PPD

DECEMBER 16, 2024

Our annual look at the state of the drug development industry highlights a dual set of challenges complicating progress. Rising costs have become a persistent challenge for drug developers, driven by a combination of internal and external pressures that have intensified in recent years.

Drug Development

thought leadership

JULY 20, 2025

Recent regulatory changes, including the transition from the EU Clinical Trial Directive to the EU Clinical Trial Regulation (EU CTR) , have harmonized approval pathways, enabling Sponsors to submit a single application covering both the applicable regulatory authorities and ethics committees through the Clinical Trial Information System (CTIS).

Clinical Trials

Drug Patent Watch

DECEMBER 11, 2024

Your Drugs Development Stage The stage of your drug development is a critical factor in selecting a CDMO. Adhering to industry standards, a preference exists for utilizing the same CDMO for both development and commercial manufacturing to enhance communication and timeline management.

Pharmaceutical Companies

Drug Target Review

APRIL 7, 2025

For example, transcriptomic processes are showing the potential to identify and track failures in gene expression and gene regulation of amyloid and tau-related biomarkers, understood as precursors to the onset of Alzheimers disease (AD).

Clinical Development

Drug Patent Watch

FEBRUARY 12, 2025

Accelerating Generic Drug Development: Strategies for Success As a pharmaceutical professional, you know how crucial it is to navigate the complex landscape of generic drug development. The generic drug development process involves several stages, from patent research to regulatory approvals.

Drug Development

The Premier Consulting Blog

OCTOBER 30, 2024

To support this, the Innovative Technologies and Advanced Manufacturing Hub (I-TEAM Hub) was created. As outlined earlier in this blog, innovative manufacturing techniques are key for producing superior quality medicine, as improvement in quality manufacturing can limit drug shortages due to quality-related issues.

FDA

Drug Patent Watch

MARCH 4, 2025

The Unseen Heroes of Generic Drug Development: Pharmacovigilance As a generic drug developer, you're no stranger to the challenges of bringing affordable medications to market. But have you ever stopped to think about the unsung heroes of generic drug development?

Drug Development

Drug Target Review

JUNE 11, 2025

Drug development is plagued by complex challenges, but multimodal AI is unlocking new opportunities. By integrating diverse data sources – from genomics to clinical insights – this approach is accelerating drug discovery, improving patient stratification and boosting success rates. Highlighting data integration.

Drugs

PPD

JULY 18, 2025

When small and emerging companies are able to build strong, trust-based relationships with regulators, they often see benefits like reduced development risk and accelerated timelines. When a company applies these approaches, even small or novice drug developers will see increased efficiency.

Regulations

Drug Target Review

JUNE 17, 2025

The dynamic behaviour of RNA transcripts, the regulation and modification of proteins, the lipid composition of membranes, the structural organisation of cells and the spatial context of tissues all play critical roles in disease progression and therapeutic response.

RNA

Drug Target Review

APRIL 30, 2025

The future of AI in CGT AI holds tremendous potential to reshape drug discovery and development in CGT. From precise target identification to optimised gene-editing techniques and streamlined clinical trial designs, AI has the capacity to transform every stage of the drug development pipeline.

Drugs

Perficient: Drug Development

JANUARY 6, 2025

Legal Compliance Many countries have regulations and laws that mandate accessibility in public services, including healthcare. It sends a strong message that the healthcare facility values and respects the needs of all patients, irrespective of their disabilities.

Compliance

Drug Target Review

JULY 7, 2025

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Institutions must invest in secure housing, specialised veterinary care and rigorous training for handlers.

Drug Research

Perficient: Drug Development

MARCH 25, 2025

It’s about keeping your data in check, your regulators off your back, and your systems speaking the same language. Parting Thought In the end, defining a data governance structure for your bank isn’t about creating a bureaucratic nightmare.

Government

The Premier Consulting Blog

APRIL 13, 2025

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ from approved products in other countries) to inform doses and development. Legislation with delayed implementation In 2021, the FDA Modernization Act 2.0

Animal Testing

Drug Target Review

APRIL 7, 2025

Involved in various physiological processes, such as vision, taste, smell, immune response and neurotransmission, GPCRs are activated by various molecules including hormones, neurotransmitters and environmental stimuli, which trigger a cascade of cellular events that help regulate bodily functions. References Sun D, et al. doi:10.1016/j.apsb.2022.02.002.

Fragment Screening

The Pharma Data

JUNE 24, 2025

The streamlined compatibility between instrument and standard minimizes guesswork and method variability, which is especially valuable in time-sensitive drug development timelines. “By Source link

Therapies

Drug Target Review

NOVEMBER 25, 2024

I went on to complete my MBA and PhD at The Institute of Cancer Research (ICR) in drug development. Gender diversity is a hot topic in pharmaceutical and biotech drug development. It used to be the case that drugs were tested only on men. This will then naturally translate into our hiring practices.

Treatment

Alta Sciences

NOVEMBER 15, 2024

4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drug development journey.

Drug Development

PPD

JULY 29, 2025

Insights from our recent FSP Trends Report demonstrate that drug developers are relying more on functional service provider (FSP) and hybrid FSP/FSO models to solve these challenges.

Clinical Trials

PPD

JANUARY 2, 2025

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success.

Clinical Development

PPD

FEBRUARY 10, 2025

Sponsors find that an FSP solution is often the best choice to help advance their drug development projects, whether they need to fill small gaps in services or support large-scale programs with dedicated teams across functions.

Clinical Trials

SugarCone Biotech

JUNE 27, 2025

Let’s dive in… Wave 2: B7-H3 Optimistically named B7-homologue-3, B7-H3, a distant relative of the immune regulatory proteins B7-1 and B7-2, has recently moved into the spotlight - not as an immune regulator but as a target of advanced therapeutic modalities including bispecific antibodies, antibody drug conjugates (ADC) and CAR-T cells.

Therapies

PPD

JULY 8, 2025

AI has applications from the simple to the complex; from automating mundane tasks and accelerating drug development, to increasing accuracy in documentation and uncovering complex correlations within vast datasets. In regulated domains, every step must be documented, auditable and reproducible to meet stringent regulatory requirements.

Clinical Research

DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global counterparts, set rigorous standards to ensure that drugs are safe, effective, and high-quality. Regulatory agencies, such as the U.S.

Drug Development

Alta Sciences

DECEMBER 31, 2024

In Issue 7 of The Altascientist , we delve into these factors, the importance of drug interaction studies, and how to limit adverse effects and maximize treatment response. The potential for an investigational drug to cause DDIs should be investigated in a stepwise manner during drug development.

Therapies

Conversations in Drug Development Trends

OCTOBER 29, 2024

Increasingly, patients and patient-led organizations are playing a pivotal role in shaping drug development, underscoring the importance of collaboration between patient organizations, CROs, and pharmaceutical and biotechnology companies.

Clinical Research

Drug Target Review

MAY 23, 2025

The tight-knit structure of the Poolbeg team allows Tremble to contribute not only to early-stage drug development but also to clinical trial design, patient stratification, and biomarker strategy. It targets the p38 MAP kinase pathway, a key signalling pathway in the body that helps regulate inflammation and the immune response.

Immune Response

Alta Sciences

JULY 18, 2025

Get in touch with us or one of our colleagues to see how our innovative solutions can speed up your drug development process. Benjamin Charron, PhD, Scientist I, Method Development, Altasciences Benjamin joined Altasciences in 2023 after developing bioanalytical sensors in academia for seven years.

Assay Development

Alta Sciences

JULY 23, 2025

With our deep expertise in regulated cellular analysis, our team ensures that every step—from sample collection and processing to transport and analysis—is optimized for precision and speed. Dr. Turcotte is always enthusiastic to share his knowledge and help Altasciences’ partners improve the quality of their drug development programs.

International

Conversations in Drug Development Trends

JULY 3, 2025

In practice, these regulations created substantial bottlenecks. For instance, the regulations required patients to remain in close proximity to the healthcare facility for a full four weeks, which became difficult if the patient needed to transfer hospitals or lived far away from certified centers.

Therapies

FDA Law Blog: Drug Discovery

JANUARY 30, 2025

Conducting with Due Diligence: How Sponsors Attend to the Resources, Monitor Progress, & Modify Study Designs to Complete Confirmatory Trials on Time FDAs authority to require confirmatory trials for a drug approved via accelerated approval have long included the ability to withdraw the drug for failure to conduct such trials with due diligence.

FDA

PPD

JUNE 17, 2025

Biopharmaceutical and biotech drug developers have faced increasing challenges in recent years. In the past decade alone, the time needed to complete a clinical trial has increased by 20–30%, and the cost to bring a new drug to market has risen to an average of about $2.6

Clinical Development

Drug Target Review

APRIL 14, 2025

By preventing infections before they occur, these drugs reduce the need for hospital treatments, including the costly intensive care unit (ICU) care that can burden healthcare systems. The spirulina-based platform Lumen Biosciences approach to drug development is radically different from traditional biopharmaceuticals.

Therapies

Drug Target Review

JUNE 18, 2025

In early-stage drug discovery, pressure is nothing new. Long timelines, strict regulation and scientific uncertainty are part of the job. His experience with early-stage drug developers makes one thing clear: traditional approaches to timelines, team structure and risk no longer stand up to today’s demands.

Drugs

Perficient: Drug Development

MAY 14, 2025

Data security and compliance with regulations like HIPAA, GDPR, or PCI are likely critical requirements for your organization. Assess included AI-enabled features such as IVAs, real-time agent coaching, customer sentiment analysis, etc. Can you demonstrate robust security measures and regulatory compliance?

Compliance

Drug Target Review

MARCH 4, 2025

GLP-1 receptor agonists are a class of medications that mimic glucagon-like peptide-1 (GLP-1), a hormone that helps regulate blood sugar and appetite. These drugs slow digestion, reduce hunger and promote feelings of fullness, making them effective for both type 2 diabetes and weight loss.

Therapies