Two Labs

Michael Rowe, Senior Director of DSCSA & Serialization at Two Labs, recently joined the Life Sciences 360 podcast to discuss the complexities and realities of DSCSA compliance. With experience supporting 55+ companies through serialization and exception handling, Michael offers a nuanced perspective on what it takes to lead within a decentralized, self-regulating supply chain—where data integrity, cross-functional alignment, and technological foresight are non-negotiable. Some key takeaways from the conversation include: > DSCSA impacts nearly every department—quality, IT, operations—and requires cross-functional leadership to succeed. > Compliance is not optional; inaccurate data can halt shipments, delay launches, and trigger costly rework. > Exception handling remains the industry’s most pressing challenge, and AI is emerging as a tool for proactive detection and resolution. Listen to the full episode here: https://lnkd.in/eCbGV79i

As the CGT landscape continues to evolve, it’s a great time to revisit the complexities of government pricing. From MDRP enrollment to Value-Based Agreements and compliance audits, strategic planning is more important than ever for emerging manufacturers. Key Considerations: - Defining “available for sale” for CGTs in MDRP - Selecting the right VBA pricing approach - Strengthening compliance & audit readiness Want to stay ahead of the evolving CGT landscape? Read the blog below to discover how Two Labs can help you navigate government pricing complexities and optimize your market access. https://bit.ly/4ik4DB7 #CellAndGeneTherapy #MarketAccess #PharmaCompliance #TwoLabs

Regulatory requirements are not slowing down - are you prepared? Our compliance eBook is here to help emerging pharmaceutical manufacturers stay ahead of aggregate spend, drug price transparency, and government price reporting challenges. Whether you missed it the first time or need a refresher, now’s the perfect time to dive back in. Get the insights you need to: - Gain clarity on complex compliance requirements - Optimize internal processes for smoother reporting - Take proactive steps to ensure ongoing compliance - Protect your company from penalties and reputational risks Download the eBook now and stay ahead of evolving regulations. https://bit.ly/4isoNZj

That’s a wrap on the HDA - Healthcare Distribution Alliance Management Conference! Our team had great conversations on specialty drug commercialization, tackling the challenges of distribution, compliance, and market access. Huge thanks to Lisa Arthurs, Jessica Randolph, MBA, Michael Rowe, and Kamaria Jordan Williams, MHA, for representing Two Labs and sharing their expertise throughout the event. Missed us at HDA? Let’s keep the conversation going - reach out to learn more about how we help pharma manufacturers navigate commercialization challenges.

This Rare Disease Day, we honor the resilience of over 300 million individuals living with rare diseases worldwide. We couldn’t be prouder to support the development and commercialization of over 200 orphan-designated drugs, and we remain committed to helping manufacturers support these patients with rare diseases. Despite significant progress, approximately 95% of rare diseases still lack an FDA-approved treatment. Recognizing the urgency, we are committed to collaborating with manufacturers to navigate complex regulatory landscapes and expedite the delivery of life-changing therapies to patients in need. If you’re working on a rare disease therapy, we would be honored to support you in bringing hope and solutions to those affected.

Next week, members of our team will be at the HDA - Healthcare Distribution Alliance Management Conference, sharing insights on specialty drug commercialization. Lisa Arthurs and Jessica Randolph, MBA will take the stage for "Planning a Specialty Launch (and Avoiding the Pitfalls)" on Monday, March 3, from 3:15 pm - 4:15 pm in Ybor IV. They’ll dive into the strategies and best practices that ensure specialty therapies reach patients efficiently and successfully. In addition, Michael Rowe and Kamaria Jordan Williams, MHA will also be attending! Be sure to connect with them and the rest of our team throughout the event! Stay tuned for key takeaways and photos from the event!

We’re thrilled to welcome Meggan Smith as our new VP of Specialty Commercialization! With her deep expertise and strategic vision, Meggan will play a pivotal role in shaping what’s next for specialty pharma—helping manufacturers navigate commercialization complexities, optimize patient access, and bring groundbreaking therapies to market. Her addition comes at a time when specialty pharma is evolving rapidly, and we’re ready to take our services to the next level. Stay tuned for more insights, innovations, and updates as we continue to expand our impact in this space. Please join us in welcoming Meggan to the Two Labs team!

Exelixis, a biopharmaceutical company dedicated to developing innovative therapies, faced increasing compliance demands as DSCSA regulations evolved. Gaps in documentation, resource constraints, and the need for standardized processes made it clear that a more structured approach was necessary. To strengthen its compliance framework, Exelixis partnered with Two Labs. Through this collaboration, Exelixis: - Upgraded SOPs from technical documents to comprehensive guidelines. - Standardized compliance for product returns, complaints, and verification. - Streamlined workflows to reduce burden and improve efficiency. With Two Labs’ expertise, Exelixis built a structured, scalable compliance framework, ensuring long-term DSCSA readiness. Want to see how Exelixis overcame compliance challenges? Read the full case study to learn more about their journey. https://bit.ly/3C86ZDg

Navigating DSCSA compliance is complex, and for Karuna Therapeutics, ensuring full adherence ahead of a significant U.S. product launch was a top priority. With evolving regulations and tight timelines, expert guidance was essential for managing serialization, traceability, and wholesaler coordination. Partnering with Two Labs provided the strategic support needed to stay compliant without delays or disruptions. From aligning with trading partners to optimizing data integrity, this collaboration kept Karuna’s product launch on track and ensured patient access. A secure supply chain starts with compliance. See how Two Labs helped Karuna Therapeutics navigate evolving DSCSA regulations and ensure a successful product launch. Read the full case study to learn more. https://bit.ly/3DT3zVg