For those launching their first product, the process can be incredibly daunting – but if you know what to look for, both the successes and the failures can help guide your launch strategy. With over 215+ new product launches since our inception, we’ve got a firm grasp on what works and what doesn’t. Here are 5 key takeaways we’ve developed over the years. [...]
Historically, the management of oncology drugs in the U.S. has remained relatively hands-off, despite high budget impact. However, the situation may be changing. Recently, there has been discussion around new management tools, shifting of financial risk, and the influence of value frameworks. In June 2020, Two Labs conducted a panel with payers, hematology and oncology providers, and representatives from several big pharma and small biotech companies with oncology [...]
Launching a drug isn’t easy. All manufacturers, no matter the classification of product they create, face challenges on the journey to bring their drug to market. However, due to the nature of their dose form, complex storage needs, stability requirements, and costs, manufacturers launching specialty drugs must often navigate more hurdles than those dealing with a traditional retail product. Not appropriately planning for or inaccurately handling these hurdles [...]
COVID-19 is impacting the healthcare system in a way we’ve never seen before, and pharmaceutical manufacturers are facing new challenges at rapid speeds. To help keep you informed, we’re releasing a special Q&A series with our experts to discuss the virus’s impact on each stage of the launch journey. Today, we spoke with DSCSA and Serialization Services Manager Michael Rowe about the effect of COVID-19 [...]
COVID-19 is impacting the healthcare system in a way we’ve never seen before, and pharmaceutical manufacturers are facing new challenges at rapid speeds. To help keep you informed, we’re releasing a special Q&A series with our experts to discuss the virus’s impact on each stage of the development journey. Today, we spoke with David Ward, Vice President for EHRx Solutions, Sara Stricker, Manager at CEEK [...]
Timing Funding PUBLIC FUNDING If a manufacturer has received public funding, they are feeling the effects of the stock market downturn and may need to find ways to decrease budget and/or bring about additional funding sources. PRIVATELY FUNDED If a manufacturer has received funding from private investors, there may be more inherent cash security, but they must [...]
At Two Labs, we know that our clients are looking for solutions. Every service we offer is about paving the way for our clients to launch their products to the market and into the hands of patients who need them. As we continue to grow, and especially as we evaluate our new reality during and after the COVID-19 pandemic, our focus is on connecting the dots to help [...]
Two Labs Joins GS1 Healthcare US Initiative Two Labs is a new member of the GS1 Healthcare US Initiative and will be joining the Rx Supply Chain Security Workgroup (RxSSC) in 2020.The GS1 Healthcare US Initiative includes over 140 healthcare manufacturers, distributors, providers, dispenser pharmacies, group purchasing organizations, government agencies and industry associations who are working together to help address challenges where GS1 Standards can have an impact. [...]
Pricing and Market Access Considerations for Cell and Gene In the past two years, four cell and gene therapies have entered the U.S. market at unprecedented prices. Most recently, Zolgensma launched at a price of $2.1 million for a one-time treatment. Payers view these new therapies as having moderate to high clinical value but have significant concerns around long term durability of effect. For example, will [...]
What is Compendia’s Impact on Product Decision Making? What is “The Compendia”? Most often, people describe the organizations that make up the Compendia as price books – and that’s understandable. After all, most of the submissions a manufacturer makes to Compendia involves price increases throughout the product launch year until they maintain price on a regular basis. And yes, pricing is absolutely a key part of what they do, however, [...]