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The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. This continued innovation highlights the complexity of the drugdevelopment process, particularly as the field is highly regulated by health authorities around the world.
Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. Antibody drug conjugated with cytotoxic payload.
TOP 5 WAYS INTEGRATED DRUGDEVELOPMENT SOLUTIONS SAVE YOU TIME AND MONEY aasimakopoulos Mon, 05/15/2023 - 16:06 Since 2004, the average cost of bringing a new drug to market has increased from $800 million to about $2.6 billion , without, for the most part, shorter development timelines.
This has opened new opportunities in pharmaceutical drugdevelopment, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.
These are exactly the types of things that were addressed at ELF Scientific Workshop in May 2024 which addressed challenges in developingtherapies for ultra rare diseases (see our blog about this here , which includes a link to the recording).
Whether as a standalone bioanalytical service or as part of an integrated program, Altasciences provides top-quality data for TK, PK, and PD determinations to support preclinical and clinical studies. All three laboratories across North America are uniformly designed and managed.
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With close to a decade of experience in the healthcare and pharmaceutical sectors, including clinicalpharmacology, James will apply his knowledge to oversee the day-to-day management of clinical operations at Altasciences’ 140-bed, Phase I clinicalpharmacology unit in Kansas City. “It
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 drugdevelopment research partner for over 30 years, continues its commitment to providing world-class bioanalytical services.
Importantly, the Principal Investigator determined that few adverse events were drug-related.” There are no TBI-specific therapies approved for the treatment of patients suffering brain injury, yet it is estimated that in the U.S. We are proud to support Ischemix in advancing this vital new therapy.” About Ischemix, Inc.
Dr. Setnik made the list of 100 honorees for her hands-on leadership and nearly 20 years of experience in clinicaldrugdevelopment, with a focus on abuse potential studies. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drugdevelopment decisions.
The award honors McHutchison’s work in developing life-changing and curative therapies for patients with the hepatitis C virus. Mukul Agarwal, former vice president of Corporate Development, at Forty Seven, Inc., Axovant – Kristin Vuori was named to the board of directors at Axovant Gene Therapies Ltd. Source link.
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The side effects of some anticancer treatments can result in dose interruptions or de-escalations, or even outright discontinuation of an efficacious therapy. subsequent superior/inferior supportive care, lifestyle changes, or use of additional therapies).
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TOP NONCLINICAL SCIENTIFIC RESOURCES eBook : Safety Assessment for Ophthalmic Products Designing preclinical studies for ocular therapies take a lot of deliberation. The Altascientist : Issue No. Read or listen now. Watch the video. Listen here.
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Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. The draft guidance enumerates key considerations for selecting an animal species for both pharmacology and toxicology studies.
The oncology drugdevelopment landscape is evolving rapidly, driven by the deployment of targeted therapies in precision medicine and regulatory initiatives like the FDAs Project Optimus. It also covers strategies for drugdevelopers who have yet to identify a biomarker, helping them advance their programs effectively.
End-to-end workflow automation, from sample receipt, processing, analysis, and reporting, will likely become an industry standard, making it an essential tool for drugdevelopment. Biomarkers are indispensable tools in clinical trials, providing critical insights that enhance the efficiency and precision of drugdevelopment.
This Guidance explicitly excludes gene therapies (a change from the draft guidance), but instead makes reference to a separate guidance that has been in place since 2020 titled Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.
Introduction Biomarkers are becoming increasingly essential in drugdevelopment and clinical practice, driving the need for more precise validation methods. 1 The journey to qualifying biomarkers for clinical and regulatory use is fraught with challenges, leading to a remarkably low success rate.
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