Two Labs

The FDA has proposed site tours for regulators to enhance their understanding of cell and gene therapies. This initiative is expected to foster closer collaboration between the industry and regulatory bodies, which is essential to accelerate the development and approval of these groundbreaking treatments. At Two Labs, we see immense potential in cell and gene therapies to transform patient outcomes, particularly for rare and debilitating diseases. Our expertise in strategic planning and market access ensures that emerging pharmaceutical manufacturers can successfully navigate the complexities of bringing these advanced therapies to market. Together, we can drive innovation and deliver life-changing treatments to those most in need. https://lnkd.in/eK5JwgzR

"The spotlight on HCP and HCO spend disclosure underscores a new era of mandatory transparency within the life sciences industry." - Chapter 1, co-authored by Brian Fittipaldi, Director of Operations, Aggregate Spend and Andy Parks, Vice President of Compliance, explores the intricacies of Sunshine Transparency and Aggregate Spend, offering essential strategies for life sciences manufacturers. Unlock the insights now and stay ahead in compliance.  https://bit.ly/4eQsqHo 

As the pharmaceutical industry evolves, so does the regulatory landscape. For emerging pharma manufacturers, navigating this maze of federal and state regulations demands not just attention but proactive compliance. Our newest ebook, "Clarity in Compliance: How to efficiently and accurately plan for and comply with aggregate spend, drug price transparency laws, and government price reporting requirements,” will arm your team with essential knowledge and strategies to manage compliance. Download today and ensure no hurdle stands in the way of your groundbreaking therapies reaching the market. https://bit.ly/4eQsqHo

With just under five months until the DSCSA November deadline, it's crucial to ensure you're fully prepared for the upcoming changes. Are you confident in your onboarding, testing, and data exchange processes? Many in the industry are still working towards full compliance, and time is running out. For manufacturers, navigating this complex landscape can be challenging. Two Labs is here to help, especially during this critical transition period. Our DSCSA experts can guide you on what to focus on in the coming months, what to expect in November, and how these changes will impact your launch strategies moving forward. https://twolabs.com/dscsa/

Dive into our latest blog, where Kyle Felmet and Riparian LLC's Jennifer Lospinoso discuss transformative strategies and key considerations that are shaping the commercialization of cell and gene therapies (CGT). Their analysis covers the rapid advancements in CGT, the strategic planning required for successful market entry, and the innovative distribution models that ensure these groundbreaking treatments reach patients effectively. https://bit.ly/4boUaQl

Patient-centricity is revolutionizing healthcare, ensuring that treatments are being developed with actual patient needs in mind. In their latest blog, Dominic Marasco and Jessica Krauser delve into how patient advocacy and real-world data are shaping drug development and commercialization. This insightful read highlights how early integration of patient perspectives not only meets regulatory requirements but also significantly enhances health outcomes. By focusing on what truly matters to patients, the industry is creating more effective and impactful treatments.

Exciting advancements in gene therapy are paving the way for transformative treatments for sickle cell disease. The FDA's recent approval of Casgevy and Lyfgenia marks a monumental step forward, offering potential cures for a condition that impacts millions worldwide. This progress highlights the critical need to ensure these therapies are accessible to all patients, irrespective of geographic or economic barriers. At Two Labs, we recognize the importance of collaboration with industry partners to overcome these challenges. Our commitment is to facilitate the availability of these life-changing treatments to every individual in need. https://lnkd.in/ePKu-Src

Today is #MedComms Day, and we're celebrating the vital role medical writers play in the pharmaceutical industry. At Two Labs, we recognize their critical contributions in bringing groundbreaking treatments to life. From developing precise, clear documentation to ensuring regulatory compliance, their expertise is essential, from research to patient care. Medical writers transform complex scientific data into accessible information, making a real difference in advancing healthcare. Join us in acknowledging their invaluable contributions!

Our team had an incredible time at #Asembia2024, where innovation and strategic conversations took center stage. From exploring patient services benchmarking in neurology to discussing the evolving landscape of Cell & Gene therapies, the insights gained are invaluable. Dive into our recap to learn about the groundbreaking work and collaborations shaping the future of patient care. https://bit.ly/3yMSPFF

We are truly inspired by Jessica Krauser and all those with Parkinson's who continue to share their voice and advocate for their health and well-being. The recent approval of the National Plan to End Parkinson’s Act is a huge step forward and brings us closer to new research opportunities, better support systems, and, ultimately, a cure for Parkinson’s disease.