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 email@example.com.
Peter T. Bigelow
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.
Vice President, Business Development
WellSpring Pharma Services
Sam Ricchezza has 20 years of business development and marketing experience in the pharmaceutical contract development and manufacturing industry. He has held a number of progressively responsible business development positions over the course of his career with Patheon, DPT Laboratories, AAIPharma and WellSpring. Sam is also a member of Contract Pharma‘s Editorial Advisory Board. In his role as Vice President, Business Development, Sam is responsible for WellSpring’s Pharma Services business development and marketing efforts and is part of WellSpring’s senior management team. Mr. Ricchezza also serves on the Board of Directors for the Niagara Escarpment Biosphere Fund.
Thomas L. Thorpe
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.
Chief Executive Officer
Lee Karras is an established pharmaceutical business executive with over twenty five years of healthcare industry related experience. Prior to joining Halo, Lee held executive leadership roles in several businesses. Most recently he was President of IBA Molecular North America, a global leader in the manufacture and distribution of generic radiopharmaceuticals.
Prior to IBA Molecular, Lee spent four years with AAIPharma Services where he was hired to reestablish the CDMO from bankruptcy and did so culminating in a successful $50MM sale to a private equity firm in 2009. Mr. Karras also spent 15 years with Cook Pharmaceutical Services and then Baxter Biopharma Solutions managing those successful CDMO businesses helping build the Baxter business into an a $200MM+ business during his tenure.
Lee has a proven track record of building scalable, yet cost effective businesses as well as managing complex contract research, manufacturing and pharmaceutical services businesses. Having worked in the contract pharmaceutical services industry over the last two decades, Lee has had to adapt and develop new business models to keep pace with the ever changing pharmaceutical landscape.
Lee holds a bachelors degree in Chemistry and an MS in Environmental Science, both from Indiana University in Bloomington.
Baxter BioPharma Solutions
Marie Keeley leads the BioPharma Solutions business for Baxter. She has over 25 years’ experience in the healthcare industry. Marie has been with Baxter for the past 15 years. Most recently, she lead the Global Anesthesia & Critical Care business. Throughout her career with Baxter, she has held leadership roles with increasing responsibilities, in sales, national accounts and business operations. Marie earned her bachelor’s degree from Northern Illinois University, in addition to her MBA from Kellogg Graduate School of Management at Northwestern University.
Vice President, Drug Product Contract Manufacturing Services
Kevin is responsible for Pfizer’s global drug product contract manufacturing business, including P&L ownership, global marketing, business development, alliance management, development services and other support functions. He leads of team of direct and indirect staff of approximately 150 people and partners with hundreds more within Pfizer to develop, manufacture and supply critical medicines to Pfizer CentreOne partners around the world. Kevin has over twenty-five years of experience in the pharmaceutical and medical devices field and more than 20 years of experience developing and leading high performing teams. He began his career with Abbott Laboratories in hospital sales, and assumed numerous other sales, marketing, and commercial leadership positions over his 15 year career with Abbott. In 2004, Kevin joined Hospira in conjunction with Abbott’s spin off of the Hospital Products Division. Since then, he has been in various U.S. and global pharmaceutical and device commercial leadership roles. Recent positions include Vice President, Global Medical Devices followed by a role based in the UK as Vice President, Commercial Operations, Europe, Middle East and Africa, where he had commercial leadership responsibility for a large portion of the region, along with regional device marketing and the UK-based aseptic compounding business. Kevin joined the legacy-Hospira Contract Manufacturing business (One 2 One) in 2011 as Vice President, Business Development and later transitioned to Vice President, Commercial Alliances. Prior to his healthcare experience, Kevin was a securities broker and financial advisor. Kevin holds a BS in Business Administration/Financial Management from Valparaiso University. He lives and works in the northern suburbs of Chicago and he and his wife Chris have two daughters in college and two golden retriever dogs. In his free time, Kevin enjoys a number of activities including water and snow skiing, golfing, hunting, fishing, motorcycling, snowmobiling, traveling and spending time with friends and family.
Director, Business Development, Spokane
Mr. Pierce’s responsibilities include the development of new business opportunities, the continuation of contract client relations and overseeing the business development and marketing departments. Mr. Pierce has held numerous positions within Jubilant HollisterStier; including Manager – QA Commercial, Manager – Regulatory Affairs CMO, Validation (Tech transfer/Project Management of early CMO projects), and Environmental Monitoring. He joined Jubilant HollisterStier in 2001, after previously working in retrovirus vaccine development in Seattle. He holds degrees in Microbiology and Cell/Molecular Biology from the University of Washington.
Rajan Puri, BSc, MSc, MBA
Vice President, Business Development
Rajan Puri joined Therapure in November 2008. He is responsible for managing the new business development efforts. Prior to joining Therapure, Rajan held senior business development positions with two different Canadian biopharmaceutical companies. Rajan started his career with Eli Lilly Canada, where he held progressively expanding positions in both regulatory affairs and product management.
3M Drug Delivery Systems
As Manufacturing Director, Mr. Romeu has responsibility for the global operations of 3M Drug Delivery Systems. He has over 30 years of experience with 3M in a variety of manufacturing and business roles both in the US and internationally. His experience with both pharma and medical device manufacturing brings a valuable perspective to development and manufacturing of specialty drug-device combination products. Through his previous roles in business development, he has worked to ensure win-win working relationships with customers, partners, and suppliers.
Mr. Romeu has a B.S. in Industrial Engineering from University of Missouri, Columbia and is a certified Six Sigma Black Belt and Master Black Belt.
Executive Vice President
Metrics Contract Services
Kimberly McClintock is Executive Vice President of Metrics Contract Services, a division of Mayne Pharma USA. Ms. McClintock has more than 18 years of experience in the pharmaceutical industry across sales, business development, project management and research and development. Prior to joining Mayne Pharma, Kim led the Drug Product and Lab Services Business Unit as Senior Director at Alcami Corp, a leading global provider of contract development and manufacturing services. She also held several management roles at Banner Pharmacaps (division of Patheon). Ms. McClintock holds a Bachelor of Arts in Chemistry from North Carolina State University and a MBA from the University of North Carolina at Greensboro.
Vice President, Strategy
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.
Director, Business Development
Piramal Pharma Solutions
Pamela is a results-driven professional with more than 20 years of experience in the pharmaceutical industry, particularly parenteral manufacturing of sterile liquid and lyophilized injectables. She is highly experienced in strategic planning, project execution, product launch, risk management and contract negotiations. For over 20 commercial launches in worldwide markets, Pamela has served as the project lead. Among her accomplishments she has managed project teams for more than 120 technology transfers of clinical and commercial products including complex formulations such as microspheres, nanosuspensions and liposomes. She’s held positions of increasing responsibility at DS InPharmatics, Ben Venue Laboratories and Roche Vitamins and Fine Chemicals and currently holds the position of Director, Business Development at Piramal Pharma Solutions. Pamela received a B.S.in Nutritional Sciences from Rutgers University and an M.S. from Case Western Reserve University.