STAT SNAX: Bite-sized Statistical Concepts

Stats Snax discusses basic statistical concepts that apply to the pharmaceutical industry using examples from CMC development areas. Designed for non-statisticians, you will learn foundational concepts that CMC statisticians encounter in their daily interactions with clients.
If you have ever wondered, “What is a p-value?” or “How is expiry determined?” – This series is for you!

Biotechnology 101

This course was developed for those interested in learning more about the field of biologic development and to fill training gaps. It features lectures by leading experts from industry and academia and covers the current state of biotherapeutics.

Formulation Strategies for Oral Delivery of Poorly Soluble Drugs

This course gives an overview of formulation strategies of poorly soluble drugs for drug dissolution enhancement. The presentations, delivered by key thought leaders, highlight fundamental principles, as well as enabling technologies, for solubility enhancement.

Immunogenicity 101: Immunogenicity of Biologically Based Therapeutics

This course provides an in depth overview of beginning through advanced topics for the assessment and interpretation of immunogenicity.

Introduction to Biomarkers

This short course steps through the fundamentals of biomarker assays and their applications in clinical trials. Discussions focus primarily on technologies, key issues in assay development, and regulatory considerations to ensure continuity of experience and best practices, sharing institutional knowledge, and making literature more accessible.

Preformulation 101: Preformulation in Drug Discovery and Development

This course highlights the fundamentals of preformulation studies and the impact of physicochemical, physicomechanical, and biopharmaceutical properties data.

Regulatory Affairs 101: Essentials of Regulatory Affairs for Pharmaceutical Scientists

This course provides an overview as well as cross-functional training in regulatory sciences to better understand current was developed for those interested in learning more about the field of regulatory affairs from the perspective of a pharmaceutical scientist. This course will discuss the expansion of marketing pharmaceutical products in emerging markets such as Brazil, Russia, India, and China and how global regulations impact the current drug development process.

Translational Science 101: Drug Discovery, Development, and Pharmacotherapy

This course features innovative technologies in translational sciences to streamline drug discovery, development, and therapeutics