In Vivo is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Watchdog And Innovator: Modernizing The FDA-Industry Relationship

Executive Summary

As each medical advance introduces a new regulatory challenge, FDA’s need for reinvention is as constant as industry’s need for innovation. If the agency is going to help sponsors bring breakthrough medicines to market, it must rethink its role as both watchdog and regulatory innovator.

You may also be interested in...



No Obvious Prescription For Biopharma Investors

In our second annual Life Science VC Survey, biopharma investors continue to look to oncology and rare disease, while their cold shoulder toward metabolic disease seems to be warming. Even though most agree the traditional biotech funding model is broken, our participants are far from convinced that new models such as asset-based financing are the answer.

Solution Development: A Model For Structuring Biotechs And Developing Better Drugs

The biopharma industry must think differently about funding high-risk/reward development of drug candidates against novel targets. Multiplexing Phase II proof-of-concept trials can light a path toward lower-risk pivotal studies and provide a model for building biotechs to deliver what patients, providers, payors, and investors all want: solutions.

As Casgevy, Lyfgenia Launches Proceed, CRISPR And bluebird bio CEOs Reassure

The CEOs of bluebird bio and CRISPR Therapeutics hope to inspire investor confidence that their gene-based therapies for sickle cell disease and beta thalassemia will be widely reimbursed in the US and EU.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

IV003762

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel