The PBOA Meeting & Conference features speakers and panelists who represent decades of expertise in pharma and biopharma outsourcing fields. We’ll post their bios as they’re confirmed!
Kalah Auchincloss, JD, MPH
Senior Vice President, Regulatory Compliance and Deputy General Counsel
Kalah Auchincloss has more than a decade of food and drug legal, policy, and regulatory experience at the FDA, on Capitol Hill, and in the private sector. Kalah spent six years at FDA, most recently, as Deputy Chief of Staff for the agency. As Deputy Chief of Staff, Kalah worked with senior FDA leadership to manage crises, develop policy decisions, implement communications strategies, and liaise with the Department of Health and Human Services, the White House, and other agencies. Kalah was also a primary point of contact in the immediate Office of the Commissioner for the six FDA Centers and other components of the Commissioner’s Office.
Prior to that role, Kalah spent time on Capitol Hill as the FDA detailee to the Senate Committee on Health, Education, Labor, and Pensions, working on the 21st Century Cures Act and other FDA-related legislation. She has also served in FDA’s Center for Drug Evaluation and Research (CDER) as a regulatory counsel in the Office of Regulatory Policy, and as Director of CDER’s Office of Unapproved Drugs and Labeling Compliance in the Office of Compliance, leading a team of more than 50 staff working on pharmacy compounding, unapproved drugs, over-the-counter drugs, and other enforcement issues.
Before joining FDA, Kalah was an associate at the law firm Foley Hoag LLP, in the firm’s health care practice group. Kalah holds a B.A. with honors from Williams College, a J.D. with honors from Georgetown University Law Center, and an M.P.H. from Harvard University.
RBC Capital Markets LLC
Mr. Cohen is a Managing Director at RBC Capital Markets, where he is responsible for the firm’s relationships with pharmaceutical and medical device outsourcing companies including CMOs and CROs. He is an accomplished M&A practitioner, having worked with and advised companies over the past 20 years on the execution of M&A transactions valued at over $75 billion. Recently he advised TH Lee and Frazier Healthcare on their acquisition of Adare Pharma, Permira on its acquisition of Cambrex and financing transactions on behalf of clients including Cambrex, AMRI, Danaher, Catalent, IQVIA and Huntsworth.
Prior to joining RBC in 2015, Mr. Cohen was a member of the Executive Leadership Team and head of Global Corporate Development at Catalent. He joined Catalent in 2010 and was responsible for developing and executing on Catalent’s inorganic growth strategy. Mr. Cohen’s transaction experience at Catalent included acquisitions, divestitures, structured transactions and emerging markets, completing 14 transactions valued at approximately $1 billion. Prior to Catalent, Mr. Cohen spent 13 years on Wall Street where he focused on healthcare M&A, particularly within the drug delivery, specialty pharma and generic pharma industries, including at JP Morgan and Bear Stearns.
President, Managing Partner
Eric Langer has over 20 years experience in biotechnology and life sciences international marketing, management, market assessment, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He is an experienced biotechnology strategist, marketing practitioner, publisher, and researcher. He has published, edited and authored numerous books, reports, and major studies on topics including: Advances in Biopharmaceutical Technology in China, Advances in Large-scale Biopharmaceutical Manufacturing, Biopharmaceuticals in the US Market, cell culture reports, media, sera, tissue engineering, stem cells, diagnostic products, blood products, genetics, DNA/PCR purification, blood components, and many others.
He lectures extensively on marketing, pricing and channel management topics, and teaches at Johns Hopkins University and American University: Biotechnology Marketing, Marketing Management, Services Marketing, Advertising Strategy, and Bioscience Communication. In 1989 he co-founded BioPlan Associates, Inc. He has launched and managed marketing programs for product lines ranging from $500k to $500 million.
Jim Miller, MBA
Founder and President
PharmSource Information Services, Inc. (ret’d.)
A preeminent expert in bio/pharmaceutical outsourcing, Jim Miller established and presided over the industry’s principal resource for serious consumers of information on contract drug development and manufacturing, PharmSource Strategic Advantage. He was editor and publisher of Bio/Pharmaceutical Outsourcing Report and Emerging Markets Outsourcing Report, before his retirement last year.
Jim served as an Editorial Advisory Board member for Advanstar Communication’s Pharmaceutical Technology and BioPharm magazines, and wrote regular columns on outsourcing for Pharmaceutical Technology, Contract Services Europe and BioPharm magazines. He served on the board of directors of the American Type Culture Collection (ATCC) from 2007 until 2016. Jim chairs the advisory committee of the PBOA.
Jim formerly was Vice President of Sales and Marketing at Circa Pharmaceuticals, Inc., a solid dose manufacturer. Prior to that, he was President of St. Anthony Publishing, a provider of database information services for the health care industry. He also was a consultant in corporate strategy with the Boston Consulting Group. Jim holds an MBA degree from the Stanford University Graduate School of Business.
Executive Vice President, Regulatory Compliance
With more than 30 years of experience as an expert in compliance issues – including more than 20 years in leadership positions in the government – Cynthia adds to Greenleaf Health’s prestige as Executive Vice President, Regulatory Compliance.
Cynthia was formerly Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research (CDER), where she led a staff of more than 300 doctors, scientists, manufacturing experts, pharmacologists, attorneys, and administrative staff. During her time at FDA, she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Among her many duties, Cynthia advised the FDA Commissioner, the CDER Director, and other senior FDA officials on significant enforcement issues.
Before joining FDA in 2014, Cynthia spent more than two decades at the Department of Justice (DOJ), where she specialized in compliance and enforcement issues. Her most recent position at DOJ was as Deputy Inspector General and Acting Inspector General, where she led a nationwide staff in investigating allegations of corruption and misconduct concerning DOJ’s employees and in conducting independent performance and compliance audits of the Department’s operations and programs. She communicated significant findings from the investigations and reviews to the Attorney General and to Congress.
Cynthia’s other positions at DOJ also provided her with an extensive background in criminal and civil enforcement work. They included Counselor to the Inspector General, Deputy Chief of the Sex Offense and Domestic Violence Section in the U. S. Attorney’s Office for the District of Columbia, Assistant U. S. Attorney, and Trial Attorney in the Civil Fraud Section of the Civil Division.
Previously, Cynthia clerked for a federal judge on the Ninth Circuit and worked as a television reporter in New Mexico and Texas. Cynthia earned a B.A., with distinction, from the University of New Mexico and a J.D., with honors, from the University of Texas School of Law.
Five Rivers Rx
Sumeet founded Five Rivers RX in October 2015. Five Rivers RX helps the pharmaceutical supply chain understand and comply with Federal and State regulations, as well as industry best practices. Drawing on the relationships and knowledge he cultivated at the helm of a distribution company, Sumeet is able to bring a unique “boots on the ground” understanding of the industry. With over 400 clients spanning Fortune 500 companies to venture-backed start-ups and independent companies, Five Rivers RX has established itself as a go-to resource for 16 different business models in the pharmaceutical supply chain.
Sumeet started his career at a regional drug wholesaler as the head of special projects which state licensing and software ERP implementation. He moved on to take a leadership role at a regional, full-line pharmaceutical distributor with responsibilities spanning purchasing, sales, operations, and finance. With the 2015 implementation of the DSCSA, Sumeet gained expertise in all aspects of the federal law as he led the creation and implementation of new processes and systems.
Sumeet Singh has been published in trade publications including Pharmaceutical Commerce and has spoken at events including ACI Controlled Substances Summit, IQPC Pharmaceutical Traceability Forum, and Chain76.
Managing Director and Partner
Ian Tzeng, a Managing Director and Partner in L.E.K.’s Boston office, joined the company in 1998 with experience in growth strategy, regulated markets, innovation, pricing, and mergers and acquisitions. He focuses on healthcare and life sciences, including pharmaceuticals, vaccines and medical devices. He leads L.E.K.’s Pharmaceutical Contract Services practice, including CROs, CDMOs, supply chain and distribution, commercial, medical, and market access services. Other areas of deep experience include rare diseases, biodefense, biosimilars and generics, and consumer-directed healthcare. Additionally, Ian has extensive consulting and board experience with nonprofit organizations in education, arts, LGBT advocacy and public service. He received a Bachelor of Arts degree, magna cum laude, in chemistry from Harvard College and is a George F. Baker Scholar, Master of Business Administration with high distinction from Harvard Business School.
David H. Windley, CFA, CPA
Managing Director – Healthcare Equity Research
Jefferies LLC – Nashville, TN office
Dave Windley is a managing director and founding member of Jefferies’ Healthcare Equity Research team. Over a 20-year career in investment research, Mr. Windley has covered a broad range of healthcare product and service sectors, including managed care, healthcare information technology, pharmaceutical services, and specialty pharmaceuticals. Dave is a five-time Wall Street Journal Best on the Street honoree and a 6-time Starmine award recipient. Dave is involved in the Nashville financial and healthcare community, having served as an officer and board member of the CFA Society of Nashville, an Alumni Board Member of the Owen Graduate School of Management, and a member of Leadership Healthcare.