woollabs overview march2013

Copyright 2013 Wool Labs, LLC. All rights reserved

Real World Experiences of Post Marketed Drugs and Devices

2

•Wool LABS uses proprietary technologies and analyses to:

- Uncover real world opinions, experiences and behavior of patients and physicians

- Answer questions, solve problems and predict future events

•Wool LABS is the ONLY organization that uses dialog data, subject matter expertise and traditional Healthcare data to uncover new ways to drive business

WHO IS WOOL LABS?

woolLABS (2013 confidential)

3

• Wool LABS provides multi-lingual (200+) market intelligence software and research solutions using as its source database:

- The ENTIRE Internet- back 11 years (web, news, blogs, User Generated Content, Twitter, etc.) NO OTHER SEARCH TECHNOLOGY CAN DO THIS

- 65,000 Local and digital radio stations NO OTHER MEDIA MONITORING TECHNOLOGY CAN DO THIS

- Broadcast and cable TV- ANY large document repository

NO OTHER SEARCH TECHNOLOGY CAN DO THIS• We use patented algorithms• We deliver via our executive dashboard (WebDig or custom)• We add new dimensions to create novel connections for clinical, drug safety, pharmacovigilance, competitive intelligence, pre-launch, brand marketing and sales

PROVEN TECHNOLOGY


woolLABS (2013 confidential) 4

WoolLABS’UNITED STATES PATENTS19 SPECIFIC CLAIMS UNDER 7 FILINGS.

5

METHOD, SYSTEM AND APPARATUS FOR IDENTIFYING AND PARSING SOCIAL MEDIA INFORMATION FOR PROVIDING BUSINESS INTELLIGENCEUnited States 61/454,474IssuedThe present invention relates to a computer implemented method, system and apparatus for identifying, collecting and parsing content for providing business intelligence. Particularly, the present invention provides a method, system and apparatus for deriving knowledge from information indicative of human communication, emotions, reactions, and experiences to evaluate trends and decisions that impact business.

As media continues to become increasingly social, expression of opinion has never been as open or as pervasive. In today's highly interactive information environment, complete understanding of sentiment, emerging topics and influential voices through all media channels is critical to maintaining informational advantages over your competition. Social cognition helps enterprise entities to utilize technological solutions to solve complex business challenges.

U.S. PATENTS


6

RELATIONAL COMPARISON OF TELEVISION AND/OR RADIO CLOSED CAPTION TEXT TO SOCIAL MEDIA COMMENTS BASED ON GEOGRAPHIC DISTRIBUTIONUnited States 61/454,474/2600,2601,2602 IssuedProviding a relational comparison of television and/or radio closed caption text to social media comments based on geographic distribution of content over the Internet, according to an exemplary system, method and/or apparatus of the present invention. WebDig, according to an exemplary embodiment of the present invention, executes a process that captures and analyzes every available television station with a closed caption signal according to a natural language processor in the same way the natural language processor analyzes social media comments. In addition all television affiliate stations have a defined geographic reach. By mapping the reach of a station with the topic and sentiment that data is compared to readership of similar comments within social media and measure the response in the social sphere. Also, exemplary implementation of the present invention account for trends in social media that are then picked up and repeated in broadcast media.

U.S. PATENTS


7woolLABS (2013 confidential)

1 2 3PATIENTS

Drug SafetyAnd

Efficacy

SERVICESHow

woolLABS Can Help

CASE STUDIESExamples Of How We Do It

PATIENT REPORTED DRUG SAFETY & EFFICACY1


9

Are about their conditions and treatments and to discuss their experiences, good and bad to:

PATIENT EXPERIENCE METRICS


1 2 3 4

COMPARE: their experiences in terms of expectations of effectivenessEVALUATE: side effects and the tradeoffs of benefit vs. tolerability

EVALUATE: their decisions and choices to follow a prescribed treatment

TEST: their physician’s explanations and diagnoses

PATIENTS ONLINE CONVERSATIONS:

10

• Most patients understand that all drugs have side effects so they want be sure the benefits are worth it

• Many of the most intolerable side effects are not considered “serious” by industry standards but are enough to have patients stop treatment including GI issues, fear of cancer or immune suppression, weight gain

• Trust concerns also factor into overall adherence rates



As a product matures, so do opinions and beliefs. Patients make decisions on two fundamental metrics:

PATIENTS MAKING DECISIONS:

1 2

Is it safe?

Does it work?

11

Warning of serious issues, at times, well in advance of the medical community and the industry. Therefore, patients are the barometer of the industry

The industry does not always listen to patients and the opinions and beliefs of physicians can overpower patient voices



1The effectiveness of a treatment

2The safety levels that they will tolerate

3The future of any drug or device

PATIENTS DETERMINE:

PATIENTS PROVIDE:

PATIENTS FEEL IGNORED:

12

With the advent of more personalized medicine, the patient is at the center of outcomes



Strong concentration of involved patient voices on the internet. Not just in simply complaining but they are:

EXPLAININGwhat they experiencing and sharing those experiences with others

EVALUATINGthe benefits of treatment vs. risks and side effects

RECOMMENDINGtreatments to others even if they disagree with their physicians

PATIENTS FIRST:

PATIENTS VOICES:

1 2 3

13

The industry, the medical community, and the FDA to listen

Their experiences with drugs, treatments, and devices in an unabashed manner

- Side effects alone are not a reason to complain or discontinue. - Side effects without perceived benefit or where the benefit does not

outweigh the value are

WHAT PATIENTS ONLINE CAN PROVIDE


1Their voices to be taken more seriously

2Their needs to drive treatment research

3Their experiences to shape the decisions of others

PATIENTS NEED:

PATIENTS WANT:

PATIENTS PROVIDE:

14

• Patients provide more information that can ever be gleaned from the text notes in medical records and in a timed sequence.

• Patients and caregivers can be knowledgeable much about the clinical aspects, morphology, and progression of their condition

• There are often gaps and even conflict in patient vs. physician opinions, knowledge and approaches

• They can provide an early warning system for serious problems

- Patients have reported drug and device problems well in advance of the industry that in results in deaths, lawsuits and loss of approvals

WHAT PATIENTS ONLINE CAN PROVIDE


PATIENTS PROVIDE:

SERVICES:HOW woolLABS CAN HELP2


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• Our methodology can monitor entire disease categories where we can undercover issues without a priori knowledge of what we expect to find

• By setting thresholds for actions, we can avoid false positives

- Low signals can be monitored over time and checked via other sources

- And when those signals are further explored with more traditional methods, those methods have some direction and guidance to increase efficiencies

• We provide both qualitative and quantitative analysis

ORGANIZING THE HAYSTACK


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• We can provide geographic analyses and demographic and special population directional information

• We can evaluate patient vs. physician beliefs and differences

• We find- Misunderstandings on drug use, - Reasons behind poor adherence, - Patterns in OTC use, - Defects in devices, - Consequences of long term drug use, - Drug interactions- Patterns in how patients make decisions about their

healthcare that impact the entire industry

ORGANIZING THE HAYSTACK


CASE STUDIES3woolLABS (2013 confidential) 18

AVANDIA: 2010woolLABS (2013 confidential) 19

20

• In 2003 and 2004, the benefits for most patients outweighed risks and for the most part patients were more hopeful

• In 2005, patients begin to become aware of risks as well as weight gain and edema. They openly discuss it but feel physicians are largely downplaying their concerns..

• In 2006, patients start to connect their concerns to congestive heart failure. This year showed early warning signs of problems for the brand. Loss of trust is the next predictable problem.

• 2007 was a pivotal year - where patient trust starts to drop dramatically. Patients question their physicians and begin to take control over their medication choices. Legal action is easily predicted to be the next course of action.

AVANDIA: 2010 STUDY


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• By 2008, patients display open hostility to the Avandia, GSK, and even their physicians. Legal discussions exploded and overtake diabetes-related conversations

• In 2009, patients become more resigned and loss of trust starts to translate to the industry. Conversations move from patients to industry analysts, marketers, and consumers who are not patients.

• By mid 2010, patients are resolute in their decisions. They are no less angry at Avandia and GSK but are now also angry at the FDA as they see the FDA as not listening either.

AVANDIA: 2010 STUDY


22

AVANDIA: 2010 STUDY

-17

-40-43 -41

-50

-44

-55-60

-50

-40

-30

-20

-10

0

2004 2005 2006 2007 2008 2009 2010

Sentiment Index


ACTOS: 2011woolLABS (2013 confidential) 23

24

ACTOS: 2011 STUDY

Sentiment & Impact SignalsThe sentiment and conversation topics about Actos over the last ten years have shown a steady and consistent declines. There are signals that represent warning signs for the brand. The impact of these signals increases as sentiment and patient behavior shows. Intervention that directly addressed patient issues could have reversed negative sentiment and damage to the reputation of the brand and company.

Signal 1 - In 2003, patients attribute adverse experiences directly to ActosConversations include more on congestive heart failure risk and continued confusion about the use of insulin with Actos. Sentiment is slightly less negative than 2002 as some diabetes patients report success with Actos. However, patients attribute the cause of their edema and weight gain to Actos even if their physicians do not concur. This signal precedes increased negativity to come and intervention at this time could have been able to change opinions. So 2003 represents an early warning of potential problems for the brand.

Signal 2 - In 2004, physicians do not acknowledge patient concerns about ActosVolume and negativity increases significantly over previous years.. Consistent themes are rapid weight gain, edema, and CHF risks; there is some physician acknowledgement of these problems which might actually have tempered some of the negative sentiment. However, physician acknowledgement is low so a deep physician-patient disconnect is developing.

Signal 3 - In 2005, patients believe Actos' benefits are not worth the side effectsThe general consensus of patients is that Actos is effective in lowering blood glucose but the side effects are not worth the benefit There is low physician acknowledgement of patient issues of rapid weight gain, edema and CHF. Anger comes into patient sentiment. Intervention at this time would have been prudent and beneficial; once we see anger enter conversations, sentiment usually does not turn back to positive on its own. So we consider 2005 a pivotal year where the right intervention could have prevented a continued decline.

Signal 4 - In 2006, patients show loss of trust in brand and FDASarcasm as an expression of anger becomes part of conversations. Our experience shows that sarcasm is associated with a loss of trust. However physician acknowledgement, especially of weight gain, we believe tempers some of the negativity. But, there is not enough physician guidance or other intervention to protect the brand as confusing data and Avandia comparisons become more prominent. Loss of trust in the product is moving toward loss of trust in physicians as well as the FDA.

Signal 5- In 2007, patients stop taking this medication without consulting their physiciansPatient reaction is much stronger, adding more negative intensity along with increased negative volume. Sarcasm and anger increase. Patients are stopping their medication on their own. Patients struggle with differentiating Avandia and Actos and just assume that they are equally dangerous. Avandia's problems did offer Actos an opportunity to clarify the facts in clear, consumer-friendly education but the brand did not choose this path. Actos tends to present information in scientific articles that put patients into the position of interpreting the information on their own.

Signal 6 - In 2008, Safety trumps EfficacyPatients interpret data themselves and it seems that they have concluded that the risks associated with Actos outweigh the benefits even though for some patients the benefits are great. Physician intervention online seems too late to change patient opinions. Also, there are two signals in 2008. First, there are few, if any, reported deaths by patient/caregivers for Actos; this keeps negativity from going as deeply as Avandia in 2008. However, patients do not know if they are at risk for heart problems prior to taking Actos. So when they experience side effects, they don't know how to interpret and without intervention, they decide to stop taking the drug.

Signal 7 - By 2009, patients are resoluteSentiment ranges from anger to hostility and is rarely ambivalent; it would not seem possible to change patient opinions now. Patients are either firmly for or firmly against Actos. There are a few physicians who speak out in favor of Actos and even TZDs as a class, but their voices are overshadowed by patients and negative sentiment. There is a core, loyal patient base however. The reports of weight gain and edema remain consistent.

Signal 8 - In 2010, new concerns, Avandia comparisons, and poor outreachSentiment and tone remainl hostile and with no patient-oriented intervention available. Fracture conversations have increased along with new bladder cancer concerns. The WellPoint study claims that Avandia and Actos have similar cardiovascular and fracture risks; Takeda's responses do not reduce negativity or increase understanding. Takeda does run advertising after the FDA hearings on Avandia aimed at encouraging patients to switch to the "safer" Actos. Unfortunately, this outreach is too late for many, just re-associates Actos with Avandia for some, and doesn't get much positive response overall.

Overall Conclusion - Damage is deep and will be difficult to changeAt no time over the last ten years has anyone reached out to the patient base to explain or to reassure. Patients tried to decipher complex studies and analyses and, right or wrong, once they draw their own conclusions, they were not going to be swayed otherwise. Most patients do not believe that Actos is safer than Avandia.


25

ACTOS: 2011 STUDY

Sentiment & Impact SignalsThe sentiment and conversation topics about Actos over the last ten years have shown a steady and consistent declines. There are signals that represent warning signs for the brand. The impact of these signals increases as sentiment and patient behavior shows. Intervention that directly addressed patient issues could have reversed negative sentiment and damage to the reputation of the brand and company.

Signal 1 - In 2003, patients attribute adverse experiences directly to ActosConversations include more on congestive heart failure risk and continued confusion about the use of insulin with Actos. Sentiment is slightly less negative than 2002 as some diabetes patients report success with Actos. However, patients attribute the cause of their edema and weight gain to Actos even if their physicians do not concur. This signal precedes increased negativity to come and intervention at this time could have been able to change opinions. So 2003 represents an early warning of potential problems for the brand.

Signal 2 - In 2004, physicians do not acknowledge patient concerns about ActosVolume and negativity increases significantly over previous years.. Consistent themes are rapid weight gain, edema, and CHF risks; there is some physician acknowledgement of these problems which might actually have tempered some of the negative sentiment. However, physician acknowledgement is low so a deep physician-patient disconnect is developing.

Signal 3 - In 2005, patients believe Actos' benefits are not worth the side effectsThe general consensus of patients is that Actos is effective in lowering blood glucose but the side effects are not worth the benefit There is low physician acknowledgement of patient issues of rapid weight gain, edema and CHF. Anger comes into patient sentiment. Intervention at this time would have been prudent and beneficial; once we see anger enter conversations, sentiment usually does not turn back to positive on its own. So we consider 2005 a pivotal year where the right intervention could have prevented a continued decline.

Signal 4 - In 2006, patients show loss of trust in brand and FDASarcasm as an expression of anger becomes part of conversations. Our experience shows that sarcasm is associated with a loss of trust. However physician acknowledgement, especially of weight gain, we believe tempers some of the negativity. But, there is not enough physician guidance or other intervention to protect the brand as confusing data and Avandia comparisons become more prominent. Loss of trust in the product is moving toward loss of trust in physicians as well as the FDA.

Signal 5- In 2007, patients stop taking this medication without consulting their physiciansPatient reaction is much stronger, adding more negative intensity along with increased negative volume. Sarcasm and anger increase. Patients are stopping their medication on their own. Patients struggle with differentiating Avandia and Actos and just assume that they are equally dangerous. Avandia's problems did offer Actos an opportunity to clarify the facts in clear, consumer-friendly education but the brand did not choose this path. Actos tends to present information in scientific articles that put patients into the position of interpreting the information on their own.

Signal 6 - In 2008, Safety trumps EfficacyPatients interpret data themselves and it seems that they have concluded that the risks associated with Actos outweigh the benefits even though for some patients the benefits are great. Physician intervention online seems too late to change patient opinions. Also, there are two signals in 2008. First, there are few, if any, reported deaths by patient/caregivers for Actos; this keeps negativity from going as deeply as Avandia in 2008. However, patients do not know if they are at risk for heart problems prior to taking Actos. So when they experience side effects, they don't know how to interpret and without intervention, they decide to stop taking the drug.

Signal 7 - By 2009, patients are resoluteSentiment ranges from anger to hostility and is rarely ambivalent; it would not seem possible to change patient opinions now. Patients are either firmly for or firmly against Actos. There are a few physicians who speak out in favor of Actos and even TZDs as a class, but their voices are overshadowed by patients and negative sentiment. There is a core, loyal patient base however. The reports of weight gain and edema remain consistent.

Signal 8 - In 2010, new concerns, Avandia comparisons, and poor outreachSentiment and tone remainl hostile and with no patient-oriented intervention available. Fracture conversations have increased along with new bladder cancer concerns. The WellPoint study claims that Avandia and Actos have similar cardiovascular and fracture risks; Takeda's responses do not reduce negativity or increase understanding. Takeda does run advertising after the FDA hearings on Avandia aimed at encouraging patients to switch to the "safer" Actos. Unfortunately, this outreach is too late for many, just re-associates Actos with Avandia for some, and doesn't get much positive response overall.

Overall Conclusion - Damage is deep and will be difficult to changeAt no time over the last ten years has anyone reached out to the patient base to explain or to reassure. Patients tried to decipher complex studies and analyses and, right or wrong, once they draw their own conclusions, they were not going to be swayed otherwise. Most patients do not believe that Actos is safer than Avandia.


26

DATA OF SIGNIFICANCE• Bone fractures

- Patients on Actos reported bone fracture problems - Takeda using Actos in MS trials where patients are at

increased risk for bone fractures• Increased risk for bladder cancer

- Concerns of bladder cancer surfaced in 2009 and 2010

• Increased risk for heart problems in younger patients

ACTOS: 2011 STUDY


27

AWARENESS AND SUPPORT INDEX- ACTOS AND WEIGHT GAIN, EDEMA, AND CONGESTIVE HEART FAILURE (CHF)

ACTOS: 2011 STUDY

0

35

25

3842

50

62 6468 70 73

0 0 0 38 10

1524

3339 39

0

10

20

30

40

50

60

70

80

Patients Physicians

Awareness & Support Index


BARIATRIC SURGERYAND DIABETES


29

• Patients discussed bariatric surgery and diabetes remission as earlier as 2000.

• They also knew that surgery type mattered and that gastric bypass was more effective than LapBand surgery

• Most supporters wondered why it took the medical community so long to mainstream the surgery and were amused when the ADA announced the grant to study the effects of bariatric surgery on diabetes.

BARIATRIC SURGERY & DIABETES


FECAL TRANSPLANT &CLOSTRIDIUM DIFFICILE


31

“I had C. diff in and so far, it has not reoccurred. I also got mine from long term use of antibiotics. The first line against Clostridium difficile is Flagyl. If this doesn't clear it up, the second medication they use is Vancomycin. I took four courses of this without being able to clear it up. Vancomycin is very expensive, with a course running $1,200-$1,400 retail. What finally got rid of this horrible disease was a Fecal Transfer, with my wife being the donor. They transfer the donor's good flora into your bowels during a colonoscopy. A few days after this was done, I was returned to normal.”

“Your brother needs to see a Gastro doctor right away. It sounds like it could possibly be Colitis or Clostridium difficile(C. diff). I had C. diff, so I know the symptoms and treatment. They usually will treat it with Flagyl or oral Vancomycin for two weeks. There is also a treatment that is still experimental here, but done quite often in Europe, called a Fecal Transfer. I would mention this to the doctor. If you need any additional information, please post and I'll do my best to help you.” “I'm going through the same thing (minus the surgery on my colon... I am investigating a fecal transplant). Hopefully taking donor stool will help rebuild the intestinal lining (fingers crossed). It should wipe out the c.diff I acquired. In the meantime, I have found taking L-Glutamine (3000-5000 mg), Florastor, and a unique probiotic called Lactobacillus Sporogenes. Doesn't help with the killer freaking burning colon pain but it does help with diarrhea.”

FECAL TRANSPLANT & C. DIFFICILE

PATIENTS HAVE BEEN HAVING CONVERSATIONS ABOUT FECAL TRANSFER AS A TREATMENT FOR C. DIFFICILE SINCE 2005


4/03/2005

4/12/2007

4/10/2011

ORAL DIABETESMEDICATION: 2011


33

ORAL DIABETES MEDICATION: 2011

49.847

42 41.940.1

37.9 37.233.6 32.4 32.2 32

30.1 28.6

24 23.5 22 20.4 19.6

0

10

20

30

40

50

60Patient-Reported Adverse Experience Index

The Ratio of Conversations in which a Patient-Experienced Adverse Event is Specifically Attributed to one of these Medications : all Specific Drug Experiences

n = 6,745. Confidence Level = 95%. Margin of Error = 1.2%

Greater than 24%

Less than 25 %

> 24 and <=25


34


56.354.2

51.249.6

47.5 46 44.642.5 42.5 42.3

37.5 37.3 36.7 36.3 35.733.9

30.1 30

0

10

20

30

40

50

60

Patient-Reported Effectiveness IndexRatio of Conversations Containing a Patient-Experienced Rating of Effectiveness Specifically Attributed to one of these Medication: all Specific Drug Experiences

n = 1,566. Confdence Level = 95%. Margin of Error = 2.48%

Less than 44%

Greater than 45 %

> 44 and <=45


35


GoalPEAI < 25PEI > 45

0

5 10 15 20 25 30 35 40 45 50 55 60

5

10

15

20

25

30

35

40

45

Metformin

Patie

nt-R

epor

ted

Adv

erse

Exp

erie

nces

Patient-Reported Effectiveness

Glucophage

50

Glipizide

Glucotrol

Glyburide

Prandin

Starlix

Amaryl

Actos

Avandia

Januvia

Onglyza

Glucovance

Oral Diabetes MedicationsPatient-Reported Adverse Experiences vs.

Patient-Reported Effectiveness

July 2011

Positive Sentiment, PEAI< 25, PEI >45

Neutral to Slightly Negative Sentiment, PEAI close to 25, PEI close to 45

Negative to Highly Negative Sentiment, PEAI> 25, PEI <45

Janumet

Duetact

Avandamet

Actoplus Met

Glyset


36


20

16.4

14.213.3 13 12.9

5.24.2 4 3.4

1.4 1.4 1.2 1.1 1 0.5 0 00

5

10

15

20

25

Incidence of Reported HypoglycemiaThe Ratio of Conversations in which Patient-Experienced Hypoglycemia is Specifically

Attributed to one of these Medications : all Specific Drug Experiencesn - 2,943. Confidence Level = 95%. Margin of Error = 1.81%

Greater than 10%

Less than 3 %

>= 3 and <= 10


37


31.5

22.5

2018.2

15.7

12.9

8.3 7.76.5 5.9

4.12.5 2.1 2 1.9 1.7

0.5 00

5

10

15

20

25

30

35Incidence of Reported Weight Gain

The Ratio of Conversations in which Patient-Experienced Weight Gain is Specifically Attributed to one of these Medications : all Specific Drug Experiences

n = 3,201. Confidence Level = 95%. Margin of Error = 1.73%

Greater than 10%

Less than 3 %>= 3 and <= 10


38

• Change in lifestyles. When diagnosed with diabetes, patients are told to change their diet and increase their exercise. Yet patients are given medication based on their current lifestyle. When patients start restricting carbohydrates and exercising, they naturally lower their blood glucose levels. Their medications, therefore, can lower their glucose levels too much when combined with their new lifestyle changes.

• Layering of diabetes drugs. Many patients are on more than one diabetes medication. Each medication has its own risk for hypoglycemia and when combined can have an overall higher risk for patients.

• Drug interactions. Patients do take concomitant medications that have impact on the effectiveness of their diabetes medication. Certain concomitant medications increase the risk for hypoglycemia.

• Self-dosing. Patients adjust the dosage and timing of their medication based on the changes they are making in their lifestyle, which again impacts risk for hypoglycemia. Physicians also encourage patients at times to “play” with their medication to see what works for them.



DPP IVs &CANCER RISKS: 2012


40

DPP IVs & CANCER RISKS: 2012

0 20 40 60 80 100 120 140

2007

2008

2009

2010

2011

Cancer risk GI problems Itching, rashes Non-healing wounds

Upper respiratory problems Muscle/joint pain Did not work as expected Other

Patient Adherence - JanuviaReasons for Stopping Medication

Percent of Negative Conversations n= 196


41


0 20 40 60 80 100 120 140

2007

2008

2009

2010

2011

Cancer risk Poor Healing Unknown safety

Patient Adherence - JanuviaReasons for Not Using



42


0 20 40 60 80 100 120

2009

2010

2011

Cancer risk GI problems Itching, rashes

Drug interaction Upper respiratory problems Muscle/joint pain

Did not work as expected Memory Loss

Patient Adherence - OnglyzaReasons for Stopping Medication



43


0 20 40 60 80 100 120

2009

2010

2011

Cancer risk Itching, rashes Upper respiratory problems

Patient Adherence - OnglyzaReasons for Not Taking Medication




woolLABSASCO MERIT AWARD

45

ASCO QUALITY CARE MERIT AWARD


THANK YOU


Presenter: Michele BennettChief Operating Officer

woolLABS

[email protected]

office: 610-230-0241mobile: 610-613-5134

983 Old Eagle School Rd, Suite 612Wayne PA, 19087

mailto:[email protected]

woollabs overview march2013

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