KIF1A

JANUARY 13, 2024

Aditi Falnikar’s presentation from our 2023 KAND Conference Read the Article Rare Roundup FDA issues final guidance on rare disease drug development As we continue to explore new therapeutic avenues for treating KAND, it is crucial to think about the regulatory steps those therapies will face.

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DNA Regulations Drug Development Disease 105

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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PPD

NOVEMBER 30, 2023

As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Five Predictions for the Drug Development Industry in 2024 1.

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Clinical Trials Trials Clinical Research Drug Development 98

Alta Sciences

JUNE 11, 2024

My Attendance at the 2024 Boston Society Cell and Gene Therapy Conference pmjackson Tue, 06/11/2024 - 20:49 , via Wikimedia Commons" data-entity-type="file" data-entity-uuid="c7a7fa8b-b2fe-4d84-a75e-d1ba3a4e2caf" src="[link] width="742" height="249" loading="lazy" /> Ecm85, CC BY-SA 3.0

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FDA Law Blog: Drug Discovery

MAY 19, 2024

By Sarah Wicks — On May 21, 2024, the EveryLife Foundation for Rare Diseases (ELF) will host a Scientific Workshop at the National Press Club in Washington, D.C. aimed at identifying and characterizing the challenges in developing therapies for ultra-rare diseases and conditions that affect exceedingly small populations.

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Disease Therapies Drug Development FDA 59

Fierce BioTech

SEPTEMBER 5, 2024

Overcoming drug development hurdles with phase-appropriate technology transfers Discover how phase-appropriate technology transfers can help you overcome regulatory challenges, reduce costs, and accelerate your path to commercialization. Learn strategies to maximize efficiency and focus on what you do best—innovating new therapies.

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Drug Development Drugs Therapies Marketing 52

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.

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Drug Development Clinical Trials Drugs Vaccine 59

Drug Target Review

SEPTEMBER 25, 2024

While these approaches often produce encouraging initial results, the development of drug resistance remains a major obstacle for long-term patient survival. Most targeted cancer therapies used today operate by inhibiting targets along well-known oncogenic signalling cascades.

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Small Molecule Therapies Regulations Treatment 105

Fierce BioTech

APRIL 3, 2024

Mini-Organs, Major Breakthroughs: How Hub Organoids Are Accelerating Oncology Drug Development dwunderlin Wed, 04/03/2024 - 17:28 Tue, 05/14/2024 - 09:30 Resource Type Webinar Dr. Sylvia F. On Demand Start Date Tue, 05/14/2024 - 10:30 Click here to login. Listing Image Hub_ListingLogo_250x190.png

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Alta Sciences

AUGUST 29, 2024

Engaging at the outset with a fully integrated and experienced drug development partner can ensure safety, with timely data sharing at every step of the drug development plan, and facilitate agile, flexible decision-making and planning.

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Drug Development Clinical Trials Small Molecule Drugs 52

Alta Sciences

NOVEMBER 13, 2024

Altasciences’ Commitment to Supporting Pharma and Biotech With Comprehensive Bioanalytical Services pmjackson Wed, 11/13/2024 - 14:50 Greater Montréal, Québec, 11/13, 2024 — Altasciences , a trusted drug development research partner for over 30 years, continues its commitment to providing world-class bioanalytical services.

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Perficient: Drug Development

MAY 1, 2024

As of mid-February 2024, the Spring ‘24 release was generally available across all instances of Health Cloud bringing with it a host of improvements and added functionality for healthcare organizations. Additionally, optimized time-to-therapy enhancements and transportation logistic modeling enhance operational efficiency and compliance.

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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. Substantial global capabilities.

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Codon

NOVEMBER 3, 2024

As an undergraduate biology student, I spent some time in a TB lab working on antibiotic resistance — a growing concern for drug developers. These challenges have led to strategies such as directly observed therapy (DOT), in which nurses or physicians monitor patients to ensure they take their medicine every day.

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PPD

MARCH 28, 2024

The biotech industry has long been at the forefront of innovation, revolutionizing health care and delivering breakthrough therapies to patients around the world. Through the first few months of 2024, the economic landscape is showing signs of returning to a semblance of normalcy, mirroring the pre-COVID era.

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Trials Clinical Trials Drug Development Clinical Research 52

Drug Target Review

DECEMBER 5, 2024

Viral vectors have been crucial in transforming the gene therapy landscape due to their natural ability to infect cells. 1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2.

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Alta Sciences

APRIL 16, 2024

Inside The Altascientist: The Benefits of PCR for Your Gene Therapy Programs pmjackson Tue, 04/16/2024 - 19:04 The gene therapy landscape continues to accelerate in preclinical and clinical research, with programs constantly in development for targeted, personalized medicines. Tags Bioanalysis Weight 15

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Alta Sciences

NOVEMBER 20, 2024

Now Available Online — Scientific Posters Presented at Eurotox 2024! EXPLORE Related resources you may be interested in: eBook: Nonclinical Studies in Cell and Gene Therapy Webinar: Best Practices to Reduce Animal Use in Toxicology Studies Webpage: The Use of Miniature Swine in Preclinical Studies Image alta-blog_4_2.jpg

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Conversations in Drug Development Trends

DECEMBER 7, 2023

Other drawbacks reported from working with these large CROs were: These performance disruptions and drawbacks have resulted in an environment of uncertainty among this CRO service provider segment in 2023, with likely ramifications extending into 2024 and beyond.

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Alta Sciences

JANUARY 11, 2024

It is estimated that there are over 6,000 monogenic diseases, affecting over 350 million people worldwide; for these diseases, cell and gene therapy may provide hope for a cure. However, there are significant challenges associated with the successful development of these complex, leading-edge therapies.

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Therapies Immune Response Disease Virus 52

FDA Law Blog: Drug Discovery

JULY 17, 2024

Earlier this month the FDA announced the first meeting of the GeMDAC will be held on August 2, 2024 to discuss a novel treatment for Niemann-Pick disease type C (and Frank and James are looking forward to being there!). By Sarah Wicks & James E. Valentine & Frank J.

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Conversations in Drug Development Trends

MAY 10, 2024

Challenges for the Inclusion of BPD Patients in a Psychedelic Trial Apart from the difficulty in establishing a diagnosis, individuals with BPD often have difficulty forming connections with healthcare providers, an element that is essential for the success of psychedelic-assisted therapy.

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Clinical Trials Trials Treatment Drug Development 95

PLOS: DNA Science

MARCH 28, 2024

A new drug has entered the arsenal against Duchenne muscular dystrophy (DMD), a genetic disease that affects boys and is challenging to treat. FDA classifies it as a “nonsteroidal treatment” – not a gene therapy, but it affects gene expression. Muscle makes up about 40 percent of body weight. million DNA bases.

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FDA Approval Treatment FDA DNA 97

DrugBank

MARCH 7, 2024

The landscape of weight loss drugs has been rapidly evolving, and 2024 is poised to be another transformative year in this market. As we step into 2024, the momentum is expected to continue, with analysts projecting the weight loss drug market to reach remarkable heights, potentially hitting $100 billion by the end of the decade.

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Pharmaceutical Companies Pharmaceuticals Clinical Trials Therapies 80

Codon

SEPTEMBER 29, 2024

2024 Statistical models of organisms have existed for decades. The earliest ones relied on simple linear regression and attempted to correlate genetic variations with observable traits or disease risks — such as drug metabolization rates or cancer susceptibility. By the end of 2024, interest in models of life had cooled.

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Engineering Virus DNA Therapies 137

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Science Regulations Clinical Trials 40

DrugBank

AUGUST 9, 2024

This high attrition rate directly results from the scientific and regulatory hurdles that drug candidates must overcome. The Investment Landscape Despite these challenges, the potential rewards for successful drug development are substantial. trillion dollars, and it is forecasted to exceed 1.4 trillion by 2028.

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Pharmaceuticals Research Pharmaceutical Companies Clinical Trials 76

Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

JULY 22, 2024

Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. Novel drug products are defined as products that have never been approved for any indication.

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Clinical Trials Trials Science FDA 52

Perficient: Drug Development

JANUARY 30, 2025

In 2024, Perficients Giving Employee Resource Group (ERG) launched the Perficient Gives Global Grants Program, a unique opportunity to support global nonprofit organizations in their mission to make a significant impact in our communities. DSDN is more than a helpful resource for her family; it has been a lifeline of connection.

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Conversations in Drug Development Trends

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Currently, there are 12 approved ADC drugs, and several hundred more are in the development pipeline.

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Clinical Trials Therapies Clinical Research Immune Response 64

LifeSciVC

JULY 11, 2023

The meeting brings together tens of thousands of physicians, scientists, patients, advocates, innovators, and those involved in oncology drug development from around the world in order to explore the latest advances in cancer treatment, clinical trials, and translational and clinical research.

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Therapies Trials Clinical Development Science 65

Fierce BioTech

SEPTEMBER 16, 2024

How next-generation phage display libraries are accelerating antibody developability Download now to learn how a next-generation phage library is overcoming the limitations of traditional antibody discovery platforms, enhancing the discovery of highly specific and effective antibody-based therapies.

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Agency IQ

FEBRUARY 12, 2024

BY RACHEL COE, MSC | FEB 7, 2024 10:21 PM CST The Bespoke Gene Therapy Consortium A collaborative effort, the Bespoke Gene Therapy Consortium (BGTC) was launched in October 2021 to “accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease.”

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FDA Therapies Clinical Trials Disease 40

Alta Sciences

SEPTEMBER 27, 2024

The growing understanding of the immune system's role in various diseases, along with advancements in drug development, have led to a natural evolution from traditional vaccines, small molecules , and cytokines , to increased targeted biologics and innovative approaches in gene therapy and vaccines.

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Clinical Trials Trials Pharmacokinetics Small Molecule 52

Drug Target Review

SEPTEMBER 18, 2024

What specific cost-cutting measures can AI provide in the manufacturing process of cell and gene therapy, and how do these compare to traditional methods? The cell and gene therapy (CGT) space provides a great example of the potential of AI. AI can vastly improve cell culture, a critical step in cell therapy production.

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Therapies Doctors RNA Production 52

Conversations in Drug Development Trends

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In recognition of the unmet need and medical urgency for innovative therapies in the sickle cell space, the FDA granted exa-cel Priority Review, with a formal decision expected by December 8, 2023.

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