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!
Vice President of Pre-Clinical and Process Development
Catalent Gene Therapy
George Buchman is Vice President of Pre-Clinical and Process Development at Catalent Gene Therapy in Baltimore, MD. He is a seasoned veteran with over 30 years of Biotechnology industry experience including Life Technologies (Thermo Fisher), Celera Genomics and Gene Logic, and broad roles ranging from R&D bench scientist, to Manufacturing, Process Development, Program Management and Business Development. George received his Ph.D. in Biochemistry from the University of Maryland in College Park.
Director • Office of Pharmaceutical Quality Operations
FDA, Office of Regulatory Affairs
Alonza Cruse is director of the Office of Pharmaceutical Quality Operations within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with FDA’s Center for Drug Evaluation & Research and the Center for Veterinary Medicine. Additionally, Mr. Cruse is leading ORA’s pharmaceutical collaboration efforts under our Program Alignment initiative.
From 2013 to 2015, Mr. Cruse served as the acting director of the Office of Medical Products & Tobacco Operations within ORA, overseeing activities such as implementation of the Generic Drug User Fee Amendments, pharmacy compounding, and the development of a new inspection protocols program.
Prior to that, Mr. Cruse was the director of the Los Angeles District Office, where his responsibilities included providing executive leadership to implement, manage and evaluate FDA’s regulatory operations. Mr. Cruse first joined ORA in 1983 as a microbiologist. He received his Bachelor of Science degree in medical technology from York College (City University of New York).
Brent Del Monte
Senior Vice President
BGR Government Affairs
Brent Del Monte currently serves as Senior Vice President at the BGR Group. In this role he represents clients, particularly life sciences companies, to help them achieve their objectives with the Federal government.
A native of Northern Virginia, after graduating from the College of William & Mary in Williamsburg, Virginia, Brent embarked on a career in public policy by joining the staff of Senator John Warner (R-VA). Brent later served on the staff of Representative Tom Bliley (R-VA), where he held various positions, all with responsibility over health care issues. While serving for Representative Bliley, Brent attended Georgetown University Law Center in the evening, graduating with high honors.
After graduating law school and clerking for United States District Judge Claude Hilton, Brent returned to the Hill where he served as a Counsel for the House Committee on Energy and Commerce, with primary responsibility over food and drug issues. In this position, he successfully saw enactment of the Medical Device User Fee Act, the Project BioShield Act, and the reauthorization of the Best Pharmaceuticals for Children Act and the Prescription Drug User Fee Act (PDUFA).
Brent then served as the Senior Vice President for Federal Government Relations at the Biotechnology Industry Organization (BIO), where he successfully worked for the successful enactment of priority legislation, such as: a pathway for the approval of biosimilars at the FDA; the Therapeutic Project Discovery Tax Credit; liability protections for bioterrorist and pandemic countermeasures; two reauthorizations of PDUFA, including important reforms to the Accelerated Approval pathway at FDA; patent reform; and the 21st Century Cures Initiative.
Commander Tara Gooen Bizjak
Senior Science Policy Advisor
Division of Regulations, Guidance, and Standards
Office of Policy for Pharmaceutical Quality (OPPQ)
Office of Pharmaceutical Quality (OPQ)
Commander Tara Gooen Bizjak is an engineering officer in the United States Public Health Service and a Senior Science Policy Advisor at the FDA. She works in the Office of Policy for Pharmaceutical Quality in the area of developing new regulations, guidance, and standards. CDR Bizjak has been with the FDA for 15 years, starting as a field investigator in the New Jersey District, primarily focusing on drug manufacturing and current good manufacturing practice (CGMP) inspections. In 2007, she transferred to CDER to the area of a manufacturing and product quality and was a subject matter contact for several CGMP topics, including pre-approval inspections, continuous manufacturing, pharmaceutical quality systems, water quality, and scale-up issues. Prior to her current role, she served in multiple roles, including branch chief and senior advisor. CDR Bizjak received a B.S. in Chemical Engineering from Cornell University, a Masters in Biomedical Sciences from the University of Medicine and Dentistry of New Jersey, and is an ASQ (American Society for Quality) Certified Quality Engineer.
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.
Founder and Chief Executive Officer
Advanced Therapies Consulting Group
Alan Moore founded Advanced Therapies Consulting Group to provide developers of cell and gene therapies specialized business and regulatory consulting to assist in the rapid progression of these innovative therapies. Previously, as VP and Commercial Chief for Advanced Therapies at WuXi Apptec in Philadelphia, he was responsible for commercial activities supporting biopharmaceutical products and advanced therapies such as cell and genetic therapies. Previously he oversaw cGMP-compliant contract manufacturing of innovative cell and gene therapies for WuXi AppTec, Inc. in WuXi’s Philadelphia-based manufacturing sites, as well as supported strategic biopharmaceutical clients.
Early in his career he held positions of increasing responsibility over a 16 year period at BioReliance Corp. (Microbiological Associates) leading to Director of Business Development, after previously serving as Director of the firm’s Biotechnology Services Division. He served then as President of Genzyme Transgenics Washington Laboratories, and Senior Regulatory Coordinator for Genzyme Corporation supporting products such as Carticel®, Epicel®, Cerezyme® , and later as Vice President of Biopharmaceutical Development Services at Genzyme Corporation’s Rockville, MD facility which provided contract development, manufacturing and testing for biological products.
Prior to joining WuXi AppTec, Mr. Moore served as Executive Vice President and Chief Business Officer at Althea Technologies (San Diego, CA), a leading provider of innovative technologies along with manufacturing and aseptic fill and finish services. Mr. Moore has presented on biopharmaceutical, cell and gene therapy development and safety to the U.S. FDA Center for Biologics Evaluation and Research, various U.S. FDA Advisory Committees, Health Protection Branch, Drugs Directorate (Canada), Therapeutic Goods Administration (Australia), Japan Health Science Council (Ministry of Health), and the U.K. Xenotransplantation Interim Regulatory Authority (UKXIRA). He has also served as a member of U.S./Japan Bilateral Forum on the Harmonization of Biotechnology Regulations (United States Department of Commerce– Predecessor to ICH), and a delegate to the International Bioindustry Forum (US/Japan/EU), The President’s Council on Competitiveness for Streamlining Federal Regulation of Biotechnology Products at The White House.
QuantumBlack – A McKinsey Company
A successful and self-motivated AI, big data, information and analytics professional with extensive top tier consulting experience, Sulay has deep experience across the pharma and biopharma value chain, including currently leading QuantumBlack’s AI/analytics and digital offering in operations – manufacturing & supply chain. He has a track record of defining and executing information & analytics strategies and road maps, implementing solutions to improve business performance, managing stakeholders and delivering tangible impact for FTSE 250 and Fortune 500 companies in the Europe and the USA. Sulay leads strategic programs dealing with complex client requirements and supports client service teams across the globe. His responsibilities include
- Leading complex engagements from strategy, roadmap and implementation covering digital, advanced analytics and business intelligence
- Articulating the business impact of digital and analytics for clients anticipating getting started or facing challenges with scaling at speed
- Developing business relevant offerings and work with client service teams on developing client opportunities, including leading and contributing to proposal development
- Demonstrating thought leadership and identify emerging technology concepts with the potential to accelerate impact to clients
- Collaborating with cross-functional teams internally and with clients on digital/analytics transformation programs
- Mentoring, coaching and developing client advisors, including contributing to internal initiatives on people development
- Building lasting, trusted advisor relationships with senior client executives
Head of Talent Management, OD and Talent Acquisition
Teresa Sankner is the Head of Talent Management and Leadership Development for Novartis Pharmaceuticals, based in East Hanover, NJ. She has over 20 years of experience building and leading global Talent Management, Leadership Development, Talent Acquisition and Organizational Development centers of excellence for companies such as Novartis Pharmaceuticals, Cardinal Health, Catalent Pharma Solutions, Pliva/Barr Pharmaceuticals and Zdenek Financial Planning.
She has worked extensively with senior executives and CEOs to create a competitive advantage in the marketplace through the implementation of Merger & Acquisition integration strategies, organizational structure redesigns, large-scale culture transformations, talent attraction, engagement and diversity strategies and business turnarounds.
Her work has included establishing global strategic and operational workforce planning, build & buy strategies, diversity and military staffing and pipeline strategies, and innovative executive and new hire on-boarding programs and engagement solutions.
Earlier in her career, Teresa served as an Executive and Leadership Coach for Landmark Education Corporation, and served as Vice President Sales in the financial services industry, where she built and led a consulting line of business for corporate executives, medical practices and hospitals.
Teresa holds a bachelor’s degree in Education and Performance from Rutgers University. She serves as a member of the Conference Board Talent Council Committee, Rutgers Pharmaceutical MBA Board, Greater Philadelphia Senior Executive Group, and the Novartis Cross-Divisional Talent Council.
Teresa has been recipient of several awards, including the Global Innovation Award, Excellence for Patients and Customers, CEO Award for Excellence in Organizational Vitality and has been recognized for Talent Management Excellence by the Blackstone Group. She has also served as a keynote speaker and presenter for several organizations including Be A Hero Hire A Hero, Diversity, Inc., NJ Organizational Development Association, Toastmasters, and the Harvard Business Conference.
Regulatory Compliance Associates
Sue Schniepp is the knowledge leader for Regulatory Compliance Associates® Inc. and is responsible for training and advising RCA staff and clients on current trends and issues facing the pharmaceutical, biotechnology, and medical device industries. Her background includes cGMPs, audit readiness, change control, investigations, supplier quality, and batch record review.
Sue has more than 35 years’ experience in quality assurance, serving in leadership roles at Allergy Laboratories, Inc.; Oso BioPharmaceuticals LLC; Searle; Abbott; and Hospira. She has served the Parenteral Drug Association (PDA) as a member of the Board of Directors, PDA / FDA Joint Regulatory Affairs Conference Chair, conference presenter, and Chair of PDA’s Regulatory Affairs / Quality Advisory Board. She was also awarded PDA’s Distinguished Service Award in 2008.
Her publications include the book Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process, for which she was awarded the 2007 PDA’s Distinguished Author Award. Sue also co-edited and contributed to the book Pharmaceutical Outsourcing: Quality Management and Project Delivery.
Since 2007, she has served as a columnist and member of the editorial advisory board for Pharmaceutical Technology Magazine and was also Chair of a USP Monograph Development Expert Committee from 2005-2010. The recipient of numerous PDA and USP Awards and Acknowledgements, Sue remains prolific in the industry through podcasts, videocasts, presentations, and webinars.
Sue holds a Bachelor of Science in Biology from Northern Illinois University in DeKalb, IL. She lives in Albuquerque, NM, but sees the world on behalf of RCA.
Robert Di Scipio
Chief Executive Officer and Chairman
Bob Di Scipio has served as a senior executive in the life science and software sectors with experience that spans data analytics, biotechnology, corporate law, enterprise risk management, software, and supply chain management. Currently, Bob serves as CEO & Chairman of Skyland Analytics, which provides cloud-based SaaS data management and data analytics solutions for biopharma manufacturers. Bob has served in management and board roles in Life Science and software organizations, including as CEO of Aegis Analytical (acquired by Accelrys/Dassault Systèmes), which developed the first manufacturing informatics software designed specifically for pharmaceutical manufacturers. He also served as the VP Business Development & Associate General Counsel of Martek Biosciences (NASDAQ:MATK, acquired by DSM) and as the General Counsel & VP Corporate Development of OmegaTech (acquired by Martek). Bob speaks and writes regularly on life science manufacturing informatics, data analytics and data integrity, outsourcing, and FDA & SEC compliance issues.
McKinsey & Company
Boyd Spencer is an Associate Partner and Leader in both McKinsey’s Pharmaceutical & Medical Products and Biologics Operations practices. He has over 20 years of experience in pharmaceutical operations with the bulk of that time spent in biologics. While at McKinsey he has served clients in multiple engagements globally, focusing on operations improvements and efficiencies (across manufacturing, procurement, quality, supply chain), due diligence for operations expansions and new modalities (e.g., cell and gene therapy), implementation leadership to realize value, and operations strategy.
Prior to McKinsey, he was a Managing Consultant with IBM’s Life Sciences Strategy and Transformation practice. Boyd also spent 12 years at Merck with roles in Operations, primarily in Technology Operations, Manufacturing, Network Strategy, Supply Chain and Procurement. He holds a Master of Business Administration, Finance and Operations from the University of North Carolina Chapel Hill and Bachelor of Science in Chemical Engineering from and University of Virginia.
General Business Manager
Adam Sybrowsky has over 10 years’ 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.
Senior Policy Advisor for Strategic Planning and Legislation
FDA, CBER – Office of the Director
Julie Tierney is a Senior Policy Advisor for Strategic Planning and Legislation in the Office of the Director in FDA’s Center for Biologics Evaluation and Research. In that role, she works on a wide range of issues related to regulatory policy development, implementation of various statutory mandates, and legislative strategy.
From 2015 to 2016, Ms. Tierney served as FDA’s detailee to the U.S. Senate Health, Education, Labor & Pensions (HELP) Committee as a Senior Health Policy Advisor, where she negotiated many of the FDA-related provisions of the 21st Century Cures Act and provided advice on other FDA-related issues. Prior to that, in her capacity as Associate Chief Counsel for Drugs in FDA’s Office of Chief Counsel, between 2008 through 2015, she provided ongoing legal counsel to FDA program staff and leadership on drug and biologic-related legal issues and served as a Team Leader.
Prior to working at FDA, Ms. Tierney practiced food and drug law at private law firms. She received her J.D. from Georgetown University Law Center and her undergraduate degree in Biology and History from Johns Hopkins University.
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.
Chris Verbicky, Ph.D., MBA
Director of Scientific and Regulatory Affairs
With nearly 20 years of experience in API and Finished Product R&D and Manufacturing operating in the CDMO industry, Dr. Verbicky has served technical and business roles, consulting on countless programs. Since 2017 Dr. Verbicky has consulted in the areas of CMC Project Management, Alliance Management, Injectable Product Development, API Process Development and Scale Up, and Licensing/Partnering.
Previously, Dr. Verbicky was Vice President of Business Development and Marketing for TCG Lifesciences, Vice President of Commercial for Piramal Pharma Solutions, Director of Business Development and Marketing for Coldstream Labs, and Manager of Project Management at AMRI. During his career he routinely consulted to develop project plans and regulatory strategies with pharmaceutical and biotech companies of all sizes.
Dr. Verbicky received his B.S. (Chemistry) from the University at Albany, a Ph.D. in Synthetic Organic Chemistry from the University of New Hampshire, and an MBA focused on Marketing from the University at Albany. Dr. Verbicky completed his post-doctoral research in the synthesis of phospholipids and sphingolipids at Queens College. He is an expert in synthetic chemistry, mechanistic investigation, process optimization, and project management. Dr. Verbicky has authored or contributed to more than 70 patents, publications, and presentations in the areas of project management, business, pharmaceutical development. He is a member of technical advisory boards for INTERPHEX, CPhI North America, and AAPS’s Contract Research Organization Focus Group.
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.