Should U.S. Health Care Depend on China?

americanthinker | July 10, 2019

Two new books expose the health dangers posed by the import of pharmaceuticals from the Peoples Republic of China. The dependence of Americas medical system on products of questionable quality does not just endanger patients today, but risks long-term problems as the push for Medicare for All or some similar national health insurance scheme grows in popularity.

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Each week, the Edward J. Miller, Sr. Blood Donor Center at Children’s National needs 100 whole blood donations and 35 platelet donations to provide our pediatric patients with life-saving surgeries and to nurse children back to health from cancer or sickle cell disease.


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FUTURE OF HEALTHCARE

Ascensus Closes Newport Merger Agreement

Ascensus | April 11, 2022

Ascensus—whose technology and expertise help millions of people save for retirement, education, and healthcare—and Newport, the Walnut Creek, California-based retirement services provider—announced today that the two companies have closed their previously announced merger, the first step in their journey together as a combined organization. The union combines the capabilities and talents of two market leaders in tax-advantaged savings and related services, serving more than 15 million savers and overseeing more than $745 billion in assets under administration as of December 31, 2021. Together, the unified company employs more than 5,400 employees across the U.S. David Musto, president and chief executive officer of Ascensus, will serve as CEO of the combined company. Laura Ramanis, who has served as interim CEO of Newport since the announcement of the transaction last fall, and Kurt Laning, executive vice president of Newport Non-Qualified and Insurance Solutions, will join the Ascensus executive leadership team, reporting to Musto. "With today's announcement, Ascensus and Newport have taken an important step in our journey towards a stronger, unified company. Clients across our lines of business will benefit from our expanded capabilities—accelerated investments in technology, data analytics, and user experiences—and broadened expertise. And both Ascensus and Newport associates can look forward to new opportunities for personal growth and enhanced career development." Musto "Ascensus and Newport share a passion for helping people save for their futures and supporting the growth and success of our partners," said Ramanis. "We look forward to continuing that mission as a combined company." With industry-leading qualified and non-qualified retirement plan services, corporate and bank-owned life insurance (COLI and BOLI) practices, fiduciary and trust solutions, and other total rewards capabilities, Newport expands the services and expertise Ascensus provides to its clients and advisor partners. Newport's clients will benefit from greater access to unique tax-advantaged savings solutions across retirement, education, and health provided by Ascensus. The combined company's investments in technology, digital capabilities, and analytics will deliver enhanced value to clients, expand client relationships, and create even better outcomes for savers. Both the Ascensus and Newport brands remain in use at closing, with the Ascensus brand representing the unified company. "Our goal over the next several months is the successful unification of our company—built on the principle of 'best of the best' and our shared cultural attributes, and executed with the interests, quality, and stability of our client relationships foremost in mind," added Musto. "As a unified organization, Ascensus and Newport share a strong commitment to serving our clients and offering more—across the tax-advantaged retirement, education, and health savings expertise for which Ascensus is known, and capitalizing on Newport's well-established qualified and non-qualified retirement services, and fiduciary and COLI/BOLI capabilities as well." Evercore acted as exclusive financial advisor to Newport in connection with the transaction. Goldman Sachs Bank USA, SPC Financing Company LLC, and KKR Capital Markets LLC led the financing consortium. Simpson Thacher & Bartlett LLP acted as transactional counsel to Ascensus and Kirkland & Ellis LLP acted as financing counsel to Ascensus. Morgan Lewis & Bockius LLP acted as legal counsel to Newport. About Ascensus Ascensus helps millions of people save for what matters—retirement, education, and healthcare. Through co-branded, private-labeled, and other governmental partnerships, our technology, market insights, and business knowledge enhance the growth and success of our partners, their clients, and savers. Ascensus is a leading recordkeeping services provider, third-party administrator, and government savings facilitator in the United States. About Newport Headquartered in Walnut Creek, California, Newport is a leading retirement services provider that helps employers—and the advisors who serve them—prepare employees for a more financially secure retirement. The company has more than $150 billion in retirement assets under administration and more than $300 billion in corporate retirement and insurance assets. Newport maintains investment objectivity, fee transparency and a commitment to flexible, responsive service. Staffed by an exceptional team of nearly 1,500 retirement, insurance, and consulting professionals, the company provides retirement solutions tailored to the needs of employers of every size, from small businesses to the Fortune 1000.

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FUTURE OF HEALTHCARE

M1 MedTech Accelerator Program Opens Applications to Early-Stage Medical Device Companies

M1 MedTech | April 05, 2022

M1 MedTech, a medical technology accelerator sponsored by Proxima Clinical Research, a contract research organization based out of the Texas Medical Center, announcedit is accepting applications for its fall cohort. M1 MedTech is looking for five to seven of the most promising early-stage medical device companies to participate in its three-month program. The program has closed its first fund and will be selecting companies over the summer for investments up to $100,000 as a combination of both cash and in-kind services. “Our program is unique in that it combines acceleration capital, company building expertise, and the regulatory and clinical services of a top CRO,” says Larry Lawson, a venture partner and investor with M1. “Access to the M1 founders’ network, both within and outside of the Texas Medical Center, sets these companies up for success. There’s no better group to build a MedTech company with, period.” “Many MedTech companies are launched by innovative first-time founders with strong scientific and medical expertise, but who have never taken a regulated product to market or built a business. After working with so many companies at various stages of this journey to market, both with Proxima CRO and with accelerators from across the country, we realized there was a gap that needed to be filled for these rising founders. They not only need regulatory and clinical assistance from experts with hundreds of success stories in this field, we found they also need assistance with design, manufacturing, business, IP, and so much more,” says Isabella Schmitt, RAC, Director of Regulatory Affairs for Proxima CRO and Principle at M1. “These rising founders need to know what they don’t know; so, we put a lot of thought into what emerging companies and rising executives really need, and from that, we built the M1 curriculum.” M1 MedTech was created to support early-stage medical device companies, offering an immersive experience that provides tangible benefits to participating companies. The program will take on a limited number of enterprises in each cohort and offer a direct approach to helping founders advance their companies and technologies. The coaching process will include a curated educational program, interactive workshops where participants can continually build out specific company deliverables, and tailored one-on-one mentoring. “This is a very personalized program for early-stage companies focused on Class II and III medical devices,” said Sean Bittner, PhD, ACC, Director of Programs at M1 MedTech. “We’re excited to welcome our first cohort this August. The medical device companies that fit best with our program are in pre-seed or seed-stage, have completed a customer evaluation, know the issues they want to address, have not progressed far enough through the pipeline to have communicated with the FDA or completed preclinical or clinical testing,” says Bittner. “We would like the companies to have completed preliminary testing but have not gone too far into the product development phase.” “This is a fantastic opportunity for an early-stage company to receive mentoring and guidance from a group of established individuals in the life sciences industry. The hands-on 12-week workshop curriculum will cover a variety of topics including company formation and management, preclinical and clinical testing, regulatory approval, among other necessary guidance as their companies begin to mature. We are excited to aid the founders in rapidly advancing toward commercialization and prepare them for critical early investment stages.” Kevin Coker, CEO at Proxima CRO and Principal at M1 MedTech Experts from Greenlight Guru, Medrio, Galen Data, and Merge Medical Device Studio join Proxima CRO as sponsors of the program and will assist with content delivery and mentoring. Applications will remain open until May 31. About M1 MedTech M1 MedTech is an accelerator/incubator designed to build MedTech companies. The program offers capital, entrepreneurial expertise, and CRO services, as well as an immersive experience offering a hands-on approach to guide founders as they become MedTech executives and advance their companies and technologies. The coaching process includes a curated educational program with a focus on regulatory and quality dynamics, one-on-one mentoring, and interactive workshops where participants can continually build out specific company deliverables.

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FUTURE OF HEALTHCARE

Trinity Health to Acquire CommonSpirit Health's Share of MercyOne Health System Become Sole Parent

Trinity Health | April 20, 2022

Trinity Health and CommonSpirit Health announced they have signed an agreement for Trinity Health to acquire all facilities and assets of MercyOne, a regional health system based in Iowa. Since 1998, MercyOne has operated under a joint operating agreement between not-for-profit Catholic health care organizations Trinity Health and Catholic Health Initiatives, which is now CommonSpirit. MercyOne is a leading health system in Iowa and serves more than 3.3 million patients each year. The system includes 16 medical centers, 27 affiliate organizations and more than 420 care sites offering a range of health and wellness services, including provider services and urgent care, and more than 20,000 colleagues including 2,000 of the state's most talented doctors and providers. "True to our shared Catholic mission, our goal is to provide high-quality, compassionate care with the best patient/member experience possible. We will accomplish that goal through a holistic approach, with a range of health services and technologies that are fully connected and coordinated. This agreement creates a fully integrated MercyOne to care for more people in a unified way." Mike Slubowski, president and chief executive officer at Trinity Health After months of analysis and due diligence, Trinity Health and CommonSpirit determined a sole parent is the best path forward for MercyOne and for the communities it serves. Trinity Health, a national health system spanning 25 states, will bring unified strategies and operations to MercyOne's care sites, including one set of system services. As an example, MercyOne will transition to Trinity Health's common platforms, including a single electronic health record (EHR), ultimately allowing patients to easily manage their care across all MercyOne services and facilities. The result is a more convenient and consistent care experience for MercyOne's communities. "After two decades of successful collaboration, we are immensely proud of our partnership with Trinity Health and our efforts to advance health care statewide," said Marvin O'Quinn, president and chief operating officer at CommonSpirit Health. "While the current structure has been instrumental in growing our health care services in Iowa, we believe this decision is ultimately what is best for our patients, colleagues, and our communities." "We strongly believe this transition to become a full member of the Trinity Health family will result in a stronger, more cohesive health system better able to offer a convenient and personalized circle of care for all we serve," said Bob Ritz, president and chief executive officer at MercyOne. "We are delighted to have the agreement in place as we plan for the future of our mission. We are grateful to CommonSpirit for more than 20 years of partnership." Trinity Health and CommonSpirit will now plan for integration, complete regulatory filings, and take other steps necessary to finalize the transaction, which is expected to be completed summer 2022. This process will be seamless for the communities MercyOne serves, and patients can continue to expect the same compassionate care they have always received. About Trinity Health Trinity Health is one of the largest not-for-profit, Catholic health care systems in the nation. It is a family of 115,000 colleagues and nearly 26,000 physicians and clinicians caring for diverse communities across 25 states. Nationally recognized for care and experience, Trinity Health's network of care includes 88 hospitals, 131 continuing care locations, the second largest PACE program in the country, 125 urgent care locations, and many other health and well-being services. Based in Livonia, Michigan, its annual operating revenue is $20.2 billion with $1.2 billion returned to its communities in the form of charity care and other community benefit programs. For more information, visit www.trinity-health.org or follow us on LinkedIn, Facebook or Twitter. About CommonSpirit Health CommonSpirit Health is a nonprofit, Catholic health system dedicated to advancing health for all people. It was created in February 2019 by Catholic Health Initiatives and Dignity Health. With its national office in Chicago and a team of over 150,000 employees and 25,000 physicians and advanced practice clinicians, CommonSpirit operates 140 hospitals and more than 1,500 care sites across 21 states. In FY 2021, CommonSpirit had revenues of $33.3 billion and provided $5.1 billion in charity care, community benefit, and unreimbursed government programs. Learn more at www.commonspirit.org. About MercyOne MercyOne is a connected system of health care facilities and services dedicated to helping people and communities live their best life. MercyOne's care providers and staff make health the highest priority. The system's clinics, medical centers, hospitals and affiliates are located throughout the state of Iowa and beyond. Headquartered in central Iowa, MercyOne was founded in 1998 through a collaboration between Catholic Health Initiatives, now CommonSpirit Health, and Trinity Health - two of the country's foremost, not-for-profit Catholic health organizations.

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HEALTH TECHNOLOGY

Texas Children's Hospital And Baylor College of Medicine COVID-19 Vaccine Technology Secures Emergency Use Authorization In India

Texas Children Hospital | December 29, 2021

Texas Children's Hospital and Baylor College of Medicine announced today that CORBEVAX™, a protein sub-unit COVID-19 Vaccine, whose technology was created and engineered at its Center for Vaccine Development (CVD), has received Emergency Use Authorization (EUA) approval from the Drugs Controller General ofIndia(DCGI)to launch inIndiawith other underserved countries to follow. Dubbed "The World's COVID-19 Vaccine", it uses a traditional recombinant protein-based technology that will enable its production at large scales making it widely accessible to inoculate the global population. The initial construct and production process of the vaccine antigen was developed at Texas Children's Hospital CVD, led by co-directors Drs. Maria Elena Bottazzi and Peter Hotez and in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialization team, to Hyderabad-based vaccine and pharmaceutical company Biological E. Limited (BE). CORBEVAX™ after completing two Phase III clinical trials involving more than 3000 subjects was found to be safe, well tolerated and immunogenic: CORBEVAX™ demonstrated superior immune response in comparison with COVISHIELD™ vaccine when assessed for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant. CORBEVAX™ vaccination also generated significant Th1 skewed cellular immune response. CORBEVAX™ nAb GMT against Ancestral-Wuhan strain is indicative of vaccine effectiveness of >90% for prevention of symptomatic infections based on the Correlates of Protection assessment performed during Moderna and Astra-Zeneca vaccine Phase III studies. CORBEVAX™ nAb GMT against the Delta strain indicates a vaccine effectiveness of >80 percent for the prevention of symptomatic infections based on published studies. While none of the subjects who took CORBEVAX™ or COVISHIELD™ had serious adverse events, CORBEVAX™ had 50 percent fewer adverse events than COVISHIELD™. In the continuous monitoring of phase II studies, CORBEVAX™ showed high persistence of immune response as indicated by <30% drop in nAb GMT till 6 months second dose as compared to >80% drop observed with majority of the vaccines. "Protein-based vaccines have been widely used to prevent many other diseases, have proven safety records, and use economies of scale to achieve low-cost scalability across the world," said Dr. Maria Elena Bottazzi, Professor and Associate Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children's Hospital Center for Vaccine Development. "Our decade-long studies advancing coronavirus vaccine prototypes has led to the creation of this vaccine, which will fill the access gap created by the more expensive, newer vaccine technologies and that today are still not able to be quickly scaled for global production." The need for safe, streamlined, low-cost vaccines for middle- to low-income countries is central to the world's fight against the COVID-19 pandemic. Without widespread vaccination of populations in the Global South, additional virus variants will arise, hindering the progress achieved by currently available vaccines in the United States and other Western countries. "This announcement is an important first step in vaccinating the world and halting the pandemic. Our vaccine technology offers a path to address an unfolding humanitarian crisis, namely the vulnerability the low- and middle-income countries face against the delta variant," said Dr. Peter Hotez, Professor and Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children's Hospital Center for Vaccine Development. "Widespread and global vaccination with our Texas Children's-Baylor-BE vaccine would also forestall the emergence of new variants. We have previously missed that opportunity for the alpha and delta variant. Now is our chance to prevent a new global wave from what might follow." "Over the years, we have worked to make quality vaccines and pharmaceutical products accessible to families around the world. With this as our backdrop, we resolved to develop an affordable and effective COVID-19 vaccine. It has now become a reality. We deeply appreciate Texas Children's Hospital Center for Vaccine Development, Baylor, CEPI, the Bill and Melinda Gates Foundation, and the government of India for their continuous support and cooperation during this journey. The combined efforts & unceasing support demonstrate that we can collectively overcome any challenge". Mahima Datla, Managing Director, Biological E. Limited ABOUT TEXAS CHILDREN'S HOSPITAL Texas Children's Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children's hospital in Texas, and among the top in the nation, Texas Children's has garnered widespread recognition for its expertise and breakthroughs in pediatric and women's health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Tower for pediatric research; Texas Children's Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children's Hospital West Campus, a community hospital in suburban West Houston; and Texas Children's Hospital The Woodlands, the first hospital devoted to children's care for communities north of Houston. The organization also created Texas Children's HealthPlan, the nation's first HMO for children; has the largest pediatric primary care network in the country, Texas Children's Pediatrics; Texas Children's Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that's channeling care to children and women all over the world. Texas Children's Global Health program leads efforts that advance health care equity through innovative collaboration in care, education and research for underserved populations globally. Texas Children's Hospital is affiliated with Baylor College of Medicine. ABOUT TEXAS CHILDREN'S HOSPITAL CENTER FOR VACCINE DEVELOPMENT Texas Children's Hospital Center for Vaccine Development is one of the leading vaccine development centers in the world. Established in Washington DC as the Sabin Vaccine Institute Product Development Partnership (PDP) in the year 2000 and after relocating to the Texas Medical Center in 2011, it rebranded as Texas Children's Center for Vaccine Development. For the past two decades it has acquired an international reputation as a non-profit PDP, advancing vaccines for poverty-related neglected tropical diseases (NTDs) and emerging infectious diseases of pandemic importance. In addition, it builds and strengthens capacity for vaccine development locally and with foreign nations and leads global efforts to guide and influence vaccine policy and advocacy through "vaccine diplomacy" as an international bridge for peace and vaccine development capacity. ABOUT BCM VENTURES Baylor College of Medicine Ventures is the commercial engine of the health sciences university, created to support the translation of academic knowledge and intellectual assets for the benefit of society. We do this by engaging university innovators, entrepreneurs and industry to fully develop ideas along their best commercial path. We foster a culture of commercialization and engage with industry to identify market opportunities for collaborative ventures. ABOUT BIOLOGICAL E. LIMITED Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio. In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

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Spotlight

Each week, the Edward J. Miller, Sr. Blood Donor Center at Children’s National needs 100 whole blood donations and 35 platelet donations to provide our pediatric patients with life-saving surgeries and to nurse children back to health from cancer or sickle cell disease.

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