Tag Archive | FDA

Consumer Health Informatics Course – TYVM Guest Lecturers

Last semester I taught Consumer Health Informatics and Web 2.0 in Healthcare in the College of Pharmacy (COP) after having coordinated several iterations of it in the MS in Biomedical Informatics Program. At the end of the COP course, I asked the students for their opinions about the most useful and least useful lectures of the semester (with an eye towards improving future offerings). Many of the students mentioned topics that were discussed by one of the six excellent guest lecturers. While I sincerely appreciate each guest lecturer’s contribution, I thought it would be even more meaningful to share a student response about each guest lecturer/topic.

I’ll use the format below to do so (lecturers appear in the order they taught during the semester):

Student quote
Guest Lecturer
Affiliation
“Lecture Topic”

The course’s most useful lecture was Dr. Kang’s since it focused on policy and the big picture instead of just one or two tools.
Jeah-Ah Kang, PharmD
Food and Drug Administration (FDA), Division of Drug Marketing, Advertising, and Communications (DDMAC)
“Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools”

Most useful was Dr. Gualtieri’s because it may be the only one that really looked at things from the patient’s side.
Lisa Gualtieri, PhD, ScM
Tufts University School of Medicine
“Blogging for Health: Communicating the Experience of Illness”

Most useful lecture was Dr. Dyer’s lecture. It was very cool seeing how healthcare was using this new tech and getting positive results. Very. Cool.
Jennifer Dyer, MD, MPH
Ohio State University, College of Medicine
“RU TAKING UR MEDS? (DR. SEZ TEXTING TEENZ HELPS!)”

I would like to see more experts like Dr. Fahrni. His lecture was most useful. It provided insight on what this breed of pharmacist does on a daily basis.
Jerry Fahrni, PharmD
Kaweah Delta District Hospital (now Talyst)
“Pharmacy Informatics – One Pharmacist’s Perspective”

The most useful topic was Dr. Mesko’s on virtual worlds because it was most forward looking. I wish we would use it more and create our own avatars.
Bertalan Mesko, MD
University of Debrecen Medical School
“Medicine in Second Life, the virtual world”

The most useful lecture topic would have to be the final lecture from Dr. Fox, it was extremely informative and I enjoyed it a lot. I’d like to see an additional lecture from him.
Brent Fox, PharmD, PhD
University of Auburn, College of Pharmacy
“The Pharmacist’s Role in Health 2.0”

 

Social media presence for the course contributors can be found here:

Lisa Gualtieri, PhD, ScM (@lisagualtieri)

Jennifer Dyer, MD, MPH (@EndoGoddess)

Jerry Fahrni, PharmD (@JFahrni)

Bertalan Mesko, MD (@Berci)

Brent Fox, PharmD, PhD (@Brent_Fox)

 

@kevinclauson

Non-inferiority Trial Design at the Anti-Infectives Summit

Recently I had the pleasure of attending and presenting at the 3rd Annual Anti-Infectives Summit in Philadelphia. It was a good opportunity to interact and see presentations by people from medicinal chemistry, biochemistry, regulatory, and other backgrounds involved in drug discovery and research. I don’t deal much these days with the preclinical perspective, so it was a refreshing change of pace. I always appreciate the chance for cross-pollination of ideas with people from different areas.

There were a number of particularly good presentations, and one common theme that I saw was the borderline-inspiring enthusiasm by the researchers. You can always tell when someone truly loves what they do and is genuinely excited by their work – and I definitely saw that. Notables included Ying Zhang, MD, PhD, from Johns Hopkins, who opened my eyes in his presentation on issues with persister bacteria and Jennifer Schranz, MD from Cempra, who gave a great overview on the FDA’s expectations for clinical trials. She took what could have been a dry topic and infused it with energy and pace – I wish I could poach her to guest lecture in one of our drug information courses on this topic.

Something else that came out of the presentations was the increased emphasis on PROs (patient reported outcomes) in clinical trials. Considering that the immediate past-director of the NIH (Elias Zerhouni) made a statement about the increasing importance of the participatory medicine model…I think it was just a question of “when”, not “if”. That point spurred several interesting chats about PROs, ePatients, Phase IV, and the development of Pharmacovigilance 2.0.

Overall it was a very positive experience. I enjoyed some science refereshers, regulatory navigation tips, and insight into the future of anti-infective drug development.

@kevinclauson

Edit: I used an audience response system (aka clickers) in my presentation and included those slides here. However, I did not use the actual attendees’ responses in the slide deck I uploaded.

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