1 PLEASING CLIENTS AT A MOLECULAR AND CELLULAR LEVEL AUGUST 7, 2015

We live in a society exquisitely dependent on science and technology, in which hardly anyone knows anything about science and technology. – Carl Sagan (1990)

3 TOPICS FOR DISCUSSION Pace of life sciences 1 Demands of the domain 2 Multi-faceted and interdisciplinary business of science 3 Focus on the customer: PDS in biotech 4 Industry challenges & beyond 5

4 SCIENCE DOMAIN: CHAOS & CHANGE Hypotheses Throughput Analyses Conclusions Ideas Experiments Data Algorithms Methods And everyone is going through the process differently… Models Data Management

5 Improvements in technology Increase in amount of data Development of algorithms EVOLVING WITH THE PROCESS Sample handling Sample processing Data storage Data analysis

6 DURATION 10+ YEARS TECHNOLOGY IS RACING FORWARD, BUT DRUG DEVELOPMENT CYCLE IS LONG LEAD IDENTIFICATION PRE- CLINICAL PRE- CLINICAL CLINICAL TRIALS PHASE I PHASE II PHASE III FDA REVIEW FDA REVIEW 3-6 YRS 6-7 YRS 1-2 YRS MANY COMPOUNDS 250 COMPOUNDS VOLUNTEERS VOLUNTEERS 1,000-5,000 VOLUNTEERS ONE APPROVED DRUG ONE APPROVED DRUG ? YRS TARGET ID & VALIDATION Genomics Proteomics Transcriptomics Epigenomics Chemistry Metabolomics Toxicity And all that data has to be “handled”!

7 DURATION >10 YEARS TECHNOLOGY IS RACING FORWARD, BUT CYCLE OF DRUG DEVELOPMENT IS LONG LEAD IDENTIFICATION PRE- CLINICAL PRE- CLINICAL CLINICAL TRIALS PHASE I PHASE II PHASE III FDA REVIEW FDA REVIEW 3-6 YRS 6-7 YRS 1-2 YRS MANY COMPOUNDS 250 COMPOUNDS VOLUNTEERS VOLUNTEERS 1,000-5,000 VOLUNTEERS ONE APPROVED DRUG ONE APPROVED DRUG ? YRS TARGET ID & VALIDATION Genomics Proteomics Transcriptomics Epigenomics Chemistry Metabolomics Toxicity LEAD IDENTIFICATION PRE- CLINICAL PRE- CLINICAL 3-6 YRS MANY COMPOUNDS 250 COMPOUNDS ? YRS TARGET ID & VALIDATION The greatest improvement to this cycle’s efficiency can be achieved before the clinical phase

8 THE LIFE SCIENCES MILIEU Chemistry Engineering Regulatory Clinical Animal Sciences Animal Sciences Biology Informatics Finance Operations IT Legal

9 Scientists and their habits Reconciling business & science Need someone to: Keep everyone focused Suggest methods Make workflows easy Do it fast! FROM SPREADSHEETS TO SYSTEMS: GETTING USERS ONBOARD

10 FOCUS ON THE CUSTOMER: DELIVERING ON THE PROMISE OF PDS Direction Identify direction of the business Direction Identify direction of the business Science Novel technologies speed up the science Science Novel technologies speed up the science Technologies Bring novel technologies to the business Technologies Bring novel technologies to the business Business Science drives business forward Business Science drives business forward

11 SYSTEM TO ACCELERATE & OPTIMIZE DRUG DESIGN

12 Covers the process Open for integration With scientific context Allows integrated questions to be posed A PRODUCT: DRUG DESIGN STUDIO

13 SYSTEM TO ACCELERATE & OPTIMIZE DRUG DESIGN

14 For specific business need To be used across disciplines With best scientific practices AT THE END OF THE DAY: PRODUCT BUILT We have software that captures & searches data. The Question is “What’s next?”

15 ONE STEP BEYOND

16 SOLUTIONS FOR THE BIOTECH BUSINESS What do I do with the petabytes of chemistry, biology, modeling, in-vivo, clinical data? Provide system for data tracking & integration How do I search it? Develop search algorithms that allow omni-directional information flow across disciplines What can I do with it? Develop analysis algorithms and visualization tools

17 EXAMPLE: ELECTRONIC NOTEBOOK GOOD: Searchable Achievable BAD: Organization Data extraction Visualization Need: Different notebooks for different disciplines (modular) with common back end and visualization layer Biologists Chemists Informaticists Clinicians Animal Scientists

18 Onsite team must speak client’s language TO ACHIEVE SUCCESS WITH CUSTOMER, REMEMBER: Business Technology Science EPAM Team

19 THANKS TO Thank You!

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