Introduction to the Course

• Instructor: Rosanna Janick (Reza)

• Course Outline:

  • Two sessions this week, one next week, sessions continue with another instructor, Doctor Stevens, returning with Reza in December.

• Course Resources:

  • Lecture slides uploaded 24 hours before class.

  • Recorded lectures available, potential delay in access.

  • Self-study materials and sample questions available online.

  • Questions about materials can be discussed in class or via email.

  • Class participation encouraged, particularly in Poll Everywhere questions.

Class Participation

• Purpose of Poll Everywhere Questions:

  • Gauge knowledge on topics to tailor depth of content.

  • Review discussed topics and provide sample exam questions.

  • The questions are not the exact exam questions but help improve discussions and understanding.

• Homework:

  • May be assigned, not turn-in or graded until December homework will be graded.

• Communication with Instructor:

  • Email for questions or office hours can be arranged.

  • Experience suggests that student questions can guide review sessions and revisions.

Exam Structure

• Exam coverage includes content from Reza's lectures and Doctor Stevens' sessions.

• Common exam question types:

  • Multiple choice, true/false, fill-in-the-blank questions based on lectures and self-study materials.

  • Focus on fundamental concepts and applications, not memorization of detailed structures or names of products.

Introduction to Biologics

• Focus on:

  • Large molecule drugs

  • Definition: "Biologics" are defined as newly developed therapeutics, primarily proteins.

• Importance of understanding the differences between biologics (large molecule drugs) and traditional small molecule drugs in pharmacy practice.

Significance of Biologics

• Current trends indicate that biologics represent a notable and rapidly growing category in the therapeutic market.

• Discussion points:

  • Growth in protein drug significance and the expanding number approved by the FDA over recent years.

  • Proven impact of biologics, specifically monoclonal antibodies, in therapeutic use, particularly in oncology.

  • Presentation of data emphasizing the rise in biologic approvals versus small molecular entities.

Understanding Protein Drugs

• Biologics primarily consist of proteins; they are larger than small molecule drugs and differ significantly in structure and type.

• Common Types of Protein Drugs:

  • Monoclonal antibodies (mAbs) are central to biologics.

  • Other therapeutic proteins may include hormones (e.g., insulin), enzymes (e.g., collagen), and cytokines.

• Major Points of Discussion About Protein Drugs:

  • Need to acknowledge their larger size (e.g., antibodies around 150 kDa) compared to small molecules.

  • Factors influencing pharmacodynamics, including the methods of administering these molecules (e.g., via injections not oral).

Market Overview

• Discussion on FDA approval rates and the significance of biologics in market comparisons, highlighting trends showing eight of the best-selling drugs being biologics.

• Examples of successful biologics:

  • Humira (adalimumab) – anti-TNF alpha, used for autoimmune diseases

  • Keytruda (pembrolizumab) – cancer treatment.

• Additional insights into therapeutic areas utilizing monoclonal antibodies and their impact on medicine.

Key Comparison with Small Molecule Drugs

• Size Comparison:

  • Small molecules are generally under 1 kDa; biologics can reach upwards of 150 kDa.

• Stability and Production:

  • Biologics cannot be synthesized like small molecules; they require living systems for production and are subject to degradation, oxidation, and various related complications.

• Safety and Side Effects:

  • Biologics often have improved target specificity resulting in fewer side effects compared to small molecules.

• Regulatory Considerations:

  • Distinction in handling generics (for small molecules) versus biosimilars (for biologics) due to the complexity in their structures and manufacturing processes.

Mechanism of Action for Biologics

• Major Mechanisms:

  • Monoclonal antibodies typically are used to target specific antigens leading to various immune responses.

  • Single target mechanisms involve blocking specific proteins or receptors.

  • Conjugated antibodies assist in delivering therapies directly to affected cells, increasing efficacy and reducing side effects.

  • Multi-specific antibodies allow targeting multiple antigens simultaneously, improving treatment modalities in cancer therapies.

  • Description of effector functions that incorporate immune system actions (e.g., complement-dependent cytotoxicity) and engagement of other immune cells for enhanced therapeutic action.

Issues with Biologics

• Addressing the inherent vulnerabilities: Biologics are prone to degradation and aggregate formation, leading to adverse reactions including reduced efficacy.

  • Highlight specific cases such as drug-induced secondary loss of response due to the body developing anti-drug antibodies.

• Importance of managing handling and administration practices to ensure product stability. Use of devices (e.g., closed system transfer devices) and mechanical agitation considerations are also critical.

Conclusion and Future Directions

• Recap of significant learnings on biologics. Need for pharmacy practices to adapt to these new modalities and innovations in the therapeutics space.

• Encouragement for students to stay engaged in ongoing discussions and exploration of these complex topics as they relate to their future careers.