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© BCC Research, 49-2 Walnut Park, Wellesley, MA 02481, USA (+1) 781-489-7301 www.bccresearch.com
The ‘PredTox’ Market Oppo...
2
Information
∗ Webcast replay recording available for a limited time: http://bit.ly/predtox-webcast
∗ Related report: In ...
3
Human Genome +10 yrs: Output?
Pharma pipelines: Disastrous!
Research concerns: Not reproducible!
Healthcare IT revolutio...
4
From Basic/Common approaches:
∗ Analyzed Increased Outsourcing to CRO in Preclinical
∗ Analyzed Trends with Pharma R&D B...
5
Opportunity fits key trends & <gaps>
Genomics
Proteomics
Metabolomics
Systems biology: Targets &
Pathways
*Key: Pipeline...
6
In Vitro and In Silico Methods for
Toxicology Revenue Growth
Estimated at 15% CAGR
2012 2017
$5 Billion $10 Billion
7
∗ Focuses on drug approvals
∗ Safety/tox has long been key gate for drug development
∗ Adverse reactions have become key...
8
∗ Track record of innovation
∗ Global research collaborations – EU/U.S./Japan
∗ Support increased testing of environment...
9
Brief overview of landscape
∗ Safety
∗ Cardio: Adverse events led to FDA standards in 2000 > strong commercial
uptake
∗ ...
10
Key – Track record of methods rigor
∗ Inspired by incumbent in vivo approaches
∗ Compared to in vivo, found animals don...
11
PredTox In Vitro and In Silico Technologies (1 of 2)
Bioinformatics ($ 0.1 B)Cellomics ($ .75 B)Foundation ($ 1.4 B) Om...
12
Cell-based Assays
In Vitro Assays
Biochemical Assays
Secondary messenger Cell integrityFunctional mechanism
• Receptor ...
13
Texture of Report (1 of 2)
Applications and systems context
• Historical perspective
Breakout Business Models
• Biomark...
14
Texture of Report (2 of 2)
Global drivers and trends
• Global pharma
• Cosmetics and Chemicals influence
• China
• Othe...
15
BCC Research – Contact Information
Phone (+1) 781-489-7301. In U.S. toll free: 866-285-7215.
Email: information@bccrese...
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Predictive in vitro & in silico Methods for Precision Medicine- Robert G. Hunter - BCC Research

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Predictive in vitro & in silico Methods for Precision Medicine- Robert G. Hunter - BCC Research

  1. 1. © BCC Research, 49-2 Walnut Park, Wellesley, MA 02481, USA (+1) 781-489-7301 www.bccresearch.com The ‘PredTox’ Market Opportunity In Vitro and In Silico Methods from Predictive Toxicology to Help Develop Precision Medicine Webcast 3/11/14
  2. 2. 2 Information ∗ Webcast replay recording available for a limited time: http://bit.ly/predtox-webcast ∗ Related report: In Vitro Toxicity Testing: Technologies and Global Markets (report code PHM017E). Search report code on our website: www.bccresearch.com. ∗ Share this with your colleagues: http://info.bccresearch.com/predictive-tox-article It has links to the webcast replay, a video where they can take a “sneak peek” at the information, a link to the report, and access to free downloads. ∗ Sign up to receive email notifications when reports are published in your chosen categories: http://www.bccresearch.com/subs/index. ∗ If you'd like to tweet about this research, please use the hashtag #bccresearch. ∗ Slides and presentation by Robert Hunter. Bob Hunter bob@predict-medicine.com Linkedin: Robert G Hunter Twitter: bobghunter
  3. 3. 3 Human Genome +10 yrs: Output? Pharma pipelines: Disastrous! Research concerns: Not reproducible! Healthcare IT revolution: How? Unmet needs impacted by PredTox
  4. 4. 4 From Basic/Common approaches: ∗ Analyzed Increased Outsourcing to CRO in Preclinical ∗ Analyzed Trends with Pharma R&D Budgets To Wider/New approaches: ∗ Extrapolated Practices from Other Industries (Cosmetics, Chemicals) ∗ Analyzed Overlap with Key Areas (Patient Care, Social) PredTox analysis approach – wider lens Result: longer-range view and actionable insights
  5. 5. 5 Opportunity fits key trends & <gaps> Genomics Proteomics Metabolomics Systems biology: Targets & Pathways *Key: Pipelines, Precision med, Biomarkers Patient empowerment – history in DTC (direct-to-consumer) advertising Ethics impacts: stem cells, 3Rs Social networks Nutrition and wellness *Key: Predictive med - Personalized, Preventive, Participatory Health IT- Electronic Health Records Diagnostics Big data *Key: Predictive med – Participation by MDs and Patients Life sciences systems Patient care Patient as consumer <Biomarkers> <EHR w/ Systems biology>
  6. 6. 6 In Vitro and In Silico Methods for Toxicology Revenue Growth Estimated at 15% CAGR 2012 2017 $5 Billion $10 Billion
  7. 7. 7 ∗ Focuses on drug approvals ∗ Safety/tox has long been key gate for drug development ∗ Adverse reactions have become key risk for FDA in making approvals ∗ Has history of systems approach ∗ Linked to pathology – liver, kidney systems ∗ Linked to environmental chronic exposure – population studies, “read-across” assessments ∗ Leveraged tissue engineering – skin, lung, blood-brain-barrier ∗ Leveraged cell imaging and other physiological “read-outs” ∗ Leveraged new test systems – stem cells, primary cells vs. immortalized cell lines Why PredTox perspective? (1 of 2) Continued…
  8. 8. 8 ∗ Track record of innovation ∗ Global research collaborations – EU/U.S./Japan ∗ Support increased testing of environmental chemicals ∗ Reduce reliance on animal testing – future: China, Russia, Brazil ∗ Cooperation with regulatory agencies: Cosmetics in EU 1990-2013, REACH, Tox21 Why PredTox perspective? (2 of 2)
  9. 9. 9 Brief overview of landscape ∗ Safety ∗ Cardio: Adverse events led to FDA standards in 2000 > strong commercial uptake ∗ Next? ∗ Toxicology: By tox domains = systems ∗ Skin and Eye ∗ Acute and Cytotoxicity ∗ Chronic and Repeated Dose ∗ Carcinogenicity and Genotoxicity ∗ Endocrine System – Estrogen receptor, thyroid ∗ Developmental and Reproductive (DART) ∗ ADME (Absorption, Distribution, Metabolic, Elimination): Metabolic focus
  10. 10. 10 Key – Track record of methods rigor ∗ Inspired by incumbent in vivo approaches ∗ Compared to in vivo, found animals don’t pertain to humans ∗ Developed rigorous methods and validation approaches ∗ Developed structured approach corresponding to human physiology ∗ Compared in vitro to other in vitro for consistency/reproducibility ∗ Incorporate in silico approaches as well ∗ Integrate mechanistic and predictive approaches
  11. 11. 11 PredTox In Vitro and In Silico Technologies (1 of 2) Bioinformatics ($ 0.1 B)Cellomics ($ .75 B)Foundation ($ 1.4 B) Omics ($ 1.5 B) Tissue engineering Stem cells Immortalized cells Primary cells Microplates, Readers Gene Expression Classifiers (Statistical) Structure- Centered Tools FLIPr Patch clamp, APC HCS Label-free Transcriptomics Proteomics Metabolomics Automation Liquid handling Reagents •Microarrays -miRNA •Next-Gen Screening •Mass Spec •Chromatography •NMR •Electrophysiology •Ion channel Flow cytometry •Imaging & Analysis Functional Classifiers (Pathways & Networks) •Estrogen- breast cancer •DILI •Metabolic vs. signaling, etc. •Multi-pathway learning •Chemoinformatic tools •“Pathway barcoding” Model-based Drug Development •QSARs + Cell-based Assays (See Figure 2) Continued…
  12. 12. 12 Cell-based Assays In Vitro Assays Biochemical Assays Secondary messenger Cell integrityFunctional mechanism • Receptor binding • Enzyme inhibition • Reporter gene (transcription- ex. GPCRs, over 1000) • Other • Membrane fns (ion channel) • Cell proliferation • Cell permeability (cytotoxicity) • Cell stability Tissue models • Animal • Human 2D 3D formats> 96 > 384 > 1536 well - $ 1.0 B kits - $ 1.4 B reagents Reagents PredTox In Vitro and In Silico Technologies (2 of 2)
  13. 13. 13 Texture of Report (1 of 2) Applications and systems context • Historical perspective Breakout Business Models • Biomarkers • Drug repositioning • Precision medicine applications (biosensors, organ on a chip, systems biology) Org/Company input, focused on: • Adoption of in vitro and in silico • Innovation for in vitro and in silico Continued… In Vitro Toxicity Testing: Technologies and Global Markets (report code PHM017E).
  14. 14. 14 Texture of Report (2 of 2) Global drivers and trends • Global pharma • Cosmetics and Chemicals influence • China • Other BRIC • Pharmerging Open revenue forecast models • Six layers of revenue models, with individual drivers • Annotated drivers, variables, calculations In Vitro Toxicity Testing: Technologies and Global Markets (report code PHM017E).
  15. 15. 15 BCC Research – Contact Information Phone (+1) 781-489-7301. In U.S. toll free: 866-285-7215. Email: information@bccresearch.com. Website: www.bccresearch.com. View the reports in our research library or download a custom-defined catalog. We offer both single report sales and subscriptions for access to whole categories of reports, including our research library of past reports. Let us know how we can help you! To contact the webcast facilitator, email: sandra.collins at bccresearch.com. About BCC Research BCC Research publishes market research reports that make organizations worldwide more profitable with intelligence that drives smart business decisions. These reports cover today's major industrial and technology sectors, including emerging markets. For more than 40 years we've helped customers identify new market opportunities with accurate and reliable data and insight. These include market sizing, forecasting, industry overviews, and identification of significant trends and key competitors. We partner with analysts who are experts in specific areas of industry and technology. Their up-to-date knowledge gives our customers unbiased measurements and assessments of these vital markets. Because our reports offer a global focus, our customers include the top companies in industries around the world as well as universities, major business schools, start- ups, consulting firms and investment companies. BCC Research is a unit of Eli Research LLC. Data and analysis extracted from these slides must be accompanied by a statement identifying BCC Research LLC, 49-2 Walnut Park, Wellesley, MA 02481, Telephone: (+1) 781-489-7301; Email: editor@bccresearch.com as the source and publisher. Thank you.

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