How Might Synthetic Biology Be Used in the Development of Pharmaceuticals?

• Current interventions are single molecules (small molecules, monoclonal antibodies, cycle-specific cytotoxics, antimetabolites, etc.) or cellular agents (genetically modified Ag resenting cells for vaccines; stem cell-derived cell therapies for cardiovascular disease, diabetes, etc.).
• Likely to be used to create cellular therapies that are designed to be more target-focused while minimizing current side effects (e.g., avoid HLA incompatibility, avoid hepatic enzyme degradation, avoid need for optimal renal function). 
• Create cells that have gene(s) that produce a therapeutic product more efficiently that in current vectors (E. coli, yeast). 
• Create ‘stem cells’ that can be more readily directed toward differentiation to more reliably and efficiently produce specialized cells for purposes of tissue repair or a therapeutic by-product.
• Create cells of microenvironments that are resistant to the nurturing of malignant cells.
• Of the approaches currently used, the minimalist construction would likely be most attractive to Pharma.  It would minimize adverse interactions with other cells or molecules or systems (like the immune system) and allow for greater control over the cellular consequences of adding or changing genes for therapeutic purposes.
• All Pharma interventions would have to be developed according to a development plan approved in advance by the regulators (FDA, EMA, Health Canada, etc.) in concert with the company.  However, the FDA can’t enforce Pharma conducting and reporting on Phase IV trials after expedited approval so it seems unlikely that they will have the discipline/resources to keep Pharma to its responsibilities for tracking agents post-approval and having a damage-control plan developed a head of time.  Still, the slow pace of developing improved regulations to ensure safety and efficacy in the short and long term may be a rate-limiting step
• Pharma would be interested in developing synthetic DNA constructs with manipulated epigenetic components, particularly for cancer therapy.