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As many industry leaders know all too well, the cost of developing a new drug in the U.S. continues to skyrocket.

Despite substantial investment from pharmaceutical companies and other sectors, only an estimated 12% of drugs entering clinical trials are ultimately approved by the Food and Drug Administration.

High development costs in turn have led to high prescription drug prices, with unsustainable costs for the domestic economy and patients alike.

Still, an inordinate amount of attention has been placed on pricing decisions from pharma companies, with insufficient prosecution of the arduous and often unpredictable nature of drug development. 

There is an urgent need to create greater efficiency in the drug development process and to accelerate the speed of drug development. 

Regulatory flexibility and innovation is thus critical to ensuring sustainability in the life sciences.

Various mechanisms exist under the FDA infrastructure for companies to expedite development and review of drugs and biologics for serious or life-threatening conditions. These include fast track designations, breakthrough therapy designations (BTD), accelerated approvals and priority review designations. 

However, when the specific technology, product or therapeutic area is considered, the review process can be subject to non-standardized outcomes. 

More specifically, drug developers have experienced discrepancies in recommendations and decisions between different reviewers within the same division. This can be based on tenure, training and other factors.

Equally worrisome, drug developers encounter discrepancies between different divisions of FDA based on the class and novelty of the product under question. 

Having a more harmonized approach between different divisions and reviewers could ultimately result in more equitable access to drugs — particularly in underserved areas of the country.

It’s been well-established that social and economic factors are known to affect access to biologics and novel therapies. 

Patients with fewer financial resources and access limitations are more likely to use generics and non-biologic drugs — treatments which are traditionally reviewed and approved by the Center for Drug Evaluation and Research (CDER). 

However — when compared to drugs approved under CDER — products under Center for Biologics Evaluation and Research (CBER) are more likely to receive a regenerative medicine advanced therapy (RMAT) designation, a BTD, or to be approved via an expedited pathway such as accelerated approval. 

In 2024, CDER approved seven of the 50 novel drugs (14%) under the accelerated approval pathway. 

Meanwhile, CBER reported a higher approval rate than CDER last year, with nearly 75% of the CBER-approved biologics having a BTD or RMAT designation.

Under the leadership of new FDA Commissioner Martin Makary, it has been encouraging to see certain priorities outlined for reducing timelines for drug development — like the use of real-world data and specific judicious use-cases for artificial intelligence. 

Again, the harmonization of these priorities between CBER and CDER is critical for the industry moving forward. 

A playbook for maximizing speed and efficiency already exists, including but not limited to minimizing the use of placebo-comparators in serious, rapidly progressive and fatal diseases.

Additionally, there is the use of well-characterized natural history data as external controls, adaptive trial designs and trials informed by patient and caregiver input. 

It is time for the life sciences industry to heed this call to action and work together to ensure our communities and loved ones thrive in an equitable way. 

Pharmacoequity requires policies geared at equitable access to the right medicine for all individuals — regardless of race, ethnicity or socioeconomic status.

This should be our north star.