Josef Bossart, PhD, explains how accurately estimating a product’s clinical development timelines is more than simply adding up the individual timelines, almost always optimistic. You need to “know” the numbers, not just calculate them.
Dr. Martin Smith explains why the pharma industry must embrace continuous processing if it’s to survive and thrive in an era of global personalized medicine.
David Domzalski, Chief Executive Officer of Foamix, discusses his company’s innovative approach to drug delivery using foam to treat dermatological conditions, like acne and rosacea.
OLIGONUCLEOTIDE DELIVERY – Dectin-1 Receptor-Mediated Delivery of Oligonucleotide Drugs Complexed With Schizophyllan Dendritic Cells & Macrophages
Kenji Arima, PhD, and Akihiko Watanabe, PhD, introduce NapaJen Pharma’s technology with a specific focus on solving some of the current challenges of oligonucleotide therapeutics.
Cheryl L. Barton, PhD, and Bianca Piachaud-Moustakis, PhD, believe the role of TIL therapy as an anticancer therapy in melanoma and possibly other solid tumors holds great promise and could become a viable course of treatment in the future.
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
Stacey Treichler, PhD, believes the development process for new biologics is complex and requires a substantial amount of time and resources, and reviews some of the areas where careful choice of CDMO is key, including cell line development and cGMP manufacturing capabilities, and how an integrated approach can be beneficial.
CONTINUOUS MANUFACTURING – Continuous Manufacturing in Pharmaceuticals: Implications for the Generics Market
Kamna Jhamb, PhD, says the highly regulated nature of the pharmaceutical sector, and the low-risk-taking nature of this market, are the two main factors that have restrained the implementation of novel methods of manufacturing by pharmaceutical industries. However, the burgeoning demand for complex and innovative therapies and rising competition have led pharmaceutical manufacturers to reconsider their methods of manufacturing.
Daniel de Boer, Chief Executive Officer of ProQR, discusses the use of RNA technology to directly target the underlying cause of genetic diseases.
Andy Lewis, PhD, discusses a range of available formulation technologies, the challenges in MR formulation development, and the use of a design-space approach with on-demand manufacturing.
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