Advances in Basic Molecular Science and Its Influence on Medicine

There have been recent advances in basic molecular science which are attributed to the exponential advancements in technology. As a result, there has been an improvement in the therapies that target unique biological mechanisms that are involved in patient illnesses. Consequently, the medicine under evaluation can become personalized to the patient in that it is possible to evaluate the medical history of the patient, the risk of the disease, and pathology through a fully customized approach.

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There are significant advantages that will come by acquiring the asset. There is a high chance that the regulatory board of US Food and Drug Administration will approve the scientific research because there was a positive response to Phase two. The positive results were more elevated to the United States population which comprised of more than half of the population sample used. A good example is the first diagnosis of a malignant AF case where 127 out of 267 patients demonstrated a definite trend towards superior benefit. As a result, this showed a 30 percent risk reduction when compared to other drugs like TOPROL-XL. Such positive feedback shows give a competitive advantage which increases the probability of approval. Since regulatory approval decisions are highly dependent on evidence of efficacy and the safety that will be gathered from the longer phase 3 investing in the idea will be advantageous because a lot of the present information gathered from the previous stages is in favor of the research.

Also, since there is enough evidence that the drug can work, the chances of investment by a more prominent company to bring the drug to a realization are higher. It is no lie that the cost of bringing a new drug to the market is quite high. It is quite unfortunate that the massive investment in research and development is not corresponding to an increase in successful approval of the products. There is much to be gained from a more efficient Phase three trial because it will ultimately lead to higher chances of getting approved and in turn helping out many of the ill people in need of a better and more efficient drug.

It is also possible to conduct the phase without compromising the rigorous safety standards set by the Food and Drug Administration. This can be done by having a novel clinical design which capitalizes on the knowledge obtained from the subpopulations of the patients for which therapy may be more efficient. As a result, the regulatory success rates will be higher, and there will be a more cost-effective and time conscious delivery of the product to the patients who have responded positively to the therapy. As a result, there will be a win-win situation.

Since the company will implement an adaptive design in its research, there is a balance of both security and flexibility which are good PROS for the company to take into consideration.

From the above-discussed pros, the development plan can, therefore, be de-risked by ensuring that there are clear standards of approval and using an adaptive design will give faster results and accelerate approval in turn.