Grantors & Exhibitors

EY

Tighter competition, regulatory scrutiny and tough enforcement heighten the risk of litigation and non-compliance. In the life sciences industry, compliance issues and risk factors need to be addressed at every turn, from research and development to marketing strategies and supply chain integrity, while the scrutiny of regulators and customers alike is increasing and rapidly changing. Our professionals understand the complex issues facing pharmaceutical, biotechnology and medical device companies. We have established experience helping companies evaluate and manage those aspects of their businesses that pose the greatest potential risks. Our dedicated team includes CPAs, certified fraud examiners, licensed pharmacists, former pharmaceutical executives, ethics and compliance officers as well as government auditors, investigators and prosecutors. For more information, please contact Tom Gregory, Global & US Leader, Health & Life Sciences, EY Forensic & Integrity Services, at (404) 817-5205 or tom.gregory@ey.com.

CHOATE

Deloitte

We are committed to helping our clients solve their most complex issues. Deloitte Risk and Financial Advisory professionals help our clients view change as opportunity for innovation and strategic movement. From threats that require immediate mitigation, to operational uncertainties, and everything in between, we focus on the full continuum and constantly innovate to see risk in its many dimensions. At Deloitte, we help our clients lead, navigate, and disrupt through complexities, to create a strategic advantage and accelerate performance. For more information, Click Here.

Guidehouse

IQVIA

IQVIA is a leading global provider of information, innovative technology solutions and contract research services dedicated to using analytics and science to help healthcare stakeholders find better solutions for companies and patients. Representing 200 life sciences companies and more than 350,000 reps and HCPs, IQVIA Commercial Compliance has seen more challenges, solved more problems, implemented more solutions and managed more meetings and engagements than any other company.

For more information visit www.IQVIA.com.

AlixPartners

AlixPartners is a results-driven global consulting firm that specializes in helping businesses respond quickly and decisively to their most critical challenges – from urgent performance improvement to complex restructuring, from risk mitigation to accelerated transformation. These are the moments when everything is on the line – a sudden shift in the market, an unexpected performance decline, a time-sensitive deal, a fork-in-the-road decision. We stand shoulder to shoulder with our clients until the job is done, and only measure our success in terms of the results we deliver. We partner with you to make the right decisions and take the right actions. And we are right by your side. When it really matters.

For more information visit www.AlixPartners.com.

Baker McKenzie

Baker McKenzie has extensive experience in the complex and fast-paced world of life sciences, advising and representing clients from startups to multi-nationals throughout a product’s life cycle. Our lawyers have served as trusted advisors to some of the world’s leading life sciences companies for over 50 years.

Strategic alliances and other life sciences transactions are critical for development and commercialization. We work with clients on cutting edge and dynamic collaboration, licensing, regulatory, M&A, joint venture, divestiture and other strategic transactions for the research, development and commercialization of biopharmaceutical and medical device products and technologies.

Our regulatory team has extensive experience in navigating the complex regulatory landscape of the retail, cosmetics, nutritional, pharmaceutical and medical device, generic products, and food and consumer packaged goods sectors. We work extensively with clients on their internal compliance issues and programs and are forward thinking and vigilant, staying abreast of applicable laws and regulations to provide clients current and forward-thinking advice and counsel across a broad range of issues.

For more information, visit www.BakerMcKenzie.com.

BRG Healthcare

Berkeley Research Group is a leading global strategic advisory and expert consulting firm that provides independent advice, data analytics, valuation, authoritative studies, expert testimony, investigations, transaction advisory, restructuring services, and regulatory and dispute consulting to medical technology and pharmaceutical companies, providers, insurers, and counsel. BRG healthcare corporate compliance and risk management professionals have experience with C-suite corporate compliance, government enforcement, and advanced transactional data analysis; and a strong understanding of the operational, technical, and legal challenges that our clients must address.

BRG professionals provide innovative, data-driven, cost-effective, and practical solutions to enhance operational efficiency, inform business decision making, and address and remediate key legal risks proactively. An important building block is our understanding of how healthcare organizations operate and interact with stakeholders in the healthcare continuum. Our reports and findings have been used to resolve critical business, regulatory, and legal challenges.

For more information visit www.thinkbrg.com.

Cutting Edge Information (CEI)

Craig B. Bleifer

The most successful companies integrate their business priorities with legal and compliance strategies and well-informed risk management. Well-documented choices, robust legal and compliance policies, training and systems protect the enterprise and engage employees. Competitive opportunities can also be obtained by closely analyzing the law and regulations, current enforcement realities, and industry best practices.

The firm leverages the extensive in-house experience of Craig Bleifer, who is is the former general counsel for Novo Nordisk, Inc., and previously was the general counsel for Daiichi Sankyo, Inc., and served as Counsel at Porzio, Bromberg & Newman. He is now the Principal of Craig B. Bleifer, LLC, a law and consulting practice focused on advising and counseling clients on healthcare industry topics. Craig has over 20 years’ experience in the US and Global healthcare industry and nearly 30 years as an attorney. He is the Past Chair, PhRMA Law Section Executive Committee, and Past Chair, Healthcare Institute of New Jersey. He has been awarded General Counsel of the Year by NJBIZ, and was awarded In-House Legal Department of the Year by New Jersey Law Journal.

For more information please visit: www.CraigBleifer.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.

Dinsmore

Helio Health Group

Helio Health Group specializes in providing consulting and data science services to clients within the life sciences industry. Helio works with clients across all stages of development from established global pharmaceutical companies to new, burgeoning gene therapy companies. Helio works with key stakeholders to provide strategic and operational compliance insights. Helio’s experts assist commercial, medical, and patient services teams with our deep industry consulting experience coupled with unique small data engineering techniques.

Helio frequently conducts risk and gap assessments to analyze the current state of our clients’ compliance operations including, but not limited to, a thorough review of process designs, system configurations, workflows, documentation, and HCP and patient touchpoints – with patient services being a major area of concern due to recent regulatory scrutiny. Upon completion of such an assessment, Helio develops business and/or technical requirements and roadmaps to provide guidance on how to augment and operationalize the company’s compliance and strategic initiatives. Helio also implements desired program enhancements and serves as a Project Management Office (PMO) and strategic advisor throughout the implementation. Other areas of compliance consulting assistance include monitoring and auditing, transparency strategy, validation and reporting services, and patient services programs and data privacy.

Helio recently launched its automated compliance monitoring tool (HelioPDR) to assist clients with (P)lanning, (D)etecting, and (R)esponding to compliance threats in this new normal of traditional and virtual activities. Helio utilizes a next-generation Natural Language Processing (NLP) infrastructure to automatically collect data from numerous systems and analyze the data in real-time. This helps to identify compliance patterns over time, pinpoint potential problems, and form effective solutions, all while increasing efficiency. HelioPDR takes a deeper look at areas such as travel and expense meals data, medical information requests, speaker programs, consulting arrangements, patient services interactions, commercial / HCP interactions, and email monitoring. Please contact us for a demo at info@heliohealthgroup.com.

For more information visit www.heliohealthgroup.com.

Hogan Lovells

Navigating complexities in the life sciences and health care industries is no easy task. Successfully competing in the space requires increasingly creative strategies and integrated solutions that protect and support your business day in and day out.

For life sciences innovators of all sizes, anywhere in the world, Hogan Lovells is that partner — from cutting-edge start-ups and boutique venture funds to world-renowned research institutions and health systems to global biopharmaceutical conglomerates.

Your business and your challenges don’t stop for oceans or disappear at national borders. Neither does Hogan Lovells. Our team of 500 life sciences and health care lawyers is located around the world but operates as if everyone is working from the same office — providing a seamless experience everywhere you do business.

And no matter the challenge — from creation to commercialization of a life-saving therapy, regulatory compliance to an international patent dispute, the formation of a strategic alliance to a complex, global merger — we’ve been there before and we understand how to prepare you for what happens next, helping you to anticipate risks and address future issues before they arise.

Learn more at www.hoganlovells.com/life-sciences or follow us on LinkedIn and Twitter.

King & Spalding

Celebrating more than 130 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 over 1100 lawyers in 20 offices in the United States, Europe, the Middle East and Asia. King & Spalding knows the pharmaceutical and medical device industry—the technologies, products and business models. Our attorneys and consultants provide sophisticated counsel to our clients in a wide range of areas, including fraud and abuse, compliance, intellectual property, regulatory, transactional, policy and litigation matters. We are a premier firm ranked by Law360 (Life Sciences “Practice Group of the Year” in 2016-2018), U.S. News & World Report (“Law Firm of the Year” for FDA Law in 2017), LMG Life Sciences, Chambers USA and The Legal 500.

For more information, please visit www.kslaw.com/capabilities/life-sciences-and-healthcare.

Lextegrity

Lextegrity provides in-house counsel, audit and compliance teams at multinational companies with next generation compliance software to help prevent and detect corruption, kickbacks, fraud and conflicts of interest in their global operations. From pre-approval of high risk expenditures through continuous monitoring of spend data, our Integrity Gateway platform consolidates disparate compliance processes and uses data and machine learning to provide informed risk insights.

Leading pharma, biotech and medical device firms use Lextegrity’s platform to handle complex life science compliance needs, from HCP Engagements and Sponsorships to Cross-Border Approvals and Annual Needs Assessments.

For more information visit www.lextegrity.com.

MediSpend

MediSpend, a global technology company providing best-in-class transparency reporting and compliant HCP engagement software solutions for the life sciences industry, is the compliance system of record for some of the world’s largest pharmaceutical, medical device, dental and emerging biotech companies. Developed by our innovative team, the MediSpend Compliance Suite represents the industry’s first global SaaS solution designed to manage the end-to-end process of HCP engagement to transparency reporting, facilitating compliance with global healthcare laws while streamlining business processes. MediSpend is headquartered in Portsmouth, N.H., with offices in Minnesota, New York and Pennsylvania.

Visit MediSpend online at www.medispend.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 – across global markets. The firm has grown steadily and strategically along with our clients and has an established presence in Asia, Europe, and Latin America. We continue to be a leader in these regions, and in the last few years have significantly expanded our support for clients in Brazil and other emerging markets of Latin America.

Paul Hastings offers a complete portfolio of services to support our clients’ complex, often mission-critical needs—from tackling among the most significant global, anti-corruption enforcement matters and resolving complex U.S. healthcare investigations, to structuring first-of-their-kind transactions, to protecting critical intellectual property, to advising on unique data governance issues, IoT development and roll-out, and proactive privacy/cybersecurity assessments, to providing the savvy compliance and legal counsel that keeps business moving forward.

For more information visit www.PaulHastings.com.

PharmaCertify by NXLevel Solutions

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Through its PharmaCertify™ division, NXLevel Solutions helps life sciences compliance professionals reduce risk and build stronger compliance cultures through training. We are not compliance consultants who happen to develop training and we are not trainers who dabble in compliance. We are training experts who live and breathe the world of life sciences compliance.

Our offerings include the Compliance Foundations™ curriculum of eLearning modules, the Compliance Reality Challenge workshop, microlearning modules, and custom learning development. For more information, contact Dan O’Connor at 609-483-6875, or visit www.pharmacertify.com.

Porzio Life Sciences

Porzio Life Sciences provides compliance tools, timely information and customized services related to the PDMA, anti-kickback statutes, aggregate spend reporting, dispute resolutions, OIG and CMS guidances, OPDP promotional violations, False Claims Act and FDA regulations to enable life science companies to comply with federal, state and global marketing and sales.

For more information visit www.pbnlaw.com.

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 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, compliance, litigation, government enforcement, and anti-corruption attorneys, has established us as the “go-to” firm when it comes to avoiding and successfully resolving litigation and government investigations. Our integrated practice, including our corporate transactional department, also allows clients to eliminate the inefficiencies associated with hiring multiple, independent firms.

For more information please visit www.ropesgray.com.

Sidley

Sidley’s global life sciences practice comprises a team of multidisciplinary lawyers with a deep understanding of the issues innovators face—from the science and technology to the business realities. We tackle the hardest problems and offer solutions that account for not only the direct risk but also the substantial relational capital at stake. Harnessing our breadth of experience, we represent prominent pharmaceutical, biotechnology, medical device, dietary supplements, life sciences investors and food clients on a range of regulatory, compliance and enforcement issues. The Life Sciences group is consistently ranked highly in Chambers across the Global, United States, Europe and Asia regions. For more information, please visit www.Sidley.com.

Skadden

With approximately 1,700 attorneys in 22 offices in the Americas, Europe and Asia Pacific, Skadden serves a broad range of clients in all sectors of the health care industry, including pharmaceutical, biotechnology and medical device companies; hospital and health care systems; and long-term care facilities. The firm advises on the full spectrum of corporate matters, including acquisitions, financings and restructurings; 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.

Potomac River Partners

Potomac River Partners is a mid-sized management consulting firm specializing in compliance services for the life sciences sector. The firm was established in 2006 by Jon Wilkenfeld on the premise that high quality consulting should be focused on creating value for clients. Potomac River Partners delivers clear, practical recommendations and implements real world solutions.

We rely on smaller, dedicated teams focused on compliance. By specializing in compliance, we can be more efficient than other consulting firms. We bring our technical expertise to help our clients clearly and concisely distill complex rules and regulations and reduce risk.

Clients turn to us because they trust us to get things done. Our clients know that compliance must be effective to survive and thrive in today’s highly regulated, dynamic environment.

Ultimately, the work we do is more than complying with regulations. It’s about helping clients operate in an ethical manner. Our work helps reduce exposure to risk, improve performance, and ultimately influences corporate reputation.

Potomacriverpartners.com

Qordata

Qordata is an all-in-one data analytics and integration start-up hustling across life sciences industry to provide meaningful solutions for ensuring regulatory compliance. We provide easy-to-use Transparency Reporting, Analytics and Compliance Monitoring solutions. Our partnerships with SAP Concur for automated transfer of T&E data from Concur and MedCompli for smooth HCP engagement, have further enabled our products to be a one-stop solution for all needs of compliance professionals.

Rockpointe Corporation

Founded in 1995, Rockpointe Corporation is a science-based medical education company whose clinical specialists, educators, and producers are dedicated to the design and implementation of integrated, certified educational initiatives that are engaging and clinically relevant to health care professionals.

Working in collaboration with clinical experts, professional societies, and government agencies, Rockpointe’s scientists, physicians, editors, managers, and medical education specialists are passionate about designing and delivering programs in which medical science and clinical need converge. Rockpointe utilizes a consistent approach to CME planning, beginning with a complete assessment and clinical practice gap analysis, designed to clearly define educational need. This process leads to the development of a comprehensive and flexible education plan, which rapidly responds to changes in science and the marketplace.