Discoveries in technology, medicine, and nutrition are emerging with accelerating speed and improving our health and quality of life. Brought to you by Lonza, “A View On” podcast is a series of short conversations with industry leaders. Join us to discuss new trends that are impacting scientific research, drug discovery and business.
The series of monthly conversations with pharma, biotech and nutrition leaders from across industry and academia covers a wide range of topics from 3D bioprinting to therapeutic cannabinoids. In under ten minutes, each podcast takes the audience on a rapid but deep dive into an exciting development that promises to profoundly change or even revolutionize healthcare.
Episode: De-risking Drug Development
Where There’s A Risk, There’s A Way: De-risking Drug Development at the Earliest Stages
Lonza’s wide array of analytical tools and professional experience create a go-to solution for small biotechs looking to decrease risk in their drug development process.
An evolving toolbox of technology and advanced scientific knowledge is fueling the growth of a wide range of next-generation drugs in today’s pipelines. These novel but complex products, while offering the ability to treat previously unmet medical needs across the globe, also present many challenges. This is often due to their unique profiles that require bespoke development and manufacturing processes as opposed to using well-known platform approaches, adding even more risk to a space fraught with uncertainty. This increasingly competitive market leaves little room for error or delay. Therefore, selecting and optimizing the right lead candidate becomes critical, as this allows you to de-risk your drug development process and maximize your chances of success.
The largest cause of failure during drug development is most often related to safety and efficacy, so it is important to have processes in place that can identify potential issues as early as possible. Simple, cost-effective in silico and in vitro assessments can help look at potential developability challenges in the earliest stages and allow for modifications to the drug candidate and its process development to mitigate potential efficacy, safety or manufacturability risks.
Many of the drugs currently in early development around the world are initially developed by small biotechs, companies that often require the support of service providers to assist and to accelerate the de-risking of their candidates This is where Lonza’s Early Development experts step in. Today’s guest is Raymond Donninger, Senir Director of Commercial Development for Lonza’s Early Development Services in Cambridge.
To start the de-risking process, the team can predict development issues very early, based on the candidate’s sequence and structure. This knowledge allows for modifications to the drug candidate and its process development to mitigate risk early and increase the likelihood of a successful first-in-human study. The experts then also apply in vitro tools to look at developability challenges and to mitigate potential efficacy, safety or manufacturability risks.
Curious to Know More?
We previously addressed the importance of immunogenicity in decreasing risk in drug production in Episode 5. To take an even deeper dive into the whole process, listen to the conversation between Martina Hestericová and Raymond Donninger, the Senior Director of Commercial Development for Lonza’s Early Development Services.
KEY TERMS in Context:
In silico immunogenicity and human cell in vitro assays are two essential ways to de-risk a molecule’s development pathway . In silico tests run computer models to predict a molecule’s interaction with the human immune system; in vitro testing assesses the molecule’s interaction with human immune cells.
The attrition of a drug candidate occurs when it reaches clinical trials but fails for one reason or another. According to Donninger, an attrition rate of nine out of ten candidates has remained stubbornly high over the years.
Attrition happens when a molecule has therapeutic potential but safety, target engagement or developability (for example complex, uneconomic manufacturing processes) issues prevent the product from reaching the market. The de-risking process aims to reduce attrition to improve the chances for viable and safe therapies to make it to market.
According to Donninger, a T-cell epitope is a sequence within the protein that has the potential to allow the immune system to recognize it as being foreign and then mount an unwanted and potentially dangerous immune response. To learn more about de-risking and immunogenicity, listen to this seas
Episode 8: Colors of Capsules
Listen to the conversation between A View On host Martina Hestericová and Ljiljana Palangetic, Lonza’s Associate Director of Hard Capsules R&D, about the challenges and solutions in current capsule manufacturing.
Episode 7: Antibody-Drug Conjugates
Iwan Bertholjotti and Lawrence Bonnafoux from Lonza give an insider look at how antibody-drug conjugates make it from development to commercialization and how they are already benefiting patients worldwide.
Episode 6: Manufacturing of Exosomes
Listen to Martina Hestericová’s conversation with Sriram Sathyanarayanan and Linda Bain as they discuss the advantages of exosome treatments, how they are developed and why the company’s early manufacturing strategy is paying off.
In this reposted episode from December 2020, we’re exploring how a better understanding of exosomes is leading to new treatments and diagnostic technologies with Uwe Gottschalk.
Listen to our special, in-house episode of the podcast ”A View On” and tune in next time as we are exploring the manufacturing challenges of exosome-based therapies with Codiak Biosciences.
Episode 5: Importance of Immunogenicity
Yvette Stallwood, head of Lonza’s Early Development Services, talks about patient safety and other advantages of early testing for immunogenicity in the drug development pipeline.
Awesome topics selection, loved the cannabinoid and exosomes
Interesting and insightful
Input from the experts directly at the source of information, i love learning about the novel therapies
Great overview of current pharma trends!