Conversations in Drug Development Trends

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

Clinical Trials 52

Clinical Trials Trials FDA Drug Development 52

PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. Enable every aspect of your complex oncology trial.

Trials 64

Trials Clinical Trials Therapies Drug Development 64

PPD

OCTOBER 12, 2023

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance.

Laboratories 52

Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

PPD

JULY 9, 2024

Biotech and biopharma companies, however, must do all of this in the face of wildly fluctuating workloads — particularly during the post-marketing phase. Download our white paper The post FSP Flex Hub Teams Maximize Efficiency Across Lifecycle Maintenance appeared first on PPD. Let’s connect.

Compliance 52

Compliance Production Clinical Research Marketing 52

PPD

DECEMBER 19, 2023

According to industry figures, the use of FSP models grew from 28% to 41% in just three years (2018-2021); by 2022, our internal research shows that nearly two-thirds of outsourcing budgets were allocated to FSP or hybrid FSP/FSO models. Read our white paper to learn the keys to successfully implementing functional service partnerships.

International 52

International Research Pharmaceuticals Drug Development 52

Agency IQ

FEBRUARY 21, 2024

As other health authorities started to require data standards, some, such as Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and China’s National Medical Products Administration (NMPA) decided to opt for CDISC for regulatory submissions. CMS in the United States ).

Science 40

Science Regulations International FDA 40

Drug & Device Law

JULY 31, 2023

It’s an interesting topic; Eric recently wrote a paper on it , and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject. no[r] a marketing product” under Lanham Act). Medicis Pharmaceutical Corp. , Leading Market Technologies, Inc. , Paragon 28, Inc.

Production 52

Production International Trials Government 52