FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

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. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

Clinical Development 69

Clinical Development Production Clinical Trials Treatment 69

PPD

MARCH 11, 2025

Breaking through research barriers Challenge #1: Small groups of patients Rare diseases impact a small number of individuals, making it difficult to recruit enough participants for clinical trials. Moreover, in some rare disease trials, it is unethical to design a control group of patients with a placebo.

Drug Development 52

Drug Development Clinical Trials Disease Trials 52

PPD

JUNE 20, 2024

Acceleration in every step of clinical research is critical to pharmaceutical developers. Yet, today’s clinical research sponsors face significant challenges. Rather than accepting the persistent delays in clinical research as disruptive, yet unavoidable, we believe they underscore the need for greater efficiency.

Clinical Research 52

Clinical Research Research Clinical Trials Pharmaceuticals 52

Vial

MARCH 6, 2024

The field of clinical research is a dynamic and rapidly evolving one. One way to ensure that you are at the forefront of these developments is by attending clinical research conferences. AACR, founded in 1907, is the world’s oldest and largest professional organization dedicated to advancing cancer research.

Clinical Research 52

Clinical Research Research Clinical Trials Trials 52

Conversations in Drug Development Trends

MAY 30, 2024

Authors: Rich Worldwide Clinical Trials Exec. These advancements have fostered increased focus from politicians, policymakers, and the investment communities backing academic and industry-sponsored research projects. Available across the globe Established efficacy in two adequate and well-controlled trials.

Treatment 81

Treatment Clinical Trials Small Molecule Therapies 81

PPD

OCTOBER 9, 2023

“Patient-centric” is used frequently to describe today’s clinical trial and health care landscape. The industry applauds that point of view and strives to include a patient-centric approach in all aspects of clinical trial designs. Patient centricity has become more than a key consideration.

Clinical Trials 98

Clinical Trials Trials Compliance International 98

Quanticate

SEPTEMBER 27, 2024

Advancements in preclinical and clinical research are driving major changes across various therapeutic areas, steering the industry into a new phase of medical innovation. Our aim is to provide valuable insights for industry professionals, stakeholders, and all those invested in the future of medical science.

Clinical Research 52

Clinical Research Research Pharmaceutical Companies Science 52

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

Trials 80

Trials Clinical Trials Regulations FDA 80

PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. Site selection presents barriers and opportunities As cell therapies expand in Asia-Pacific, areas with large hospitals are often the main hubs for innovation.

Therapies 97

Therapies Clinical Trials Clinical Research Trials 97

PPD

NOVEMBER 16, 2023

In clinical research, access to timely, curated data is critical to mitigate risk and drive operational effectiveness. One common challenge for clinical trial sponsors is coordination of data across an array of vendors and systems. Expertise to easily assimilate diverse data systems and anticipate gaps.

Clinical Research 59

Clinical Research Research Clinical Trials Trials 59

Vial

DECEMBER 4, 2023

Clinical research is an integral component of the healthcare ecosystem. The success of clinical research hinges crucially on patient participation; however, attracting and retaining participants can often pose significant challenges. Patient Payments in Clinical Research: Perception Over the Years In the U.S.,

Clinical Research 52

Clinical Research Research Clinical Trials Regulations 52

On Medicine

FEBRUARY 8, 2024

This is in contrast to reactive deprescribing, which is stopping a medicine in response to present harm, e.g., when side effects of a medicine cause a person to fall. Why is the CHARMER trial important? The CHARMER trial aims to i ncorporate proactive deprescribing as a routine aspect of care in Older People’s Medicine wards.

Hospitals 109

Hospitals Trials Doctors Clinical Research 109

National Drug & Alcohol Research Centre Blog

JULY 13, 2021

NCCRED was funded through the Strategy, and commenced in 2018, to build clinical research capacity and work towards establishing evidence-based treatment approaches for both methamphetamines and other emerging drugs of concern. Why do a clinical research priority setting study?

Clinical Research 52

Clinical Research Research Clinical Trials Trials 52

PPD

NOVEMBER 7, 2023

The underrepresentation of diverse groups in clinical research is an area of regulatory, scientific and industry focus, partly due to the recent U.S. Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”

Clinical Trials 59

Clinical Trials Trials Clinical Research Disease 59

PPD

AUGUST 28, 2024

For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. This is why oncology trials must be built around patient needs, and sponsors need to balance the complexity of oncology trials with a patient-centric mindset. Many of these patients’ conditions are disabling.

Trials 69

Trials Clinical Trials Drug Development Therapies 69

Fierce BioTech

DECEMBER 23, 2024

As Phase 1 clinical trials include several different design types with multiple objectives (e.g. png Listing Introduction Join this webinar to receive expert guidance and learn key considerations for successfully planning pharmacy activities in early phase trials. Listing Image DrVince_ListingLogo_250x190.png

Pharmacy 52

Pharmacy Trials Clinical Trials Clinical Development 52

Drug Target Review

DECEMBER 16, 2024

In this interview, she discusses her path to becoming a physician and clinical researcher, the obstacles she faced, and her dedication to improving outcomes for cancer patients. Dr Hingorani also shares insights into the strengths women bring to STEM, the importance of mentorship, and her vision for the future of oncology research.

Medical Schools 52

Medical Schools Clinical Research Drug Development Trials 52

PPD

DECEMBER 16, 2024

The drug development industry faces rising costs and increasingly complex protocols as top challenges, with 49% of developers citing costs as their primary concern and 39% pointing to protocol complexity as a key hurdle, according to a recent survey of 150 drug developers worldwide by the PPD clinical research business of Thermo Fisher Scientific.

Drug Development 52

Drug Development Clinical Trials Compliance Trials 52

Vial

JUNE 24, 2024

The fields of artificial intelligence (AI) and machine learning (ML) are increasingly influencing clinical research and development (R&D). Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery.

Clinical Trials 52

Clinical Trials Trials Clinical Research Treatment 52

Vial

JUNE 12, 2024

Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinical research. PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated.

Clinical Trials 52

Clinical Trials Trials FDA Clinical Research 52

The Pharma Data

MARCH 11, 2021

Eli Lilly and Company (NYSE: LLY) today announced that data from programs across its oncology portfolio and pipeline will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, to be held virtually April 10-15, 2021. LY3484356, an oral SERD, is currently being studied in a Phase 1/2 clinical trial.

Research 52

Research Clinical Trials Trials FDA Approval 52

Advarra

AUGUST 14, 2023

The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight deadlines. The clinical trial process is both expensive and time-consuming, and ends more often in failure than success. Advarra surveyed 1,000 random U.S. In total, 82.8%

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

PPD

SEPTEMBER 7, 2023

For more than 40 years, drug developers have been dedicated to advancing HIV clinical research in the quest for treatments and, ultimately, a cure. But they also present challenges for both patients and drug developers — and underscore the urgent need for a functional cure. million new infections in 2022.

Clinical Trials 52

Clinical Trials Trials Clinical Research Drug Development 52

Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. This allows the IBC to assess whether the clinic has the facilities to safely handle the IP and prevent exposure or release at that site.

Engineering 52

Engineering Clinical Research Research Virus 52

Vial

JUNE 18, 2024

The success of clinical trials hinges on increasing access to participation by all eligible patients, including populations that have been underrepresented due to the barriers highlighted below. Specifically, U.S. Patients underlined the need for transparency by pharma and other related companies to build trust and partnership.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

Broad Institute

NOVEMBER 25, 2024

As a proof of concept, a drug designed to target a newly discovered biological node is showing efficacy in treating rare genetic diseases in the kidney, the eye, and the brain and is now making its way to clinical trials in collaboration with a pharmaceutical partner. You can learn more about how clinical trials work here.

Clinical Trials 52

Clinical Trials Disease Trials Therapies 52

PPD

SEPTEMBER 25, 2023

As the clinical trial landscape evolves, drug developers are faced with novel challenges and changes in study recruitment, trial size and structure, and more. Decentralized Trials Digital and decentralized clinical trials  (DCTs) continue to expand and have become a standard solution for drug developers.

Drug Development 104

Drug Development Clinical Trials Drugs Trials 104

PPD

JANUARY 5, 2023

In an industry survey led by PPD, Thermo Fisher Scientific’s clinical research business, rare diseases emerged as a top therapeutic area in drug developers’ pipelines, with 39% of global biotech and biopharma leaders pursuing therapies in the broad rare disease space.

Disease 52

Disease Trials Clinical Trials Clinical Research 52

The Pharma Data

JANUARY 14, 2021

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. The ASCO GI presentation slides are available on the company’s website.

Trials 52

Trials Treatment Therapies Clinical Trials 52

Advarra

MARCH 14, 2023

AMCs and Health Systems Integrating a clinical trial management system (CTMS) enables the regulatory team to pull protocol details and place them into eReg. This saves staff members time since they do not have to look up individual records to make sure credentials are present for each one.

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

PPD

JUNE 29, 2023

Finding the right patients, connecting with the right sites and leveraging the right expertise present challenges. To be competitive, drug developers must run their trials efficiently and within budget and timelines, while still maintaining quality to support authorization.

Clinical Trials 52

Clinical Trials Trials Drug Development Clinical Research 52

Advarra

OCTOBER 14, 2022

In the context of decentralized clinical trials (DCTs), we have seen an explosion of new devices and apps interacting with participants and collecting information throughout a trial, all with the participant never setting foot in a traditional clinical research site. What is this innovation?

Clinical Trials 52

Clinical Trials Trials FDA Clinical Research 52

The Pharma Data

SEPTEMBER 10, 2020

Full data from the Phase 3 CROWN study in lung cancer will be presented during the Presidential Symposium. Data to be presented include findings from the Phase 3 CROWN study of LORBRENA ® (lorlatinib)* in first-line ALK-positive non-small cell lung cancer (NSCLC), building on Pfizer’s extensive heritage in precision medicine research.

Therapies 52

Therapies Clinical Trials Production Trials 52

Conversations in Drug Development Trends

JUNE 13, 2024

The FDA Oncology Center of Excellence (OCE) is committed to further enhancing oncology research and as a result, has recently implemented several projects aimed to revolutionize oncology clinical trials. However, BLRM tends to be more conservative compared to other Bayesian designs, prioritizing patient safety above all else.

Trials 52

Trials Clinical Trials Drug Development Clinical Development 52

Vial

FEBRUARY 21, 2024

Clinical trials are needed to determine whether a medical device can produce sufficient proof of its efficacy. However, medical device sponsors and developers are limited by the complex regulatory processes and the high costs associated with the design of running clinical trials for their products.

Clinical Trials 52

Clinical Trials Trials Compliance Regulations 52

Conversations in Drug Development Trends

MAY 23, 2024

By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology.

Trials 52

Trials Clinical Trials Therapies Treatment 52

The Pharma Data

APRIL 12, 2022

20% variant allele frequency reduction – At the time of analysis with > 2 year follow up the survival estimate was 100% in patients who had improvements in bone marrow fibrosis or variant allele frequency – Results were presented at the American Association for Cancer Research annual meeting.

Medical Schools 52

Medical Schools Trials Disease Clinical Development 52