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Life Sciences -Industry, Challenges, Opportunities

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Title: No Slide Title Author: Kirk Bailey Last modified by: Chubb & Son a division of Federal Insurance Co. Created Date: 2/2/2000 4:47:00 PM Document presentation format – PowerPoint PPT presentation

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Title: Life Sciences -Industry, Challenges, Opportunities


1
  • Life Sciences -Industry, Challenges,
    Opportunities
  • Christine Fernandez and Mike Costas
  • October 2012

2
Disclaimer
  • The material in this presentation has been
    prepared solely for informational purposes by
    Chubb Insurance Company of Canada. The material
    is compiled from external sources and from
    proprietary Chubb data. We do not represent as
    to its accuracy or completeness. The content of
    this presentation is intended to provide a
    general guide to the subject matter discussed.
    For specific circumstances, specialist advice
    should be sought.

3
Agenda
  • Global Market vs Canadian Market
  • Targeted life science segments
  • Property considerations
  • Liability considerations
  • Human clinical trials
  • Why choose Chubb?

4
Life Sciences Opportunity Global Market
Dynamic Growth
  • Medical Devices - 350B Market
  • Biotechnology - 250B Market
  • Pharmaceuticals - 1.1 Trillion by 2014
  • Dietary supplements - 74B Market
  • Emerging segments
  • Drug Discovery
  • Proteomics
  • Bioinformatics
  • Genomics
  • Nanotechnology
  • Health Information Technology

5
Life Sciences OpportunityCanadian Market
  • Medical Devices
  • Revenue of 3B
  • Approx 1,000 development and manufacturing firms
  • Approx 600 firms engaged in wholesale
    distribution
  • Biotechnology/biopharmaceuticals
  • Biopharmaceutical market has 180 private and
    public firms, all in different phases of the
    development cycle
  • 500 new products currently in development
  • Focus Toronto, Vancouver and Quebec
  • Pharmaceuticals and Biopharmaceuticals
  • Pharmaceutical market place is still dominated by
    US owned brand name drugs 78 of sales.

6
Life Sciences OpportunityCanadian Market
  • Reasons for optimism
  • Low-cost advantage
  • Favourable tax treatment for RD
  • Scientific research and experimental development
    program
  • Supportive network of associations
  • BIOTECanada
  • Ontario Bioscience Industry Organization
  • MaRS

7
Chubbs Targeted Life Science Industry Segments
  • Medical Devices
  • Biotechnology / Pharmaceuticals
  • Healthcare Product Service Organizations
  • Third party outsourcing
  • Dietary Supplements
  • Drug Discovery Technologies
  • Bioinformatics, genomics, proteomics,
    combinatorial chemistry, high throughput
    screening, computational sciences, etc.)

8
Medical Device Target Customers
  • Clinical Applications
  • Monitoring Equipment
  • Diagnostic Imaging Equipment
  • Surgical/Dental/Therapeutic Equipment
    Instruments
  • Lab/Research Equipment Instruments
  • Medical Software/Healthcare Information
    Technology
  • Optical/Ophthalmic Instruments Lenses

9
Pharmaceuticals - Biotechnology Target Customers
  • Therapeutic Products
  • Diagnostic Test Kits (including reagents)
  • Biotech Equipment
  • Bioinformatics Software
  • Drug Delivery Systems
  • Veterinary Products
  • Healthcare Information Technology
  • Industrial and Agricultural biotechnology
    products are not targeted

10
Service Organizations
  • Companies performing drug and device development
    services for others
  • Contract Research Organizations
  • Contract manufacturers
  • Contract sales organizations
  • 5.5 Billion industry with rapid growth

11
Important Property Considerations for Life
Sciences Companies
  • Changing nature of operations over time,
    exposures evolve over a firms life cycle
  • Unique exposures - i.e. spoilage, change in
    temperature/humidity, radiation, contamination
  • Need for backup power, temperature alarms,
    disaster recovery planning
  • Complex supply chains

12
Important Property Considerations for Life
Sciences Companies
  • High-valued lab equipment
  • Protection for Scientific Animals
  • Research Development Income
  • Pollutants/contamination
  • Lengthy recovery due to delays in validation and
    regulatory approval

13
Important Liability Considerations for Life
Sciences Companies
  • Off-label Study Information Dissemination
  • Invasion of Privacy
  • Faster Review Periods by Regulatory Bodies
  • Clinical Trial Controls
  • TV Internet Advertising/Promotion/social media
  • Plaintiff lawyers monitoring of FDA information
  • Post Market Surveillance

14
Clinical Research Process
  • Pre-Clinical - animal testing, cell cultures,
    computer modeling
  • Phase 1 - Safety focus
  • Phase 2 - Safety efficacy
  • Phase 3 - Safety efficacy (large scale)
  • Approvals by health regulatory agencies
  • Phase 4 - Post-Market studies

15
Clinical Trials
  • Clinical trials are voluntary research studies,
    conducted in
  • people, that are designed to answer specific
    questions
  • about the safety and/or effectiveness of drugs,
    vaccines,
  • other therapies, or new ways of using existing
    treatments.
  • Over 50,000 trials conducted worldwide with 20MM
    people enrolled in those trials
  • Many countries require compulsory local insurance
    to protect their citizens Germany, France,
    Spain, Columbia, Brazil, Australia.

16
Most Common HCT Claim Allegations
  • Failure to monitor study properly
  • Failure to select qualified/competent clinical
    investigators/staff
  • Failure to properly inform (therapeutic
    misconception, risk, rights)
  • Failure to perform per contract-CROs
  • Failure to adhere to research standards
  • Conflict of interest
  • Non-compliance
  • Privacy

17
Sample of Clinical Trial Cases
  • TeGenero/Paraxel U.K. TGN1412 clinical trial
    case.
  • Fialuridine (FIAU) (NIH,Lilly, and others)
  • Jesse Gelzinger vs. UPenn
  • Ellen Roche vs. John Hopkins
  • Quinn vs. Abiomed
  • Nicole Wan vs. Rochester MIT
  • Suthers /Martin vs. Amgen
  • Source http//www.sskrplaw.com/gene/index.html

18
Sold Product Allegations
  • Failure to warn (labeling, advertising, safety
    surveillance, off-label, study results, etc,)
  • Product Defects
  • Product not doing what it was intended to do
    (design defect)
  • Fraud
  • Negligence

19
High Profile Cases
  • Vioxx - Cox 2 inhibitor
  • Hormone replacement therapies
  • Anti-depressants
  • Accutane
  • Drug Eluting Stents
  • Contact Lens solution
  • Metal-on metal hip implants
  • Surgical mesh

20
Coverages tailored to unique Life Sciences
property exposures
  • Property enhancements
  • Spoilage / Change in Temperature Coverage
  • RD Property (research animals, cell cultures,
    etc.)
  • RD Business Income (contemplates grants,
    milestone payments, endowments, etc)
  • Ordinary payroll coverage included
  • Pollutants (radioactive contamination,
    microorganisms)
  • Radioactive Contamination (Typical PD / BI
    sublimit 250,000)
  • Physical vs. Operational Restoration of Property,
    Unlimited Extended Period of Indemnity
  • Contingent Business Interruption (Dependent
    Business Premises - worldwide)

21
Coverages tailored to unique Life Sciences
Liability exposures
  • Premises Operations on Occurrence trigger,
    defence costs outside the limit
  • Product Liability - Claims Made, defence within
    limit
  • Human Clinical Trials
  • Ability to insure admitted foreign trials in many
    jurisdictions
  • Professional Liability Endorsements (clinical
    investigators, medical sales personnel)
  • Errors Omissions cyber liability and privacy
    remediation available
  • Product Withdraw Expenses - 25,000 included with
    higher limits available

22
WorldCert for Foreign Trial Placements
  • State-of-the-art, interactive clinical trial
    insurance and certificate management system.
  • Web based system features include
  • Instant trial insurance quotes.
  • User-controlled no waiting for an insurer to
    complete back-end processes for certificate
    issuance.
  • Instant issuance and modification of global
    clinical trial insurance certificates.
  • Database of country-specific insurance
    requirements.
  • Certificate issuance in the local language.
  • Capability to email certificates to anyone
    worldwide.
  • Customized insuring options

23
Chubb Value Proposition
  • World-class claim service based on a no-hassle
    philosophy
  • The strongest level of underwriting acumen
  • The ability to grow with companies throughout
    their life cycle
  • A willingness to engage on companies of all
    hazard groups
  • Tongue depressors to pacemakers
  • Vitamins to Vaccines
  • Superior, well-diversified portfolio of broad
    language policies.
  • One of the largest specialty Loss Control teams
    globally
  • Global Network and Financial Strength

24
Chubb Life Sciences
  • Thank you for your participation
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