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.

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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? ”.

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Agency IQ

JULY 7, 2023

What is the state of pharmaceutical quality in the U.S.? Call it murky A new report published by the FDA’s Office of Pharmaceutical Quality (OPQ) promises a look at the current “State of Pharmaceutical Quality.” Read AgencyIQ’s analysis of FDA’s QMM White Paper here.]

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H1 Blog

NOVEMBER 15, 2023

Since KOLs play such a critical role, engaging with the right KOLs is a key strategy for pharmaceutical companies to stay ahead of the game. Compliance ensures that interactions between pharmaceutical companies and KOLs are transparent, fair, and free from any undue influence.

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PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. As a leader in early phase development oncology trials, we are dedicated to using our vast experience to enhance the patient experience and successfully bring new therapies to market.

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PPD

DECEMBER 19, 2023

While the FSP model is growing in popularity and serves a critical role in pharmaceutical development, getting the most out of this model requires dedicated roles to drive implementation, communications and planning. Read our white paper to learn the keys to successfully implementing functional service partnerships.

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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.

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The Pharma Data

DECEMBER 28, 2020

Our new directors are well-recognized for their leadership and accomplishments in the biopharmaceutical, biotechnology and pharmaceutical industries, as well as in public capital markets and corporate governance.” ” The new directors are: Raphael (“Rafi”) Hofstein, Ph.D. Dr. Hofstein received his B.Sc.

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The Pharma Data

JANUARY 6, 2021

… Biopharmaceutical products represent up to 20 percent of the total pharmaceutical market and are growing at a rate of nearly eight percent annually. . DOWNLOAD TO LEARN MORE>>>> Source link.

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The Pharma Data

JANUARY 7, 2021

The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs. Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs).

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Production FDA Pharmaceuticals Marketing 52

The Pharma Data

NOVEMBER 16, 2020

To ensure the safety, quality and efficacy of a drug product prior to market roll out, it is critical life sciences companies can uphold the integrity and security of the data generated throughout an entire product’s lifecycle. For further information on how we process and monitor your personal data click here.

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The Pharma Data

MARCH 20, 2021

Fermentation is used in the production of renewable feedstocks for food products and ingredients, beverages, pharmaceutical compounds, nutraceuticals, through to fine and bulk chemicals. The Kluyver Center applies microbial genomics to improve the performance of microorganisms in industrial fermentation processes.

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FDA Law Blog: Biosimilars

JANUARY 24, 2024

If this vision is achieved, the United States can bring innovative biotechnologies and products to markets faster while building a more robust supply chain ecosystem. generic pharmaceutical industry, resulting in low profit-margins. The first goal under Theme 1—Goal 1.1—is The cost of implementing these technologies must be addressed.

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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.

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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.

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