Huron Life Sciences
Huron Life Sciences serves the continuum of life sciences organizations, from biopharmaceutical to large multinational pharmaceutical companies to device and diagnostic manufacturers and the law and investment firms that support these organizations. Our unmatched expertise and collaborative approach enable us to deliver unique solutions that bridge the process of scientific discovery and sustainable business-model creation with strategies that reduce the risks associated with regulatory and government scrutiny. Huron Life Sciences has helped hundreds of organizations across the globe achieve financial, operational and strategic objectives to drive innovation and, ultimately, deliver value to patients.

Learn more at www.huronconsultinggroup.com/lifesciences or follow us on Twitter: @Huron

Deloitte
You can't predict the future, but you can prepare for a changing market and heightened regulatory landscape. At Deloitte, we help our life sciences clients develop strategies, mitigate risks, and prepare for the future. With over 70 years of industry experience and the innovation, deep understanding, and commitment of over 3,000 professionals, we provide a range of technical and advisory services to help clients transform their organizations. Our approach can deliver strategies that take the shape of your business goals, today and into tomorrow. To learn more, visit www.deloitte.com/us/lifesciences.

EY
About EY's Fraud Investigation & Dispute Services
Dealing with complex issues of fraud, regulatory compliance and business disputes can detract from efforts to succeed. Better management of fraud risk and compliance exposure is a critical business priority -- no matter what the industry sector is. Our more than 3,000 fraud investigation and dispute professionals around the world bring the analytical and technical skills needed to quickly and effectively conduct financial and other investigations and gather and analyze electronic evidence. Working closely with you and your legal advisors, we assemble the right multidisciplinary and culturally aligned team and bring an objective approach and fresh perspective to these challenging situations, wherever you are in the world. And because we understand that you need a tailored service as much as consistent methodologies, we work to give you the benefit of our broad sector experience, our deep subject matter knowledge and the latest insights from our work worldwide.

For more information visit www.ey.com/us/fids.

Navigant
In the complex regulatory environment of today's Pharmaceutical, Biotech, Medical Device and Diagnostics industries, companies and their counsel face an increasing number of dispute, regulatory, compliance and investigation issues that have the potential for significant financial, economic and reputational impact. Navigant is the firm of choice when companies and their counsel need a resource who can successfully and efficiently integrate the skills of complex data management and analysis with the synthesis of highly complex healthcare transactions, rules, regulations, data, documents and business practices to bring meaningful value to the co-development of a dispute, regulatory, compliance or investigation strategy and execution.

For more information visit www.Navigant.com or contact Saul B. Helman, M.D., Managing Director, (317) 228-8726.

PwC
PwC's Pharmaceutical and Life Sciences Industry group is dedicated to delivering effective solutions to the complex strategic, operational, and financial challenges facing pharmaceutical, biotechnology, and medical device companies. We provide industry-focused assurance, tax, and advisory services to build public trust and enhance value for our clients and their stakeholders. More than 195,000 people in 157 countries across our global network of firms share their thinking, experience, and solutions to develop fresh perspectives and practical advice.

For more information, visit www.pwc.com.

AlixPartners, LLP
AlixPartners is a leading global business advisory firm of results-oriented professionals who specialize in creating value and restoring performance at every stage of the business life cycle. We thrive on our ability to make a difference in high-impact situations and to deliver sustainable, bottom-line results.

The AlixPartners Life Sciences team assists pharmaceutical, medical device, and biotechnology companies through a range of business, compliance, regulatory and transaction-related issues. We leverage industry, operational, and economic expertise to address urgent, high-impact business challenges.

Our multidisciplinary team consists of:

• Professionals who have worked in the industry for several years
• Former regulators
• Forensic accounting and investigations experts
• Expert witnesses and litigation support specialists
• Valuation and economic experts
• eDiscovery, data, and technology experts
• Intellectual property experts including certified licensing professionals

Arnold & Porter
Arnold & Porter LLP, an 800 lawyer firm with offices in the US and Europe, is ideally positioned to serve the needs of the Biopharmaceutical and Medical Device community. Our team of more than 50 regulatory and compliance attorneys advise life sciences companies in developing, implementing and refining global compliance programs that address regulatory and enforcement risks confronted at each stage of product research and development, manufacturing, marketing and distribution. We regularly advise companies in matters raising complex compliance issues, developing practical solutions to the challenges associated with conducting clinical trials in jurisdictions with varying healthcare systems, the complexities and risks of pharmaceutical supply chains, interactions with physician and patient populations, managing co-development and co-promotion arrangements, and outsourcing of functions in areas such as research, pharmacovigilance and manufacturing. We also vigorously defend our clients in a broad range of investigations and enforcement matters.

For more information please visit www.arnoldporter.com or contact Daniel A. Kracov, Partner, (202) 942-5120.

Cooley, LLP
For over 40 years, attorneys in Cooley's Life Sciences practice have played an instrumental role in the growth of many of the industry's leading life sciences companies. Our client base includes hundreds of public and private companies, based in the United States and abroad, and spans the full spectrum of industry sectors including pharmaceuticals, R&D, therapeutics, drug delivery, drug formulation, and medical devices and technologies.

We deliver an unparalleled combination of innovative legal expertise, deep industry knowledge and practical understanding of our clients' business needs. Cooley is widely recognized as a leading law firm in life sciences and was ranked Law Firm of the Year in Biotechnology by US News & World Report - Best Lawyers "Best Law Firms" in the first year the category was awarded. Cooley has a leading group of health care and life sciences regulatory attorneys who understand the challenges and opportunities facing the industry. In an environment filled with an increasing number of evolving laws and regulations, our team has the depth of experience necessary to navigate the ever changing rules of the marketplace for providers, manufacturers, suppliers, payors, technology companies and investors in this space.

Cooley has 850 lawyers across 12 offices in the United States, China and Europe. We have an entrepreneurial spirit, deep substantive experience, and a commitment to solving clients' most challenging legal matters.

For more information, please visit www.cooley.com.

Davis Wright Tremaine
Those of us in the Davis Wright Tremaine health care practice group devote nearly all of our time to industry-specific matters. This allows us to develop niche practices within the field that serve needs unique to the health care market. We also understand the business issues and regulatory developments that affect health care delivery and compliance, and as a unified team we can match the attorney with the niche expertise that best addresses client needs. For more information visit our website at www.DWT.com.

Grant Thornton's Life Sciences/Pharmaceutical Practice
Grant Thornton provides audit, tax and advisory services to the life sciences/pharmaceutical industry, a sector of strategic focus for our firm. Our experience includes working with both large and small life sciences companies giving us a thorough appreciation for what companies need to execute their growth strategies. This translates into well-informed ideas and proven solutions that are relevant.

The people in the independent firms of Grant Thornton International Ltd provide personalized attention and the highest-quality service to public and private clients in more than 100 countries. Grant Thornton LLP is the U.S. member firm of Grant Thornton International Ltd, one of the six global audit, tax and advisory organizations. Grant Thornton International Ltd and its member firms are not a worldwide partnership, as each member firm is a separate and distinct legal entity. In the United States, visit Grant Thornton LLP at www.GrantThornton.com/lifesciences.

HealthCare Appraisers
HealthCare Appraisers provides a full spectrum of valuation services and Fair Market Value solutions exclusively for the healthcare and life sciences communities:

• U.S. and Global Valuation Services - Compensation arrangements for HCPs and KOLs; intellectual property; royalty and licensing arrangements; marketing programs; clinical trials arrangements; data acquisition and sales; and business valuations
• U.S. and Global Consulting Services - Non-traditional HCP compensation programs; enterprise-wide acceptance of standardized FMV ranges; exception policies and guidelines for HCP compensation; data acquisition analyses and remuneration (credits); multi-company integration of intellectual property; mergers and acquisitions advisory; and optimal capital structure analyses

Hogan Lovells
With more than 350 lawyers around the world focused on serving the life sciences industry, Hogan Lovells offers knowledgeable, timely and effective counsel on legal issues affecting how life sciences companies conduct business. Our multidisciplinary team has country- and region-specific experience in the US, Europe, Asia and Latin America with pharmaceuticals (Rx and OTC), biologics, medical devices, food products, and cosmetics. Our regulatory, corporate, litigation and intellectual property practices collaborate to provide advice that is strategic, integrated and practical.

Our global presence and deep industry knowledge allow us to help clients successfully develop and commercialize products by addressing regulatory and business issues, such as obtaining approval and managing product life cycles; addressing coverage, reimbursement, and pricing considerations; and maintaining post-approval compliance in product promotion, manufacturing and pharmacovigilance. High rankings in Chambers and other global directories year to year speak to the quality and effectiveness of our work.

For more information visit www.hoganlovells.com.

IMS Health
IMS Health is a leading global information and technology services company providing clients in the healthcare industry with comprehensive solutions to measure and improve their performance. Drawing on information from 100,000 suppliers, and on insights from more than 55 billion healthcare transactions processed annually, IMS Health's approximately 10,000 employees drive results for healthcare clients globally. Customers include pharmaceutical, consumer health and medical device manufacturers and distributors, providers, payers, government agencies, policymakers, researchers and the financial community.

IMS Health's AggregateSpend360 is a proactive, web based solution for disclosure and transparency compliance. AggregateSpend360's automated reporting and out-of-the-box report templates make it easy to comply with transparency regulations in the U.S. and globally. Trusted by more than 60 companies globally, this market-leading solution is fully supported by a team of industry leaders in compliance, legal research, product development, implementation, and support that guide you along in the complex, changing world of transparency.

For more information, visit www.IMSHealth.com.

King & Spalding
Celebrating more than 125 years of service, King & Spalding is an international law firm that represents a broad array of clients, including half of the Fortune Global 100, with 800 lawyers in 17 offices in the United States, Europe, the Middle East and Asia. The firm has handled matters in over 160 countries on six continents and is consistently recognized for the results it obtains, for uncompromising commitment to quality and for dedication to understanding the business and culture of its clients. King & Spalding was recently chosen by U.S. News & World Report and Best Lawyers as the "Law Firm of the Year" for FDA law and LMG Life Sciences selected the firm as one of the finalists for "Regulatory Firm of the Year" in 2015.

For more information about our FDA & Life Sciences practice, please contact Mark Brown at (202) 626-5443 or visit www.kslaw.com.

Paul Hastings
Paul Hastings provides innovative compliance and legal solutions to many of the world's top pharmaceutical and life sciences companies, large and small, in markets across Asia, Europe, Latin America, and the United States. We offer a complete portfolio of services to support our clients' complex, often mission-critical needs--from structuring first-of-their-kind transactions, to protecting critical intellectual property, to resolving complicated global anti-corruption enforcement matters, to providing the savvy compliance and legal counsel that keeps business moving forward.

Paul Hastings has grown steadily and strategically along with our clients across global markets in the critical pharmaceutical and life sciences sector. We have a significant and strategic presence across Europe, and were one of the first U.S. law firms to establish a presence in Asia, where we continue to be a leader in the region, and have significantly expanded our support for clients in Brazil and other emerging markets of Latin America.

More information can be found at www.PaulHastings.com.

Polaris
Polaris helps Pharmaceutical, Biotech, and Medical Device Companies to be compliant with laws and regulations in- and outside the US. We provide a best in class compliance technology platform. With offices in Europe and the US, and a team over 225, we are the largest global compliance technology provider.

The world's largest life sciences companies rely on us to achieve their health care compliance goals, to add value to their bottom lines and to always know what's next. With proven global expertise in providing insightful consulting, strategic business process optimization and technology solutions, Polaris is the world's leader in innovative, end-to-end compliance solutions for life sciences companies. Only Polaris specializes exclusively in consulting and technology solutions for life sciences healthcare law compliance so we are uniquely positioned to assist our customers to increase efficiency, mitigate risk and improve patient safety.

For more information, please visit: www.polarismanagement.com.

Porzio Life Sciences
Porzio Life Sciences, LLC (PorzioLS) provides the life sciences industry with Internet-based products enabling companies to comply with marketing and sales federal and state laws and regulations, as well as, distribution licensing, sampling and a growing body of state life sciences compliance requirements. PorzioLS provides compliance tools and customized services, related to the PDMA, anti-kickback statutes, aggregate spend reporting, OIG and CMS guidances, OPDP promotional violations, False Claims Act and FDA regulations, such as the Porzio Compliance Digest and Porzio AggregateSpendID®, a best in class aggregate spend system capable of handling state and federal transparency reporting and dispute resolutions, in addition to sample transparency reporting.

Porzio AggregateSpendID® is nearing completion of the latest release of the system, Version 5, which streamlines transaction flow, improves user experience with more visibility of the data and has upgraded the underlying architecture of the application for current and future reporting requirements. Porzio AggregateSpendID® continues to streamline state and federal marketing disclosures by automating the collection and accurate reporting of expenses directed to healthcare practitioners and organizations.

The Porzio Compliance Digest (PCD) is the first interactive, Internet-based compliance database on state, federal and international laws, regulations and pending legislation. The completely redesigned PCD includes new system features such as benchmark polling, user-friendly navigation and interactive, color-coded maps to track active legislation. Comprised of ten distinct databases, the PCD covers drug and device distribution licensing, transparency legislation, sample and trade product distribution, and trends in government investigations.

Through our Distribution Licensing Services, we identify and attain all required licenses based on a company's unique distribution model. Finally, our formula-based approach to sample accountability, Significant Loss Threshold Assurance, ensures that customers neither over or under report sample losses.

The International Life Sciences Transparency Database contains invaluable guidance on ex-US disclosure obligations pertaining to HCP, HCO and PO payments and provides information on laws and codes related to: transparency reporting requirements, limitations or prohibitions on financial interactions with healthcare providers and organizations, anti-bribery or anti-corruption, data privacy, and company compliance programs related to interactions with healthcare providers.

Porzio GST™ is a Provider Management Simplified solution, focused on Global Spend Transparency, with an easy-to-use and configurable interface that will enable companies to capture and manage the data elements that are necessary for meeting their reporting obligations in ex-US countries. In June 2015, system enhancements including increased system speed and functionality, easily facilitates data collection and transparency reporting from Japan, Australia and all European jurisdictions.

These compliance tools and customized services facilitate companies' compliance with US and ex-US marketing and sales regulations, which has propelled PorzioLS into an industry leader in life sciences marketing and sales compliance.

Strengthen your compliance program today by visiting www.porziolifesciences.com or contacting us 877-477-7411.

Ropes & Gray
We routinely advise clients on developing effective compliance policies to avoid the debilitating effects of government investigations, regulatory enforcement actions, or other litigation based on alleged noncompliance with applicable laws and regulations. Our command of FDA regulatory, health care compliance, research compliance and global anti-corruption issues is critical for clients operating in these highly regulated industries. For companies that are the subject of government investigations, our understanding of the government enforcement landscape enables us to defend complex proceedings involving simultaneous civil, criminal and administrative actions.

This depth and breadth of experience, coupled with our interdisciplinary team of leading regulatory, health care compliance, research compliance, government enforcement, and anti-corruption attorneys, has established us as the "go-to" firm when it comes to avoiding and successfully resolving government investigations. Our integrated practice, including our corporate department, also allows clients to eliminate the inefficiencies associated with hiring multiple, independent firms.

For more information please visit www.ropesgray.com.

Sidley Austin
Sidley Austin LLP is a premier law firms with an internationally recognized life sciences practice, representing major pharmaceutical, biotechnology, medical device, dietary supplements and food clients. Many lawyers in our team are acknowledged leaders in healthcare, privacy, data security and information law. Sidley consistently ranks among the top firms in Asia, Europe and the U.S., and was recently named a “Life Cycle Firm of the Year” by LMG Life Sciences Awards 2014. We also received first-tier national rankings in Biotechnology Law, FDA Law and Healthcare Law in the U.S. News - Best Lawyers "Best Law Firms" rankings for the fifth consecutive year, and each year since the survey's inception. Sidley is also recognized for service and responsiveness, having been once named the "Most Recommended Law Firm in the Pharmaceutical Industry" in the BTI Industry Power Rankings.

For more information visit www.Sidley.com or contact Scott Bass, (202)736-8684 and James Stansel, (202) 736-8092.

Skadden
With approximately 1,600 attorneys in 23 offices in the United States, Europe, Asia and Latin America, Skadden serves a broad range of clients in all sectors of the health care industry, including pharmaceuticals and medical technology. The firm represents pharmaceutical and medical technology clients at every stage of a company's development, from initial public offering to global M&A and corporate finance; and all manner of litigation and regulatory matters, including government investigations, mass torts and product liability litigation, intellectual property counseling and patent litigation, and FDA and health care compliance. Skadden has assisted many companies in developing and implementing global anti-bribery and anti-corruption compliance programs and represented numerous companies in related government investigations. For more information, visit www.skadden.com.

WLH Consulting, Inc.
WLH Consulting, Inc. partners with biopharmaceutical and medical device companies to provide comprehensive compliance solutions.

Services include:

• Define compliant behavior expectations
• Assess current commercial compliance systems, processes and tools
• Design Field Based Monitoring processes to ensure compliant healthcare practitioner
• interactions with "closed loop" follow-up and real time reporting
• Develop learning solutions that drive behavioral change
• Provide Compliant Documentation Blended Learning Solution
• Prepare SOPs and Guidance for Commercial Functions

Berkeley Research Group
BRG Healthcare experts work with health plans and insurers, life sciences companies, health providers, and their counsel to develop objective, data-driven, and innovative answers to their most complex questions. We offer a full array of financial and reimbursement advisory, corporate compliance and risk management, dispute, litigation and investigation support, and expert testimony services and have the agility to assemble teams with specific, nuanced talent needed to address a particular issue.

For more information visit www.thinkbrg.com.

BMI SYSTEM
Through the creation of bespoke solutions for the pharmaceutical, medical device and cosmetic industries, BMI SYSTEM is the leader in providing software solutions dedicated to transparency and regulatory compliance. Beyond BMI SYSTEM's extensive experience in the IT sector, the team possesses in-depth knowledge of the healthcare industry, which allows us to deliver best-of-breed business and technical solutions. For more information visit www.BMI-SYSTEM.com.

FTI Consulting
FTI Consulting, Inc. is a global business advisory firm dedicated to helping organizations protect and enhance enterprise value in an increasingly complex legal, regulatory and economic environment. FTI Consulting professionals, who are located in all major business centers throughout the world, work closely with clients to anticipate, illuminate and overcome complex business challenges in areas such as investigations, litigation, mergers and acquisitions, regulatory issues, reputation management and restructuring. For more information, visit www.fticonsulting.com/hc or contact Jayson Dukes, Senior Managing Director, at (212) 499-3644.

NXLevel Solutions
NXLevel Solutions, through its PharmaCertify™ brand, provides off-the-shelf and custom commercial compliance eLearning, mobile applications, data-driven communication portals, curriculum analysis, and live training workshops to the pharmaceutical and medical device industries. PharmaCertify™ solutions offer practical, real-world compliance knowledge, delivered in balance with the training goals and objectives of your entire organization. Our subject matter expertise covers the critical areas of risk for life sciences staff, including the Sunshine Act; on-label promotion; adverse events; federal and state regulations; speaker programs; and gifts and meals.

For more information about our compliance training products and services, or to see a demo, visit www.pharmacertify.com or contact Sean Murphy at 609-466-2828 ext. 25.

PleaseTech
PleaseTech specializes in collaborative document review and co-authoring solutions designed to transform the key business process of producing compliant, quality documents. PleaseTech's flagship product, PleaseReview™, enables Microsoft Word and other document types to be co-authored and reviewed in a collaborative, controlled and secure environment. PleaseReview is used extensively by Life Science organizations and provides its customers with a valuable process enhancement that demonstrably saves them time and money whilst giving their users access to extensive, easy-to-use functionality.

Benefits include:

• Simultaneous, secure access to the same document(s) for multiple participants.
• Complete management and control over the document and review process.
• Extensive functionality including automated comment and change consolidation.
• Full accountability and traceability with its comprehensive reporting capabilities.
• Can be seamlessly integrated with leading document and content management platforms.

Policy and Medicine | Life Science Compliance Update
Your go-to sources for analysis and synthesis of legal, regulatory and compliance issues impacting the life science industry. Visit us at: policymed.com and lifescicompliance.com.

Potomac River Partners
Potomac River Partners is a specialized management consulting firm focused on healthcare compliance. We offer comprehensive consulting and training services focused on helping clients mitigate risk, improve transparency and strengthen organizational compliance. Our clients include some of the largest global pharmaceutical companies, small and mid-sized firms in the biotech and medical device sectors, as well as service providers for the life science industry such as contract sales organizations and logistics suppliers.

Our core service areas include:

• Policies and Procedures
• Training & Communication
• Auditing & Monitoring
• Aggregate Spend

The Red Flag Group
The Red Flag Group is a global integrity and compliance firm. We apply our unique set of advice, technology and business intelligence applications to effectively manage the integrity and compliance risks of our customers and any third parties that they engage or manage. We focus on managing the four major risk areas of customers, sales, suppliers and human capital amid the ever-changing regulatory landscape. Our suite of services comprises tailored project advisory, due diligence covering more than 190 countries, and technology solutions. Together these help companies turn compliance into a competitive advantage.

For more information visit www.redflaggroup.com.

Seton Hall Law's Center for Health & Pharmaceutical Law & Policy
Seton Hall Law's Center for Health & Pharmaceutical Law & Policy advances scholarship and recommendations for policy on the varied and complex issues posed by health and pharmaceutical law. As a nationally ranked Health Law program, the Center fosters informed dialogue between policymakers, consumer advocates, the medical profession, and industry in the search for solutions to the ethical, legal and social questions presented in the health and pharmaceutical arena.

In addition, the Center is a leader in providing healthcare compliance education and training in the U.S., and Europe and Asia-Pacific on national and international mandates that apply to the safety and promotion of drugs and devices. The Center also hosts conferences and educational programs, inviting leading experts from the public and private sectors to examine cutting edge policy issues.

Launched in April 2007, the Center extends Seton Hall Law School's national reputation in health law to the life sciences arena and offers a challenging health law curriculum through its M.S.J., J.D. and LL.M. degree programs, and online Graduate Certificates, and online M.S.J. The Center operates under the leadership of a full-time Executive Director, Simone Handler-Hutchinson, and draws upon the intellectual strength of the Seton Hall Law School faculty and research fellows who bring to the Center's work nationally recognized expertise in health and pharmaceutical law, not-for-profit governance, intellectual property law and bioethics, among other areas.

For further information or inquiries about the Center and its varied programs, please visit the website at law.shu.edu/CenterforHealth and law.shu.edu/compliance, or contact Simone Handler-Hutchinson, Executive Director of the Center.

The Society of Corporate Compliance & Ethics (SCCE)
The Society of Corporate Compliance & Ethics (SCCE) is a non-profit, pan-industry association dedicated to improving the quality of corporate governance, compliance and ethics.

Our magazine and e-newsletter can keep you informed about how to manage the latest issues. Come to our conferences to build out your network and hear directly from other professionals, at a discounted, members-only rate. The Compliance Academies can provide you with intensive training in the essentials of managing a compliance and ethics program. They are also excellent training for obtaining the Certified Compliance and Ethics Professional (CCEP) designation.

Can't travel? Our online social network (http://community.corporatecompliance.org) provides you with online interaction with thousands of compliance and ethics leaders around the world. Or try a web conference to learn right from your desk. To learn more about the SCCE, visit us at www.corporatecompliance.org, and join more than 4,500 other professionals who are already members of the SCCE.