Leaders in Pharmaceutical Business Intelligence (LPBI) Group

11:30AM 11/13/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

11:30 a.m. – Keynote Speaker – Role of Genetics and Genomics in Pharmaceutical Development

Role of Genetics and Genomics in Pharmaceutical Development

There was a time when pharmaceutical companies attempted to develop drugs that could be used to treat large populations of individuals diagnosed with a particular disease. These drugs were used to treat large groups of patients and were not always effective for all patients. The paradigm of drug development is changing where highly targeted drugs that would be highly effective in specific sub populations of patients are becoming the new norm. Dr. Skovronsky will describe how the pharmaceutical industry as a whole and Lilly in particular is taking advantage of the new knowledge about the genetic basis of disease to develop highly effective therapies.

•  early detection
• how do drugs work in Alzheimer’s Disease (AD) – difficult to conduct Clinical Trials
• Personalized the treatment as early on as possible: looking inside the brain and track the disease
• images of the pathology of AD – Amyloid imaging using agents
• diagnostics test on autopsy of AD brains after death
• Risk of Progression
• amyloid deposition over time – Dynamics of accumulations
• Autopsy of brains of AD: MANY AD patients have negative scans
• Clinical Trial definition of AD: 22% did not have amyloid — WERE TREATED WITH ANTI Amyloid DRUGS (22% Solanezumab, 16% Bapineuzumab)
• 1/2 have DX of AD and treated with targeted drug — have negative Scans for Amyloid deposits — NOT PROGRESSING
• those progressing are those with Positive Scans
• 18 month and 36 month – Progression of Amyloid — Only at Positive scans
• A4 Trial Dx Florbetapir
• Rx solanezumab – symptomatic dementia vs AD
• Markers o=for the disease – Neural degeneration – Tau in temporal lobe
• Treat patient with start of Tau — avoid progression to amyloid deposition

CANCER

• Companion Diagnostics (CD) vs Therapeutics – start to find the biomarkers at the same time: Drug and Diagnostics
• DNA, RNA, Protein
• Diagnostics –>> translation
• CLIA lab at Eli Lilly for companion diagnostics
• Biomarker Negative vs Positive ans a spectrum of results
• Immunohistochemistry (IHC) for protein expression – simple assay, complicated test
• two different agent at two different albs — give two different diagnostics
• Tumor heterogeneity: Glioblastoma
• Tissue scarce resource — it is separated in time Biopsy taken at different times
• Detection of chromosomal – Liquid Biopsy – Exosomes
• mRNA, miRNA
• Summary: Prime key porters to quickly bring therapies to patients

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

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