Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. What is a Pre-Clinical CRO? billion in 2022 and is projected to reach US$10.2

Clinical Research 52

Clinical Research Clinical Trials Research Trials 52

Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S.

Disease 52

Disease Clinical Trials FDA Approval FDA 52

Conversations in Drug Development Trends

FEBRUARY 21, 2024

Planning for an early AME study with Worldwide will not only satisfy FDA requirements, but its data can also contribute valuable information to the start of your clinical trial and help anticipate what your compound will need for approval, thereby saving time and reducing costs.

Clinical Trials 80

Clinical Trials Pharmacy Clinical Pharmacology FDA 80

NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

ACTIV was founded last April to accelerate drug research that typically requires more than a decade of clinical ups and downs to develop a safe, effective therapy. Cutting through the usual red tape and working with an intense sense of purpose, the partnership took a mere matter of weeks to set up its first four clinical trials.

Clinical Trials 52

Clinical Trials Trials Hospitals Vaccine 52

The Pharma Data

NOVEMBER 10, 2020

Dr. Liu shared his over 30 years of R&D experience in drug development both in the global pharmaceutical companies and world renowned scientific research institutions. By joining Innovent, Dr. Liu will be responsible for global R & D, pipeline strategy, business development and international operations.

Biosimilars 52

Biosimilars Clinical Trials International Clinical Development 52

Agency IQ

JUNE 9, 2023

The problems: Although the current regulation stimulated orphan drug research, it didn’t do enough The regulation fostered development of medicines for rare diseases since implementation, but not enough. Additionally, the smaller potential customer base may provide an insufficient return on the investment into research.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

Codon

JUNE 2, 2024

This discordance, or lack of “ predictive validity ” when translating results across organismal boundaries, is perhaps most harmful in the biomedical field; despite extensive testing in mouse models, only 10 percent of drugs that make it to clinical trials ever make it to market.

Laboratories 115

Laboratories Research Disease Science 115