Factors for Ensuring a Successful Launch and Market Access for Specialty Drugs and Novel Cell or Gene Therapies
For the multitude of scientists, researchers, and professionals who are immersed in drug research and development (R&D), clinical trials, regulatory approvals, and other aspects of pre-commercialization, product launch dates seem too far off in the future and may not require immediate focus. However, whether the drug is first-to-market or a new indication, its launch, market access, and commercial success rely heavily upon careful consideration of the challenges as early as before Phase I—prior to the clinical trial phase, or about four to six years into development. This is a significant departure from legacy launch plans, which are now proving woefully inadequate for introducing a specialty drug or novel cell or gene therapy (CGT) in an increasingly complicated and challenging marketplace.
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