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…

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…

Additional Panelist: Paula Russell, _Health Canada_

The cell and gene therapy field spans an enormous range of product types and technologies with the potential to provide curative treatments for a wide range of serious diseases…

Our ability to treat diseases previously untreatable through the delivery of adeno-associated virus (AAV)-based gene therapies has been a tremendous advancement in pharmaceutical development…

Join us for an engaging fireside chat delving into the revolutionary landscape of cell and gene therapy…