Amarin Corp Plc (AMRN)

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AdComm Members Due Diligence

Although we don't know the final members of the panel, here is some info I've put together on the ones listed on the website. Good luck everyone and thanks for all the knowledge shared on this site.

I feel pretty good about this panel, but I'm not sure how Dr. Thomas Webber (could not find much info on him), Connie Newman (she is pro-statins), and the consumer rep will vote.

AdCom Members Due Diligence
Members: https://www.fda.gov/advisory-committees/endocrinologic-and-metabolic-drugs-advisory-committee/endocrinologic-and-metabolic-drugs-advisory-committee-roster

1. Dr. Michael Blaha
? Expertise: Caridology, Lipidology
? Favorable quotes about REDUCE-IT being a landmark study; see: https://www.nbcnews.com/health/heart-health/drug-fish-oil-cuts-risk-heart-attack-stroke-study-finds-n934701

2. Dr. Elizabeth Chrischilles
? Expertise: Pharmacoepidemiology, Comparative Effectiveness Research
? She has researched how to reduce cardiovascular disease and suggests she is open to new approaches; See: https://ahajournals.org/doi/10.1161/CIRCOUTCOMES.117.004188
? Her publications: https://icts.uiowa.edu/about-us/leadership/elizabeth-chrischilles-phd
? Research: Design and Testing of a Mobile Cardiovascular Risk Service with Patient Partners; research from integrated healthcare systems suggests that risk factors can be controlled better and treatment strategies for cardiovascular disease can be markedly improved by using a centralized cardiovascular risk service (CVRS) managed by pharmacists. The objective of this project is to develop and test a mobile app enabled pharmacist managed CVRS for disseminating and implementing evidence-based guidelines in practice.
? Research: MEDication Focused Outpatient Care for Underutilization for Secondary Prevention; to determine if a web based CVRS within diverse primary care offices can improve cardiovascular disease guideline adherence using the guideline advanced metrics; See: https://www.fammed.wisc.edu/medication-focused-outpatient-care-for-underutilization-of-secondary-prevention-med-focus/

3. Dr. James de Lemos
? Expertise: Cardiology
? Has collaborated with Dr. Budoff and Christie Ballantyne on journal articles

4. Dr. Susan Ellenberg
? Expertise: Biostatistics
? Research has focused on data monitoring committees and clinical trial designs; See: https://www.nejm.org/doi/full/10.1056/NEJMra1510066
? Given the rigor of the REDUCE-IT trial and DMC she should understand the DMC would have intervened in the trial if MO was impacting the results
? Rigorous clinical trials in public health emergencies are essential. See: https://www.ncbi.nlm.nih.gov/pubmed/29177461

5. Marvin Konstam
? Expertise: Cardiology
? Professor of Medicine at Tufts
? Completed training at Massachusetts General and Brigham and Women’s Hospitals
? Recipient of Lifetime Achievement Award from The Heart Failure Society of America
? Voted “Yes” on the EMPA-REG Outcome study that ended up being a 12-11 vote that the study provided substantial evidence to establish that empagliflozin reduces cardiovascular mortality. All practicing cardiologists on the committee voted yes; See: https://www.acc.org/latest-in-cardiology/articles/2016/06/28/17/00/fda-panel-votes-to-establish-that-diabetes-drug-reduces-cv-mortality

6. Cecilia Low Wang
? Expertise: Endocrinology, Diabetes, and Metabolism
? Faculty University of Colorado Denver School of Medicine
? Conducts clinical research on diabetes and metabolism
? Clinical interests include complications of diabetes (particularly cardiovascular disease); See: http://www.ucdenver.edu/academics/colleges/medicalschool/departments/medicine/EndocrinologyMetabolismDiabetes/faculty_staff/Pages/WangC.aspx
? Cardiovascular and Limb Outcomes In Patients with Diabetes and Peripheral Artery Disease; See: https://www.researchgate.net/publication/329672011_Cardiovascular_and_Limb_Outcomes_in_Patients_With_Diabetes_and_Peripheral_Artery_Disease_The_EUCLID_Trial
? Research on PCSK9 and the elevated residual cardiovascular risk due to inadequate lowering of LDL-C levels or non-LDL related dyslipidemia; See: https://www.ncbi.nlm.nih.gov/pubmed/29095667
? Diabetes & Cardiovascular Risk; see: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.116.022194

7. Anna McCollister-Slipp – Consumer Representative

8. Connie Newman
? Expertise: Diabetes
? Professor NYU School of Medicine
? Chair of the writing group for the AHA’s Scientific Statement on the safety of statins
? She is pro-statins; see: https://www.ncbi.nlm.nih.gov/pubmed/26318980?otool=nynyumlib&myncbishare=nynyumlib
? Authored papers with Christie Ballantyne

9. Dr. Ken Burman
? Expertise: Endocrinology, thyroid cancer
? Professor of Medicine at Georgetown
? One of the 17 yes votes who approved the LEADER trial
? Additionally, the AdCom Chairperson, Dr. Kenneth Burman, previously voted in favor of Novo Nordisk's (NVO) insulin degludec and insulin degludec/aspart when chairing a prior AdCom. Roth Capital analyst Rahimi reads this as a strong sign that he is receptive to new therapies and as a positive for Vascepa's review, she said.
Read more at:
https://thefly.com/landingPageNews.php?id=2950505
? Quote about Crestor perhaps leading to higher numbers of diabetes cases: https://uk.reuters.com/article/astrazeneca-crestor/update-2-us-panel-backs-wider-use-of-astrazenecas-crestor-idUKN1521901920091215

10. Dr. Thomas J. Webber
? Expertise: Endocrinology
? Associate Professor Duke University Medical Center

11. Dr. Jack Yanovski
? Expertise: Pediatric Endocrinology
? Focuses on growth and obesity in children
? See: https://irp.nih.gov/pi/jack-yanovski
? He has looked at obesity and cardiometabolic risks; see: https://jamanetwork.com/journals/jama/fullarticle/1774038