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.
Director, Regulatory Operations Officer
CDR Lyle Canida is a PHS officer with over 10 years at FDA. He has a Pharm.D., M.S. in Pharmacoepidemiology, and is Certified in Public Health. During his time with FDA he has worked in various roles including IND and NDA reviews for clinical pharmacology genomics and overseeing postmarket safety of drugs, foods, cosmetics and dietary supplements. More recently, he has been with the Office of Pharmaceutical Quality helping to drive quality surveillance programs and other initiatives.
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.
Monica M. Commerford, Ph.D.
Head of Regulatory Affairs
Thermo Fisher Scientific Patheon Viral Vector Services
Monica M. Commerford, Ph.D., is currently the Head of Regulatory Affairs at Thermo Fisher Scientific Patheon Viral Vector Services. She previously worked as a Microbiologist and Consumer Safety Officer in Branch IV in the Division of Microbiology Assessment, Office of Process and Facilities, Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research at the Food and Drug Administration. She is an expert in the microbial control, product quality microbiology, and sterility assurance of Investigational New Drug Applications and Biological License Applications submitted to CDER and performed pre-license inspections of biological product manufacturing facilities. In addition, she has participated in writing policies and a draft guidance document. Dr. Commerford earned her B.S. in Biochemistry and Molecular Biology from Michigan State University and her Ph.D. in Microbiology and Molecular Genetics from Harvard University. In addition to her regulatory experience, she was also a Sallie Rosen Kaplan post-doctoral research fellow in the Laboratory of Molecular Biology at the National Institutes of Health.
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.
Senior Associate – Pharma Market Director
Christa has been in the pharmaceutical industry for over 25 years and is a leader and Subject Matter Expert. Christa is a well-recognized speaker at conferences and is frequently on-stage teaching others about regulatory requirements, operational issues, and what to expect in the future of the industry. Christa champions approaches that integrate strong project execution and technical solutions. Christa is on the Steering Committee for the ISPE Community of Practice for Sterile Products Processing, a certified ISPE Instructor of the Sterile Product Processing Baseline guide, former Chair of ISPE’s Women in Pharma group, as well as an author of the most recent ISPE Sterile Processing Baseline Guide. Christa provides guidance and leadership to clients on how and when to utilize common or innovative solutions and continuously promotes the technical growth of people willing to learn more to advance the industry. She was recently awarded an honor as a 2019 Influential Woman in Manufacturing.
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.
Regional Account Executive
Adam Sybrowsky has over a decade of project management experience within the product and quality management spheres of the life sciences and other regulated sectors. As a general business manager at MasterControl, he has been instrumental in all phases of the creation of the company’s new manufacturing software solution, from planning and development to beta testing and launch. In his current role, Sybrowsky works closely with C-level stakeholders and quality engineers to demonstrate how digitized solutions can help manufacturers improve quality while also reducing production errors and delays while obtaining gaining greater operational efficiencies.
He is Project Management Professional (PMP) certified and has a wealth of experience leading business projects with multimillion-dollar portfolios. Sybrowsky has consistently assisted clients in increasing productivity and efficiency by helping them implement quality and project management principles and planning. He holds a bachelor’s degree in Russian with a minor in business management from the University of Utah.
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.
Anders Vinther, Ph.D.
Global Head of Technical Operations
Dr. Anders Vinther joined Intarcia in May 2018 as VP Global Quality and Engagement. In November 2019 he became the Global Head of Technical Operations accountable for the Intarcia manufacturing and supply chain. Prior to this position, Anders served as the Chief Quality Officer at Sanofi Pasteur, where he was accountable for cGMP compliance, quality leadership, and the quality of the company’s vaccines worldwide. During his time at the company, he successfully led a global culture change in 10,000+ employee manufacturing organization catalyzing drastically enhanced compliance, performance and engagement. Anders has also held global leadership positions in Roche and Genentech including leading Biologics Quality and merging Quality operations between the two companies. He previously was the co-founder of a CMO, which was successfully sold several years ago. Anders has 30 years of business and biopharmaceutical experience and is a thought leader in quality leadership. He is actively involved in activities related to enhanced innovation in the industry and reduced drug shortage worldwide.
Anders holds a Ph.D. and M.Sc. in chemical engineering from the Technical University of Denmark in Copenhagen, Denmark.
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.
Vice President, Vetter Development Service, External Affairs
Vetter Pharma-Fertigung GmbH & Co.
Jörg Zimmermann is currently Vice President External Affairs for Vetter Pharma Fertigung GmbH&Co KG, Ravensburg, Germany. In this role, he manages the relationships with regulatory agencies, professional organizations and other partners in the pharmaceutical industry. Before taking this role, he was responsible for Vetter Development Service which includes manufacturing science & process development, technology & process transfers, project & service analytics and drug delivery systems. Within Vetter, Jörg has held various positions in process implementation, new product introduction, lyophilization process development and as production manager before becoming Director of Production of Vetter’s production site at Lake Constance in 2000. There he managed 5 production lines for aseptically prefilled injection systems. In September 2010 he became responsible for the process development and process introduction group at Vetter before being promoted to Vice President in November 2014.
Jörg has volunteered as conference chair, track leader and speaker at conferences by ISPE, PDA, and Concept Heidelberg for over 20 years. IN 2016, Jörg was elected to the International Board of Directors of ISPE. His current role is Vice Chair in the International Board of Directors and member of the Executive Committee. Jörg studied pharmacy in Freiburg, Germany and Cardiff, Wales and is a registered pharmacist.