Remove Biopharma Remove FDA Remove Networking Remove Safety
article thumbnail

Meeting rising demands of a new radiotheranostic era

European Pharmaceutical Review

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Hospital staff must also be protected from radiation while handling the agent.

article thumbnail

Drug repurposing, real world data and AI/ML: perspectives and opportunities

Clarivate

Drug candidates have a high rate of failure, as only 10% of de-novo drugs put through clinical trials finally obtain market approval, with the highest rate of attrition occurring at phase I and II of clinical trials (assessing safety, tolerability, dosage, efficacy, and side effects). This process allows to impute/predict missing links.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

The Caregiver Vertical: How Pharma Engages

Pharma Marketing Network

The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. Extension of the patient: expanding the role of caregivers in biopharma development.

Pharma 98
article thumbnail

ESMO 2022: Ten key takeaways on Europe’s top oncology event

Clarivate

Based on the TROPICS-02 trial results, Gilead has submitted a supplemental biologics license application (sBLA) to the FDA, seeking a label expansion for TRODELVY in the much larger setting of metastatic HR+/HER2-negative breast cancer. Key ESMO findings. months; HR: 0.321, P<0.001). months; HR: 0.321, P<0.001). Market impact.

article thumbnail

Embedding the Patient Point of View in Everything You Do

PM360

Cure” put me on a path to work across a network of incredibly smart, passionate, and well-meaning stakeholders to connect dots, create forums for sharing ideas, drive patient-centered approaches, and eliminate lost-in-translation moments. Fortunately, the industry is increasing its discussions around improving patient inclusion and DEI.

article thumbnail

6 research and development life sciences predictions for 2023

pharmaphorum

Veeva’s industry experts share their predictions about how breaking down silos across clinical, regulatory, safety, and quality teams will benefit patients. This will enable biopharmas to create a more streamlined drug development process rooted in lean process execution and higher-quality data.”.

Safety 108
article thumbnail

The State of the Union in Cancer Innovation

PM360

However, due to conjugation instability and unfavorable safety profiles of currently available ADCs, we can still do more to ensure ADCs are more broadly available and amenable options for the patients who need them. What Other Developments Within Oncology Excite You? When Will this Breakthrough Result in Treatments?