Cost Effective and Efficient Progression of Lead Drug Candidates to First in Human Studies in Two Largest Economies in the World: USA and China

Drug discovery and development can be described as the sum of multiple steps taken by biotech and pharmaceutical companies to identify and study new chemical or biological entities and convert these into approved marketed medical products. The entire process takes, on average, more than 10 years and over $1-2B, to bring a product to market.

During this process the attrition rate at all stages of drug discovery and early development are high; hence, sponsors are seeking ways to conduct early-stage drug development studies in the most cost-effective manner. The other consideration is the timeline needed to reach first in human (FIH) studies– the faster we can conduct these studies, the better it is for companies seeking to advance these leads further into development or sell the promising assets to potential buyers who are prepared to conduct additional clinical trials beyond Phase 1 studies. 

The elements of drug development leading to IND submission and the conduct of FIH studies include: Drug Metabolism & Pharmacokinetics (DMPK), Safety/Tox, Bioanalytical (GLP/non-GLP) and CMC. With limited and dwindling resources in biotech/pharmaceutical companies, a significant portion of the task of advancing lead compounds to clinical are now conducted by Contract Research organizations (CROs) who are very well equipped to conduct these early development studies. Very often study sponsors struggle to outsource studies, often in small pieces, to reliable CROs. 

Managing the costs and tracking timelines/samples/reports at multiple CROs often become a very inefficient and costly task. It is important to seek CROs that can provide a one stop shop option to drive cost-savings and efficiency, including accelerated timelines to reach FIH studies. Furthermore, proper project management, resolving issues with the best available science, and ability to provide proper/relevant regulatory guidance, are essential components of this one stop shop facilities. To keep the prices manageable (especially with the high attrition rate), many sponsors are also seeking more cost-effective alternatives overseas, including conducting studies in countries such as China (second largest economy in the world).

Frontage Labs has been engaged in R & D activities over the last 20+ years, with substantial investments in facilities in both USA and China. Over the years, it has built a full-service science-driven organization that has participated in bringing products to the market for numerous clients. With its dual presence in USA and China, and being a strong science and issue driven organization, Frontage is now offering end to end services to advance clients’ lead candidates to FIH at very reasonable cost (estimated to be 50% less than what it costs to conduct these studies internally or outsource to multiple vendors) and with constricted timelines. 

In this presentation we will describe the complete package that Frontage offers to clients seeking to advance their lead candidates to FIH and beyond.

This webinar is sponsored by Frontage.