drug repurposing anlaytics

Download Drug Repurposing Anlaytics

Post on 27-Jan-2016

5 views

Category:

Documents

3 download

Embed Size (px)

DESCRIPTION

Presented by Dr. Nandu Gattu at GSIB National Conference on Business Analytics in GITAM Univeristy Visakhapatnam on 12th December 2015

TRANSCRIPT

  • Role of Big Data & Pharma Analytics in Rescuing Failed or Shelved Compounds

    Nandu Gattu, PhD Vice President, GVK Biosciences

  • December 21, 2015 GVK BIO Confidential 2

    Pharma Business Analytics

    Data + Science + Business = Pharma Business Analytics

    24%41%

    24%

    11%

    Source: Everest group

  • December 21, 2015 GVK BIO Confidential 3

    Pharma Business Analytics

    Research & Development

    Sales & Marketing

    Strategy

    Patient & Care Giver

    Identification of new drugs

    Patient Stratification

    Better Clinical trial Design

    Rescue the failed drugs

    Recycle current drugs

    Supply Chain & Distribution

    Manufacturing Operations

    Effective Pre-clinical exp

    Pharma Analytics

    Research & Development Analytics

  • December 21, 2015 GVK BIO Confidential 4

    Drug Discovery & Development Process

    Major Challenges:

    Soaring R&D Cost

    Longer duration

    High Attrition Rate or Lower Success Rate

    Failures due to efficacy

    Failures are mostly in the clinical phase only

    $ 1.5 Billion 14 years

  • December 21, 2015 GVK BIO Confidential 5

    Pharma R&D Spend vs. Approvals

    25 X

    2 X

  • December 21, 2015 GVK BIO Confidential 6

    Pharma Strategy The Number Game

    Drug Discovery & Development Cost

    $ 5 Billion & 14 YearsPer Drug

    Forbes 2013

    Company Global Rank # of Drugs 10 Y R&D ($ M) R&D per Drug ($ M)J&J 8 13 67624 5202GSK 6 11 57595 5236Pfizer 1 10 77786 7779Novartis 3 10 60727 6073Merck & Co 4 9 49133 5459BMS 12 9 30352 3372Roche 5 8 70928 8866Sanofi 2 6 60768 10128Bayer 16 5 33118 6624Amgen 14 5 21350 4270Genzyme 2 5 4814 963AstraZeneca 7 4 38245 9561Eli Lilly 10 4 26710 6678Takeda 13 4 24132 6033Eisai 24 4 11534 2884Biogen Idec 33 4 9470 2368Genetech 5 4 6277 1569Forest 38 4 5184 1296Shire 32 4 3827 957Wyeth 1 3 22702 7567Schering-Plough 4 3 18845 6282Astellas 18 3 12582 4194Gilead 21 3 5527 1842Baxter 22 3 4627 1542Novo Nordisk 17 2 9251 4626Celgene 27 2 7193 3597Teva 11 2 6763 3382Lundbeck 42 2 3527 1764Abbott 9 1 13183 13183UCB 33 1 4325 4325Yamanouchi 18 1 4321 4321Fujisawa 18 1 4286 4286Shionogi 36 1 3854 3854

    Global rank $ 2B;

    http://www.forbes.com/sites/matthewherper/2013/08/11/the-cost-of-inventing-a-new-drug-98-companies-ranked/

  • December 21, 2015 GVK BIO Confidential 7

    http://www.phrma-jp.org/archives/pdf/profile/Profile_2010_FINAL.pdf

    http://www.discoverymanagementsolutions.com/the-organization-of-biopharmaceutical-rd/common-goals-between-discovery-and-development/innovation/nme-output-versus-rd-expense-perhaps-there-is-an-explanation/

    Drug Discovery & Development

    # of Projects for One Launch

  • December 21, 2015 GVK BIO Confidential 8

    Percent R&D Budget Spent

    Decreased Pre-clinical Cost

    Increased Clinical Cost

  • December 21, 2015 GVK BIO Confidential 9

    Pharma Innovation Root cause for Failures

    Forbes 2013

  • December 21, 2015 GVK BIO Confidential 10

    Nature Reviews in DD, 2011, 10(5), 328

    Nature Reviews in DD, 2011, 10(2), 87

    Pharma Innovation Root cause for Failures

    Retrospective Analysis

    Phase II Failures (2008-2010)(108 Failures)

    Retrospective Analysis

    Phase III Failures (2007-2010)(83 Failures)

  • December 21, 2015 GVK BIO Confidential 11

    Pharma Innovation Strategic step for Success

    Identify New Indications

    Steep increase in R&D Cost

    Repurpose the Failed Candidate

    Drug Discovery & Development Cost

    $ 5 Billion & 14 Years ?

    Big ticket & long duration

    High Odds 57:1 >50% Clinical Costs

    Low success rate in Clinical Phase

    Efficacy is the main culprit

    De

    -ris

    k th

    e in

    vest

    me

    nts

    Stre

    ngt

    he

    n t

    he

    po

    rtfo

    lio

  • December 21, 2015 GVK BIO Confidential 12

    Drug Repurposing is real

    http://thomsonreuters.com/products/ip-science/04_038/drug-repositioning-cwp-en.pdf J Clin Pharmacol. Nov 2007; 64(5): 563565; Journal of Market Access & Health Policy 2014, 2: 22813.

    DRUG ORIGINAL INDICATION NEW INDICATION

    Amphotericin B Fungal infections Leishmaniasis

    Aspirin Inflammation, pain Antiplatelet, Colorectal Cancer

    Bromocriptine Parkinsons disease Diabetes mellitus

    Finasteride Prostate hyperplasia Hair loss

    Gemcitabine Viral infections Cancer

    Methotrexate Cancer Psoriasis, Rheumatoid arthritis

    Raloxifene Cancer Osteoporosis

    Duloxetine Depression Detrusor Instability

    Miltefosine Breast Cancer Visceral Leishmaniasis

    Retinoic acid/Tretinoin Severe acne Acute promyelocytic leukemia

    Thioridazine Schizophrenia QTc prolongation, Antimicrobial agent

    Imatinib Chronic Myeloid Leukemia Gastrointestinal stromal tumor,

    Propranolol Angina, Hypertension Migraine

    Botulinum Toxin A Blepharospasm, Cervical dystonia Axillary hyperhidrosis

    Bosentan Monohydrate CHF PAH

    Crizotinib Anaplastic large-cell lymphoma NSCLC

    Galantamine Pot-polio paralysis and Neuro Pain Alzheimers

    Plerixafor HIV Mobilization of hematopoietic stem cell

    Rituximab Non-Hodgkins Lymphoma RA

  • December 21, 2015 GVK BIO Confidential 13

    Drug Re-purposing

    Drug Re-Purposing: Identification of additional therapeutics indications for existing marketed drugs or clinical candidates

    It is a strategic approach to drug development to extract added value from prior Research and Development investments

    The Drug Re-positioning concept is not new; So far more than 300 FDA approved repurposed drugs are in the market

    Repurposed drugs generated approximately $20 Billion annual sales in year 2012

    All major pharmaceutical companies are interested and invested in drug repurposing program

    Drug Repurposing science is moving from serendipitous discovery to data driven approach.

    Recycle

    Reinvent

  • December 21, 2015 GVK BIO Confidential 14

    Why Drug Re-purposing ?

    Drug Development Drug Repurposing

    Cost $1.5 B to develop $300- $400 M to develop

    Time for R&D 12-14 years 2-6 years

    Experiments Complete set Significantly less

    Cost Vs benefit Lower Higher

    Success rate Low Relatively better

    Complexity High Relatively less

    Ph II to Market 10% 25%

    Ph III to Market 50% 65%

    Approximately 200 Drug candidates per year are placed in the shelve for variety of reasons

    Majority of the Phase III compound are failing due to efficacy only

    Pharma companies looking for novel strategic ways to build or strengthen the portfolio

    Time and Money matters

    Repurposed Drugs

  • December 21, 2015 GVK BIO Confidential 15

    Sildenafil (Viagra) A Billion Dollar Repurposed Drug

    The little blue pill

    Pfizer discovered Sildenafil in 1992 for cardiovascular diseases

    Pfizer tried this drug for Hypertension and Ischemic heart diseases

    Drug had little effect on angina

    REPURPOSED

    In 1998, FDA approved Sildenafil for Erectile Dysfunction

    BECAME A BILLION DOLLAR DRUG

    REPURPOSED AGAIN

    In 2006, FDA approved this drug for Pulmonary Arterial Hypertension

    Revolutionized the lives of Millions of people

  • December 21, 2015 GVK BIO Confidential 16

    Thalidomide A Billion Dollar Repurposed Drug

    Thalidomide was synthesized in 1954 Hailed as wonder drug that provides safe,

    sound sleep Given to pregnant women to treat symptoms

    associated with morning sickness Thalidomide was a catastrophic drug with

    tragic side effects When thalidomide was taken during pregnancy

    it caused birth defects short extremities

    After 44 years

    In 1998, Thalidomide was approved as repurposed drug for Leprosy by FDA

    After 52 years

    In 2006, Thalidomide was approved as repurposed drug for Multiple Myeloma by FDA

    A Billion Dollar Drug

  • December 21, 2015 GVK BIO Confidential 17

    Big Data Analytics in Pharma World

    Big Data Analytics is crucial for Repurposing Data driven Science

  • December 21, 2015 GVK BIO Confidential 18

    GVKBIO Repurposing Integrated Platform - GRIP

    Repurposing Algorithms

    Analytic s Engine

    Visualization Tools

    GRIDGVKBIO Repurposing Integrated Database

    Novel Repurposing Ideas

  • December 21, 2015 GVK BIO Confidential 19

    GVKBIO Repurposing Integrated Database (GRID)

    Proprietary DatabasesGOSTAR (SAR Database with 6 M compounds)

    GOBIOM (Biomarker database)CTOD (Clinical Trial Outcome Database)

    Public DatabasesMore than 40+ Public database

    GVKBIO Repurposing Integrated Database (GRID)

    Target Drug

    Disease

    Understanding the relationship among Drug Disease Target is key to identify new alternative Indications

  • December 21, 2015 GVK BIO Confidential 20

    Drug Repurposing Integrated Database

    Target Disease

    Drug

    GenePathwayDiseasesBiomarkersTarget/EC50, IC50 etc..Gene expressionTranscription factorClinical trial infoMarketed drugsAdverse eventsDrug-protein interactions

    GenePathwayDrugsBiomarkersGene expressionClinical trial infoDisease gene relationship

    DrugsPathwayDiseasesBiomarkersTarget/EC50, IC50 etc..Tissue specific expressionGene expression drugs, diseaseTranscription factorClinical trial infoMarketed drugsTarget-Target interactions

  • December 21, 2015 GVK BIO Confidential 21

    Drug Repurposing Algorithms

    Drug Repurp

Recommended

View more >