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Confidential

(c) 2014 My Own Med , Inc

Vicki Seyfert-Margolis, PhD

CEO, My Own Med, Inc.

Translational science: How technology and the consumers are the new drivers of

innovation

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Translational Medicine


Are We Translating

Or

Are We

?

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Are we confusing

with ?

Who has the knowledge and where do we find it?

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Medical Product Development- A Different Approach


Discovery Clinical Trial Product on Market Patients

Redefine patient as co-researcher

Reverse engineer to drive smarter basic research and

product development

Stratify patients by:

•Genetics

•PROs

•Behavior

•Disease definition

Redefine patient as co-inventor

1. Drive science

2. Drive smart product development

1. Digital engagement- app, web, social media

2. Data driven

3. Family focused

4. Market information- digital, crowd source

Empowered Patient

with decision

making authority

with their health

providers,

Knowledge

1. Integrated products: App + Drug, Drug/Device, Drug/Digital

2. Understand Patient Behavior

3. Understand Disease Definition

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We don’t start with the patient or community


• System is not effectively promoting patient prevention and health management.

• Patients have not traditionally had the tools to effectively manage their health between doctor visits.

• Patient perspectives are not adequately incorporated into point of care or into how we develop medical products today.

• Patient and community knowledge not part of clinical research continuum in any real way.

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This has led to problems for medical product developers


• Limited information exists on patient status from healthcare visits (ties to medication performance)

• Limited consumer inputs on preferences and outcomes associated with medications

• Lack of performance metrics to obtain better reimbursement

• Large and growing conversation about products via social media

Pharma does not have a handle on what consumers think about their products and how it ties to utilization and linkage to biology

• PDUFDA V requires enhanced tools to understand the benefit risk assessment and the use of PRO to expedite drug development

Pharma companies lose

an est. $188 B annually in revenues in the U.S.

because patients fail to take

their prescribed medications.

Source: capgemini

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Patient Perspective: Patient‐Focused Drug Development


• Assessment of a drug’s benefits and risks involves analysis of severity of condition and current state of the treatment armamentarium

• Patients who live with a disease have a direct stake in drug review process and are in a unique position to contribute to drug development

• Review process could benefit from a systematic approach to obtaining patient perspective on disease severity or unmet medical need

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FDA B‐R Framework Identifies 5 Key Considerations


Through case study analysis, several key considerations were identified that cut across different regulatory decisions:

o Severity of Condition

o Unmet Medical Need

o Benefit

o Risk

o Risk Management

• Severity of Condition and Unmet Medical Need provide regulators with the clinical context for weighing benefits and risks and the associated uncertainties

• Benefit and Risk incorporate expert judgments based on evaluation of the efficacy and safety data

• Risk Management incorporates expert judgments on the expected impact of efforts to reduce and further characterize risks

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Qualitative research can be used to establish PRO content validity


This might include: • Focus groups to generate a pool of patient outcome‐related domains and

their components

• What symptoms and functions or activities impacted by disease that are most important to patients

• Surveys including a larger and more diverse sample patients with a given condition

• E.g., examine the importance and relevance of domains identified by literature review, expert opinion or among a smaller set of patients, to validate these items and perhaps explore other measurement characteristics

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Example: People with Chronic Pain


Focus groups conducted with patients who experience chronic pain identified 19 aspects of their lives (outcome domains) that are significantly impacted by the presence of their symptoms and for which improvements were important criteria that they use in evaluating the effectiveness of any treatment*

*”Identifying important outcome domains for chronic pain clinical trials: An IMMPACT survey of people with pain”, D.C. Turk et al., Pain, 137 (2008) 276‐285

Falling asleep at night Participating in recreational/social Staying asleep at night activities Sex life Physical activities (walking, climbing Taking care of family stairs, etc.) Relations with family Hobbies Relations with friends Enjoyment of life Employment Emotional well‐being (feeling sad, etc.) Household activities, running errands Fatigue, feeling tired Planning activities Weakness Participating in family events/activities Difficulty concentrating

Difficulty remembering things

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It’s a start but……

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Knowledge in the social media space

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treato.com

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MEDICRAWL

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MediCrawl mines vast amounts of health care social media data by querying multiple

sources using available APIs and an innovative web crawling/scraping bot indexed to the

Food and Drug Administration’s (FDA) and National Library of Medicine’s National Drug

Code (NDC). Data from targeted sites is parsed from HTML, XML, Text, images, RRS,

CSS, JSON, REST as well as other formats into the MediCrawl’s relational social media

database where it is filtered, organized and analyzed.

Use targeted Words and/or Phrases to construct a custom social media mentions

database

Review large samples of raw data returns and then develop custom filters to apply to

each campaign

Monitor growing social media mining database

Robust reporting engine, including custom reporting

Social Media Trend Analysis

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Start with the Health Consumer- The Quantified Self- Passive Monitoring


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But there is more- health is social


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Who Are Caregivers?


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Sources of Health Care Information


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Family-Based Management

(c) 2014 MyOwnMed, Inc

MyOwnMed’s mobile application suite can be user-configured for individual or multiple profiles,

empowering not only individuals to better manage their own health, but giving parents and other

caregivers the tools they need to help manage the health and wellness of the entire family.

Patients need technology for connectivity not in isolation- beyond the portal

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Clinical Trials

Communication/social media

• Medical History • Lab Results • Billing Info • Demographics • Meds

Electronic Health Records Disease Knowledge

• Specific to drug/therapy

• Journal • Scores

• Facebook • Twitter • Patient Advocacy

• Journals/Surveys • Nutrition/Menu planning • Exercise/Wellness • Meds (OTC, Alternatives) • In Between Doctor visit activities • Patient Report Info

• Capture Health provider experiences

• Pull EHR data, clinical trial data and social media to understand patient behaviors

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Connections beyond the patient and family- also the community

(c) 2014 MyOwnMed, Inc

• Patients

• Ability to link, access and manage yourself, your minor children, spouse and/or aging parents.

• Personalize & manage your health & busy schedule all in one place.

• Access to important health information, including drug information, allergies, vital signs, journal, and more.

• Community building Sharing information through the mobile platform to

connect to communities (disease, local, healthcare system, ethnic, etc.)

How do you

feel today?

I feel much

better!

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Patient to Data to Communities to Solutions


Mobile Platform to Support Health Outcomes & Patient Engagements

Products / Services

Value Added

MyOwnData

• Data: User-submitted

data adds to the value

proposition for both

families and medical

professionals; we reflect

useful findings back to

users as well as to

hospitals and

manufacturers

• Flexible: Learning-based

systems meet the

specialized needs of

health systems and

patient populations

MyOwnSolutions

• Community: Opportunities

for users to engage with

each other and their

clinicians through groups

and message boards,

creating lasting

relationships that are key

to long-term usage of the

app

• Clinical Trials

• Integrated Product

Solutions

My Own Med App

• User Experience: A

smooth, fully

customizable experience

for end users of every

type — patients, their

loved ones, and their

medical professionals

• Reducing hospital

readmission rates

• Increase

medication

compliance and

adherence

• Consumer Health Retail

Pharmacy

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Who has the knowledge and where do we find it? The Social Franchise- building knowledge together

Documents

Translational science: How technology and the …c.ymcdn.com/sites/ · Translational science: How technology and the consumers are the new drivers of ... Sex life Physical activities