Emerging manufacturers face critical hurdles with government pricing programs, especially when it comes to cell and gene therapies. From enrolling in the Medicaid Drug Rebate Program to navigating the complexities of best-price reporting, ensuring compliance is no small feat. With Value-Based Agreements (VBAs) becoming a vital strategy, how can you effectively manage pricing while ensuring patient access? Explore Jennifer Lospinoso, Managing Director & Consulting Lead at Riparian LLC, latest insights on overcoming these challenges, staying compliant, and ensuring your CGTs reach those who need it most. Read her full insights here: https://bit.ly/47lCfK2
About us
Two Labs, founded in 2003 and headquartered in Columbus, Ohio, is a leading pharmaceutical services company that partners with pharma and biotech companies across the globe. We know that no two paths to launch are alike, so we deliver customized integrated commercial solutions that guide our clients’ new product launches from clinical to commercial, as well as provide strategies for continued market viability for drugs already on the market. Our expertise and insights from more than 290+ launches have given us a proven track record of success across all major therapeutic areas with unmatched client satisfaction. In 2018, we embarked on a journey of unprecedented growth by acquiring Pennside Partners Ltd. and MKO Global Partners, and CEEK Enterprises in early 2020 before being acquired by London-based Envision Pharma Group later in 2020. In 2021, Two Labs then acquired Riparian, a consulting and SaaS company. As part of the global Envision Pharma Group family, we are proud to be backed by their best-in-class technology and artificial intelligence solutions, medical strategy, medical communications, publication planning & delivery, and patient engagement services, as well as offer access to their proprietary services through Okra.ai, 90TEN, and Riparian.
- Website
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http://www.twolabs.com
External link for Two Labs
- Industry
- Pharmaceutical Manufacturing
- Company size
- 51-200 employees
- Headquarters
- Powell, Ohio
- Type
- Privately Held
- Founded
- 2003
- Specialties
- pharmaceutical
Locations
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Primary
110 Riverbend Ave
Powell, Ohio 43065, US
Employees at Two Labs
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John Chambers
QA engineer with video, mobile, & web testing experience. I have excellent programming skills.
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Scott Anderson
Senior Director Trade Operations and Analytics at Two Labs Pharma Services
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Melissa Landers
Strategic Operations Executive in Biopharma With 20+ Years Experience Consulting to Regulatory, Medical Affairs, and Commercial Leadership
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Danel Couch
Account Manager at Two Labs
Updates
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Navigating compliance in the pharmaceutical industry can be challenging, especially for emerging manufacturers. That's why we’ve created an all-inclusive eBook to help you master the essentials— aggregate spend, drug price transparency, and government price reporting—all in one place! Whether you're preparing for a product launch or enhancing your compliance strategy, our guide will equip you with actionable steps and insights to: > Streamline reporting processes > Stay ahead of state and federal regulations > Avoid penalties and safeguard your business > Build a foundation of transparency and ethical practices Download the eBook now! https://bit.ly/3Lchsyab
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At the Alliance for Regenerative Medicine's #CellandGene Meeting on the Mesa, we’re diving deep into the complexities of launching cell and gene therapies. Our very own Kyle Felmet, VP of Specialty Commercialization will lead the panel, "Anatomy of a CGT Launch: Operationalizing Cell and Gene Therapy." Join us to gain actionable insights from industry experts on making your next CGT launch a success. Don't miss this opportunity to learn from the best in the business! #CellandGeneTherapy #CGTLaunch #TwoLabs
We are excited to bring you an unmissable panel at the Alliance for Regenerative Medicine's #CellandGene Meeting on the Mesa: "Anatomy of a CGT Launch: Operationalizing Cell and Gene Therapy," hosted by Kyle Felmet, VP, Specialty Commercialization, at Two Labs (an Envision Pharma Company). Launching cell and gene therapies is complex, and we’re diving deep with industry experts who’ve mastered the art of: - Tackling complex reimbursement landscapes and negotiating with payers - Streamlining patient-specific logistics to ensure timely and safe delivery - Navigating regulatory hurdles that can challenge even the most seasoned teams - Developing launch strategies that drive success from clinical trials through post-launch - Coordinating cross-functional teams to keep everyone aligned and moving forward This session will offer real-world insights and proven strategies that can help attendees bring groundbreaking therapies to patients more effectively. #cellandgene #meetingonthemesa #lifesciences
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With the pharmaceutical industry racing towards full DSCSA compliance this November, the FDA and industry stakeholders are taking significant steps to secure the drug supply chain. A key development in this effort is the enhanced CDER NextGen Portal—a powerful tool designed to streamline critical communications and improve process efficiency. Our latest blog, Tatiana Salvano, explores how this portal supports: - FDA 3911 submissions - Suspect drug investigations - Waiver Exception & Exemption (WEE) submissions Discover the benefits, challenges, and whether this tool is the right fit for your organization here: https://bit.ly/4dRARkv
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Hello from Washington, D.C.! Michael Rowe, Greg Makin, Tatiana Salvano, and Amanda Addezio are excited to be at the 2024 Healthcare Distribution Alliance Traceability Seminar! Stop by Booth 20 to chat with our team about how Two Labs can support your traceability and compliance needs. Let’s discuss how we can help safeguard your supply chain and ensure you’re ready for the future of pharmaceutical compliance.
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Happy International Dog Day!🐾 What better way to celebrate this day than giving a nod to the “two labs” who inspired our name - Hunter and Barnaby! These two pups have been at the heart of our story, symbolizing the loyalty and dedication we bring to our work every day. Join us in celebrating all the furry friends who bring joy to our lives.
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Michael Rowe, Greg Makin, Tatiana Salvano, & Amanda Addezio are heading to the 2024 HDA - Healthcare Distribution Alliance Traceability Seminar in Washington, D.C., next week! Visit them at Booth 20 to learn how our innovative solutions can help you stay ahead of compliance challenges and secure the integrity of your drug supply chain.
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Compliance in the pharmaceutical and medical device industries requires a strategic approach to HCP and HCO spending disclosures. Chapter 5 of our latest ebook, "Clarity in Compliance," focuses on three essential steps to ensure your reporting is thorough and accurate: - Identify Reportable Activities with Precision: It’s not always obvious which vendor activities need to be reported. Learn how to systematically identify all potentially reportable interactions, reducing your risk of missing crucial data. - Conduct Comprehensive Spend Inventory Assessments: Beyond the basics—uncover hidden reportable expenditures through detailed assessments. Understand the full scope of your financial interactions and ensure no transfer of value is overlooked. - Develop Robust Reporting Documentation: Create clear, detailed documentation to avoid inconsistencies and errors. From methodology to playbooks, build a solid foundation for ongoing, accurate compliance reporting. Download the full eBook to dive deeper into these strategies and streamline your compliance processes: https://bit.ly/3Lchsya
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Navigating the complex world of pharmaceutical compliance isn't just about staying on the right side of the law—it's about safeguarding your company’s future. Chapter 4 of our eBook, "Clarity in Compliance," dives deep into the penalties associated with non-compliance in government price reporting and drug price transparency. Whether it's hefty fines, civil and criminal judgments, or even suspension from federal programs, the risks are real and significant. This chapter outlines critical actions to help avoid these pitfalls, ensuring your data submissions are accurate and timely. Download our ebook today: https://bit.ly/3Lchsya
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“I like to say that there's a breadcrumb of serialized data that moves with the product as it moves, as it changes hands, and as a way for companies to have their own database to use in a suspect drug investigation to help identify counterfeits.” In the second video of his interview series, Michael Rowe dives into the importance of serialized data in the pharmaceutical supply chain, highlighting how each breadcrumb of data ensures the safety and integrity of medications. Whether you're in manufacturing, distribution, or pharmacy operations, understanding these nuances is essential for maintaining compliance and protecting patient safety. Check out his full interview below!
📹 In this part of his Pharmaceutical Commerce Magazine video interview, Michael Rowe, Two Labs ’ Senior Director of #DSCSA/Serialization Compliance Services, discusses the state of affairs surrounding the #DrugSupplyChainSecurityAct, along with opportunities for improvement