FALLS CHURCH, Va. (PRWEB)
May 10, 2023

In this webinar, medical device manufacturers will be updated on the current IVD and LDT regulatory landscape and potential implications of the Verifying Accurate Leading-edge IVCT Development Act (VALID Act).

Michael M. Gaba, FDA Practice vice chair, Colleen Faddick, Health Care Operations Practice chair, and Christopher C. Rorick, senior policy advisor from the Public Policy Practice Group at Polsinelli, will explain why there is significant interest in further regulating these diagnostic mechanisms beyond what the FDA currently has in place via the Clinical Laboratory Improvement Amendments (CLIA) and medical device policy, and the implications for ensuring adequate clinical validation if the VALID Act becomes law.

Webinar attendees will:

• 
  Understand the current CLIA framework and LDTs
• Comprehend the FDA regulation of IVD tests as medical devices and their regulatory stance towards LDTs
• Understand the history and development of the VALID Act and the framework to define and regulate in vitro clinical tests (IVCT)
• Learn the legislative pathways and prospects for the VALID Act to become law and FDA implementation timelines
• Gain clarity on what it means for a test to have adequate clinical validation
• Recognize the business implications for labs that have historically built their models around the development of LDTs

Webinar Details

The Return of VALID:

What the Future Holds for IVDs and LDTs

An FDAnews Webinar

Wednesday, May 17, 2023, 1:30 p.m.-3:00 p.m. EDT

https://wcg.swoogo.com/the-return-of-valid

Tuition:

$287

Easy Ways to Order:

Online: https://wcg.swoogo.com/the-return-of-valid

By phone: 888.838.5578 or 703.538.7600

About WCG FDAnews:

WCG FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on WCG FDAnews’ newsletters, books, databases, webinars and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations. Learn more at fdanews.com.

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NORTH BETHESDA, Md. (PRWEB)
May 09, 2023

ISPE today announced the 2023 Facility of the Year Awards (FOYA) Winners at the 2023 ISPE Europe Annual Conference in Amsterdam, The Netherlands. The award-winning projects selected by the FOYA program set the standard for pharmaceutical facilities of the future by demonstrating excellence in facility design, construction, and operations.

Categories winners include:

The FOYA judges’ panel has also awarded Honorable Mention to:

“We are thrilled to be recognizing this year’s FOYA category winners for their outstanding work in the pharmaceutical industry,” said Tom Hartman, ISPE’s President and CEO, “These exceptional facilities demonstrate a strong commitment to improving patient care and enhancing global health, which is truly inspiring. ISPE congratulates all the winners and is proud to showcase their accomplishments as models for excellence in the design, construction, and operation of pharmaceutical manufacturing facilities.”

ISPE 2023 Facility of the Year (FOYA) Category Awards Winners

The Innovation Category was awarded to Chugai Pharma Manufacturing Co., Ltd. for its facility in Shizuoka Pref, Japan for the FJ2 Project. The FJ2 facility will enable Chugai to establish its own stable supply chain for APIs that are difficult to manufacture on a large scale, including high potency APIs, from early clinical development through to market launch. Chugai implemented several innovative design and equipment concepts in the facility to protect both the product and the worker. The Chugai FJ2 project focused on the process and employee safety throughout the entire project design and employed innovative ways to achieve these goals.

The Operations Category was awarded to WuXi Biologics Ireland Limited for its Contract Research, Development and Manufacturing Organization (CRDMO) facility in County Louth, Ireland. This site uses hybrid, single-use, scale-out production technology for multiproduct mAb and recombinant protein drug substance. A Design-Assist project model with IPS was used to design and build the new facility which with this collaborative approach significantly reduced cost, time, and re-work. Ultimately, this project is an inspiring landmark that proves that facilities can be developed on a highly accelerated schedule, using innovative solutions while complying with regulatory requirements, overcoming unknown barriers, cooperation with the community, and upholding project success and product safety.

SERUM Institute of India Pvt. Ltd. won the Supply Chain Category for its project “NISHWAS” located in Maharashtra, India. SERUM is a vaccine manufacturer and produces over 2.5 billion doses annually. In record time, Serum’s “NISHWAS” project manufactured a COVID-19 vaccine in large number of doses in spite of the challenging work environment. The construction modifications of manufacturing buildings, which were already 70% complete, were executed in two months, with uncompromised EHSS compliance. Through highly focused and exceptional project execution, real-time project risk management coupled with close multi-disciplinary coordination to prevent rework, Serum’s “NISHWAS” project exemplifies how to deliver in a record time a large pharmaceutical manufacturing capability and capacity during crisis to serve humanity unmet needs.

The Pharma 4.0TM Category was awarded to Genentech for their South San Francisco Clinical Supply Center located in San Francisco, California, USA. The Genentech Clinical Supply Center (CSC) uses advanced manufacturing technologies and employs an agile modular design to enable on-demand delivery of Genentech’s medicinal pipeline to clinical trials patients. This project is recognized with the FOYA 2023 Pharma 4.0™ category winner award as a role model on how the application of bold objectives, deep alignment and end-to-end planning, innovation in applying digital technologies, integration, and challenging paradigms all lead to a facility that delivers improved outcomes in terms of construction, safety, facility productivity and patient access to innovative medicines.

The first of two companies to be awarded in the Social Impact Category is Takeda SA for its project Glassia Manufacturing Building located in Lessines, Belgium. This facility produces plasma-derived therapy that is a sterile, ready-to-use, liquid preparation of purified human Alpha-1 Antitrypsin protein. This state-of-the art facility operates with the latest digital and sustainable technologies. Takeda achieved through this thought the application of novel approaches, standards and practices a sustainable facility design to ensure effective use of energy, minimize waste, reduce carbon footprint and reduce environmental impact.

The second of two companies to be awarded in the Social Impact Category is SERUM Institute of India Pvt. Ltd. for its project “NISHWAS” located in Maharashtra, India. The NISHWASH project and its ability to quickly deliver much-needed COVID vaccines to a populous country like India was invaluable in ensuring India’s resilient fight against COVID. This project and its outcome had profound impact on many other developing countries where vaccine manufactured by SERUM was administered. For these reasons, SERUM’s NISHWAS project is also recognized for the FOYA 2023 award in the category of “Social Impact”, as it exemplifies agility in delivering a positive impact on the well-being of millions of people in an accelerated timeframe.

Nexus Pharmaceuticals, Inc. was awarded an Honorable Mention for its Project Tomorrow in Pleasant Prairie, Wisconsin USA. Nexus is a woman-led, minority-owned, and family-owned healthcare company that specializes in developing priority generics, such as hard-to-formulate critical-need molecules that are routinely in short supply. The Nexus business model is focused on innovating processes to transform difficult-to-manufacture specialty and generic injectables into products that are easier to use and less labor-intensive to make. As a small generic company, the design and technology included in Project Tomorrow is impressive and in line with current industry standards.

The 2023 FOYA Category Winners will be formally recognized at the ISPE Facility of the Year Awards Banquet and Dinner on 15 October 2023, in Las Vegas, Nevada, where the 2023 FOYA Overall Winner will also be announced. Held in conjunction with the 2023 ISPE Annual Meeting & Expo, the banquet will feature acceptance speeches from the FOYA recipients and presentations from noted industry leaders.

For more information contact:

Jessie Hardy, Senior Director of Membership & Chapter Relations, ISPE

Tel: +1-813-739-2293 ext. 228

Email: jhardy@ispe.org

About the ISPE Facility of the Year Awards Program

Established in 2005, The Facility of the Year Awards (FOYA) recognize state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation, while sharing the development of new applications of technology and cutting-edge approaches. Visit ISPE.org/FOYA for more information.

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ARLINGTON, Va. (PRWEB)
May 09, 2023

Timed with the formal end of the COVID-19 public health emergency on Thursday, a National Association of Chain Drug Stores (NACDS) television and digital ad is punctuating the occasion with a “thank you” to pharmacists and pharmacy teams.

The ad states:

“It’s a normal day again in America. We’ve all been through a lot the past few years. But when things have seemed most uncertain there has been one constant, one trusted force for hope: America’s pharmacists. Dedicated, relentless, with more than 300 million COVID shots given in local pharmacies. With a commitment to a healthy America that is unbreakable – that opened the nation and our lives. It’s a normal day again. Thank you.”

The TV ad will begin to appear on Thursday in the Washington, D.C. market, and will extend to selected states. NACDS began to distribute the ad digitally today.

In releasing the ad, NACDS President and Chief Executive Officer Steven C. Anderson said, “We want pharmacists and pharmacy teams to know that their dedication, professionalism, knowledge, trust, accessibility, and sacrifice remain deeply appreciated and top-of-mind. They helped to save and reopen America, in ways that include the more than 302 million COVID-19 vaccinations provided in pharmacies – including more than two-thirds of all adult COVID-19 vaccinations given during the 2022-2023 season. Pharmacists and pharmacy teams also helped to address individuals’ needs within their communities, as the healthcare professionals who kept their doors open at a time of extreme concern and uncertainty.

“Just as NACDS advised the federal and state governments of policies needed to make possible pharmacy’s pandemic response, we will continue to convey clearly the policies necessary for the pharmacy access that patients need and expect. In just a few examples, states need to make permanent the pharmacy access made possible by the federal PREP Act (Public Readiness and Emergency Preparedness Act). The U.S. Congress needs to enact the Equitable Community Access to Pharmacist Services Act (H.R. 1770) to ensure Medicare beneficiaries have access to pharmacist services approved by the states. The federal and state governments need to do their part to bring about comprehensive pharmacy benefit manager (PBM) reform to take on the practices of pharmaceutical middlemen.”

Over a one-week stretch in April, NACDS lauded two major victories for patient access. The Biden Administration announced it would extend through December 2024 many of the PREP Act pharmacy-access provisions and also announced action on COVID-19 vaccine access for uninsured individuals. NACDS had advocated consistently for these initiatives over the course of approximately two years.

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AMARILLO, Texas (PRWEB)
May 09, 2023

Bristol Park at Amarillo Assisted Living & Memory Care, a Sagora Senior Living community, is hosting a Route 66-themed, Texas-sized party to celebrate the grand reopening of its Memory Care program. Called Back on the Map, the event will be held on Tuesday, May 16 and is open to all members of the public.

The community had been closed for renovations since last summer.

“We are so excited for people to see what we have done with Memory Care,” Sagora Senior Living Vice President of Corporate Operations Christal Hoffman said. “These renovations ensure that the community continues to provide exceptional care to residents and their family members in line with Sagora’s Resident First philosophy.”

The celebration will feature a ribbon cutting by the Amarillo Chamber of Commerce in addition to refreshments, music and tours of the community.

The event’s theme was chosen to honor Amarillo’s history and heritage as a key city along Route 66, America’s mother road. It also highlights one of the features that is at the center of the Bristol Park at Amarillo experience: a community common area that is modeled to look like a small-town main street. This unique space is in a central location, designed to feature some of the key components of a small-town setting.

“Main Street is a unique, purpose-driven experience that enhances resident comfort while serving as a gathering space for our residents,” Hoffman said. “It is designed to be familiar and reinforce a sense of belonging. In a lot of ways, it’s similar to Route 66’s role in the Amarillo area.”

The event will take place from 4-6 p.m.

ABOUT BRISTOL PARK AT AMARILLO

Bristol Park at Amarillo utilizes the latest in Memory Care research to provide purposeful, stimulating programming for those with Alzheimer’s disease and dementia. The Memory Care program is designed around Sagora’s Pathways Program, which incorporates sights, sounds, smells and familiar tasks in order to build a comfortable, home-like atmosphere.

In addition to Memory Care, Bristol Park at Amarillo features an Assisted Living program that is designed to support residents as they go about their daily life. Care plans are individualized, meaning that each resident receives the support that they need in order to match their specific needs.

ABOUT SAGORA SENIOR LIVING

Sagora Senior Living is among the nation’s top 50 senior housing providers and is guided by a Resident First philosophy. The company operates more than 60 communities in 12 states, with Cottages, Independent Living, Assisted Living and Memory Care living options. For additional information, please visit Sagora.com.

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ARLINGTON, Va. (PRWEB)
May 09, 2023

Three years and more than seven million casualties later, the COVID-19 pandemic is officially no longer a global health emergency, according to a recent statement by the World Health Organization (WHO). Dr. Tedros Adhanom Ghebreyesus, director general of WHO, announced COVID-19’s endemic designation in early May, though the decision had been carefully considered for quite some time prior to becoming official.

The endemic designation also marks the end of the coordinated global action that was necessary to protect the world’s population from the new and nefarious virus. It is now up to individual countries to determine how to effectively manage COVID in a way that each deems best.

The end of COVID as public health emergency of international concern came with a warning from Dr. Ghebreyesus in an official statement, that “the worst thing any country can do now is to use this news as a reason to let down its guard, to dismantle the systems it has built, or to send the message to its people that COVID-19 is nothing to worry about.”

Dr. Ghebreyesus’s sentiment echoes what was previously announced by leading medical market research firm Kalorama Information in its recent report COVID-19 Testing Markets, 2023, which answers what will happen to the ever-changing COVID-19 in vitro diagnostic (IVD) testing market as the pandemic recedes and becomes endemic. Most notably, Kalorama emphasized that the COVID-19 virus has proven to be very persistent and capable of mutating—producing a substantial number of variants. This is not expected to change, creating an ongoing need for COVID-19 testing.

“COVID-19 testing has been at the forefront in battling the pandemic. And even with its endemic status, the virus is here to stay even as it becomes less of a global health emergency. As a result, we expect nations worldwide to remain vigilant about managing COVID-19 along with other respiratory viruses and diseases. This includes maintaining and strengthening commitments to IVD tests targeting COVID-19 specifically,” says Bruce Carlson, vice-president and publisher of Kalorama Information.

Diagnostics have been critical in the response to COVID-19. At the height of the pandemic it became very apparent that rapid and accurate tests were absolutely critical for identifying and managing infected individuals.

During 2020 and 2021, revenues from COVID-19 testing were substantial compared to all other diagnostic testing assays and instruments. In 2020, COVID-19 diagnostic testing accounted for 20% of the total diagnostic testing market. The COVID-19 diagnostic testing climbed to more than a quarter of the total IVD diagnostic testing market in 2021. As the pandemic slowed, the COVID-19 diagnostic testing segment dropped to less than a quarter of the total IVD diagnostic testing market in 2022.

Kalorama Information estimates that the global COVID-19 IVD market reached $29.6 billion in 2022, consisting of immunoassay and molecular testing. Immunoassay COVID-19 testing accounted for more than half the market’s total and will continue to claim the lion’s share through the foreseeable future. Meanwhile, rapid testing for COVID-19 had estimated sales of more than $10 billion in 2022.

Looking ahead, sales in the global COVID-19 testing market will invariably decrease due to the shift to endemic status, a reduction in demand for COVID-19 testing, and the availability of cheaper immunoassay testing.

For more information or to purchase the market research report “COVID-19 Testing Markets, 2023,” visit: https://kaloramainformation.com/product/covid-19-testing-market-update-2023/.

ABOUT KALORAMA INFORMATION

Kalorama Information, part of Science and Medicine Group, is the leading publisher of market research in healthcare areas, including in vitro diagnostics (IVD), biotechnology, medical devices, and pharmaceuticals. Science and Medicine Group supports companies seeking to commercialize the rapidly changing marketplace at the intersection of science, medicine, and technology. Comprised of industry-leading brands, Science and Medicine Group serves analytical instrument, life science, imaging, and clinical diagnostic companies by helping them create strategies and products to win markets and provide platforms to digitally engage their markets through a variety of innovative solutions. Kalorama Information produces 30 reports a year. The firm offers a Knowledge Center, which provides access to all published reports.

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