BMSC303 - Drug Development

Year

Credit points

Campus offering

Prerequisites

BIOL205 Pharmacology 1

Unit rationale, description and aim

Biomedical science students require sound knowledge of therapeutic agents to enable them to work in the pharmaceutical industry, medical technology field, health information areas or as a springboard for graduate programs.

In this elective unit, students will explore the drug development cycle, molecule discovery to release to the market. Students will gain a broad understanding of the processes and decision making steps in the development of new drugs, investigating regulatory and legal requirements and constraints. The unit will introduce the principles of clinical trailing, from development of the protocol, conduct of the trial and reporting of results. The unit will take a Quality Use of Medicines approach, examining the roles and responsibilities of key players in each phase of development, making reference to the National Medicines Policy. The aim of this unit is to provide studetns with an understanding of the drug development cycle within the context of the National Medicines Policy.

Learning outcomes

To successfully complete this unit you will be able to demonstrate you have achieved the learning outcomes (LO) detailed in the below table.

Each outcome is informed by a number of graduate capabilities (GC) to ensure your work in this, and every unit, is part of a larger goal of graduating from ACU with the attributes of insight, empathy, imagination and impact.

Explore the graduate capabilities.

On successful completion of this unit, students should be able to:

LO1 - Appraise and critique the time, drivers and cost involved to take a pharmaceutical from laboratory discovery to commercial product (GA2, GA4, GA5, GA8). 

LO2 - Compare how active ingredients can be isolated from a biofermentor (e.g. penicillin manufacture) or plant tissue culture (GA4, GA5, GA6, GA8). 

LO3 - Describe differences between research grade and clinical grade preparations of pharmaceuticals, excipients and biologicals in terms of GMP (Good Manufacture Process) needed for clinical trials (GA4, GA5, GA6, GA8). 

LO4 - Critique the difficulties involved in the interpretation of pre-validation results of unknown variables prior to clinical trials (GA4, GA5, GA6, GA8). 

LO5 - Interpret basic information from clinical trials and predict potential problems or concerns associated with a medication based on this data suggesting appropriate follow-up trials and/or monitoring of a new compound (GA4, GA5, GA6, GA8). 

LO6 - Compare and contrast the regulatory controls and reporting requirements associated with the safety of pharmaceutical medicines versus complementary medicines that exist in Australia in the pre-marketing period (i.e. types clinical trial notification and steps to product registration) (GA4,GA5, GA6, GA8). 

Graduate attributes

GA2 - recognise their responsibility to the common good, the environment and society 

GA4 - think critically and reflectively 

GA5 - demonstrate values, knowledge, skills and attitudes appropriate to the discipline and/or profession 

GA6 - solve problems in a variety of settings taking local and international perspectives into account

GA8 - locate, organise, analyse, synthesise and evaluate information 

Content

Topics will include: 

• Natural products as pharmaceuticals (plant alkaloids, antibiotics from fungal/bacterial culture) – historical discoveries with plants, e.g. digitalis from foxglove. 
• Isolation of an active ingredient from bacterial/fungal culture (biofermentors for antibiotics) or plant tissue culture (e.g. plant alkaloid such as the antimalarial artemisinin). 
• Modification of existing structures to produce more effective compounds or to provide temporary solutions to drug resistance (e.g. from quinine to chloroquine, hydroxychloroquine, amodiaquine). 
• Biostructure-based drug design (peptides, organic compounds, antibodies) for: Enzymes, Receptors, Ion Channels 
• Transporters (carrier molecules) 
• Drug modification to improve bioequivalence, solubility, half-life and delivery (e.g. bovine insulin to recombinant proteins and antibodies). 
• Pre-trial validation (tissue culture and animal studies) 
• Clinical trial phases (1-3) and management (TGA registration (CTX or CTN) and Australian New Zealand Clinical Trials Registry (ANZCTR)). 

Protocol development, pharmacokinetics, ethics, risk assessment, drug interactions, considerations for drugs used for prophylaxis versus treatment 

• Regulation of the manufacture of therapeutic goods (GMP) Research grade to clinical grade to scale up processes 

Differences between manufacture of prescription versus complementary medicines 

• Roles of key partners in licencing, monitoring drug safety and pharmacovigilance 

Lifecycle approach to development and regulation (reporting, product recalls and alerts, unforeseen events) – 6 steps to registration of product in Australia, patents and intellectual property protection 

• Maximising therapeutic value: use of approved product for other indications (other applications), earlier interventional use, combination therapies, further formulations and changes to delivery 

Learning and teaching strategy and rationale

This unit uses an active approach with on-campus lectures and workshop classes that are supported by online activities. Lectures allow teachers to convey necessary information so that students can gain an overall understanding and make connections between different components. Lectures will also provide opportunities for students to check their understanding and ask questions. Workshop classes will consolidate student learning in a supported environment. In workshop classes students will work collaboratively and engage in activities such as reading, writing, discussion, or problem solving to promote analysis, synthesis and evaluation of class content. Case studies will also be used so that students can explore how what they have learned applies to real world situations.  

Assessment strategy and rationale

The assessment strategy used allows students to progressively develop their knowledge of drug development from discovery to registration, manufacture legislation to allow production of the final product. The first assessment task is a mid-semester test which will primarily provide studetns with feedback on their knowledge of the various processes involved in drug discovery in preparation for the subsequent assessments. The second assessment task is a written assessment where students evaluate a new drug seeking registration with the regulatory for inclusion on the Australian Register of Therapeutic Goods (ARTG). This authentic assessment task allows students to apply their knowledge of pharmacology to a real situation. The final assessment task is the end-of-semester examination which will assess integration and application key concepts covered in this unit.     

Overview of assessments

Representative texts and references

Krogsgaard-Larsen P, Stromgaard K, Madsen U. Textbook of drug design and discovery. 4th Edition CRC; 2012 

Ng R. Drugs: From discovery to approval.4th Edition Wiley Blackwell; 2015 

Wu-Pong S, Rojanasakui Y. Biopharmaceutical drug design and development. 2nd Edition Humana Press; 2008. 

Hill, RG. And Rang, HP. (2012). Drug Discovery and Development (Technology in Transition) (2nd ed.) Elsevier Health Sciences, UK. 

Smith, DA., Kubinyi, H., Waterbeemd, H., Walker, H. and Walker, DK. (2012). Pharmacokinetics and Metabolism in Drug Design (3rd ed.) Wiley-VCH Verlag GmbH, Weinheim, Germany. 

Castanho, M. and Santos, N. (2011). Peptide Drug Discovery and Development. Wiley-VCH Verlag GmbH, Germany. 

The National Strategy for Quality Use of Medicines (2002) Commonwealth of Australia 

Australian Medicines Handbook (2016) Australian Medicines Handbook