Category Archives: Health

What is new in the field of Health. Trending topics, and cutting edge research in the are of Health. Press Releases that give us updates on Health.

Pittsburgh, PA Organization, Women Against Abusive Relationships, Launches Project for Males and Transgender Victims of Abuse


Roxanne Epperson

Founder, Women Against Abusive Relationships.

This year we are expanding our services to men and the transgender community through the ASK Project ((After Shelter Kare). ASK will provide services and resources that will hopefully prevent victims from returning to an abusive situation once they leave..

Roxanne Elizabeth Epperson, founder of Women Against Abusive Relationships (WAAR), knows the patterns of abuse which started when she was a child.

At age 7, a babysitter forced Roxanne to suckle her breast.

At age 13, she was raped three times by her 19-year-old boyfriend, a heroin user.

At age 16, an older family friend raped her.

At age 18, a jitney driver drove her to the dark woods, parked, and forced her to fondle him.

It’s not surprising that Roxanne, like many other victims of abuse, didn’t feel good about herself. “I hated my body and nose for various reasons stemming from negative external messengers. My mother told me my nose was too broad. An ex-boyfriend told me I shouldn’t wear my hair short because my nose was too big. I felt he confirmed what my mother had said.” Roxanne continues: “I thought I was in love, yet it was not love because he hurt me, and love should not hurt. One night he spat in my face, dragged me down the hallway, punched, and strangled me. I began a new life by almost losing my life,” Roxanne concludes.

Roxanne’s new life began by saying no more to abuse and changing the lives of victims with similar stories when she launched WAAR in 1999. The organization helps women and girls to heal from abuse by taking a journey inward, discovering their authentic selves, and loving themselves. “We create products and services that encourage self-love and have support groups, a podcast, and a guide that help our clients to know how to leave unhealthy relationships. We are in schools, churches, community centers, and other safe locations. In 2001 we started offering workshops and conferences for women, teens, and service providers throughout Allegheny County. In 2004, we launched a partnership with UPMC Magee-Women’s Hospital where our Healing Space initiative was born,” Roxanne says. “This year we are expanding our services to men and the transgender community through the ASK Project ((After Shelter Kare).” This latest initiative is Roxanne’s response to learning more about others affected by domestic violence. ASK will provide services and resources that will hopefully prevent victims from returning to an abusive situation once they leave the shelter.

“If you love yourself, you minimize your chances of being in an unhealthy relationship,” Roxanne offers. She also reflects on domestic violence and how it, as a public health crisis, leads women to depression and suicidal thoughts. In addition, only 34% of people injured by partners receive medical care. In recognition of her work, last year Roxanne received a Survivor of the Year Award presented by Theresa’s Fund. The fund is an Arizona-based 501(c)(3) nonprofit charity that focuses on changing the landscape of domestic violence services. Though grateful for the recognition, Roxanne feels everyone in the domestic violence movement is a hero. “I am thankful for the honor, yet much work remains. I am on a personal and professional mission to help one million women and girls to heal after experiencing domestic or sexual violence trauma. I pray for the day that women and girls are no longer beaten, raped, and disrespected. As we begin serving men and transgender populations through ASK, we will advocate as strongly for them as well,” Roxanne concludes.

To learn more about WAAR, visit their website at https://waarheals.org/. You can also contact Roxanne at info@waarheals.org or 412-723-2320.

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Cherished Houston Health Museum Appoints Dr. James Flowers to its Board of Directors


James Flowers, PhD, CSAT, LPC-S

“I am humbled to bring more attention to mental health through interactive exhibits and meaningful discussion and assist in furthering the Houston Health Museum’s purpose of empowering healthier living.”

Houston’s cherished Smithsonian-affiliated Museum, The John P. McGovern Museum of Health, and Medical Science, has appointed Dr. James Flowers to its Board of Directors.

Dr. James Flowers, Ph.D., CSAT, LPC-S, is a mental health veteran with over 25 years of industry experience. As founder of the prestigious J. Flowers Health Institute, he helps lead the charge in providing concierge diagnostics and treatment services to individuals and families struggling with complex mental health and medical issues with institutions in Houston and the United Kingdom.

As a Board member of The John P. McGovern Museum of Health and Medical Science, Dr. Flowers says not only does the museum’s mission statement reflect his core passion in his life, but he’s also eager to uphold the museum’s mission of fostering wonder and curiosity about health, medical science, and the human body.

“I am humbled to bring more attention to mental health through interactive exhibits and meaningful discussion and assist in furthering the Houston Health Museum’s purpose of empowering healthier living,” said Flowers.

With a steady flow of visitors, the Health Museum works to become an even greater vehicle for families to understand their bodies, take proactive measures to be healthy, live longer and begin to counteract the rapidly rising costs of managing health.

The Houston Health Museum has served over 2.5 million visitors and continues to grow with the help of its board of directors.

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How can the Industry do Better? Upcoming Webinar Hosted by Xtalks


Making research accessible to underrepresented populations is only part of the solution.

The industry has faced the lack of clinical trial diversity head-on by working to improve access to clinical trials. However, making research accessible to underrepresented populations is only part of the solution. The webinar’s core will be a discussion on how to reach and gain trust with underrepresented patients.

Improving inclusion in clinical research can be done with the use of practices uncovered by industry-leading experts. Expanding research within community-based sites where patients receive healthcare is a prominent way to provide access to underrepresented populations. Integrating into community healthcare practices and bringing new-to-research patients into clinical trials requires building trust with patients, supporting the practice/physicians with infrastructure to do research work and creating confidence in the community. The speakers will also look at how decentralized/hybrid trials ease the burden of participation for underrepresented populations while delving into how technology must meet those patients’ needs and what is required to trust that patients will use the technology.

Register to delve into the clinical trial diversity puzzle and find out how the industry can do better.

Join Ryan Brown, Vice President Diversity Solutions, Circuit Clinical; Dr. Irfan Khan, MD, CEO, Circuit Clinical; Elizabeth George, Senior Director, Diversity & Inclusion, Site and Patient Engagement, Labcorp; Brenda Medina, Vice President, Technology Delivery & Offshore Operations, Medidata Solutions; Dr. Guarang Brahmbhatt, MD, Chief Medical Officer, Riverside Medical Group; and Dr. Dany Dominguez Perez, Senior Director, Solutions, NextGen Community Health Collaborative, for the live webinar on Thursday, January 26, 2023, at 1pm EST (10am PST).

For more information, or to register for this event, visit The Clinical Trial Diversity Puzzle: How can the Industry do Better?

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com

For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

Contact:

Vera Kovacevic

Tel: +1 (416) 977-6555 x371

Email: vkovacevic@xtalks.com

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Henry Community Health Adopts MOLLI Surgical Technology to Improve the Patient Experience


News Image

Henry Community Health recently became the first hospital in Indiana to adopt MOLLI®, an award-winning wire-free and radiation-free technology that improves the experience of patients going through breast cancer surgery.

Recently, MOLLI was named to Fast Company’s list of the “Next Big Things in Tech,” and recognized by TIME as one of the “Best Inventions” in medical care. The device makes it easier for radiologists to mark a lesion and for surgeons to quickly locate the marked lesion, precisely remove it and achieve better results for their patients.

“For patients needing breast cancer surgery, marking the lesion has traditionally been an agonizing experience — requiring them to get up early the morning of surgery to have a long wire inserted into their body to mark the location. With MOLLI, we can implant the tiny marker at their convenience — up to 30 days before surgery,” explained Todd Wright, MD, a radiologist at Henry Community Health. “We’re thrilled to be able to make the patient’s experience simpler and less traumatic.”

The MOLLI technology is precise, reliable, and easy to use. It features the MOLLI Marker® — about the size of a sesame seed — which is detected using the MOLLI Wand®. The MOLLI Tablet® then displays the distance between the tip of the MOLLI Wand and the MOLLI Marker in millimeters, helping surgeons locate lesions quickly and accurately.

“Not only our patients but also our clinicians can benefit from this new technology,” said Sara Kovacic, DO, FACOS, Henry Community Health Surgical Specialists. “I no longer have to worry about a wire marker moving during surgery or becoming dislodged, causing the localization to be inaccurate. MOLLI makes it significantly easier to locate the lesion and more precisely remove it.”

“We are honored to be of service to the team at Henry Community Health,” said Ananth Ravi, Ph.D., President and CEO of MOLLI Surgical. “A patient’s experience of care is just as important as the treatment itself. We are encouraged to see our device in the hands of the talented team at Henry Community Health as they continue to deliver excellent care close to home for people living with breast cancer.”

About Henry Community Health

Henry Community Health is a nonprofit community health system that combines nationally recognized expertise with a true commitment to personal connection with our patients. We’re proud to have served our neighbors with excellent healthcare in a compassionate, supportive environment for over 90 years. With state-of-the-art equipment and facilities, we use the latest technologies and techniques to provide excellent care to each patient. At Henry Community Health, we make time to listen to your concerns, provide a thoughtful diagnosis and develop a customized plan for your care. Our healthcare model focuses on community, seeking to reduce chronic health problems and promote wellness throughout eastern Indiana.

Henry Community Health has been recognized by the Center for Medicare and Medicaid Services (CMS) as a 5-Star Facility. Visit us at hchcares.org.

About MOLLI Surgical

MOLLI Surgical started in the operating room, where surgeons were using dated tools to treat cancer patients — and we knew we could do better. Our surgical wand is precise, reliable, easy to use, and built with the realities of the operating room in mind. More importantly, it is built with patients in mind. Our technology replaces procedures to mark lesions with one that is more precise, efficient, and cost-effective.

MOLLI® has been recognized by TIME as one of 2022’s “Best Inventions” in the Medical Care category. The company has been named to Fast Company’s list of the “Next Big Things in Tech,” recognizing tech breakthroughs across industries that promise to transform the future. We are proud to build the advanced equipment that patients prefer to have and that physicians prefer to use. Follow us on Facebook, LinkedIn, Twitter, and YouTube.

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From Knowledge Curation to Clinical Trial Simulation, Upcoming Webinar Hosted by Xtalks


When embarking on a new R&D program, scientists face a strategic imperative to assemble the best and most relevant available data and insights.

These past few years have marked the acceleration of the adoption of in silico techniques for more efficient and innovative clinical research. When embarking on a new R&D program, scientists face a strategic imperative to assemble the best and most relevant available data and insights.

Jinkō, Novadiscovery’s in silico clinical trial simulation platform, has been designed to build and maintain a high-quality knowledge repository, allowing teams to seamlessly cooperate, both internally and with external thought leaders.

During the first part of this webinar, featured speaker Dr. Friehs, will explain her role and how she uses jinkō with her fellows to extract, classify and qualify pieces of knowledge in a systematic, transparent and traceable manner, and use these in research reports and literature reviews. After that, featured speaker Frédéric (CPO of Novadiscovery) will showcase how this knowledge is then leveraged directly within jinkō to help lower cost and ethical constraints as well as achieve greater trial efficiency through the design and simulation of in silico trials. This will be illustrated with two practical use cases using Nova’s non-small cell lung cancer (NSCLC) disease model of epidermal growth factor receptor (EGFR) mutated lung adenocarcinoma (LUAD). First, by exploring a large range of doses and then by testing eligibility criteria refinement and its impact on treatment effectiveness.

Join this webinar to learn more about using a clinical trial simulation platform to generate auditable and reproducible digital evidence.

Join Frédéric Cogny, CPO, Novadiscovery; and Dr. Ingeborg Friehs, Boston Children’s Hospital & Harvard Medical School, for the live webinar on Monday, January 30, 2023, at 11am EST (4pm GMT/UK).

For more information, or to register for this event, visit In Silico: From Knowledge Curation to Clinical Trial Simulation.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com

For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

Contact:

Vera Kovacevic

Tel: +1 (416) 977-6555 x371

Email: vkovacevic@xtalks.com

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Sunbit surpasses 100,000 service professionals certified to offer its point-of-sale lending technology


Sunbit announced that more than 100,000 in-store service professionals (Sunbeasts) have been certified to offer Sunbit’s POS lending technology to millions of customers at more than 17,000 locations.

Service professionals are essentially the day-to-day face of our company, and giving them the support and recognition they deserve is of paramount importance to us. We’re proud that the Sunbeast program has made a difference in so many lives.

Sunbit, the company building financial technology for everyday expenses, announced today that more than 100,000 in-store service professionals have been certified to offer Sunbit’s point-of-sale lending technology to millions of customers. Sunbit’s “Sunbeast” enablement program was built for Sunbit-certified in-store service professionals (Sunbeasts). The appreciation program recognizes the people offering Sunbit in the field. In all, Sunbeasts have helped more than a million people get the services or care they need, realizing over a billion dollars in incremental revenue for their businesses.

“Getting a new set of tires or replacing a filling isn’t a desirable or planned purchase, but is a part of navigating our everyday lives — and these types of purchases usually require a conversation or a consultation along with human touch. In today’s environment, relationships still matter, especially when it comes to the essential purchases we need in order to live our daily lives,” said Idan Tzror, Chief Retail Officer, Sunbit. He added, “That is why we invest so heavily in the front line associates of our merchant partners via the Sunbeast program. Service professionals are essentially the day-to-day face of our company, and giving them the support and recognition they deserve is of paramount importance to us. We’re proud that the Sunbeast program has made a difference in so many lives.”

The Sunbeast credentialing process is conducted in-person at a merchant location or through Sunbit’s online learning management system (LMS). Because Sunbit is introduced to consumers through a service professional, the company gives extra care and attention to its certification process, including an intensive legal section which has a strict 100% passing criteria, ensuring that consumers fully understand the lending product options available to them.

“I’ve seen a lot of technology and financing tools come and go,” said Cynthia Garcia, Treatment Coordinator at Apple Dental – Apple Dash. “But many don’t last, because smart service associates won’t risk their customer relationships to offer something they don’t believe in. Sunbit is different. It works for nearly everyone who walks through our doors, regardless of circumstances. It’s fair, fast and fee-free. And many of my Sunbit customers come back again. The Sunbeast program helps me make the most out of every customer interaction.”

Once certified, Sunbeasts can access continuing education and engagement programs through an online knowledge center, ongoing training events, competitions, award ceremonies, and a gamified rewards system, all supported through a robust mobile app. The gamified Sunbeast app enables associates to benchmark their performance against their peers, learn, compete, and perform missions, all while earning rewards for participation.

Additional rewards can be unlocked through attending workshops, answering surveys, providing feedback, watching training videos, and more.

“I’ve never experienced anything like Sunbit’s Sunbeast program,” said Danny Ventura, Service Advisor for Toyota of San Bernardino. “Most vendors just give us a couple of pamphlets and expect us to offer their product to our customers. With Sunbit I’m confident that I’m helping customers (or patients) to get what they need, when and how they need it. And, competing for rewards against my colleagues is just a bonus!”

For more information on the Sunbeast program go to http://www.sunbeast.com.

About Sunbit

Sunbit builds financial technology for real life. Our technology eases the stress of paying for life’s expenses by giving people more options on how and when they pay. Sunbit offers a next-generation, no-fee credit card that can be managed through a powerful mobile app, as well as a point-of-sale payment option available at more than 17,000 service locations, including auto dealership service centers, optical practices, dentist offices, veterinary clinics, and specialty healthcare services. Sunbit was included on the 2022 Inc. 5000 list. The financial technology company has also been named as a Most Loved Workplace®, Best Point of Sale Company, A N.A. Deloitte Technology Fast 500 company and as a Top Fintech Startup by CB Insights. Loans are made by Transportation Alliance Bank, Inc., dba TAB Bank, which determines qualifications for and terms of credit. The Sunbit Card is issued by TAB Bank, pursuant to a license from Visa U.S.A. Inc. Use of the card is subject to the cardholder agreement.

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FAScinate Therapeutics Completes Part 1a of Phase 2 Study of Company’s Parkinson’s Disease Drug Candidate “KM-819”


FAScinate Therapeutics, Inc.

FAScinate Therapeutics, Inc.

We are pleased with the prospects of KM-819 as a disease-modifying treatment for Parkinson’s disease as we progress through Phase 2 trials. Part 1a showed favorable safety even at very high doses, and we are excited to now initiate Part 1b. KM-819 shows great promise.

Clinical stage drug development company FAScinate Therapeutics, Inc. today announced the successful completion of Part 1a, the initial stage of Phase 2 studies, for the Company’s Parkinson’s Disease drug candidate “KM-819,” with the results showing a favorable safety profile. Part 1a involves a dose-escalation approach with KM-819 in healthy elderly subjects, designed to assess the pharmacokinetics and safety of the drug candidate at several different doses beyond the dose tested in Phase 1 trials.

The subsequent stage, Part 1b, will be a dose-finding study of KM-819 in Parkinson’s Disease patients where the pharmacokinetics and safety profile will be evaluated at three doses, including a high dose tested in healthy test subjects. The results will then be used to select the doses used for the main Part 2 study, a 24-month trial of the selected doses evaluating both the safety and efficacy endpoints of KM-819 on the progression of Parkinson’s Disease.

KM-819 is a potent inhibitor of FAF1, a key regulatory protein in cell death pathways, apoptosis and necrosis, and leads to neuronal cell protection in pre-clinical studies. Furthermore, high levels of FAF1 lead to the suppression of autophagy, resulting in the accumulation of alpha-synuclein, which often appears in Parkinson’s patients as Lewy bodies in dopaminergic neuron cells in the midbrain. Thus, FAF1 may be a significant target when it comes to the development of disease-modifying treatments for Parkinson’s Disease. In various preclinical cell and animal studies, KM-819 demonstrated protective properties for dopaminergic cells and the inhibition of alpha-synuclein accumulation in such cells.

The Phase 2 trial of KM-819 in Parkinson’s disease was approved by the FDA in November of 2021, and Part 1a was initiated in July of 2022. Parkinson’s Disease is a neurodegenerative disease and the second most common central nervous system (CNS) disease following Alzheimer’s Disease, affecting more than a million people in the US. It disrupts normal movement and also causes numerous non-movement symptoms. It is known to be caused by the premature death of dopaminergic neuron cells in the midbrain. Currently, there are many drugs that address the symptoms of the disease, but effective disease-modifying therapies for stopping or slowing down the progression of Parkinson’s Disease in patients are nonexistent. KM-819 is designed to address this pressing need.

FAScinate Therapeutics said, “We are pleased with the prospects of KM-819 as a disease-modifying treatment for Parkinson’s disease as we progress through Phase 2 trials. Part 1a showed favorable safety even at very high doses, and we are excited to now initiate Part 1b. KM-819 shows great promise when it comes to the neuroprotection of dopaminergic cells, including GBA mutation, as well as in clearing alpha-synuclein.”

About KM-819

KM-819 is a small molecule developed as an inhibitor for FAF1, a proapoptotic protein, targeting various degenerative diseases. It has shown superior neuroprotective efficacy in Parkinson’s Disease models, and clinical trials are underway with the aim of proving its efficacy in human patients. KM-819 may be also explored as a potential treatment for other degenerative diseases, including multiple system atrophy (MSA). It shows an excellent safety profile in both long-term animal toxicology studies and the human clinical trial Phase 1 study that has been completed.

About Parkinson’s Disease

Parkinson’s Disease is the second most common chronic CNS disease after Alzheimer’s Disease, estimated to afflict 6 to 10 million patients worldwide and 1 million in the United States. It is more common in elderly people, with 2-3% of those aged 65 and over now affected, and there are expectations of an increase in the number of patients as the population continues to age. The current standard of care is symptomatic treatments by supplementing dopamine or dopamine agonists or analogous mechanisms, so a disease modifying treatment is an urgent need in order to address the impact of Parkinson’s Disease.

About FAScinate Therapeutics Inc.

FAScinate Therapeutics Inc., a subsidiary of the Korean Biotech company Kainos Medicine Inc., is a clinical stage biotechnology company based in San Diego, California focused on the development of novel therapeutics for central nervous system diseases. FAScinate has licensed KM-819 for clinical development and commercialization from Kainos Medicine, and is developing it for phase 2 study in the US for Parkinson’s Disease. For more information, please visit http://www.fascinatetherapeutics.com

Forward-Looking Statements

This press release contains forward-looking statements. These statements relate to, among other things, the potential of KM-819 as a disease-modifying therapeutic stopping or slowing the progression of Parkinson’s disease. These statements are identified by their use of terms and phrases such as “will,” “potentially,” “suggest,” “targeting,” “expect,” “aiming,” “prove,” “estimated,” and other similar terms and phrases. These statements are based on estimates, assumptions, and projections that may not be proven to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties, and other factors. FAScinate Therapeutics undertakes no obligations to update publicly any forward-looking statements contained in this press release as a result of new information, future events or changes in FAScinate Therapeutics’s expectations.

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Protect Environmental Launches National Radon Risk Search Tool


Protect Environmental Launches National Radon Risk Search Tool
https://www.protectenvironmental.com/radon-search-results/?zipcode=40202&avgradon=5.3

Learn more about the radon risk in your community.

During National Radon Action Month, Protect Environmental launches a National Radon Risk Search™ tool to help communities understand the risk created by exposure to radioactive radon gas and prevent radon-induced lung cancer.

In conjunction with the launch of its next generation online presence, Protect Environmental announced today the launch of its National Radon Risk Search™ tool. The interactive search tool pulls from the company’s comprehensive database of radon test results, which represents more than 2.5 million results compiled from sources such as the Centers for Disease Control and Prevention (CDC), as well as Protect Environmental’s own internal testing data, to provide the following radon risk information for communities across the United States: (1) highest radon level recorded in a building tested within the community; (2) average radon level of buildings tested within the community; (3) percentage of buildings tested within a community with a radon level above the Environmental Protection Agency’s (EPA) action level of 4.0 pCi/L; and, (4) percentage of residential buildings characterized for radon risk within the community. The interactive search tool is designed to empower communities with vital information to understand the impact of radon in the places where community members live, work, and learn.

Radon is a naturally occurring colorless, odorless, tasteless, radioactive gas that derives from the breakdown of Uranium. According to the EPA, exposure to the gas is responsible for the deaths of more than 21,000 persons in the United States each year, making it the leading cause of lung cancer among non-smokers, second overall to smoking for all lung cancer incidents. Radon migrates into buildings through preferential pathways, such as gaps, cracks, and crevices in the building foundation, where it can accumulate in unsafe levels. The only way to know if the occupants of a building are at risk is to test the building. If a problem exists, occupant exposure can be mitigated using effective, efficient, and economical construction methods.

“Knowing and understanding the risk created by exposure to radon, a radioactive, cancer-causing gas that often accumulates in unsafe levels in the places where we live, work, and learn, is essential to preventing radon-induced lung cancer,” says Kyle Hoylman, CEO of Protect Environmental. “Our interactive search tool makes understanding this risk much easier, which we hope will lead to more communities taking action to prevent this deadly disease.”

About Protect Environmental

Protect Environmental is a national leader in the environmental consulting and construction industry, focusing on radon and chemical vapor intrusion management. With a proven track record spanning 18 years and more than 200,000 completed projects in all 50 U.S. states and 2 U.S. territories, the company delivers expert service from its trusted professionals to provide peace of mind protection to property owners seeking to build and maintain healthy, safe, and sustainable indoor environments. For more information, call 502-410-5000 or click on https://www.protectenvironmental.com.

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CS Analytical CSO Brandon Zurawlow Recognized by PDA for Contributions to TR-86 Package Integrity Testing


PDA for Contributions to TR-86 Package Integrity Testing

Brandon brings a logical and scientific outlook, along with passion and dedication, to helping clients and the marketplace as a whole interpret and meet strict and everchanging regulatory requirements for package integrity testing.

CS Analytical Laboratory, the world’s only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services for drug product and medical device container systems, is excited to announce that Chief Scientific Officer Brandon Zurawlow has been formally recognized by the Parenteral Drug Association (PDA) for his contributions to Technical Report No. 86, Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing. PDA Technical Report No. 86 offers guidance on container closure integrity testing, expanding on and offering additional insights to the now well-established USP 1207.

“As an organization, the entire CS Analytical Team is proud of the work that Brandon has performed and we, like all of industry, appreciate the contributions he has made in helping to improve and advance the integrity and overall qualification testing requirements of medical product package systems,” commented CS Analytical CEO Brian Mulhall, “He brings a logical and scientific outlook, along with passion and dedication, to helping clients and the marketplace as a whole interpret and meet strict and everchanging regulatory requirements for package integrity testing. We see it daily and it is nice to see an organization like the PDA recognize his contributions. Patient safety is improved because of people like Brandon.”

As outlined by the PDA “this technical report is a consensus-based resource surrounding the challenges encountered in using complex package systems and introduces important elements to consider in decision-making. It also offers an examination of the technologies available for package integrity testing not yet established by peer-reviewed research. This technical report focuses on the challenges facing the pharmaceutical industry that use complex packaging systems for sterile drugs and biologics (e.g., syringes, syringe assemblies, bulk containers). It also presents information on some innovative methods for package integrity testing using existing technologies, including the potential impact of cryogenic conditions. The intent is to update information and incorporate experiential learning which is not addressed in PDA Technical Report 27 and USP 1207. It also serves as a technical resource, focusing particularly on sterile products and encouraging a risk-based approach and leveraging testing to better understand, analyze, and eliminate the risks during developmental phases. Use of the appropriate testing during each manufacturing phase can help in evaluating and mitigating residual risks.”

To further review or purchase this report, please use this link: https://www.pda.org/bookstore/product-detail/6132-tr-86-pharmaceutical-package

About CS Analytical Laboratory

The only FDA regulated, cGMP laboratory dedicated exclusively to the complex world of drug and medical device container and package qualification testing, the CS Analytical Team includes the world’s leading experts on all relevant USP and EP requirements and the thought leaders and pioneers on CCI (container closure integrity – CCI) testing. Offering a full suite of laboratory services to include all USP, EP and JP procedures specific to glass, plastic and elastomers as well as complete USP 1207 services that span basic feasibility studies, component qualification programs and advanced method development and validation for helium leak testing, vacuum decay, high voltage and headspace analysis leak testing. CS Analytical is the one source that can ensure your medical product container and package system meets the strict and complex regulatory requirements.

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