Rising Developments and Your Future in Pathology

Presentation Transcript

Rising Developments and Your Future in Pathology Jared N. Schwartz, MD, PhD, FCAP President, College of American Pathologists Presbyterian Health Charlotte, NC John Winbern Turner, MD, FCAP Johnston-Willis Hospital Richmond, VA

Emerging Developments and Your Future in Pathology What is going on in medicinal services? By what method will that influence your profession as a pathologist? What are the developing innovations? What would you be able to improve set yourself up? What actions is the College taking to help you en route?

Prediction is troublesome, particularly about the future Niels Bohr, 1885-1962

Traditional experimentation strategy for care is no more drawn out worthy Weight & age may influence medicate determination & measurement or other intercession Doctor makes a "no doubt" conclusion, may arrange tests to affirm, and recommends a treatment arrange (generally sedates or potentially surgery) Patient presents with manifestations Plan works or doesn't work, +/ - reactions? Treatment arrange achievement Doctor changes treatment arrange The intermittent result: imperfect treatment, delayed times of experimentation, medicinal resistance, and expanded cost — variables that can build understanding horribleness and mortality

disregarding all the cash and exertion dedicated to biomedical research, the results are not extremely fulfilling Over 60% of patients determined to have Type II diabetes have blood sugars that surpass the suggested target level Only 17% of patients with coronary illness ever achieve the national rules treatment objectives for cholesterol administration Among patients determined to have dejection, just half report a half change in manifestations in the wake of utilizing upper drugs 32% of patients who got a fake treatment additionally encountered a half change in side effects!

Patient reaction rates to a noteworthy medication in chose classes of treatment Source: Physicians' Desk Reference

What does the purchaser need? Astounding Reasonable cost Delivery as quick as could be allowed Minimal burden Access to mind with the most recent innovation Reduced hazard Confidence and trust

… and they are being "taught" by the media

Help! Quick and exact results Understandable and valuable data Direction on treatment Low costs- - may not be as critical What does the patient's treating doctor need?

Market request and rising advancements are quickening the move to "Exactness" medication Provision of nurture ailments which can be accurately determined and consequently treated to have typically compelling guidelines based treatments Precision advances driving the interruption of existing human services plans of action Precise finding must go before typically powerful treatment Requires innovation advance on two fronts Understanding the reason for illness Ability to distinguish those easygoing elements Source: Christensen/Hwang

Precision prescription is not new; consider the historical backdrop of irresistible sickness treatment Earliest classification plans: unethical behavior, shortcoming of confidence Unsanitary conditions in the city Exposure to influenced people; contact with specific creepy crawlies and creatures Microscopes and different recoloring systems Identification of microorganisms that brought on infection with covering indications offering pieces of information to the forcefulness and spread of malady and the guess Tailored anti-toxin treatment in view of the types of living being Molecular subtype and resistance profile of the included strain

Lister embraces germ-free method in surgery Koch demonstrates Germ Theory with disclosure of B. anthracis Semmelweis proposes handwashing to counteract spread of sickness 1670 1720 1770 1820 1870 1920 Reed demonstrates mosquitoes are vector for yellow fever Pasteur investigates Germ Theory of Disease Leeuwenhoek watches "little creatures" under magnifying instrument Ehrlich presents the corrosive quick recoloring system Jenner oversees smallpox antibody Fleming finds Penicillin It took hundreds of years of huge occasions to get us to this point The cost of diagnosing and treating irresistible ailments has declined 5% every year since 1940 Source: Christensen/Hwang

Today, Cancer is encountering a comparative move toward exactness medication Farber creates 1 st chemotherapy for leukemia Novartis dispatches Gleevec, the 1 st sub-atomic focused on medication, to treat myeloid leukemia 2 sorts: leukemia & lymphoma 1920 1930 1940 1950 1960 1970 1980 1990 2000 2010 Disease of the blood 38 sorts of leukemia; 51 sorts of lymphoma 3 sorts of leukemia (intense, endless, preleukemia) and 2 sorts of lymphoma (slothful, forceful) Source: Mara Aspinall, Genzyme

Precision solution suggests personalization and every one of its advantages Diagnosis foreseeing danger of malady Determining whether a treatment is working Monitoring sound individuals to distinguish early indications of infection Producing more secure medications by anticipating potential for unfavorable impacts prior Targeting gatherings of individuals well on the way to profit by a medication, while keeping its utilization from the individuals who might be hurt by it Producing better restorative items Ready access to data Decreasing social insurance costs

Diagnostic tests and information reconciliation are the basic connections to the accomplishment of customized prescription

Industry perceives the open door and will work with anybody Are diagnostics the new ponder tranquilize on Wall Street?

What sorts of rising advances will affect my future practice?

Practice of drug is moving from the treatment of sickness to the forceful advancement of wellbeing

IVDs will turn out to be progressively crucial segments of the social insurance framework High esteem Dx give basic data to help doctors settle on clinically applicable choices Molecular Dx and AP are quickest developing portions AP market is developing at 15% CAGR and moving towards computerization and digitalization Continued development of Pap is probably going to back off when MDx measures begin picking up acknowledgment Other high development sections ICH, ISH and extraordinary stains Digital pathology Tissue microarrays Source: Scientia

Signs & Symptoms In vivo Imaging Techniques In vitro Laboratory Tests Molecular diagnostics is at the center of the customized solution vision Diseases will be analyzed much sooner than the patient starts to show any confirmation utilizing customary devices Molecular Diagnostics … and biomarkers will be an essential apparatus

Compression of the biomarker improvement course of events is quickening progress 1977: FDA favors PSA for patients as of now analyzed 2002-04: Period and review examinations on survival 2007: "220 therapeutics rising"; 100 in Phase II; 20 on market Preclinical exploratory Clinical test & approval Retrospective longitudinal Prospective screening Cancer control 1996-7: 4 new compound element therapeutics affirmed for prostate growth 1994: PSA endorsed as prescient pointer PSA Biomarker advancement: 30 years Source: Bartsch, et al, IBM (Imaging) Biomarker Summit III, Jan 2007

Technology Overview Potentially capable indicators of movement free survival Assays check uncommon occasions – epithelial tumor cells in the fringe circulatory system and contrast with built up recurrence profiles May foresee treatment reaction more rapidly than expected clinical practice with radiologic imaging (2-3 days versus 2-3 months), permitting fast treatment change FDA-endorsed for patients with metastatic bosom malignancy; instrument for anticipating movement free and general survival, observing illness movement Ongoing examination assessing viability for other tumor sorts Circulating Tumor Cells What is the effect of CTC measures on pathology? Innovation Curve: CTC Assay 3 Consensus Adopters 4 Cautious Adopters 5 Late Adopters 2 Early Adopters 0 Pre-Clinical 1 Innovators Probability of Adoption into Clinical Use Other Metastatic Breast Cancer Expected rate of reception: Slow Barriers: Only clinical proof is getting help observing for metastatic bosom growth Accelerators: FDA endorsement of extra applications/tumor sorts

Impact might be emotional… or not CTC Assays for Therapy Monitoring OP Test Volumes, US Market * Potential Impact by Indication Tests (Thousands) 35 30 25 20 15 10 5 0 2006 2008 2010 2012 2014 2016 Current use only restricted to inquire about As clinical advantages are built up, use will become essentially * Source: Sg2 Analysis, 2007

Technology Overview VC utilizes CT innovation as a contrasting option to optical screening colonoscopy VC digitally reproduces the CT picture into 2D and 3D pictures of colonic luminal surfaces (achievable, manipulatable, post strategy audit) Early studies demonstrate VC offers affectability and specificity like OC; VC does not require sedation Patients with suspicious VC exams instantly alluded for an optical colonscopy, regularly on same day, for conceivable biopsy and additionally polyp extraction Screening Virtual Colonoscopy What is the effect of Screening VC on pathology? Innovation Curve: Screening VC 3 Consensus Adopters 4 Cautious Adopters 5 Late Adopters 2 Early Adopters 0 Pre-Clinical 1 Innovators Probability of Adoption into Clinical Use Expected rate of reception: Moderate Barriers: Public inclination; Payment—must be driven by supplier Accelerators: Publicity for screening, open inclination

Q1 '04 Q2 '04 Q3 '04 Q4 '04 Q1 '05 Destructive or positive effect? Development in Virtual and Optical Colonoscopy, US Market * Total Colonoscopies (Virtual & Optical) University of Wisconsin * # of Procedures # of Procedures (Millions) 3000 2500 2000 1500 1000 500 0 9 8 7 6 5 4 3 2 1 0 Optical Colonoscopy (Screening) Virtual Optical - 9% Optical Colonoscopy (Therapeutic) +59% >200% Virtual Colonoscopy (Screening) 2006 2008 2010 2012 2016 2014 VC will increment colorectal growth screening and restorative volumes Pathology volumes for colon