share Analysis offers the analysis of vendors considering their contribution to the overall market. It provides the idea of its revenue generation into the overall market compared to other vendors in the space. It provides insights into how vendors are performing in terms of revenue generation and customer base compared to others. Knowing market share offers an idea of the size and competitiveness of the vendors for the base year. It reveals the market characteristics in terms of accumulation, fragmentation, dominance, and amalgamation traits.

The report provides insights on the following pointers:

1. Market Penetration: Provides comprehensive information on the market offered by the key players

2. Market Development: Provides in-depth information about lucrative emerging markets and analyze penetration across mature segments of the markets

3. Market Diversification: Provides detailed information about new product launches, untapped geographies, recent developments, and investments

4. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, certification, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players

5. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and breakthrough product developments

The report answers questions such as:

1. What is the market size and forecast of the Global Leukapheresis Market?

2. What are the inhibiting factors and impact of COVID-19 shaping the Global Leukapheresis Market during the forecast period?

3. Which are the products/segments/applications/areas to invest in over the forecast period in the Global Leukapheresis Market?

4. What is the competitive strategic window for opportunities in the Global Leukapheresis Market?

5. What are the technology trends and regulatory frameworks in the Global Leukapheresis Market?

6. What is the market share of the leading vendors in the Global Leukapheresis Market?

7. What modes and strategic moves are considered suitable for entering the Global Leukapheresis Market?

Market Dynamics

Drivers

Restraints

Opportunities

Challenges

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/2l9hhj

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World’s First CAR-T for NMOSD Treatment, IASO Biotherapeutics’ Equecabtagene Autoleucel, Receives IND Approval by NMPA – PR Newswire

Posted: August 22, 2022 at 3:01 am

SHANGHAI, NANJING, China and SAN JOSE, Calif., Aug. 19, 2022 /PRNewswire/ -- IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, announced today that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) approved its investigational new drug (IND) application (Acceptance No.: CXSL2200233CXSL2200234) for the new extended indication of Neuromyelitis Optica Spectrum Disorder (NMOSD) for a fully human BCMA chimeric antigen receptor autologous T (CAR-T) cell Injection (Equecabtagene Autoleucel, CT103A). This is the world's first IND approval for CAR-T in NMOSD treatment.

The new IND application is based on clinical data from an investigator-initiated clinical study of Equecabtagene Autoleucel. Subjects in the study were NMOSD patients with poor symptom control who had at least one year of treatment with at least one immunosuppressant. The study's primary objective was to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) profiles in NMOSD patients treated with Equecabtagene Autoleucel. As of March 20, 2022, 12 subjects received Equecabtagene Autoleucel cell infusion, including three in the 0.5106 CAR-T cells/kg dose group and nine in the 1.0106 CAR-T cells/kg dose group. The study data initially showed that the Equecabtagene Autoleucel injection was safe in patients with relapsed/refractory NMOSD in the 0.5106 CAR-T cells/kg and 1.0106 CAR-T cells/kg dose groups. All patients experienced Grade 1-2 CRS (Cytokine Release Syndrome) and no Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) events. In terms of efficacy, all subjects observed improved Expanded Disability Status Scale (EDSS) scores after infusion. Fifty percent experienced improved visual acuity, 67% improved their walking ability, and 75% experienced improved bladder function. After a median follow-up of 5.5 months, 11 / 12 (92%) subjects did not observe any disease recurrence.

Wen (Maxwell) Wang, M.D., Ph.D., Chief Executive Officer and Chief Medical Officer of IASO Bio, said, "As one of the first companies to conduct research on CAR-T to treat autoimmune diseases worldwide, our BCMA CAR T-cell therapy represents a significant milestone for Investigator Initiated Trial (IIT) data of relapsed and refractory NMOSD, an autoimmune disease with serious complications, blindness, and paralysis."

The existing treatment of NMOSD can only decrease the number of relapses within a certain period and has little effect on the functional recovery of sensory, nervous, and motor systems. BCMA CAR T-cell therapy can reduce the disability score and improve the functions of sensory, nervous, and motor systems, providing a milestone proof-of-concept for CAR-T therapy to treat autoimmune diseases caused by auto-antibodies produced by plasma cells. The IND's approval demonstrates further momentum for IASO Bio to promote the expansion of CAR-T therapy and launch products beyond the treatment of malignant tumors to the treatment of autoimmune diseases. IASO Bio will initiate and complete the clinical study per submitted protocol to prepare for new drug application (NDA) and to bring hope to NMOSD patients.

About Equecabtagene Autoleucel (CT103A)

Equecabtagene Autoleucel (CT103A) is a BCMA chimeric antigen receptor autologous T cell injection, a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3 activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, and integrated in-house manufacturing process improvement, the construct of the BCMA CAR-T is potent and Equecabtagene Autoleucel shows prolonged persistency in patients. The NMPA accepted the New Drug Application for Equecabtagene Autoleucel for the treatment of elapsed/refractory multiple myeloma (R/R MM).Equecabtagene Autoleucel also received Breakthrough Therapy Designation by the NMPA in February 2021 and Orphan Drug Designation (ODD)by the U.S. FDA in February 2022.

In addition to multiple myeloma, the NMPA has received IND application of Equecabtagene Autoleucel for the new expanded indication of Neuromyelitis Optica Spectrum Disorder (NMOSD).

About Neuromyelitis Optica (NMO)

Neuromyelitis Optica (NMO) is an acute or subacute inflammatory demyelination disorder of the central nervous system, an antibody-mediated idiopathic inflammatory disease of the nervous system. NMO Spectrum Disorders (NMOSD) are marked by NMO-IgG antibodies in the serum, covering NMO and NMO-related diseases. The first onset of NMOSD is seen at all ages, mostly in young and middle-aged people, with a median age of 39 years. The prevalence of NMOSD is high in Asian populated areas, and middle-aged women are the most prevalent group. According to Frost & Sullivan, the number of NMOSD cases in China was around 49,300 and 173,000 worldwide in 2021. AQP4-Ab is a foremost pathogenic antibody of NMOSD, and many clinical studies have confirmed that this antibody may cause pathological damage to the central nervous system in animals and humans. Its diagnostic specificity is up to more than 90%, with the positive rate of AQP4-Ab in NMOSD patients ranging from 40% to 90%. NMOSD is a highly recurrent disease with a high disability rate. More than 90% of patients have a multitemporal course, 60% relapse within one year and 90% relapse within three years, with sequelae found in most patients such as severe visual impairment, physical dysfunction, and urination and defecation disorders.

About IASO Bio

IASO Bio is an innovative biopharmaceutical company specializing in the development and manufacture of cellular therapeutics and antibody drugs. The company is expanding into solid tumors and autoimmune diseases with the development of hematologic oncology cell-based drugs and antibody drugs as the cornerstone of innovation. It offers a complete platform from early discovery, registration, and clinical development to commercial production. IASO Bio owns many technology platforms, including a fully human antibody discovery platform, a high-throughput CAR-T drug preference platform, a general CAR technology platform, a production technology platform, and a clinical translational research platform. It has more than 10 products at different stages of development, including Equecabtagene Autoleucel (CT103A)fully human BCMA chimeric antigen receptor autologous T cell injection, which received NDA acceptance of the China NMPA for the treatment of elapsed/refractory multiple myeloma (R/R MM).Equecabtagene Autoleucel also received Breakthrough Therapy Designation by the NMPA in February 2021 and Orphan Drug Designation (ODD) by the U.S. FDA in February 2022. In addition to multiple myeloma, the NMPA has received IND application of Equecabtagene Autoleucel for the new expanded indication of Neuromyelitis Optica Spectrum Disorder (NMOSD). Additionally, its product CT120 (fully human CD19/CD22 dual-target CAR-T cell injection) has entered the clinical research stage for the treatment of CD19/CD22-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) and relapsed/refractory acute B-lymphoblastic leukemia (B-ALL) and granted FDA Orphan Drug Designation (ODD).

Leveraging its strong management team, rich product pipeline, cutting-edge R&D, and business model, and with the introduction of innovative drugs that truly solve clinical pain points and open new treatment paths, IASO Bio is becoming one of the industry's most influential and innovative pharmaceutical companies. For more information, please visit http://www.iasobio.comor http://www.linkedin.com/company/iasobiotherapeutics.

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World's First CAR-T for NMOSD Treatment, IASO Biotherapeutics' Equecabtagene Autoleucel, Receives IND Approval by NMPA - PR Newswire

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Jefferson doctors publish new book, ‘Tapestry of Health,’ with tips on wellness – On top of Philly news – Billy Penn

Posted: August 22, 2022 at 2:59 am

Note: This article is a paid placement and does not necessarily reflect the views or opinions of Billy Penn at WHYY.

With the United States long at the forefront of medical breakthroughs, why do so many Americans still get sick with preventable illnesses?

Around 60% of adults in the U.S. have a chronic disease, according to the CDC, and over 40% have more than one.

The fast-growing field of integrative medicine looks to address that problem. Its practitioners are trained to consider the whole patient the person instead of just the symptoms or the disease. Its the driving philosophy behind the Marcus Institute of Integrative Health Jefferson Health in Philadelphia, where doctors just published a book with insights and tips on how you can use this thinking to further your own health.

Called Tapestry of Health: Weaving Wellness into Your Life through the New Science of Integrative Medicine (Kales Press), the book is by Marcus Institute founding director and CEO Daniel Monti, MD, and Medical Director Anthony Bazzan, MD.

It presents a step-by-step plan of evidence-based restorative approaches and emerging cutting-edge strategies. Its been well-received by readers, rocking a 4.4-star rating on Amazon, and by other experts in the field,

This book is so incredibly timely and important, writes Sara Gottfried, a doctor with four NYT best-sellers who provided the new books forward, because it helps you understand this new paradigm of health a massive shift that affects healthcare providers and patients alike,

As its currently structured, the authors say, the medical field suffers from an overemphasis on acute care, which is a reactionary approach. Under this model, when a person gets sick, medical care is sought and a standard treatment be it drugs or surgery is prescribed. Theres no doubt this approach has saved many lives. But it is not enough.

Heart disease, cancer, stroke, and diabetes are leading causes of death and disability in the U.S., accounting for the majority of the nations $4.1 trillion a year in health care costs.

In many cases, these illnesses are significantly exacerbated by key lifestyle risk factors. Some, such as tobacco use, are straightforward and easy to understand. Others, including the vital role of diet and specific nutrients, physical inactivity, and stress effects on immunity, are more complex.

In the case of immune resilience, the pandemic is a perfect example of how acute care medicine dominated the conversation.

Everyone understandably became very focused on the COVID-19 pathogen. However, what got lost was the state of the host i.e. people! For example, we know nutritional status affects the immune response to the virus, and that stress in general affects the immune system in very measurable ways. So while we very much needed an effective vaccine, we also needed tools to maximize immune wellness to maximize the host response to infection. That largely did not happen.

Some in medicine have begun to recognize the gap, which is why a new paradigm is emerging that integrates the best of modern medicine with proactive, holistic and preventive care.

Thomas Jefferson University is at the forefront of this movement. The Philly institution recently created the first-ever Department of Integrative Medicine & Nutritional Sciences at Sidney Kimmel Medical College. The new department includes the clinical programs of Jefferson Healths Marcus Institute of Integrative Health. These programs have introduced an approach to care that is a multifaceted partnership, connecting all aspects of well-being, including the physical, emotional, intellectual, spiritual, social, and nutritional.

To learn more about the book and other resources, visit the Tapestry of Health website.

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Sure Signs Your Immune System Isn’t as Strong as it Should Be Eat This Not That – Eat This, Not That

Posted: August 22, 2022 at 2:59 am

Your immune system works hard to fight off forein invaders like infections and germs to keep you healthy and it never gets a break. It works around the clock everyday to protect you, so helping your immune system stay strong is vital to your overall well-being. So how can you help strengthen your immunity? Eat This, Not That! Health spoke with Dr. Michael Hirt, a Board Certified Nutrition from Harvard University and Board Certified in Internal Medicine and is with The Center for Integrative Medicine in Tarzana California who shares what to know about your immune system, signs it's too weak and how to help boost it. As always, please speak with your physician for medical advice. Read onand to ensure your health and the health of others, don't miss these Sure Signs You've Already Had COVID.

Dr. Hirt tells us, "You know exercise can make your heart stronger. You know puzzles can make your brain smarter. However, even after two years of pandemic health lessons, people are still puzzled as to how to reliably make their immune system stronger. Like your cardiovascular and nervous systems, the immune system is subject to the same lifestyle choices that affect the rest of your body. Eat too much sugar, drink too much liquor, shorten your sleep hours, and you should not be surprised that you are going to wake up with your heart pounding, brain fogged in, and the start of a sore throat. You are the sum of your choices, and a robust immune system is no exception to your cumulative health investments (or lack thereof)."

"The innate programming of your immune system is only to attack microbial threats and coordinate repairs ranging from skin scrapes to broken bones," says Dr. Hirt. "Under the influence of environmental toxins, intestinal imbalances (from diet and bacteria), and genetic tendencies, some parts of your immune system can go 'rogue' and attack the body it was sworn to only defend. This is called an auto-immune condition because the immune system is attacking parts of self like joints, skin, or internal organs. This is never supposed to happen, serves no evolutionary benefit, and requires major lifestyle changes, detoxification, and medical interventions to stop the attack and remove the triggers of self-attack. Without a coordinated healing effort, the immune system will likely continue to attack itself and require strong, immune-suppressive measures."

Dr. Hirt shares, "If you're thinking of trying to boost your immune system, consider how you would boost the effectiveness of your nation's defense forces. To have a stronger, more effective military, you would feed them healthy food, ensure they are well rested, avoid unnecessary stress, house them on clean bases, provide cutting edge equipment, and have plenty of munitions so they never run out of bullets and missiles. Same with your immune system. Eat the healthiest food you can, in the cleanest environment you can, under the least stress you can, having had the most restful sleep you can, and taking the best vitamins you can including zinc, vitamin C, and vitamin D. Just like our military, your immune system never gets to take a collective break from defending you from all threats, both foreign and domestic."

Dr. Hirt states, "Most adults get a cold or flu 2 3 times yearly. If you're calling in sick on a monthly basis, you could have a more significant immune deficiency that needs testing and treatments."

"When you cut your self, superficial wounds typically take seven days to heal," Dr. Hirt tells us. "If you are watching your skin take weeks to heal, then your immune system may be compromised."6254a4d1642c605c54bf1cab17d50f1e

According to Dr. Hirt, "When you get an upper respiratory infection, most people with healthy immune systems can fully recover in ten days. If your symptoms go on for most of the month, then there may be issues with the strength of your immune responsiveness."

"There are many reasons to be tired," Dr. Hirt says. "Many people are surprised to learn that one of them is a weak immune system, or low white blood cell count. If you are experiencing unusual fatigue, make sure your healthcare provider includes a screening test for your immune system."

Heather Newgen

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The Breathing Trick That Could Help You Fall Asleep Almost Instantly – Newsweek

Posted: August 22, 2022 at 2:59 am

One simple breathing technique that takes just over a minute to complete could help you fall asleep faster and get a better night's rest overall, according to experts.

The technique, known as 4-7-8 breathing, was developed by Dr. Andrew Weila trained medical doctor and founder of the Arizona Center for Integrative Medicine.

Weil developed the technique, which is based on breathing exercises found in yoga, for the purposes of managing stress and anxiety.

But experts told Newsweek the technique can also be useful for people who are having trouble sleeping.

Sleep is crucial to our physical and mental health, enabling our body to recover and wake up feeling refreshed.

But large portions of the population don't get sufficient sleep, have poor sleep quality, or have trouble falling asleep as a result of sleep disorders, medical conditions or mental health issues.

According to the American Sleep Association, 50 to 70 million adults in the United States have a sleep disorder, with insomnia being the most common one.

Around 10 percent of adults suffer from chronic insomnia, while many more suffer short-term issues. Meanwhile around 25 million U.S. adults have obstructive sleep apneaa sleep disorder characterized by repeated obstruction to the airway during sleep.

In addition, 35 percent of adults report getting less than seven hours of sleep during a typical 24-hour periodless than the minimum recommend amount.

"The 4-7-8 breath that I teach is the most powerful relaxation method that I've discovered," Weil said in a video demonstration of the technique. "It's very simple, requires no equipment, takes very little time, costs nothing."

This is how to practise the technique correctly:

The speed with which you do the technique is not necessarily important. What is important is maintaining the 4-7-8 ratio between the counts.

According to Weil, this is a technique that you have to practise regularlyat least twice a dayto benefit from fully.

"You can do it more frequently than twice a day but never more than four breath cycles at one time," Weil said in the video.

According to Weil, it may take four to six weeks before you notice any physiological changes from the practise.

Over time he said it could help to lower heart rate, lower blood pressure, improve digestion, improve circulation, and to help people fall asleep.

"It is the most effective anti-anxiety techniques that I've found," he said. "I've taught it to patients with the most extreme forms of panic disorder, who eventually brought that under control, just relying on this breathing technique."

According to Patrick McKeown, a leading international expert on breathing and sleep, and author of bestselling books like The Oxygen Advantage, changing our breathing can have a profound impact on our physical and mental states.

"With breathing exercises one can down-regulate and up-regulate, giving us control over how our minds and bodies react to external stimuli," McKeown told Newsweek. "For sleep, breathing and mental health, functional breathing is instrumental.

"Knowing what exercises to practise can be life changing as we learn to change states. It's not about taking the deep breath. It's much more than that!"

According to McKeown, how a person breathes during the day will influence our breathing patterns during sleep.

"If our breathing patterns mean we are breathing through the mouth, with a faster rate and from the upper chest, (rather than from the diaphragm) this will increase the risk of sleep issues including insomnia, snoring and sleep apnea."

McKeown said that for people with functional breathing who are able to slow down their respiratory rate to around three breaths per minutelike during 4-7-8 exerciseextended exhalation will help activate the bodies relaxation response.

"When the rest and digest response is activated, one feels sleepy and experience increased watery saliva in the mouth," he said. "Slowing breathing rate also enables a better gas exchange to take place from the lungs to the blood.

"Practising this breathing technique before going to bed will not only help people fall asleep but will noticeably improve quality of sleep and when practiced regularly, will lead to a better quality of life all around."

Michael Breus, a clinical psychologist who is a diplomate of the American Board of Sleep Medicine and a fellow of the American Academy of Sleep Medicine, told Newsweek he is a "huge fan" of the 4-7-8 breathing technique.

According to Breus, the technique lowers the heart rate to the point it needs to be at night when some is trying to fall asleep.

"I have adopted this method, as both a 'help you fall asleep' but more of a 'help you get back to sleep' method," Breus told Newsweek. "Most people do not know this metric, but in order to get to a state of unconsciousness you need a heart rate of 60 or below, to get there. So, when you wake up in the middle of the night and your anxiety is high because you looked at the clock, this can help you get back to sleep."

In addition, Breus said there is plenty of data to show that diaphragmatic breathing helps to lower anxiety, which has been linked to difficulties falling and staying asleep.

"Most people are what we call 'shallow breathers' meaning that they do not use their full lung capacity, unless during full-on physical activity," Breus said. "This type of breathing requires more breaths per minute to get the required volume of air to live. More breaths per minute equals increased heart rateand we know we need to get to 60, which is usually down from where people tend to sit naturally (unless you are an athlete)."

Breathing for four counts in will slowly fill the lungs, holding for seven enables oxygen exchange to the fullest, and breathing out for eight pushes all the excess carbon dioxide out of the lungs and allows more fresh, highly oxygenated air to enter the system, and so the heart does not have to work as hard, according to Breus. This leads to a lowering of the heart rate.

McKeown said it is important to note that not everyone will be able to practise 4-7-8 breathing.

"People with poor breathing already experience a breathlessness that we call 'air hunger'. Slowing down the respiratory rate to three breaths per minute will be impossible for them to practise. It could even cause a disruption to their breathing," he said.

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Can You Really Drink Too Much Water? We Investigated – mindbodygreen

Posted: August 22, 2022 at 2:59 am

While the ideal amount of water varies for each person depending on your geographic location, body type, and more, according to Dana Cohen, M.D., integrative medicine physician and co-author of Quench, you should aim to drink about half of your body weight in ounces of water each day to ensure youre staying adequately hydrated.

However, while it would take a lot to reach the point of "overhydrating," it is, in fact, possible to drink too much water. "In overhydration an excess of water dilutes the electrolyte concentrations in the blood, causing imbalance throughout the body's many systems," physician Catherine Waldrop, M.D., previously told mbg.

In fact, drinking too much water can even lead to an electrolyte imbalance called hyponatremia, that can have some fairly gnarly side effects on the body. "Mild hyponatremia is characterized by gastrointestinal tract symptoms, nausea, vomiting, loss of appetite," one study revealed. In short, hyponatremia is essentially low sodium in the blood.

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Qualities Clinicians Need to Have to Deliver Integrative Care – HealthLeaders Media

Posted: August 22, 2022 at 2:59 am

In a recently published report, Northwestern Health Sciences University (NWHSU) has identified seven domains of knowledge, skills, and behaviors that clinicians need to provide the best integrative care.

Integrative care has many elements. At NWHSU, the concept of integrative care extends beyond multi-disciplinary care, including team-based and holistic care, interprofessional collaboration, and partnerships between patients and communities. Integrative care also includes interdependent considerations such as genetics, social determinants of health, community support and resources, and beliefs and habits that influence health.

Domain 1, values, ethics, culture, and diversity: In integrative care, clinicians work with colleagues in other professions in a climate of mutual respect and shared values, with the recognition that there is diversity in and between disciplines as well as diversity in patient populations.

Values, ethics, culture, and diversity are the connective tissue of integrative care and a transdisciplinary approach to healthcare, says Michele Renee, DC, director of integrative care at NWHSU. "It is the shared mindset that unifies diverse paradigms of healing, creating a dynamic approach in which each point of view is honored and yet not sufficient in and of itself. We are also acknowledging the importance of social factors, from socio-economic status to religion to cultural norms, and professional diversity, from indigenous healing to mainstream medicine to complementary and integrative healthcare approaches. All these differences are important considerations in providing robust, multifaceted, and individualized approaches to care."

Domain 2, patient-centered care: Clinicians should seek out, integrate, and value contributions and engagement of the patient, family, and community in designing and providing care.

Patient-centered care acknowledges the pivotal role of patients in their care, Renee says. "Patient-centered care calls out the importance of acknowledging the bio-psycho-social-spiritual nature of whole person care. It is vital that healthcare providers are not doing to the patient, but rather with the patient. Our patients are active participants in care and the most important person in a healthcare team."

Domain 3, roles and responsibilities: Clinicians should use knowledge of their role and the role of other professions to identify and address the healthcare needs of patients, families, and communities.

"For team-based care to work, we must each understand the part we play, the unique skills others bring, and how we all fit into the larger picture. This is a dynamic process, created uniquely for each person we serve. These skills are essential to ensure care is complete and wraps around our patients and communities," Renee says.

Domain 4, interprofessional communication: Clinicians should be responsive and responsible in their communication with patients, families, communities, and other healthcare professionals, which helps establishing a team approach to health and the treatment of disease.

Communication is often where healthcare fails, so shared communication competencies are essential, Renee says. "This includes understanding ourselves, acknowledging biases, identifying and resolving conflict when it arises, and documenting care in a way that is universally understood. Multilayered communication is key to building trusting relationships."

Domain 5, team and teamwork: Clinicians should practice relationship-building values and embrace team dynamics to perform effectively in different team roles to plan, deliver, and evaluate patient-centered care that is safe, timely, efficient, effective, and equitable.

Patients and communities rely upon their healthcare teams knowing how to evaluate, plan, and deliver care, Renee says. "This involves designing and implementing evidence-informed systems that support effective teamwork, and creating accountability for each care team member to focus on all aspects of patient and population focused problem solving. Team-based care goes beyond what happens in the treatment room or hospital to include social determinants of health and health equity."

Domain 6, collaborative leadership: Clinicians should foster shared leadership and collaborative practice of care.

Healthcare professionals need to cultivate the skill of passing the baton as needed, Renee says. "One provider may be providing the primary intervention at one moment in time and complementary care at another. The needs of the patient change over time and the care team needs to be prepared to collaborate and share leadership accordingly, leaning on one another's unique insights and expertise as needed."

Domain 7, well-being and resilience: Clinicians need to recognize that the health of an individual has positive and negative effects on their ability to make change around them and adopt sustainable strategies to address challenges, while remaining committed to their sense of purpose.

Building a resilient healthcare system starts with the well-being of healthcare professionals, Renee says. "Health creation begins with prioritizing self-care, which in turn reduces burnout and improves job performance and satisfaction. Learning the skills to identify one's circle of influence, develop a growth mindset, and cultivate grit prepare providers to better support patients in their own health creation by putting the focus on well-being and resilience instead of disease management."

Christopher Cheney is the senior clinical care editor at HealthLeaders.

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