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. With the new EU HTA Regulation impacting orphan medicines, navigating these pathways has become even more challenging.

Drug 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

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

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 Target Review

APRIL 30, 2025

In the rapidly evolving field of cell and gene therapy (CGT), the ability to manage complex biological data, optimise manufacturing processes, and accelerate drug discovery is crucial. The future of AI in CGT AI holds tremendous potential to reshape drug discovery and development in CGT.

Drugs

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 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.

Drugs

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

The Premier Consulting Blog

OCTOBER 30, 2024

In recent years, advanced manufacturing has gained traction in the pharmaceutical industry, transforming how drugs are developed, produced, and delivered. It is recognized, however, that there is a learning curve across the industry and FDA that is inherent to the development of such novel technologies.

Regulations

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

Drug Target Review

APRIL 7, 2025

The challenge of GPCR drug discovery G protein-coupled receptors (GPCRs) are one of the most desirable and challenging target classes in drug discovery, as their mutation can lead to a wide range of diseases such as cancer, cardiovascular disorders and neurological conditions.

Fragment Screening

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

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

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).[ One great example is the FDAs 505(b)(2) New Drug Application (NDA) pathway. Legislation with delayed implementation In 2021, the FDA Modernization Act 2.0

Animal Testing

Drug Target Review

AUGUST 6, 2025

The approach could offer a new angle on a disease that has thus far resisted most conventional drug development strategies. It’s been like a detective story,” says Stephen Pinkosky, Vice President of Drug Discovery and Early Development at Esperion.

Therapies

Drug Target Review

NOVEMBER 25, 2024

As the CEO of iOnctura, an innovative oncology biopharmaceutical company she co-founded in 2017, Catherine has played a key role in advancing the development of highly targeted small molecules aimed at revolutionising cancer treatment. I went on to complete my MBA and PhD at The Institute of Cancer Research (ICR) in drug development.

Treatment

The Pharma Data

JUNE 24, 2025

Biologic drugs, including monoclonal antibodies, have become essential in the treatment of a wide array of conditions, from autoimmune diseases to various cancers. For manufacturers, researchers, and regulators alike, this alliance represents more than a logistical convenience—it’s a blueprint for the next era of therapeutic innovation.

Therapies

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. It’s equally important to communicate your long-term plans.

Drug Development

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. Documentation/medical writing : Regional regulatory agencies (such as the U.S.

Clinical Development

Drug Patent Watch

FEBRUARY 26, 2025

The Complex World of Biologic Drugs: Navigating Patent Applications As a biotech professional, you're likely no stranger to the intricacies of developing life-changing treatments. But have you ever stopped to think about the patent landscape surrounding biologic drugs? It's a complex world, to say the least.

Drugs

Drug Target Review

MAY 23, 2025

At the forefront of this development is Dr Liam Tremble, Principal Scientist at Poolbeg Pharma, whose background as an immunologist and cancer researcher gives him a unique perspective on this promising drug. “It takes a family to develop a drug and identify the opportunities and pitfalls.

Immune Response

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 29, 2025

Biopharma and biotech industries are facing remarkable challenges as the cost of developing new drugs has surged dramatically and clinical trial timelines have extended significantly. These elongated timelines are contributing to soaring costs, with the average cost of developing a new drug rising to approximately $2.6

Clinical Trials

FDA Law Blog: Drug Discovery

JANUARY 30, 2025

As a result of reforms enacted by the Food and Drug Omnibus Reform Act of 2022 (FDORA), FDAs authority to approve as well as withdraw an accelerated approval was given new regulatory teeth to ensure that confirmatory trials are conducted expeditiously. However, the meaning of due diligence has long been a question.

FDA

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

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

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

Drug Target Review

APRIL 14, 2025

A deep interest in political science and the political economy of drugs led him to focus on how drugs are priced and distributed across different jurisdictions. Preventative drugs, unlike antibiotics used to treat infections, are taken proactively, which opens a broader market.

Therapies

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

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

DECEMBER 31, 2024

One of the most important factors to consider during the course of your early-phase clinical research is drug-drug interactions (DDIs), which occurs when one drug alters the effect of another, either by reducing its effectiveness or elevating systemic concentrations to potentially dangerous levelsultimately causing side effects.

Therapies

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

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

Drug Target Review

AUGUST 8, 2025

While monoclonal antibodies and antibody-drug conjugates continue to drive therapeutic pipelines, bispecific T-cell engagers (TCEs) are gaining momentum as a versatile and scalable class of immunotherapies. Regulators are also providing clearer pathways for bispecifics, further fuelling TCE development.

Engineering

Drug Target Review

MARCH 4, 2025

In this interview, Bagnall explains how this approach is improving patient outcomes and driving the development of better obesity drugs. Much like cancer treatment, where some patients respond well to targeted therapies while others see little effect, obesity drugs also produce varied results.

Therapies

The Premier Consulting Blog

JANUARY 14, 2025

The FDAs Oncology Center of Excellence (OCE) plays a pivotal role in fostering innovation, collaboration, and efficiency in the development and evaluation of oncology products. The AAP is inherently associated with the OCE, as cancer drugs account for about 85% of all accelerated approvals granted in the past decade i.

Clinical Trials