Drug Development with Translational Pharmaceutics

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As the pharmaceutical industry faces increasing pressure to accelerate drug development, many contract development organizations are recommending early development programs. Scientists discussed the current roadblocks in the traditional drug development process and explains how productivity can be improved and timelines shortened by implementing a new approach the company refers to as Translational Pharmaceutics. Be the part of 20th World Conference on Pharmaceutical Chemistry and Drug Design in Dubai, UAE during September 03-05, 2018. Describe the state of affairs of researches, thesis, projects and enlighten us with your innovation and meet pharmacists, apothecaries, druggists, scientists, experts and technologists.

https://drug-chemistry.pharmaceuticalconferences.com

There are many factors that can delay the development and eventual commercialization of novel therapeutics. One of the most intractable factors is the conventional trial-and-error approach to new drug development, under which the drug developer typically decides upon a fixed formulation type and two to three dosage strengths in the preclinical phase, often before completion of toxicology studies. To advance the molecule into first-in-human (FIH) clinical trials, the drug developer then must invest significant quantities of drug substance, which may be in scarce supply, in preparation of large batches of each of these dose strengths as a means to provide sufficient quantities and flexibility of drug product to cover the early development program. When that molecule fails toxicology, or if the selected drug product format turns out to be suboptimal following clinical dosing, the drug developer must start all over again, which will require obtaining regulatory approval for a redesigned trial with a modified formulation or dosage strength. Each iteration of redesign, resubmission, and re-evaluation can significantly delay marketing authorization and commercialization.

One of the biggest challenges in today’s environment is the sheer competitiveness of the marketplace, in which it is imperative for innovator companies to deliver first- or best-in-class medicines. That pressure has increased the emphasis on new molecular targets and disease mechanisms that offer the potential to deliver breakthrough therapies. However, due to the very nature of translational science, the majority of investigational programs will fail at or before proof of concept (POC), resulting in high attrition rates in Phase II.

 For further details visit https://drug-chemistry.pharmaceuticalconferences.com/

Roza Palv
Program Manager- Pharm Chem 2018
Email: pharmaceuticalchemistry@pharmameetings.com

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