Grantors & Exhibitors
We thank the following Grantors and Exhibitors for their support in helping to make this conference possible.
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.
Fraud Investigation & Dispute Services, Life Sciences team
Industry insight and global experience: the intelligent connection
Tighter competition, regulatory scrutiny and tough enforcement heighten the risk of litigation and non-compliance. In your industry, compliance issues and risk factors need to be addressed at every turn from research and development to marketing strategies and supply chain integrity. And 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. By making the intelligent connection between your business operations, markets and third-party relationships, we can help you get to the root cause of problems arising from impropriety. Our dedicated team includes CPAs, government contract analysts, economists, licensed pharmacists and certified fraud examiners, as well as former pharmaceutical executives, ethics and compliance officers and government auditors, investigators and prosecutors.
For more information visit www.ey.com/fids or contact Ted Acosta, Principal, Fraud Investigation & Dispute Services +1 212 773 3022 (firstname.lastname@example.org), Mariusz Witalis, Partner, Fraud Investigation & Dispute Services +48 22 557 7950, (Mariusz.Witalis@pl.ey.com), or Rajiv Joshi, Partner, Fraud Investigation & Dispute Services +91 22 61921569 (email@example.com)
The rapidly evolving health care needs of our population, coupled with the development of new markets, present limitless opportunities and an evolving set of challenges for life sciences companies. Whether your company concentrates on pharmaceuticals, medical devices, bioengineering or research, Grant Thornton’s Life Sciences Practice can help. Our comprehensive range of advisory, audit and tax services can help your company achieve a real competitive advantage, now and into the future. Learn more at www.grantthornton.com/lifesciences.
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 operational, financial, and reputational impact. Navigant efficiently integrates the skills of complex data management and analysis with the synthesis of highly complex healthcare transactions, rules, regulations, data, documents and business practices to offer solutions and deliver powerful results.
For more information visit www.Navigant.com or contact Saul B. Helman, M.D., Managing Director, (317) 272.5426.
We are dedicated to providing effective solutions to the complex business challenges facing pharmaceutical and life sciences companies. We’re a network of firms in 157 countries with more than 223,000 people who are committed to delivering quality in assurance, advisory and tax services. For more information, visit www.pwc.com/pharma
The AlixPartners Life Sciences team assists pharmaceutical, medical device, and biotechnology companies, as well as their business partners, through a range of business, compliance, regulatory and transaction-related issues. We leverage industry, operational, and financial expertise to address urgent, high-impact business challenges.
Our multidisciplinary team consists of:
• Professionals who have worked in the industry for several years
• Compliance experts and 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
In today’s fast paced global market timing is everything. You want to protect, grow or transform your business. To meet these challenges we offer clients small teams of highly qualified experts with profound sector and operational insight. Our clients include corporate boards and management, law firms, investment banks, investors and others who appreciate the candor, dedication, and transformative expertise of our teams. We’ll ensure insight drives action at that exact moment that is critical for success. When it really matters.
We support legal, compliance, and investigation executives by providing objective, critical thinking in urgent, high-stakes situations — when it really matters via 25+ offices across North America, South America, Europe, and Asia. For more information visit www.alixpartners.com or contact Yogesh Bahl, Managing Director, +1 (212) 845-4082.
Arnold & Porter Kaye Scholer LLP, an 1000+ lawyer firm with offices in the US, Europe and Asia, 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.apks.com or contact Daniel A. Kracov, Partner, (202) 942-5120.
Our lawyers have acted as trusted advisers to the world’s largest healthcare companies for more than half a century. Among the first firms to provide comprehensive industry advice — covering biopharmaceuticals, medical devices, and healthcare services — we have broad experience and a sophisticated understanding of the global life sciences market that few can match. We help healthcare companies soundly navigate intensifying legal and commercial risks, realize opportunities for expansion and growth, and stay ahead of the innovation curve.
Our international network spans 47 countries, including the largest healthcare markets in the world. Many of our practices — including M&A, Tax, Compliance, Healthcare Regulatory, Employment, Intellectual Property, and Dispute Resolution — are ranked among the world’s leading. Our lawyers have developed a depth of knowledge in the industry in respect of various market players including manufacturers, distributors, research institutions, clinical trial bases and health and regulatory authorities. For more information www.BakerMcKenzie.com.
Berkeley Research Group’s Healthcare practice combines extensive industry expertise with the ability to harness and leverage people, processes, and data to deliver innovative and independent solutions to your most complex problems.
BRG Healthcare experts are keenly aware of the many pressures creating challenges, disruption, and risk in the industry. Ever-changing government regulations, decreasing margins, mounting financial pressures, and increased focus on fraud detection are some of the most pressing. All of this happens in the midst of a rise in healthcare transactions and an industrywide shift to a value-based care delivery model to improve quality and care outcomes.
BRG professionals recognize that while many healthcare organizations are facing similar pressures, each organization is unique. For more information visit www.thinkbrg.com.
For over 40 years, lawyers 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 counsel to more than 1400 public and private life sciences companies across the globe and serve as counsel to more than 50% of the companies on the NASDAQ Biotechnology Index. Cooley has a leading group of health care and life sciences regulatory lawyers 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 900 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.
Covington & Burling LLP offers one of the largest and most comprehensive life sciences practices in the world. We represent biotech, pharmaceutical and medical device companies in the U.S., Europe, Asia and other major and emerging markets. Our lawyers are adept at seamlessly integrating the firm’s extensive regulatory, corporate, policy, competition, intellectual property, litigation, and other expertise to meet the specialized needs of life sciences companies around the world. Our team features numerous alumni of the FDA, HHS and other key regulatory agencies in the US, Europe and Asia, as well as two former general counsels of pharmaceutical companies. We are the only firm recognized by Chambers as a “Band 1” firm for Life Sciences across their U.S., UK, Europe, China and Global surveys. For more information visit www.cov.com.
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.
FTI Consulting, Inc. is a global business advisory firm dedicated to helping organizations manage change, mitigate risk and resolve disputes: financial, legal, operational, political & regulatory, reputational and transactional. With more than 4,600 employees located in 28 countries, FTI Consulting professionals work closely with clients to anticipate, illuminate and overcome complex business challenges and make the most of opportunities. For more information visit www.FTIConsulting.com.
G&M Health, LLC is a health and life-science service company offering compliance management services, computer validation, project management, audits & assessments, aggregate spend services, Corporate Integrity Agreement (CIA) management, training and regulatory support services. G&M was founded by recognized legal and regulatory compliance experts in the healthcare industry, who have worked with and/or advised over 100 pharmaceutical and biotech companies over the last 20 years. Our mission is to be the premier provider of innovative, quality, efficient and compliance-oriented solutions for the healthcare industry.
For more information, visit www.gmhllc.com/new/.
Navigating complexities in the life sciences and healthcare industries is no easy task. Successfully competing in the space requires a partner with a holistic, collaborative approach and a global perspective. It calls for a strategy informed by asking the right questions and rooted in identifying creative solutions to your unique challenges.
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 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.
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 900 lawyers in 19 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.”
For more information about our FDA & Life Sciences practice, please contact Mark Brown at (202) 626-5443. www.kslaw.com
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 transactions, to protecting critical intellectual property, to resolving complicated U.S. healthcare and 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, out of our new São Paulo office, and other emerging markets of Latin America.
More information can be found at www.PaulHastings.com.
Polaris, a QuintilesIMS company, is the world’s leading healthcare compliance software and consulting firm, providing innovative solutions to Life Sciences companies.
Our services range from best-in-class compliance software to expert consulting, planning and strategic guidance from the industry’s leading compliance authorities. Polaris also offers competitive data analytics and end-to-end managed services.
Polaris is headquartered in New York City, with worldwide offices in Amsterdam, Boston, Hong Kong, New Brunswick, Paris and San Francisco.
Since 2001, the world’s most recognized pharmaceutical, biotech and medical device companies have relied on Polaris as their trusted life sciences compliance solutions partner. Learn more at www.polarismanagement.com.
Porzio Life Sciences helps pharmaceutical, medical device and biotechnology companies satisfy federal, state and ex-US marketing and sales obligations. Our best-in-class compliance solutions include: the Porzio Compliance Digest, with real-time databases of enacted laws, pending legislation and government enforcement actions; Porzio AggregateSpendID®, which tracks and reports healthcare provider and organization expenditures; and Porzio GST®, which enables companies to capture and manage data for meeting reporting obligations in almost 40 ex-US jurisdictions. Further, Porzio Life Sciences provides compliance services, such as assistance with acquiring and maintaining distribution licenses. For information, visit www.porziolifesciences.com.
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 transactional department, also allows clients to eliminate the inefficiencies associated with hiring multiple, independent firms.
For more information please visit www.ropesgray.com.
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. Harnessing a breadth of experience, we represent prominent pharmaceutical, biotechnology, medical device, dietary supplements and food clients on a range of regulatory, compliance and enforcement issues. Strong advocacy on behalf of our clients consistently earns our team acknowledgement from industry publications. This includes being named “Life Cycle Firm of the Year” at the inaugural LMG Life Sciences Awards in 2016. 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 seventh consecutive year, and each year since the survey’s inception. In addition, our service and responsiveness earned us recognition in the BTI Industry Power Rankings as a “Most Recommended Law Firm in the Pharmaceutical Industry.”
For more information please visit www.Sidley.com.
With approximately 1,700 attorneys in 22 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.
ACL’s Compliance Management Platform reduces the burden of compliance by helping you manage the end-to-end compliance process. The ACL platform enables you to track and quickly map the requirements that matter most, capture and assign flagged issues for remediation throughout your compliance review, while documenting everything to provide clear automated reporting for the board, management and regulators. Learn more at www.acl.com.
Cutting Edge Information (CEI) is a Market Research Company that specializes in collecting and analyzing global FMV data. To CEI, collecting and analyzing FMV data is not an ancillary function, but our primary function.
Our data approach has been accepted by the majority of the largest pharmaceutical companies, as it reduces regulatory and compliance risk, is customizable, increases HCP acceptance of compensation fairness, and can be delivered in almost any format to meet existing FMV system needs. Our FMV customers currently include over 100 companies, and we are the provider of choice to 2 of the top 5 pharmaceutical companies in the world.
We pride ourselves on exceptional, personalized customer service. We are the FMV data provider of choice for the pharmaceutical industry.
For more information visit www.cuttingedgeinfo.com.
Dayhuff Group, premiere IBM partner, brings the power of IBM Watson’s cognitive computing to the pharmaceutical industry. WatsonARIESD is a full-scale pharmaceutical solution developed to create efficiency in patient safety, signal detection/adverse events management, FDA compliance and more.
IBM Watson has the power to correct unresolved oversights and make pharmacovigilance more effective. The amount of data created is overwhelming, finding the signal in the noise becomes a problem of scale as it is buried under millions of pages taking resources away from productive tasks. Watson is able to dig through millions of data points in a matter of minutes, effectively assisting in signal detection and overall AEM, FDA compliance, discovery, and patient safety.
Specialties include Enterprise Content Management, BI, Analytics and Artificial Intelligence. Dayhuff plans for the categorization, easy access, dispensation and protection of information. Our award-winning solutions leverage the latest Watson technologies to enable new insights for our customers.
More information can be found at www.dayhuffgroup.com
Joining leadership and strategy to achieve tangible results.
Dovetail Consulting Group partners with companies to think through strategy, providing pragmatic advisory solutions rooted in real-world experience. Our team of experts and industry veterans understands what matters to our clients getting advice and deliverables that will actually be utilized and create significant value. We’ve lived it and we’ve done it, and we’re here to support you.
We combine relevant industry experience with consulting discipline and structure. We bring only experts to engagements and accept only work to which we can give our full attention. This focused approach enables us to design and implement the right-sized solution for each client’s needs.
For more information visit firstname.lastname@example.org
Independent Commercial Compliance™ (ICC) is a health care compliance agency focused on promotional compliance related matters in the pharmaceutical industry. At ICC we specialize in Field Sales Force and Speaker Program Monitoring, building tailored processes to ensure effective monitoring solutions. ICC maintains an established infrastructure of over 40 highly experienced professionals geographically dispersed throughout the continental United States to monitor sales and marketing field activities. The geographic dispersion allows for reduced monitoring travel costs and increased client efficiencies, and delivers monitoring for hundreds of live events each year. Further information on ICC can be found at www.independent-commercial-compliance.com, and contact Shawn Reardon of ICC at (908) 370-4085..
Life Science Compliance Update is a monthly publication providing comprehensive, up-to-date compliance information for pharmaceutical, biotechnology, and device manufacturers. Each issue covers important news and analysis, with input from top compliance officers and healthcare attorneys across the industry. For more information visit www.LifeSciCompliance.org.
Through its PharmaCertify™ division, NXLevel Solutions helps life sciences companies reduce risk and build stronger compliance cultures with innovative training products and services. The company’s offerings include the Compliance Foundations™ curriculum of eLearning modules, Compliance QuickTakes™ microlearning modules, custom learning development, and Compliance 365—a cloud-based continuous learning system that drives long-term retention of compliance training through review and reinforcement, gamification, microlearning, and assessment.
For more information, contact Dan O’Connor at 609-483-6875, or visit www.pharmacertify.com.
Potomac River Partners is a specialized management consulting firm focused on compliance for the life science industry.
Our team serves as an extension of your compliance program. We are experts on the laws and regulations, but we don’t provide purely academic or legalistic recommendations. Instead, we listen to your objectives and then implement real change that reduces risk for your organization in a smart, efficient way.
Our core service areas include:
• Policies & Procedures
• Training & Communication
• Auditing & Monitoring
• Aggregate Spend
For additional information, call (703) 430-5944 or visit our website at potomacriverpartners.com.
Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy is a leader in providing healthcare compliance education and training in the U.S., Europe, Latin America, 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 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 J.D., online M.S.J. and LL.M. degree programs, and online Graduate Certificates. The Center 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, bioethics, not-for-profit governance, intellectual property law, and financial services, among other areas.
The Center 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.
VALIDU provides expense reporting compliance and security while reducing or eliminating expense fraud, waste, and abuse. VALIDU’s patent pending technology is the first of its kind to audit activity as it’s occurring rather than after the fact. “Compliance in Motion” is made possible by automating the compliance auditing process to validate onsite event participants via photo, signature and/or proprietary, secure fingerprint identification software. This is achieved using our mobile application and web-based user interface which allows VALIDU to work in real-time with the representative. This means each expensed customer event will be documented within the framework of a living attendance and expense auditing tool. VALIDU software provides a suite for customers to maintain vigilance and transparency over onsite event attendee verification. VALIDU software also provides date/time/GPS/receipt image stamped flattened PDF logs for validated event participants that can be directly emailed to any reporting corporate repository. This makes the integration with pre-existing systems seamless, as well as, streamlining an otherwise arduous expense reporting process for sales representatives. Partnering with VALIDU ensures that the employee spend will meet company compliance and federal regulations while encouraging good business practice in reporting.
For more information visit www.VALIDU.net.
Interested in becoming a Grantor or Exhibiting?
Click Here for more information or contact Justin Sorensen at 206-452-0609.