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Much anticipated clinical trial data for Immunovant’s experimental FcRn inhibitor could catalyze businessdevelopment decisions for its parent, Roivant Sciences.
Pfizer Inc says it will maintain its supply of medicines to Russia but it will not initiate new clinical trials in the country, while Bayer is suspending investment projects and new-businessdevelopment in that market.
Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. Gareth Powell is a businessdevelopment officer for the NIHR Clinical Research Network (CRN).
COVID-19 has transformed the way we think about patient participation in trial design – but there are still many barriers to overcome in improving engagement. Speakers at the NIHR’s recent virtual event for the pharma industry discussed best practices for bringing patient insights into research.
Just ask Michaele Linden-Johnson, FACHE, MBA, LCSW, director of clinical trials and businessdevelopment at the Medical Center of the Americas (MCA) Foundation Cardwell Collaborative in El Paso, Texas. We’re all about developing a workforce designed to reflect our patient population,” Linden-Johnson says.
in an effort to raise money and awareness promoting diversity on all levels in clinical trials. But obstacles loom for the plucky bikers, says Sergio Armani, ACRP Ride4DEI Creator, and EVP, BusinessDevelopment, Helios Clinical Research. Learn more about Velocity's involvement with the ACRP Ride4DEI →.
In the latest episode of the pharmaphorum podcast, Dr Paul Tunnah speaks to head of Patient Engagement at Syneos Health, Marie Emms, and Elligo executive vice president and general manager of Worldwide Clinical Trials Early Phase Services, Keith Fern. The post The evolution of clinical trials: the pharmaphorum podcast appeared first on.
Across the industry, pharma companies are turning to AI and real-world data to address many of the challenges of running clinical trials. Can the combined potential of new AI technologies and real-world patient data hold the key to overcoming the challenges in clinical trial design that have historically led to trial failure?
Clinical trials are the engine for pharmaceutical innovation, but their means of capturing and communicating data are stuck in the past. While many pieces of the drug development process have digitised to keep pace with the speed of technological advancements, clinical trials continue to lag amidst pharma’s digital transformation.
Pharma companies face many challenges when involving patients in the design of clinical trials – but doing so can have huge benefits further down the line, improving the sustainability and quality of research. He said that this can be used to shape trials to make them easier for patients, with potential benefits in terms of adherence.
Recognizing the need to support VirTrial’s customers around the globe, Emil Hoeck has been named International Director of BusinessDevelopment and will be based in Denmark. VirTrial is a telemedicine company providing a stable, long-standing virtual care management (VCM) platform to transform the clinical trial industry.
After experiencing significant growth in the clinical trial solutions market in 2021, Crucial Data Solutions has added another industry veteran to its leadership team. Founded in 2010, Crucial Data Solutions (CDS) provides the most innovative low-code/no-code data and clinical trial management technology on the market today.
Josh Sackman, president and co-founder of AppliedVR, and Web Sun, president and co-founder of Komodo Health, relay how their newly formed collaboration reshapes the clinical trial process by using data, helping to cut costs and allowing for evaluation of broader patient populations. . Distinct offerings.
CAMP4’s CSO David Bumcrot PhD tells Pharmaceutical Technology that the company plans to see clinical trials go forward for their urea cycle disorder programs late next year. Ultragenyx Pharmaceuticals has an orthinine transcarbamylase (OTC) activator drug in Phase III trials. Future Possibilities.
Technology costs: fees for site-owned platforms such as a clinical trial management system (CTMS), eRegulatory management system, eSource platform, or any other specialized digital solution used during the trial. The more you can learn from previous trials, the more confidently you can negotiate your next one.
Previously viewed as a ‘nice to have’ for the pharma industry, virtual trials were already moving from a theoretical to a practical proposition before COVID-19 accelerated their transition. Increasing patient access to clinical trials. Ensuring new types of trial designs remain patient friendly.
In addition, job seekers are also scrambling to find strategies for further developing their career pathways. In this webinar, Chris and myself share some pragmatic approaches for all to implement in order to take advantage of a HOT clinical trials industry!
Merck will be responsible for leading the preclinical pharmacology and biology trials. We are looking forward to working with Merck as this will speed up the process of bringing novel effective treatments to conditions with high unmet medical needs.”
The OGA inhibitor was evaluated in three clinical studies including a double-blind, placebo-controlled, randomised Phase I trial and human positron emission tomography (PET) CNS target engagement study. The company now intends to conduct a Phase II clinical trial for determining the optimal dose range and efficacy of ASN90.
The company also intends to use the funding to develop its precision neuroscience platform. Recently, it completed subject enrolment in a Phase IIa clinical trial of NMRA-140, which is a kappa opioid receptor antagonist in development to treat the major depressive disorder. Neumora has raised nearly $650m in capital to date.
There is also increasing data from large-scale randomised clinical trials demonstrating their impact on improving asthma outcomes,” says Dr. Giselle Mosnaim, clinical associate professor at the University of Chicago Pritzker School of Medicine.
With just under a week left before Theranos founder Elizabeth Holmes is set to begin her 11-year prison sentence, the former CEO has appealed her conviction, calling it ‘unjust,’ asking for a new trial or a reduced prison term. Holmes founded healthcare startup Theranos in 2003.
The finished product dosage form, clinical development and the final products’ marketing and sales across the globe will be handled by Insud. . The companies initially signed a partnership last year and developed the first Dispersome drug product, which is readied for upscaling, GMP production and clinical trials in humans.
Thomas Kassberg, Chief Business Officer, Ultragenyx. The result is new modalities and new technologies that enable a broad range of biotech and pharmaceutical companies to work together to bring therapies to rare disease patients.
Healthcare technology firm Seqster has introduced a new version of its service that aims to help pharma companies work with patients’ data while on virtual clinical trials. What Seqster does for pharma clinical trials is it brings together in real time a health record for participants. The new Seqster 7.1 The new Seqster 7.1
If the patient can’t come to the trial, we have to bring the trial to the patient, and that is what is happening in record time. Dan McDonald, vice president, global businessdevelopment. I predict a point where there is no such thing as poor attrition rates or issues with recruitment for trials. and Europe.
Pharmaceutical drug research and development (R&D) activities are capital-intensive, which makes the outsourcing of clinical dose manufacturing and marketing popular.
OncoImmune was founded in 2000 based on the scientific discoveries of the company’s founders who moved their lead product from a basic concept into clinical trials for multiple indications. OncoC4 is a spinout of OncoImmune, which was acquired by Merck in December 2020.
While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own businessdevelopment, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. Image by WikiImages from Pixabay.
CRISPR Therapeutics and Vertex are also in the running with their gene-editing candidate CTX001, in phase 1/2 trials which are due to generate final results later this year. GBT’s inclacumab – another P-selectin antibody that could encroach on Adakveo – is in a pair of phase 3 trials due to generate results next year.
The Cardiff-based company’s pipeline also includes an oral testosterone in clinical trials for hypogonadism, as well as a modified-release levothyroxine for hypothyroidism and oligonucleotide-based therapy for Cushing’s disease in preclinical development. In July, Diurnal reported product sales of around £2.3
Évelyne Newton joins as Vice President of BusinessDevelopment, Sandra Stark is Vice President of European Operations and Maria Lehretz is the new Medical Director at Velocity’s recently acquired site in Leipzig, Germany. She has 20 years’ experience in businessdevelopment and key account management in the clinical trials arena.
From telehealth to digital trials, customer engagement to healthcare data, Healthware Group outlines the key trends that are expected to shake up digital health this year. Clinical trials get more and more digitalised. Aging in place’ becomes more commonplace.
It was rejected by the FDA as a treatment for triple-negative breast cancer (TNBC), while Merck withdrew a US approval in small cell lung cancer (SCLC) after disappointing results in a confirmatory trials. The drug also looks set to lose a stomach cancer indication after yesterday’s FDA advisory committee meeting, for the same reason.
According to GlobalData’s clinical trials database, there are currently 1,231 planned and ongoing trials for gene therapies and gene-modified cell therapies alone. It’s much more complex and it has to be 100% correct, or else patients are really at risk,” explains Michael MacNeir, vice president of BusinessDevelopment, Sharp Clinical.
Century will handle preclinical development, with BMS taking over when the programmes reach the clinical trial stage. The big pharma’s head of research and early development – Rupert Vassey – said the Century’s platforms “show promise and are complementary [BMS’] existing cell therapy technologies.”
From enabling patient choice during clinical trials to strengthening vital partnerships across the quality ecosystem, connected data will become the lifeblood that enables life sciences teams to collaborate efficiently and effectively in 2023. She is responsible for product strategy, customer engagement, and businessdevelopment.
We in the clinical trials industry are a community made up of countless numbers of people from thousands of companies. We are pleased to award Dan McDonald and thank him for his contribution to many OECT summits as a valued keynote speaker, presenter, and moderator regarding important clinical trial subjects,” Sharma said.
Followed by Russia , Indonesia, and Korea, the second phase of the COVID-19 clinical trial was approved in Italy on Friday, December 18, 2020. Currently, it is smoothly progressing with the approval for Phase 2 clinical trials in four countries, and it is expected to see the results sequentially starting as early as the third quarter of 2021.
“We have a working proof-of-concept that confirms applicability in dry, wet-hot, and cold applications,” said Yoav Gaon, CEO and businessdevelopment manager of B.T. This significantly shortens lab-and-line food trial time and costs. Sweet, in the same press release.
OSLO, Norway–( BUSINESS WIRE )– Ultimovacs ASA (“Ultimovacs”, ticker ULTIMO), today announced that Ton Berkien will join Ultimovacs’ management team as Chief Business Officer (CBO), effective December 1, 2020.
He was due to start at GSK this morning to lead the commercial aspects of its businessdevelopment, seeking out late-stage deal opportunities as the pharma group tries to build up its pipeline and step up sales growth in the wake of its separation from consumer health business Haleon.
Raw ingredients themselves may also behave differently at this stage, says Ingrid Coyle, MEDELPHARM’s director corporate businessdevelopment and communication. Moving away from trial and error. Certain challenges, like those related to the flowability of the blend, can only be tackled this way.
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