Chrysalium Consulting SARL, 78470 Saint Rémy lès Chevreuse, France.
Nucl Med Biol. 2013 Feb;40(2):155-66. doi: 10.1016/j.nucmedbio.2012.10.012. Epub 2012 Dec 4.
Four criteria are essential in the acceptance by investors of new radiopharmaceuticals: the existence of a market and a medical need, the quality of the science and technology behind the new molecule, the feasibility and compliance with regulations and the limited competitive landscape. Potential investors need to get more convincing market evidence, largely beyond the nice preclinical data generated to the point of first discussion. A properly protected compound not jeopardized by earlier published results is a must. A guarantee of an easy and secured source of the ligand is obvious. A safe access to the radionuclide in volumes corresponding to the targeted market is rarely taken into account, but of utmost importance. The evaluation of new drugs by investors will include the evaluation of the real market size for the targeted indication and the position of the drug in the healthcare environment at the time to market. This includes the potential competition with other radiopharmaceuticals, but also with conventional drugs or competitive modalities also at time to market. Both criteria are usually not easily accessible to researchers whose acquaintance remains limited to the scientific and technical part. Starting from this set of information, a first business plan can be deduced based on a best estimate for price per dose and a rough evaluation about the chance and level of reimbursement. In the following most of the events are covered that could jeopardize the development of the drug, focusing on the industrial, economic and regulatory aspects, comprehending the detailed analysis of the currently best available radionuclides.
存在市场和医疗需求、新分子背后的科学技术质量、法规的可行性和合规性以及有限的竞争格局。潜在投资者需要获得更有说服力的市场证据，这些证据在很大程度上超出了最初讨论时产生的良好临床前数据。必须有一个受保护的化合物，不受早期发表结果的影响。一种安全且有保障的配体来源是显而易见的。很少有人考虑到，但非常重要的是，放射性核素的安全获取量与目标市场相对应。投资者对新药的评估将包括对目标适应症的实际市场规模的评估，以及药物在上市时在医疗保健环境中的定位。这包括与其他放射性药物的潜在竞争，但也包括与常规药物或竞争模式的竞争，这些也将在上市时进行考虑。这两个标准通常不容易被研究人员获得，因为他们的认识仍然局限于科学和技术部分。从这组信息出发，可以根据剂量的预估价格和对报销的机会和水平的粗略评估，基于最佳估计，制定初步的商业计划。在接下来的内容中，我们将重点关注工业、经济和监管方面的内容，对目前可获得的最佳放射性核素进行详细分析，涵盖了可能危及药物开发的大多数事件。
