TOP REASONS TO ATTEND: � Standardize privacy, security and trust across the life sciences

� Mitigate the risks associated with storing sensitive data in the cloud

� Maintain privacy while using mobile devices and social media

� Develop protocols and processes to prevent data breaches and minimize brand damage in the a� ermath of a breach

� Understand federal and state regulations and directives and convey cybersecurity risks to stakeholders

LIFE SCIENCE DATA PRIVACY, INTEGRITY AND SECURITY SUMMIT Technical Strategies for Secure and Accessible Health Data and Patient Records in Clinical Trials

Mollie Shields-UehlingPresident and CEOSAFE-BIOPHARMA ASSOCIATION

CHAI

RPE

RSO

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AUGUST 12-13, 2015 // SONESTA HOTEL // PHILADELPHIA, PA

Fran WietChief Privacy O� icerTAKEDA PHARMACEUTICALS

Jon WilkinsonChief Privacy O� icer

PHILIPS HEALTHCARE

DISTINGUISHED SPEAKER FACULTY INCLUDES:

Michael A. Towers, CISSPVice President, Information

Security O� icerACTAVIS

To Register Call 866-207-6528 or Visit www.exlevents.com/dataprivacy

Danielle Benoit Manner, Privacy Counsel, PFIZER

Bob Guay, Manager, Information Security, BIOGEN IDEC

Kari K. Loeser, Senior Director and Senior Compliance Counsel, JAZZ PHARMACEUTICALS

Agatha L. O’Malley, Head of Privacy, Global Compliance and Risk Management, SHIRE

Gary Secrest, Former Director WW Information Security,JOHNSON & JOHNSON and Chief Technology O� icer, SAFE-BIOPHARMA ASSOCIATION

William Thies, Ph.D., Senior Scientist in Residence, ALZHEIMER’S ASSOCIATION

To Register Call 866-207-6528 or Visit www.exlevents.com/dataprivacy

PRIMARY AUDIENCEDear Colleague,

In the summer of 2014, more than five million patients had their personal, financial and medical data compromised in health system privacy breaches. According to a 2014 report, healthcare and pharmaceutical companies have the worst cybersecurity among the S&P 500.

The security landscape is changing and it’s impacting the way that the industry operates globally. Experts predict that it’s only a matter of time before the life science industry could su� er from large-scale security breaches similar to those experienced recently by Home Depot, Target, JPMorgan Chase and Sony, among others.

The Life Science Data Privacy, Integrity and Security Summit is the premiere forum to guide the industry with timely and vital data privacy and security strategies to ensure protected clinical data. This event focuses on strategic cybersecurity measures for collecting, storing and transferring personal medical data.

This conference addresses HIPAA/HITECH regulations as well as pending personal privacy laws in Europe, Russia and Asia. Participants will gain valuable insights on how to find the right level of privacy and security controls appropriate for their organization, mitigate risks associated with storing sensitive data in the cloud, maintain privacy while using mobile devices and social media, and develop protocols to prevent data breaches.

Additionally, industry experts will present case studies on minimizing brand damage in the a� ermath of a data breach, complying with federal and state regulations and directives, and developing best practices for conveying cybersecurity risks to executives and boards of directors. And since implementing IT strategies for disease management is a topic with major growth potential for the industry, this conference explores it in depth.

We are thrilled to provide you with unique case studies, panels and interactive sessions on how to:

� Standardize privacy, security and trust across the life sciences � Identify the right level of privacy/security controls appropriate for your company � Enhance data protection in an evolving technological landscape � Mitigate risks while storing sensitive data in the cloud

Join industry leaders and privacy/security professionals to discuss best practices for successful data protection.

I look forward to seeing you in Philadelphia!

Sincerely,

Charleen FamigliettiConference Production Director ExL Eventscfamiglietti@exlevents.com

This conference is designed for representatives from pharmaceutical, biotechnology and medical device companies with responsibilities in the following areas:

� Data Privacy

� Information Security

� Privacy

� Information/Governance Technology

� Data Management/Protection

� Big Data Security/Privacy

� Compliance/RA

� Server Technology and Security

� Regulatory A� airs

� Quality

� Legal

� Commercial Operations

� Clinical Operations

� Internal Audits

� Information Governance

� Privacy Compliance

� IT Risk Assurance

This conference is also of interest to:

� Data Privacy So� ware Providers

� Digital Signature Solution Providers

� Cloud-Based Security Services

� Security So� ware Providers

� Data Management So� ware Companies

� Data Analytics

� IT Consultants/Contractors

� Health Law Attorneys

Sonesta Hotel Philadelphia1800 Market Street, Philadelphia, PA 19103215-561-7500The new Sonesta Hotel Philadelphia offers a spectacular downtown location convenient to whatever brings you to the City of Brotherly Love. Located near world-class restaurants and boutique shopping at ritzy Rittenhouse Square in Center City, the hotel is within the business district and walking distance to many popular Philadelphia attractions, historic landmarks, museums and theaters.

Room Reservations: If you require overnight accommodations, please contact the hotel to book your room. ExL Events has reserved a block of rooms at a discounted rate for conference participants. We encourage participants to make reservations by Monday, July 20, 2015. To make reservations guests can call 1-800-SONESTA (766-3782) and request the negotiated rate for “ExL’s August Meetings.” Please book your room early, as rooms available at this rate are limited.

VENUE INFORMATION

DAY ONE // WEDNESDAY, AUGUST 12, 2015

To Register Call 866-207-6528 or Visit www.exlevents.com/dataprivacy

OU

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Y

8:00 Registration and Continental Breakfast

9:00 Chairperson’s Opening RemarksMollie Shields-Uehling, President and CEO, SAFE-BIOPHARMA ASSOCIATION

SECURITY AND REGULATORY TACTICS

9:15 KEYNOTE Convey the Importance of Effective Security Measures to Your Internal Organization

� Communicate the need for security measures to stakeholders

� Prioritize defenses for incoming data

� Report risk management business to key stakeholders

Michael A. Towers, CISSP, Vice President, Information SecurityOffi cer, ACTAVIS

10:00 CASE STUDY Standardize Privacy, Security and Trust Across the Life Sciences

� Discuss how Big Pharma, the FDA and the EMA created the SAFE-BioPharma digital identity and digital signature standard to facilitate trust in Internet transactions and to improve workfl ow effi ciencies

� Understand how the standard has facilitated trusted cyber collaboration in R&D

� Learn about the standard, the global ecosystem supporting its use, and the innovative ways big and small pharma organizations are implementing it in their operations

Mollie Shields-Uehling, President and CEO, SAFE-BIOPHARMA ASSOCIATION

10:45 Networking and Refreshment Break

SECURITY IN NEW MEDIA AND NEW MARKETS

11:15 Enhance Data Protection in an Evolving Technological Landscape

� Hear from a cross-industry expert on their experience in balancing convenience, privacy and security

� Collaborate with other industries to accelerate development of security and privacy strategies

Cindy Cullen, CCSK, CISSP, CISM, SSBB, ITILv3, MCS, Security Strategist, HP ENTERPRISE SECURITY

12:00 Luncheon

1:00 Maintain Privacy While Utilizing Mobile Devices and Social Media

� Understand the emerging fi eld of cybersecurity and its impact on devices and mobile applications

� Find the right balance between cyber freedom and access to personal data

� Assess the changing risk landscape as mobile technology evolves

Jon Wilkinson, Chief Privacy Offi cer, PHILIPS HEALTHCARE

1:45 Ensure Data Privacy and Security While Working with Vendors in Emerging Markets and Overseas

� Prepare for the EU’s Data Protection Directive changes (2016)

� Safeguard your organization’s data privacy and security while working with vendors in emerging markets (Asia and Russia)

� Address local privacy requirements and language barrier concerns

Agatha L. O’Malley, Head of Privacy, Global Compliance and Risk Management, SHIRE

2:30 Mitigate Risks Associated with Storing Sensitive Data in the Cloud

� Utilize cloud-based technology for effective data protection � Find the balance between effective security settings and convenient access for consumers

� Understand different types of cyber thieves and hackers and their motivations

Gary Secrest, Former Director WW Information Security, JOHNSON & JOHNSON and Chief Technology Offi cer, SAFE-BIOPHARMA ASSOCIATION

3:15 Networking and Refreshment Break

3:45 View Security and Protection Through a Marketing Lens � Reduce damage to your brand in the event of a data breach and other security incidents

� Explore the impact of a data breach through a marketing lens � Safeguard marketing strategies and sensitive company information through effective security measures

� Discuss FTC guidelines for consumer-generated health

Fran Wiet, Chief Privacy Offi cer, TAKEDA PHARMACEUTICALS

4:30 INTERACTIVE ROUNDTABLE DISCUSSION Develop an Out-of-the-Box Approach for Safeguarding Clinical Health Data

In this interactive session, you will get a chance to discuss your data security and privacy problem-solving skills with peers, exchange views, and learn how others tackle various challenges.

ModeratorLauren Steinfeld, Chief Privacy Offi cer, PENN MEDICINE

5:15 Day One Concludes

DAY TWO // THURSDAY, AUGUST 13, 2015

To Register Call 866-207-6528 or Visit www.exlevents.com/dataprivacy

8:00 Continental Breakfast

9:00 Chairperson’s Day One RecapMollie Shields-Uehling, President and CEO, SAFE-BIOPHARMA ASSOCIATION

PRIVACY AND SECURITY LAWS

9:15 Regulatory Update: Understand Recent Privacy and Security Laws

� Navigate state and federal privacy laws to ensurecompliance

� Discuss the implications that security does not directly correlate to compliance

� Assess the adequacy of the FDA’s corrective actions following the FDA breach on HIPAA/HITECH regulations as well as pending personal privacy laws in Europe, Russia and Asia

� Understand the process of an independent security audit

Peter Alterman, Ph.D., Chief Operating Offi cer, SAFE-BIOPHARMA ASSOCIATION and Former Senior Advisor to the National Program Offi ce, NATIONAL STRATEGY FOR TRUSTED IDENTITIES IN CYBERSPACE (NSTIC)

UPDATING YOUR SECURITY STRATEGIES

10:00 PANEL DISCUSSION Design Strategies for Data Security and Mitigate Risk for Data Breaches in Clinical Trials

� Address how to manage and transfer data during company mergers and acquisitions

� Drive risk management initiatives to prevent security threats

� Benchmark strategies for protecting patient information

Fran Wiet, Chief Privacy Offi cer, TAKEDA PHARMACEUTICALS Danielle Benoit Manner, Privacy Counsel, PFIZERBob Guay, Manager, Information Security, BIOGEN IDECKari K. Loeser, Senior Director and Senior Compliance Counsel, JAZZ PHARMACEUTICALS

10:45 Networking and Refreshment Break

11:15 Address the Patient Perspective for Data Privacy During Clinical Trials

� Understand the concerns of the consumer/patient

� Debate the pros and cons of using EHRs/EMRs

� Learn what motivates the patient to share personal data and what inhibits the patient from sharing important information with HCPs

� Grasp how patients prioritize privacy and convenience

William Thies, Ph.D., Senior Scientist in Residence, ALZHEIMER’S ASSOCIATION

12:00 CASE STUDY Discuss the Implications of a Data Breach in the Mental Health Industry

� Improve privacy for mental health clinical data � Incorporate incident response strategies

Kari K. Loeser, Senior Director and Senior Compliance Counsel, JAZZ PHARMACEUTICALS

12:45 Luncheon

1:45 The Trust Component: Make Global Clinical Connections Work

� Learn how a robust, Internet-supported clinical research process relies on trust, information sharing and mutually respectful relationships between participating stakeholders

� Explore these considerations within the context of the information schemes that facilitate and support effective clinical research systems

� Explain how ACRES is working with SAFE-BioPharma and other key allies to achieve a functional and secure federated trust framework

Greg Koski, Ph.D., M.D., President and Co-Founder, ALLIANCE FOR CLINICAL RESEARCH EXCELLENCE AND SAFETY (ACRES)

2:30 Implement Practical Cybersecurity Risk Measurements for Meaningful Metrics

� Integrate threat intelligence information into metrics initiatives � Redefi ne internal metrics to pave the way for relevant and useful data

� Contextualize data points

Bob Guay, Manager, Information Security, BIOGEN IDEC

3:15 Afternoon Networking Break

3:45 Develop Protocols to Prevent Data Breaches � Deploy a data breach prevention team and utilize learningmanagement systems to enhance training

� Work with IT to implement tactical security measures � Discuss risk management strategies

Lauren Steinfeld, Chief Privacy Offi cer, PENN MEDICINE

4:30 Conference Chairperson’s Closing RemarksMollie Shields-Uehling, President and CEO, SAFE-BIOPHARMA ASSOCIATION

4:45 Conference Concludes

SPONSORSHIP AND EXHIBITING OPPORTUNITIES

Do you want to spread the word about your organization’s solutions and services to potential clients who attend this event? Take advantage of

the opportunity to exhibit, present an educational session, host a networking event or distribute

promotional items to attendees. ExL works closely with you to customize a package that suits all of

your needs. To learn more about these opportunities,

contact Matthew Halvorsen, Senior Business Development Manager, at 917-258-5163 or

mhalvorsen@exlevents.com.

TERMS AND CONDITIONS

Payment:Make checks payable to ExL Events, Inc. and write code C644 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other o� ers and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options.

**Please Note: There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague occurring within � ve business days of any ExL conference.**

Cancellation and Refund Policy:If you need to cancel your registration for an upcoming ExL event, please note the following policies derived from the Start Date of the event:

• Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to another ExL event valid for 12 months from the voucher issue date.

• Less than four weeks: A voucher to another ExL event valid for 12 months from the voucher issue date.

If you cancel within � ve business days or at any time after receiving the conference documentation, the voucher issued will be $395 less.

To receive a refund or voucher, please fax your request to 888-221-6750.

Credit Vouchers:Credit Vouchers are valid for 12 months from date of issue. Credit Vouchers are valid toward one (1) ExL event of equal or lesser value. If the full amount of said voucher is not used at time of registration, any remaining balance is no longer applicable now or in the future. Once a Credit Voucher has been applied toward a future event, changes cannot be made. In the event of cancellation on the attendees’ behalf, the Credit Voucher will no longer be valid.

Substitution Charges:There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within � ve business days of the conference.

ExL Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare, hotel or any other costs incurred by registrants.

ExL Events’ liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date, content, speakers or venue.

*The opinions of ExL speakers do not necessarily re� ect those of the companies they represent or ExL Events, Inc.

Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, signi� cant e� ort to � nd a suitable replacement will be made.

GROUP DISCOUNT PROGRAMS*Offers may not be combined. Early Bird rates do not apply. To find out more on how

you can take advantage of these group discounts, call 866-207-6528.*

Save 25%For every three simultaneous registrations from your company, you will receive a

fourth complimentary registration to the program (must register four at one time).

Save 15% Can only send three? You can still save 15% off of each registration.

REGISTRATION FEES

EARLY BIRD PRICING*Register by June 26, 2015

Conference $1,895

STANDARD PRICING* Register After June 26, 2015

Conference $2,095

ONSITE PRICING*

Conference $2,195

*Includes Sales Tax and Service Fees

MEDIA PARTNERS

QUESTIONS? COMMENTS?

Do you have a question or comment that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader? Please email Conference Production Director Charleen Famiglietti at cfamiglietti@exlevents.com.

WAYS TO REGISTER5

www.exlevents.com/dataprivacy

866-207-6528

registration@exlevents.com

888-221-6750

ExL Events, Inc.494 8th Ave, Fourth FloorNew York, NY 10001

To Register Call 866-207-6528 or Visit www.exlevents.com/dataprivacy

LIFE SCIENCE DATA PRIVACY, INTEGRITY AND SECURITY SUMMIT Technical Strategies for Secure and Accessible Health Data and Patient Records in Clinical Trials

AUGUST 12-13, 2015 // SONESTA HOTEL // PHILADELPHIA, PA

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REGISTER TODAY

Mollie Shields-UehlingPresident and CEOSAFE-BIOPHARMA ASSOCIATION

CHAI

RPE

RSO

N

Code: C644

www.exlevents.com/dataprivacy

ExL Events, Inc.494 8th Ave, Fourth FloorNew York, NY 10001

866-207-6528

888-221-6750

registration@exlevents.com

Card Number: Exp. Date:

Name on Card:

Signature:

Fran WietChief Privacy O� icerTAKEDA PHARMACEUTICALS

Jon WilkinsonChief Privacy O� icer

PHILIPS HEALTHCARE

Michael A. Towers, CISSPVice President, Information

Security O� icerACTAVIS