Endpoints Studio topics are informed by the stories our readers are most interested in and the areas they want to know more about. Our topics are carefully screened and continually updated to elicit thought-provoking dialogue and intrigue. Choose from our rotating menu of topics that can be adapted across our versatile suite of Studio products.
As with clinical trial recruitment, optimistic forecasts rarely align with actual output in gauging cell and gene manufacturing capacity. While underestimating capacity results in lost opportunity, overestimating capacity results in an unsustainable financial burden with huge overhead and ballooning COGS. So, how does the panel calculate risk in their capacity modeling?
There’s no shortage of curveballs when it comes to supply chain security and manufacturing comparability. As the industry transitions to more diverse models of transit and production, what are some of the early decisions with supply integrity and manufacturing scale that translate well in the later stages of commercial manufacturing and supply?
The FDA’s clearly established parameters on durability for gene therapies have vexed some leaders in this field. The agency has rejected several promising therapies amid real and theoretical risks that can arise across development. With just a few years of data, how are developers measuring long-term benefits and durability while making the case for these once-and-done approaches to disease?
We’ve heard a lot about the latest cell and gene therapies in the clinic and the growing pipeline of therapies ahead. Although logistics and safety challenges remain, many believe that the field promises a slew of curative therapies across rare, emerging and persistent diseases in our lifetimes. What will we see over the next decade and who will lead the way there?
The FDA’s first gene therapy hearing ended without conclusive guidance on some key topics that have plagued gene therapy developers for years. While panelists issued recommendations to better understand trial side effects such as liver toxicity and neuron damage, how should developers proceed amid other lingering unknowns?
These days, coming up with the right surrogate endpoint for your cancer drug is essential to finding the shortest path to market. As developers navigate a complex regulatory environment, we’ll examine strategies to carefully identify surrogate endpoints. How can we learn from what others are doing in the field and what will we see next?
The new era of decentralized clinical trials is upon us. That’s not only changed the game with patient recruitment and visitation, but also with how patient data is collected across wearables, patient apps and other remote monitoring tools. How should you plan to adjust to this new model of trial design, and what are the opportunities and pitfalls ahead?
Antibody R&D is blazing ahead on a number of fronts after the frenzy unleashed during the global pandemic. As researchers examine new ways of understanding the immune system and its response to disease, what can we expect with the next generation of antibody development? And how will it impact everyone in the fight to treat both infectious and non-infectious diseases?
When it comes to the microbiome, the list of potential targets is immense. Pioneers headed to the market underscore both the potential to better define the field, as well as the vast amount of research that has yet to be done. What can we learn from how one of these players in particular is chartering new territory?
The current biotech boom has seen money flowing from every direction. One (often overlooked) source is coming from royalty deals, where companies can negotiate a set income from both commercialized and experimental drugs at certain milestones and breakthroughs. How does this monetization work? And is it right for you?
Influencer marketing is a powerful asset in any pharmaceutical marketer’s toolkit. However, choosing the wrong ambassador and failing to understand your core audience can sabotage even the best-laid plans. What can we learn from brands that are going bold — and striking media gold? And where do you start to build trust with the full patient network?
Influencer marketing is a powerful asset in any pharmaceutical marketer’s toolkit. However, choosing the wrong ambassador and failing to understand your core audience can sabotage even the best-laid plans. What can we learn from brands that are going bold — and striking media gold? And where do you start to build trust with the full patient network?
Every decision in late-stage (and even early-stage) drug development is an opportunity to set the stage for future commercial success. From anticipating supply needs to planning ahead for commercial scale-out, what are some practical strategies to create a seamless, adaptive manufacturing plan that spans development to commercialization? And where is the industry headed next with automation and technology?
COVID-19 presented the world with a variety of steep challenges. For drug companies, one of the biggest was keeping the supply chain intact. We’ll take a look at where the weaknesses are, and how one CDMO changed the game.
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