15 years has passed since the Human Genome Project, involving the identification and mapping of all the genes of the human genome, was declared complete. Work on the project (which formally started in 1990 and spanned 15 years) involved international collaboration between scores of scientific researchers and funding of ~US$3 billion. As one of the world’s greatest collective scientific endeavours, the successful unravelling of the human DNA sequence has paved the way for vast developments in biotechnology innovation and opportunities for advancements in a wide range of fields, from food and agriculture and animal husbandry through to high value human therapeutics.

Biological and molecular medicine has emerged as one of the most anticipated applications of the DNA sequence, with biopharmaceuticals (or biologics) based on recombinant DNA technology and pharmacogenomics-led drug therapy widely capturing the interests of the biotech and healthcare industries.

Using drugs that are gene based or extracted from biological materials, or based on an individual’s unique genome, offers the promise of targeted treatment for illness and disease that is more precise, potentially more effective and with fewer side effects than traditional pharmaceuticals.

But will these biotech advancements fulfil their promise?

Annual global sales of biopharmaceutical medicines are now worth over US$200 billion and represent 20% of the total pharmaceutical market.

Pharmacogenetics, the study of single genes that have major effects on the action of particular drugs has been a recognised science since the 1950s. Pharmacogenomics subsequently developed as a related discipline through realisation that the controls of most drug responses are multi-factorial. However, the growth of pharmacogenomics has really only been made possible recently with advancements in methods that allow the study of multiple genes or gene patterns, such as high throughput sequencing technologies.

Through a deeper understanding of the influence of genetic variation on drug response and the accumulation of knowledge of an individual patient’s genotype, the promise of pharmacogenomics-led drug therapy is that the administration of drugs and other therapies may be made more precise and personalised and could even allow for preventative treatment through predictive prescribing.

However, despite the promise that biologics (particularly those based on gene, cell or tissue engineering) hold for providing a novel range of biological medical products and solutions to problems associated with the delivery of effective and less invasive therapeutics, the roadmap for biopharma and genomic medicine companies hoping to secure a piece of this burgeoning market involves many structural, legal, regulatory and ethical challenges.

So what are the issues that the industry will have to face in 2018 (and beyond)?

Biopharmaceuticals

Pharmacogenomics-led drug therapy