Saul B. Helman MD MBA BS Managing Director - Epsilon Life Sciences
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Saul B. Helman MD MBA BS Managing Director Epsilon Life Sciences 111 South Wacker Drive; 50th Floor Chicago, Illinois 60606 Office: 317.550.4508 Mobile: 317.294.1228 shelman@epsilonlifesciences.com Summary Dr. Saul B. Helman has over two decades of life sciences experience, both in management roles and consulting. Saul has significant international experience with healthcare, bio-pharmaceutical and medical device companies. Saul spends most of his professional consulting time providing support in investigations, litigation and compliance integration matters involving life sciences companies. Applying his knowledge secured through working in international marketing and clinical development in industry, Saul has led projects involving expert witness testimony, litigation support, compliance implementation and assessment and investigation support. Saul has led the support of clients and external counsel with investigations of fraud and abuse in industry. Saul's experience includes the development and implementation of global healthcare compliance programs, support of clients through Deferred Prosecution Agreements and Corporate Integrity Agreements, Pre- IRO support, Board and Executive level support through compliance program implementation or evaluation, auditing and monitoring of healthcare compliance programs, support of outside counsel through complex litigation matters including off-label promotion, clinical data management and disclosure, fraud and abuse (False Claims Act, Anti-Kickback Statute and Foreign Corrupt Practices Act) and aggregate spend reporting (Physician Payment Sunshine Act). In addition, Saul has conducted risk assessments and remediation of manufacturing, regulatory, clinical, marketing and sales departments. Prior to his consulting career, Saul has led a number of organizations across the healthcare continuum, including a global medical staffing organization in the United Kingdom, a home health/home infusion/durable medical equipment/prosthetics and orthotics company in Indiana, and running a rural healthcare clinic in South Africa. Saul has also led the global launch of pharmaceuticals, international new product planning and various therapeutic area strategies in the bio-pharmaceutical industry.
Education
• Bachelor of Science degree in Anatomy, Genetics and Paleoanthropology, University of the
Witwatersrand, South Africa,
• Medical Doctor (MBBCh), University of the Witwatersrand, South Africa,
• Master of Business Administration in Global Marketing and the Strategic Management Process,
Oxford Brookes University, United Kingdom,
Professional Experience
• Epsilon Life Sciences
Managing Director and President, 2021 – present
• Guidehouse Inc. / Navigant Consulting, Inc.
Partner, 2007 – 2021
• KPMG LLP
Director, 2005 – 2007
• Eli Lilly & Company
Director, 2001 – 2005
• Optioncare
President, 1999 – 2001
• NES International
Regional Vice President, 1993 – 1999
• Professional Practice, 1991 – 1995
Professional Affiliations
• Association of Certified Fraud Examiners
• South African Inherited Disorder Association (Life Member)
• General Medical Council, United Kingdom
• Health Professions Council of South Africa
• Institute for the Study of Man in Africa
3/23/2021 Page 2 of 13Disputes / Litigation Support
• Expert witness in a securities case related to the effectiveness of the Compliance Program in place
at the time of certain public filings within a major medical device company. Provided an expert
report, rebuttal and deposition. [Brad Mauss, Individually and on Behalf of All Other Persons
Similarly Situated v. Nuvasive, Inc., Alexis V. Lukianov, Kevin C. O’Boyle, and Michael J.
Lambert. 2017].
• Expert witness in a change of control case related to the time and effort involved in potential
transfer of major biotherapeutic agents from the licensee to the licensor. Provided expert written
report, deposition and testimony in a court of arbitration. [Centocor Ortho Biotech Inc., v.
Schering-Plough Corporation, and Schering-Plough (Ireland) Company. 2010].
• Engagement lead for the expert advisory support of external counsel in preparation for securities
case related to the release of clinical data by a major bio-pharmaceutical company. Re-established
timelines, activities and analysis related to clinical trial development, implementation and data
management. [Pfizer. 2011].
• Expert witness in a medical device royalty dispute which included delivery of expert reports on
the contribution, royalty rate and fair market value related to the design and development of
medical devices. Provided expert written report. [W. Norman Scott, M.D. v. Zimmer Holdings,
Inc. 2009].
• Expert witness in a dispute involving a manufacturer and contract manufacturer related to
strategic manufacturing and supply chain related decisions. Provided an expert report, deposed
and awaiting testimony. [MSD Consumer Care, Inc. (f/k/a Schering-Plough Healthcare Products,
Inc.), v. Actavis Totowa LLC and Actavis LLC (f/k/a Actavis, Inc.). 2014].
• Expert report delivered in an off-label promotion case, including analysis of marketing and sales
activities related to compendia listing, access and reimbursement. [Cell Therapeutics, Inc. v. The
Lash Group, Inc. and Documedics Acquisition Co., Inc. 2008].
• Expert support in the causation analysis of multiple off-label cases associated with Government
investigations.
3/23/2021 Page 3 of 13Investigations
• Engagement lead for the investigation of Foreign Corrupt Practices Act related activities in Latin
America of a major medical device manufacturer, including eDiscovery, data analysis, forensic
accounting and operational risk identification. The findings of this investigation provided the basis
for corrective action and the expansion of a global compliance program to address global
compliance concerns, including Foreign Corrupt Practices Act related risks.
• Engagement lead for assessment of potential settlement quantification related to a DOJ
investigation of a medical device company’s healthcare professional relationships across royalty,
fee-for-service and clinical arrangements and alleged compliance deficiencies. These projects
included contractual reviews, assessment of controls, and identification of deficiencies and
quantification of potential exposure.
• Engagement lead for the investigation of potential fraud and compliance violations in major
biopharmaceutical’s third-party contracts with Contract Research Organizations. These projects
included risk assessments, contract reviews, process reviews and organizational structure changes.
• Engagement lead for a major bio-pharmaceutical company’s internal investigation outsourced
team, providing investigative support for cases that were focused on single event, single subject
compliance related allegations.
• Engagement lead for a defendant in an Office of Inspector General and Department of Justice
investigation of a pharmaceutical manufacturer’s alleged violation of the Medicaid Rebate statute.
We analyzed Medicaid rebates, including Class of Trade and 340B assignment and calculation
methodologies.
• Engagement support for the investigation of potential STARK violations at a major
metropolitan/academic medical center. Identified potential areas of violation and quantified the
potential exposure in anticipation of settlement.
• Engagement lead for an investigation of billing practices associated with a Durable Medical
Equipment provider, including reviews of medical necessity, coding and related document
management. Developed exposure model and provided counsel quantification of the potential
refund required to Government.
• Clinical support in a number of investigations across home health care and hospital settings related
to billing, coding and medical necessity.
3/23/2021 Page 4 of 13Compliance
• Engagement lead for multiple Pre-Independent Review Organization engagements for medical
device and pharmaceutical companies, providing insights into Independent Review Organization
expectations, supporting the development of appropriate responses to system and transaction
reviews and assisting clients with responding to Independent Review Organization requests and
recommendations.
• Engagement lead for multiple Independent Review Organization engagements for hospital
providers, distributors, medical device and pharmaceutical companies, conducting transaction
reviews and system reviews in accordance with Corporate Integrity Agreement requirements.
Areas of review have included (not limited to) arrangements, promotional material, grants,
charitable contributions, incentive compensation, call plans, sample distribution plans, speaker
programs, compendia, clinical research, publications, medical inquiry management and risk
assessment reviews. Annual reports provided to the Compliance Department and Office of
Inspector General – Health and Human Services.
• Board advisor per Corporate Integrity Agreement requirement, with focus on evaluating the
effectiveness and sustainability of the healthcare compliance program of multiple pharmaceutical
and medical device companies. Reviews included evaluation across the seven elements as
promulgated by the Office of Inspector General – Health and Human Services, a review of
structure and resourcing and testing of high-risk areas. Annual reports provided to the Compliance
Committee, Board of Directors and Office of Inspector General and/or Federal Monitor.
• Engagement lead for the response of a major medical device company to a Deferred Prosecution
Agreement and Corporate Integrity Agreement in the context of their financial relationships with
consultant surgeons. This project included the development of the Needs Assessment database
and Arrangements Database, Fair Market Value for payments to surgeons in the context of
consulting, product design (royalty), clinical trials and pre-clinical trial related payments. I also
acted as consultant to the Chief Compliance Officer on all matters related to compliance and the
company’s response to the Deferred Prosecution Agreement and Corporate Integrity Agreement,
including quarterly reports, pre-Independent Review Organization readiness, audit readiness and
technology implementation.
• Engagement lead for the development and implementation of new compliance departments and
programs with companies in the pre-market / pre-approval stage. These projects include initial
compliance risk assessments, establishment of governance (e.g. Compliance Committee),
development of written standards (Code of Conduct, policies and standard operating procedures
and business practices documents), development of compliance training and the implementation
of an auditing and monitoring program.
3/23/2021 Page 5 of 13• Engagement lead for multiple compliance audits, monitoring programs and risk assessments of
compliance with regulatory and internal guidelines conducted for medical device and bio-
pharmaceutical companies, some of which were under civil and criminal investigation by the Office
of Inspector General and Department of Justice. Areas of risk evaluated included the review of
healthcare professional contracting, sales force analysis, third party distributor agreements,
expenditure in sales, marketing (incl. off-label promotion), research and development,
outsourced/vendor agreements and related compliance policies, practices, and activities. Our
support included identifying areas of deficiency and related risk, implementing controls and
associated training and disciplinary guidelines.
• Developed and implemented a comprehensive risk assessment process for a major retail pharmacy
and specialty pharmacy group, with a focus on financial flow and product flow. Established a
prioritized list of risk junctures that enabled the organization to invest in mitigation aligned with
greatest risk. Business enhancements were also identified through this process.
• Led the evaluation, recommendation and implementation of a compliance program for a major
international ophthalmic lens manufacturer/optical laboratory operator/optical retail clinic
network to conduct a compliance gap assessment and develop an effective corporate compliance
program. This included a gap analysis process that helped identify existing elements of a
compliance program and enhancements to support a more robust program while managing
business needs and opportunities.
• Led the evaluation of the integration of the pharmaceutical division of an eye care manufacturer
into a pharmaceutical company in the context of compliance program integration. Identified areas
of difference aligned with business model, customer base and strategic objectives and identified
areas for improvement in the context of efficiency and sustainability.
• Evaluated specialty pharmacy arrangements with a bio-pharmaceutical manufacturer as it relates
to bona fide business arrangements for services per contract, fair market value for these services
and overall compliance with contract requirements. A governance structure was developed and
implemented, including a Fair Market Value process, annual review of contracts and audit
schedule.
• Provided compliance training content and delivery for a major medical device company across
multiple stakeholders, including the Board of Directors, Compliance Committee, Leadership
Team, Professional Affairs department and field teams. Training included: False Claims Act, Anti-
kickback Statute, Foreign Corrupt Practices Act, Surgeon contractual requirements, Fair Market
Value.
• Engagement lead for the development and implementation of a comprehensive Compliance
Evaluation and Risk Assessment Process for bio-pharmaceutical and medical device companies,
including the underlying technology platform supporting automation of aspects of risk gathering,
risk scoring, risk prioritization and oversight planning.
3/23/2021 Page 6 of 13• Engagement lead for the development and implementation of a global compliance program at a
major medical device company, in the context of the Federal Sentencing Guidelines, relevant
applicable industry guidance, regulatory and statutory requirements, and other relevant Office of
Inspector General standards. This included advising the Board of Directors on their fiduciary
responsibilities in the context of potential government oversight and ongoing investigations.
Support in prioritizing implementation included structure and context of such a program,
developing the structure, policies, procedures, training program, communication program and
related development of tools and technologies (including advising on the acquisition and
implementation of software) to support the global program.
• Engagement lead for the implementation of an integrated Open Payments reporting system for
the purpose of Sunshine Act transparency reporting. This engagement included the mapping of
all transactions across a major medical device manufacturer and validating the ultimate open
payments report.
• Engagement lead for multiple projects associated with the assessment of fair market value for
physician/surgeon contracts with industry for consultative work and royalty arrangements. These
reviews included an assessment of existing policies and procedures, rate cards and guidance on
industry norms, fair market value quantifications and fair market value calculator development
and implementation.
3/23/2021 Page 7 of 13Additional Experience
• Supported the development of CLIA certified labs for the purpose of Covid-19 testing during the
pandemic. CLIA certification was achieved within 4 weeks.
• Helped a number of manufacturers with their ‘going back to the workplace’ planning related to
the Covid-19 pandemic.
• Supported a regulatory due diligence review of potential target acquisition related to implantable
devices and related adverse events and clinical outcomes.
• Supported the development and submission of a 505(b)(2) submission to the FDA for a diagnostic
radioisotope.
• cGMP gap assessment of a major international pharmaceutical company, including the
identification of deficiencies and deviations that warranted immediate corrective action. Quality
manual reviews and enhancements were implemented.
• Supported various quality assurance related projects, involving various aspects of clinical
development and manufacturing, including the development and implementation of corrective and
preventative action plans.
• Engagement lead for a risk assessment of the manufacturing division of a global bio-
pharmaceutical company, including the review of cGMP implementation, vendor audits and
policies and procedures. Significant organizational changes and technology enhancements were
implemented and supported by the team.
• Ran a franchise of a national home infusion company, reviewing and enhancing the operations,
including case management and billing. In reorganizing the company, Saul also established more
comprehensive home health services, durable medical equipment, prosthetics and orthotics,
establishing the facilities for these services and the entire case management process through billing
and collection. An infusion suite was also developed to support the emerging biologicals in the
rheumatoid therapeutic area, becoming the largest distributor of Enbrel and Remicade within the
State of Indiana.
• Both in Industry and in consulting, Saul has led and provided support to the New Product
Planning process, including the assessment of asset (molecule) value, market opportunity
assessments, internal trade-off, and business development decision making.
• Engagement lead for multiple portfolio management and life cycle planning engagements,
identifying areas of risk and improvement that ultimately drive value to both clients and their
customer (patient) base. Market opportunity assessments and related modeling of potential price
bands and related revenues supported this process. Through the implementation of customized
solutions for specific companies, decision-making processes are accelerated, funding decisions
become more focused and molecules move through the pipeline at an accelerated rate.
3/23/2021 Page 8 of 13• Working with risk management or internal audit departments, Saul has provided support in the
assessment and development of drug advancement decision making processes in three of the big
ten bio-pharmaceutical companies.
• Saul has guided small start-up, midcap and big ten bio-pharmaceutical companies through
corporate, departmental and brand management strategy development projects, providing
framework, content, analysis and implementation plans.
• Engagement lead and major contributor in the development and designs of clinical protocols for
a major bio-pharmaceutical company in anticipation of spinning out a critical care portfolio.
Protocols provided the basis for budget and return on investment estimates and subsequent
decisions for potential investors.
• Led the successful commercial launch of a $1BN complex recombinant device delivered molecule.
Saul has significant International experience in commercialization of premium priced biotech
agents in both the US and OUS markets. Clinical trial planning is a critical component of
successful commercialization, as endpoints and study design impact on the ability to deliver data
that is both clinically relevant and demonstrates clinical and economic value.
• International brand lead for a co-marketed primary care product in the peri-launch period,
coordinating efforts across global and country level brand teams and the licensed partner in
anticipation of launch. Overall, responsible for a global portfolio of two products with over $1
billion in annual sales.
• Developed and implemented a new platform driven strategy in inflammation and
immunomodulation research that delivered 2 promising pharmaceutical candidates within 6
months of implementation – the fastest candidate selection process ever experienced in this
particular company.
• Developed and implemented long term customer based therapeutic area strategies that supported
the financial decision-making processes in Research and Development. Key investment decisions
guided the process of molecule advancement, business development (both in-licensing and out-
licensing) and termination of projects early – “Quick Win/Quick Kill”.
• Led a number of small healthcare companies in both the US and UK out of the threat of
bankruptcy through the introduction of fiscal discipline, business process and strategic direction.
Industries included home healthcare, durable medical equipment, home respiratory services, home
infusion services, emergency on call primary care physician services, ambulatory care clinics,
contractual medical staffing.
• Reorganized the patient acceptance process and related coding, billing and collection process for
a specialty pharmacy / home infusion company, resulting in a turnaround of cash flow within 6
months and a significant reduction on bad debt.
• Saul has also been a practicing physician in both South Africa and the United Kingdom, as both
a primary care physician and hospitalist, with a focus on women’s health.
3/23/2021 Page 9 of 13Thought Leadership
• Berger, D.M. and Helman, S.B. January 2021. How Employers Can Address Employee & Public
Health by Mitigating COVID-19 Contagion Threats
• Helman, S.B., Horton, C., Farrar, J.M., Mullady, K., Norris, K., Kio, K. December 2020.
Considerations for Rebooting Speaker Programs Post-Pandemic
• Berger, D.M. and Helman, S.B. September 2020. What's the Right Way to Return to the
Workplace?
• O’Shea, S., Helman, S.B., Berger, D.M. and Roth, J. August 2020. Regulatory Implications Of
The CARES Act On Over The Counter Drugs. Pharmaceutical Online.
• Berger, D.M., Farrar, J.M., Helman, S.B. and Zimiles, E. July 2020. From Testing to SOPs –
Developing a “Back to the Workplace” Framework That Will Pass the Coming Employee
Referendum
• Helman, S.B., Farrar, J.M., Carufel, J. and Prinzi, L. June 2019. A Prosecutor's Guide to
Evaluating a Compliance Program: What Should Your Board Be Asking?
• Helman, S.B., Lewko, S.M. and Horton, C. May 2019. Key Takeaways from 2019 CBI
Pharmaceutical Compliance Congress
• Farrar, J.M., Helman, S.B., Horton, C. and Dingler, C.A. May 2018. Key Takeaways from 2018
Pharmaceutical Compliance Congress
• Helman, S.B., Farrar, J.M., Horton, C.J., Segobiano, B., Dingler, C. and Riehle, K. February
2018. Physician, Feed Thyself: New Jersey’s Restriction on Pharmaceutical Payments
• Helman, S.B., Chandler, M. and Longawa, C. May 2017. 2017 Compliance Update: DOJ and OIG
offer 2 new Resources to Evaluate Compliance Program Effectiveness
• Helman, S.B. April 2015. What’s a Board to Do? Practical Guidance for Boards of Directors on
Addressing Compliance Program Effectiveness
• “Take Your Medicine: How International Corruption Impacts the Life Sciences Industry,”
Navigant Client Publication, October 2015.
• Weiss, W., Aponte, D and Helman, S.B. October 2014. Navigating the Uncertain World of Off-
Label Promotion
• Kvistad, S. and Helman S.B. August 2014. Expedited Access for Premarket Approval Medical
Devices: A Tortoise? Or a Hare?
• Farrar, J.M., Williams, J., Dingler, C., Boone, C. and Helman, S.B. August 2014. FDA’s New
Social Media Draft Guidances: Reason to be Atwitter?
• Helman, S.B. et al. February 2014. OIG Releases FY2014 Work Plan: Focus on Executive
Compensation and Affordable Care Act in 2014
• Helman, S.B. and DeLong, J. January 2014. A New Era for Life Sciences Companies – Fair Market
Value and the Physicians Payment Sunshine Act, Investigations Quarterly (IQ) Magazine 15
• Thiel, S., Helman, S.B. and Hittle, C. October 2013. Overview of FDA Guidance for Mobile
Medical Applications
• Helman, S.B. and Castro, C. June 2013. Planning and Delivering Effective Compliance Training
• Helman, S.B. et al. May 2013. Sunshine Act Research Payments – Considerations for Federal
Reporting
3/23/2021 Page 10 of 13• Helman, S.B. April 2013. Centers for Medicare & Medicaid Services 42 CFR Parts 402 and 403.
Medicare, Medicaid, Children’s Health Insurance Programs; Transparency Reports and Reporting
of Physician Ownership or Investment Interests. A Summary
• Helman, S.B. and Tanselle, J. March 2013. Sunshine Act Alert – Complexities in Allocating the
Value of Food and Beverage
• Helman, S.B. and Eschle, R. March 2013. Compliance Effectiveness Review: What's a Board to
Do
• Helman, S.B. et al. February 2013. Here Comes the Sun! The Final Rule for Implementation of
the Sunshine Act is Finally Here
• Helman S.B. and Wieczorek, E. January 2013. Evolving Healthcare Regulations: Increased
Corruption Exposure for Healthcare Institutions, Manufacturers and Providers – Tips on
Mitigating this Risk
• Helman, S.B. and DeLong, J. November 2012. Fair Market Value is Critical in Implementing the
Physician Payments Sunshine Act
• Helman, S.B. et al. September 2012. PPSA Reporting: Extend Your Sunshine to Your Primary
Customer, the Physicians and Teaching Hospitals
• Helman, S.B. et al. July 2012. Steps DEA Registrants Can Take Now to Combat Controlled
Substance Diversion
• Helman, S.B. June 2012. Compliance Concerns in Clinical Research: Sponsors and Sites Beware
• Helman, S.B. and Castro, C. May 2012. Field Force Monitoring: Creating a Compliance Culture
That Works
• Helman, S.B., et al, October 2009 Volume 6 Number 2, “Clinical Trial Compliance: New Focus
on IRBs”. American Bar Association Health eSource
• Helman, S.B., et al, September 28, 2009, “Board and Executive Certification of Compliance
Effectiveness: Implementation Implications of a Compliance Program Aligned with CIA Trends”.
Corporate Compliance Insights
• McKee, J.K. and Helman S.B., 1991 Variability of the Hominid Juxtamastoid Eminence and
Associated Basicranial Features. Journal of Human Evolution 21: 275-281.
• Editor. The Leech. 1986-1988. Medical School Journal.
• The Star National Newspaper – Scientific contributor 1980-1986.
• Include recent articles, speaking engagements, and other relevant information. Limit to content
developed in the past 3-4 years, include relevant links.
3/23/2021 Page 11 of 13Speaking Engagements
• PCF - The 21st Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices
Forum, November 6, 2020. “Meaningful Board Engagement and Support for Board Oversight of
the Compliance Program”
• CBI - 17th Annual Pharmaceutical Compliance Conference, August 13, 2020. “Compliance
Compass: Guiding Insights on Emerging Risk Areas from Industry’s Trusted Advisors”
• Podcast: Patient Services in an Evolving COVID-19 Era for Life Sciences Companies. Helman,
S.B., Edwards, D. and Horton, C. May 2020.
• Podcast: Evolving Commercial Operations in the COVID-19 Era. Helman, S.B., Zamirowski, J.,
Gebrehiiwet-Wilder, A., Etchberger, J. and Ninan, N. April 2020.
• Podcast: Field Force Monitoring in the COVID-19 Era: New Challenges, Same Objective, New
Approach. Farrar, J.M., Helman S.B. and Gebrehiiwet-Wilder, A. March 2020
• ReedSmith / Navigant Annual Washington DC Healthcare Conference, May 4th, 2017. “Using
Data to Defend FCA Cases – Can you Measure Compliance?”
• CBI - 13th Annual Pharmaceutical Compliance Conference, April 27, 2017. “Promotional
Compliance”
• Dubai Health, February 1, 2017. Fraud and Abuse in Healthcare – The US Context.
• CBI - 12th Annual Pharmaceutical Compliance Conference, April 26, 2016. “CARE and Concern
– Risk Assessment and Emerging Enforcement Trends”
• American Health Lawyers Association. ACE Webinar Series Part I. December 8, 2015. “Advanced
Issues in Pharmaceutical Manufacturer Compliance Programs”
• Center for Trustworthy Organizations, Fordham University, November 9, 2015. “Creating Trust
and Increasing Patient Value - The Role of the Pharmaceutical Industry in a Changing Health
Care System”
• SEAK – Non-Clinical Careers for Physicians. October 24, 2015. “Opportunities for Physicians at
Consulting Firms”
• PCF - The 16th Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices
Forum, October 21, 2015. “Scientific Exchange: What Every Compliance Officer Should Consider”
• PCF - The 16th Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices
Forum, October 21, 2015. “Risk Assessments Better Practices”
• Columbus Business First. September 17, 2015. “Responding to Whistleblowers and Government
Investigations”
• Illinois Association of Healthcare Attorneys. October 21, 2014. “New and Emerging Risks in Life
Sciences”
• PCF - The 14th Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices
Forum, October 26, 2013. “Monitoring in a World of Abundant Data”
• CBI - 10th Annual Pharmaceutical Compliance Conference, January 30, 2013. “Planning and
Delivering Effective Compliance Training”
• PCF - The 13th Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices
Forum, November 6, 2012. “Compliance Effectiveness Reviews: Benefits to the Board of Directors
and Beyond”
• LexisNexis® Emerging Issues Webinar Series, September 15, 2012. “The Sunshine Act – Best
Practices for Industry Compliance and the Pathway to Improved Patient Care”
3/23/2021 Page 12 of 13• CBI - 6th Annual Tracking State Laws and Aggregate Spend, August 16, 2012. “Collecting and
Reporting Clinical Spend”
• Navigant/Blank Rome CLE, August 15, 2012. “Partly Cloudy with a Chance for Investigation:
The Sunshine Act”
• CBI - 9th Annual Pharmaceutical Compliance Conference, January 25, 2012. “FCPA: Lessons
from Sunshine”
• CBI - 5th Annual Tracking State Laws and Aggregate Spend, August 16, 2011. “Bringing the
Physician Out of the Dark — Communicating Sunshine and Verifying Reporting Accuracy”
• Pepper Hamilton – Life Science Speaker Series, February 23, 2011. “The Foreign Corrupt Practices
Act: Important Lessons for Life Sciences Companies Operating in International Markets”
• CBI - 8th Annual Pharmaceutical Compliance Congress, January 24, 2011. “Compliance Program
Basics”
• McGuire Woods - 2nd Annual Medical Device, Durable Medical Equipment & Diagnostics
Conference, November 3, 2010. “Compliance Effectiveness and Board Certification”
• PCF - The 11th Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices
Forum, October 23, 2010. “Compliance Effectiveness and Board Certification”
• CBI - 4th Annual Forum on Tracking State Laws and Aggregate Spend, August 16, 2010.
“Pursuing Compliance Effectiveness with HCP Aggregate Spend Management and Reporting”
• CBI - 7th Annual Pharmaceutical Compliance Conference, January 25, 2010. “Managing Effective
Compliance Programs for Biotech and Medical Device Companies”
• PCF - The 10th Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices
Forum, November 12, 2009. “How to Communicate With the Board of Directors About Your
Compliance Program”
• PCF - The 10th Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices
Forum, November 12, 2009. “How to Communicate and Collaborate about Compliance with
Colleagues in Related Functions and Departments”
• Engage! 2008 User Group Conference, October 15, 2008. “How to Implement an effective
Compliance Program”
• RAPS Horizon 2008 Conference, March 26, 2008. “Mitigating Potential Liability Risks from New
Technologies”
• Pharmaceutical Internal Audit Forum, March 5, 2007. “Enterprise Risk Management Across the
Value Chain”
• Merrill Lynch Analyst’s Forum, December 11, 2006. “R&D Productivity”.
• CBI – Bio/Pharmaceutical Grants – Liability, Standardization, Regulations, September 14, 2006.
Workshop: “Emerging Compliance Standards and Requirement Across the Life Science Industries
and an Overview of Cases that Contributed to the Increased Scrutiny”
• CBI’s 2nd Annual Forum on - Early Stage Commercialization Strategies for the
Bio/Pharmaceutical Industry, April 20, 2006. “Optimizing Commercialization in R&D Through
Pricing, Reimbursement And Access”
• Bio 2006, April 9, 2006. Moderator and speaker “The Transformation of the Biomedical Industry”
• CBI’s 4th Leadership Summit on Portfolio Evaluation and Strategic Investment, September 27,
2005.
3/23/2021 Page 13 of 13You can also read
