Life Sciences Compliance Training - Speaker Biographies

U.S. Compliance Certification Program for Smaller Life Sciences Companies

PROGRAM SCHEDULE for March 27-29, 2017 | San Francisco, California

 

Speaker Biographies
A-J K-Z
  1. Kirstin Ault
  2. Randy Bagwell
  3. Carolyn Bruguera
  4. Katherine Buckley
  5. Bret A. Campbell
  6. Susan Clarke
  7. Peter Claude
  8. Daniel A. Cody
  9. Torrey Cope
  10. Scott Cunningham
  11. Jack DiCanio
  12. Naoko Fujii
  13. Wendy Goldstein
  14. Charles Gunther
  15. Jacquie Haggarty
  16. Joshua Hill
  1. Fabiana Lacerca-Allen
  2. Hae-Won Min Liao
  3. John P. Oroho
  4. Kathleen Peterson
  5. Sumita Ray
  6. Kenia Rincon
  7. Elaine H. Tseng
  8. Sara Winslow

KIRSTIN AULT

Kirstin Ault is an Assistant United States Attorney in the Criminal Division of the United States Attorney’s Office for the Northern District of California.  She specializes in criminal Health Care Fraud prosecutions.

Ms. Ault was previously assigned to the Northern District’s Organized Crime and Drug Enforcement Task Force, where she handled prosecutions of large-scale drug-trafficking organizations.


RANDY BAGWELL

Randy BagwellColonel Randy Bagwell is the Staff Judge Advocate (General Counsel) for Joint Base Lewis-McChord, Washington (JBLM), one of the largest bases in the military, with over 45,000 service members assigned. In this position, he leads a legal office of over 200 lawyers and paralegals providing a full range of legal services, including criminal law, administrative law, federal labor law, environmental law, contracts, government ethics, and family law.

As a Judge Advocate, Colonel Bagwell has served as a legal assistance attorney, defense counsel, senior prosecutor, administrative law attorney, operational law attorney, ethics counselor, international law attorney, Deputy Staff Judge Advocate, and Staff Judge Advocate. He is admitted to practice in Arkansas and Texas as well as before the Supreme Court of the United States, the Court of Appeals for the Armed Forces, the Army Court of Appeals, and the Supreme Court of Arkansas.

Colonel Bagwell’s operational assignments include service in Afghanistan as the Staff Judge Advocate of the 82nd Airborne Division, in Iraq as the Chief of Operational Law for Multinational Forces – Iraq, and again in Afghanistan as the Staff Judge Advocate and NATO legal advisor for Regional Command –South and 3rd Infantry Division.

Colonel Bagwell has been awarded the Legion of Merit and Bronze Star Medal, along with other awards.

Colonel Bagwell will assume new duties as the Dean of the Army Judge Advocate General’s school, the only ABA certified law school in the military, in July 2016.

Colonel Bagwell holds a Bachelor’s degree in Business Marketing, a Master’s degree in National Policy and Strategic Studies, a Juris Doctor degree, and an L.LM in military law. Additionally, he has completed a one-year academic fellowship with the Office of the Director of National Intelligence’s General Counsel’s office. He has also taught international law at the U.S. Naval War College.


CAROLYN BRUGUERA

carolyn-brugueraCarolyn Bruguera is a Principal at IMS Health. She has extensive experience in the design, implementation, and management of global compliance programs for life sciences and medical technology companies.  She joined IMS Health through R-Squared Services & Solutions, where she served as Vice President of Consulting Services.  She previously served as General Counsel to Hansen Medical, a manufacturer of robotics for intravascular procedures.  She also served as General Counsel to Micrus Endovascular Corporation, from its initial public offering through its acquisition by Johnson & Johnson.  At Micrus, she oversaw the Company’s compliance with a three-year nonprosecution agreement under the Foreign Corrupt Practices Act allegations, and implemented a global compliance program covering all of the Company’s worldwide operations.

Ms. Bruguera has assisted dozens of companies with compliance needs, including initial compliance program implementation, gap assessment and remediation, training of personnel and distributors, template development, and outsourced compliance officer services.  She has also advised major trade associations, including AdvaMed and Eucomed, on international transparency, codes of conduct, and third-party relationship management.  She is a frequent speaker on compliance and transparency topics.

Ms. Bruguera received her undergraduate degree from Harvard University and her J.D. from the University of California at Berkeley.  She speaks English and French, and is a member of the California bar.


KATHERINE BUCKLEY

katherine-buckleyKatherine Buckley is a partner at PwC's Pharmaceutical and Life Sciences Advisory Risk Consulting Practice.  She is an experienced pharmaceutical and life sciences industry consultant with over 15 years of experience providing regulatory compliance, commercial contracting and operations, risk management and dispute resolution services to the pharmaceutical industry.  Her experience includes compliance program design, policy and procedure development, policy adherence assessments, compliance training, and design and vision of future state contracting, government price reporting, and healthcare professional interaction compliance programs.

Ms. Buckley has significant experience helping the industry implement compliant price reporting practices for the Center for Medicare and Medicaid Services (CMS), Public Health Services (PHS), and Veterans Administration (VA) price reporting programs.  Over the years, she has led multiple implementation, recalculation, merger, and integration efforts.  She has also served as the engagement Director for Independent Review Organizations involving the review of government pricing and sales and marketing.  In connection with these efforts, she performed government pricing gap analyses related to policies, procedures, and calculation components, assessed CoT and transaction type requirements, and developed price type configurations and reports for implementation in go-forward system.


BRET A. CAMPBELL

bret-campbellBret A. Campbell is a partner in Cadwalader, Wickersham & Taft's White Collar Defense and Investigations group. He represents clients in a broad range of complex criminal, regulatory, and civil litigation matters involving international corruption and the Foreign Corrupt Practices Act, as well as securities, healthcare, accounting, and commercial fraud. He has extensive experience managing internal corporate investigations and cross-border criminal and regulatory matters, often in proceedings before the U.S. Department of Justice and the Securities and Exchange Commission.

In addition to his litigation practice, Mr. Campbell conducts FCPA and regulatory compliance due diligence reviews in connection with mergers, acquisitions, and other complex corporate transactions. He has directed numerous global due diligence review of proposed investments and business combinations in industries and jurisdictions presenting significant risks of corruption and fraud.

Mr. Campbell also advises clients on corporate governance issues and on the implementation of compliance codes. He helps companies assess risks in their international operations, and counsels on the development and implementation of policies, procedures, and systems designed to prevent and detect potential violations of law. He regularly provides training on FCPA and related issues to his clients' legal, compliance, and internal audit departments.

Mr. Campbell’s clients include U.S. and foreign companies and individuals in the pharmaceutical, energy, medical device, telecommunications, financial services, defense, computer software, and aerospace industries. Recent engagements include litigation and internal investigations involving activities in Western and Eastern Europe (including Russia), Asia, Africa, the Middle East, Latin America, and South America.

Mr. Campbell writes and speaks frequently on regulatory, criminal law, and compliance issues, and has served as a faculty member of Seton Hall Law School's Healthcare Compliance Certification Program. He has spoken at events for the American Conference Institute, the Pharmaceutical Compliance Congress and Best Practices Forum, the Practising Law Institute, the Society of Corporate Compliance and Ethics, the Pharmaceutical Internal Audit Forum, and has co-chaired the American Conference Institute's annual conference on FCPA & Anti-Corruption for the Life Sciences Industry.

Mr. Campbell received a B.A., with honors, from Hobart College, and a J.D., cum laude, from Vermont Law School.


SUSAN CLARKE

susan-clarkeSusan Clarke currently serves as the Group Leader for Johnson & Johnson’s Global Surgery Group (WEST) and is the lead Compliance Officer for the Specialty Surgery Group of companies within the Global Surgery organization.  She first joined Johnson & Johnson in 1999, supporting the development and maintenance of Quality Systems, before transitioning into Health Care Compliance.  As an HCCO, she has supported the development of compliance programs in three operating companies and has enjoyed the opportunity to create a dedicated monitoring function for the Global Surgery orgnaization. Prior to joining Johnson & Johnson, Ms. Clarke was a Certified Lead Quality Auditor, Certified Quality Trainer, and Quality Systems professional for Baxter Healthcare and Inamed.

Ms. Clarke is a graduate of California State University, Long Beach, and is a certified Corporate Compliance and Ethics Professional (CCEP).


PETER CLAUDE

peter-claudePeter Claude is an advisory partner in the San Francisco office of Pricewaterhouse Coopers (PwC), where he leads its national Risk Consulting practice across its Health Industries sectors. Mr. Claude brings an in-depth knowledge of the pharmaceutical and life sciences industry to his extensive process and controls background as well as an international perspective from a four-year tour of duty in Switzerland. Mr. Claude’s experience over the past 23 years includes international and U.S. governance risk and compliance work for a broad range of pharmaceutical, biotechnology, and medical device manufacturers and pharmacy benefit managers.

Mr. Claude was the principal author of "Recapturing the Vision," PwC's groundbreaking study on improving the Pharmaceutical Industry's reputation, and of several published studies on compliance issues in the Medical Device Industry. He is a frequent speaker on industry issues, compliance issues, and related process improvement topics.

Mr. Claude received a Bachelor’s of Business Administration from the University of Notre Dame.


DANIEL A. CODY

daniel-codyDan Cody is a member of the Life Sciences Health Industry Group, practicing in the area of health care regulatory law in the firm's San Francisco, California office.  Prior to transferring to San Francisco in 2003, he resided in the firm's Washington, D.C. office. He has been working with Reed Smith since 1998.

Mr. Cody's practice encompasses a wide variety of health law matters, including regulatory, fraud and abuse, privacy, and transactional practices.  Mr. Cody has counseled and advised health care clients concerning complex Medicare and Medicaid reimbursement and coverage issues.  He has advised clients regarding compliance and investigations involving federal and state fraud and abuse laws, including the federal False Claims Act, federal and state anti-kickback statutes, federal and state referral prohibitions, and state corporate practice of medicine provisions.  He has represented clients in regulatory and fraud and abuse matters in federal court, and before federal and state entities such as the Department of Justice, Centers for Medicare & Medicaid Services, Office of Inspector General, and state administrative agencies.  Mr. Cody also has advised clients regarding health care privacy matters, and has conducted regulatory due diligence and prepared and negotiated general commercial agreements.

Mr. Cody was recognized by the Legal 500 in the category of Healthcare: Service Providers in 2014, and was featured as one of California’s Top 20 Attorneys Under the Age of 40 in the Daily Journal (January 21, 2009).  Also, he has been named an “Outstanding Young Healthcare Lawyer” by Nightingdale’s Healthcare News in 2008.  Mr. Cody is affiliated with the American Bar Association, Health Law Section, the American Health Lawyers Association, the California Society for Healthcare Attorneys, the New York State Bar Association, District of Columbia Bar Association, and serves as a board member for the National Health Law Program and Larkin Street Youth Services.

Mr. Cody received his B.A. from Swarthmore College and his J.D. from William & Mary School of Law.


TORREY COPE

torrey copeTorrey Cope is a partner in the Food, Drug and Medical Device Regulatory group, who advises clients in the life sciences industry on matters involving FDA regulation of their products.  As an experienced regulatory lawyer with scientific training, he has a passion for helping pharmaceutical, biotechnology, and medical technology companies identify and overcome their most challenging regulatory and strategic problems.  His substantive experience includes matters associated with FDA requirements for clinical trials, marketing authorization, promotion, good manufacturing practice (GMP), and product safety.  This includes work for companies at the forefront of innovation, who are developing novel products in emerging technological fields such as immunotherapy, regenerative medicine, genetic testing/next generation sequencing (NGS) and digital health.

Mr. Cope also has extensive experience handling non-regulatory matters for life sciences clients.  For example, he develops FDA-based defenses to healthcare enforcement investigations arising under the False Claims Act (FCA), handles challenges to competitor advertising before the National Advertising Division (NAD), and serves as FDA counsel in product liability cases, civil litigation, and FDA enforcement proceedings.  In addition, he regularly works hand-in-hand with colleagues in Sidley’s Emerging Companies and Venture Capital, Private Equity, Securities, M&A, and Technology & IP Transactions groups, to provide life sciences companies with full integrated, strategically-oriented regulatory advice on a wide variety of transactions.

Prior to law school, Mr. Cope conducted research in molecular biology, then was a quality control microbiologist for a major sterile drug manufacturer.

Mr. Cope received a B.S., summa cum laude,  in Microbiology from Oregon State University and his J.D. from the University of Southern California Gould School of Law, where he was a member of the Order of the Coif and the Southern California Law Review.  Following law school, he clerked for Judge Percy Anderson, U.S. District Court, C.D. of California.


SCOTT CUNNINGHAM

scott-cunninghamScott Cunningham is a partner at Covington & Burling and a member of the firm’s Food and Drug practice group. He represents pharmaceutical, biotechnology, and medical device companies as well as trade associations in matters before the FDA, Congress, state and federal courts, and other regulatory and enforcement agencies. Mr. Cunningham has significant experience in areas including new product development and clinical trials; IRBs; new product approvals; Hatch-Waxman exclusivities and product life-cycle management; advertising and promotion; False Claims Act and Anti-Kickback compliance issues and pharmaceutical investigations; Orphan Drug; pediatric exclusivity; manufacturing and cGMPs; import/export; controlled substances; SEC disclosure; and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices.

Mr. Cunningham also has an active pro bono practice, where he regularly serves as a Guardian ad Litem representing children in neglect & abuse and child custody cases. He has been honored in the Washington DC Super Lawyers, FDA (2013-2014) and the Chambers USA-America’s Leading Business Lawyers, Healthcare: Pharmaceutical/Medical Products Regulatory (2012).

Mr. Cunningham received his B.A. from University of Pennsylvania and his J.D., cum laude, from University of Pennsylvania Law School. He was also a judical clerk for the Honorable R. Barcaly Surrick, U.S. District Court, Eastern Distrcit of Pennsylvania, from 2000-2001.


JACK P. DICANIO

jack-dicanioJack DiCanio is a partner at Skadden, Arps, Slate, Meagher & Flom LLP and the head of litigation practice at the firm’s Palo Alto office. His career encompasses a diverse trial practice focusing on complex, high-stakes federal and state court litigation, as well as white collar defense. Mr. DiCanio is annually ranked in Chambers USA’s prestigious Band 1, along with Skadden’s West Coast Litigation practice. He is also recognized in other publications for his successes on behalf of his clients, including by The Best Lawyers in America.

Mr. DiCanio previously served as an assistant United States attorney for the Central District of California. As the deputy chief of the General Crimes Section, he was responsible for training and supervising assistant United States attorneys in federal criminal practice and trial advocacy. During his tenure with the Department of Justice, Mr. DiCanio received the Attorney General’s Distinguished Service Award (the second-highest award within the Department of Justice).

Mr. DiCanio served on the Rampart Independent Review Panel, which was responsible for reviewing the policies, tactics, and disciplinary procedures of the Los Angeles Police Department. He also served as counsel to the Blue Ribbon Committee on Child Protection.

Mr. DiCanio received his B.A., magna cum laude, from University of Notre Dame, and his J.D. from Boston College Law School.


NAOKO FUJII

naoko-fujiiNaoko Fujii is Principal of Clementine Consulting LLC.  For eight years, she has assisted over ten start-ups create and implement low cost, scalable healthcare compliance, FDA advertising, and good clinical practices (GCP) compliance programs to meet requirements to launch their first FDA-regulated product.  She has her own FDA Regulatory Consulting business and often serves as the interim or full-time compliance officer for start-ups.  Recently, she assisted Relypsa, Portola, Anacor, MAP, Affymax, Exelixis, Medivation, AcelRx, Heron, XenoPort, ChemGenex, and Theravance set up compliance programs to prepare for the launch of their first product.

Ms. Fujii started her career as an FDA regulatory attorney in the Washington, D.C. office of the law firm of Weil, Gotshal & Manges, and then moved to New York/New Jersey to work as a corporate counsel for Merck and Pfizer, participating on the launch teams of Proscar®, Fosamax®, and Viagra®.  She moved to California in 2004 to become the Compliance Officer for Johnson & Johnson’s West Coast biotech operating companies and currently lives in Palo Alto, California.

Ms. Fujii graduated from Stanford University with honors and distinction in 1985, and Georgetown University Law Center in 1988.


WENDY GOLDSTEIN

wendy-goldsteinWendy Goldstein is a partner at Cooley LLP, a member of the firm’s business department, and a partner in its Health Care & Life Sciences Regulatory Practice in the New York Office. She concentrates her practice in healthcare fraud and abuse and government health care program matters relevant to manufacturers, payors, and other ancillary providers in the health care life sciences space. She also represents those entities that invest in such concerns.

Specifically, Ms. Goldstein is involved with counseling clients regarding the research, manufacture, sale, promotion, distribution, pricing, and import/export of pharmaceuticals, biologics and medical devices. She also counsels regarding government health care program compliance risks, including designing, implementing, and assessing the effectiveness of corporate compliance programs, conducting board of directors training, conducting internal investigations relating to compliance matters, providing self-disclosure counsel, and preparing Office of the Inspector General of Department of Health & Human Services (OIG) advisory opinion requests. Ms. Goldstein drafts and negotiates co-promote agreements, drug rebate agreements, supply chain arrangements, fee-for-service agreements, and third-party vendor arrangements as well as conducts health regulatory due diligences. She defends pharmaceutical manufacturers in all phases of government investigations and inquiries, and negotiates settlement agreements and OIG corporate integrity agreements on behalf of manufacturers in connection with the resolution of qui tam and other government actions, and defends companies in data breaches. Ms. Goldstein also counsels third-party payors in connection with the delivery of outpatient prescription drug benefit and speciality drug benefit programs offered under insured and self-insured products. Such counsel includes topics relating to fraud and abuse, reimbursement, coverage, relationships with vendors such as pharmacy benefit managers, wholesalers and dispensers, Medicare Part D, ERISA, corporate compliance, privacy, antitrust, and state law issues.

Prior to joining Cooley, Ms. Goldstein served as a partner in the New York office of a leading law firm specializing in, among other practices, health care and life sciences, where she was the chair of the firm's Health Care and Life Sciences Practice Steering Committee and the Pharmaceutical Industry Health Regulatory Practice Group.

Ms. Goldstein speaks and writes extensively on issues relating to fraud and abuse, board governance, government program pricing, corporate compliance, government enforcement activity relevant to the life sciences and managed care industries, and health care reform. She is a contributing author to the ABA Health Law Section Pharmaceutical Law treatise. She authored Chapter 8: Federal and State Regulation and Enforcement of Pharmaceutical Manufacturers’ Advertising and Promotional Activity in the 2015 and 2014 Practising Law Institute Pharmaceutical Compliance and Enforcement Answer Book. She has served as an adjunt professor of health care fraud and abuse at Pace University School of Law. She has also served on several advisory boards for industry publications and legal associations, including the New York State Bar Association Committee on Medical Research and Biotechnology and the New York City Bar Committee on Bioethical Issues.

Ms. Goldstein serves on the board of directors of several non-profit health care associations and educational institutions. She is also actively involved in pro bono activities relating to pediatric oncology research and other health care education and access initiatives.

Ms. Goldstein has been ranked by Chambers USA as one of America's leading lawyers for health care (2008 to 2014). She was selected for inclusion in The Best Lawyers in America (2013-2016) and in New York Super Lawyers - Metro (2006 to 2014), which cited her among its "Top 100" (2010 to 2012) and its "Top 50 Women" (2006, 2007, and 2009 to 2014). She was also selected as a Life Science Star in LMG Life Sciences 2012 and 2013, and was named by LMG as “Attorney of the Year” for Healthcare Pricing and Reimbursement in 2013. She was recognized as a leading lawyer in the 2012 Legal 500 United States, in the Healthcare Insurer category. She was also named as one of Nightingale’s Outstanding Young Healthcare Lawyers in 2007.

Ms. Goldstein received her B.A. from University of Michigan, her M.P.H. from University of Texas Health Science Center, and her J.D. from University of Houston Law Center.


CHARLES GUNTHER

Charles Gunther is Supervisory Special Agent at the Federal Bureau of Investigation (FBI).  He has served as an FBI Special Agent for over eighteen years.  He is currently assigned as Program Coordinator of the Complex Financial Crimes Program in the San Francisco Field Office of the FBI.  In his role, Mr. Gunther also manages a squad of FBI Special Agents, Intelligence Analysts, and others who investigate Corporate and Securities Fraud, Mortgage Fraud, Health Care Fraud, Bank Fraud, and Bankruptcy Fraud.

Prior to assignment in San Francisco, Mr. Gunther worked in Washington D.C. as the Acting Section Chief of Cyber Intelligence, responsible for the review and analysis of all FBI cyber analysis.  Mr. Gunther also previously worked at FBI Headquarters in the Financial Crimes Section, working in both the Health Care Fraud Unit and the Economic Crimes Unit.  In the Health Care Unit, he initiated the Internet Pharmacy Fraud Initiative, and in the Economic Crimes Unit, where he set up and assisted in the obtaining of funding for the FBI Regional Corporate Fraud Response Teams.

Mr. Gunther earned a Degree in Finance, and in March 1996, after a career as a Bond Trader and Broker in the Securities Industry, Mr. Gunther joined the FBI as a Special Agent.  Initially assigned to the Los Angeles Field Office, he investigated Securities Fraud, Bankruptcy Fraud, and Financial Institution Fraud.  In 1999, Mr. Gunther was transferred to the San Francisco Field Office, where he investigated Health Care Fraud and Securities Fraud matters, and was a member of the FBI Evidence Response and Hazmat Teams.


JACQUIE HAGGARTY

jacquie-haggartyJacquie Haggarty is Associate General Counsel at 23andMe, a leading personal genetics company.  Prior to joining 23andMe, she served as senior commercial counsel at Genomic Health, a molecular diagnostics company, focused on international legal and health care compliance.  She began her career at Latham & Watkins.

Ms. Haggarty received her B.A. from the University of California at Berkeley, an M.P.P. from Harvard’s Kennedy School, and her J.D. from Georgetown University Law Center.


JOSHUA HILL

joshua-hillA former federal prosecutor, Josh Hill is now a partner at Sidley Austin, LLP, and practices in its White Collar, Complex Commercial Litigation, and Securities Litigation practice groups. Mr. Hill handles a wide range of litigation and regulatory matters, including corporate internal investigations, health care fraud and abuse investigations, Securities & Exchange Commission investigations, securities litigation, shareholder derivative suits, and commercial litigation. He also puts to use his M.A. and B.A. degrees in Economics by working closely with experts in quantitative fields such as financial valuation, damages analysis, and biostatistics. Mr. Hill is also the pro bono coordinator for the San Francisco office.

While serving as an Assistant U.S. Attorney in the Northern District of California, Mr. Hill investigated and prosecuted a wide range of offenses, including wire and mail frauds, bank fraud, criminal tax, immigration violations, and violent crimes. An accomplished trial attorney, he tried seven cases to jury verdict, including wire fraud and embezzlement offenses, and argued numerous appeals before the Ninth Circuit.

Mr. Hill serves as a Board Member of the Lawyers’ Committee for Civil Rights Under Law, a nonpartisan, nonprofit organization, formed in 1963 at the request of President John F. Kennedy, to enlist the private bar's leadership and resources in combating racial discrimination and the resulting inequality of opportunity. Additionally, he is a member of the Lawyers’ Committee for Civil Rights of the San Francisco Bay Area, the Edward J. McFetridge American Inn of Court, the Bar Association of San Francisco’s Judiciary Committee, and the Northern District of California Criminal Justice Act Panel. Mr. Hill has served as a court-appointed mediator in two cases filed in the Eastern District of New York. He also served as a Law Clerk to the Honorable Jack B. Weinstein of the U.S. District Court for the Eastern District of New York.

Mr. Hill has a J.D. from Yale Law School, an M.A. in Economics from Johns Hopkins University, and a B.A. in Economics from Morehouse College.


FABIANA LACERCA-ALLEN

fabiana-lacerca-allenFabiana Lacerca-Allen is President of Ethiprax Consulting. She has had more than 20 years of experience working for leading American companies such as Bristol-Myers Squibb Company, Microsoft, Merck, and AT&T. She has counseled and litigated in the field of international business transactions and international environment law, and has extensive experience in the pharmaceutical industry in leadership roles in charge of legal and compliance teams. She has counseled and represented clients in a broad range of questions, including strategic business initiatives ensuring compliance with laws and regulations, and corporate policy.

Ms. Lacerca-Allen has provided legal support and strategic advice on opportunities and trends in law, particularly within the government sector, as well as with major and strategic corporate accounts. She has established policies and oversight on key areas of compliance affecting international markets and has been able to positively impact the perception of compliance, creating compliance training programs and relevant standard operating procedures.  She has also been involved in validating and aiding due diligence in the compliance industry.

Ms. Lacerca-Allen is well-recognized in the industry, and is frequently requested as a speaker and participant in forums.  Recognized by Hispanic Executive Magazine in 2013, she serves as Chair to the Bay Area Ethics & Compliance Association (BECA) and served as Co-Chair for CBI, an Advanstar company serving the life sciences industry.

Ms. Lacerca-Allen was invited to join the Gioja Research Institute while she was a student researching environmental law.  She was the recipient of UCLA’s tuition waiver in 1992 based on merit and recognition, and she represented UCLA in the Roscoe Foundation National Essay Contest, submitting a paper on global warming.

Ms. Lacerca-Allen received her Bachelor of Law degree from the Universidad de Buenos Aires. She obtained her LLM degree from UCLA in June 1993, obtaining the highest grade awarded on her thesis.


HAE-WON MIN LIAO

hae-won-min-liaoHae-Won Min Liao is Senior Counsel in Gilead’s Commercial Legal group, where she is responsible for managed care contracting, government price reporting, antitrust, privacy, and fraud and abuse issues. Prior to joining Gilead, she was a partner at Sidley Austin LLP, where she represented a variety of clients, including pharmaceutical and medical device manufacturers, biotech companies, durable medical equipment suppliers, hospitals, and other healthcare entities.

Ms. Min Liao’s practice has included compliance counseling related to price reporting under the Medicare and Medicaid programs, the Federal Anti-Kickback Statute, and the Sunshine Act. She has experience in drafting and negotiating managed care contracts, analyzing exclusion and personal liability risks, preparing compliance policies, and reviewing distribution systems. Her practice has involved strategic advice related to services fees, coverage and reimbursement of products, and competitive bidding. She has performed internal corporate investigations and defended companies in government investigations involving healthcare fraud and abuse allegations and the False Claims Act.

Ms. Min Liao was recognized in the LMG Life Sciences in 2013, 2014 and 2015 as a Regulatory Life Sciences Star. She is also ranked in Chambers USA: America’s Leading Lawyers for Business in 2009 as “Associate to Watch” and in both 2010 and 2011 as “Up and Coming.”

Ms. Min Liao received her B.A., cum laude, from Yale University, and her J.D. from The University of Chicago Law School.


JOHN P. OROHO

john-orohoJohn Oroho is Executive Vice President and Chief Strategy Officer of Porzio Life Sciences, LLC.  He meets regularly with companies to identify sales and marketing issues and to propose solutions that streamline their practices in meeting compliance requirements of all 50 states and the District of Columbia.

Mr. Oroho is also a principal of the law firm, Porzio, Bromberg & Newman P.C., and practices in the Life Sciences Compliance and Commercialization Department.  He concentrates his law practice in regulatory compliance with respect to the Prescription Drug Marketing Act (PDMA), Anti-Kickback statute, False Claims Act, and Medicare and Medicaid fraud and abuse.

Mr. Oroho previously served as Senior Vice President and General Counsel for the PDMA Alliance, a national trade association focused on sample distribution and pharmaceutical marketing and sales compliance.

Mr. Oroho has an extensive pharmaceutical regulatory and compliance background.  He spent three years as General Counsel for Integrated Pharma Technologies and Computer Systems Services & Consulting, Inc.

Mr. Oroho received his B.S. from the United States Merchant Marine Academy, where he graduated with honors, and his J.D. from the University of Notre Dame School of Law.


KATHLEEN PETERSON

kathleen-petersonKathleen A. Peterson is a member of the Cooley Business Department and Special Counsel in Cooley's Health Care & Life Sciences Regulatory practice in its Washington, D.C. office.  She has provided health regulatory counsel to a range of industry clients, including pharmaceutical, biologic and biotechnology manufacturers, distributors, PBMs, managed care organizations, specialty pharmacies, clinical laboratories, and investment firms.

Ms. Peterson's experience includes analyzing contracting, reimbursement, and fraud and abuse issues in connection with federal and state health care programs (including Medicare Parts B and D, and Medicaid), counseling regarding government drug pricing calculations, marketing practices, rebate contracting practices, grants, coupon programs, consulting relationships, CME programs, medical communications, repackaging, drug sampling, marketing and price disclosure laws, false claims, kickbacks, and inducements, coordinating responses to government investigations and inquiries, and conducting internal compliance reviews.

In addition, Ms. Peterson implements corporate compliance programs, and performs compliance training at field and management levels; advises on various clinical trial and FDA regulatory issues, including OPDP compliance, Phase IV trials, and REMS; reviews and analyzes health reform developments regarding life sciences and pharmacy benefits issues; and counsels regarding managed pharmacy issues and negotiating complex pharmacy benefit management agreements.

Prior to joining Cooley, Ms. Peterson was a partner in another leading law firm, where she was a key member of the Pharmaceutical Industry Health Regulatory practice group.  Separately, Ms. Peterson has worked in-house as Senior Corporate Counsel to a pharmaceutical company, where she was the primary internal legal counsel for commercial sales and marketing issues.

Ms. Peterson authored the chapter on the Medicare Part D drug benefit in the American Health Lawyers Association's "Medicare Law" (3rd ed. 2012).  She has been selected as a Life Sciences Star by LMG Life Sciences, based on peer opinion, client feedback, and independent research, each year from 2012 to 2014.  She was also recognized as a Washington, DC “Rising Star” by Super Lawyers in 2014.  She served as the Vice-Chair of the American Health Lawyers Association Medicare Part D Task Force from 2006 to 2008, and is a frequent public speaker on a range of issues pertaining to the pharmaceutical, biologic, and managed care industries.

Ms. Peterson received her B.A. from State University of New York, College of Geneseo, and her J.D with honors in Health Law Concentration from Boston University School of Law.


SUMITA RAY

sumita-raySumita Ray is Chief Compliance Officer & Associate General Counsel at Pharmacyclics.  She leads the company's Global Compliance Program and Healthcare Law Department in both the U.S., and outside of the U.S.  Since joining Pharmacyclics in April 2013, she has had over 15 years of global Legal, Regulatory, and Compliance experience in the pharmaceutical and biotech industries.  Her legal and compliance practice involves collaboration with and advising, among others, the Clinical Development, Medical Affairs, Sales and Marketing, Manufacturing and Quality business units on strategies and tactics to meet their business goals in an ethical, legally sound, and compliant manner.

Prior to joining Pharmacyclics, Ms. Ray was Senior Director & Corporate Counsel at Elan Pharmaceuticals in San Francisco, where she was a member of the company’s Legal Leadership Team, and Head of the BioNeurology Law Group, leading and managing a team of lawyers and paralegals in global support of Elan’s pipeline and marketed products.  In 2010, she was significantly involved in the negotiation and resulting $200 Million settlement of Elan’s Corporate Integrity Agreement with the Office of Inspector General, and the subsequent drafting, implementing, and training of the global business on key policies and procedures related to a Global Compliance program.  Prior to joining Elan, Ms. Ray served as Corporate Counsel in the in-house legal department of AstraZeneca Pharmaceuticals for over two years, followed by Genentech for three years, where she was the Lead Legal and Compliance Counsel for each respective company’s blockbuster drug product, successfully facilitated several FDA label negotiations, approvals and subsequent product launches, and was the primary legal advisor for all product-related regulatory and compliance matters.  Prior to moving in-house, Ms. Ray spent nearly five years as a pharmaceutical and products liability litigator at a major Philadelphia based law firm, where she spent a significant amount of time on the FEN-PHEN pharmaceutical products liability case and related investigation, among other large and historic pharmaceutical cases.

Ms. Ray has a B.S. in Microbiology & Chemistry from the University of Arizona and a J.D. from Temple University Law School.


KENIA RINCON

Kenia Rincon is Director of Health Information Privacy and Security at PricewaterhouseCoopers, LLP.  She has 20 years of industry experience in leadership and implementation of information security, privacy, IT audit and compliance, and risk assessment processes, including development and implementation of enterprise-wide processes for security and privacy risk assessment, and data protection compliance verification at large healthcare providers, academic medical centers (post-breach), and multinational pharmaceutical companies.

Ms. Rincón is a HealthCare Information Security and Privacy Practitioner (HCISPP),  Certified Information Privacy Professional (CIPP), Certified Information Systems Security Professional (CISSP), Certified Information Security (CISM), and a Six Sigma Green Belt.  She also holds a Master of Science in Information Systems Engineering.


ELAINE H. TSENG

elaine-tsengElaine Tseng is a partner at King & Spalding and a member of the firm’s FDA & Life Sciences Practice Group. In her practice, she advises medical device, pharmaceutical, and biotechnology companies on a variety of FDA approval, compliance, and enforcement matters.

Ms. Tseng previously served as Regulatory Counsel at the Food and Drug Administration, where she received the Department of Health and Human Services Secretary’s Award for Distinguished Service and other FDA honors.

Ms. Tseng has been invited to speak on topics of FDA regulation for groups including the American Conference Institute (ACI), the Advanced Medical Technology Association (AdvaMed), the Biotechnology Industry Organization (BIO), and the Center for Business Intelligence (CBI).

Ms. Tseng received her B.A., magna cum laude, from Cornell University, and her J.D. from Harvard University.


SARA WINSLOW

Sara Winslow is an Assistant United States Attorney and a Deputy Chief of the Civil Division in the United States Attorney s Office for the Northern District of California.

She supervises that office’s civil False Claims Act cases, including health care and pharmaceutical fraud. Ms. Winslow was previously a Trial Attorney at the U.S. Department of Justice’s Civil Division in Washington, D.C., where she handled False Claims Act cases across the country.



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