Natural history studies provide researchers with a better understanding of a disease’s progression, supporting clinical trial design, among other benefits, say industry experts commenting on the FDA’s new draft guidance.
Researchers describe a technique to quantify a person’s “immune age,” information which could help design and analyze clinical trials – improving the drug development process, among other “impressive” possibilities, says industry expert.
Twist Bioscience, a synthetic DNA provider, enters a strategic collaboration with LakePharma to bolster antibody discovery and optimization for biologic drug development.
LabCorp’s collaboration with Mission Bio will use single cell-sequencing technology to understand the genetics of rare cell populations, which could be key to making clinical trials successful, says CEO.
Evotec AG is partnering with the Mark Foundation for Cancer Research to discover and develop first-in-class therapeutics in oncology using its new drug discovery platform.
Drug development advisory firm Rosa & Co. enters research agreement with Chugai pharmaceutical to provide access to PhysioPD research services for translational biology.
Consolidating its businesses under one brand, Altasciences is transitioning to an early drug development CRO – and looking to add a CDMO to manufacture drugs up to Phase II volumes.
Ligand Pharmaceuticals enters an agreement with Genagon to provide access to its drug development platform capable of producing fully human antibodies.
The UK-based private equity firm CBPE has purchased a majority stake in Simbec-Orion and will expand the CRO's reach both geographically and across all business units.
The industry has a “tremendous opportunity” to build on its progress by further improving operational performance in the face of pricing and patient access challenges.
Potentially increasing costs and dropping returns from investing in innovative medicines and devices will be among the main challenges faced in 2019, says industry analyst.
Moving forward, China will take a more integral role in global drug development, following several regulatory changes designed to accelerate innovation.
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.
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.
RxCelerate is opening its first office in the US to be closer to clients and meet a "huge demand" for drug discovery and development services in the greater Boston area.
Nascent next-generation processing technologies are expected to have a significant effect on how drugs are brought to market – faster and more cost-effectively than ever before, says industry expert.
A proof-of-concept study using patient-derived cells to test drug response in clinical trials demonstrates the benefits of precision medicine, movement to which is the future of study design, says researcher.
Quotient Sciences, a drug development services organization, will expand its operations with a new early phase formulation development and clinical trial manufacturing facility.
Specialized capsules and encapsulation techniques can streamline early phase clinical studies – and help researchers meet drug program timelines, says CDMO.
The drug development consultancy Certara this week has purchased a pharmacometrics modeling workbench and released a cloud-based platform to allow therapeutic decision-making apps to be delivered at the point of care.
The price of running a clinical trial to obtain FDA approval is a fraction of the total drug development cost – challenging traditionally held beliefs about the amount of money required to study prescription drugs, according to new research.
The platform will be designed to help life sciences organizations improve productivity, efficiency, and innovation in early stage drug development, says Accenture executive.
Industry executives are welcoming the FDA’s draft guidance on expansion cohort use in first-in-human clinical trials – the increasing use of which is evidence of a changing drug development paradigm, says CRO.
LabCorp signed several partnership deals in the second quarter of 2018 as the company aims to enhance the drug development process and continues to invest in its CRO business.
Ignoring pediatric considerations is no longer an option for the development of new medicines – though clinical trials in children are still not widely accepted by society, explains industry executive.
Innovations in drug development positively affect clinical trial timelines, market launch likelihood, and patient access – though adoption remains low, says report.
There is an increased need for transparency to improve the conduct of pediatric clinical trials and enhance the site investigator experience, says Syneos executive.
Avista Pharma Solutions, Inc. has acquired Solid Form Solutions, Ltd. to provide customers with a broader suite of services as a single company, says CEO.
As the industry continues to externalize components of the supply chain, global regulatory authorities are requiring a “quality-by-design” (QbD) approach to help mitigate risk across the drug development process.
Last week, President Donald Trump announced Scott Gottlieb as his nomination for the new US FDA commissioner – a candidate that ACRO says, “understands the complexities of drug development.”
Sensors, computer vision, machine learning, and cloud computing are enabling preclinical researchers to conduct higher quality studies in a shorter period of time.
Charles River Laboratories is conducting new studies using animal models to give insight into therapeutic strategies where pharma companies expect to see the most success.
Certara’s new consulting firm will rely on modeling and simulation expertise to expedite the drug development process, as China commits to increasing innovation.