Risk. Reinsurance. Human Resources.
Aon Risk SolutionsLife Sciences Practice
Providing End-to-End Solutions for Life Sciences CompaniesLife Sciences Practice
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The Life Cycle Risk Continuum
Life Sciences companies face numerous and unique challenges as their life cycles evolve. How these risks are mitigated and identified can be the fundamental difference between financial success and business failure. Aon provides Life Sciences companies with end-to-end risk solutions, supporting organizations from the initial discovery phase to final product launch.
Discovery / Preclinical
Clinical (Phase 1)
Clinical (Phase 2 & 3)
Regulatory Approval /
Launch Preparation
Post Approval / Product Launch
1The Life Cycle Risk
Continuum
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The Life Cycle Risk Continuum
An overview of industry-specific risks a Life Sciences company will likely face during their growth phases:
• Strong life sciences industry and product expertise providing tailored risk management advice
• Dedicated claims advocacy and management for complex product liability litigation and securities class actions
• Specialized life sciences service team that proactively assesses your risk profile in a high growth environment
• Significant market relationships and industry presence to secure the broadest, most cost effective risk management program
• Aon Global Client Network—the largest equity-owned global client network to efficiently and effectively secure admitted policies for multi-country, multi-site clinical trials and additional global insurance needs
We Address Your Risk Management Needs
Workers’ Compensation
Risk
Minimal Employee Base
Minimal Exposure
O�ce/LabEquipment/R&D
Discovery/Preclinical Clinical Phase 1 Clinical Phase 2 and 3
Regulatory Approval/ Launch Preparation
Post Approval/Product Launch
Small Employee Base
Property/Raw Material Manufacturing
Raw Material Sources
U.S. ClinicalTrials
InternationalClinical Trials
Product Liability
Manufacturing Capacity
Environmental/Pollution Liability
Private D&O Public D&O (IPO)Fiduciary
Employer Practice Liability
Property/Business Interruption
Auto Fleet for Sales Force
Manufacturing/Transportation/Raw Materials/Third-Party
Trade Credit/Business Continuity/ERM
Medium/Large Employee Base
Auto/General Liability
Property
Product Safety
Executive Liability
Supply Chain
Builder’s Risk
Environmental
5 4 3 2 1
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Solutions Across the Life Cycle Risk Continuum
Life Sciences companies face a growing number of unique and complex risks in areas such as products and clinical trials, directors’ and officers’ and supply chain liability. Today’s companies need comprehensive solutions at every stage of product development, testing, regulatory review and launch.
Based on deep industry knowledge and years of experience, Aon Risk Solutions’ Life Sciences Practice offers a range of risk management solutions across the entire life cycle risk continuum. Coverage is designed to address specific industry requirements such as market trends and pricing, contract language, individual market risk appetites and how the Life Sciences industry views risk.
As a result, Aon professionals can provide Life Sciences companies with industry-specific solutions that offer the following advantages and benefits:
• A flexible, customized approach for each individual client
• Global reach and presence in every region and market in the world
• Adherence to industry best practices and the ability to replicate successful risk management strategies
• Use of key benchmarking and actuarial analytics to support decision-making for program structures such as limits, retentions and pricing
• Access to top-level executive underwriters at leading Life Sciences insurance companies
• A seasoned team of attorneys to offer proven claims advocacy expertise in large product-liability class action and securities class action litigation
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Worldwide Support from Aon Clinical Trial Specialists
As clinical trials have moved from the United States and Western Europe to emerging regions such as Eastern Europe, Latin America and Asia amid increased scrutiny and compliance regulations, the likelihood that a clinical trial may be negatively impacted is on the rise.
Aon assists Life Sciences companies conducting global clinical trials through a coordinated effort supported by clinical trials specialists housed within the world’s largest equity-owned network.
Eastern Europe
Latin AmericaAsia
These specialists are trained in: • Understanding the international
regulatory environment for clinical trials
• Developing programs designed to protect clients from liabilities
• Helping to ensure the proper certificates are issued to allow the trial to proceed
In addition, our clinical trials specialists support our Life Sciences clients with: • Access to insurance expertise in 120
countries
• Management of controlled global master programs with certificate issuance in almost every country around the world complementing insured, fronted and captive structures
• Coordination and timely delivery of clinical trial certificates with trial managers and Contract Research Organizations globally to satisfy regulatory and ethics committee requirements
• Proprietary database of global clinical trials regulations
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Eastern Europe
Latin AmericaAsia
HawaiianIslands (USA)
Gulf Of A
den
Red Sea
The Gul f
Car ibbean Sea
Nor thSea
T imorSea
TasmanSea
East S iber ian Sea
Ber ing Sea
Sea OfJapan
EastChina
Sea
SouthChina
Sea
Pacific Ocean
Mediter raneanSea
Caspian Sea
Bay Of Bengal
Arabian Sea
BlackSea
Gulf Of Mexico
Pacific Ocean
At lant ic Ocean
Indian Ocean
Arct ic Ocean
Sea OfOkhotsk
Barents Sea
Kara SeaLaptev Sea
Nor wegian Sea
Beaufor t Sea
Hudson Bay
Ba�n Bay
Davis St rait
At lant ic Ocean
Southern OceanScot ia Sea
Ascension Island (Uk)
St. Helena (Uk)
NetherlandsAntilles (Nl)
FalklandIslands (Uk)
Reunion Islands (Fr)
CaymanIslands (UK)
New Caledonia (Fr)
Sao Tome & Principe
Tahiti
Symbols Illustrating Clinical TrialsInsurance Characteristics
Compulsory Clinical TrialsInsurance Requirements
Key to Symbols
Medical Malpractice is a Standard Policy Extension
Foreign Entity may be Listed as Named on a Local Policy
High Compulsory Limit of Liability
Compulsory Limit of Liability
Aon O�ce
Admitted Insurance LawsMay Apply
No CompulsoryClinical Trials Requirements
CompulsoryClinical Trials Requirements
Compulsory Clinical Trials Requirements with Extended Reporting orLife-of-Trial Requirements
No Data Available
Coverage is Available on a No Fault Basis
Standard Clinical Trials Insurance Coverage may not include Trial
Participant Pre-Enrollment Screening
Clinical Trials Insurance Policies allow Direct Reimbursements
to Trial Participants
No Compulsory Requirements; However, Standard Practice Dictates Clinical Trials Coverage
United Arab Emirates
Latvia
Ghana
French Guiana (Fr)
Cabinda (Angola)
Melilla (Spain)
Gibraltar (UK)Ceuta (Spain)
Canada
United StatesOf America
Mexico
Belize
Honduras
NicaraguaEl Salvador
Guatemala
Costa Rica
Panama
Bahamas
HaitiDominican Rep
Jamaica
St. Kitts&
Nevis
Antigua & Barbuda
Anguilla
Virgin Islands (US)
DominicaSt. Lucia
Barbados
Grenada
Trinidad & Tobago
Guyana
Suriname
Venezuela
Colombia
Ecuador
Peru
Bolivia
Brazil
Paraguay
Uruguay
Argentina
Chi
le
Greenland
Iceland
UnitedKingdom
Ireland
NorthernIreland
France
Spain
Germany
Italy
Norway
Swed
en
Denmark
Netherlands
Belgium
Guernsey
Isle of Man
Luxembourg
Liechtenstein
MonacoSan Marino
VaticanAndorra
Port
ugal
Austria Hungary
Poland
Ukraine
Belarus
Estonia
Finland
Romania
Montenegro
Moldova
BulgariaBosnia
Albania
Serbia
F.Y.R. Macedonia
Greece
Malta
CyprusLebanon
Palestine
Israel
Syria
Jordan
Turkey
Egypt
LibyaAlgeria
Tunisia
Mali
Western Sahara(Morocco)
Niger
Chad
Sudan
Mauritania
Morocco
Cape Verde
Guinea
BurkinaFaso
Benin
Cameroon
Gabon
CentralAfrican Republic
Nigeria
Uganda
Zambia
Namibia
Botswana
Zimbabwe
SouthAfrica
Tanzania
Madagascar
Mozambique
Ethiopia
Kenya
EritreaYemen
Oman
Bahrain
Qatar
Kuwait
SaudiArabia
India
Bhutan
Burma(Myanmar)
Sri Lanka
Maldives
Seychelles
Comoros
Mauritius
Thailand
Cambodia
Vietnam
MacauHong Kong
Singapore
Brunei
Russia
Kazakhstan
Mongolia
China
Uzbekistan
TurkmenistanTajikistan
Afghanistan
KyrgyzstanAzerbaijan
Georgia
Armenia
Pakistan
IranIraq
Malaysia
Indonesia
Japan
North Korea
South Korea
Taiwan
Philippines Micronesia
Palau
Guam
Papua NewGuinea
Timor Leste
Solomon Islands
VanuatuFiji
New Zealand
Samoa
Niue (Nz)French
Polynesia
Tonga
Australia
St. VincentAruba
Kiribati
Tuvalu
Nauru
Marshall Islands(Usa)
Alaska (US)
Togo
Cote D'ivoire
Congo
Angola
Cuba
Djibouti
Laos
Nepal
Bangladesh
Somalia
Eq Guinea
Gambia
Guinea Bissau
Lesotho
Liberia
Burundi
Rwanda
Malawi
Senegal
Sierra Leone
Swaziland
Slovakia
Czech Rep
Lithuania
Slovenia
Switzerland
Puerto Rico (US)
Victoria
New SouthWales
Sarajevo
Bermuda (UK)
Croatia
Guadeloupe (Fr)
Democratic RepublicOf Congo
Symbol Definitions:
Compulsory Clinical Trials Insurance Requirements:Government mandated clinical trial liability insurance, evidence ofwhich must be provided by sponsors to regulators before regulatoryauthorities will grant approval to commence the trial.
Extended Reporting or Life-of-Trial Requirements:Government mandated insurance regulations requiring that clinicaltrials insurance include extended reporting or “tail” liability for a periodof time following the completion of a clinical trial or life-of-trial coverage.
Compulsory Limit of Liability:Government regulated clinical trial insurance with limit of liabilityrequirements (in some countries limit requirements vary bytrial size/number of human subjects).
High Compulsory Limit of Liability:Government regulated clinical trial insurance with limit of liabilityrequirements in excess of $5 million (in some countries limitrequirements vary by trial size/number of human subjects).
Medical Malpractice is a Standard Policy Extension:Professional liability coverage for trial investigators as part of their participation in the study is a standard coverage under the local clinical trials liability policy.
Coverage is Available on a No Fault Basis:A type of clinical trial liability policy under which insureds areindemnified for losses regardless of fault.
Foreign Entity may be Listed as a Named Insured on a Local Policy:A foreign sponsor can be listed as the named insured under the localclinical trial liability policy without the need of a local legal representative.
Admitted Insurance Requirements May Apply:Local country law requires that insurance be purchased from anadmitted or locally licensed insurance company in the countryin which the clinical trial is being conducted.
Aon Office:Countries where Aon has a physical presence (in one or multiple cities)and can assist life sciences clients in obtaining local clinical trial insuranceand can provide input on local customs and regulations.
Risk. Reinsurance. Human Resources.
Aon Life Sciences Clinical Trials Risk Map Aon Risk Solutions | Life Sciences Grouptel: 1+215.255.1857
e-mail: [email protected]
© Copyright Aon plc 2015. All rights reserved. Published by Aon Global Corporate Marketing and Communications.
The information contained in this map is based on Aon experience as of the publishing date (05/1). The environment (both regulatory and practical) for clinical trials is constantly changing and this map should not be solely relied upon without further consultation from an Aon Life Sciences professional.In addition, ethics committees, regulatory authorities and published guidelines within individual countries can di�er depending upon individual study requirements and the views of individual regulators and ethics committees.
Aon’s proprietary database contains information on local and regional regulations, ethics committee requirements and market practices for clinical trials insurance for individual countries. Based on this wealth of information, Aon Risk Solutions’ Life Sciences Practice develops a Clinical Trials Risk Map as a resource for Life Sciences companies conducting or planning to conduct clinical trials abroad.
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Powerful Tools for Risk Management Decision-Making
Product benchmarking
The industry’s largest proprietary products liability and D&O database, providing relevant data tailored to specific size and needs
Actuarial risk analysis
An industry-leading actuarial practice that provides loss forecasts and analysis specific to Life Sciences companies
Industry analysis
Aon Risk Solutions’ Life Sciences Industry Report, covering industry-specific insurance and financial trends, product benchmarking and peer risk management insight
Aon has invested significant resources to create a comprehensive platform of
analytical tools to help Life Sciences companies make informed risk management
decisions. These resources include:
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Our expertise, your resource–across the industry and around the world
Aon Risk Solutions’ Life Sciences Practice serves more than 400 organizations worldwide, ranging from early-stage research and development units up to large pharmaceutical companies. Backed by the resources of more than 69,000 professionals in 120 countries, we can apply our collective experience and expertise to the specific challenges of individual clients such as:
• Pharmaceutical manufacturers
• Generic and OTC pharmaceutical companies
• Biotechnology and biopharmaceutical companies
• Genomic and proteomic companies
• Drug delivery system companies
• Diagnostic substance companies
• Medical device and equipment manufacturers
• Life Sciences services: Contract Research Organizations, Contract Marketing Organizations and drug distributors
An Unparalleled Offering of Products and Client Services
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A leader working with leaders
We are a recognized leader in risk management advisory services for Life Sciences companies. Our clients include:
50%of the NYSE Arca Biotech
Index
6of the 10
largest pharma companies
8of the 10
largest biotech companies
of the 10 largest medical device
companies
54of the 6 largest clinical research
organizations
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A major presence in the market
Effectively managing risk for the most complex Life Sciences companies in the world requires a service and product offering unparalleled in the industry and is dependent upon ongoing product innovation. Aon Risk Solutions’ Life Sciences Practice offering includes the following products and services:
• Insurance Broking—unparalleled product knowledge across all areas of risk in the industry
• Global Clinical Trials Insurance—coordination and placement
• Captive Insurance— Management and Services
• Risk Quantification and Modeling
• Enterprise Risk Management
• Business Continuity Management
• Supply Chain Management
• Business Interruption Valuation
• Property Engineering and Risk Control
• Crisis Management and Communication
• Reputational Risk Management and Brand Restoration
• Claims Response Planning
• Product Recall Assessment
• Human Capital Management
• Health and Benefits
An unwavering commitment to the
highest levels of service and innovation
for our clients.
Our presence in specialized Life Sciences
products includes:
USD200M USD100M
USD78B
in annual Clinical Trials and Product Liability premiums
in Life Sciences D&O premiums
in premium managed globally, across industries
Management of more than and more than
backed by
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Aon Client Promise Framework—Our Commitment to You
The Aon Client Promise framework includes the five pillars of our promise, a comprehensive training curriculum, and a robust methodology for ensuring a consistent client experience.
Aon Client PromiseComprised of five pillars—partnership, expertise, innovation, excellence, and results—the Aon Client Promise articulates the commitment we make to our clients.
Aon Client Promise AcademyThe Academy offers unique learning experiences focused on listening for and responding to client needs, building knowledge of the full breadth of Aon capabilities, and understanding the pillars of the Aon Client Promise.
Aon Client Promise Methodology
Discover We will collaborate to understand both your near- and long-term business priorities, how we can add value to your organization, and help you respond to changing market dynamics.
Develop We will jointly author a plan to define how we will work together during the year, outline our commitments to you, and define how we will measure our success.
Deliver We will follow through on our plan, executing with excellence and tracking outcomes.
Review We will seek your input on how we are doing both through informal feedback sessions and annual surveys.
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Contact Aon Today
Aon professionals can provide your organization with the experience, tools and deep industry expertise required to maintain a competitive edge in today’s marketplace. Contact the following representatives to learn more about specialized solutions from Aon Risk Solutions’ Life Sciences Practice.
Jim WaltersManaging DirectorAon Risk Solutions Life Science Practice+1.215. [email protected]
Edwin AlbersDirectorAon Risk Solutions Life Science [email protected]
The Aon Life Sciences Group has been assisting life sciences
companies with securing international clinical trials insurance for
over 30 years. We have the largest equity-owned global network
in the world, housing clinical trials specialists who provide our life
sciences clients with industryleading expertise and accountability.
Our experts constantly review country-by-country clinical
trials regulations in order to provide our clients with industry-
leading risk management advisory and brokerage services.
About Aon Life Sciences Group
About Aon Aon plc (NYSE:AON) is a leading global provider of risk management, insurance brokerage and reinsurance brokerage, and human resources solutions and outsourcing services. Through its more than 69,000 colleagues worldwide, Aon unites to empower results for clients in over 120 countries via innovative risk and people solutions. For further information on our capabilities and to learn how we empower results for clients, please visit: http://aon.mediaroom.com.
© Aon plc 2015. All rights reserved.The information contained herein and the statements expressed are of a general nature and are not intended to address the circumstances of any particular individual or entity. Although we endeavor to provide accurate and timely information and use sources we consider reliable, there can be no guarantee that such information is accurate as of the date it is received or that it will continue to be accurate in the future. No one should act on such information without appropriate profes-sional advice after a thorough examination of the particular situation.
www.aon.com
16908 05/15
Risk. Reinsurance. Human Resources.