The Critical Importance of Real-Time Access to Clinical Study Performance
The need to see real-time study performance is vital, as teams focus on meeting timelines and ensuring resources are appropriately allocated, writes EVP of WCG, Jonathan Zung.
Who’s Going to be Disrupted by Shifts in European Health Strategy?
Peter O’Donnell writes of the support of ‘disruptive’ change in European health systems from European health professionals and policymakers from a recent gathering.
The ‘Quest’ for an Effective Partner in Pharma and Biotech
David Freeman, General Manager, Information Ventures, for Quest Diagnostics, discusses how his company can be an effective partner for pharma and biotech firms.
Addressing the Unique Needs of Emerging Biopharma in Drug Development
CEO of Synteract, Steve Powell, discusses the advantages that mid-sized CROs-like his own-offer emerging drug developers to navigate continually changing processes.
Fighting High Prices for Innovative Drugs with State-Owned Generic Production
A strongly-worded plan for reining-in profit-driven drug firms receives immediate backlash as arguments over drug pricing and patient access continue to rage around Europe and the US.
Overcoming the Complexities of Neurodegenerative Clinical Trials
COO and CMO of BrainStorm, Ralph Kern, discusses how his company is overcoming challenges and advancing science in neurodegenerative disease.
A Name that European Clinical Trials Will Get to Know—and Maybe Love
Peter O'Donnell discusses the outpouring of support for Stella Kyriakides, who has been designated to lead European Union health policy for the next five years, and how she might need every bit of it.
Emerging Biopharma Tackles the Opioid Crisis
Dr. Steven Fox, CEO of Akelos Inc., discusses the challenges of developing new non-opioid medical products as the need intensifies as the crisis worsens.
Novartis Data Manipulation Spotlights Wider Concerns
Regulatory enforcement actions, policy updates, and new guidelines show that ensuring the reliability of clinical data is an ongoing priority.
No End in Sight to European Debates About Drug Firms’ Influence on Regulators
The two-year inquiry into possible maladministration at the EMA has intensified.
Alzheimer’s Disease Research Finds New Beginnings
Dr. Daniel Alkon, President & Chief Science Officer at Neurotrope, discusses novel approaches to AD therapy development and why his company chose to target patients with advanced AD for their own.
Overcoming The Hurdles of Starting up a Biopharmaceutical Company
CEO of eXIthera, Neil Hayward, talks about his experience overcoming the challenges of starting up an emerging biopharmaceutical company, including the challenges of preclinical and early-stage development.
Big CROs Dive into Offering AI/ML Solutions
Benjamin Hughes, SVP of AI and Real-World Data at IQVIA, discusses how AI is changing the clinical trial paradigm, and how the technologies IQVIA is developing are different from other tech companies that specialize in AI/ML
How AI is Transforming Clinical Trials: A Look Into the Code
Krishnan Nandabalan, CEO of InveniAI, discusses how artificial intelligence is shifting the clinical trial paradigm in studies for areas like oncology and the central nervous system.
Patient Experience Comes to Drug Development
Irfan Khan, writes that though we celebrate MyStudies' teams work, the FDA’s Patient Engagement Advisory Council deserves specific credit for bringing the patient voice into the design thinking for technologies in clinical research.
Patient Centricity Goes Global
Barbara Lopez Kunz, Global Chief Executive at the Drug Information Association discusses how involvement of patients in healthcare is critical for success.
Down with Drug Reference Pricing!
PhRMA in Europe cries of trailing the US after adopting reference pricing.
Navigating Genomic Therapy Development
Moe Alsumidaie interviews Sandy Macrae, Chief Executive Officer of Sangamo Therapeutics, Inc., who discusses navigating the new wave of genomic medicine.
Five Strategies for Conducting Successful Pediatric Trials
Sandra Pagnussat, of QPS, explores strategies to help combat the unique set of challenges that pediatric trials present.
Big Data is Built From Tiny Fragments
Do patients really want to share their data? Nearly half of the rare disease patients responding to an international survey, are against their data being shared outside or even within the medical field.
CMC Considerations for Gene Therapy and Regenerative Medicine Studies
The unforeseen challenges with clinical trial execution in gene therapy and regenerative medicine studies, such as unchanging FDA regulations, discussed.
AI Mitigates Clinical Trial Placebo-Response
Dominique Demolle, CEO of Tools4Patient, discusses the effect artificial intelligence is having on the statistical impact of clinical trial placebo response.
Regenerative Medicine Companies Pursue Unique Regulatory Pathways
Yaky Yanay, CEO of Pluristem, talks with Moe Alsumidaie about his experience and the strategies Pluristem implemented in regenerative medicine clinical trials.
Too Fast or Too Slow? Debate Intensifies over FDA Regulatory Requirements
Concerns for patient safety are raised with the recent surge in new drugs receiving fast-track FDA approval. Jill Wechsler reports.
Denmark's Medicines Agency Tightens Up on Conflicts of Interest
New rules in Denmark to eliminate potential conflict-of-interest issues follow the lead of the European Medicines Agency's repeated attempts to rebut allegations of pro-industry bias.
Getting Ready for Godot: Rehearsals for Europe's New Clinical Trials Rules
Peter O'Donnell discusses the European Commission's compendium and how triallists are not only obliged to comply with the current rules, but at the same time to prepare themselves for the future rules.
The Growing Threat to Clinical Trials and Research in a Fracturing Europe
The consequences UK faces after being pulled out of the EU without any healthcare and research deal may affect all of Europe.
The possibility of a "no-deal" Brexit scenario would have severe repercussions for clinical trials not only in the UK, but the rest of Europe as well.
The Changing Needs of Mid-sized Sponsors
Becky Carpenter, Head of North America/Euro Operations at WuXi Clinical, a newly formed CRO, discusses the evolution of the mid-sized pharma and CRO space-and the level of support now needed for some of the smaller and more nimble customers.
Large CROs Adapt to Emerging Biopharma Companies
Chris Smith, COO of IQVIA Biotech, discusses with Moe Alsumidaie how large CROs are responding to EBP targets.
