Recent advances in both disciplines, in fact, allow to re-design the configuration of the sensing elements – either by modifying toggle switches and gene networks, or by producing synthetic entities mimicking key properties of natural molecules.
In all of the projects, synthetic entities are combined with biological agents to engineer biomimetic, tissue-inducing agents.
All these products were based on synthetic entities, and the majority, 12 (75%), were intended for oral use, whereas 4 (25%) were intended for systemic use.
Although not significant, it shows that the odds of authorisation for products based on existing synthetic entities may be about four times higher compared to biotechnological products.
This finding is not unexpected, as the development of existing synthetic entities into drug products is generally considered much more straightforward than the development of a biotech product.
Furthermore, existing synthetic entities compared to biotechnology products tended to have a higher likelihood of reaching approval status (OR = 3.9, 95% CI = 0.9 16.6).
Although the association for innovative synthetic entities [e.g. new chemical entities (NCEs)] such as imatinib was not statistically significant compared to biotechnology products (OR = 2.0, 95% CI = 0.7 6.1), existing synthetic entities, such as arsenic trioxide and busulfan, were associated with higher chances of market authorisation (OR = 3.3, 95% CI = 1.1 10.6).
…the ethical issues that most warrant consideration relate to the possible risks of releasing synthetic entities into the environment… …the ethical issues that most warrant consideration relate to the possible risks of releasing synthetic entities into the environment… Each of these points should be addressed before releasing a synthetic organism into the environment.
Moreover, we found a tendency toward an association for the type of product, with an OR (95% CI) of 3.9 (0.9–16.6) for existing synthetic entities compared to biotechnology products, while no association was observed for innovative synthetic entities compared to biotechnology products (OR = 1.9, 95% CI = 0.5 7.7).
However, in our view, the ethical issues that most warrant consideration relate to the possible risks of releasing synthetic entities into the environment, given that predicting their future behaviour is a challenging task.
