Accelerate oncology drug development: A data-driven approach to clinical decisions
BioPharma Drive: Drug Pricing
MARCH 24, 2025
Speed vs. success in oncology trials: Discover data-driven strategies to accelerate drug development.
Redefining Acceleration of the Drug Development Journey
PPD
NOVEMBER 11, 2024
It is hard to ignore some of the most pressing, long-term trends driving the push to accelerate innovation and progress in drug development. It demands a comprehensive, collaborative approach that reduces complexity and allows for just-in-time decision-making throughout the drug development journey. billion in 2023 to 1.2
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Non‐Hydroxamate Inhibitors of IspC Enzyme in the MEP Pathway: Structural Insights and Drug Development Potential
Chemical Biology and Drug Design
MARCH 18, 2025
The review provides a comprehensive analysis of non-hydroxamate inhibitors for IspC, an enzyme crucial in the MEP pathway, highlighting its structural diversity and improved drug development potential.
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Leveraging AI Solutions for Clinical Trial Efficiencies
PPD
JANUARY 15, 2025
As clinical trials become increasingly complex, particularly in decentralized trials and rare disease studies, sponsors experience increased challenges in site selection, forecasting and resourcing, and patient recruitment and enrollment. Discover how AI is used to optimize key aspects of clinical trial management. Get in touch.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management.
How AI will reshape pharma by 2025
Drug Target Review
DECEMBER 20, 2024
Artificial intelligence (AI) has revolutionised many industries, yet its adoption in pharmaceutical drug development has been notably slower. For years, AI and machine learning (ML) were often dismissed as little more than advanced statistics with little practical value in drug development.
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Key Trends Drug Developers Need to Know to Succeed
PPD
OCTOBER 31, 2024
As the pharmaceutical industry continues to evolve, drug developers encounter new challenges and opportunities in their pursuit of innovation. From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape.
Merck suffers bad week as 3 Keytruda combination trials fail
BioPharma Drive: Drug Pricing
DECEMBER 8, 2023
The setbacks for Merck demonstrate the challenge drug developers face in improving on Keytruda, which has brought in at least $18 billion so far this year for its maker.
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When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities
FDA Law Blog: Drug Discovery
JANUARY 30, 2025
However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.
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Understanding the Regulatory Environment in Japan for Generic Drug Development
Drug Patent Watch
DECEMBER 30, 2024
The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Types of Drug Applications The PMDA accepts three main types of drug applications: Investigational New Drug (IND) : Required for conducting clinical trials in Japan.
Overcoming Orphan Drug Development Challenges with Real-World Data and Evidence
PPD
MARCH 11, 2025
Developing treatments for individuals living with rare diseases is critical, but orphan drug development is laden with unique obstacles that necessitate innovative, multifaceted approaches. Moreover, in some rare disease trials, it is unethical to design a control group of patients with a placebo.
Discovery of 'new rules of the immune system' could improve treatment of inflammatory diseases, say scientists
Science Daily: Pharmacology News
JUNE 18, 2024
Tests, in mice, of a drug developed by the researchers showed that regulatory T cells can be attracted to specific body parts, boosted in number, and activated to suppress immune response and rebuild tissue. Clinical trials in humans are now planned.
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The Real Cost of Complexity: What Every Drug Developer Needs to Know
PPD
DECEMBER 16, 2024
Our annual look at the state of the drug development industry highlights a dual set of challenges complicating progress. Pressure and requirements to engage diverse patient populations in trials have become more challenging and expensive, requiring tailored strategies that can stretch both resources and budgets.
How Clinical Trial Trends are Redefining Drug Development
Quanticate
SEPTEMBER 13, 2024
With the implementation of technology rapidly increasing, stricter regulatory standards, and growing demand for innovative treatments, the trends within the industry continue to evolve, impacting the future of clinical trials both positively and negatively.
Real-World Evidence in Clinical Drug Development
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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Praxis hits trial setback; Bristol Myers lays off staff in New Jersey
BioPharma Drive: Drug Pricing
FEBRUARY 28, 2025
The brain drug developer is continuing a trial despite a recommendation it be stopped for futility. Elsewhere, Eli Lilly struck a molecular glue deal and Zevra sold a priority review voucher.
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Accelerating the new wave of CAR T therapy trials
BioPharma Drive: Drug Pricing
SEPTEMBER 16, 2024
Worldwide Clinical Trials is at the forefront, partnering with drug development teams to map this new path forward. Applying CAR T-cell therapy in new clinical settings presents unique challenges.
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Q&A: How to jump-start new psychiatric and neurological drug development
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. The key problem is that there appear to be many different underlying mechanisms that lead to depression. Biomarkers could take many forms.
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Roche autoimmune disease drug disappoints in closely watched trial
BioPharma Drive: Drug Pricing
MARCH 21, 2024
Though the medicine hit its goal in a Phase 3 study in myasthenia gravis, the results fell short of expectations in a boost to rival drug developers like Argenx and AstraZeneca.
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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development
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.
The evolution of AI in drug discovery: learning from history’s mistakes (Part 2)
Drug Target Review
MARCH 24, 2025
To understand the significance of this goal, it is important to recognise the current drug development process. This uncertainty contributes to the high failure rate and enormous costs of drug development. Currently, understanding these aspects requires extensive animal testing followed by human trials.
Including Patients with Borderline Personality Disorder in Clinical Trials
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.
How to Optimize Drug Development by Combining FSO and FSP Models
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. Overseen by an insourced project manager. Contracts are milestone- or unit-based.
The Growing Role of CROs in Clinical Trials
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.
The Collaboration Between Industry and Academia in Drug Development
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.
Continuous Innovation with WorldwideEdge™ — A World of a Difference in Bioanalytic Operations
Conversations in Drug Development Trends
JANUARY 21, 2025
Rigorous procedures to ensure that drugs are effective and safe. Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. No matter how small, any lack of efficiency can snowball into costly delays in drug approval.
How to Prioritize Pediatric Populations in NASH Trials
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.
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Investigator Initiated Trials (IITs): Introduction, regulatory view, study design preferences, and p …
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.
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Virtual Support Improves Patient, Site and Sponsor Experiences in Clinical Trials
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.
The Data-Driven Future of Drug Development
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. This was seen in the case of the BRAF V600E mutation test for melanoma patients receiving vemurafenib.
Why Including Patients in FDA Engagement Will Benefit Your Trial
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.
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Considering Master Protocol Use in Your Trial: Evaluating Basket and Umbrella Trial Designs
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?
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What Do Patients Have to Say about Gene Therapy Trials? An Upcoming FDA Public Meeting to Hear from Patients and Caregivers
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.
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Patient-Centric Strategies for Successful Oncology Trials
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.
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Liquid biopsy helps advance oncology drug development
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.
Lantern Pharma's Pioneering Role in AI-Driven Oncology Drug Development with the RADR® Platform
DrugBank
JUNE 6, 2024
In the rapidly evolving landscape of oncology drug development, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development. Lantern Pharma's RADR ® platform stands as a pivotal advancement in the fight against cancer.
Pharmacognosy and Drug Patents: Unveiling Nature’s Medicinal Treasures
Drug Patent Watch
DECEMBER 9, 2024
This approach has led to the discovery of numerous potential drug candidates. From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development. Q: How long does a drug patent last?
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Key factors shaping the future of clinical services organizations in the APAC market
BioPharma Drive: Drug Pricing
SEPTEMBER 30, 2024
Clinical services organizations can help pharma with global drug development and clinical trial challenges.
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From Research Studies to Your Pharmacy Shelves: The Drug Development Process
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.
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6 Operational Considerations You Need To Know for Psychedelic Trials
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.
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Retail pharmacies: Biopharma’s bridge to better patient experiences and outcomes
BioPharma Drive: Drug Pricing
JANUARY 27, 2025
Pharmacies play a key role in improving drug development and patient care, offering insights, clinical trial support and personalized patient programs.
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Navigating the challenges and opportunities of AI in drug development and personalised medicine
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.
Enhancing Your Experience: What to Expect From Us in 2025
PPD
FEBRUARY 12, 2025
Unlocking new levels of value with expanded offerings We are launching more dynamic and integrated service offerings that leverage the very latest automation and integrations to accelerate your unique drug development journey in new and different ways.
Preclinical vs. Clinical Biomarkers: Understanding Their Distinct Roles in Drug Development
Crown Bioscience
MARCH 14, 2025
The Importance of Biomarkers in Drug Development Biomarkers have become essential tools in modern drug discovery and development, enabling researchers to predict drug efficacy, monitor disease progression, and tailor treatments to specific patient populations.
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