Sia/LBG

Big Changes Ahead for Laboratory Developed Tests (LDTs)! In April 2024, the FDA introduced a groundbreaking rule requiring LDTs to meet the same rigorous standards as in vitro diagnostic devices (IVDs). This pivotal shift ensures enhanced reliability, safety, and consistency in clinical testing—but it also introduces significant compliance challenges for clinical labs. Here’s what this means for labs: ?? Premarket review and post-market surveillance are now mandatory for LDTs. ?? Labs must adapt their quality systems and assay validation processes to meet both CLIA and FDA IVD regulations. ?? Navigating these changes requires meticulous planning, robust infrastructure, and expert guidance. How Latham BioPharm Group, part of Sia Partners Can Help: We recently partnered with a diagnostics company to: ? Develop an LDT for immediate clinical use while laying the groundwork for a future IVD. ? Establish CLIA-compliant infrastructure for LDTs and FDA-ready quality systems for IVDs. ? Achieve Breakthrough Device Status for their future IVD while successfully launching their LDT. Your Lab’s Success Starts Here: To comply with the new FDA rule, clinical labs must: Understand its impact on validation plans, quality systems, and commercialization strategies. Learn to engage effectively with the FDA. Don’t let these new regulations catch you off guard. With Latham BioPharm Group, you’ll gain the expertise and support needed to navigate this evolving regulatory landscape with confidence. Let’s Talk! Contact Tim Alcorn, [email protected], today to learn how we can help your lab thrive in this new era of diagnostics. #ClinicalLabs #Diagnostics #LDTs #FDARegulations #QualityCompliance #RegulatoryExpertise?

Tightening cybersecurity of HIPPA data is a necessary change.

The U.S. Department of Health and Human Services (HHS) has proposed significant changes to the HIPAA Privacy and Security Rules.?HIPAA Security Rule Notice of Proposed Rulemaking to Strengthen Cybersecurity for Electronic Protected Health Information | HHS.gov. These changes aim to strengthen cybersecurity measures for protecting electronic protected health information (ePHI) and adapt to evolving cybersecurity standards. These changes will directly impact both HIPAA Covered Entities and Business Associates, emphasizing the need for robust compliance strategies. At Sia Partners, we are industry leaders in life sciences, data privacy, and security, offering end-to-end HIPAA compliance services to help your organization adapt to these changes. Our Services Include: Global Data Privacy and Security Risk Assessments and Management HIPAA Privacy and Security Rule Compliance Assessments Compliance Gap Mitigations Official Certification of HIPPA Compliance Stay ahead of the curve and safeguard your sensitive health information with our trusted expertise. Contact us today to learn more about how we can support your compliance needs. Contact us today to learn how we can help you navigate these regulatory changes and safeguard your organization’s compliance. Contact: Tim Alcorn, Managing Director at [email protected] or David Zar, Principal Consultant at [email protected]. #HIPAA #DataPrivacy #Cybersecurity #Compliance #LifeSciences #HHS #HealthcareSecurity #SiaPartner https://lnkd.in/ggK5qsG9

Advancing Cancer Immunotherapy:?SON-1010 Cytokines have long been recognized for their potential in cancer immunotherapy, but achieving clinical success has remained a challenge. The recently published research article, “SON-1010: an albumin-binding IL-12 fusion protein that improves cytokine half-life, targets tumors, and enhances therapeutic efficacy,” represents a significant step forward in cytokine-based therapies. We’re thrilled to share that LBG’s DJ Rezac contributed to this groundbreaking work, alongside an incredible team of researchers: John Cini, Richard T. Kenney, Susan Dexter, Stephen J. McAndrew, Rukiye-Nazan Eraslan, Rich Brody, Rebecca Boohaker, Susan E. Lapi, and Pankaj Mohan. This innovative platform offers new hope for advancing cancer treatments by enhancing IL-12 delivery to the tumor microenvironment, improving therapeutic efficacy, and addressing toxicity challenges seen in prior approaches. Read the full article to learn more about this project and technological approach. https://lnkd.in/eYvRbBxc #CancerResearch #Immunotherapy #IL12 #BiotechInnovation #TumorMicroenvironment #Oncology #Cytokines

We are proud to announce that Dr. Allen Duplantier, Dr. Amy Noon, PharmD, RPh, MBA, and their exceptional team will be presenting a poster at next week’s CBD S&T Conference! Poster Topic: "Use of AI and Advanced Computer Systems to Develop Drugs Against New Emerging Threats" This poster highlights the progress of our MCDC project focused on developing inhibitors of alphavirus infection. Dr. Amy Noon shares: "A key success of this program has been collaboration. At the conference, we look forward to learning about new developments and requirements in the field, networking, exploring opportunities for additional collaboration, and reconnecting with friends and former colleagues." Leading the Team is Dr. Allen Duplantier, a medicinal chemist with over 20 years of experience across industry, government, and consulting. Dr. Duplantier has expertise in all stages of early drug discovery and development, including hit-to-lead, lead optimization, candidate selection, and IND submission. We are thrilled to be part of this pivotal event and can’t wait to engage with fellow innovators in the field. If you are attending the conference, be sure to stop by and connect with the team! https://lnkd.in/eTsgkMQw #DrugDevelopment #LathamBiopharmGroup

Latham BioPharm Group, a part of Sia Partners is pleased to announce the presence of Sarah K. Herring, Ph.D. and Christine Hantouche, PhD, MBA at the 2024 Annual American College of Toxicology Conference. Our experienced Product Development subject matter experts are looking forward to engaging with you and your team to help efficiently advance your pipeline programs through your next milestone. To schedule a meeting please contact Sarah K. Herring at [email protected] https://lnkd.in/dc76CfrV https://lnkd.in/gpikngQr #toxicology #nonclinical #productdevelopment #safetyassessment #ACTOX2024

Be sure to catch up with Robert Huebner (LION) at the World Vaccine Congress in Barcelona from October 28th – 31st! ??? We’re thrilled that Niall Cunneen from Sia Partners will be joining Bob at this event. It’s going to be an incredible opportunity for networking and discussions around the latest advancements in vaccines and healthcare. Looking forward to seeing everyone there! #WorldVaccineCongress #HealthcareInnovation #SiaPartners

Patrick Falvey, Principal Consultant at Latham BioPharm Group, shared insights while leading an engaging panel discussion on "Global Trends in Biomanufacturing" at #CPHIMilan today. The panel kept the audience fully engaged throughout the morning session! "Overall, a great day!" noted Patrick. ?? CPHI Milan, one of the largest global pharma events, brings together over 60,000 industry professionals—what an incredible platform to discuss the future of biomanufacturing! #Biomanufacturing #PharmaTrends #LathamBiopharmGroup #CPHI #GlobalPharma #Innovation https://lnkd.in/eNnzDgHd

We are excited to announce that LBG's Robert Huebner will be speaking at the upcoming The World Vaccine Congress Europe 2024! Robert will be presenting on the topic, "New Technologies for Flu Vaccines: Better Vaccines?". With over 30 years of R&D experience in vaccines, especially influenza vaccines, Dr Huebner takes a look at the impact of introduction of new technologies on influenza vaccines and their effectiveness. “With concerns about H5N1 20 years ago there have been major investments in new vaccine technologies for influenza vaccines. These have not yet translated into significantly more effective vaccines thus far. Let’s look at what’s in the development pipeline to change that.” ------------------- – Robert Huebner The World Vaccine Congress Europe gathers global thought leaders to discuss the latest advancements in vaccine technology platforms, global health, pandemic preparedness, therapeutic vaccines, zoonotic diseases, and development across the entire vaccine life cycle. Catch Robert's presentation on Day 3 - Thursday, October 31st at 09:30. LBG is proud to be a sponsor of this event. Learn more about the event and join us: https://lnkd.in/erbvn2wa Event Details & Speaker Information https://lnkd.in/emQyTZ5U Learn more about Dr Huebner’s training and background on LinkedIn: https://lnkd.in/ep29vv_v

We are so excited that Tiffany McGinnis from Latham BioPharm Group, part of Sia Partners was able to share her expertise at the recent webinar titled "Understanding Site and Patient Challenges: Empowering Sponsors with Tech to Drive Success". This webinar hosted by YPrime and presented by Applied Clinical Trials, highlighted the critical role of technology in clinical research. Other key speakers were Mike Hughes, and Drew Bustos. “As clinical research becomes increasingly digitized, sponsors must navigate a complex technological ecosystem that affects every aspect of trials, from site operations to patient engagement” from the YPrime event overview. The key learning objectives of this webinar were to learn how to: - Implement targeted support strategies for sites and patients, emphasizing the importance of comprehensive training and onboarding. - Improve site and patient experience through technology optionality. - Choose and deploy effective, flexible technological solutions. - Enhance data integrity and overall trial success. - Chart a path forward for integrating remote technologies. - Foster improved communication between all parties involved in the trial process. To learn more, contact Tiffany McGinnis directly. https://lnkd.in/gXdFHKMq