A toxicologist’s viewpoint on developing oncology drug products

With oncology growth rates on the rise, pharma companies are pressured to develop and manufacture life-saving therapies with speed and agility. Cancer growth rates are driven by environmental factors, lifestyle choices, and an aging population. Approximately 42% of the oncology market pipeline is attributed to oral solid doses*. Since oncology drugs are commonly categorized as highly potent, they require various handling and safety strategies. Attend this webinar to hear toxicologist, Joe Galati, discuss:

  • Criteria for evaluating highly potent small molecules
  • Toxicity binding systems
  • Downgrading a molecule from high potent to low potent:
  • Safety and handling strategies

*Source: IQVIA- Global MIDAS Edition Includes antineoplastic agents (L01) and endocrine therapy (L02)- 248 molecules, OSD includes: tablets, ODT, capsules

Joe Galati
Senior Director of Global Toxicology Services, Thermo Fisher Scientific

Bio: Dr. Joe Galati is the Senior Director of Global Toxicology Services and has 20 years of experience in the pharmaceutical industry, in the field of occupational toxicology and patient/product safety. Involved in evaluating the toxicity of compounds (active pharmaceutical ingredients, intermediates, contaminants, etc.) in order to assign appropriate toxicity categorizations/bands, determine low potency versus high potency, and develop occupational exposure limits for worker safety, as well as threshold of toxicological concern/permitted daily exposure/acceptable daily exposure values for patient safety. Also involved in identifying whether the handling of compounds complies with the requirements for Good Manufacturing Practice in a multi-product facility and advising on potential drug product quality/regulatory concerns, such as cytotoxic, cytostatic, hormone, sensitizer, and others. A full member of the U.S. Society of Toxicology, as well as the Society of Toxicology of Canada, with a Ph.D. in Pharmacology and Molecular Toxicology from the University of Toronto. Also, an author of several peer-reviewed publications, and a presenter at various international scientific meetings, conferences, and universities, in North America and Europe.

Joe Galati

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