The predictive value of animal models is less than 50%, which makes them less informative than a coin flip, says AAPS speaker – who also argues that clinical trial participants are not fully aware of the risks.
More than six million pet dogs are diagnosed with cancer every year – posing researchers with the opportunity to co-develop drugs for humans and animals.
The FDA has proposed a study to create a non-animal based model for drug development as part of its overall commitment to reduce the number of animals used in research.
Strong collaboration across the company’s clinical, commercial, and integration solutions teams led to a “solid performance,” said Syneos CEO Alistair MacDonald.
Synteract’s clients will benefit from a single source model, says CEO, following the acquisition of KinderPharm, a PA-based CRO focused on all phases of pediatric drug development.
Messenger RNA is demonstrating success in vaccine manufacturing and CureVac is giving it the place to do so with the development of a prophylactic vaccine with mRNA at its core.
The pharmaceutical industry has increasingly been adopting artificial intelligence – which has demonstrated the ability to predict instances of schizophrenia with 74% accuracy.
Bernard McGarvey, formerly of Eli Lilly, spoke with us about first principles of engineering in pharma, following his keynote ‘Engineering First Principles Applications to Pharmaceutical Manufacturing.'
TriNetX announced it will add claims data from 190m patients to its network, including ambulatory care, medical claims, and pharmacy claims, to enable researchers to query and analyze the information.
It’s a phrase we’ve all heard a thousand times – often from clients explaining why they didn’t go with your business as they’ve opted for the assumed ‘safe bet’ of a global leader.
Scientist.com has more than 70 employees across the globe, with offices in San Diego, Boston, the UK – and soon, Japan, with plans to open several satellite offices across the country.
Metrics Contract Services’ newly-opened manufacturing site has qualified two commercial bottling lines for serialization with DSCSA requirements set to be enforced this month.
While the industry has made significant strides in its aim to improve patient-centricity and engagement – the same principles need to be applied to clinical trial site relationships, says Syneos.
PCI Pharma Services is expanding its clinical site in Rockford, IL – following a string of acquisitions and expansions to help meet an increased demand for services
SGS has expanded its Chennai, India-based laboratory with the addition of inductively coupled plasma mass spectrometry systems to address updated ICH Q3D regulatory guidelines.
Charles River is eyeing M&A opportunities in every segment of its business, fueled by global market demand and a “fundamental shift” in the pharmaceutical industry, says CEO.
The US opioid crisis has been driven by early use in standard care, says Opiant director Gabrielle Silver, who urges pharma to ‘think differently’ to enable change.
PharmaCyte Biotech has contracted Medpace to conduct the clinical trial using its novel live-cell encapsulation technology, Cell-in-a-Box, which the company says could revolutionize cancer treatment.
The MA-based CRO Veristat is partnering with Triumph Research Intelligence to provide centralized and risk-based monitoring solutions to improve clinical trial compliance.
Parexel is adopting Medidata’s Shyft Analytics platform to bolster its real-world evidence generation and outcomes research offering to biopharmaceutical and medical device clients.
India-headquartered Glenmark Pharmaceuticals has opened a 100,000-square-foot facility on the East Coast for the manufacture of fixed dose formulations.
Immuno-oncology clinical trials are fundamentally different from traditional oncology studies as it pertains to logistics, and require close coordination across several stakeholders, says CRO.
Tracking the chain of custody for trial kits and ensuring patient data blinding – in compliance with HIPPA and GDPR – are among the unique logistical challenges to direct-to-patient clinical trials.
To manage the supply chain challenges faced by natural disasters, experts say to expect the unexpected – ensuring a strong shipping strategy is in place with temperature control and robust management.
Securing the clinical supply chain comes down to the notion of ‘compliance’, which is transitioning from a ‘nice to have’ to a ‘need to have,’ says Cryoport.
PRA Health Sciences is looking at and assessing various opportunities using real world data – as the company has become reliant on data as part of its clinical process, says CEO.
Sandoz is the latest Zhejiang Huahai Pharmaceutical customer to issue a nationwide recall after trace amounts of a probable carcinogen were found in the supplier’s API.
Patients cite their doctor as the most trusted source of clinical trial information, a sentiment that resonates in advertising – which cannot take a “one-size-fits-all" approach – according to a recent report.
This week in-PharmaTechnologist attended AAPS PharmSci360 in Washington, D.C. where discussions and thought-provoking ideas bounced across sessions – here, we highlight some of the most significant.
Medrio’s FDA-compliant tablet-based electronic-consent application for clinical trial participants looks to improve comprehension with graphics and videos.
The health care social network Inspire is expanding its research solutions to help life science stakeholders integrate the patient voice and experience into research.
Sharp has signed a preferred partnerships agreement with an MA-based CMO to reduce “friction” for clients while decreasing the time, cost, and complexity of managing clinical trials.
With less than one month until the US DSCSA deadline, RAPS member Greg Cathcart says the biggest concern for firms is understanding what is required, and when.
