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As our understanding of the underlying biology of disease grows more sophisticated, emerging therapies operate on increasingly complex biopathological systems and mechanisms. Safety biomarkers account for adverse effects of a therapy under study. There are several types of biomarkers to consider.
Developing treatments for individuals living with rare diseases is critical, but orphan drugdevelopment is laden with unique obstacles that necessitate innovative, multifaceted approaches. By tailoring treatment approaches to these preferences, researchers can better address the needs of different patient subgroups.
At the forefront of this transformation is Dr Ebrahim Delpassand, a nuclear medicine physician and the driving force behind RadioMedix (RMX), a radiopharmaceutical company focused on developing targeted diagnostics and therapies.
Our annual look at the state of the drugdevelopment industry highlights a dual set of challenges complicating progress. Rising costs have become a persistent challenge for drugdevelopers, driven by a combination of internal and external pressures that have intensified in recent years.
As Vice President of Oncology Early Development (OED) at AbbVie , she leads the charge on translating bold scientific ideas into real-world impact – and she’s doing it with a focus on some of the most tenacious cancers out there. Checkpoint inhibitors revolutionised cancer therapy; however, significant unmet clinical needs remain.
Background on the Grants Program Launched as part of the Orphan Drug Act of 1983, this program aims to encourage research and development of drugs, biologics, medical devices, and medical foods for rare diseases, defined as conditions that affect fewer than 200,000 people in the U.S.
A personal journey to Alltrna Michelle Werner’s career has spanned over 20 years in the pharmaceutical industry, where she developed her expertise in oncology drugdevelopment at leading companies such as Bristol Myers Squibb, AstraZeneca, and Novartis.
Drugdevelopment 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. Highlighting data integration.
AI was the focus of more than 70 poster and paper presentations, highlighting its growing impact in the field. These presentations demonstrated how advanced machine learning models are being deployed to enhance diagnostic accuracy, especially in early glaucoma detection. conference locations.
This approach has led to the discovery of numerous potential drug candidates. From Lab to Market: The Long Road of DrugDevelopment Once a promising compound is identified, it enters the long and costly process of drugdevelopment. Q: How long does a drug patent last?
For example, a tumour’s resistance to therapy may not stem from its mutational profile alone but from its interaction with surrounding stroma or immune cells – invisible interactions in dissociated, bulk sequencing data. Integrated multiomics is the future The impact on drugdevelopment could be profound.
Antibody-drugconjugates (ADCs) represent a significant advancement in drug discovery, combining the precision of monoclonal antibodies with the cancer-killing power of cytotoxic drugs. Wangs research focuses on developing mechanistic mathematical models to quantitatively characterise ADC-induced toxicities.
They have interesting patterns of expression in different cancer indications; thus, diverse therapies for attacking these targets have been developed. SCLC generally has a “hot” tumor microenvironment (TME) meaning that it is infiltrated by immune cells, including the T cells that are activated by immune checkpoint therapies.
With more than 40 clinical and commercial-stage assets in active development, BeOne Medicines is demonstrating a scale of ambition matched by few in the field. BeOne Medicines’ rise has been fueled by a strategic commitment to innovation at every level of the drugdevelopment continuum.
Altasciences At CPHI Americas 2025 pmjackson Thu, 07/03/2025 - 13:41 In the ever-changing drugdevelopment world, staying agile is essential to enabling more informed decisions, faster. It’s a challenge that affects a large percentage of new drug candidates—one we’re passionate about helping to solve. The response?
By Amy Raymond, PhD, PMP, Executive Director, Therapeutic Strategy Lead, Rare Disease Cell and gene therapies (CGTs) include cutting-edge approaches that offer the hope of a healthier, happier, and better tomorrow for a wide range of patient populations. Below, we discuss some of these challenges in cell therapy trials.
DARPin therapeutics were a prominent theme at AACR 2025 , with Molecular Partners presenting a trio of preclinical programmes spanning radiopharmaceuticals and immune cell engagers. “My passion for science drew me to DARPin technology, and I was eager to contribute to the development of new DARPin therapies.”
Dr Pooja Hingorani, Senior Medical Director of Oncology Early Development at AbbVie , shares her journey in STEM, from her early days in New Delhi to her impactful career in oncology research and drugdevelopment. Opportunities in clinical research and drugdevelopment were not always easy to come by.
These data offer new hope to the CDD community, which has long struggled with a lack of effective seizure control therapies. The lack of approved therapies specifically indicated for CDD means that treatment strategies are often based on off-label use of anti-seizure medications, with limited success.
This model not only promises a broader market but also presents tangible benefits for patients. By preventing infections before they occur, these drugs reduce the need for hospital treatments, including the costly intensive care unit (ICU) care that can burden healthcare systems.
Despite recent advances in gene therapy for sickle cell disease (SCD) , automated red blood cell exchange (aRBCX) remains a cornerstone therapy that plays a vital yet underutilised role in managing complications and enhancing quality of life for millions living with this devastating condition worldwide.
Increasingly, patients and patient-led organizations are playing a pivotal role in shaping drugdevelopment, underscoring the importance of collaboration between patient organizations, CROs, and pharmaceutical and biotechnology companies.
Established in 2017 under the 21st Century Cures Act, the OCE brings together multidisciplinary scientific expertise to accelerate the review and approval of drugs, biologics, and medical devices for cancer care. These reviews have provided life-saving cancer therapies a median of 3.1 Program What is it?
In Issue 7 of The Altascientist , we delve into these factors, the importance of drug interaction studies, and how to limit adverse effects and maximize treatment response. The potential for an investigational drug to cause DDIs should be investigated in a stepwise manner during drugdevelopment.
Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. and elsewhere in its 2025 fiscal year and plans to present detailed results at an upcoming medical meeting.
Drugdevelopment is a complex and highly regulated process. Before a therapy can be approved for patient use, it must undergo extensive clinical testing and strictly adhere to regulatory guidelines. One of the most significant challenges in drugdevelopment is global regulatory variability.
As an undergraduate biology student, I spent some time in a TB lab working on antibiotic resistance — a growing concern for drugdevelopers. 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.
Contract Development and Manufacturing Organizations (CDMOs) are at the forefront of this shift, playing a crucial role in bringing innovative therapies to market. Today, they’re strategic partners in drugdevelopment and manufacturing, offering end-to-end solutions that can make or break a pharmaceutical company’s success.
With a particular focus on biologics, cell, and gene therapies, Galbraiths work is centred on equipping drugdevelopers with the tools, insights, and support needed to advance their therapies from concept to clinic. We are driving rapid analytics to support the release of cell and gene therapies and other biologics.
Case Study: How Altasciences Overcame Pharmacological Challenges in a GLP-1 IND-Enabling Study pmjackson Thu, 04/24/2025 - 21:43 For emerging therapies with pronounced pharmacological effects, thoughtful study design is critical to ensuring reliable and interpretable data.
Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. Progress developing a treatment for leukemia led the company in 2021 to price a $177 million initial public offering.
Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. billion purchase of Intra-Cellular Therapies , according to data tracked by BioPharma Dive.
Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. says US won’t donate to global vaccine effort View all Events 07 JUL Webinar | 10 a.m.
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In a recent webinar, Challenges of DrugDevelopment in Early Parkinsons Disease , Tom Babic, MD, PhD , our Vice President of Scientific Solutions in Neuroscience, uses his 40+ years of experience to share invaluable insights into the current state and future directions of early Parkinsons disease (PD) research.
Solid tumors present a significant challenge to clinical research due to their complex and heterogeneous nature. This approach improves treatment outcomes over traditional broad-spectrum therapies, which are prone to more side effects and adverse events.
Defining Long COVID: Clinical Criteria and Diagnostic Challenges Long COVID, as defined by the US Department of Health and Human Services, encompasses signs, symptoms, and conditions present for a minimum of four weeks after initial SARS-CoV-2 infection.
When researchers gave people willow bark extract corresponding to 240 mg of salicin, then looked at how much salicylic acid was present in their blood over time, it was the equivalent of taking 87 mg of aspirin ( 300 mg to 600 mg is recommended per dose, with up to 3600 mg allowed per day).
From the presentation of the REVERSE-IT and STRIDE trials to additional studies on lipid-lowering therapies and heart failure treatments, this webinar reflected on key study results and their implications for future cardiovascular research.
Applying CAR T-cell therapy in new clinical settings presents unique challenges. Worldwide Clinical Trials is at the forefront, partnering with drugdevelopment teams to map this new path forward.
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As the clinical trial landscape evolves, drugdevelopers are faced with novel challenges and changes in study recruitment, trial size and structure, and more. The adoption of new innovations, strategies and technologies offers opportunities to address persistent challenges and develop suitable approaches for the future.
But commitment to neuroscience drugdevelopment is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer. Part of the challenge is that patients present with very different kinds of clinical phenotypes, meaning the populations are heterogeneous.
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