Building in Solutions for Anticipated Challenges in CAR T Development Programs, Upcoming Webinar Hosted by Xtalks


These therapies require specialized sites, recruitment strategies and clinical development partners experienced in delivery of these complex programs.

CAR T-cell therapies are fundamentally changing the landscape of cancer treatment. Successful commercialization of multiple CAR T treatments, plus continued advancements in the technologies, combine to make this a very active segment of drug development. Despite the excitement and hope they have brought to the patient and research communities, the sponsors developing these therapeutics are encountering challenges that have delayed and seriously threatened the advancement of their programs. These therapies require specialized sites, recruitment strategies and clinical development partners experienced in delivery of these complex programs.

In this webinar, attendees will hear from speakers partnering with the sponsors developing novel CAR T therapeutics. Their corporate and personnel experience in delivering these complex programs has armed them with the lessons learned to design current and future CAR T programs in anticipation of expected challenges. Register to hear these speakers address the most common challenges and questions they hear from their CAR T sponsors.

Register today for an informative overview of how to address the challenges arising in CAR T-cell development programs. Attendees are encouraged to bring their questions, notepad and colleagues to this webinar!

Join experts from Worldwide Clinical Trials, Missy Green, MBA, Associate Director, Project Management; Jake Boyd, Director, Project Management, Oncology; Amy Raymond, PhD, PMP, Senior Director, Therapeutic Strategy Lead, Rare Diseases; and Daniel A. Perez, CCRP, Global Head, Patient Experience, Diversity & Inclusion, for the live webinar on Wednesday, June 14, 2023, at 11am EDT (4pm BST/UK).

For more information, or to register for this event, visit Building in Solutions for Anticipated Challenges in CAR T Development Programs.

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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Drug Delivery — Addressing Global Regulatory Challenges in Co-Packaged, On-Body Systems, Upcoming Webinar Hosted by Xtalks


As the number of patients suffering from such disorders increase, so does the demand for more convenient and patient-friendly drug delivery systems.

Chronic clinical conditions are among the leading causes of death and disability globally. Typically, individuals are required to medicate on a daily, weekly and/or monthly basis. Now more than ever, patients want to make treatment a smaller part of their life. The development and commercialization of self-administrable medicinal products outside a clinic, hospital or healthcare provider environment, is an attractive alternative for healthcare expenditure and patients because of the flexibility and desire to reduce clinic visits. As the number of patients suffering from such disorders increase, so does the demand for more convenient and patient-friendly drug delivery systems.

Over the past five years, significant improvements have been made to address dose volumes and treatment options, such as monoclonal antibody-based therapies. These treatments often have viscous, highly concentrated drug formulations that require higher doses and delivery volumes that are typically outside the range of standard syringe capabilities. Novel drug delivery technologies are being introduced, specifically, large volume, on-body drug delivery systems. The novelty of these solutions has increased the complexity of regulations and particularly how to navigate the regulations from a global perspective.

Currently, the majority of large volume wearable injectors are primarily present in North America and Europe, within which the principal global regulatory frameworks are led by, or based on, the United States and European regulations. These large-volume on-body delivery systems are typically co-packaged with pre-filled drug cartridges i.e., co-packaged combination products.

However, the pathway to approval differs between the US and Europe which can lead to diverse, complex regulatory strategies when developing a product that must meet both regulatory frameworks.

Register to learn about on-body drug delivery systems and addressing their complex global regulatory requirements.

Join experts from West Pharmaceutical Services, Inc., Paul Scannell, Director Regulatory Affairs Combination Products, EU; and Adam Coblentz, Principal, Regulatory Affairs Intelligence, for the live webinar on Thursday, June 15, 2023, at 10am EDT (4pm CEST/EU-Central).

For more information, or to register for this event, visit Drug Delivery — Addressing Global Regulatory Challenges in Co-Packaged, On-Body Systems.

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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Developing and Validating Robust Cell-Based Assays for GMP QC Testing, Upcoming Webinar Hosted by Xtalks


The use of cell-based assays has the potential to revolutionize growing therapeutic areas, allowing for the development of more targeted and effective drugs.

Cell-based assays in developing cutting-edge therapeutics have become increasingly important in recent years. With advancements in technology and the US Food and Drug Administration (FDA)’s removal of animal testing requirements, cell-based assays for QC testing have become a crucial component in the drug development process to demonstrate efficacy and potency.

In this webinar, attendees will gain knowledge on the latest cell-based technology as well as some important aspects of GMP requirements for bioassays and how these cell-based assays have been used to support drug development efforts for treating complement-mediated diseases., including insights into the challenges and solutions.

The relevance of cell-based assays is that they are customizable and can be tailored to specific needs. They are also readily available and have a high-throughput capacity, making them ideal for large-scale drug screening. In addition, cell-based assays provide a more accurate representation of how a drug will interact with human receptors, reduce variability, and cost than animal testing.

The use of cell-based assays has the potential to revolutionize growing therapeutic areas, allowing for the development of more targeted and effective drugs. It can also aid better understanding of complex diseases’ mechanisms, such as autoimmune disorders and inflammatory diseases.

Register for this webinar to learn how the use of GMP compliant cell-based assay can lead to the development of more effective and targeted drugs

Join experts from Svar Life Science, Therese Segerstein, MSc, Portfolio Director; Jordi Rodó Morera, PhD, Global Innovation & Scientific Lead; Azra Alajbegovic, PhD, Scientist; and Camilla Melin Fürst, PhD, Senior Scientist and Project Manager, for the live webinar on Wednesday, June 14, 2023, at 11am EDT (4pm BST/UK).

For more information, or to register for this event, visit Developing and Validating Robust Cell-Based Assays for GMP QC Testing.

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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Bergeson & Campbell, P.C. Publishes Memorandum Outlining Key Supply Chain Considerations Regarding PFAS


PFAS – What to Know Now, and What to Expect

PFAS – What to Know Now, and What to Expect

Companies producing, processing, distributing, and/or using these substances must be aware of global legal and scientific developments and take steps now to minimize legal, regulatory, and commercial risk.

Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are attracting global legal, regulatory, commercial, and litigation attention as no other “emerging contaminant” has. Companies producing, processing, distributing, and/or using these substances must be aware of global legal and scientific developments and take steps now to minimize legal, regulatory, and commercial risk.

Bergeson & Campbell, P.C. (B&C®) and its global consulting affiliate The Acta Group (Acta®) have prepared this 20-page memorandum to assist stakeholders in preparing a PFAS gameplan. It offers a high-level outline of issues, focusing on the most significant bans and restrictions, the most impactful potential legal developments regarding PFAS, and the most important steps chemical product manufacturers should be taking now to identify, diminish, and supplant, as appropriate, PFAS in their supply chains.

We hope this information is helpful. We would be pleased to provide additional information and assist with PFAS-related scientific, regulatory, or legal questions that you may have. The full document can be downloaded at: https://www.lawbc.com/uploads/docs/PFAS_Summary.PDF

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Compliancy Group is the New Hampshire Psychological Association Endorsed Solution for HIPAA and OSHA


Compliancy Group

Healthcare Compliance Simplified

“Mental health professionals are extremely busy. This is why we aim to make compliance as quick and painless as possible. We are honored to have been selected to provide NHPA Members a streamlined way to meet their requirements” – Liam Degnan, Director of Strategic Initiatives, Compliancy Group.

Compliancy Group is the New Hampshire Psychological Association (NHPA) Endorsed Solution for HIPAA and OSHA.

As the endorsed solution for HIPAA and OSHA compliance, Compliancy Group will provide NHPA Members an automated compliance management and tracking software at a special members-only rate. Compliancy Group’s software, the Guard, eliminates the burden of compliance in a simple, fast, and affordable way.

“Mental health professionals are extremely busy. This is why we aim to make compliance as quick and painless as possible. We are honored to have been selected to provide NHPA Members a streamlined way to meet their requirements” – Liam Degnan, Director of Strategic Initiatives, Compliancy Group.

Managing and understanding compliance can take time, making proper compliance an arduous task for busy practices. Compliancy Group’s guided software walks you through implementing an effective compliance program.

Compliancy Group Resources

HIPAA and OSHA Explained

HIPAA Compliance Checklist

HIPAA Recipe Book

About Compliancy Group

Compliancy Group’s simplified software and Compliance Success Team, remove the complexities and stress of compliance, helping healthcare professionals achieve it with ease. They give practices confidence in their compliance plan, increasing patient loyalty, and profitability of their practice while reducing risk.

As an Endorsed Solution, psychologists can be confident in their compliance program.

About the New Hampshire Psychological Association

The New Hampshire Psychological Association has been the voice of psychology in the State of New Hampshire and a steadfast champion of the mental health community. Operating from a positive core – grounded in compassion, dedication to the field, and community-mindedness – NHPA’s mission is to advance psychology as a science, as a profession, and as a means of promoting human welfare.

Locally and nationally recognized for its achievements, NHPA is an active and thriving organization for professionals with degrees in psychology and affiliated mental health fields.

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A True Understanding Of God’s Love Would Transform Your Life


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God’s absolute love for us, shown through Christ’s sacrifice, is the most misunderstood love in our society, but it is the pursuit of experiencing God’s perfect love that makes life such a gift. In that truth, we find all the hope we will ever need

Author Otilyn Bonal seeks to show God’s children how immensely they are loved in Relentless Pursuit: A Heart After God ($15.49, paperback, 9781662871320; $23.99, hard cover, 9781662871337; $6.99, e-book, 9781662871344).

Bonal’s heart yearns to help others heal from traumatic pasts, and she understands how fundamental hope is to that process, and how many people are living without it. She wants her readers to fully grasp the extent of the Father’s unconditional love for them so they can be uplifted and empowered.

“God’s absolute love for us, shown through Christ’s sacrifice, is the most misunderstood love in our society, but it is the pursuit of experiencing God’s perfect love that makes life such a gift. In that truth, we find all the hope we will ever need,” said Bonal.

Otilyn Bonal is a spiritual and life coach born in West Africa Liberia who came to the United States in 2003. She is the founder of Shine Your Light Outreach Inc., an organization that looks after Liberian children and single mothers. Bonal resides in Pennsylvania with her husband and two sons.

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Xulon Press, a division of Salem Media Group, is the world’s largest Christian self-publisher, with more than 15,000 titles published to date. Relentless Pursuit is available online through xulonpress.com/bookstore, amazon.com, and barnesandnoble.com.

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Don’t Let The End Time Trees Blind You To The Majesty Of The Divine Forest


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Over years of study and teaching, I began to realize that the Bible did not seem to say what many claimed it said about end of the world, the return of Jesus, and eternal destiny. This prompted more intense study and organization of thought that resulted in writing the book

Author Marc Paladino shares the results of his eschatological research in The Threshold of Exile: Examining New Testament Prophecy and Eternal Destiny ($24.49, paperback, 9781662868351; $9.99, e-book, 9781662868368).

While many search for predictions in end-time prophecy, Paladino believes they are missing the mark. Throughout his personal study, he has found that Jesus and the apostles referenced Old Testament prophecies and presented them to a new audience in their day and that the cross cannot be overestimated in these discussions.

“Over years of study and teaching, I began to realize that the Bible did not seem to say what many claimed it said about end of the world, the return of Jesus, and eternal destiny. This prompted more intense study and organization of thought that resulted in writing the book,” said Paladino.

Marc Paladino has been serving the Lord in a variety of settings since the age of 20 as a Bible Teacher, Associate Pastor, Elder and Administrator, as well as a Coordinator for a Detroit-area alliance of inner city and suburban churches. Now retired from the field of manufacturing quality assurance, he resides in Michigan with his wife Judy and enjoys their three adult children and six grandchildren. Paladino is also the author of After the Walls Came Down (2011).

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Xulon Press, a division of Salem Media Group, is the world’s largest Christian self-publisher, with more than 15,000 titles published to date. The Threshold of Exile is available online through xulonpress.com/bookstore, amazon.com, and barnesandnoble.com.

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State of Hawai‘i Adopts Handtevy System to Improve Pediatric and Adult EMS Care


The State of Hawai‘i’s Emergency Medical Services (EMS) has partnered with Handtevy, a national leader in point-of-care emergency technology, to provide its award-winning mobile application and training program to all state-licensed EMS agencies. The Handtevy system will be accessible to all ground-based, 911-responding services in Hawai‘i, empowering EMS teams to consistently deliver the highest quality emergency care to both pediatric and adult patients.

The Handtevy system is a mobile application that provides access to accurate medication dosing, equipment sizing, protocol sets, and point-of-care checklists for EMS clinicians within seconds. The app is further enhanced by an award-winning metronome, a cutting-edge feature that expertly guides frontline personnel during critical CPR and defibrillation. In addition to this, it smoothly integrates with Hawai‘i’s EMS electronic health record platform, providing seamless, real-time documentation of interventions, thereby improving patient outcomes and operational efficiency.

During the week of May 8th, 2023, Handtevy’s nationally accredited educational course, widely adopted throughout the US, successfully certified over 40 instructors across the state, equipping EMS personnel with the latest knowledge, skills, and resources to confidently provide the highest quality care for all sick and injured patients.

“We are excited to bring this cutting-edge technology to front line EMS clinicians in Hawai‘i. EMS personnel will now have access to the latest lifesaving tools and techniques, ultimately leading to more lives saved,” said Dr. Alvin C. Bronstein, chief of EMSIPSB. “This unique initiative focuses on the special needs of sick and injured children and represents a significant milestone in the state’s delivery of pre-hospital pediatric emergency care.”

The Handtevy System is supported by the state’s Emergency Medical Services for Children program (EMSC) and funded by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under the EMSC State Partnership Grant. Federal funding for the Handtevy System was made possible through the dedicated efforts of the late Hawai‘i U.S. Senator Daniel K. Inouye, who championed the legislation that established the EMSC program.

“We are excited to work with Hawai’i’s EMS agencies and to support their efforts to improve emergency care for the 1.4 million residents of the state,” said Dr. Peter Antevy. “The combination of Handtevy’s mobile application and educational resources will provide Hawai’i’s EMS professionals with the tools they need to make a difference in the lives of those who reside on the islands, as well as the millions who visit each year.”

For more information on the Handtevy system, please visit http://www.handtevy.com or contact the Hawai’i State Department of Health’s Emergency Medical Services & Injury Prevention System Branch (EMSIPSB), which houses Hawai‘i’s EMS for Children (EMSC) Program.

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Catapult Healthcare Solutions awarded Health Care Staffing Services Certification from The Joint Commission


Catapult Healthcare Solutions, a national healthcare staffing and workforce management services company, has earned The Joint Commission’s Gold Seal of Approval® for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards. The Gold Seal is a symbol of quality that reflects a health care organization’s commitment to providing safe and quality patient care.

Healthcare staffing firms place temporary staff in organizations that direct or provide patient care. Healthcare Staffing Services Certification demonstrates Catapult Healthcare Solutions efforts to address how qualifications and competencies of staff are determined, placement of staff and how their performance is monitored.

Catapult Healthcare Solutions underwent a rigorous virtual review on May 12, 2023. During the accreditation process, a team of Joint Commission reviewers evaluated compliance with related Healthcare Staffing Services Certification standards spanning several areas including competency of healthcare staff, performance reviews, compliance, and emergency management. Joint Commission standards are developed in consultation with health care experts and providers, measurement experts and patients. The reviewers also conducted interviews with various leadership within the organization to understand the company’s history, vision, mission, and culture. During the process, we are pleased to share that Catapult Healthcare Solutions received no recommendations for improvement in its initial audit. The outcome of the evaluation underscores our efforts and unwavering dedication to upholding the nationally established benchmarks set by The Joint Commission, both presently and in the future.

“Health Care Staffing Services Certification recognizes health care staffing firms committed to fostering continuous improvement in patient safety and quality of care,” says Deborah Ryan, MS, RN, interim executive vice president, Accreditation and Certification Operations, The Joint Commission. “We commend Catapult Healthcare Solutions for using certification to strengthen its program structure and management framework, as well as to enhance its staff recruitment and development processes.”

“Catapult is extremely honored to have earned this certification from The Joint Commission and the principles it serves towards ongoing quality standards, patient safety and performance improvement”, said Joseph Turner, President of Catapult Healthcare Solutions. “This recognition signifies our organization’s commitment to providing the most qualified healthcare professionals and service to our client partners and healthcare organizations across the continuum of care.”

“Our organization and colleagues are proud to have received The Joint Commission’s Gold Seal of Approval recognizing our unwavering dedication to both meeting and exceeding the most rigorous standards in both health care and patient care,” said Patrick Burke, CEO of Catapult Solutions Group. “We are dedicated to providing a higher standard of service to all those we serve and the advancement of the clinical delivery model for the betterment of healthcare organizations.”

Catapult Healthcare Solutions is a subsidiary of Catapult Solutions Group, which was ranked #1 Fastest Growing Staffing Firms by Staffing Industry Analysts in 2022, in addition to Modern Healthcare’s Best Places to Work in 2022 and 2023, Dallas Morning News Top 100 Places To Work in 2022, and Best Companies to Work for in Texas by The Texas Association of Business in 2022. Catapult Healthcare Solutions offers both rewarding local and travel contract assignments and workforce solutions throughout the country for registered nurses, allied health and non-clinical healthcare professionals. Their approach is centered as a progressive culture, people enabled healthcare staffing and technology company dedicated towards fostering direct personal relationships and positive clinical outcomes with an overarching ethos towards “A Hire Standard” in helping to Catapult Your Healthcare Direction.

For more information, please visit The Joint Commission website.

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Dr. Marta Pazos, Skincare Coach, Cosmetic Chemist, and Innovator, Launches Two-Week Skin Coaching Series


Dr. Marta Pazos, founder of Rejuvalift Beauty, creates a skincare coaching video series.

“I’ve helped thousands with skin ailments and developed cutting-edge skincare solutions. Now, I’m taking that knowledge straight to consumers via hands-on, high-quality videos created in a simple format where I teach all courses.” – Dr. Marta Pazos, Founder of Rejuvalift Beauty.

Dr. Marta Pazos, Skincare Coach, Cosmetic Chemist, and Innovator, Launches Two-Week Skin Coaching Series

The founder of Rejuvalift Beauty has helped thousands with skin ailments and has worked for the biggest cosmetic brands developing cutting-edge skincare solutions.

Dr. Marta Pazos, the founder of Rejuvalift Beauty, announces the launch of her 15-Step Skincare Rejuvenation Program, a skincare coaching series of educational videos discussing skin ailments and treatments based on her two decades in the industry. The program helps consumers become their own best solutions for treating their skin. The cosmetic brand is the first to offer a coaching program that complements its product line. The Dr. Marta Skincare Coaching series is now included for free with any Rejuvalift product purchase.

A skincare coach, cosmetic chemist and innovator, Dr. Marta gives participants an insider’s look at achieving healthier skin and uncovers tips on pro-aging techniques. She has created this one-of-a-kind curriculum to coach attendees on achieving their skincare goals in less than five minutes daily. Emmy-winning and longtime TV anchor John Biffar of PeaceVision™ studio, produced the curriculum.

“My dual experience as a researcher and product developer gives me a unique perspective on skin’s needs, with a focus on Global methods, originating in the Far East” said Dr. Marta. “I’ve helped thousands with skin ailments, worked for some of the biggest cosmetic brands globally, and developed cutting-edge skincare solutions. Now, I’m taking that knowledge straight to consumers via hands-on, high-quality videos created in a simple format where I teach all courses.”

The first five videos are now being offered on a free preview as Dr. Marta embarks on a nationwide media and promotional appearance tour. This curriculum also includes an introductory video that breaks down each subject into easy-to-understand topics for the general public. Attendees receive insight and education on caring for their skin, the body’s biggest organ, without surgery. Among the courses are:


  • How to Love the Skin You’re In
  • Your Body’s Tools & Hormones
  • Can Sleep Really Affect Your Skin?
  • How the Environment Affects Your Skin
  • Preventing Age Spots & Skin Cancer
  • Understanding Skin Care Labels
  • Is Hydrating & Moisturizing the same?

“In today’s world, we commonly have nutritional coaches, life coaches, and exercise coaches, amongst others,” added Dr. Marta. “I hope we can add a skin coach to that list. The visible results and increased knowledge are priceless.”

The course is priced at $79.00 Click here to sign up. Purchase a Rejuvalift product and receive it free with coupon code provided with online or Retail store purchase. Information on http://www.drmarta15.com or Rejuvalift Beauty, visit http://www.rejuvaliftbeauty.com.

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About Dr. Marta:

Dr. Marta Pazos is a creator, innovator and owner of the Rejuvalift Brand, with over 20 years of experience developing specialty formulations for cosmetic and skincare products. As the lead cosmetic chemist for Rejuvalift®, Dr. Marta leverages her expertise as a formulation chemist to develop products using the minimum number of ingredients to deliver non-surgical advanced tightening and lift results.

Her passion for skincare began in her teenage years when she battled acne. She quickly learned that when you look good, you feel good. Her skincare journey and interest in chemistry led her to the U.S. from her native Spain. A Fulbright scholar, Dr. Marta earned her doctorate in Polymer Science from the University of Akron. Since then, her career has taken her to North America, Europe and Asia assignments.

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