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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 clinicaltrials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
The market for each target class likely asymptotes with the number of Pharma or large biotech who can clinicallydevelop and commercialize such assets; thus, there is intense focus on the first handful of assets to market. Additional trials (e.g., ALT) continue to build momentum in the indication.
After explosive and frenetic activity in the clinicaltrial industry during the COVID era, the past two years have seen challenging market dynamics and a drop-off in activity. Every one of us working in clinicaldevelopment has felt this slowdown, but as we begin 2024, there is reason for optimism.
According to the United Nation’s 2024 World Population Prospects data, the global population of those 65 years old and over will grow from 0.8 Accelerate your drug development and clinicaltrial goals and benefit from our 360° CDMO and CRO solutions and expertise. billion in 2023 to 1.2 billion in 2035.
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 clinicaltrial landscape in 2024. Five Predictions for the Drug Development Industry in 2024 1.
Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.
Simpler ClinicalDevelopment From Day Dot blussier Fri, 06/21/2024 - 19:10 HTML Connecting the Dots With Comprehensive CRO Solutions When you CONNECT THE DOTS, you open a world of possibilities. Ready for a simpler drug development journey? At Altasciences, we connect the dots, so you don’t have to. WATCH THE VIDEO.
External Control Arms (ECAs) provide comparative evidence when recruiting patients is difficult or unethical in randomized controlled trials. ECAs have significant potential to save resources and accelerate access to innovative treatment.
Insights in FIH studies provide valuable information on potential dosing, efficacy, and safety, and serve as a good guide for the regulatory requirements needed throughout clinicaldevelopment. jpg Tags ClinicalTrials Weight 1
As Phase 1 clinicaltrials include several different design types with multiple objectives (e.g. png Listing Introduction Join this webinar to receive expert guidance and learn key considerations for successfully planning pharmacy activities in early phase trials. Click here to login. Listing Image DrVince_ListingLogo_250x190.png
Data monitoring committees (DMCs) review ongoing clinicaltrial data to make recommendations regarding trial conduct based on risk-benefit. DMCs are an essential component to ensuring the integrity and safety of clinicaltrials. The draft is open to public comment until April 15, 2024.
However, accelerated approval comes with a condition: sponsors must conduct confirmatory trials to verify the drug’s anticipated clinical benefits using robust outcome measures. Concerns have arisen over delays—sometimes spanning over 7–8 years—that may expose patients to risks before confirmatory trials are completed.
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.
The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinicaldevelopment should emphasize sensitivity over specificity in CNS effects. Tags ClinicalTrials Weight 12 View the Driving Simulation Fact Sheet for more information.
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. Asia, and Europe.
Top 5 Scientific Resources in CNS ClinicalTrials blussier Thu, 03/21/2024 - 18:09 HTML CNS Center of Excellence Resource Library Altasciences has an extensive understanding of psychiatric and neurologic disorders, stemming from our decades of conducting complex studies in various therapeutic indications impacting the central nervous system.
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. Let the CRO know any key outcomes from each.
This would open up a pipeline of next generation chemotherapies for the Group with significant clinical and commercial value in a chemotherapy market that is expected to grow to $56 billion by 2024. Dosing of first patients will commence when we have responded to that feedback and received approval to proceed.
Beyond the standard tumour-informed assay, we collaborated with Natera to create a more sensitive tumour-informed test using its Signatera molecular residual disease testing technology for research use in our AMPLIFY-201 clinicaltrial. In later stage trials, additional clinicaltrial designs are made possible by liquid biopsy.
Redig, SVP and Head of ClinicalDevelopment at HotSpot Therapeutics, as part of the From The Trenches feature of LifeSciVC The American Cancer Society for Oncology (ASCO) annual meeting is among the highlights of the clinical oncology calendar. By Amanda J.
One crucial aspect of this process involves establishing data safety monitoring boards (DSMBs) (also known as data monitoring committees [DMCs]) to oversee clinicaltrials. Traditionally, pharmaceutical sponsors have formed a new DSMB for each individual trial.
We are currently testing this approach in two early-stage clinicaltrials evaluating a pair of PTPN2 inhibitors,” said Arthur Levinson, founder and CEO of Calico.
Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinicaltrials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. from 2024 to reach US$129.8 with full-year revenue of US$23.04 of total revenue).
For others this may serve as a reminder of some of the pitfalls that can befall biotech companies this time of year and what the key questions are to ask yourself and the team to manage through the madness and finish strong in 2024. ClinicalTrials Are your clinicaltrials on track? Do you have ample drug supply?
The Costs of Working with a CRO Running clinicaltrials is an integral part of the pharmaceutical industry, crucial to the development and approval of new drugs and treatments. However, because these trials come with a significant financial burden, sponsor companies are constantly seeking ways to optimize their operations.
Overall, SRP-001’s modulation of pain signalling genes and pathways through endocannabinoid enhancement and FAAH inhibition supports its potential as an effective non-opioid pain therapeutic, validating the planned clinicaltrials. Scientific Reports 14, 11103 (2024).
As we think about our own future with our Phase 2 ready program, we discuss internally how well we fit venture funds’ criteria today and just what is an ’ideal‘ investment profile in 2023 going into 2024? In addition, these products have established a clinicaldevelopment path that supported a drug approval that is applicable to our program.
[link] Immunity is complex and can be dangerous when exploited clinically, as demonstrated by the lethal administration of TNF, or anti-CD40L antibody (Biogen) or CAR-T cells expressing the CD16 Fc-receptor (Unum), among many other examples. 124507 and references within this excellent 2024 review: [link].
Since the 1970s, when hybridoma technology enabling the generation of monoclonal antibodies (mAbs) was first developed, 1 antibody-based therapeutics have become one of the most rapidly growing drug categories, with applications across cancer indications, immune disorders and infections. Antibodies to watch in 2024. 2024 Jan 5;16(1).
Currently there is no cure for hepatitis B, however there are several drugs in clinicaldevelopment to improve the lives and clinical outcomes for persons with chronic HBV infection, including functional cure strategies.
Notably, we anticipate initiating the first clinical study of CNP-103 in late 2024, on the heels of our Series A announced earlier this year on January 30. Could you explain the development of CNP-108 for T cell immunogenicity in gene therapy, and how it induces the immune system to build a tolerance to gene therapy treatments?
At Dyne, over the past couple of years we invested in thoughtful planning for our global clinical and regulatory strategy, conducted comprehensive preclinical studies to understand our candidates, put in place our manufacturing network, all to be prepared to conduct our first clinicaltrials this year.
By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. The agency issued a new draft guidance on DAPs in June 2024, several months after the Congressional deadline had passed.
So far in 2023, the Office has co-authored fifteen guidance documents—the majority of which were drafts—offering insight into the agency’s thinking on several key policy issues, such as clinicaltrial diversity and the accelerated approval pathway. These issues are especially apparent in treatments that are intended for chronic use.
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.”
BY LAURA DIANGELO, MPH , RACHEL COE, MSC | JUL 23, 2024 9:54 PM CDT Biosimilarity and interchangeability: A quick recap The Biologics Price Competition and Innovation (BPCI) Act of 2009 intended to increase the number of biologic products on the market by creating two types of approvals for biosimilar products.
by the time Bancel made it over to Flagship, where Afeyan delivered his pitch: He wanted Bancel to work on a startup that had so far hired only a single staff scientist and conducted just one mouse trial. The real cost is clinicaldevelopment. ” Asimov Press (2024). . “It was about 6 p.m. Why rock the boat?
December 31, 2022 [link] PDUFA 50 issue a new MAPP on approaches to address CMC challenges for CDER-regulated products (drugs, biologics) with accelerated clinicaldevelopment timelines (e.g., October 1, 2022 March 31, 2024 [link] GDUFA The Generic Drug User Fee Amendments VI Commitment Letter may be found here.
Since these issues could occur during the investigational phase of clinicaldevelopment as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.
BY RACHEL COE, MSC | APR 11, 2024 1:06 PM CDT Regulatory background: Product potency and assays As defined in statute , the FDA uses the term “potency” to refer to the “specific ability or capability” of a product to “effect a given result.” In contrast, stakeholders who have only been monitoring the FDA’s formal means of communication (i.e.,
BY ALEXANDER GAFFNEY, MS, RAC | JAN 2, 2024 8:47 PM CST Regulatory background on guidance documents FDA guidance documents are used to fill in the gaps of regulation. For the FDA, guidance documents come in a variety of different forms and formats. That sort of information is extremely important for some stakeholders.
Researchers must characterize the anti-drug-antibody (ADA) response in preclinical and clinical studies and report any ADA-positive samples as a risk-based approach. Regulatory Considerations for Oligonucleotide Drug Development and Safety In 2024, the U.S.
The preclinical findings, together with the early evidence of tolerability and efficacy coming from the MATCH Phase I study, laid the foundations for our characterisation and engineering platform, used to develop Resolution Therapeutics’ lead product, which will be tested in patients starting later this year.
Authors: Rich Worldwide ClinicalTrials Exec. This trend is on the rise despite recent disappointments with clinicaltrial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. Director, Therapeutic Area Medical Lead.
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