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<strong>Innovative</strong> <strong>Analytics</strong> to Track<br />

Competitor Landscape and<br />

Trial Developments<br />

<strong>Pharma</strong> <strong>CI</strong><br />

September 2010<br />

505 Montgomery Street, 11 th Floor<br />

San Francisco, CA 94111<br />

Tel: 415-874-3310<br />

Fax: 415-358-4466<br />

E-mail: info@larvol.com


Table of Contents<br />

•Introduction<br />

•Challenge #1:<br />

Managing Time & Resources Effectively<br />

•Challenge #2:<br />

Monitoring Changes to Competitor Landscape<br />

•Challenge #3:<br />

Mining Social Media for Insights<br />

•Appendix<br />

CONFIDENTIAL<br />

2


The Larvol Group offers customized intelligence<br />

reports to the pharmaceutical industry<br />

•Subscription based service<br />

•Our Team:<br />

• ~ 80 professionals worldwide<br />

• Expertise in all major therapeutic areas<br />

• 2/3 of team have MDs or PhDs<br />

•Our clients include 8 of the top 10 pharmaceutical companies<br />

CONFIDENTIAL<br />

3


Table of Contents<br />

•Introduction<br />

•Challenge #1:<br />

Managing Time & Resources Effectively<br />

•Challenge #2:<br />

Monitoring Changes to Competitor Landscape<br />

•Challenge #3:<br />

Mining Social Media for Insights<br />

•Appendix<br />

CONFIDENTIAL<br />

4


Challenge #1: How do I manage time and<br />

resources efficiently and avoid information<br />

overload?<br />

Challenge<br />

• Forced to consult a broad range of sources<br />

• Inundated with reams of information and random alert updates<br />

• Automated alerts are not distilled to fit your needs<br />

Solution<br />

• Use an integrated solution that pulls core data into a single location<br />

• The Larvol Group has domain experts across all major therapeutic areas<br />

- Dedicated teams distill high impact news to identify important changes<br />

in your field<br />

- Using customized reports, we hone in your specific topics or areas of interest<br />

• Reports allow you to leverage your time and focus on high end strategic implications<br />

CONFIDENTIAL<br />

5


Executive Dashboard: distills weekly information<br />

from disparate sources<br />

FDA Websites<br />

Press Releases<br />

SEC Filings<br />

Blogs<br />

Report<br />

Financial Analysts<br />

<strong>Conference</strong>s<br />

KOLs<br />

PubMed<br />

Weekly Reports:<br />

•Every Monday, send PDF file<br />

•News and trial updates from prior Monday<br />

through Saturday night<br />

Monthly Reports:<br />

•Each month, send PPT<br />

•Reflect news, trial and analytic updates for<br />

entire month<br />

CONFIDENTIAL<br />

6


Comprehensive Report: offers important data<br />

sets and analysis in a single location<br />

CONFIDENTIAL<br />

7


News Highlights: quickly review top news<br />

for the week<br />

CONFIDENTIAL<br />

8


Table of Contents<br />

•Introduction<br />

•Challenge #1:<br />

Managing Time & Resources Effectively<br />

•Challenge #2:<br />

Monitoring Changes to Competitor Landscape<br />

•Challenge #3:<br />

Mining Social Media for Insights<br />

•Appendix<br />

CONFIDENTIAL<br />

9


Challenge #2: How to track changes to hundreds of<br />

competitor trials and milestones in a timely way?<br />

Challenge<br />

• Very difficult to stay on top of a huge volume of competitor trials<br />

• In certain areas, such as oncology, analyzing lines of therapy can be complex<br />

• Need a compact way to map out the competitor landscape that shows where each<br />

agent is playing, level of advancement, volume of trials, etc.<br />

Solution<br />

• Use a visually crisp, detailed trial tracker to monitor trial changes, upcoming data<br />

release and anticipated regulatory filings<br />

• Access trial analysis including patient population, line of therapy, monotherapy vs.<br />

combo, comparator, status, timeline, etc.<br />

• Quickly scan the tracker for updates that occurred during prior week or month<br />

CONFIDENTIAL<br />

10


Overall Heatmap: Inflammation, MOAs<br />

vs. Indications<br />

Notes: Color indicates highest phase attained for that indication; 6=Filed; M=Discontinued / failed trial; Some clinical trials will have multiple<br />

indications evaluated, hence numbers may be duplicated for different indications<br />

Double-Counting: Since multiple indications can be evaluated in a trial, some double-counting may occur. To see actual number of trials<br />

(without redundancy) refer to ‘Total Trials ’<br />

Abbreviations: SLE: Systemic Lupus Erythematosus, RA: Rheumatoid Arthritis, UC: Ulcerative colitis; MS: Multiple sclerosis; ITDM: Islet<br />

transplantation in type 1 diabetics; TTP: Thrombotic Thrombocytopenic Purpura; ITP: Idiopathic Thrombocytopenic Purpura<br />

CONFIDENTIAL<br />

11


VEGF Heatmap (Onco MOA Report): volume &<br />

phase of active trials across all tumor types<br />

RCC<br />

Lung<br />

CRC<br />

Breast<br />

Brain<br />

Liver<br />

Pancreatic<br />

Prostate<br />

HNC<br />

Hemat<br />

Melanoma<br />

Gastric<br />

Other<br />

solid<br />

Avastin (bevacizumab) 33 103 129 114 55 20 18 18 18 20 14 19 130<br />

Nexavar (sorafenib) 41 29 10 15 9 53 11 8 8 20 13 5 75<br />

Sutent (sunitinib) 59 16 11 20 10 7 3 12 5 6 3 9 57<br />

Votrient (pazopanib,GW786034) 6 3 2 5 2 1 3 1 1 1 24<br />

Zactima (vandetanib, ZD6474) 3 21 5 6 9 1 1 5 2 1 4 21<br />

aflibercept (AVE0005) 1 3 4 1 2 0 1 7 1 14<br />

Recentin (cediranib, AZD2171) 4 10 6 2 5 2 2 1 5 1 1 22<br />

axitinib (AG-013736) 4 3 2 0 0 0 0 1 7<br />

Vargatef (BIBF 1120, indolinone) 4 1 1 0 2<br />

ramucirumab,(IMC-1121B) 1 1 1 1 1 1 1 1 1 4<br />

motesanib (AMG 706) 3 1 2 0 1 6<br />

ABT-869 1 2 1 1 2 2<br />

Marketed Phase 3 Phase 2 (N>100) Phase 2 (N


Competitor Dashboard (Onco Tumor Report):<br />

most advanced phase by market segment<br />

HER2+<br />

Product<br />

Company<br />

Adj / Neoadj Met 1 st Met 2 nd Met 3 rd + All Comers<br />

Tykerb (lapatinib) GSK P3 NDA filed: Apr ‘09 Approved: Mar ‘07 Approved: Mar ‘07<br />

Herceptin (trastuzumab) Genentech (Roche) Approved: Nov ‘06 Approved: Sep ‘98 Approved: Sep ‘98 Approved: Sep ‘98<br />

Afinitor (everolimus) Novartis P3 P3 P2 P2 P2<br />

Arimidex (anastrazole) Roche P3 P3 P3<br />

Votrient (pazopanib) GSK P2<br />

Avastin (bevacizumab) Genentech (Roche) P3 P3 P3<br />

neratinib (HKI-272) Wyeth (Pfizer) P3 P3 P3 P3<br />

Omnitarg (pertuzumab) Genentech (Roche) P2 P3 P2<br />

trastuzumab-MCC-DM1 Genentech (Roche) P2 P2 P3<br />

Abraxane (paclitaxel) Abraxis P3 P3 P2 P3<br />

epothilone D Roche + Kosan P2<br />

HER-2 ICD vaccine Univ Wash. P2 P2<br />

Iressa (gefitinib) Astra Zeneca P2 P2<br />

Ixempra (ixabepilone) BMS P2 P3 P2 P2 P2<br />

panobinostat Novartis P2 P2<br />

Sprycel (dasatinib) BMS P2 P2 P2 P2<br />

Approved NDA Submitted Phase 3 Phase 2<br />

Criteria: Analysis of “Core” pipeline list (selected marketed and pipeline P2+ products , chosen by client for these agents, profiled trials P2+<br />

with N>50)<br />

Color : indicates the highest status of development in US market<br />

CONFIDENTIAL<br />

13


Trial Tracker: Industry trials for Select P2+<br />

Agents (Core List)<br />

Criteria: includes Core Pipeline list (select P2+ Agents); for these Core agents, all trials from P2 onwards have been profiled and select<br />

P1 trials<br />

CONFIDENTIAL<br />

14


Upcoming Milestones: browse upcoming<br />

regulatory and clinical events for Core agents<br />

CONFIDENTIAL<br />

15


Table of Contents<br />

•Introduction<br />

•Challenge #1:<br />

Managing Time & Resources Effectively<br />

•Challenge #2:<br />

Monitoring Changes to Competitor Landscape<br />

•Challenge #3:<br />

Mining Social Media for Insights<br />

•Appendix<br />

CONFIDENTIAL<br />

16


Challenge #3: How can I monitor online patient<br />

conversations and derive insights?<br />

Challenge<br />

• No time to sift through countless message boards and social media outlets<br />

• How can I flag sites of interest and monitor the content?<br />

• What metrics can I use to get a higher level view and derive insights?<br />

Solution<br />

• Use a vendor who mines social media sites in a systematic way<br />

• Identify top 50 sites in terms of activity for your specific area of interest (e.g.,<br />

advocacy site message boards, health forums, etc.)<br />

• Analyze buzz level and sentiment, look for trends and interesting insights<br />

CONFIDENTIAL<br />

17


Social Media Tracking Benefits<br />

Why Track Social Media?<br />

• Primary resource for many patients.<br />

50-65% of Americans use the internet to<br />

find information about specific diseases<br />

and treatments<br />

• Provide insight into patient experiences,<br />

preference and needs<br />

• Gain competitive advantage by being in<br />

tune with patient and medical<br />

community’s reaction to competitor<br />

products<br />

What can be tracked with<br />

Social Media?<br />

• Adverse experiences discussed online<br />

(AEDOs)<br />

• Patient access or lack of access to drugs<br />

• Pricing of prescribed drugs<br />

• Patient satisfaction and preferences<br />

• Pattern of use<br />

CONFIDENTIAL<br />

18


Larvol Methodology for Tracking Social Media<br />

Social Media Types<br />

• Social networks – Facebook, etc.<br />

• Blogs – single author or expert posts<br />

• Patient forums – focused sites for the<br />

interactive discussion of specific diseases<br />

and disease topics<br />

Steps<br />

• Gather – using natural language<br />

processing methods<br />

• Categorize – using domain experts<br />

• Annotate – using social media<br />

experienced analysts<br />

• Analyze – sentiment and buzz level<br />

Ethical Guidelines:<br />

We adhere to strict ethical considerations in collecting, maintaining, and presenting all<br />

data. We will only access sites we have legal access to and will respect the terms of use<br />

of each site we visit. We will store all information regarding individual blogger posts<br />

stripped of all personal details to eliminate the possibility of patient identification.<br />

CONFIDENTIAL<br />

19


Monthly Buzz: Compare monthly level of<br />

discussion of core drugs at a glance<br />

CONFIDENTIAL<br />

20


Sentiment Analysis: Compare how patients view<br />

core drugs as reported in social media<br />

CONFIDENTIAL<br />

21


Adverse Experiences Described Online (AEDOs):<br />

Side effects discussed online for core drugs<br />

• Nausea is the most commonly experienced side effect in Byetta users – roughly half of those describing an adverse event report nausea<br />

• Januvia users report a large variety of AEDOS, with no consistently expressed AEs<br />

• Symlin users rarely describe adverse experiences. When they do, it tends to be either nausea or hypoglycemia<br />

• Actos users report weight gain and swelling more often than any other adverse experiences – experiences that are very rare for other agents<br />

• Victoza users commonly describe nausea and headache, among others – instances of AEDOs have been increasing of late<br />

CONFIDENTIAL<br />

22


Top 50 Blogs/Forums: Sentiment Analysis<br />

CONFIDENTIAL<br />

23


Posts: Blog and Forum patient postings<br />

for the month<br />

Long time patient – example of Internet Poster Type<br />

Note: We would have the ability to add certain types of custom tags to each entry<br />

e.g., New Patient, Long Standing Patient, Health Care Provider<br />

CONFIDENTIAL<br />

24


Table of Contents<br />

•Introduction<br />

•Challenge #1:<br />

Managing Time & Resources Effectively<br />

•Challenge #2:<br />

Monitoring Changes to Competitor Landscape<br />

•Challenge #3:<br />

Mining Social Media for Insights<br />

•Appendix<br />

CONFIDENTIAL<br />

25


Reports may have a broad, pan-indication focus or<br />

may offer a deeper dive into a given disease<br />

Broad<br />

Pan-Indication<br />

Focused<br />

Disease-Specific<br />

Onco MOA<br />

report<br />

(10 MOAs)<br />

Inflammation<br />

MOA report<br />

HER2+<br />

Breast<br />

Report<br />

Multiple<br />

Sclerosis<br />

Report<br />

CONFIDENTIAL<br />

26


KOL Tracker: follow activities for your<br />

top opinion leaders<br />

• Track activities of 12-20 opinion leaders:<br />

– Publication and presentation activity (conference & CME)<br />

– Clinical trial involvement<br />

CONFIDENTIAL<br />

27


Financial Analyst Monitor: track what analysts are<br />

saying and predicting for your market<br />

• Analyst report titles offered post-embargo period (5-14 days post-release); includes ><br />

1,600 contributors<br />

• Does not include full report downloads (although we could help you obtain them –<br />

pricing per report varies)<br />

CONFIDENTIAL<br />

28


Bruno Larvol<br />

Bruno Larvol, has nearly 17 years of successful consulting, entrepreneurial and financing experience in the biotechnology and<br />

pharmaceutical industry while working with industry leaders such as The Wilkerson Group / IBM Consulting, Lehman Brothers, Delphi<br />

Ventures, Millennium, Sandoz (Novartis), and Abbott Laboratories. Mr. Larvol founded and served as CEO of Cognia, a genomics<br />

database and software. He holds an MBA with distinctions from the Kellogg School of Management and an MS in biotechnology from<br />

Northwestern University. He obtained an undergraduate degree summa cum laude from Sorbonne University, Paris. Mr. Larvol serves<br />

on the Biotechnology Advisory Board of the Kellogg Graduate School of Management<br />

• Consulting projects include:<br />

– Developed the immunology strategy of a top-tier pharmaceutical company, including prioritizing the most attractive areas of<br />

investment<br />

– Worked with the CEO of a large public biotechnology company to form a spin-out backed with $10MM in financing to take<br />

advantage of a new business opportunity. The spin-out was acquired for $100MM<br />

– Hired as interim executive for a proteomics spin-out based on a technology from a public biotechnology company. Wrote the<br />

business plan and helped secure $10MM in financing<br />

– Established the marketing plan for a new non-sedating antihistamine drug as part of a joint-venture between two<br />

pharmaceutical companies<br />

– Served as lead advisor to the program which became IBM’s $100MM Blue Gene project<br />

– Hired by a healthcare venture capital fund to devise a turn-around strategy for a portfolio company. Project resulted in a<br />

change of strategy and a $30M financing<br />

– Authored a multi-client benchmarking study on productivity in drug discovery. The study was used for marketing purposes for<br />

more than three years<br />

• Other experience includes:<br />

– Developed a new marketing strategy for Abbott’s anti-infective drug Biaxin<br />

– Solved market positioning problem for asthma drug marketed by Sandoz (Novartis)<br />

– Conducted pharmaceutical M&A and financing engagements with Lehman Brothers<br />

CONFIDENTIAL<br />

29


Laura Farmer<br />

Over the past 17 years, Laura Farmer has led a wide range of strategy, marketing and commercialization projects within the<br />

biopharmaceutical industry. Through her work, Ms. Farmer has developed expertise across numerous functional groups and<br />

therapeutic areas, including oncology, rheumatoid arthritis, and infectious diseases<br />

• Past work has included projects such as:<br />

– Identified priority tumor indications for two lead oncology agents based on market attractiveness, advisory board and<br />

quantitative survey input, robust financial modeling, entry and expansion tactics and franchise considerations<br />

– Developed detailed brand plan and tactical launch plans for a rheumatoid arthritis drug through collaboration across 30<br />

functional groups and vendors. Pressure-tested plans and budgets, ensuring comprehensiveness and alignment with overall<br />

strategic goals<br />

– Formed a pricing and reimbursement strategy for an emerging oncology therapeutic for a biotechnology firm<br />

– Created in-depth materials for an advisory board meeting with rheumatoid arthritis opinion leaders to address key market<br />

trends and assess trial design and commercial prospects for an emerging product<br />

– Evaluated strategic commercialization options for a biologic drug for lupus<br />

– Wrote business plan for a cardiovascular device company that received funding and subsequently achieved an IPO<br />

– Authored major portions of an in-depth and widely quoted industry outlook, entitled Forces Reshaping the Performance and<br />

Contribution of the U.S. Medical Products Industry - prepared for the Health Industry Manufacturers Association and<br />

presented to Congress<br />

• Other experience includes:<br />

– Ms. Farmer consulted with Straticore, Publicis Healthcare, Insight Strategy Advisors, True North Partners, CSC Healthcare and<br />

The Wilkerson Group for top pharmaceutical and biotech firms. She holds a bachelor of arts, cum laude, in political science<br />

and premedical studies from Yale University<br />

CONFIDENTIAL<br />

30

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