Craig Bleifer, JD
Craig Bleifer 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. www.CraigBleifer.com 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. Contact: craig@CraigBleifer.com.
Chief Compliance, Ethics & Risk Management Officer; TG Therapeutics, Inc.; Former, Vice President, Deputy Global Chief Compliance Officer, Celgene; Former Executive Director, Head of Risk Management Center of Excellence, Novartis Pharmaceuticals; New York, NY
Christie is currently Chief Compliance, Ethics, and Risk Management Officer for TG Therapeutics. She has over 15 years of experience implementing, guiding, and constructing proactive healthcare compliance, corporate compliance, and enterprise risk management strategies and programs for some of the world?s most successful pharmaceutical and biotechnology companies. She has extensive success designing organizational governance structures for optimal operations, ensuring a customized approach that is right sized for the company.
Christie brings a welcomed personability and deeply rooted passion to enterprise-wide global compliance management with intent focus on managing stakeholder relationship through the intersection of compliance and bottom-line results to enable business progress while proactively managing risk.
Christie holds a Healthcare Compliance Certification from Seton Hall, Risk Management for Corporate Directors and Business Finance Certifications from Harvard Business School, a Leading Global Projects Project Management Certification from Thunderbird School of Global Management, and a LEAN Six Sigma Black Belt Certification. She completed an extensive number of trainings throughout her career focused on effective executive leadership for women, brand building, and diversity and inclusion.
Michael R. Clarke, CCEP
Vice President, Global Chief Compliance Officer, ConvaTec; Former Vice President, Corporate Compliance, Indivior Inc.; Former Vice President, Ethics & Compliance, Americas, Actavis, Inc.; Former Vice President and Compliance Officer, Biomet Spine & Bone Healing Technologies; Bridgewater, NJ
Michael R. Clarke is the Global Chief Compliance officer for ConvaTec, Inc., a global medical technology company. He was previously Vice President, Deputy Compliance Officer for Indivior Inc., a global specialty pharmaceutical manufacturer in Richmond, VA. Earlier, Mr. Clarke was Vice President, Ethics & Compliance - Americas for Actavis plc, now known as Allergan, as well as Vice President and Compliance Officer for EBI, LLC, d/b/a Biomet Spine & Bone Healing Technologies, a division of global orthopedic medical device company Biomet, Inc. He also served as a compliance officer or ethics officer for the University of Medicine & Dentistry of New Jersey and Medco Health Solutions.
Since becoming a senior compliance leader over 17 years ago, Mr. Clarke has created or managed global ethics & compliance programs, which activities include educating employees and third parties on compliance policies and procedures; monitoring sales, marketing and medical affairs HCP interaction activities; conducting and overseeing third party due diligence efforts; counseling on OFAC requirements; overseeing internal investigations and implementing risk mitigation processes to reduce the prevalence of corruption, fraud and bribery risks.
Before working in-house as a compliance professional, Mr. Clarke practiced corporate, civil and criminal law as a litigation partner with the law firm of Drinker Biddle & Reath LLP, as an associate with other law firms and was an Assistant Deputy Public Defender in Essex County, New Jersey. Michael is a member of the Association of Corporate Counsel; a past Chair of the ABA's Business Law Section's Corporate Compliance Committee (from 2006 ? 2010); and a former co-chair of the Ethics & Professional Responsibility Committee of the National Bar Association. He has been a panelist or moderator for numerous ethics & compliance presentations on aspects of creating and managing global ethics & compliance programs, including presenting at the Seton Hall Law School Healthcare Compliance Certification Program. He became a Certified Compliance and Ethics Professional in December 2018. Michael is married with two adult sons and received his J.D. from Cornell Law School as well as his A.B. from Brown University.
Jenny McVey, MS, PHD
Compliance Risk Strategy & Management, Novo Nordisk Inc., Compliance Lead, Hands International Editorial Board Member, Policy & Medicine Compliance Update, Princeton, NJ
Jenny is currently the lead for Risk Strategy and Management at Novo Nordisk Inc. She has over fourteen years of experience in corporate governance and healthcare compliance in the pharmaceutical, medical device, and life sciences industry. Experience ranges from evaluating, development, and executing compliance requirements for corporate compliance programs, including medical affairs and commercial activities, corporate policies, compliance risk assessment and management, global commercialization product launches, global medical education, and field sales training. She has provided substantial support for the management of external investigations with the Health and Human Service Office of Inspector General (OIG), including remediation of compliance concerns relating to promotional, medical affairs, and external funding (charitable contributions, sponsorships) activities, and overall compliance program design and implementation.
John C. Auerbach, MA
Managing Director, Berkeley Research Group LLC, New York, NY
Mr. Auerbach has over twenty years of experience managing complex domestic and international corporate investigations, disputes, compliance assessments, and pre-M&A due diligence. He specializes in corporate integrity issues related to anti-bribery and corruption, third-party risk management, anti-money laundering, and financial fraud.
As a forensic investigation, business intelligence and compliance specialist, he has directed numerous investigations and compliance reviews in response to US and overseas regulatory enforcement actions, including Foreign Corrupt Practices Act, UK Bribery Act, money laundering, antitrust, anti-dumping and sanctions violations, as well as securities fraud and accounting restatement matters. He has particular experience with matters in the life sciences, financial services, consumer product, and technology sectors.
Before joining BRG, Mr. Auerbach was a partner in a Big Four Forensic Services group. He was managing partner of the firm's forensic practice in Greater China for nine years before returning to its US forensic practice in New York in 2014. Before that, he was a managing director with a corporate investigations and risk consulting firm and head of the firm's mainland China practice. He is a fluent Mandarin speaker, widely recognized subject-matter expert and public speaker on issues related to fraud, corruption, and operational risk management in China.
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Michael Jelen, MBA
Director, Berkeley Research Group LLC, Austin, TX
Michael Jelen is a Director in the Global Applied Technology Practice and a creator of the BRG DRIVE Technology Platform. He is an expert on digital technologies and has authored reports and testified in US Federal Court on issues of computer forensics and data integrity.
He has 15 years of experience working with various tools to manage and analyze large quantities of complex data for clients across many industries. Mr. Jelen turns complex data into actionable insights, forensically investigates disparate datasets, and builds bespoke software solutions. He implements advanced technologies, including DLT/blockchain, machine learning, and artificial intelligence in Healthcare, Financial Services, and several other industries. Mr. Jelen regularly advises local, state, and national governments across the globe on technology strategy and policy.
Mr. Jelen applies advanced technologies to private and public sector problems to engineer creative solutions that improve performance, efficiency, and human outcomes.
Inspired by his client work, Mr. Jelen saw the BRG DRIVE web platform as an opportunity to liberate data from technical analysts to enable collaboration with key business stakeholders. His experience gained from building and managing an online software platform has led to investigatory and advisory roles related to many areas of software and web development. He has served as the expert technical advisor in several cases at large multinational firms, and engineered solutions to leverage technology as a conduit and force multiplier for BRG's numerous deep industry experts.