Category Archives: Regulatory

Conducting Inpatient Clinical Research During a Pandemic

23rd Annual Symposium on Clinical & Pharmaceutical Solutions through Analysis (CPSA USA 2020)

Mary Ann Diliberto, The Children’s Hospital of Philadelphia

“We need to find better ways to connect to get work done.” – Mary Ann Diliberto, The Children’s Hospital of Philadelphia

Marry Ann Diliberto describes many of the challenges for clinical research since the onset of the pandemic.  During March 2020, all clinical research stopped, creating difficulties for patients and important studies.  In Mary’s group, they had over 25 studies, managed by 15 staff members – all had to be shut down.  She describes the feeling and thoughts during the onset of the pandemic:  When can we resume research safely and efficiently?  We need to be helping these patients.  We need to be able to see the patients!  After these initial challenging times, Mary and her teams have worked together to implement new protocols and systems, within the reality of the new normal.

Microsampling Is Well Established. Now It’s Just A Matter of How We Implement It!

23rd Clinical & Pharmaceutical Solutions through Analysis USA (CPSA USA 2020)

Pre-Conference Workshop – Microsampling

Sponsored by New Objective

Enaksha Wickremsinhe, Eli Lilly & Co.

“Easy to understand unhealthy, how do we understand healthy?” – Enaksha Wickremsinhe, Eli Lilly & Co.

Microsampling in patients is already an established method, but how do we increase adoption and integrate into current workflows?  Enaksha talks about how we are all patients, and that we all have or will ride the healthcare train.  Our goal is to stay healthy, but often we only visit the doctor’s office when we are sick.  Enaksha describes a world where microsampling plays an important role in describing health – possibly sampling at home – instead of only going to the clinic or doctor’s office when we are sick.  Ubiquitously implementing these new processes using existing, mature technologies has gained momentum – but it has and does take a village to get it done.

Microsampling: Why Can’t a Human Serve as Their Own Control?

Clinical & Pharmaceutical Solutions through Analysis USA (CPSA USA 2020)

Pre-Conference Workshop – Microsampling

Sponsored by New Objective

Kevin Bateman, Merck

“The sharing part is important, it motivates others to do the same” – Kevin Bateman, Merck

The microsampling community continues to improve technologies and solutions for the patient, while working towards understanding human biology.  During Kevin’s CPSA Everyday, Microsampling edition, he describes a Vison that is dedicated to motivating others to engage in microsampling – in a collaborative way.  While working through the complexity of iterative loops for development of technology to solutions (from a perceived failure, to understanding, to improving the science or process) we can work together with each other’s expertise, for the patient.  Each human is different, and such: Why can’t each human be their own control?  Starting from a heal prick at birth, can we simply have more data points?  Kevin discusses a Vision that also speaks towards patient adherence and regulatory aspects for implementing micosampling solutions. In the end, improving healthcare is not a competition, it is actually a team sport.