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Options for Medical Students to Follow: The Biomedical Industries Pathway
Vasilios Papademetriou is a cardiologist and professor of medicine at Georgetown University who has collaborated extensively with the biomedical industry. He discusses several career pathways for medical students in the biomedical industry, including doing clinical trials sponsored by industry, serving on advisory boards, and collaborating on research. He provides examples of physicians who have successfully worked with industry to develop new drugs and devices.
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Options for Medical Students to Follow: The Biomedical Industries Pathway
- 1. Vasilios Papademetriou, MD,DSc, FACC, FACP, FAHA Professor of Medicine (Cardiology) Georgetown University Washington DC Options for Medical Students to Follow: The Biomedical Industries Pathway
- 2. › I ama cardiologist-Interventional › Professor of Medicine ( Cardiology) › Director of Cardiovascular Research for > 25 years › Have done basic research ( early on)- NIH,VA Medical Center › Lately ClinicalTrials ( Mostly) – Collaborated with the industry – Part of several NIH ,VA sponsored trials › For the last 5 years I served as a member of the Cardio renal Panel of the FDA ( Approval of new drugs) – Rivaroxaban – Droxidopa etc A few things about myself
- 3. › Develop NewDrugs › Develop New Devices – Diagnostic – Interventional – Sensors – Imaging Aim of the Industry
- 4. New Drugs Discoveryand Development Test many compounds Mechanism of action Rout of administration etc Preclinical Research In vitro and in vivo Dosing and toxicity in animal models Clinical Research FDA Review FDA Post-Marketing Safety Monitoring Clinical Research Phase 1 Dosage & safety 20 to 100 healthy volunteers Phase 2 Efficacy & side effects Several 100s of people Phase 3 Efficacy and adverse events 300 to 3,000 people Phase 4 Safety and efficacy Several 1000s of people RESEARCH & DEVELOPMENT Only 1:10 new drugs makes it to the FDA and cost can be up to one BILLION $
- 5. New Devices Devicediscovery and concept Preclinical research-Prototype Pathway to approval FDA Review FDA Post_ Marketing Monitoring Pathway to approval FDA established risk-based classification system Class I Class II Class III Safety and Efficacy Proof of concept/First in man study Controlled trials Placebo or sham control studies Outcome data DEVICE DEVELOPMENT PROCESS
- 6. Foreign Medical Graduates: Optionsin Biomedical Industries Work for the Industry Maximize your potential Optimize chances for success Collaborate with the industry Graduates of the EUC
- 7. › As aPhysician working in private practice or Academia – Clinical Research ( Phase I,II,III or IV studies) – Investigator initiated projects – sponsored by the industry – Basic research of interest to the industry › Serve on advisor boards – Help the industry understand clinical implications of their studies – Design the right kind of research – Interpret the results of clinical trials › Steering committees – Direct and supervise clinical studies – Analyze results – Publish research papers Collaborate with the industry (Part time job)
- 8. › Physicians ofDCRI – Robert Calif › Brigham and Women's Research Center – Mark Pfeffer › Contributed to the development of many of the drugs we use today: – ACE inhibitors – Beta blockers – Statins – Diabetes drugs Collaborating with the industry
- 9. • Pre clinicaltesting • Toxicity studies Drug Development • First in human study • Proof of efficacy and safety Proof of concept • Pivotal study • Phase I, II, III and IV studies Clinical Development Program › Research & Development – Invent and test new therapies – Design and Direct Clinical Trials › Direct Marketing – Education – Promotion Working for the Industry as a Physician
- 10. Afferent andEfferent Renal fibers Can affect blood pressure control Afferent fibers originate from the kidney and transfer signals to the brain After processing can affect the function of the heart, the blood vessels and the kidney Efferent fibers transfer signals from the brain to the kidney and can affect Na and fluid absorption, plasma renin activity and aldosterone production SYMPATHETIC RENAL DENERVATION CONCEPT Papademetriou et al. Circulation 2014;129:1440-51
- 11. FIRST IN MANSTUDY: SYMPLICITY HTN-1 -14 -21 -22 -24 -27-10 -10 -11 -11 -17 -50 -40 -30 -20 -10 0 10 1 month (n=41) 3 months (n=39) 6 months (n=26) 9 months (n=20) 12 months (n=9) Mean Change in Blood Pressure (mmHg) Presented with 95% Confidence Intervals Systolic Diastolic Lancet 2009
- 12. RENAL DENERVATION SYSTEMSWITH CE MARK APPROVAL IN EUROPE
- 13. ST JUDE MEDICALRENAL DENERVATION SYSTEM
- 14. STAGES OF RENALDENERVATION Papademetriou, Tsioufis, Doumas…… Circulation 2014;129:1440-51
- 15. LESION PATTERNS USINGTHE ENLIGHTEN SYSTEM
- 16. NOREPINEPHRINE REDUCTION 16 Renalnerve ablation using the EnligHTN ablation system shows significant reduction in k idney NE at the 30 and 90 day time points vs. Sham PTA Balloon (N=30 k idneys) 65% reduction
- 17. Average systolic bloodpressure during control (CON) and for 8 weeks after renal denervation Correlation between SBP and mean and renal tissue norepinephrine (NE) levels CATHETER-BASED RADIOREFREQUENCY RENAL DENERVATION LOWERS BLOOD PRESSURE IN OBESE HYPERTENSIVE DOGS Each bar represents the average of 7 days of blood pressure measurements, 18 hours a day NEPI change: -42%
- 18. ENLIGHTN I: 12MONTH DATA Papademetriou V, Tsioufis C,,,,,,,,Hypertension 2014 Worthley S, Tsioufis C……Papademetriou V; EHJ 2013
- 19. Almost twodecades ago the 4S first showed that simvastatin effectively improve survival in patients with cardiovascular disease (CVD), and initiated a revolution in the treatment of atherosclerotic heart disease Results with other statins confirmed and enhanced these results Other newer and/or novel compounds were abandoned either because of lack of efficacy or unacceptable side effects Recently ezetimibe-in the IMPROVE-IT study- showed further improvement of outcomes when added to a statin. Yet the incremental reduction of LDL-C was modest and additional benefits small, but the study confirmed the impression that “ Lower is better” That’s where PCSK9 come into play MANAGEMENT OF DYSLIPIDEMIAS AND PCSK9 INHIBITORS
- 20. “Are considered abreakthrough in the management of dyslipidemias because” Are safe and Very-very effective WHY ARE PSCK9 INHIBITORS IMPORTANT?
- 21. SAFE BECAUSE AREHUMANIZED MONOCLONAL ANTIBODIES
- 22. HOW LDL PARTICLESARE CLEARED
- 23. PSCK9 TAGS LDL-RFOR DESTRUCTION
- 24. EVOLOCUMAB BINDS TOPCSK9 PREVENTING IT FROM BINDING THE LDL RECEPTORS
- 26. CARRIERWITHTHE INDUSTRY Graduatedfrom the School of Pharmacy Graduated from Medical school Specialized in Internal Medicine Practiced for 10 years Finally Joined Astra Zeneca as a Scientist-Medical Leeson Works in that position ever since Lives a comfortable-fulfilling Interesting life Medical Leeson specialist withAstra Zeneca
- 27. BRIGHT EXAMPLES ArisBaras MD Graduated from London high School Duke college Duke Medical Worked on his MD/MBA dual degree at Duke University.As an undergraduate at Duke, he studied biology and economics. Aris has been fascinated with pursuing biomedical discoveries and the development of life-saving therapies since he was in high school. One of Aris’ mentors has been Dr. RoyVagelos, former CEO and chairman of Merck. Aris lives in Durham, North Carolina with his wife, Lia, and their son, Parker.School Joined Regeneron 2years ago, his already a multimillioneur Through my association with Dr. RoyVagelos, I started working with the translational medicine team at Regeneron. One of the group’s functions is to thoroughly vet drug candidates before embarking on risky and expensive investments in clinical development programs
- 28. LEADING WITHINTHE INDUSTRY Graduated Medical School in Athens Greece Scholarship at the NIH.Worked and discovered the gene for Parkinson’s disease Recruited by Novartis and worked as a researcher for a few years on Gene targeted therapies Recruited to start his own biotech company FormedVANDA pharm Developed and sold first drug for $570 million Vanda Pharmaceuticals Reports Preliminary Fourth Quarter and FullYear 2015 Results and 2016 Financial Guidance - Fourth quarter 2015 HETLIOZ® net product sales are expected to be approximately $15.1 million - 2015Total revenues are expected to be approximately $109.9 million - 2016Total revenues are expected to be between $143 and $153 million
- 29. REACHINGTHETOP GeorgeYancopoulos, MD,PhD of Greek origin, Founding scientist, President and CEO of Regeneron. Graduated from Columbia Un and Joined Regeneron in 1989 11th most highly cited scientists in the word in the 1990s He was the PI and got approval of 4 drugs ( aflibercept, ziv- aflibercept,rilonacept and alirocumab) He is now the highest paid Chief executive His Company is worth more than $48 billion The quality of Regeneron science has been recognized in the academic scientific community as well as through a very tangible metric: our four FDA-approved products, as well as every one of our clinical candidates, were discovered and validated in Regeneron's labs. Regeneron Genetics Center ,Target Discovery , Drug Candidate Platforms, Protein Production -