Through more than a decade of experience in private practice and positions within the FDA and on the Hill, Wade Ackerman has acquired unique insights into the evolving legal and regulatory landscape facing companies marketing FDA-regulated products.
As a partner at Covington, Mr. Ackerman advises clients on FDA regulatory matters across a range of sectors, including drugs and biologics, cosmetics, medical devices and diagnostics, and digital health products and services associated with drugs and traditional devices. He serves as one of the leaders of Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable resources across the broad array of legal, regulatory, commercial, and policy issues relating to the development and marketing of digital health technologies.
Until June 2016, Mr. Ackerman served as Senior FDA Counsel to the U.S. Senate Health Education, Labor & Pensions (HELP) Committee. In this role, he was involved in all major legislative initiatives, oversight hearings, and other Senate activities concerning the FDA and the Federal Food, Drug, and Cosmetic Act. From January 2015 through June 2016, he helped negotiate many of the FDA-related provisions in the 21st Century Cures Act, which included reforms to FDA’s review and approval of new drugs, devices, combination products, and digital health software. He also worked closely with the FDA and other stakeholders as Congress examined legislative reforms in other key areas, including diagnostics and laboratory developed tests, cosmetics, and over-the-counter drugs.
Before taking his Senate role, Mr. Ackerman served for more than five years as Associate Chief Counsel within the FDA’s Office of Chief Counsel. He was responsible for providing legal advice to the FDA’s Center for Drug Evaluation and Research (CDER) and the Office of Commissioner (OC) on a wide range of issues. While at FDA, he also helped to develop and implement the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 and the Drug Quality and Security Act (DQSA) of 2013—both significant reforms to FDA’s regulatory authorities.
George “Chip” Cannon
George (Chip) Cannon, Jr. focuses his practices on energy regulatory and commercial matters, with a concentration on the production and delivery of electric energy and related products, including from wind, solar and other renewable energy resources. He has been involved in representations before the Federal Energy Regulatory Commission (FERC), the U.S. Department of Energy (DOE), federal courts and state regulatory commissions on behalf of electric utilities, independent power producers, project developers, energy traders, financial institutions, and manufacturers of renewable technologies.
Mr. Cannon regularly analyzes issues under the Federal Power Act, the Public Utility Regulatory Policies Act, the Public Utility Holding Company Act of 2005, the Energy Policy Act of 2005, the American Recovery and Reinvestment Act of 2009, and various state energy industry restructuring statutes. He has represented clients before FERC in a broad range of matters affecting the domestic energy industry, including issues related to transmission investment and open access, the operation of competitive wholesale energy markets, and the development and implementation of market rules relating to market power and mitigation. He regularly assist clients with all regulatory aspects of acquisitions, divestitures and financings of projects subject to FERC jurisdiction, including obtaining required FERC and state public service commission approvals. He is also experienced in energy and asset management issues, including negotiating and drafting management, service, and fuel and power purchase/sale agreements.
He is familiar with the incentive-based programs associated with the development of renewable energy resources, including various state Renewable Portfolio Standards and Smart Grid technologies, and is experienced in drafting contracts for the purchase and sale of Renewable Energy Credits and other green attributes. Mr. Cannon has assisted clients in accessing programs administered by the DOE, including the Load Guarantee Program and other programs under DOE’s Energy Efficiency and Renewable Energy Office, and state energy programs.
Ann Claassen is counsel with the Latham & Watkins’ Environment, Land & Resources Department. Her practice focuses on chemical regulation under programs administered by US federal agencies, including EPA, FDA, CPSC, NTP, CDC, DOT, OSHA, state and Canadian provincial environmental agencies, including California’s ARB and OEHHA, and foreign regulatory agencies, including Environment Canada, Health Canada, Ontario MOE, the EU Environment DG and the Japanese Ministry of the Environment. She regularly advises clients on matters arising under TSCA, CAA, EPCRA, FIFRA, CWA, RCRA, CERCLA, FFDCA, FHSA, Prop 65, REACH and other regulatory programs. Ms. Claassen provides compliance counseling, drafts comments on proposed rules and agency initiatives, assists clients in enforcement matters, and assists clients with product stewardship and communications issues. Much of her work involves integration of legal principles with toxicology and risk assessment science. She was on brief for two successful judicial challenges to EPA rulemakings (one under CAA and one under RCRA) and has contributed to successful petitions to delist chemicals from EPCRA Section 313. She has developed training presentations on TSCA, toxicology and chemical nomenclature.
Ms. Claassen is a co-author of the Environmental Law Institute ELR Pesticide Regulation Deskbook and a contributor to the ELR TSCA Deskbook. She has taught the TSCA portion of the NYU Summer Institute in Environmental Law, and has made presentations at various environmental seminars and conferences.
Ms. Claassen received her BA, magna cum laude, in Biochemistry from The Colorado College and undertook graduate studies in Physical Chemistry at the University of New Mexico. Prior to entering law school, she worked as an environmental consultant focusing on water quality and water resource issues, and she also spent two years heading the ground water monitoring portion of the New Mexico RCRA program.
Ms. Claassen received her JD, summa cum laude, from the University of New Mexico in 1989. She clerked for the Honorable James M. Sprouse, US Court of Appeals for the Fourth Circuit, for a year prior to beginning her practice with Latham & Watkins in Washington, D.C.
Dan Clivner is co-leader of Sidley Austin’s Private Equity practice, managing partner of the Los Angeles and Century City offices and a member of the firm’s Executive Committee. Dan handles high-profile transactional matters for clients in the media and entertainment, telecom, technology, financial services and retail industries.
He has extensive experience advising both domestic and international private equity and corporate clients on a variety of matters related to M&A, corporate governance and securities law matters such as leveraged buyouts, joint ventures, public company acquisitions and restructurings. Dan also advises boards, management, special committees and investment banking firms on domestic and international corporate transactions.
Prior to joining Sidley, Dan served as managing partner of the Los Angeles office of an international law firm. In 1996, he relocated to Los Angeles from New York to advise The Seagram Company and NBC Universal (formerly Universal Studios) in connection with numerous television, theme park, motion picture and music acquisition, disposition and financing transactions, including the acquisition of Polygram N.V., the sale of USA Networks and PolyGram Filmed Entertainment and Seagram’s merger with Vivendi SA.
Dan was ranked by Chambers as a leading lawyer (Band 2) in Corporate/M&A: Private Equity in California and recognized as the 2016 Corporate Lawyer of the Year by the Century City Bar Association. Law360 also recognized him as a “2016 MVP” for Private Equity. He earned his J.D. from St. John’s University School of Law, where he was editor of the St. John’s Law Review. Dan received his B.B.A. in finance and economics, with honors, from Baruch College.
Jaime M. Crowe joined White & Case in 1997. Based in Washington, DC, he is a member of the Firm’s Litigation and International Arbitration Groups. Mr. Crowe has broad litigation experience, with particular emphasis on antitrust disputes. His international arbitration experience primarily has focused on the representation of state sovereigns before the International Centre for the Settlement of Investment Disputes (ICSID). Mr. Crowe’s work over the years has included Representation of parcel tanker company Stolt-Nielsen S.A. in a landmark criminal case brought by the Antitrust Division of the United States Department of Justice, Representation of Stolt-Nielsen S.A. in defense of securities class action brought in federal court in Connecticut., Counsel for Upsher-Smith Laboratories, Inc., a US pharmaceutical company accused of antitrust violations in In the Matter of Schering-Plough, et al. (FTC Docket No. 9297), and in Victor Pey Casado and Presidente Allende Foundation v. Republic of Chile (ICSID ARB/98/02), counseled the Republic of Chile in formulating its strategy and preparing its submissions objecting to jurisdiction.
Daniel Franklin is counsel in the New York office of O’Melveny & Myers. His practice focuses on labor and employment, complex business litigation, class actions, and mass torts, among other matters. He represents a broad array of clients including major airlines, insurers, real estate developers and contractors, brokerage holding organizations and franchisors, and tech companies.
Before joining O’Melveny, Daniel worked at the World Bank, where he analyzed international and foreign-domestic laws applicable to the Bank’s projects. He also assisted negotiations with client governments regarding the Bank’s standard bidding documents, and revised and updated the Bank’s procurement guidelines.
Daniel has an active pro bono practice, and has represented individuals and organizations in a wide range of matters. Before joining O’Melveny, he worked with several non-profit organizations, including The Synergos Institute, an international organization dedicated to fighting poverty and promoting equity in the developing world. In addition, he interned with public officials in the United States and the United Kingdom, including then U.S. Senator Joseph R. Biden, Jr.
Daniel is dedicated to diversity awareness and was recently selected as one of the National LGBT Bar Association’s 40 Best LGBT Lawyers Under 40. He was a founding member of the LGBT Bar Association of New York’s Public Interest Law Committee and is a member of the Williams Institute’s Legal Council.
Michael Gottfried recently joined Landau & Berger LLP, a firm specializing in bankruptcy proceedings, commercial litigation, and in loan restructurings and workouts. Prior to joining Landau & Berger, Michael was a partner at Kirkland & Ellis LLP, where he focused on the representation of debtors, creditors, creditors’ committees and asset purchasers in corporate restructurings and bankruptcies, and served as Chairman of Kirkland’s Los Angeles Diversity Committee.
Michael is currently a member or affiliated with the American Bankruptcy Institute, American Bar Association, LAMBDA Leadership Council, Financial Lawyers Conference, Firmwide GLBT Subcommittee, Los Angeles Bankruptcy Forum, Los Angeles County Bar Association, and The State Bar of California, Insolvency Law Committee.
Jeffrey S. Haber
Jeffrey Haber is a partner in the Los Angeles office of Paul, Hastings, Janofsky & Walker. Mr. Haber focuses his practice in land use and real estate development. He has significant experience in all areas of entitlement law, transactional real estate, administrative law and lobbying, construction and architectural law, and political law, including negotiating major real estate purchase agreements, preparing environmental impact reports, negotiating development agreements, drafting and negotiating construction and architectural contracts, and drafting and processing municipal and state legislation.
Mr. Haber has represented museums, hospitals and motion picture studios, as well as commercial developers of office, hotel, retail, residential and mixed-use projects.
Mr. Haber is lead land use and real estate counsel for several public and private companies and entities including Cedars-Sinai Medical Center, the largest private hospital in the western United States, The J. Paul Getty Trust, DreamWorks Animation, IAC, and Regent Properties.
Mr. Haber has hosted numerous political fund-raisers and is an active contributor to local charities. He provides pro bono counsel to AIDS Project Los Angeles, the largest AIDS services organization in the western United States, and was Chair of the Board of Directors from 2001 through 2004. He is also a member of the Board of Directors of Equality California. He is a licensed California real estate broker and a registered lobbyist in the cities of Los Angeles and West Hollywood. Mr. Haber received his J.D. from Yale Law School in 1987, and his B.A., magna cum laude, in English, from Yale University in 1984. He is admitted to practice in California.
Laurie F. Hasencamp
Laurie Hasencamp spends most of her time on volunteer community service since she retired from law in 2002. In addition to being a member of the Williams Institute Founders Council and chair of the Williams Institute Legal Council, she is chair of the USC Law School Board of Councilors and a member of the boards of directors of Lambda Legal, GLSEN (effective Jan. 2009), The Serra Project (chair of the board; agency provides housing for homeless people with HIV/AIDS), and the Children Affected by AIDS Foundation. She is a 1985 graduate of USC Law School and a 1980 graduate of Pomona College. Laurie clerked for the Honorable Warren J. Ferguson, United States Court of Appeals for the Ninth Circuit following law school. She then practiced bankruptcy law with Latham & Watkins and Irell & Manella before becoming a Legal Research Director and Director of Network of Legal Experts for LRN, the Legal Knowledge Company. She came out of retirement a few years ago to be the Interim Executive Director of The Serra Project, the Interim Managing Director of the Office of Development and Graduate Relations at USC Law School, and adjunct lecturer for a section of the USC Law School first-year legal writing class. Before law school, she was an assistant operations officer at Lloyds Bank California. In 2008 she received a Women of Distinction award from USC as a community leader. She is married to Mike Lurey.
David A. Kettel
David Kettel was educated at the University of California at Davis, from which he earned a B.A. degree in Economics in 1982, and Tulane University School of Law, where he was named a Maritime Scholar and from which he received his J.D. degree in 1985. David practiced civil litigation in Los Angeles from 1985 until 2000, first as an associate and then as a partner at the Los Angeles office of Baker & Hostetler, a firm based in Cleveland, Ohio. In private practice, David tried many cases to verdict and was the lead trial attorney for Long Beach Housing Development Company (“LBHDC”), wherein LBHDC prevailed at trial and on appeal, proving its tax exempt status, Long Beach Housing Development Company v. County of Los Angeles and State Board of Equalization, NC 019229.
In 2000, David left private practice and became a Director at LRN, Inc., a leading provider of software solutions for corporate governance, ethics and compliance issues. David subsequently returned to the practice of law and from 2002-2008 worked in the Criminal Division of the United States Attorney’s Office in Los Angeles. As a federal prosecutor, David worked with various federal agencies, including the FBI, IRS, DEA, ATF, Secret Service, and the Department of Homeland Security, and has investigated, prosecuted and tried numerous criminal cases, including matters involving bank fraud, identity theft, narcotics smuggling, child pornography, illegal alien smuggling, and bank robbery. In 2003, David assisted the Secret Service in shutting down one of the largest false identification document factories in Los Angeles and prosecuting its principals. U.S. v. Gary Vazquez, et al., CR 03-1260-SJO.
David was born in New York and resides in the Hollywood Hills with his partner, Mike Gleason.
Michael S. Lurey
Michael Lurey is a partner in the Los Angeles office of Latham & Watkins, where he has practiced since 1970. He is the chair of the firm’s Southern California Insolvency Practice Group and former co-chair of the firm’s global Insolvency Practice Group. He also chaired the firm’s Finance Department from 1988 to 1991, which administers finance, commercial law and insolvency matters. Mr. Lurey regularly represents debtors, borrowers, lenders, creditors’ committees and other parties in all aspects of insolvency matters, including chapter 11 cases and out-of-court restructurings. He has represented borrowers, secured creditors and creditors’ committees in major financing transactions and out of court restructurings. He has also represented lenders and borrowers in new financings and structured finance transactions.
Mr. Lurey currently represents the Chief Liquidating Officer of MII Liquidation, Inc. (the successor to Metabolife International, Inc.) and the trustee of the liquidating trust formed under the liquidating plan confirmed by MII. He is serving as special litigation counsel in the chapter 11 cases of Franchise Pictures LLC and its affiliates. He also represents the liquidation trust established under the chapter 11 plan confirmed by Consolidated Freightways Corporation, et al as chapter 11 debtors. Mr. Lurey served as counsel to Leap Wireless International Inc. and Cricket Communications, Inc. as chapter 11 debtors. Leap and Cricket confirmed pre-negotiated chapter 11 plans of reorganization under which the secured indebtedness of the debtors was converted into the equity of the reorganized companies. He was counsel to NorthPoint Communications Group, Inc. et al as debtors in possession in their chapter 11 cases, through which they sold substantially all of their assets on a going-concern basis. He also represented the official creditors’ committees in the chapter 11 cases of Superior National Insurance Group, Inc. and MedPartners Provider Network, Inc., which successfully confirmed chapter 11 plans of liquidation. He represented the secured bank groups in the chapter 11 cases of Matthews Studio Equipment Group, and Global Health Sciences, Inc. and their affiliates, and negotiated the liquidation of the bank groups’ collateral in each of these cases.
Mr. Lurey is a frequent lecturer and chairperson for the American Bankruptcy Institute, the California Bankruptcy Forum, the Practising Law Institute and various other state educational organizations. He has published articles on numerous aspects of secured and unsecured lending, second lien financings, fraudulent transfer laws, chapter 11 cases and loan restructurings and is co-author of Matthew Bender’s treatise “Collier Lending Institutions and the Bankruptcy Code”(1985) and annual updates for that treatise.
Mr. Lurey was listed as a top-tier bankruptcy and restructuring lawyer in California by Chambers USA 2007 and named as an Outstanding Bankruptcy Lawyer of 2003 by Beard Group Inc.’s Turnarounds and Workouts Reporter. He has been listed as a leading insolvency and restructuring counsel in Who’s Who Legal every year since they initiated their review of insolvency counsel and has been named in The K&A Restructuring Register America’s Top 100 each year since its inception. Mr. Lurey was selected for membership in the American College of Bankruptcy in 1994. Mr. Lurey is a member of the Los Angeles County Bar Association and was the chairperson of the Commercial Law and Bankruptcy Section of that association from 1981 to 1982. He has been a member of the Committee on Business Bankruptcy and the Corporation, Banking and Business Law Section of the American Bar Association since 1974. Mr. Lurey is a member and past president of the Financial Lawyers Conference in Los Angeles.
Candace L. Matson is a partner in Sheppard Mullin’s Los Angeles office where she specializes in construction law. Ms. Matson represents owners, lenders, contractors, subcontractors, design professionals and others as an advocate in a wide range of private and public contexts relating to construction. The subject of such representation includes the preconstruction, construction and post-construction phases. Ms. Matson also serves as an arbitrator and mediator of construction disputes, both privately and through the auspices of various ADR providers. She is a graduate of the UCLA School of Law and is licensed in California.
Don McMinn is a partner at Hollingsworth, LLP in Washington, DC and practices in the Firm’s Insurance and Pharmaceutical Products groups. Mr. McMinn participates in the defense of MDL proceedings, from the time of the decision to petition for MDL status through the multi-month trial and settlement of “bellwether” plaintiffs. He conducts depositions, develops expert testimony concerning causation and damages issues, and engages in motion practice to eliminate opponents’ causation experts on Daubert grounds.
Mr. McMinn works extensively on behalf of policyholders seeking to maximize environmental coverage. In doing so, he has developed strong relationships with specialized accounting consultants and has significant experience in the use of sophisticated computerized allocation models. He represents clients involved in litigation of issues arising out of overlapping coverage, including the application of other-insurance clauses and the impact vel non on the insured of the contribution and subrogation claims of one of its insurers against another. He advises clients with respect to coverage issues arising out of product liability claims and matters involving workplace exposure to noise and hazardous substances.
Mr. McMinn regularly speaks to groups of policyholders and of lawyers concerning insurance topics, including managing the insured-insurer relationship and securing defense costs in the event of a conflict between an insured and its insurers. He has served on the editorial board of the Insurance Coverage Law Bulletin since 2009 and is an Adjunct Professor of Law (teaching insurance law) at The George Washington University Law School.
Mr. McMinn served as a Note & Comment Editor for the New York University Law Review. After graduating from law school, he clerked for Chief Judge Manuel L. Real of the United States District Court for the Central District of California.
Jackson Pai practices in the International Trade Client Service Group of Bryan Cave Leighton Paisner LLC. His practice covers a range of international and trade issues, including customs, export control, the Foreign Corrupt Practices Act, the World Trade Organization, and international corporate transactions.
Prior to joining the firm in 2007, Mr. Pai served as the first legal advisor for Taiwan’s Permanent Mission to the WTO in Geneva from 2002 until 2006. In that capacity, he participated in all of the more than 20 WTO disputes to which Taiwan was a party or third party during that period. On behalf of Taiwan, he drafted a number of third-party submissions, oral statements, and written replies to questions of the Panel. He also attended the substantive meetings of the Panel and the Appellate Body where Taiwan was allowed to participate and replied to questions by the Panel or Appellate Body at the meetings.
From 2000 to 2002, Mr. Pai worked in Washington, D.C., assisting small family farmers, farm associations and small agricultural businesses on agricultural trade policy issues in front of Congress. During law school, Mr. Pai clerked for the American Civil Liberties Union in Washington, D.C., and New York City and interned for a summer at the State Department. Mr. Pai is fluent in Mandarin and Taiwanese.
Edward Sadtler is a partner in Kirkland’s New York intellectual property group. Edward focuses his practice on transactions involving intellectual property and technology, such as licensing, joint venture, joint development, outsourcing, and distribution agreements, as well as mergers and acquisitions, private equity investments, secured lending and restructuring matters where intellectual property and technology are important. His practice also includes counseling clients on the clearance, protection and enforcement of trademarks and on privacy and other issues related to doing business on the Internet. Edward’s experience includes working with both Fortune 100 and rapidly growing technology-driven companies and covers many industries, including financial services, retail sales, travel services and communications.
Edward also advises numerous non-profit organizations on intellectual property and coordinates a program for attorneys and summer associates representing domestic violence victims in filing petitions seeking permanent resident status with the U.S. Citizenship and Immigration Services.
Colin B. Vandell
Colin Vandell is a member of Venable’s Litigation practice in Los Angeles. Mr. Vandell represents industry-leading companies and high-profile individuals in complex business litigation, including commercial disputes, intellectual property litigation, mass torts, and consumer protection actions. His practice encompasses a variety of industries, including entertainment and media, real estate, hospitality, and consumer products.
Mr. Vandell has extensive experience in all aspects of civil litigation, including large-scale discovery, alternative dispute resolution, and trial work on high-value matters involving numerous significant issues of first impression. The commonsense approach pursued by Mr. Vandell across his litigation matters has yielded immensely successful results for both plaintiff and defendant clients. By charting a concerted strategy from the outset, and working closely with clients at each step of the litigation process, Mr. Vandell has repeatedly demonstrated that lawsuits may be pursued and resolved efficiently and effectively.
Tom Watson is a partner in the Complex Litigation Department of Hennigan Dorman LLP. Mr. Watson’s primary expertise is in the trial and arbitration of complex civil cases with an emphasis on business litigation, energy litigation, securities litigation, bankruptcy litigation, patent litigation and the False Claims Act. He has represented a variety of Fortune 500 companies, investment firms and hedge funds, high tech companies, energy companies, and high net worth individuals.
Mr. Watson’s practice takes him to federal and state courts across the country, and he has had numerous trials, including both jury and bench trials. He is also experienced in representing clients in arbitration, with a particular specialty in arbitration under the rules of the American Arbitration Association.
His relevant experience includes the successful defense of Sempra Generation following a four-week jury trial in a case brought by the California Department of Water Resource claiming fraud and breach of contract involving a $6.6 billion long-term energy contract that the state signed as part of then-Governor Davis’s response to the California energy crisis. Mr. Watson also successfully defended Sempra Energy in an arbitration brought by Occidental Energy Ventures Corp., in which Occidental claimed more than $100 million in actual damages for breach of fiduciary duty relating to the joint development of a power plant.
Mr. Watson represented, as part of a team of lawyers, two whistleblowers in connection with two qui tam lawsuits brought against HCA Inc., then the nation’s largest for-profit healthcare provider, for Medicare cost-report fraud. HCA Inc. paid $881 million to the United States to settle the cases and related charges. At the time, the qui tam settlement was the largest in U.S. History.
Most recently, Mr. Watson won a $9.5 million judgment plus post-confirmation interest in the amount of about $1.5 million in a dispute involving a “no call” provision under a bond indenture favor of Pacific Investment Management Company (“PIMCO”), Deutsche Asset Management, and Castlerigg Master Investments following a 4-day bench trial before the United States Bankruptcy Court, Southern District of Mississippi. The Bankruptcy Court’s 107-page opinion is likely to be a leading authority on the enforceability of “no call” provisions and prepayment premiums in bankruptcy cases.