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Associate Members

 

All 2018 new members are indicated with an asterisk (*)

Associate Members

Law Firms Insurance Consulting Groups
Akin Gump Strauss Hauer & Feld LLP Medmarc Accenture
Arnold & Porter LLP   Avalere Health LLC
Hogan Lovells US LLP Educational Services Berkeley Research Group, LLC (BRG)
King & Spalding UL EduNeering Cognizant Technology Solutions
Latham & Watkins LLP   Deloitte & Touche LLP
Reed Smith LLP Employment Services L. E. K. Consulting LLC
Sidley Austin LLP Korn Ferry Novasyte, LLC
    Porzio Life Sciences, LLC
Business Intelligence Supply Chain Management PRIA Healthcare
IQVIA Global Healthcare Exchange (GHX) PricewaterhouseCoopers LLP
  FedEx Services IQVIA
Accounting/Tax Services Quality Management Regulatory and Quality Solutions LLC
Baker Tilly Vichow Krause, LLP MasterControl Inc. Russell Reynolds Associates
Grant Thornton LLP Sparta Systems, Inc. UL LLC
     

Akin Gump Strauss Hauer & Feld LLP

Akin Gump Strauss Hauer & Feld LLP is a leading international law firm. From capitalization through postmarket representation, health care policy and legislative strategy, we work with clients to ensure that their global regulatory strategies and legislative interests are aligned to maximize opportunities for coverage and reimbursement, entry into new markets and further research and development.

Contact: Nathan A. Brown, Partner, Akin  Gump Strauss Hauer & Feld LLP

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Accenture

Accenture is a global management consulting, technology services and outsourcing company, with more than 358,000 people serving clients in more than 120 countries. Combining unparalleled experience, comprehensive capabilities across all industries and business functions, and extensive research on the world’s most successful companies, Accenture collaborates with clients to help them become high-performance businesses and governments. The company generated net revenues of US$31.0 billion for the fiscal year ended Aug. 31, 2015.

Contact: Doug Mowen, Managing Director

View our white papers

Disrupt or Be Disrupted: Prescriptions for life sciences in the age of digital medicine

Accenture Technology Vision 2015 for Life Sciences

Patient Services: Pharma’s Best Kept Secret

Breaking free from the cost-cutting cycle in the life sciences industry

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Arnold & Porter LLP

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 on addressing the risks confronted at each stage of product research and development, manufacturing, marketing, sales and distribution. We routinely advise companies on the implementation and enhancement of global compliance programs, and vigorously defend our clients in a broad range of investigations and enforcement matters.  

Contact: Daniel A. Kracov, Partner and Co-Chair, FDA & Healthcare Practice, or Allison Shuren, Partner and Co-Chair, FDA & Healthcare Practice

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Avalere

Avalere is a vibrant community of innovative thinkers dedicated to solving the challenges of the healthcare system. We deliver a comprehensive perspective, compelling substance, and creative solutions to help you make better business decisions. As an Inovalon company, we prize insights and strategies driven by robust data to achieve meaningful results.

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Baker Tilly is a leading advisory, tax and assurance firm whose specialized professionals guide clients through an ever-changing business world, helping them win now and anticipate tomorrow. We work with medical device, pharmaceutical and biotechnology companies through all stages of their lifecycle. Our comprehensive services address risk, business opportunities, market access and compliance.

Contact: Mike McKee, Partner and Life Sciences Industry Leader, 612.876.4694

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BRG is a global consulting firm that helps leading organizations advance in three key areas: disputes and investigations, corporate finance, and strategy and operations. Headquartered in California with offices around the world, the company are an integrated group of experts, industry leaders, academics, data scientists, and professionals working beyond borders and disciplines. BRG harnesses its collective expertise to deliver the inspired insights and practical strategies that clients need to stay ahead of what's next.

BRG has in-depth experience across a wide range of industries and markets, from construction and energy to technology and healthcare. No matter what sector your business is in, we have experienced professionals who understand the challenges you face—making us better equipped to help solve them.

Contact: Ed  Buthusiem, Managing Director
Contact’s email: ebuthusiem@thinkbrg.com

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Cognizan

Cognizant's Life Sciences practice is committed to helping change millions of lives for the better by partnering with clients to build solutions to healthcare challenges, continually improve the way they do business, set the pace in clinical development, strengthen their regulatory infrastructure, and increase competitiveness. Cognizant serves 28 of the top 30 global pharmaceutical companies, 9 of the top 10 biotech companies, and 12 of the top 15 medical device companies.

Contact: Sriraman Nagajaran, Associate Vice President & SBU Head, Life Sciences

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Deloitte

Deloitte’s life sciences and health care industry group is composed of more than 7,300 professionals in over 90 countries. We understand the complexity of today’s life sciences industry, including the journey to redefine patient-centric care, innovate, and grow, and can help clients through the challenges that each part of the journey can bring. Our professionals are backed by a global organization whose tools, industry-wide experience, and knowledge are aligned to help companies see what’s in front of them and what’s ahead. Our team can pull together the resources and cross-discipline capabilities to help formulate the right strategy and turn it into reality.

Contact: Lynn Sherry, Senior Marketing Manager Life Sciences

View our white papers

Mobilizing MedTech for mHealth: Market trends and potential opportunities

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Connecting people with goods, services and ideas creates opportunities and improves lives. FedEx believes that a connected world is a better world, and that belief guides everything it does.

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Global Healthcare Exchange, LLC

Global Healthcare Exchange, LLC (GHX) drives costs out of healthcare with cloud-based supply chain management technology and services to help enable better patient care and savings by maximizing automation, efficiency, and accuracy of business processes. GHX offers healthcare providers and suppliers an open and neutral electronic trading exchange that delivers procurement and accounts payable automation, contract and inventory management, vendor credentialing and management, business intelligence, and other supply chain-related tools and services.

For more information, visit www.ghx.com and The Healthcare Hub.  

Contact:  Denise Odenkirk, AVP Supplier Sales and Services, 609.216.4512

View our white papers

Taking an Industry Leadership Position in UDI Adoption

Strategies for Healthcare Supply Chain Collaboration

Solving Pricing Alignment in Healthcare

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Grant Thornton LLP (Grant Thornton) is the U.S. member firm of Grant Thornton International Ltd, one of the world’s leading organizations of independent audit, tax and advisory firms. Grant Thornton has revenues in excess of $1.7 billion and operates 59 offices.

Contact: Donna Wachman, Industry Marketing Associate Director

For more information, visit www.grantthornton.com.

 


A.T. Kearney

Bringing a medical device to market involves addressing a host of issues: regulatory approval, patents, financing, manufacturing, distribution, and more. After your product debuts, the challenges continue throughout its life cycle, from running compliance programs to responding to enforcement actions. And if you’re operating globally, the last thing you want to do is to oversee a patchwork of different firms in different locations. That’s where Hogan Lovells comes in. With more than 500 life sciences and healthcare lawyers across the globe, we work closely with you and each other to tackle tough issues and difficult-to-enter markets – no matter where you are today or want to be tomorrow. We leverage the vast experience gleaned from guiding companies of all sizes through the hard-to-navigate healthcare environment. We ask the right questions and explore uncovered possibilities to put your product in the best position for success.

Contacts:

Janice Hogan, Partner, Philadelphia

Jonathan Kahan, Partner, Washington D.C.

Yarmela Pavlovic, Partner, San Francisco

Thomas Beimers, Partner, Minneapolis

View our white papers

Digital Health: The issues you need to consider to leverage its full potential in 2017 

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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 medical device industry—the technologies, products and business models. Our attorneys and consultants provide sophisticated counsel to our medical device clients —including many of the best known names in the industry — 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.

Contact: Mark Brown, Partner, 202.626.5443

White papers/reports

King & Spalding's FDA & Regulatory Client Alerts

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Korn Ferry

At Korn Ferry, we design, build, attract and ignite talent. Since our inception, clients have trusted us to help recruit world-class leadership. Today, we are a single source for leadership and talent consulting services to empower businesses and leaders to reach their goals. Our solutions range from executive recruitment and leadership development programs, to enterprise learning, succession planning and recruitment process outsourcing (RPO).

Visit http://www.kornferry.com for more information on Korn Ferry, and http://www.kornferryinstitute.com for thought leadership, intellectual property and research

Contact:  Richard M. Arons, Office Managing Director

View our white papers

The Seven CEOs: The essential purpose of succession management

The signposts: The unmistakable markers that identify high-potential leaders

Precision talent intelligence: The definitive four dimensions of leadership and talent

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L.E.K. Consulting

Latham & Watkins LLP is an international law firm with a global footprint of more than 2,400 lawyers in more than 30 offices. Latham’s award-winning practices throughout the life sciences industry guide clients through their most significant and cutting-edge legal challenges through a combination of in-depth industry knowledge, legal acumen and strategic business advice. The firm operates as a fully integrated ‘one firm’ firm, embodying a collaborative approach to client service and ensuring the firm’s clients have a legal team that understands the economic, regulatory and political climates in which they operate.

Contact: Stuart Kurlander, Partner

View our white papers

President Obama Signs the 21st Century Cures Act Into Law

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L.E.K. Consulting

L.E.K. Consulting is a global management consulting firm that uses deep industry expertise and rigorous analysis to help business leaders achieve practical results with real impact. We are uncompromising in our approach to helping clients consistently make better decisions, deliver improved business performance and create greater shareholder returns. The firm advises and supports global companies that are leaders in their industries — including the largest private and public sector organizations, private equity firms and emerging entrepreneurial businesses. Founded more than 30 years ago, L.E.K. employs more than 1,000 professionals across the Americas, Asia-Pacific and Europe. 

Contact: Megan DeNovellis, Marketing Coordinator

View our white papers

What’s Next for U.S. Healthcare Under Trump?

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MasterControl

Founded in 1993, MasterControl Inc. creates software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner. MasterControl’s integrated solutions accelerate ROI and increase efficiencies by automating and securely managing critical business processes throughout the entire product lifecycle. More than 1,000 companies worldwide, ranging in size from five employees to tens of thousands, rely on MasterControl cloud solutions to automate processes for new product development, clinical, regulatory, quality management, supplier management, manufacturing and post-market surveillance. MasterControl solutions are well-known for being scalable, easy to implement, easy to validate and easy to use.

Contact: info@mastercontrol.com, 866-747-8767

View our resources:

Demo: MasterControl Quality Management System (QMS) Overview

Quality Management Toolkit

Recent webinars:
RIM “By Numbers”: A Quick Guide to Improving Your Global Submissions | View the recording

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Medmarc

Industry specific insurance and related risk management solutions

Created in 1979 by the healthcare technology industry, Medmarc’s purpose is to be the superior provider of liability insurance and related risk management solutions and to support the development, testing and delivery of medical products that save lives and improve the quality of life. Through collaboration with our parent company, ProAssurance, and our clinical trial industry experts, we provide a single source of innovative healthcare liability insurance solutions to the life sciences companies we serve.  From ideas and prototypes to the reality of commercialization and success – We can Meet Your Changing Needs. Call me to discuss the cost of insurance coverage, what coverages are needed and when for your business plan. 

Contact: George Ayd, (703) 652-1309

View our white papers

UDI Fundamentals, Ask an Expert

What are the best practices for dealing with FDA inspections?, Ask an Expert   

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Novasyte

Novasyte Health, an IQVIATM company, partners with medical device and diagnostic manufacturers, offering tech-enabled, outsourced commercial service teams and technologies. This includes contract clinical, field technical, inside sales and recall support. Our flexible model enables us to deploy and manage teams that expand and contract to meet our clients' customer-facing needs. Technology is wrapped around all of the offerings and program success is tracked and measured with our real-time business intelligence analytics. This provides our clients with critical insights into their most important resources - their people, patients and customers.  

View our white papers:

Innovating MedTech Product Recalls. When Results Speak.

Medical Device Conversion Excellence. Know the Trends.

Contact: Tim Gleeson, Chief Executive Officer, 949.214.5900

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Porzio Life Sciences is dedicated to helping pharmaceutical, medical device and biotechnology organizations master the evolving regulatory environment.  We enhance the marketing and sales programs of a range of companies:

  • Pharmaceutical and Medical Device Manufacturers and Distributors
  • Virtual Pharmaceutical Companies
  • Contract Sales Organizations
  • Vendors to Life Sciences Industry
  • Wholesale Distributors and Labelers

Contact: Tuyet Dorr, Marketing & Client Services Manager
Contact’s email: ttdorr@pbnlaw.com

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PRIA         

PRIA is a healthcare management firm determined to bring the latest medical devices, treatments, and procedures to physicians and patients nationwide. Since 2012, it has been our goal to combat the increasingly faulty and unpredictable reimbursement system – one that is blocking innovation and preventing providers from giving patients the care they need. Our patient access programs overcome investigational / experimental denials by leveraging clinical data, expert case management, and centralizing the messaging of physicians, patients, and medical device manufacturers. Our patient-based approach to support authorization and appeals gives our clients true transparency into the case by case adoption of your procedure by payers and builds a foundational argument for establishing positive coverage policies.

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PwC

PwC’s Pharmaceuticals 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 the PwC global network of firms share their thinking, experience, and solutions to develop fresh perspectives and practical advice.

Contact: Meredith Berger, PwC Pharma/LS Marketing Manager

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Sharing a Vision to Drive Healthcare Forward
Healthcare is an industry designed to help humans. As a global community, IQVIA continuously invests and commits to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources.

IQVIA is inspired by the potential and propelled by the possibilities. We share the vision to drive healthcare forward. To see how we can help accelerate progress and achievements. Others are developing these medical breakthroughs. We do our part by using breakthroughs in insights, technology, and human intelligence to reimagine and deliver ways to help make them a reality.

It’s bigger than better clinical trials. Or advances in technologies and analytics. Or faster insights. It’s about exploring a new path to better health outcomes via Human Data Science. It’s about harnessing the power of the IQVIA CORE™ to channel the insights, commercial and scientific depth, and executional expertise that drive maximum value for our customers.

Motivated by the industry we help, we’re committed to providing solutions that enable life sciences companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes forward.

Contact: Pam Weagraff, Director, Med Tech Regulatory
Contact’s email: pamela.weagraff@iqvia.com

 

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Reed Smith

Reed Smith’s global Life Sciences Health Industry Group is multidisciplinary, involving the skills and experience of a core practice group of nearly 200 attorneys devoted entirely to the life sciences and health care fields. We have represented virtually every type of enterprise connected with the life sciences health industry—including many of the world’s largest pharmaceutical and medical device manufacturers, and all types of health care providers. Our work for device clients includes matters involving FDA regulatory counseling; reimbursement issues for new and established medical technology; contract pricing strategies; investigations; health care fraud and abuse compliance; and intellectual property issues.  We were honored to assist AdvaMed in matters involving the Association’s Code of Ethics with Health Care Professionals, and the CMS Open Payments (Sunshine) legislation and regulations.

Contact:  Elizabeth B. Carder-Thompson, Partner 

View our white papers

Analysis of CMS' Proposed Medicare "Comprehensive Care for Joint Replacement" Model

3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles

Cybersecurity for Medical Devices: A Risk Mitigation Checklist for In-House Counsel

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R&Q provides regulatory and quality solutions that accelerate the success of medical device companies and improve people’s lives. R&Q exists to promote economic growth through regional partnerships, to provide a rewarding place to work, and to improve communities.

Contact: Stephen Biernacki, Marketing Manager

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Russell Reynolds Associates

Russell Reynolds Associates is a global leadership advisory and search firm. Our 425+ consultants in 46 offices work with public, private and nonprofit organizations across all industries and regions. We help our clients build teams of transformational leaders who can meet today’s challenges and anticipate the digital, economic and political trends that are reshaping the global business environment. From helping boards with their structure, culture and effectiveness to identifying, assessing and defining the best leadership for organizations, our teams bring their decades of expertise to help clients solve their most complex leadership issues.

Contact: Ernie Brittingham

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Sidley Austin LLP

Sidley Austin LLP is a premier law firm providing a broad range of services to meet the needs of large and small businesses across a multitude of industries, financial institutions, governments and individuals. Our Global Life Sciences practice counsels clients across three continents on the spectrum of issues manufacturers face throughout the life cycle of their products. Our team of more than 300 practitioners assists with matters involving all key areas of law, including: food, drug and medical device regulatory; compliance, enforcement and litigation; intellectual property; antitrust/competition; corporate and technology transactions; private equity; FCPA/anti-corruption; government strategies; privacy, data security and information law.

Contact: Rebecca K. Wood, Partner, 202.736.8663

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Sparta Systems

Sparta Systems, an industry pioneer and leading provider of enterprise quality management software (EQMS) solutions, enables businesses to safely and efficiently deliver their products to market. Its TrackWise® EQMS, a trusted standard among highly regulated industries, is used by quality, manufacturing and regulatory affairs professionals to manage compliance, reduce risk and improve safety across the global enterprise. Headquartered in New Jersey and with locations across Europe and Asia, Sparta Systems maintains an extensive install base in the pharmaceutical and biotechnology, medical device, electronics manufacturing and consumer products markets.

Contact: Colleen Nugent, Product Marketing Manager

View our white papers and eBooks

Using Automation to Gain Efficiencies with Product Registration Tracking 

Turning Medical Device Complaints into Quality Management Intelligence 

Five Steps to UDI Compliance Through EQMS 

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UL

UL provides comprehensive services to support medical and IVD companies with global regulatory submissions.  Our local services include integrated systems registrations for ISO 13485, Canada CMDCAS, European Notified Body under MDD and IVDD Brazil – INMETRO and Risk Management ISO 14971.  Our experienced engineers provide safety assessments to IEC 60601, IEC 61010, Home use devices, software, cybersecurity and CB Scheme.  Our Human Factors Engineering experts provide usability design support and validation testing.  Our pre-clinical and clinical experts provide testing and validation for sterility, shelf life, biocompatibility, CRO ISO14155 and more.  Our technical consultants provide technical documentation, regulatory submission support, mock audits, supply chain services, regulatory learning management systems and more.  

Contact: Jefferson Barr, UL Eduneering, 609.627.5391

View our white papers

A Playbook for FCPA and Anti-Bribery Compliance Training & Communication

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