New Strategies Generate Optimism for Targeting “Undruggable” KRAS

Vassiliki Papadimitrakopoulou, MD After 30 years of frustration, investigators are starting to make headway in their quest to develop therapies that counteract oncogenic mutations in the KRAS gene, a high-priority target in precision medicine that has long been deemed “undruggable.” 1-3 The discovery of binding pockets on a mutant […] Click here to view original[…]

Analog & Digital Approaches to Better Patient Engagement

Patients and regulatory authorities are asking for more patient/sponsor communication over the drug development cycle. At the same time, many sponsors seek to better understand the value of different investments to meet this demand. They are converting patient insights into journey maps and case studies that are producing a variety of new technologies and services[…]

Can Drug Development be AGILE? – Part II

Agile Methodology is not new – except in the realm of clinical drug development.  As you will see, there are ways to use this old IT technique to enhance your drug development team’s chances of hitting their goals. Agile methods were developed to overcome weaknesses in a conventional engineering process.  Agile development can provide important benefits.[…]

Pharmacovigilance Webinar: Avoid CAPAs and Enhance Health Authority Inspection Readiness

Anxious that your upcoming Health Authority Inspection will bring more CAPAs? Your organization spends a considerable amount of effort and resources on processing pharmacovigilance cases — but you’re still not sure your upcoming inspection will leave you without an additional CAPA headache. Ever wonder what it would be like to go into an inspection confident[…]

Patient Engagement – Ensuring Diversity in Clinical Trials

No one would disagree that diversity in clinical trials is critical.  Diversity ensures that novel drugs will be effective and safe for all patients.  But, a new FDA report shows that clinical trials may not reflect real-world demographics.  And these trials may not be diverse enough to ensure patient safety. For instance, the latest report shows only 48% of drug[…]

Patient Centricity – Improving Study Performance by Putting Patients First

Patient centricity ideas are everywhere today.  But, too often it is not seen by patients in a clinical trial. It seems like – the patient is at the center but the patients’ point of view is not. Patient Centricity – Sponsors vs. Patients Today, patients are asking for more input with sponsors throughout the drug development cycle.  And regulatory[…]

Concierge & Coaches: Mayday for Patient Engagement in Clinical Trials?

About five years ago, Amazon launched its contribution into the already crowded tablet market, the Kindle Fire.  While at its core it was like many other Android based tablets, Amazon built Kindle Fire’s user interface from the ground up.  It included some innovative features unseen in other similar products. One of the more innovative features was[…]

Do Patients Really Want to Use Your Patient Portal?

In June of 2016, Salesforce.com commissioned a survey conducted by Harris Poll of 2,025 adults aged 18 or older.  Of these adults, there were 1,736 who had both medical insurance and a primary care doctor. Respondents were sub-grouped, based on generational demographics: Baby Boomers (55+) Generation ‘X’ (35-54) Millennials (18-34) The survey included data on patients’ interest[…]

Patient Engagement Ideathon Winner: Changing the Message of Clinical Trials

The Center for Information & Study On Clinical Research Participation concluded its first Ideathon. The $10,000 prize went to C2: The Clinical Study Change Agent Collective. The team included members of FCB Health with input from a few notable Pharma companies as reported in this press release. Ideas for Patient Engagement in Clinical Trials The team[…]

Patient Engagement Solutions: Cleveland Clinic On Not Being Dumb With Smartphone Apps

What can you do to improve patient engagement solutions?  As part of its series of “Pop Health” forums, HIMMS last week invited Cleveland Clinic Chief Experience Officer Adrienne Boissy, MD, to speak.   She shared Cleveland Clinic’s insights on how to improve patient engagement.  Her key message:  more apps are not the answer. Dr. Boissy was[…]