Pharmaust - Media & News, page-138

@Peeteepoo

Post #: 75797151

…has a direct co-relationship with this comment by our CEO/MD recently “Hopefully I was able to outline the many advantages and incentives on offer “

Pete, yes, definitely many incentives and advantages...

Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.

As of June 30, 2024, the FDA has approved 317 breakthrough therapy designated products, and lists that there have been 1516 total requests for the designation with 587 designations granted.

Breakthrough designation gives:

• Intensive guidance on an efficient drug development program
  • taking steps to ensure that the design of the clinical trials is as efficient as practicable

• • • such as by minimising the number of patients exposed to a potentially less efficacious treatment (when scientifically appropriate)

• • i.e. gather the nonclinical and clinical data necessary for approval is as efficient as practicable

• • providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug

• Organizational commitment involving senior managers
  • involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review

• • assigning a cross-disciplinary project lead for the FDA review team to facilitate an efficient review of the development program,

• • and to serve as a scientific liaison between the cross-discipline members of the review team (i.e., clinical, pharmacology-toxicology, chemistry, manufacturing and control, compliance)

• • for coordinated internal interactions and communications with the sponsor through the review division’s Regulatory Health Project Manager

And it really is incentive piled upon further, and much more serious incentives,

Breakthrough includes:

• All Fast Track designation features:

• • More frequent meetings with FDA to discuss the drug's development plan

• • to ensure collection of appropriate data needed to support drug approval

• • more frequent written communication from FDA

• • • about such things as the design of the proposed clinical trials and use of biomarkers,

• • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met

• • Rolling Review,
    • which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA,

• • • rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

• • • BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
    
    Cheers,
    Ice