Clinical trial disparities and how to build a more inclusive future
pharmaphorum
OCTOBER 30, 2023
Clinical trial disparities and how to build a more inclusive future Mike.
October, 2023
124 
Opinion: How AI Can Accelerate and Improve Clinical Trial Recruitment
BioSpace
OCTOBER 26, 2023
New platforms are emerging to help biopharma companies fill their human studies more efficiently, but barriers remain to their successful implementation.
Join 32,000+
Insiders
Sign Up for our Newsletter
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
On a journey to diverse, inclusive, and more efficient rare disease trials
pharmaphorum
OCTOBER 27, 2023
On a journey to diverse, inclusive, and more efficient rare disease trials Mike.
FDA Lifts Hold on Mersana’s Antibody-Drug Conjugate Following Patient Death
BioSpace
OCTOBER 31, 2023
The regulator has released Mersana Therapeutics’ antibody-drug conjugate XMT-2056 from its clinical hold, allowing the biotech to proceed with Phase I studies of the candidate with a lower starting dose.
The New Age of Decentralized Clinical Trials
Advertisement
This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Health Literacy Month: How industry communication can impact patient health literacy
Antidote
OCTOBER 20, 2023
Since 1999, October has been designated as Health Literacy Month , a month dedicated to promoting patient-centricity in healthcare communications across the industry. Health literacy refers to a person’s ability to find, understand, and use health-related services and make informed decisions for themselves and others.
Evolving with the patient: Optimising CAGT post-trial long-term follow-up
pharmaphorum
OCTOBER 27, 2023
Evolving with the patient: Optimising CAGT post-trial long-term follow-up Mike.
Sign up to get articles personalized to your interests!
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
More Trending
Hyloris wins painkiller approval amidst amplified anti-opioid efforts
Pharmaceutical Technology
OCTOBER 18, 2023
The FDA approved Hyloris’s non-opioid painkiller as the agency increases efforts to mitigate an opioid crisis.
UPDATED: Pfizer plans to shutter New Jersey site, discloses layoffs amid $3.5B cost-cutting drive
Fierce Pharma
OCTOBER 30, 2023
Editor's note: This story has been updated with a comment from Pfizer. An earlier version of the story stated that nearly 800 jobs would be affected. | After plunging COVID revenues prompted Pfizer to embark on a cost-cutting crusade, more details about the company's savings efforts are coming into focus.
Parkinson’s Research Buoyed by Alzheimer’s Advances
BioSpace
OCTOBER 1, 2023
After a groundbreaking year in the Alzheimer’s space, Parkinson’s disease researchers express renewed hope based on a greater biological understanding of neurodegeneration.
Understanding primary sclerosing cholangitis symptoms
Antidote
OCTOBER 30, 2023
Primary sclerosing cholangitis (PSC) is an autoimmune disease that mainly targets bile ducts in the liver. PSC is a rare condition, impacting about 1 in 10,000 people worldwide , and it is diagnosed twice as frequently in men as it is in women.
Commercial Drug Sourcing for Clinical Trials
Advertisement
The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors
CAR-TCR 2023 – Matt Lakelin
pharmaphorum
OCTOBER 27, 2023
At CAR-TCR in Boston last month, pharmaphorum’s Jonah Comstock caught up with Matt Lakelin, co-founder of TrakCel, a software company that helps makers of advanced therapies manage their supply chain.
A decade later, biotech’s CRISPR revolution is still going strong
Bio Pharma Dive
OCTOBER 11, 2023
Once the specialty of a few select drugmakers, CRISPR gene editing is now an essential technology for a growing group of biotechs, many led by former students of the field's pioneering scientists.
ADDF announces speech database to identify biomarkers for Alzheimer’s
Pharmaceutical Technology
OCTOBER 24, 2023
SpeechDx will contain recorded voice samples and other data, which will be used to develop algorithms for creating new speech biomarkers.
With COVID sales in free-fall, Pfizer slashes revenue forecast by $9B and preps for major cost cuts
Fierce Pharma
OCTOBER 16, 2023
As the coronavirus outbreak has shifted to the endemic phase, drugmakers have warned of a drop in demand for COVID-19 products, with the impact coming into focus during the fall vaccination season. | Pfizer has slashed its 2023 revenue projection by $9 billion because of declining demand for COVID products. The company now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion.
How Machine Learning Drives Clinical Trial Efficiency
Advertisement
Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
NASH on the Cusp: An Emerging Market Opportunity
BioSpace
OCTOBER 22, 2023
The non-alcoholic steatohepatitis space is still a “big mystery,” analysts tell BioSpace, but its connection to weight loss could provide an additional opportunity for contenders.
LogiPharma USA 2023: Tracy Nasarenko Provides a Synopsis of “DSCSA—Final Checks to Have Before Deadlines.”
Pharmaceutical Commerce
OCTOBER 5, 2023
In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Tracy Nasarenko, Sr. Director of Community Engagement for Pharmaceuticals, GS1 US highlights her “DSCSA—Final Checks to Have Before Deadlines.
AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s
FDA Law Blog
OCTOBER 16, 2023
By Gail H. Javitt & Steven J. Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The first article—“Is the Eye the Window to Alzheimer’s?
Verve gets FDA green light to run base editing study in US
Bio Pharma Dive
OCTOBER 23, 2023
The trial, which is ongoing in the U.K. and New Zealand, has been on hold in the U.S. since late last year as the FDA sought more details on Verve’s in vivo treatment for heart disease.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Lisata receives orphan drug designation for pancreatic cancer therapy
Pharmaceutical Technology
OCTOBER 18, 2023
Lisata has received orphan drug designation from the EMA's Committee for Orphan Medicinal Products for LSTA1 to treat pancreatic cancer.
As COVID sales crater, Pfizer takes $5.6B in inventory write-offs on Paxlovid, Comirnaty
Fierce Pharma
OCTOBER 31, 2023
For Pfizer, several years of pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials. | Pfizer's pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials.
Relay Therapeutics Pauses Lirafugratinib Rare Cancer Plans Due to IRA
BioSpace
OCTOBER 12, 2023
The biotech will pause its lirafugratinib program for a rare bile duct cancer to target a larger FGFR2-altered solid tumors population, citing the Inflation Reduction Act as a driving decision factor.
AstraZeneca granted licence for Nanoform’s AI technology
Pharma Times
OCTOBER 23, 2023
STARMAP will accelerate the selection of AZ’s best molecule candidates - News - PharmaTimes
2022 Research: The Rapid Rise of Ocean Freight Visibility
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Podcast: The British start-up taking psychedelic therapy mainstream
BioPharma Reporter
OCTOBER 16, 2023
In our first podcast interview of 2023, BioPharma Reporter spoke with Dr Sarah Bateup, therapy lead at Clerkenwell Health, about the potential of psychedelic medicine and her work within the psychedelic therapy training space.
Vertex, CRISPR therapy for sickle cell passes FDA panel test
Bio Pharma Dive
OCTOBER 31, 2023
The high-profile meeting focused on the theoretical risks of CRISPR gene editing, as both the FDA and its advisory committee appeared convinced by the efficacy of the companies’ exa-cel treatment.
The use-case for NGS
Drug Discovery World
OCTOBER 25, 2023
DDW Editor Reece Armstrong speaks to Dr Darrell Green , Lecturer in RNA Biology Biomedical Research Centre Norwich Medical School University of East Anglia, about his work using next generation sequencing (NGS) and the areas the technology is impacting within drug discovery and development. RA: What areas of drug discovery and development are NGS technologies impacting most?
Merck’s Keytruda wins coveted FDA nod around surgery for early lung cancer—with a surprise
Fierce Pharma
OCTOBER 16, 2023
Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. | Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer. The drug's label already includes an overall survival win from a key trial.
An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
Opinion: The Potential of Neurofilament Light Chain as a Biomarker in Parkinson’s Disease
BioSpace
OCTOBER 22, 2023
While sensitive and specific biomarkers for Alzheimer’s disease have recently taken a leap forward, the Parkinson’s space has lagged behind. Neurofilament Light Chain could change that.
Empowering patients: How to match to clinical trials
Antidote
OCTOBER 3, 2023
Clinical trials are an integral part of the medical industry, as they are required for any new treatment to be approved. Every medicine used today, whether prescription or over the counter, is a result of the rigorous research process that is a clinical trial — and for these trials to take place, volunteers are vital.
CAR-TCR 2023 – Tim McGuire
pharmaphorum
OCTOBER 20, 2023
At CAR-TCR last month in Boston, pharmaphorum Editor in Chief Jonah Comstock grabbed some time with Tim McGuire, director of business development at biomanufacturer Resilience.
Tracking the FDA’s meeting on Vertex, CRISPR’s sickle cell therapy
Bio Pharma Dive
OCTOBER 31, 2023
Expert advisers are reviewing the companies’ case for approval of what could be the first medicine based on the gene editing technology. Follow their discussion here.
Making the Case for Case Management for Cell and Gene Therapies
Advertisement
As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements. Deviations from the intended supply chain can delay timelines and affect these high value products, which can be detrimental to budgets, but more importantly can have dire effects on the patients whose lives depend on receiving these critical doses safely and on time.
Let's personalize your content