Making the decision to work with a consultant during the journey to a drug’s regulatory authorization can help smooth out many bumps along the way. But it’s essential that transparency, full and clear communication, and industry experience are part of the equation.

Experts explain the investment interest by pointing to several trends, spanning new therapeutics, the scale-up of new modalities, and ongoing innovation. But what will it take for these breakthroughs to realize their potential in the clinic and deliver effective treatments to patients?

In an industry where regulatory hurdles, financial barriers and clinical trial enrollment challenges all present obstacles for biopharma, how could COVID-19 vaccines reach patients so quickly? And is it possible to leverage the practices that soared vaccines through FDA emergency use and approvals processes once the pandemic is over?

In an industry where regulatory hurdles, financial barriers and clinical trial enrollment challenges all present obstacles for biopharma, how could COVID-19 vaccines reach patients so quickly? And is it possible to leverage the practices that soared vaccines through FDA emergency use and approvals processes once the pandemic is over?

While developing a drug delivered by injection, an up-and-coming biotech company ran into an all-too-common challenge: Injection site reactions and sub-optimal pharmacokinetics. An attempt to reformulate mitigated the injection site reaction, but the pharmacokinetics were still not where they needed to be.

In biotech, there’s a big difference between “trajectory” and “velocity.” Getting a drug to market quickly, after all, doesn’t always mean that you’re on the path to building a sustainable company. For your biotech to thrive over the long term, it’s critical to continue any forward momentum while ensuring you don’t run out of fuel halfway through your journey.

Summary: In this eBook, learn more about strategies that successful emerging biopharma and biotech companies have used to move their discovery to market.

Strategic analytical partnerships are important in the development of new pharmaceutical products, especially biologics. In this article, experts discuss the growing need for partners who can provide niche technologies to accelerate development projects.

With increased focus and efforts on developing treatments for diseases with smaller patient populations, diseases for which there are no currently approved treatments, and diseases that have historically not prioritized by the pharma industry. Accelerating the approval process offers significant benefits, but the reduced timelines can create significant challenges.

While accelerated development programs are intense by design, few have a similar regulatory experience—particularly when it comes to Breakthrough Therapy Designation (BTD).