Drug Hunting: The Science of Making New Medicines

This course introduces and summarizes the different steps of preclinical drug discovery, wrapping up with a brief description of the subsequent clinical trials and the importance of competitive intelligence in project strategy.  It provides a high-level overview for those interested in a more general understanding of the topic and forms the foundation for a more in-depth exploration of topics covered in other courses in this series. Target audience: This course is suitable for life scientists, clinicians, and individuals from fields that support drug discovery (e.g., patents, finance, licensing, etc.) interested in learning more about the pharmaceutical/biotechnology sector. Advanced undergraduate coursework or practical familiarity/working knowledge in biological sciences and organic chemistry is recommended.

This course covers the stages of drug discovery in which promising compounds (leads) are identified, their optimal and suboptimal characteristics determined, and the suboptimal characteristics optimized to create a candidate suitable for the clinic.  The course is built around a case study on the discovery of an antimalarial therapy.  Assays useful for screening new compounds are outlined, examples of selection criteria for leads are discussed - such as potency, efficacy, and pharmacokinetics - and the structure activity relationships that contribute to the optimization of a lead series are considered.  The phenotypic approach used by the antimalarial program will be briefly contrasted with a target-based program on a different target. Target audience: This course is suitable for life scientists, clinicians, and individuals from fields that support drug discovery (e.g., patents, finance, licensing, etc.) interested in learning more about the pharmaceutical/biotechnology sector. Advanced undergraduate coursework or practical familiarity/working knowledge in biological sciences and organic chemistry is recommended.

This course begins with a review of routes of administration, ADME (absorption, distribution, metabolism, & excretion), and the use of in vivo drug concentration-time data to determine key pharmacokinetic parameters, like volume of distribution, half-life and clearance.  The course then emphasizes in vitro assays that allow rapid prediction of ADME and PK properties for evaluation of new compounds.  The later stages of the course focus on how drug discovery teams study this PK/PD relationship, as well as dose size and frequency predictions which ultimately assist in selection of a compound for advancement into the clinic.   This course is suitable for life scientists, clinicians, and individuals from fields that support drug discovery (e.g., patents, finance, licensing, etc.) interested in learning more about the pharmaceutical/biotechnology sector. Advanced undergraduate coursework or practical familiarity/working knowledge in biological sciences and organic chemistry is recommended.

In this course we will focus on how active compounds are developed into a formulation suitable for dosing in animal studies and early human clinical trials.  Factors such as the route of administration, enhancing the solubility of the drug substance, the crystalline form of the drug substance, drug substance vs. drug product, storage requirements, and how special requirements of the patient population play a role in the design of an ideal formulation will be covered.  Finally, some of the differences encountered when formulating a biologic vs. a small molecule will be discussed. Target audience: This course is suitable for life scientists, clinicians, and individuals from fields that support drug discovery (e.g., patents, finance, licensing, etc.) interested in learning more about the pharmaceutical/biotechnology sector. Advanced undergraduate coursework or practical familiarity/working knowledge in biological sciences and organic chemistry is recommended.

Patient safety is of paramount importance for any drug discovery program.  This course looks at some of the lessons learned which have influenced how promising molecules are currently evaluated for safety risks.  In vitro and in vivo toxicology and safety studies are discussed, why they are performed, and how the data they provide guide a safety risk assessment, including determining a therapeutic index or safety window for a drug.  Finally, the course will look at how safety data guide human dose selection, and some of the studies performed during clinical development. Target audience: This course is suitable for life scientists, clinicians, and individuals from fields that support drug discovery (e.g., patents, finance, licensing, etc.) interested in learning more about the pharmaceutical/biotechnology sector. Advanced undergraduate coursework or practical familiarity/working knowledge in biological sciences and organic chemistry is recommended.