As coverage and reimbursement landscapes change, drug developers must assess how healthcare systems will handle the incoming wave of treatments for rare diseases that often carry a high list price, and they should prepare for restrictive practices that pass more of the costs along to patients. Developers can speed orphan medicines to patients through better communication of value to payers and other stakeholders.
The pace of innovation in oncology, with aggressive drug development, new approaches such as immunotherapies, increasing patient segmentation and multiple drug targets even within a single cancer type demands equally creative responses from regulators. The US Food and Drug Administration (FDA) has expedited cancer-drug development through mechanisms and incentives such as the accelerated approval program, the breakthrough therapy designation and the Orphan Drug Act. Associated initiatives such as adaptive study endpoints, reliance on earlier evidence supplemented by real-world data and less complex trial designs have helped to ease the pathway for cutting-edge cancer therapies.
The German tech company LabTwin is launching its voice-activated (VA) lab assistant at BIO in Philadelphia in June. The technology is a game-changer for scientists working in labs and is a major advance in the digitization of the laboratory.
The critical time for many drug development companies frequently comes after successful clinical trials, during the regulatory approval process, and beyond. Moreover, the 2018 survey Formulation in the Drug Product Development Process found that formulation issues had led to project failure and significant delays during drug product development.
The life sciences industry’s commitment to digital transformation is increasing, but few organizations are digitally maturing. Here’s how companies can take an enterprisewide approach to digital transformation.
Lot-to-lot variability is a common problem in bioprocess manufacturing, one that frustrates efforts to plan more effectively for downstream output. Pressure to achieve lot-to-lot consistency has intensified in recent years. This is partly due to more stringent regulatory requirements, in particular around trace metals. The pressure also reflects internal demand for manufacturing efficiencies, as biopharmaceutical companies grapple with issues such as rising drug-development costs and tougher barriers to market access.
Safe and efficient delivery is a fundamental challenge for personalized medicine, gene therapy and genetic medicine. Specialized and unique delivery systems are required, depending on the biology and the physiology of the target. Of the many and varied efforts to develop controlled-release, nano-compartmentalized therapeutic agents, Liposomes and Lipid-nanoparticle (LNP) systems are two of the most promising.
In the 12th edition of EY’s medtech report, The Pulse of the Industry, we examine the annual performance of the medical device industry in the context of the technological advances and rising customer expectations associated with the Fourth Industrial Revolution. To thrive in this transformative age, medtechs must adapt their business models to meet the increased expectations of consumers and other health care stakeholders.
An increasingly data-rich healthcare sector presents both opportunities and challenges for the MedTech industry, just as it does for the health systems and patients served by MedTech products.
Used intelligently and appropriately, the vast quantities of real-world data emanating from multiple healthcare sources, such as electronic medical records (EMRs), claims databases, products and disease registries, provide the raw material for real-world evidence (RWE) that can inform strategy and decision-making throughout the MedTech-product lifecycle.
Mike Ward, head of pharma content, sat down with Srinivasa Karri, a strategist with Oracle Health Sciences, to discuss the survey findings and highlight how companies can best manage the torrent of clinical data from multiple sources that will underpin their regulatory submissions.
US FDA is an ever-evolving organization, from recent changes to facility inspections under its so-called "Program Alignment" initiative, to plans to harmonize the agency's Quality System Regulation with international quality systems standard ISO 13485 – just to name two big-ticket reforms.
Adoptive Cellular Transfer (ACT): Novel Cancer Trials Demand That Participating Sites Act Differently
As more pharma and biotech companies bring their ACT platforms to the clinic, there is a need for the assistance of clinical research organisations (CROs) to support the conduct of clinical trials. Valued for their relationships with trial centres, CROs have been thrust into the forefront of operationalising ACT studies. So what can sites expect and commit to when participating in ACT trials?
Iron deficiency is a global public-health challenge in need of urgent attention. It affects more people than any other nutritional disorder, particularly in the developing world, but also with significant prevalence in industrialized countries
The history of stem cell research has been marked by a combination of great promise, disappointment and controversy. But progress is being made, with a number of stem cell therapies approved and many more in the late-stage pipeline. While the US has lagged behind other regions in stem cell therapy approvals, recent developments on the regulatory front are intended to provide a clearer path forward and accelerate development.
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Pharmaceutical Development And Manufacturing: Challenges And Opportunities
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