1. Ensuring Robust Data Privacy Policies & Systems that Maintain Security, Mitigate
Breaches and Potential Reputational Harm, while Upholding Compliance with Evolving
Regulations and Jurisdictions on a State-wide as well as International Level
500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com
Tracy Hickey
Associate Director Compliance—
Operations, Training, &
Communications
SHIRE PHARMACEUTICALS
John Baur
Former Senior Manager—Privacy
Compliance, Health Care Compliance
& Privacy
JOHNSON & JOHNSON
Jacob G. Springer
Global Privacy Officer & Compliance
Counsel
ABBOTT LABORATORIES
Michael Mcneil
Global Product Security &
Services Officer
PHILIPS HEALTHCARE
Brad Rostolsky
Partner
REED SMITH
Jeremy Livianu
Privacy Officer
NEVRO CORP.
Agatha O’Malley
Co-Lead Commercial Privacy Practice
BOOZ ALLEN HAMILTON
Former Head of Privacy
SHIRE PHARMACEUTICALS
Michael D. Molinaro
Chief Information Security Officer
BIOREFERENCE LABORATORIES INC.
Patricia Hilbrands
Privacy Officer
ARTHREX
Jennifer Couture
Counsel, PENAC Privacy &
Commercial Counsel
PHILIPS NORTH AMERICA
Daniel J. McBride
Director, Privacy Office
MERCK
Megan Mikkelsen
North America Chief Privacy Officer
TEVA PHARMACEUTICALS
Gail ObryckI
Former Senior Manager Global Privacy
Policy & Communications
JOHNSON & JOHNSON
President
GO 2 CONSULTING
Murali Mani
Senior Privacy Officer
PHILIPS GROUP INNOVATION
Priya Mannan
Executive Director and Associate
GC of Global Pharma Compliance
& Data Privacy
NOVARTIS
K Royal, CIPP/US, CIPP/E
VP, AGC, Privacy and Compliance
Privacy Officer
CELLTRUST CORPORATION
Aldo M. Leiva, ESQ.
Partner
LUBELL | ROSEN
Gregory Albertyn
Global Privacy Officer
BIOGEN IDEC
DISTINGUISHED PRESENTERS INCLUDE:
LIFE SCIENCE DATA PRIVACY
JULY 27-28, 2015 | PHILADELPHIA, PA
OPEN DIALOGUE & GROUP SHARE
Each formal presentation is followed by a
minimum of 10 minutes of open dialogue
and all attendees are invited to become
participants.
UNPARALLELED NETWORKING
Multiple networking opportunities will take
place throughout the course of the two-day
meeting.
NO SALES PITCHES
Sales presentations from outside con-
sultants are prohibited to ensure confer-
ence content and focus remains strictly
educational.

2. LIFE SCIENCE DATA PRIVACY
DAY ONE | MONDAY, JULY 27
500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com
8:00 REGISTRATION AND MORNING COFFEE
8:50 OPENING REMARKS
9:00 BALANCING RISK, REPUTATIONAL & FINANCIAL HARM IN
PATIENT DATA PRIVACY
As the number of security breaches and privacy regulations continue to in-
crease in number and complexity, executives throughout the life sciences
industry are working to ensure data remains protected and private. Potential
non-compliance or data breaches result in not only financial harm, but can also
result in tremendous reputational harm, which is often seen as more damaging
than financial damages. Executives must take a forward thinking approach to
mitigating risks, developing comprehensive policies and procedures, and at the
same time increase the visibility and importance of privacy throughout the life
science corporation.
• Elevating the importance of data privacy throughout the corporation
• Methods for evaluating and mitigating potential risk factors
• Forecasting for future threats and privacy regulations
John Baur, Former Sr. Mgr.—Privacy Compliance, Health Care Compliance &
Privacy
JOHNSON & JOHNSON
Gail ObryckI, Former Sr. Manager Global Privacy Policy & Communications
JOHNSON & JOHNSON
President, GO 2 CONSULTING
9:45 BEST PRACTICES FOR BUILDING A PRIVACY
INFRASTRUCTURE FROM THE GROUND UP
While many companies have data privacy initiatives in place, looking at how a
company may begin building a privacy policy from the beginning stages will help
industry executives better understand ways to improve their own programs. Cre-
ating new frameworks for patient data privacy policies will allow companies to
find pitfalls within their privacy structures, allowing them to be highlighted and
addressed. By dissecting one company’s experience implementing new data
privacy standards, executives will better focus on ways to create new and im-
prove old data privacy regulations within their organizations.
• Challenges in the execution of new privacy policies
• Mitigating issues in changing company culture
• Working to identify potential partners
• Positive lessons learned
Jeremy Livianu, Privacy Officer
NEVRO CORP.
10:30 COFFEE & NETWORKING BREAK
11:00 PANEL: COLLABORATION BETWEEN PRIVACY &
TECHNOLOGY TEAMS
Privacy and technology teams in life science organizations must work together
to develop and maintain privacy measures and to ensure the protection of data
throughout all avenues within organizations. Teams must ensure that privacy
reaches beyond policy and is embedded within the infrastructure of training
and technological safeguards from the ground up. Understanding how priva-
cy and technology teams can work better together is one way executives can
strong ground on which to build upon.
• Ensuring privacy is more than just a policy
• Evaluating various technologies for data protection
• Development of internal safeguards with security
• Issues surrounding intranet security internally
• Understanding the importance & opportunities in encryption
Megan Mikkelsen, North America Chief Privacy Officer
TEVA PHARMACEUTICALS
Gregory Albertyn, Global Privacy Officer, BIOGEN IDEC
Jacob G. Springer, Global Privacy Officer & Compliance Counsel
ABBOTT LABORATORIES
11:45 ADDRESSING PRIVACY CONSIDERATIONS IN VARIED US
JURISDICTIONS
Organizations must participate in the responsible sharing of patient data, es-
pecially when transferring patient level data across state jurisdictions. Patient
data privacy regulations vary state-by-state, with some of the stricter regula-
tions in California and Texas, and an examination of data transfer rules and
regulations will help executives develop better privacy policies in regards to
these regulations. Companies that operate state to state will find the dissection
of jurisdictional requirements beneficial to developing company-wide policies.
• Overview of states with strict privacy regulations
• California
• Texas
• Ensuring a corporate-wide privacy policy covers all requirements
• Considerations when transferring data across state-lines
• Recent cases of interest to life sciences organizations
Jennifer Couture, Counsel, PENAC Privacy & Commercial Counsel
PHILIPS NORTH AMERICA
12:30 LUNCHEON FOR ALL CONFERENCE PARTICIPANTS
1:30 DEVELOPING ADVANCED TRAINING PROGRAMS TO ENSURE
COMPLETE DATA PRIVACY
Life science companies employ thousands of individuals at varying levels of
security clearance who have access to sensitive patient level data that must
remain private. Organizations must create privacy policies, as well as evolve
them based on technological advances, to ensure that data is secure. The ap-
propriate and continual training of employees on company privacy policies, the
correct handling of personal data, as well as relevant data-use procedures, will
reduce the likelihood of a data breach occurrence at the hands of human error.
• Development of comprehensive training programs
• Providing a thorough and clear definition of privacy
• Proactive training and re-training opportunities
• Security concerns surrounding mobile devices
• Handling situations of employee data theft
Agatha O’Malley, Co-Lead Commercial Privacy Practice
BOOZ ALLEN HAMILTON
Former Head of Privacy, SHIRE PHARMACEUTICALS
Tracy Hickey, Associate Dir. of Compliance, SHIRE PHARMACEUTICALS
2:15 PROACTIVE MANAGEMENT OF A PRIVACY BREACH
Given the immense amount of data being collected and managed by life sciences
companies, there is a tremendous need for proactive management of potential
breach situations. Organizations that have experienced such a breach, where
data has been compromised, including potentially patient data, have learned
considerable lessons and have taken great steps to ensure data is recovered
and suitably protected moving forward. A retrospective analysis from an organi-
zation that has handled a privacy breach, learning what could have been done
differently and how the aftermath was tackled, will assist executives in learning
how to better avoid a breach, as well as develop internal response protocols.
• Initial steps taken to identify the breach
• Systematic resolution of privacy breach
• Lessons learned & preventative steps for the future
Jacob G. Springer, Global Privacy Officer & Compliance Counsel
ABBOTT LABORATORIES
3:00 COFFEE & NETWORKING BREAK
3:15 METHODS FOR PROTECTING PATIENT DATA IN THE BIG DATA
REVOLUTION
The analysis of large data sets at lightening speeds has fueled the big data rev-
olution and its use in targeted marketing and sales techniques. The life science
industry must work to utilize big data technology to its fullest potential, while
also ensuring that all patient data remains private. Working to understand ways
in which to ensure that all patient data remains anonymous and fully de-identi-
fied, as well as dissecting anxieties surrounding privacy and mobile devices, life
science executives will learn how to use big data to its fullest potential.
• Understanding where data privacy falls within big data
• Strategies and methods for anonymizing data
• Data privacy concerns within mobile devices
K Royal, VP, AGC, Privacy & Compliance Privacy Officer
CELLTRUST CORPORATION
4:00 ENSURING DATA PRIVACY THROUGH HIPAA AND HITECH
REGULATORY FRAMEWORKS
Although in many cases, not directly affected by HIPAA and HITECH regulatory
constraints, the industry remains at time in contact with patient data and as
such must have a thorough awareness of these privacy frameworks. With the
Office of Civil Rights is currently conducting the second round of audits for cov-
ered entities to ensure compliance with ongoing HIPAA regulations, assessing
and ensuring reasonable safeguards are in place is required. Through clarifica-
tion of current interpretation on where HIPAA and HITECH offer guidelines to the
life science industry, executives will ensure privacy guidelines are being met.
• Relevance of HIPAA and HITECH within the life science corporation
• Clarifications of the Final Rule for HIPAA and HITECH
• Integrating privacy rules into informed consent
• Implications of HITECH on medical technology & imaging
Michael D. Molinaro, Chief Information Security Officer
BIOREFERENCE LABORATORIES INC.
4:45 LIMITING LIABILITY THROUGH ELIMINATING PATIENT DATA
CONTACT
As uncovered entities, device and diagnostic companies developing equipment
and technologies that encounter sensitive patient identifying data need to make
efforts to limit their encounters with that patient data. Restricting the amount of
patient identifying data that organizations interact with reduces potential data
breaches as well as acting as a safety measure against other liabilities. Ex-
ploring ways in which organizations can limit their own access to unnecessary
patient information, and the benefits of such, life science executives will better
understand how to limit their own liability.
• Reducing access to patient data
• Benefits of limiting access to data
• Reducing prospective liability
Priya Mannan, Executive Director and Associate GC of Global Pharma
Compliance & Data Privacy, NOVARTIS
5:30 CONCLUSION OF DAY ONE SESSIONS

3. 500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com
LIFE SCIENCE DATA PRIVACY
DAY TWO | TUESDAY, JULY 28
8:00 REGISTRATION AND MORNING COFFEE
8:20 CHAIRPERSON OPENING REMARKS
Aldo M. Leiva, ESQ., Partner, LUBELL | ROSEN
8:30 FDA REGULATIONS ON CYBERSECURITY
Technological advances made in the life science industry are integral to the
forward movement and progress of developing medical devices and diagnostic
equipment. In 2014 the FDA issued a final ruling concerning cybersecurity and
the life science industry titled “Content of Premarket Submissions for Manage-
ment of Cybersecurity in Medical Devices,” specifically targeting medical de-
vices, which outlined the FDA’s main concerns as well as steps organizations
should take in order to minimize and prevent cybersecurity risks. Identifying rec-
ommendations made by the FDA will assist life science executives in the pres-
ervation of patient privacy as well as the prevention of cybersecurity breaches.
• Concerns surrounding proliferation of new multi-function devices
• Understanding potential risks early on in product design
• Creating effective management systems for potential threats
Michael McNeil, Global Product Security & Services Officer
PHILIPS HEALTHCARE
9:15 GLOBAL PATIENT DATA PRIVACY REGULATIONS
As pharmaceutical and medical device corporations continue to commercial-
ize products around the world, compliance with evolving international privacy
considerations is a top priority. With the rapid pace of regulatory change, and
varied policies on both a country-by-country as well as regional basis, ensuring
ongoing global compliance is a considerable challenge. Understanding the crit-
ical points of international regulatory frameworks and how to formulate policies
and procedures that protect data on a global scale is essential in the rapidly
evolving life science market.
ONGOING EUROPEAN PRIVACY REFORMS
European Union laws and regulations stand at the forefront of patient data pri-
vacy laws with a 27-country directive restricting the use, sharing, storage and
collection of personal data. Countries across the European Union view data
privacy holistically, allowing the directive to become the paradigm for other pa-
tient data privacy laws and initiatives. Dissecting what makes the EU directives
distinct will help executives develop strategies for their continual global growth.
• Data Protection Directive 1995/46/EC
• e-Privacy Directive 2002/58/EC
• Strict penalties for violations
Murali Mani, Senior Privacy Officer, PHILIPS GROUP INNOVATION
10:00 COFFEE & NETWORKING BREAK
10:30 DEVELOPING POLICIES ACROSS LATIN AMERICA
As Latin American countries continue to develop and become contenders in
the life science industry, many countries are developing and implementing new
patient data privacy regulations and standards at great speed. Some countries
have adopted regulations similar to the EU directives; others have begun to
develop regulations that are tailored to their own country. While a number of
countries have developed polices that mirror European standards and regula-
tions, others have taken a more individual approach, developing unique regu-
latory frameworks from the ground up. Understanding specific Latin American
regulations will allow for executives to better move within patient data privacy
guidelines relative to specific Latin American countries.
• Rule of habeas data
• Adoption of omnibus data privacy legislation
• Rooted in EU directive, yet differ country-to-country
Aldo M. Leiva, ESQ., Partner, LUBELL | ROSEN
11:15 ENSURING PATIENT PRIVACY WITHIN SALES & MARKETING
STRATEGIES
As life science companies work to promote sales and marketing strategies to
ensure consumers are being reached in the most effective ways possible, ex-
ecutives must endeavor to make certain patient data privacy is maintained.
While targeted sales and marketing strategies are an ideal way to promote new
drugs, therapies and technologies, using specific patient data to reach con-
sumers presents issues concerning the maintenance of personally identifiable
information via social media marketing and targeted ads. Focusing on privacy
policies and their roles in sales and marketing campaigns, while also identifying
ways to prevent breach and ways to employ social media channels in these
campaigns, executives will be better able to ensure patient privacy while using
patient information for targeted ads.
• Addressing unclear guidelines surrounding privacy
• Potential privacy breaches in sales & marketing initiatives
• Balancing a need for greater marketing success with privacy
• Utilizing online and social media outlets while maintaining privacy
Megan Mikkelsen, North America Chief Privacy Officer
TEVA PHARMACEUTICALS
Brad Rostolsky, Partner, REED SMITH
12:00 LUNCHEON FOR ALL CONFERENCE GUESTS
1:00 DATA PRIVACY RISKS WITH THE DEVELOPMENT OF MOBILE
TECHNOLOGY
The privacy risks associated with the development of mobile applications and
the use of data from mobile devices are less obvious and more nuanced than
most existing technologies and data collection environments. Mobile devices,
such as smart phones, tablets, wearable technologies, personal navigation de-
vices and other devices that are continuously associated with their users have
changed traditional data collection paradigms. These devices are often always
on, digitally connected to the Internet or to each other, capable of generating
vast quantities of data about the daily lives of their users that can be made
readily accessible through apps, wireless networking, Bluetooth connectivity,
radio frequency identification, and global positioning system logging. The po-
tential for ubiquitous collection, generation, analysis and sharing of data raises
new privacy risks and also challenges existing models for protecting privacy.
Daniel J. McBride
Director, Privacy Office
MERCK
1:45 PRIVACY CONSIDERATIONS IN SECONDARY USE OF CLINICAL
DATA
Biotech and pharmaceutical companies collect vast amounts of data for use in
extensive research; the storing of that data for later use poses challenge as well
as controversy. Informed consent allows the signal use of patient level data,
and the ethicality of multiple uses of data comes into question when determin-
ing if secondary uses violate privacy rules and informed consent. Exploring the
instances in which secondary usage of data is reasonable will facilitate discus-
sion amongst executives allowing the determination of how informed consent
plays a role in data privacy.
• Areas of privacy considerations within informed consent documents
• Communicating privacy stipulations to clinical research teams
• Determining where secondary use of data might breach privacy rules
• Ensuring de-identification and anonymization of clinical data
Patricia Hilbrands
Privacy Officer
ARTHREX
2:30 PRIVACY AND PROTECTION OF DATA WHEN WORKING WITH
3RD PARTY PROVIDERS
Ensuring appropriate privacy safeguards surrounding consumer data is a con-
tinued challenge for life science corporations, especially as they evolve into
mobile health applications and partner with developers to further engage and
connect with consumers online. When working with third party vendors, ensur-
ing the privacy and security of data must be at the forefront of importance, and
privacy executives are eager to ensure data is protected. Through thoughtful
front-end communication with third party suppliers that focuses on the need
for privacy and security to ongoing monitoring of suppliers, privacy will be main-
tained and assured.
• Monitoring third-party vendors for privacy rules
• Safe harbor regulatory requirements for privacy
• Protection of clinical and insurance patient data
Gregory Albertyn
Global Privacy Officer
BIOGEN IDEC
3:15 PROGRAM CONCLUSION

4. LIFE SCIENCE TRANSPARENCY REPORTING
DECEMBER 7-8, 2015 DALLAS, TX
500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com
Clarifying Inconsistent Interpretations of Reporting both Monetary &
Non-Monetary Transactions with Healthcare Professionals on a Federal,
State & International Level to Maintain a Risk-Based Approach to
Transparency Reporting & Compliance
TOPICS TO BE ADDRESSED INCLUDE:
KEY SPEAKERS INCLUDE:
CMS PERSPECTIVE ON THE FUTURE OF TRANSPARENCY REPORTING & INITIATIVES TO INCREASE EFFICIENCY
LIMITING COMPLIANCE RISK WHILE STREAMLINING REPORTING AT THE STATE LEGISLATIVE LEVEL
DATA INTEGRITY PANEL: BEST PRACTICES AND LESSONS LEARNED
DEVELOPING EFFECTIVE TRAINING PROCESSES FOR EXECUTIVES REPORTING COLLECTED DATA
MITIGATING COMPLIANCE RISK IN TRANSPARENCY REPORTING
PANEL DISCUSSION: HCP PERSPECTIVES ON TRANSPARENCY REPORTING AND ITS EFFECTS ON THE INDUSTRY
MONITORING EVOLVING INTERNATIONAL REGULATIONS FOR AGGREGATE SPEND REPORTING
PANEL DISCUSSION: CAPTURING INTERNATIONAL SPEND TO ENSURE COMPLIANCE
PANEL: GLOBAL REPORTING SYSTEMS AND PLATFORMS TO STREAMLINE TRANSPARENCY REPORTING
UPCOMING EVENT
Kelly J. Tope
Director of Compliance Operations &
Transparency, US & Canada
ZIMMER BIOMET
John Sheehan
Associate Director, Global Transparency
Change Management Operations
BRISTOL-MYERS SQUIBB
Lee H. Rosebush
Partner
BAKER HOSTETLER
Colleen Martin Roberts
Of Counsel
KRIEG DEVAULT