Quanticate

AUGUST 2, 2024

Real-world evidence (RWE) is changing clinical drug development, bridging the gap between controlled clinical trial environments and the complexities of everyday patient experiences.

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Drug Development Clinical Trials Drugs Trials 104

Broad Institute

DECEMBER 18, 2023

Brain disorders are difficult to study and many drug candidates have failed in clinical trials, causing pharmaceutical companies to reduce their investments or even exit the field entirely.

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Drug Development Clinical Trials Drugs Disease 130

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

Clinical Development 69

Clinical Development Production Clinical Trials Treatment 69

Drug Target Review

DECEMBER 23, 2024

While these therapies hold great promise for improving cancer treatment outcomes, their development presents significant challenges, especially in achieving the optimal balance between efficacy and safety. To explore these challenges further, we spoke with Cheng Wang, a postdoctoral researcher at the University at Buffalo.

Research 52

Research Treatment Therapies Drug Development 52

Drug Patent Watch

DECEMBER 9, 2024

In the vast realm of pharmaceutical research and development, there’s a fascinating intersection between ancient wisdom and modern science. This intersection is where pharmacognosy meets drug patents, creating a unique landscape that shapes the future of medicine.

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Drugs Drug Development Pharmaceuticals Production 97

Antidote

JULY 8, 2022

This includes the six to seven years that the medicine will go through clinical trial phases, plus a few others that we’ll discuss below.

Pharmacy 98

Pharmacy Drug Development Clinical Trials Research 98

ProRelix Research

MAY 15, 2023

Clinical Research Organizations (CROs) are companies that provide support to the pharmaceutical and biotech industries by managing various aspects of the drug development process and conducting clinical trials. In this […] The post Clinical Research Organizations: Importance, Services, Selection Process and Future.

Clinical Research 97

Clinical Research Research Clinical Trials Drug Development 97

PPD

JULY 29, 2024

In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drug development.

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Clinical Research Clinical Trials Research Trials 98

Conversations in Drug Development Trends

JANUARY 21, 2025

Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. Rigorous procedures to ensure that drugs are effective and safe.

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Clinical Trials Laboratories Trials Drug Development 78

Conversations in Drug Development Trends

MAY 10, 2024

Over the past two decades, industry-sponsored clinical trials have targeted treatments for BPD, yielding some promising outcomes; however, broader psychiatric research often excludes BPD patients, a trend that extends to the emerging field of psychedelic studies.

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Clinical Trials Trials Treatment Drug Development 95

Conversations in Drug Development Trends

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

Research 52

Research Clinical Trials Therapies Immune Response 52

PPD

JULY 6, 2023

It’s estimated that nearly three out of every four clinical trials are conducted by contract research organizations (CROs), highlighting just how much sponsors value — and rely on — the work that CROs perform. Surveys show that CROs improve trial efficiency and increase productivity.

Clinical Trials 98

Clinical Trials Trials Drug Development Testimonials 98

PPD

SEPTEMBER 6, 2023

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster.

Drug Development 98

Drug Development Clinical Trials Drugs Clinical Research 98

ProRelix Research

APRIL 5, 2023

Clinical trials form the decisions for regulatory approval of drugs and medical devices and as a result are the most important step of a drug development program.

Trials 98

Trials Clinical Trials Drug Development Research 98

DrugBank

AUGUST 15, 2024

Drug development is challenging, including not only the complexities of biomolecular drug mechanisms but also the convolutions of regulatory pathways and commercialization strategies. This includes funding large-scale clinical trials and establishing robust manufacturing/distribution networks.

Drug Development 80

Drug Development Clinical Trials Drugs Therapies 80

Codon

NOVEMBER 3, 2024

Even after microbiologists discovered the bacterium that causes the illness in 1882, it wasn’t until the 1920s that researchers were able to develop a vaccine for TB. As an undergraduate biology student, I spent some time in a TB lab working on antibiotic resistance — a growing concern for drug developers.

Vaccine 96

Vaccine Trials Therapies Clinical Trials 96

PPD

JUNE 7, 2023

Food and Drug Administration (FDA) for approval , much work remains for drug developers aiming to advance treatments for pediatric populations. Reflecting Patient Diversity in NASH Trials Data from NASH clinical trials within adult populations may support clinical research into treatment for pediatric populations.

Trials 98

Trials Clinical Trials Clinical Research Disease 98

Broad Institute

OCTOBER 11, 2023

Manguso, who’d recently graduated from college and was conducting research at the University of Copenhagen as a Fulbright scholar, moved back to the Boston area to be with his mother as she underwent treatment. By then, a few cancer immunotherapies had entered clinical trials and only a handful had been approved by the FDA.

Research 137

Research Immune Response Clinical Trials Therapies 137

PPD

AUGUST 14, 2024

Clinical trials have significantly increased in complexity over the last 20 years, creating new challenges. One of the top reported challenges facing drug developers today is recruiting, enrolling and retaining the right patients for studies. The increase in complexity isn’t just creating challenges for patients.

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Clinical Trials Trials Clinical Research Research 92

Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

FDA 96

FDA Trials Clinical Trials Disease 96

DrugBank

OCTOBER 17, 2024

Data science has emerged as an innovative tool in the biopharmaceutical industry, leveraging the power of machine learning and artificial intelligence to drive innovation and efficiency across the entire drug development lifecycle.

Drug Development 70

Drug Development Metabolic Stability Clinical Trials Drugs 70

Broad Institute

NOVEMBER 2, 2023

Bayer and Broad Institute extend cancer therapy research collaboration By Corie Lok November 2, 2023 Breadcrumb Home Bayer and Broad Institute extend cancer therapy research collaboration Long-standing industry-academia collaboration has already resulted in three clinical oncology candidates.

Therapies 105

Therapies Research Small Molecule Clinical Trials 105

FDA Law Blog: Drug Discovery

MARCH 13, 2023

Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). By Larry J.

Therapies 98

Therapies Trials FDA Clinical Trials 98

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. Many of these patients’ conditions are disabling.

Trials 69

Trials Clinical Trials Drug Development Therapies 69

PPD

FEBRUARY 12, 2025

Its important for your clinical research organization (CRO) to continually assess and invest in capabilities that help drive the success of your clinical program. There are three core areas we are strategically addressing this year. They include: 1.

Clinical Supply 69

Clinical Supply Clinical Trials Drug Development Clinical Research 69

PPD

MAY 18, 2023

For neurodegenerative disease research, the care partner, or caregiver, is equally important as the person with dementia. Even with stronger awareness of studies, drug developers must contend with the inherent lack of trust between the dementia community and clinical trials. There’s little time to lose.

Clinical Trials 86

Clinical Trials Trials Clinical Research Doctors 86

Conversations in Drug Development Trends

OCTOBER 26, 2022

Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. Psychedelic trials need to be done with scientific rigor. Our team published recently in The Journal of Psychedelic Psychiatry exploring how we can bring more rigor to these trials.

Trials 97

Trials Clinical Trials Licensing Licensing 97

Conversations in Drug Development Trends

MARCH 1, 2024

These designs facilitate streamlined trial logistics and centralized governance and create higher-quality data. Master protocols allow a trial to perform multiple tests on diverse patient populations or diseases under a unified design. Do you have various stakeholders invested in the success of your development programs?

Trials 78

Trials Disease Drug Development Clinical Trials 78

Drug Target Review

DECEMBER 16, 2024

Dr Pooja Hingorani, Senior Medical Director of Oncology Early Development at AbbVie , shares her journey in STEM, from her early days in New Delhi to her impactful career in oncology research and drug development. Opportunities in clinical research and drug development were not always easy to come by.

Medical Schools 52

Medical Schools Clinical Research Drug Development Trials 52

Drug Target Review

JULY 18, 2024

Why is detecting cancers via liquid biopsy before they become visible on imaging important for drug development, not just diagnostics? We believe liquid biopsy is very helpful for oncology drug development because the reduction and clearance of circulating DNA occurs quickly before radiographic imaging is available.

Drug Development 59

Drug Development Clinical Trials Drugs Vaccine 59

Drug Patent Watch

DECEMBER 12, 2024

Understanding the Pharmaceutical Market Dynamics The pharmaceutical industry is a complex ecosystem where branded drugs and generics coexist, each playing a vital role in patient care and market dynamics. Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period.

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Licensing Licensing Drugs Biosimilars 96

Drug Target Review

OCTOBER 30, 2024

Now take a step further: envision testing drugs in these organoids to identify the ones that can treat disease safely and effectively without needing to run expensive clinical trials first. Creating replicas of organs in vitro has been a goal of researchers for over a century.

Treatment 105

Treatment Disease Clinical Trials Molecular Biology 105

PPD

FEBRUARY 10, 2025

A recent white paper from the PPD clinical research business of Thermo Fisher Scientific details how these functions have evolved over the years to the point where multiple outsourcing models are now commonly utilized. Electronic medical records (EMRs), for example, exemplify the evolving role of technology in clinical trials.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

Drug Target Review

JULY 18, 2023

Artificial Intelligence (AI) is poised to transform the field of target discovery in drug development, offering immense potential to enhance efficacy, personalised medicine, and accelerate the development of innovative compounds.

Drug Development 98

Drug Development Drugs Clinical Development Pharmaceutical Companies 98

Conversations in Drug Development Trends

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. What Differentiates Mid-Size CROs?

Clinical Trials 136

Clinical Trials Clinical Development Trials Pharmaceutical Companies 136

PPD

SEPTEMBER 16, 2024

The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drug development. In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery.

Clinical Development 98

Clinical Development Clinical Trials Clinical Research Trials 98

DrugBank

AUGUST 9, 2024

Investment Trends in Pharmaceutical Research and Development Investing in the pharmaceutical sector presents a unique set of challenges and opportunities; let’s examine them in more detail.    The average cost of bringing a new drug to market is about $2.6

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Pharmaceuticals Research Pharmaceutical Companies Clinical Trials 76