In Life Sciences 4.0: securing value through platform-based businesses, EY’s latest edition of our Progressions series, we explore how health is being reimagined as a result of scientific and technological change and rising customer expectations. We also examine the ramifications for life sciences companies’ market offerings, business models and the new capabilities needed as the disciplines of health care and technology merge to become “health technology.”
Articles & Features
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.
For more than 20 years – from the passage of the US Food and Drug Administration Modernization Act (FDAMA) in 1997 until just this year – the life sciences industry has had little to go on when deciding what health economic information about products could be shared with payers. This was especially true with regard to products or indications that had not yet been granted marketing approval; the boundaries of what was permissible were blurry at best.
Pharma has woken up to label optimization. Figuring out, in advance of your pivotal trial, what robust and compelling language you need in your label has become one of the most strategic issues in drug development.
Downloads & Multimedia
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| Research Reports
|Addressing the Data Challenges of Pharmacovigilance||Download PDF|
|How to Efficiently Manage Clinical Trial Comparator Sourcing Challenges||Download PDF|
|Clinical Trial Randomization and Supply Management Systems of Tomorrow||View Video|
|Addressing the Data Challenges of Pharmacovigilance||View Video|
|Simplifying Regulatory Processes For Post-approval Changes With Unified RIM||Register|
|More Patients, Faster. The Next Evolution Of Oncology Drug Development||Register|
|Disrupting The Status Quo Of eClinical Identity Management: Removing The Burden At Clinical Trial Sites||Register|
|Does the UK’s Life Sciences Industrial Strategy And Sector Deal Make Brexit Easier to Swallow?||Register|
|Addressing Key Challenges In The Clinical Development Of Combination Immuno-oncology Therapies||Register|
|eConsent: Better For The Patient, Better For The Site||Register|
|What's Next In eCOA? - New Insights Into Equivalence Testing Methodology And Implications For BYOD||Register|
|Using Innovative Materials To Drive Medical Device Design||Register|
|Using Innovative Materials To Drive Medical Device Design - Part 2||Register|
|Body Fluids Analysis With Linearity Down to Zero||Register|
| Whitepapers & Special Reports
|Accelerating Cancer Drug Development||Download PDF|
|Improving Pharma R&D Efficiency: The Case for a Holistic Approach to Transforming Clinical Trials||Download PDF|
|Meeting Growth Challenges Roundtable||Download PDF|
|Innovation UK: Pushing life science frontiers in the North of England||Download PDF|
|Medical Devices Aren’t Luxury Goods, So Why Does Medtech Try to Sell Them That Way?||Download PDF|
|Translating Innovation Medtech Made Local||Download PDF|
|Positioning Key Accounts at the Center of Medtech’s Commercial Model||Download PDF|
|Assessing Patient Availability||Download PDF|
|Adaptive Design Years Later; What have we learned?||Download PDF|
|Applying Disruptive Innovation in CNS Clinical Trials to Reduce Variability||Download PDF|
|Cell And Gene Therapy Rapid Approvals Can Pose Commercialization Challenges||Download PDF|
|Successful Linguistic Validation of Clinical Outcomes Assessments||Download PDF|
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