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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.
The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drug development. In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinicalresearch and drug discovery.
Like many aspects of life in the 21st century, this era of scientific advancement and increased partnership is largely driven by next-generation technologies that are streamlining workflows, breaking down silos and empowering scientists to extract the most prescient insights from their data throughout the drug development process.
This exclusive interview with Dr Sharon Benzeno, Chief Commercial Officer, Immune Medicine at Adaptive Biotechnologies, unveils some ground-breaking research on T- cell therapy for cancer , which has seen the first TCR-based therapeutic candidate progress to clinicaldevelopment, offering promising advancements in innovative cancer treatments.
2 Unmet needs in lung cancer treatment Recent decades have seen significant advancements in lung cancer treatment, especially with the introduction of targeted therapies and immunotherapies, which have notably improved survival rates. 18 Indeed, early-phase clinical studies exploring TsAbs in solid tumours have recently commenced.
Reaching the end goal of delivering transformational new treatment options for patients can take a decade or more even when companies execute successfully and are well capitalized. The post Looking for Opportunities to Accelerate ClinicalResearch in Rare Diseases appeared first on LifeSciVC.
Despite these advancements, challenges for widespread effective care remain due to the heterogeneous patient population, opening the door for further development of treatments for T2D. Obesity is a major factor in the prevalence of T2D, and it is vital to develop T2D treatments with this in mind.
Instead of the standard approach where studies are designed to address a primary focus, a parallel study method — a format that incorporates multiple endpoints and objectives, modifications, treatment arms and dose selections into a single protocol — is being rapidly adopted.
To keep a pulse on this rapidly changing industry, the PPD clinicalresearch business of Thermo Fisher Scientific surveyed 150 leaders in the biopharma and biotech industries for the second consecutive year. Differences in size, resources and agility have led the two groups to take different approaches to clinicaldevelopment.
In China, the high incidence of solid tumors is driving an urgent need for advanced therapies, spurring the push for new treatment approaches. When sponsors are armed with this knowledge, it expedites the ability to expand and scale CGT development. Factoring in cultural dynamics is key to enabling new therapy treatment success.
In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy. Source link: [link].
I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as ClinicalResearch Manager at AstraHässle, a mid-size Swedish pharma company.
This has aligned with the broader curation of a number of new dose-escalation and efficacy designs for clinicaldevelopment in oncology. A nuanced understanding of these considerations enables sponsors to ask more complex questions like:
7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. One step closer to a novel treatment.
In this IO arena, we continue to search for additional treatments that can further benefit patients. Immune checkpoint inhibitors, a well-established class of IO treatments, are designed to improve the ability of T-cells to fight cancer by removing inhibitory or suppressive mechanisms that may dampen the anti-cancer functions of T cells.
These algorithms can swiftly navigate extensive databases of clinical trial information to pinpoint potential matches between patients and trials, considering various factors such as treatment protocols and geographical considerations.
To spur more frequent engagement between patients, sponsors, and regulators, Richie Kahn and Jenn McNary co-founded Canary Advisors , a patient engagement consultancy that works to better align development programs with patient needs.
Nevertheless, the potential to pioneer and move the needle for patients with few treatment options drives me to push through. Advancements in gene and cell-based medicine have the potential to meaningfully address diseases where there are no available treatments. The impact on patients and their families could be life-changing.
The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of clinical trial participants. Sponsors should ensure a diverse multidisciplinary team of stakeholders supports the design of the study and the clinicaldevelopment plan.
We are strongly encouraged by these data and the potential for a frontline targeted treatment that can improve overall survival,” said Zev A. Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase ClinicalResearch at the Jonsson Comprehensive Cancer Center.
In an effort to slow the spread of the disease and prevent a second wave, pharma companies around the world are continuously looking to advance new methods of treatment. This week’s round up dives into developments from companies based in Australia and the US. Saama Technologies, Inc. ,
December 1, 2023 — Precision for Medicine, the first global biomarker-driven clinicalresearch organization, is the recipient of a new accreditation from The College of American Pathologists (CAP) for its tissue and histopathology laboratory in Winston-Salem, North Carolina. Winston-Salem, Nc.,
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. In his presidential address, outgoing ASCO president Dr.
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. Public awareness: Education campaigns to raise awareness about HBV transmission and prevention.
For decades, cytotoxic-based chemotherapy has been the main treatment for all kinds of cancers. Fu, 2022) Clinicalresearch progress of ADC After decades of efforts, more than 100 ADCs are currently under clinicaldevelopment.
A Modern Twist for the Gold Standard of ClinicalResearch The gold standard for clinicalresearch intended for regulatory approval is the randomized controlled trial that compares an investigational drug candidate to either a placebo, active control, or standard of care (SoC).
It’s an exciting process—anticipating development risks, predicting outcomes, and aligning these with the greater vision of medical advancement. The true joy comes from navigating these complexities and asking the right questions early on, because these foundational steps are critical to the success of any clinicaldevelopment process.
Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinicaldevelopment arena. billion each year.
The clinicalresearch industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight deadlines. The clinical trial process is both expensive and time-consuming, and ends more often in failure than success. of respondents reported they know what clinical trials are.
CRO Leadership Awards recognize companies judged by customers as exceeding expectations BETHESDA, MD, May 25, 2023 – Precision for Medicine, the first biomarker-driven clinicalresearch organization (CRO), announces its wide recognition in the 2023 CRO Leadership Awards. For more information, visit PrecisionForMedicine.com.
This acquisition allows us to vastly expand our capabilities and deliver efficient and strategic solutions that drive the path forward for manufacturing complex treatments while ensuring reliable and consistent drug supply chains.” This convergence is driving faster clinicaldevelopment and approval. Bethesda, Md.,
Oncology Despite significant progress in cancer research, many patients face limited treatment options. The Vial Oncology CRO offers sponsors solutions to support their research, including optimized study design, innovative patient recruitment strategies, and advanced data analytics.
Clinicalresearch is a key component of developing. A critical component of our medicinal product development is clinicalresearch. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. Our core areas of research are: Immunology.
However, despite their increasingly ubiquitous role in the clinicalresearch industry, the question remains as to the extent of their participation. That is, how many clinical trials are actually managed by these organizations? Understanding the Numbers: How Many Clinical Trials Utilize CROs? between 2023 and 2032.
Deucravacitinib demonstrated efficacy no matter baseline characteristics, including weight , disease severity and former treatment with biologic or non-biologic therapies. Deucravacitinib also demonstrated durable efficacy in scalp psoriasis through 52 weeks of treatment (Poster Number: P1391).
Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Typical clinicaldevelopment timelines for anticancer drugs average an estimated 6.7
The Company is required to develop and submit to the FDA an improved potency assay prior to enrolling the efficacy phase of the RUBY trial. EDIT-301 is an experimental, ex vivo gene editing cell medicine in development for the treatment of sickle cell disease. Clinical trial materials are being manufactured by Editas Medicine.
The FDA, already chronically understaffed, reassigned many reviewers to focus on COVID treatments. Many companies are unable to develop these niche therapies because of the associated costs and limited financial return. Communication issues between sponsors and the FDA is an ongoing issue in CGT development.
We are very honored to have someone of Dr. Zeldis’ caliber lead our scientific research and clinicaldevelopment teams. Later as CMO and President of ClinicalResearch, Medical Affairs, Drug Safety, Quality, and Regulatory at Sorrento Therapeutics, Inc, he helped to advance its unique immuno-oncology programs.
vice president and global head of oncology clinicaldevelopment at AbbVie. “Data obtained from this exploratory analysis holds promise for potential future clinicalresearch,” said Jacqueline S. The most common SAEs were pneumonia (n= 4, 12%) and splenic infarction (n= 2, 6%).2 Garcia, M.D.,
Cadavid will be responsible for the strategy, direction and execution of the company’s clinicaldevelopment programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinicaldevelopment group.
an emerging leader focused on the treatment of kidney disease, sepsis and organ injury, today announced the appointment of Maarten Kraan, M.D., We are a dedicated team driven to bring treatment options to severely ill patients, their families and acute care professionals. 20, 2020 09:00 UTC. Find out more about us online at: www.am-pharma.com.
The trial is the first-in-human clinical study investigating the duoCAR T-cell therapy for the treatment of HIV. “So far, there have been no adverse events observed that were related to the treatment and the two participants are doing fine.”
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing multiple therapies targeting hematological malignancies and autoimmune diseases.
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