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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 clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
Developing treatments for individuals living with rare diseases is critical, but orphan drugdevelopment is laden with unique obstacles that necessitate innovative, multifaceted approaches. Developing effective ECs requires more than just matching clinical trial inclusion and exclusion criteria within the RWD source.
Your DrugsDevelopment Stage The stage of your drugdevelopment is a critical factor in selecting a CDMO. Adhering to industry standards, a preference exists for utilizing the same CDMO for both development and commercial manufacturing to enhance communication and timeline management.
As a result, drugdevelopers make better decisions more quickly (removing 50% of study timeline whitespace) to bring new therapies to market faster. As risks are identified, customized action plans are created and provided to clinical teams to keep studies on track.
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.
In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drugdevelopment.
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.
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. To qualify as endpoints, biomarkers used in early phases must be relevant to later stages of drugdevelopment.
For clinicalresearch professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Food and Drug Administration (FDA) Parallel Scientific Advice procedure, which aims to increase dialogue between the two agencies and sponsor companies.
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.
In preparation for World Orphan Drug Congress Europe, we interviewed Nathan Chadwick, Senior Director, Therapeutic Strategy Lead, Rare Disease, and Derek Ansel, MS, LCGC, Vice President, Therapeutic Strategy Lead, Rare Disease, to hear their insights into the current progress in rare disease research and their hopes for 2025.
proudly announces the return of attorney Sarah Wicks to its drugdevelopment and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of productdevelopment and commercialization.
The PPD clinicalresearch 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.
By Ivana Magovčević-Liebisch, CEO of Vigil Neuroscience, as part of the From The Trenches feature of LifeSciVC Patients and their care partners are at the center of our work in the life sciences industry – but at what point during the drugdevelopment process should companies start to engage these key stakeholders?
How to Facilitate Your Ophthalmic DrugDevelopment tchichekian Thu, 07/06/2023 - 01:11 HTML From Discovery to Market, We’ve Got You Covered. As a leading partner in ophthalmic drugdevelopment , Altasciences has an outstanding track record formulating, testing, and manufacturing ophthalmic products.
The demand for these medications, which play a vital role in managing diabetes and obesity, has far outpaced production capabilities, leading to widespread scarcity. The post Current ClinicalResearch Trends in GLP-1 (Glucagon-Like Peptide 1) Treatment appeared first on Worldwide Clinical Trials.
This significance and focus are ever more apparent when the starting cellular material is imperative to drugproduct success. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.
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. About QuartzBio QuartzBio helps overcome the data chaos inherent in modern drugdevelopment.
Meeting the never-ending challenges of drugdevelopment in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinicaldevelopment functions. are outsourced.
Under the stresses of the COVID-19 pandemic, drugdevelopment organizations faced difficult decisions about keeping staff employed and productive. Read on to learn more about rebadging as a valuable solution under an FSP model in clinicalresearch , and what to look for in a partner.
Selection of the appropriate design requires holistic consideration of your investigational product(s), patient population(s), and program specifics. Umbrella Studies Umbrella studies evaluate multiple investigational products (IPs) within a single disease. When Are Master Protocols Appropriate? Contact us.
Increasing diversity in clinical trials not only makes the findings more relevant to various patient groups, but also enhances knowledge about the disease or medical product being studied. This, in turn, provides crucial insights that help ensure the medical product’s safe and effective use among patients.
While this is a small number of people in each rare disease patient community, the significant and continued growth of rare disease drugdevelopment is unsurprising given that there are over 10,000 rare diseases , with more being discovered every year.
Clinicalresearch serves as the foundation for advancing medical knowledge, improving patient care, and ensuring the safety and efficacy of new investigational products.
The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinicalresearchers to discuss the latest advancements and challenges in oncology research. Interested in hearing more insights from Matt?
If your company is struggling to hire qualified clinicalresearch associates (CRAs), you’re not alone. A decade-long CRA talent shortage intensified as the COVID-19 pandemic increased strain on the clinicalresearch industry at large.
E&C lawmakers grill directors of FDA medical product centers Wednesday’s House E&C Health Subcommittee Hearing featured an extensive grilling of the leaders of FDA’s three medical products centers: CDER, CBER and CDRH. House of Representatives’ Energy and Commerce (E&C) Committee on Thursday, May 22.
In clinicalresearch, the role of drug packaging systems cannot be overlooked. Industry guidelines require biopharmaceutical and biotechnology companies to test their pharmaceutical packaging systems, as the systems often experience prolonged and intimate contact with drugproducts, drug substances and intermediates.
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. In many cases, higher levels of sponsor oversight are even required by regulation.
With the depth of knowledge to support all types of pharmaceutical products across all phases of development, we provide services ranging from end-to-end assay development to platform expansion, designed with the client’s timeline and budget in mind.
The advent of outsourcing in clinicalresearch came about in the 1980s based on transactional business-to-business interactions, which focused on the completion of specific development tasks. See how to unlock the full power of your CRO partner in our white paper, Optimal Outcomes in ClinicalResearch and ProductDevelopment.
When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drugdevelopment pathway. Once the CTA is submitted, the EU requires a new CTA for any new protocols amended.
The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drugdevelopers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.
Contract research organizations (CROs) are an integral partner of the drugdevelopment process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinical trials are actually managed by these organizations?
Introduction The biopharma industry is poised to make revolutionary advances in and redefine drugdevelopment, and the current climate for innovation appears ideal. The McKinsey analysis found that R&D productivity remains low. Development costs remain high (60 – 70% of total costs).
Nearly two-thirds of drugdevelopers’ outsourcing budgets are now allocated to functional service provider (FSP) models or FSP hybrid models, according to research conducted by the PPD clinicalresearch business of Thermo Fisher Scientific. Escalations and risk mitigation.
To lead in productdevelopment and partner with customers in solving everyday challenges, we gather information regularly about current practices and future trends,” said Volker Eckelt, PhD, Senior Strategy Leader, PerkinElmer Life Sciences. “To Pharma companies must improve productivity and efficiency amidst rising R&D costs.
This blog will outline three characteristics of a successful nonclinical program to support entry into clinical trials for a cell or gene therapy product. Can you identify a safe AND efficacious clinical dose? As in all nonclinical drugdevelopment programs, the goal is to identify potential safety issues in humans.
Clinicalresearch 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 clinicaldevelopment.
However, over the past decade, a trend toward incorporating multiple study populations into one protocol has slowly gathered momentum among drugdevelopers. Improved prioritization Promising pipeline candidates with a strong early development protocol may see a positive impact to the net present value of an early-stage asset.
We are pleased that to date our lead product candidate has aligned DCI profiles as expected. In April 2023, we presented preliminary safety data at the AACR Annual Meeting where our lead product candidate was observed to be well tolerated with no dose limiting toxicities observed in cancer patients through the first four dose levels.
Casgevy, the commercial product formerly known as exa-cel, is administered by taking stem cells out of a patient’s bone marrow and editing a gene in the cells in a laboratory, with the modified cells then infused back into the patient after conditioning treatment to prepare the bone marrow. What Does the Future of Gene Editing Hold?
Maintaining a product’s ongoing availability to consumers requires the developer to comply with safety and quality standards across every region where the product is marketed, for as long as it is marketed. However, completing this work is only half the challenge.
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