OFFICERS
President
Gil Roth
Gil Roth is the founder and president of the Pharma & Biopharma Outsourcing Association (PBOA). In this role since 2014, he advocates for the regulatory, legislative, and general business interests of the CMO/CDMO sector. He has recruited many companies into the association, organized PBOA’s various working groups and committees, helped negotiate industry user fee programs, testified to Congress on behalf of PBOA members, educated Congressional staff on this sector’s role and interests, given presentations at FDA and other regulatory bodies, managed PBOA’s annual membership conference, and more.
In 1999, he helped launch Contract Pharma, which swiftly became the premier magazine covering the pharma/biopharma outsourcing and contract services industry. He served as editor of Contract Pharma from October 1999 until February 2014, chronicling the evolution of the pharmaceutical outsourcing sector. He also helped build the magazine’s annual Contracting & Outsourcing Conference & Exhibition into a top-tier event for both contract service providers and their clients.
In 2013, while reporting on an article about the Generic Drug User Fee Amendments (GDUFA), Mr. Roth had the idea to build a trade association for CMOs and CDMOs, in order to provide them with a voice in regulatory and legislative areas and to raise awareness of the pivotal role they play in healthcare. He stepped down from the editorship of Contract Pharma in February 2014 in order to take on the full-time job of launching the PBOA and building its roster of member companies.
Gil Roth received a B.A. from Hampshire College in 1993, and an M.A.L.A. from St. John’s College (Annapolis, MD) in 1995. He was an associate editor and managing editor for several business-to-business magazines before becoming the founding editor of Contract Pharma, a role he held for nearly 15 years. He can be reached at gil.roth@pharma-bio.org.
Chairman
Peter T. Bigelow
President
xCell Strategic Consulting
Peter Bigelow is the President of xCell Strategic Consulting, a consulting firm to the pharmaceutical industry. He recently served as Interim President of the Qualitest Pharma division of Endo Health Solutions, Inc. Prior to founding xCell, he served as the President of North America Commercial Operations at Patheon and also held the role of CEO.
He previously spent 14 years with Wyeth, where he was responsible for global supply of Wyeth’s Consumer Healthcare products. He also held a variety of senior Engineering and Operations roles for the Prescription Drug side of the Wyeth business. Peter also spent 14 years at SmithKline Beecham (now GlaxoSmithKline) before joining Wyeth. His assignments included significant international project work in Europe and the Far East and operations experience with injectable product manufacturing.
Peter is a member of the International Leadership Forum of the ISPE and is a frequent speaker at Industry events. He serves on the board of IPS, a global engineering services company, and the Advisory Board of Tracelink, Inc. He has a BS in Mechanical Engineering from Villanova University and an MBA from Philadelphia University. Peter and his wife Lynn reside in Valley Forge, PA.
Treasurer
Cornell Stamoran
Vice President, Strategy
Catalent, Inc.
Founding Board Member
Catalent Applied Drug Delivery Institute
Cornell Stamoran serves as Vice President of Strategy for Catalent, Inc., the leading global provider of advanced delivery technologies and development solutions for drugs, biologics, and consumer health products. Mr. Stamoran leads Catalent’s strategic planning and market intelligence efforts, as well as supporting its government affairs, investor relations, global M&A and technology innovation and acquisition activities. He also serves as a founding Director of Catalent’s Applied Drug Delivery Institute. Cornell has spent more than 25 years engaged with the health care industry, including 23 years in advanced drug and biologic delivery and outsourcing. He currently serves on the Editorial Advisory Board of Drug Development and Delivery magazine; on several industry conference advisory teams; and on the steering committee for the Healthcare Institute of New Jersey.
Secretary
Vacant
Chris Verbicky
Director, Regulatory & Scientific Affairs
PBOA
Chris Verbicky serves as Director, Regulatory & Scientific Affairs at PBOA (non-officer). In this role, he coordinates the activities of PBOA’s Quality Technical Group, develops docket submissions to FDA, and provides technical expertise to other PBOA special interest groups and regulatory and legislative submissions. Chris is the Managing Director of CurVe Consultants, a provider of support in the areas of business management, business development, marketing, alliance management, product development, and project management to pharma/biotech firms and CDMOs. He has held roles at TCG Life Sciences, Piramal Pharma Solutions, Coldstream Laboratories, Johnson Matthey Pharma Services, and AMRI. He has a B.S. in Chemistry from SUNY Albany, a Ph.D. in Synthetic Organic Chemistry from University of New Hampshire, and an MBA in Marketing from SUNY Albany. Chris was a Founding Trustee of PBOA.
TRUSTEES
Tedd Green
Chief Operating Officer, Co-Founder
INCOG BioPharma Services
Tedd is an experienced and accomplished leader in the biopharmaceutical services industry. While President of Cook Pharmica, a contract development and manufacturing service provider of biologic drug substance and injectable drug products, Tedd led the company from a small start-up to a globally recognized leader in the industry. Over a twelve-year period with a very talented team, Cook Pharmica grew to eight hundred people strong serving a majority of the world’s top biotech and pharmaceutical companies. Cook Pharmica was a founding member of the PBOA and Tedd was an inaugural Board Member and served on the PBOA Board from 2014 – 2017. After the successful sale of Cook Pharmica to Catalent, Tedd served as Senior Vice President of Catalent Biologics.
In 2020, Tedd co-founded INCOG BioPharma Services, a service provider to the global biopharmaceutical industry specializing in injectable drug product development and manufacturing. Tedd serves as Chief Operating Officer of INCOG and is a member of the board of directors of Genezen, a viral vector CDMO. Tedd’s professional passion is working alongside good people to deliver exceptional service enabling the efficient development and commercialization of life-saving and life-enhancing medicines to help patients in need around the world.
Leonard M. Levie
Chairman and Group Director
Avara Pharmaceutical Services
Leonard M. Levie is the Chairman and Founder of American Industrial Acquisition Corporation and the AIAC Foundation Inc. As such, he is also Chairman of AIAC’s subsidiaries or affiliates, including Arnprior Aerospace, Avara Pharmaceutical Services, BeLink Solutions, Bradford Space, Champlain Cable, Canadian Kraft Paper Industries, Combi Wear Parts, Consolidated Industries, D2A, Epalia, Eurofoil, Forte Micro, Gecoe, Holophane, IP3 Plastics, Lenape Forged Products, Malaga Aerospace Defense Electronic Systems, Metallwarenfabrik Gemminger, Neotiss, Shriro Group, SuperAlloy Manufacturing Solutions, Titanium Fabrication Corporation, Umbilicals International, and Vermont Aerospace Industries. In addition, he previously served as Chairman of former AIAC units, including All Circuits, Amnitech, JST Transformateur, MCI, and Sodiamex. Mr. Levie has been a guest lecturer at the Harvard Business School, the University of Chicago Graduate School of Business, the Association for Corporate Growth, and the Turnaround Management Association. In addition, he served as a panelist with the Hon. Fabius Laurent, former Prime Minister of France, on Investing in France, at the Consulate General of France in New York City, October 1, 2015. He is the Director Forest Products Association of Canada, Fellow of the Royal Geographical Society, and Member of the Alexander Graham Bell Legacy Society of the National Geographic Society. You can find his full bio at Avara’s Our Team page.
Stu Needleman
Chief Commercial Officer & Chief Patient Centricity Officer
Piramal Pharma Solutions
Stuart Needleman is the Chief Commercial Officer at Piramal Pharma Solutions (PPS), where he leads all global business development activities. Delivering a portfolio of services that spans discovery to clinical and commercial supply of both drug substances and drug products, Mr. Needleman has guided the business development team to record results during his tenure. He has a track record of driving sustainable growth at attractive margins and has experience in developing seamless, integrated drug development and manufacturing solutions.
Mr. Needleman also serves as Chief Patient Centricity Officer for PPS, where his mission is to facilitate patient-centric behavior across the global organization. In this position, he ensures that employees at every level of the company – from the production floor to the C-Suite – understand the role they play in the company’s objective of helping to reduce the burden of disease on patients.
Mr. Needleman has close to three decades of experience in the pharmaceutical services industry and is an authority on the contract services segment, having held leadership roles in global business development, sales and marketing, and operations. Before joining PPS, Mr. Needleman served as President of Laurus Synthesis, a subsidiary of Laurus Labs, and as President and Chief Operating Officer of Aptuit, a global contract services company. During his career, he also held key roles at Cambrex, Oxford Asymmetry, ChiRex, and Rhodia Pharma Solutions.
Mr. Needleman has a Bachelor of Science Degree in Chemical Engineering and an MBA from Rensselaer Polytechnic Institute (RPI).
Jessica Settimi
President
Thermo Fisher Scientific
Jessica Settimi is currently the Sr. Director Strategy and Marketing Development. She has been responsible for the operations, strategy and commercial growth of the continuous manufacturing businesses at Patheon, part of Thermo Fisher, which is centered around a novel processing technology for the pharmaceutical industry. Jessica joined Patheon in 2013 and has served in several roles including Strategy, Innovation and Marketing. Prior to her roles at Patheon, she worked as a consultant through the Center for Innovation Management Studies at NC State University focusing on the application of big data analytics in the biopharmaceutical industry. She earned a Master of Business Administration and Master of Microbial Biotechnology from North Carolina State University and holds a Bachelor of Science in Biotechnology from Rochester Institute of Technology.
Thomas L. Thorpe
CEO
Afton Scientific
Mr. Thorpe has over 35 years of professional experience in pharmaceutical operations, entrepreneurial initiatives and investment banking. Tom is currently the CEO of Afton Scientific, the parent of AnovaFill, a cGMP contract manufacturer of clinical and commercial sterile injectable drugs. Afton Scientific is also the world’s premier provider of pre-sterilized (Ready-to-Fill®) vials and components for cGMP aseptic processing.
He is the former Chairman of the Virginia Biotechnology Association (Virginia Bio) a statewide organization that promotes the scientific, legislative and economic agenda of the life sciences industry in the Commonwealth of Virginia.
He holds a BS degree in Chemical Engineering from the University of Connecticut and an MBA from University of Virginia. Tom lives in Charlottesville with his wife and three daughters and still enjoys getting knocked around playing ice hockey and lacrosse.
Timothy C. Tyson
Co-Founder, Chairman and CEO
TriRx Pharmaceutical Services, LLC
Timothy Tyson is currently Co-Founder, Chairman and CEO of TriRx Pharmaceutical Services, LLC. and He is also, Chairman of Thayer Leadership, Vice Chairman of the Hotel Thayer and currently serves on the board of Syros Pharmaceuticals, Inc. Mr. Tyson previously served as Chairman of Icagen, a high throughput screening company, that was successfully sold to Ligand. He was also previously Chairman and CEO of Aptuit LLC, a Contract Research Organization that was successfully sold to Catalent, AMRI and Evotec. He was Chairman and CEO from 2008 to 2012 leading a restructuring, acquisition and successful sale of a major portion of the company prior to stepping out as CEO to serve and guide the company as Chairman up until 2016. His corporate career spans over 35 years in the pharmaceutical industry. From 2002-2008, Mr. Tyson served as COO, President and CEO of Valeant Pharmaceuticals International. During this period, sales grew 69% and earnings increased 135%. He led a major restructuring of the company and established a highly effective Research and Development capability which developed a best in class epilepsy compound, Potiga, which was approved in 2010, and a promising pro-drug for hepatitis C.
Prior to joining Valeant, Mr. Tyson ran multiple divisions for GlaxoSmithKline and was a member of the Corporate Executive Team. During his 14-year tenure at GlaxoSmithKline, he was President, Global Manufacturing and Supply and ran Glaxo Dermatology and Cerenex Pharmaceuticals, the GSK Oncology and CNS Division. Mr. Tyson was also responsible for managing all sales and marketing for GlaxoWellcome’s U.S. operations, where he launched 32 new products, eight of which reached sales of greater than $1 billion/year. Mr. Tyson held executive positions in technical operations and R & D, at Bristol-Myers from 1980-1988. Prior to his tenure at Bristol-Myers, he was a manufacturing manager at Procter & Gamble. He served on active duty as an officer in the United States Army from 1974-1979 and spent 14 years in the United States Army Reserves.
Mr. Tyson is a 1974 graduate of the United States Military Academy at West Point. While on active duty at Ft. McClellan, AL, he earned a Master of Public Administration, in 1976, and a Master of Business Administration, in 1979, from Jacksonville State University. In 2002, Mr. Tyson received a Bicentennial Leadership Award from the United States Military Academy at West Point and was named 2007 Alumnus of the Year at Jacksonville State University. He is a co-owner and Vice Chairman of the Historic Thayer Hotel at West Point and co-founder, owner and Chairman of the Thayer Leadership Group.
He has served on the board of directors for Tyme Technolgies Inc; BDSI; Icagen; Aptuit; Valeant Pharmaceuticals International; the Pharmaceutical Research and Manufacturing Association (PhRMA); BIOCOM; the CEO Roundtable for the University of California at Irvine; the Dean’s Executive Forum at Cal State Fullerton; the CEO Roundtable on Cancer; the Health Sector Advisory Board at Duke University; the International Leadership Forum of the International Society of Pharmaceutical Engineers and as a visiting lecturer at Cambridge University in the UK. He is a member of the Six Sigma Hall of Fame. Mr. Tyson has served on the board of directors for non-profit organizations in Raleigh-Durham, NC and Orange County, CA and with the United Way and is a major supporter of Children of Fallen Patriots and the Joint Services Special Operations Fund.
