Bringing new medicinal products to patients worldwide and ensuring uninterrupted supply of high-quality medicines can involve complex and lengthy processes…

Harsha Gunawardena, _Johnson & Johnson Innovative Medicine_

ELUCIDATION OF A UNIQUE HIGH MOLECULAR MASS SPECIES IN A BISPECIFIC ANTIBODY USING NATIVE ELECTROSPRAY IONIZATION ORBITRAP MASS SPECTROMETRY

As a follow-up to Tuesday's very impactful Keynote presentation, join us in-person or online as we come together as a community and brainstorm ways to further Sonia's mission to prevent prion disease…

In the rapidly evolving biotechnology sector, small and virtual companies play pivotal roles in innovation and development…

This Technical Seminar will be available to watch on demand 24/7 before and during the Symposium. Click on this session to access the presentation video…

The pharmaceutical industry is increasingly viewed as a key sector systemically important in reversing nature loss.     One of the sector’s key dependencies is on the horseshoe crab , a species that is vital to marine ecosystems only located in a few locations globally…

Prior knowledge is fundamental for the progression of science and critical for efficient product development and informed regulatory assessments of product safety and quality…

Access to advanced medical treatments remains a significant challenge in lower and middle-income countries (LMICs), often due to barriers in manufacturing, distribution, and regulatory complexities…

Eric Bishop, _Cygnus Technologies, LLC_

Session Speaker: 

Peptides, proteins and oligonucleotide are becoming essential medical treatments for many progressive, debilitating, or life-threatening diseases. However, the development of these potential therapies can be derailed by product immunogenicity as it can impact on safety and efficacy…

Drug-device combination products such as prefilled syringes, autoinjectors, etc. can play an important role to ensure patient convenience, compliance, and enhance therapeutic impact of the drug…

Innovations in therapeutic modalities are continually emerging as viable treatment options for a multitude of disease indications…

In this session, regulatory leaders from the EMA, Health Canada, PMDA, Health Canada, and international health authorities including WHO will delve into the challenges hindering the path to regulatory reliance and approval of advanced technologies…

Jeff Patrick, _ BioAgilytix Labs_

Potency analytical control strategies are critical to support biopharmaceutical drug and vaccine development throughout the product lifecycle…

Monitoring and control of endotoxin are critical aspects of an overall microbial control strategy necessary to ensure drug product quality and patient safety…

Keynote Speaker: Sonia Vallabh, Ph.D…