Transforming Drug Development at Lilly

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These slides are from a Health 2.0 New Orleans meeting on November 21, 2013 with special guest speaker Tom Krohn of Eli Lilly.

Health & Medicine

Transforming Drug Development
It’s not just for researchers – you can participate!
Health 2.0 New Orleans
November 21, 2013
Thomas Krohn, RPh, MBA
Eli Lilly and Company

Drug Development - today
Precompetitive Competitivepatent
Innovation Process

Business Model Performance
Source: FDA.gov
Productivity Down, Costs Up Future revenues under pressure
Unsustainable Business Model

Disruptive Innovation
to S1'
to S2
S1
Time
Performance
Disruptive
Change
Simpler, Faster, Cheaper?

Patient Communities
Patients as microexperts – not subjects

Clinical Research as part of Healthcare
Public Perception
•  94% of people recognize the importance of participating in clinical research
in order to assist in the advancement of medical science. Yet 75% of the
general public state they have little to no knowledge about the clinical
research enterprise and the participation process. (www.centerwatch.com)
•  Less than five percent of cancer patients participate in clinical trials. If ten
percent participated, studies could be completed in one year, instead of the
three-five years that studies currently require. (National Cancer Institute)
•  It's not uncommon for your cancer doctor or treatment team to discuss the
option of a clinical trial as the best treatment choice for your cancer type.
(www.mayoclinic.com)
Standard of Care Clinical Trial
Info & Innovation

ClinicalTrials.Gov and Patients
98,000,000
Pageviews/Month1
Sources:
1) clinicaltrials.gov site
2) D. Zarin 2007 Overview
47,000,000
Patient driven pageviews/Month
2
What if….?

1
Patient-
Centric
Design
Patient
Voice
2
Patient-Centric Study Representation & Voice
Study Representation
Informed Consent
DocumentCt.Gov
Study Design
Open
Platform
Patients
• Clear eligibility
• Risk/Benefit
• My doctor’s role
• Study treatment
• Time to results
• Logistics
Design Challenge
ctdesign.challengepost.com
November 14

Patient-Centric Information
Open
Platform
Patients
labs.lillycoi.com

Clinical Open Innovation
Open
Platform
Patients
api.lillycoi.com
Daily
Updates
Open
Web
REST
API

Enabling patient matching to studies
Open
Platform
Patients
api.lillycoi.com
Daily
Updates
Open
Web
REST
API
Patient Study
“Target Profiles”
Study Sponsors
Patient &
Communities
Personal Electronic
Medical Records
Match
Process
Consent
to
Match

Patient Engagement App Challenge
http://patientengagement.challengepost.com

Join the transformation
•  Learn the business model
•  Understand patient needs
•  Identify options for value creation
•  Explore open data and patient engagement
•  Participate in challenges
Most people are afraid of making mistakes.
Leaders are afraid of missing opportunities.

References
•  Website: www.lillycoi.com
•  API: api.lillycoi.com
•  App Lab: labs.lillycoi.com
•  Whitepaper: link
•  Twitter: @Lilly_COI, @takmad

Health Datapalooza IV: June 3rd-4th, 2013 Action Beats and Announcements Patient-Centered Outcomes Research Institute (PCORI) Challenge Winners PCORI challenged teams to develop a proposal or prototype for a patient/researcher ‘matching’ mechanism or system that can effectively connect potential partners interested in seeking funding for rigorous patient-centered outcomes research. Two winners will be announced. Presenter: Anne Beal, Chief Operating Officer, Patient-Centered Outcomes Research Institute (PCORI)

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Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol that is rapidly distributed in the body and brain. Ethanol alters many neurochemical systems and has rewarding and addictive properties. It is the oldest recreational drug and likely contributes to more morbidity, mortality, and public health costs than all illicit drugs combined. The 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) integrates alcohol abuse and alcohol dependence into a single disorder called alcohol use disorder (AUD), with mild, moderate, and severe subclassifications (American Psychiatric Association, 2013). In the DSM-5, all types of substance abuse and dependence have been combined into a single substance use disorder (SUD) on a continuum from mild to severe. A diagnosis of AUD requires that at least two of the 11 DSM-5 behaviors be present within a 12-month period (mild AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria). The four main behavioral effects of AUD are impaired control over drinking, negative social consequences, risky use, and altered physiological effects (tolerance, withdrawal). This chapter presents an overview of the prevalence and harmful consequences of AUD in the U.S., the systemic nature of the disease, neurocircuitry and stages of AUD, comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and pharmacotherapies for AUD.

BRACHYTHERAPY OVERVIEW AND APPLICATORS

Krishan Murari

Physiology of Chemical Sensation of smell.pdf

MedicoseAcademics

Title: Sense of Smell Presenter: Dr. Faiza, Assistant Professor of Physiology Qualifications: MBBS (Best Graduate, AIMC Lahore) FCPS Physiology ICMT, CHPE, DHPE (STMU) MPH (GC University, Faisalabad) MBA (Virtual University of Pakistan) Learning Objectives: Describe the primary categories of smells and the concept of odor blindness. Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction. Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain. Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential. Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes. Key Topics: Olfactory Genes: 3% of the human genome accounts for olfactory genes. 400 genes for odorant receptors. Olfactory Membrane: Located in the superior part of the nasal cavity. Medially: Folds downward along the superior septum. Laterally: Folds over the superior turbinate and upper surface of the middle turbinate. Total surface area: 5-10 square centimeters. Olfactory Mucosa: Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell. Sustentacular Cells: Produce mucus and maintain ionic and molecular environment. Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months. Bowman’s Gland: Secretes mucus. Stimulation of Olfactory Cells: Odorant dissolves in mucus and attaches to receptors on olfactory cilia. Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve. Quality of a Good Odorant: Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble. Facilitated by odorant-binding proteins in mucus. Membrane Potential and Action Potential: Resting membrane potential: -55mV. Action potential frequency in the olfactory nerve increases with odorant strength. Adaptation Towards the Sense of Smell: Rapid adaptation within the first second, with further slow adaptation. Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system. Primary Sensations of Smell: Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid. Odor Detection Threshold: Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm). Some toxic substances are odorless at lethal concentrations. Characteristics of Smell: Odor blindness for single substances due to lack of appropriate receptor protein. Behavioral and emotional influences of smell. Transmission of Olfactory Signals: From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition. Primitive, less old, and new olfactory systems with different path

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Transforming Drug Development at Lilly

1. Transforming Drug Development It’s not just for researchers – you can participate! Health 2.0 New Orleans November 21, 2013 Thomas Krohn, RPh, MBA Eli Lilly and Company

2. Drug Development - today Precompetitive Competitivepatent Innovation Process

3. Business Model Performance Source: FDA.gov Productivity Down, Costs Up Future revenues under pressure Unsustainable Business Model

4. Moore’s vs. Eroom’s Law

5. The Far Side by Gary Larson

6. Incremental Improvement

8. Disruptive Innovation to S1' to S2 S1 Time Performance Disruptive Change Simpler, Faster, Cheaper?

9. Disruption in motion

10. Generation and Access to Data

11. Patient Digital Monitoring

12. Patient Communities Patients as microexperts – not subjects

13. Patient-Driven Research

14. The Disruption Power to the Patient

15. Clinical Research as part of Healthcare Public Perception •  94% of people recognize the importance of participating in clinical research in order to assist in the advancement of medical science. Yet 75% of the general public state they have little to no knowledge about the clinical research enterprise and the participation process. (www.centerwatch.com) •  Less than five percent of cancer patients participate in clinical trials. If ten percent participated, studies could be completed in one year, instead of the three-five years that studies currently require. (National Cancer Institute) •  It's not uncommon for your cancer doctor or treatment team to discuss the option of a clinical trial as the best treatment choice for your cancer type. (www.mayoclinic.com) Standard of Care Clinical Trial Info & Innovation

16. ClinicalTrials.Gov and Patients 98,000,000 Pageviews/Month1 Sources: 1) clinicaltrials.gov site 2) D. Zarin 2007 Overview 47,000,000 Patient driven pageviews/Month 2 What if….?

17. 1 Patient- Centric Design Patient Voice 2 Patient-Centric Study Representation & Voice Study Representation Informed Consent DocumentCt.Gov Study Design Open Platform Patients • Clear eligibility • Risk/Benefit • My doctor’s role • Study treatment • Time to results • Logistics Design Challenge ctdesign.challengepost.com November 14

18. Patient-Centric Information Open Platform Patients labs.lillycoi.com

19. Clinical Open Innovation Open Platform Patients api.lillycoi.com Daily Updates Open Web REST API

20. Enabling patient matching to studies Open Platform Patients api.lillycoi.com Daily Updates Open Web REST API Patient Study “Target Profiles” Study Sponsors Patient & Communities Personal Electronic Medical Records Match Process Consent to Match

21. Patient Engagement App Challenge http://patientengagement.challengepost.com

22. Join the transformation •  Learn the business model •  Understand patient needs •  Identify options for value creation •  Explore open data and patient engagement •  Participate in challenges Most people are afraid of making mistakes. Leaders are afraid of missing opportunities.

23. References •  Website: www.lillycoi.com •  API: api.lillycoi.com •  App Lab: labs.lillycoi.com •  Whitepaper: link •  Twitter: @Lilly_COI, @takmad

24. Thanks!

Transforming Drug Development at Lilly

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