Clinical Development, Clinical Research and Production

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.

Clinical Development

Clinical Development Production Clinical Trials Treatment

The rising impact of biomarkers in early clinical development

Drug Target Review

APRIL 7, 2025

Investigational products with novel mechanisms of action are also assessed for safety in unique ways, creating complexities that can be more dynamically and effectively monitored using biologically relevant biomarkers. Biomarkers can play a crucial role throughout clinical development, especially in early phases.

Clinical Development

Clinical Development Clinical Trials Clinical Pharmacology Trials

How FSP Models Help Biotech Companies Augment Their Clinical Development Needs

PPD

JANUARY 2, 2025

Because biotech companies need to remain flexible and agile while remaining on time and on budget they are harnessing innovations to navigate unexpected drug development challenges and leveraging strategies to fill gaps in resources and expertise. FSP outsourcing is growing faster than FSO.

Clinical Development

Clinical Development Clinical Trials Trials Regulations

The AI model that is changing clinical trial design

Drug Target Review

JULY 1, 2025

Chief Executive Officer Steve Herne has spent more than 25 years in clinical research, with senior roles at WCG, Bioclinica and Covance. Unlearn’s digital twins are now in use in both early and late-stage clinical trials, with adoption continuing to grow. Unlearn is one of the few companies applying this approach at scale.

Clinical Trials

Clinical Trials Trials FDA Disease

Managing Opportunities and Risks in Generative AI Use for Clinical Research

PPD

JULY 8, 2025

Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinical research. These domains are ripe for innovation. Errors jeopardize patient safety, regulatory compliance and trust.

Clinical Research

Clinical Research Research Compliance Government

Leveraging AI Solutions for Clinical Trial Efficiencies

PPD

JANUARY 15, 2025

As risks are identified, customized action plans are created and provided to clinical teams to keep studies on track. Modernize resource planning Automating resource demand forecasting for studies using machine learning and inputs from AI-driven solutions helps increase productivity and ensures timely and accurate data. Get in touch.

Clinical Trials

Clinical Trials Trials Clinical Research Drug Development

Navigating Clinical Development Challenges to Advance Idiopathic Pulmonary Fibrosis Treatments

PPD

JUNE 20, 2025

Prioritizing the idiopathic pulmonary fibrosis patient experience in clinical trials Understanding the patient experience is paramount to the success of idiopathic pulmonary fibrosis clinical development. Even attending their regular clinic visits can be exhausting and stressful. Ready to connect?

Clinical Development

Clinical Development Treatment Clinical Trials Trials

Overcoming Orphan Drug Development Challenges with Real-World Data and Evidence

PPD

MARCH 11, 2025

Real-world data (RWD) and real-world evidence (RWE) have emerged as transformational tools in addressing these hurdles, advancing rare disease drug development. Developing effective ECs requires more than just matching clinical trial inclusion and exclusion criteria within the RWD source.

Drug Development

Drug Development Clinical Trials Disease Trials

Leveraging Remote-Based Regional Hubs to Improve Efficiencies and Meet Timelines

PPD

JUNE 17, 2025

These hubs support a geographically distributed remote workforce that provides greater stability and project continuity while offering the global expertise and capabilities needed to bolster clinical development success.

Clinical Development

Clinical Development International Drug Development Clinical Research

POLB 001: tackling cytokine storms before they start

Drug Target Review

MAY 23, 2025

It takes a family to develop a drug Trembles role at Poolbeg is multifaceted, reflecting the collaborative ethos of the companys scientific team. I take responsibility for identifying pre-clinical research that can support our clinical programs, as well as designing and overseeing its execution, he explains.

Immune Response

Immune Response Therapies Treatment Clinical Trials

PRITELIVIR MESYLATE

New Drug Approvals

JULY 8, 2025

Pritelivir (development codes AIC316 or BAY 57-1293 ) is a direct-acting antiviral drug in development for the treatment of herpes simplex virus infections (HSV). It is currently in Phase III clinical development by the German biopharmaceutical company AiCuris Anti-infective Cures AG. Crute, J.J.; Tsurumi, T.; Olivo, P.D.;

Virus

Virus DNA Clinical Trials Treatment

Best-in-Class Solutions Accelerate Development of GLP-1 Therapeutics

PPD

APRIL 14, 2025

Expertise that accelerates your clinical development success The PPD clinical research business of Thermo Fisher Scientific has significant experience in customized Phase I-IV metabolic clinical trials. Were applying that expertise and commitment to every aspect of developing and running successful GLP-1 studies.

Clinical Trials

Clinical Trials Trials Clinical Development Disease

Coordinating the Cell Journey: Essentials in Early Clinical Development

PPD

MARCH 13, 2024

This significance and focus are ever more apparent when the starting cellular material is imperative to drug product success. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.

Clinical Development

Clinical Development Clinical Trials Therapies Trials

Navigating Varying Regulatory Feedback in Clinical Oncology Trials: A Guide for Clinical Research Professionals

Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Additionally, consider the locations of your trial; if it is multiregional, you can start planning for your overall product approval strategy.

Clinical Research

Clinical Research Trials Clinical Trials Research

Unveiling neoantigen-directed cancer treatment

Drug Target Review

JUNE 9, 2023

This exclusive interview with Dr Sharon Benzeno, Chief Commercial Officer, Immune Medicine at Adaptive Biotechnologies, unveils some ground-breaking research on T- cell therapy for cancer , which has seen the first TCR-based therapeutic candidate progress to clinical development, offering promising advancements in innovative cancer treatments.

Treatment

Treatment Packaging Clinical Research Therapies

Hybrid FSP/FSO Solutions Enable Flexibility and Agility to Keep Biotech Trials On Time and On Budget

PPD

OCTOBER 8, 2024

The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinical development activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinical development functions.

Trials

Trials Clinical Trials Clinical Development Clinical Research

FSP Engagements Continue to Gain Popularity, Drive Success

PPD

MARCH 26, 2024

The PPD clinical research business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.

Clinical Research

Clinical Research Pharmaceutical Companies Clinical Development Drug Development

The Evolution of Adaptive Protocols: Early Clinical Development

PPD

NOVEMBER 9, 2023

Our dedicated, global and highly experienced cross-functional early development team is ready to support you through this journey. The partner you select for your early phase studies is critical in enabling you to achieve your overall development timeline efficiently and within budget.

Clinical Development

Clinical Development Drug Development Clinical Research Treatment

The Expansion of Cell Therapies in Asia-Pacific

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. There is a race in the field to overcome these challenges to enable the success of CGT products in Asia-Pacific.

Therapies

Therapies Clinical Trials Clinical Research Trials

How the FSP Model Augments Biotech Sponsors’ Internal Capabilities

PPD

OCTOBER 21, 2024

Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinical development functions. are outsourced.

International

International Clinical Development Clinical Trials Clinical Research

QuartzBio, a Part of Precision for Medicine, Acquires SolveBio and Expands Software-as-a-Service (SaaS) Data Management Solutions for Clinical Research & Development (R&D)

Precision for Medicine

JANUARY 23, 2023

QuartzBio’s suite of end-to-end SaaS solutions provides pharmaceutical and biotech clients with a fully connected data ecosystem linking sample, biomarker, and clinical data to improve collaboration, planning and R&D productivity. Canada, Europe and Australia. For more information, visit PrecisionForMedicine.com.

Clinical Research

Clinical Research Research Clinical Development Engineering

Pharmacy Considerations for Early Phase Trials

Fierce BioTech

DECEMBER 23, 2024

As Phase 1 clinical trials include several different design types with multiple objectives (e.g. First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), Logos Attribution 0 Attribution 0 Primary Category Biotech On Demand Off Enable Automatic On Demand On Registration Login Link Already registered?

Pharmacy

Pharmacy Trials Clinical Trials Clinical Development

How an FSP Model Can Ensure Business Continuity During a Business Disruption

PPD

SEPTEMBER 6, 2023

Under the stresses of the COVID-19 pandemic, drug development organizations faced difficult decisions about keeping staff employed and productive. Benefits of Rebadging Under an FSP Model in Clinical Research A functional service partnership (FSP) model in clinical research can help sponsors navigate unforeseen staffing challenges.

Clinical Research

Clinical Research Regulations Packaging Drug Development

Evolution of Clinical Operations Drives FSP Staffing Models to the Forefront

PPD

OCTOBER 2, 2024

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area.

Clinical Trials

Clinical Trials Clinical Development Clinical Research Trials

Seven Strategies to Avoid Common Pitfalls in Vaccine Development

PPD

JUNE 13, 2023

To rise above the competition, sponsors must understand the common pitfalls of vaccine development and have strategies in place to avoid them. It is imperative that the right vaccine development partner demonstrates expertise from early clinical development to study design, execution, regulatory submission and commercialization.

Vaccine

Vaccine Clinical Trials Clinical Research Trials

Regulatory Trends in Cell and Gene Therapies

Advarra

NOVEMBER 29, 2022

Recent Problems in Cell and Gene Therapy Development. Dealing with confusing regulatory guidelines is one of the top obstacles researchers face as they develop CGT products 1. In the last two years, there haven’t been any CGT product approvals, primarily because of the COVID-19 pandemic.

Therapies

Therapies Clinical Trials FDA Production

Pfizer CMO Steps Down, Stanford Professor to Transition into Role

The Pharma Data

JANUARY 4, 2021

From 2016 to 2018, he served as chief development officer for oncology at Pfizer, where he was responsible for leading clinical research, development, and lifecycle management of all promising oncology products.

Pharma Companies

Pharma Companies Clinical Development Clinical Research International

How to Keep Studies on Time and Budget Amid CRA Talent Shortages

PPD

JUNE 22, 2023

If your company is struggling to hire qualified clinical research associates (CRAs), you’re not alone. A decade-long CRA talent shortage intensified as the COVID-19 pandemic increased strain on the clinical research industry at large.

Clinical Research

Clinical Research Clinical Trials Trials Drug Development

The Art of Recruitment and Talent Development in FSPs

PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development.

Clinical Research

Clinical Research Clinical Development International Engineering

Five Benefits of a Dedicated Operations Lead for FSP Engagements

PPD

JULY 18, 2023

Nearly two-thirds of drug developers’ outsourcing budgets are now allocated to functional service provider (FSP) models or FSP hybrid models, according to research conducted by the PPD clinical research business of Thermo Fisher Scientific. Escalations and risk mitigation. Performance management.

Clinical Development

Clinical Development Drug Development International Clinical Research

Conduct of clinical trials & Postmarketing Commitments

The Pharma Data

MARCH 15, 2021

Clinical research is a key component of developing. A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. The clinical development process.

Clinical Trials

Clinical Trials Trials Clinical Development Clinical Research

Meiji Seika Pharma Sets up a New Subsidiary in the US

The Pharma Data

JANUARY 4, 2021

for expanding activities in the US with its initial focus on facilitating clinical development. Burr Boulevard, Teaneck, NJ 07666 (3) President: Yasushi Miyazawa (4) Scope of business: Clinical research and development (5) Paid in capital: US$100,000. (2) Location: 500 Frank W.

Pharmaceutical Companies

Pharmaceutical Companies Clinical Development Pharmaceuticals Clinical Research

FDA’s LDT Proposal and Its Impact on Clinical and Regulatory Professionals

The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. billion each year.

Laboratories

Laboratories Clinical Development FDA Regulations

[Webinar] How biotech companies can improve clinical supply planning and distrib…

The Pharma Data

SEPTEMBER 15, 2020

During her medical practice, Seredina worked in clinical research as an investigator. The results of her research were published in a number of articles highlighting her knowledge of the critical challenges of clinical sites and of the importance of being patient-centric. The webinar will take place at: .

Clinical Supply

Clinical Supply Clinical Trials Doctors Clinical Development

The Power of Bespoke Hybrid FSP/FSO Solutions

PPD

JUNE 17, 2024

Each model delivers a distinct set of capabilities to the study sponsor: In an FSP arrangement, the contract research organization (CRO) performs a specific function or multiple functions (clinical operations, pharmacovigilance, etc.) across protocols, medicinal products, a portfolio of studies or the entire company.

Clinical Trials

Clinical Trials Clinical Development Trials International

Galecto Appoints Anne Prener to its Board of Directors

The Pharma Data

JANUARY 7, 2021

Galecto has an exciting pipeline of product candidates within fibrosis and cancer and a lead candidate in phase 2 for Idiopathic pulmonary fibrosis (IPF). Before that, Dr. Prener was Global Therapeutic Area Head of Hematology and Vice President, Clinical Research Hematology at Baxalta. Dr. Prener holds a Ph.D.

Small Molecule

Small Molecule Clinical Development Production Science

How Many Clinical Trials Are Run by CROs?

Vial

FEBRUARY 29, 2024

However, despite their increasingly ubiquitous role in the clinical research industry, the question remains as to the extent of their participation. That is, how many clinical trials are actually managed by these organizations? Understanding the Numbers: How Many Clinical Trials Utilize CROs? between 2023 and 2032.

Clinical Trials

Clinical Trials Trials Clinical Research Drug Development

TG Therapeutics Announces Pricing of Upsized Public Offering of Common Stock – Dec 15, 2020

The Pharma Data

DECEMBER 14, 2020

The Company anticipates using net proceeds from the offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes. Morgan Securities LLC, Goldman Sachs & Co.

Clinical Trials

Clinical Trials Clinical Development Production Trials

BioSpace Movers & Shakers, Dec. 18

The Pharma Data

DECEMBER 17, 2020

He previously served as vice president, for drug device industrialization at AbbVie, where he led product scale-up and industrialization projects for drug-device combinations. Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs.

Small Molecule

Small Molecule Clinical Development Engineering Pharmaceuticals

Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

Conversations in Drug Development Trends

MARCH 7, 2024

Here are a few factors to consider: Key Distinctions Between CTAs and INDs One primary distinction to note between a CTA and an IND submission is that the CTA is protocol-specific, while the IND is product-specific. The post Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

Clinical Trials

Clinical Trials Trials FDA Drug Development

Could Keytruda/Lenvima Combo Help Treat Advanced Renal Cell Carcinoma?

The Pharma Data

NOVEMBER 9, 2020

It is very clear that in this study, the addition of ipilimumab did not add clinical benefit but did add toxicity. The product is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight off tumor cells. Source link.

Research Laboratories

Research Laboratories Laboratories Treatment Therapies

How to Harness the Follow-the-Sun Model in Your FSP Engagement

PPD

DECEMBER 12, 2023

A follow-the-sun model offers several advantages, but it takes specialized expertise to implement and operationalize for clinical development and post-marketing surveillance. Clinical research and post-marketing surveillance involves ongoing data analysis and interpretation. Ready to maximize your operational efficiency?

Compliance

Compliance Clinical Research Trials Clinical Trials

Precision for Medicine Acquires Baseline Controls, Expanding the Company’s End-to-End Manufacturing Solutions for Life Science Companies

Precision for Medicine

JUNE 26, 2023

About Precision for Medicine Precision for Medicine is the first biomarker-driven clinical research and development services organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments more precisely and effectively. Bethesda, Md.,

Science

Science Small Molecule Clinical Research Engineering

Keys to Success in Vaccine Development for Special Populations

PPD

MAY 11, 2023

From study participants’ consent, to minimizing the patient and caregiver burden, to planning for different needs at different stages of the pediatric immune system, there are many factors to consider when conducting clinical research with this specific population.

Vaccine

Vaccine Clinical Trials Long-Term Care Facilities Trials

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

The rising impact of biomarkers in early clinical development

Trending Sources

How FSP Models Help Biotech Companies Augment Their Clinical Development Needs

The AI model that is changing clinical trial design

Managing Opportunities and Risks in Generative AI Use for Clinical Research

Leveraging AI Solutions for Clinical Trial Efficiencies

Navigating Clinical Development Challenges to Advance Idiopathic Pulmonary Fibrosis Treatments

Overcoming Orphan Drug Development Challenges with Real-World Data and Evidence

Leveraging Remote-Based Regional Hubs to Improve Efficiencies and Meet Timelines

POLB 001: tackling cytokine storms before they start

PRITELIVIR MESYLATE

Best-in-Class Solutions Accelerate Development of GLP-1 Therapeutics

Coordinating the Cell Journey: Essentials in Early Clinical Development

Navigating Varying Regulatory Feedback in Clinical Oncology Trials: A Guide for Clinical Research Professionals

Unveiling neoantigen-directed cancer treatment

Hybrid FSP/FSO Solutions Enable Flexibility and Agility to Keep Biotech Trials On Time and On Budget

FSP Engagements Continue to Gain Popularity, Drive Success

The Evolution of Adaptive Protocols: Early Clinical Development

The Expansion of Cell Therapies in Asia-Pacific

How the FSP Model Augments Biotech Sponsors’ Internal Capabilities

QuartzBio, a Part of Precision for Medicine, Acquires SolveBio and Expands Software-as-a-Service (SaaS) Data Management Solutions for Clinical Research & Development (R&D)

Pharmacy Considerations for Early Phase Trials

How an FSP Model Can Ensure Business Continuity During a Business Disruption

Evolution of Clinical Operations Drives FSP Staffing Models to the Forefront

Seven Strategies to Avoid Common Pitfalls in Vaccine Development

Regulatory Trends in Cell and Gene Therapies

Pfizer CMO Steps Down, Stanford Professor to Transition into Role

How to Keep Studies on Time and Budget Amid CRA Talent Shortages

The Art of Recruitment and Talent Development in FSPs

Five Benefits of a Dedicated Operations Lead for FSP Engagements

Conduct of clinical trials & Postmarketing Commitments

Meiji Seika Pharma Sets up a New Subsidiary in the US

FDA’s LDT Proposal and Its Impact on Clinical and Regulatory Professionals

[Webinar] How biotech companies can improve clinical supply planning and distrib…

The Power of Bespoke Hybrid FSP/FSO Solutions

Galecto Appoints Anne Prener to its Board of Directors

How Many Clinical Trials Are Run by CROs?

TG Therapeutics Announces Pricing of Upsized Public Offering of Common Stock – Dec 15, 2020

BioSpace Movers & Shakers, Dec. 18

Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

Could Keytruda/Lenvima Combo Help Treat Advanced Renal Cell Carcinoma?

How to Harness the Follow-the-Sun Model in Your FSP Engagement

Precision for Medicine Acquires Baseline Controls, Expanding the Company’s End-to-End Manufacturing Solutions for Life Science Companies

Keys to Success in Vaccine Development for Special Populations

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