Two Labs

Navigating today’s healthcare landscape can be overwhelming for patients, especially those requiring advanced treatments like cell and gene therapies. In his latest article in Pharmaceutical Commerce Magazine, Paul Battaglia, VP of Patient Support Services, peels back the role patient services programs play in their ability to break down barriers like coverage limitations and high costs. Because at the end of the day, it is all about making sure patients receive the support and transparency they need. Read the full feature to explore the future of patient services and how we can continue to improve access and care through innovation. https://lnkd.in/g8WhGVDk

The FDA has announced another delay in DSCSA enforcement, offering the industry some much-needed breathing room. But don't mistake this as a time to ease up. With serialized data quality still hovering around 75%, this extension is crucial for preventing widespread product quarantines that could disrupt patient care. Michael Rowe, Senior Director of DSCSA/Serialization Compliance Services, provided some insights on how companies can use this extension to improve data accuracy, resolve serialization issues, and ensure full compliance before the final enforcement deadline. However, the staggered enforcement timeline introduces new challenges. The industry will continue navigating a "dual environment" of lot-level and serialized tracing, which can create confusion as both systems run concurrently. Managing this complexity will require careful planning and coordination. This extension isn't just a break—it's a critical window to fix persistent issues. This time around, the FDA guidance has emphasized that if companies have not initiated the required data connections with trading partners, that is not covered under this exemption. The FDA is allowing products to move, but companies that are not actively participating in sending information could be held accountable. Feedback from the industry is less about missing data connections, but the most significant gaps remain in data correction and exception management. Companies must use this time to develop robust processes. It's also important to note that as the industry improves data accuracy, quarantine procedures may still be necessary to root cause and fix issues during this additional enforcement discretion. Additionally, now may be the right time to reassess your serialization solution provider. Are you facing data delays, latency issues, or unresponsive service? If so, act quickly. The next six months offer a vital opportunity to evaluate your provider's performance and address any weaknesses before full enforcement takes effect. At Two Labs, we're here to help you navigate these changes, optimize your systems, and ensure your team is fully prepared for DSCSA compliance. Don't wait—reach out to us today. https://twolabs.com/dscsa/

Our very own Kyle Felmet, VP of Specialty Pharmacy, led a fantastic panel in front of 140+ attendees at #MeetingOnTheMesa, exploring cell and gene therapy launch's key hurdles. From commercialization strategies to ensuring patient access, the discussion provided crucial insights for the CGT community. Thank you to Austin Fisher, VP, Patient & Channel Access at Autolus Therapeutics, Michael Storey, Medication Use Strategist at Nationwide Children's Hospital, and Monet Stanford, Director, Access and Reimbursement Policy at Alliance for Regenerative Medicine, for coming together to provide a holistic conversation about CGT in today's market.

Day 2 was another impactful day at #MeetingOnTheMesa alongside Envision Pharma Group and our team members Kyle Felmet, Courtney Johnson, Michael Esselman, Philip Kozak, Jasmine Patel, MPH, Liz Durbin, Paige Nelson, Tony Santangelo, Christy Iannelli, and Nicholas Bell. The conversations around the future of cell & gene therapy keep inspiring us! Be sure to stop by our booth and learn how we’re partnering to transform access and compliance solutions.

Today our team had the incredible opportunity to participate in a #BreastCancerAwareness month packing party for Tina’s Warriors (Tina Valbh, BS Pharm, RPh ) at the National Association of Specialty Pharmacy (NASP) conference. Jennifer Moran, Kristie Russ, Christin Bush and the Two Labs team came together to support a meaningful cause and make a positive impact in our community. Thank you to everyone who contributed their time and effort!

This week we're diving deep into the future of cell and gene therapy. Stop by our booth today or find us at the conference to learn more about how we’re driving innovation in market access and compliance!

The journey to commercializing Cell and Gene Therapies (CGTs) is complex, but crucial advancements are being made. In their latest blog, Kyle Felmet, VP of Specialty Commercialization, and Paul Archer, Chief Commercial Strategy Officer at Envision Pharma Group, explore key trends reshaping the CGT landscape, from the growing focus on rare diseases to the impact of AI in optimizing costs and patient care. Discover what it takes to navigate the commercialization challenges in this rapidly evolving field. Read their blog below!

Did you know our Strategic Consulting team at Envision Pharma Group helps small and emerging pharmaceutical companies unlock their full potential? Here’s how they partnered with one client to transform clinical setbacks into strategic success, ultimately leading to a $6.7 billion valuation: 1. Corporate restructuring: They helped streamline operations and realign resources for future growth. 2. Portfolio prioritization: Strategic alignment of assets allowed for focused development and key transactions. 3. Program management excellence: Integrated cross-functional plans kept high-value drug candidates on track. Download the eBook: https://lnkd.in/esGyK-vF

Did You Know? Emerging pharma manufacturers face the same commercialization hurdles as big pharma but often with fewer resources. Our 0 to 60 Guidebook offers a comprehensive roadmap to help emerging pharma companies streamline every step of the commercialization process. So, what's inside? • How we help emerging manufacturers do more with less • The full range of Two Labs’ integrated solutions • Two Labs’ expertise and results after 20+ years of serving the biopharma industry Download the guidebook now and discover how to accelerate your commercialization journey: https://bit.ly/47KErLp

With the 2024 DSCSA compliance deadline fast approaching, the HDA Traceability Seminar provided key insights on how the pharmaceutical supply chain can adapt to meet the stringent requirements. In our latest blog,Tatiana Salvano, Consultant for DSCSA/Serialization Compliance Services, breaks down a few takeaways from the seminar: > 𝗪𝗮𝗶𝘃𝗲𝗿𝘀 & 𝗘𝘅𝗲𝗺𝗽𝘁𝗶𝗼𝗻𝘀: Leveraging WEEs (Waivers, Exceptions, and Exemptions) to navigate compliance hurdles while ensuring supply chain security remains intact ahead of the DSCSA deadline. > 𝗘𝘅𝗰𝗲𝗽𝘁𝗶𝗼𝗻 𝗛𝗮𝗻𝗱𝗹𝗶𝗻𝗴: The seminar underscored critical steps to manage supply chain disruptions effectively while maintaining traceability—a pivotal focus for ensuring continuity in an increasingly complex landscape. > 𝗘𝗻𝘀𝘂𝗿𝗶𝗻𝗴 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝘄𝗶𝘁𝗵 𝗩𝗲𝗿𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗥𝗼𝘂𝘁𝗲𝗿 𝗦𝗲𝗿𝘃𝗶𝗰𝗲: Best practices were shared on how to effectively utilize VRS to meet DSCSA verification requirements, ensure compliance and safeguard product integrity throughout the supply chain. Read Tatiana's full recap here: https://bit.ly/3XnAU0M