One of the great promises of 21st century healthcare is that medical care can be tailored to the genomic and metabolic profile of the individual. This promise, though very desirable and elegant in its concept, has repercussions that extend far beyond the technology that makes it possible at present. The adoption of personalized medicines (PM) will require fundamental changes in drug development, healthcare infrastructure, diagnostics and therapeutics business models.
Over the past 10-15 years, a tremendous amount of effort has been placed by pharmaceutical and biotechnology industries in developing personalized medicines (PM). As per a 2016 Progress Report published by the Personalized Medicine Coalition (PMC), more than 20% of New Molecular entities (NME) approved by the FDA in each of the past three years are personalized medicines. This is a sharp increase from 2005, when PM accounted for just 5% of NME approvals. By their inherent approach to disease control, PM often fall within the purview of Fast Track or Breakthrough Therapy tracks for regulatory approval.
From a CMC perspective, a key requirement for developing a successful PM based pipeline is to understand the patient and healthcare provider needs early in product design and development. The expectation is that such an interaction can help in improving therapeutic outcomes, prevent medication errors, and incorporate considerations of special populations. It is also quite possible that due to their niche patient populations, PM based drug products may need to adopt new manufacturing models based on emerging technologies such as continuous, modular, or additive manufacturing. This deviation from the traditional approach of scaling up and manufacturing implicitly places emphasis on understanding the variations in material properties of drug substance and excipients, manufacturing design space, equipment comparability evaluation, commercial dress requirements, container closure studies, and SUPAC implications earlier in the product’s development cycle.
This conference is centered on two themes:
1) Design and development of patient centric products
2) Flexible and innovative manufacturing technologies and platforms to enable patient centric products.
Detailed agenda coming soon!
Presentation files/handouts will be available only in electronic format and available for download from our website (passcode protected). All attendees will be responsible for bringing their own laptops or other electronic devices to the workshop to access speakers’ materials.