The PBOA Meeting & Conference features speakers and panelists who represent decades of expertise in pharma and biopharma outsourcing fields.
Ilisa B.G. Bernstein, PharmD., J.D.
Office of Compliance
Dr. Ilisa Bernstein is the Deputy Director of Office of Compliance in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). She leads this Office in promoting and protecting public health through outreach, strategies and actions that minimize consumer exposure to unsafe, ineffective, and poor quality drugs.
From 2011 to 2013, Ilisa was the Acting Director of Office of Compliance in CDER at the U.S. Food and Drug Administration (FDA). In this role, she led the management of strategies, activities, and polices for drug compliance and enforcement. From 2006 to 2010, Ilisa was Director of Pharmacy Affairs at FDA, where she focused on drug integrity and security and the U.S. drug distribution system, counterfeit drugs, drug importation, prescription and OTC drug labeling, drug safety, and internet issues, and served as FDA’s primary liaison to the pharmacy community. From 2003 to 2006, she was Senior Advisor for Regulatory Policy and from 1991 to 2002, she was a Senior Science Policy Advisor in the Office of the Commissioner.
Ilisa started her career at FDA in 1988 as a Pharmacokinetic Reviewer in CDER, where she was responsible for reviewing and evaluating the pharmacokinetic aspects of investigational drugs used for AIDS and HIV infection. From 2002 to 2003, Ilisa was a Senior Associate Director at Pfizer, Inc. in the Regulatory Liaison Office in Rockville, Maryland. She served as a liaison between Pfizer and FDA, and provided guidance and advice on emerging policies, regulations, and legislation and their impact on Pfizer’s global operations. Ilisa completed a post-doctoral residency at the National Institutes of Health, focusing on clinical and research pharmacokinetics. Ilisa received her Doctor of Pharmacy degree from The University of Michigan College of Pharmacy and her Juris Doctor degree from The American University Washington College of Law.
RBC Capital Markets LLC
Mr. Cohen is a Managing Director at RBC Capital Markets, where he is responsible for Healthcare Mergers & Acquisitions and the firm’s relationships with pharmaceutical and medical device outsourcing companies including CMOs. He is an accomplished M&A practitioner, having worked with and advised companies over almost 20 years on the execution of M&A transactions valued at over $75 billion. Prior to joining RBC in 2015, he was a member of the Executive Leadership Team and head of Corporate Development at Catalent, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products and a Blackstone portfolio company which completed its IPO in July 2014. He joined Catalent in 2010 and, after developing and initiating Catalent’s inorganic strategy, completed 14 transactions valued at approximately $1 billion.
Mr. Cohen’s transaction experience at Catalent included acquisitions (Aptuit CTS, Micron Technologies, 49% interest in RP Scherer Eberbach), divestitures (Catalent’s Printed Components and North American Packaging businesses), structured transactions (Redwood Bioscience minority stake/call option/buyout) and emerging markets (two China JVs and acquisition of Relthy Laboratorios in Brazil). He has extensive experience evaluating the acquisition and monetization of pharmaceutical products, having completed multiple transactions including the acquisition of US rights to propranolol ER from Forest Laboratories.
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.
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 – 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, of pharmacy compounding, and of 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.
Sr. Director of Process Architecture and Technology
Sam Halaby is world renowned for his application of “Manufacturing Dynamics” to the design of pharmaceutical facilities and for his collaboration with other industry experts in global compliance, containment philosophy and continuous manufacturing. Sam’s proven approach is designed to drive process architecture through the clear definition of unit operations and material movement, with the ultimate goal of leveraging analysis tools to optimize production. He is currently the ISPE Co-Chairman of the Containment COP and has formerly been the Chairman for the ISPE Manufacturing Subcommittee and has been a Steering Committee Member for ISPE COP Sterile Products Processing. Sam is an INTERPHEX Technologies Tour veteran and highly sought after speaker. His areas of expertise include
- Oral Solid Dosage (OSD)
- Advanced Aseptic Processing
- Biological Processing
- Manufacturing Operations
- Potent Compound Containment
- Continuous Manufacturing
- Process Architecture
- Multiproduct Facilities
- Production Optimization
- “Manufacturing Dynamics”
- Conceptual Design
- Strategic Planning
Vice President of Market Research
Kate Hammeke has been working in cross-industry market research for over a decade, and 7 years of CMO/CRO market research and market strategy consulting experience. Her research has informed the CMO Leadership Awards for those 7 years.
Kate leads the contract manufacturing market research division at Industry Standard Research. Kate oversees both the syndicated and custom research projects for drug innovator and contract manufacturer clients. Prior to joining Industry Standard Research, Kate served as Director of Marketing Intelligence at Nice Insight, playing an integral role in the development of the research division of That’s Nice. She also designed the first industry-wide study on selecting outsourcing partners during the drug development cycle for the pharmaceutical and biotechnology sector. Kate has developed and coordinated custom research projects for more than 50 major brands in the Fortune 500. Using her industry knowledge, Kate has written dozens of articles related to pharmaceutical outsourcing for numerous industry publications, including as a regular contributor to Life Science Leader.
Deborah Howard, Esq., M.S.O.D.,
President and Founder
Guiding Change Consulting
Deborah Howard is a leading organizational consultant, ICF certified professional coach, and author who previously worked as a public interest lawyer. She brings intercultural insight and a passion for social justice to her work as a change catalyst – helping leaders and their teams transform themselves and the world by tapping into their wisdom and creative potential.
Deborah is a member and former board member of the NTL Institute for Applied Behavioral Science, author of Repairing the Quilt of Humanity: A Metaphor for Healing and Reparation, and serves on the Editorial Board of The Journal of Applied Behavioral Science.
Her work with organizational leaders and teams includes:
- Coaching leaders to live and work in alignment with their purpose and values, enabling them to re-ignite passion and bring out the best in themselves and others
- Working with team members to strengthen their relationships and collaborate creatively across differences
- Enabling leaders to make strategic decisions to overcome challenges, manage change and fulfill their organizational mission
Vice President Regulatory Affairs
Catalent Pharma Solutions
Harry Jeffreys has 28 years of pharmaceutical and medical device industry experience, across Quality Assurance, Quality Control and Regulatory Affairs. His experience spans aspects of global product development, approval, manufacture and product lifecycle management of a range of diverse dosage forms such as parenterals, oral solids and liquids including small molecules, biologics, and radiopharmaceuticals, as well as implantable medical devices and various diagnostic products. His Quality roles have been both operational and corporate, supporting manufacturing sites, product development teams, functional partners, leading quality strategy and policies, and interfacing with diverse global regulators. He is currently responsible for Regulatory Affairs and Compliance at Catalent Pharma Solutions. Harry holds a B.S. degree in Chemistry from Kean University.
Paula Katz (INVITED)
Director of Manufacturing Quality Guidance and Policy
FDA, CDER Office of Compliance
Paula R. Katz, J.D., is Director of Manufacturing Quality Guidance and Policy in CDER’s Office of Compliance. She leads an interdisciplinary staff of senior compliance officers and technical experts who focus on CGMP enforcement and drug quality policy issues. Ms. Katz frequently advises Center and Agency leadership regarding manufacturing supply chain controls, contract manufacturing, data and application integrity, administrative law and procedure, and regulatory policy development and enforcement strategy. Ms. Katz has chaired Agency working groups and directed the development of guidance for industry, regulations, and legislation; managed responses to Congressional oversight and other stakeholder inquiries; and conducted domestic and international inspections, case evaluations, and enforcement actions. She is a frequent presenter at industry and agency meetings, conferences, and training events. Prior to joining FDA in 2009, Ms. Katz was a litigation associate at a large law firm in Washington, D.C., where her practice included regulatory compliance, white-collar crime, and general commercial litigation. Ms. Katz is a graduate of the University of Virginia and the University of Virginia School of Law.
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.
Niraj Mehta, Ph.D
Associate Director for Global Regulatory Policy
Office of Global Regulatory Operations and Policy
FDA, Office of the Commissioner
Dr. Mehta was a key member of team that negotiated the amended Pharmaceutical Annex to the 1998 US-EU Mutual Recognition Agreement in 2017. Dr. Mehta joined FDA in 2008, as a Senior Pharmacologist within the Center for Drug Evaluation’s Office of New Drugs and then the Office of Compliance. Dr. Mehta received his Ph.D. in Pharmacology and Molecular Sciences from the Johns Hopkins University School of Medicine in 2007.
Jim Miller, MBA
Founder and President
PharmSource Information Services, Inc.
A preeminent expert in bio/pharmaceutical outsourcing, Jim Miller established and presides over the industry’s principal resource for serious consumers of information on contract drug development and manufacturing, PharmSource STRATEGIC ADVANTAGE. He is editor and publisher of Bio/Pharmaceutical Outsourcing Report and Emerging Markets Outsourcing Report.
Jim serves as an Editorial Advisory Board member for Advanstar Communication’s Pharmaceutical Technology and BioPharm magazines. He writes regular columns on outsourcing for Pharmaceutical Technology, Contract Services Europe and BioPharm magazines. Jim chairs the advisory committee of the Pharma & Biopharma Outsourcing Association (PBOA). He served on the board of directors of the American Type Culture Collection (ATCC) from 2007 until 2016.
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.
Distinguished Professor of Chemical Engineering
For the last 27 years, pharmaceutical product and process design has been Professor Muzzio’s main research and educational focus. His research interests comprise continuous manufacturing, pharmaceutical formulation, powder mixing, powder flow, segregation, compression, mixing and flow of liquids and suspensions, capsule filling, tablet dissolution, and tablet coating. He is a frequent lecturer at FDA events, and in 2012-2015 he was a voting member of the FDA committee on Pharmaceutical Sciences and Clinical Pharmacology. He is the principal investigator of a $4M FDA grant on continuous manufacturing, and the director of the Janssen/Rutgers alliance on Advanced Manufacturing.
Professor Fernando Muzzio is also the director of the National Science Foundation Engineering Research Center on Structured Organic Particulate Systems. The center, which has a total budget in excess of $8 million per year, focuses on pharmaceutical product and process design, with special emphasis on continuous manufacturing, particle engineering, and personalized medicine. FDA and 45 companies are currently members of the center.
Dr. Muzzio founded Mixing Consultants Inc. in 1996, co-founded AcumenBiopharma in 2012, and founded Integra Continuous Manufacturing Systems in 2014.
Cornell Stamoran, Ph.D.
Vice President, Strategy & Govt. Affairs
Founder & Co-Chair
Catalent Applied Drug Delivery Institute
Cornell Stamoran serves as Vice President of Strategy and Government Affairs 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, market intelligence and government affairs efforts, as well as supporting its investor relations, global M&A and technology innovation and acquisition activities. He also serves as Co-Chair and Director of Catalent’s Applied Drug Delivery Institute (www.drugdeliveryinstitute.com).
Cornell has spent nearly 30 years engaged with the health care industry, including more than 25 years in advanced drug and biologic delivery and outsourcing. Cornell is a trustee of the Pharma/Biopharma Outsourcing Association, a trade association for CMOs and CDMOs. He also serves on the finance committee of the Controlled Release Society; the Editorial Advisory Board of Drug Development and Delivery magazine; on several industry conference advisory boards; and served on the cross-Industry team which negotiated the GDUFA II reauthorization with the FDA.
Robert G. Sussman, PhD, DABT
SafeBridge Consultants, Inc.
Dr. Sussman is currently Managing Director of SafeBridge Consultants, Inc., a Trinity Consultants company that provides environmental health and safety services to pharmaceutical, chemical, biotechnology and other industries. With more than 25 years of experience, he is a recognized expert in the evaluation of occupational hazards of potent pharmaceutical compounds and has delivered numerous papers and lectures on the subject. Dr. Sussman has extensive experience in: (1) performing risk assessments including evaluating toxicological and exposure information to determine potential health effects of chemicals, (2) presenting toxicological data to regulatory agencies and assessing the potential impact of environmental, health and safety regulations on chemical and pharmaceutical companies, (3) evaluating safe levels for product cross-contamination by drug substances or other chemicals, and (4) the testing of chemicals for their toxic effects and the interpretation of data from these tests. Dr. Sussman has provided clients with the practical aspects of applying toxicological data to worker and consumer exposure situations for potent and toxic compounds handled in the workplace. He has provided training and technical support to diverse audiences to meet regulatory requirements and to provide solutions to their environmental health and safety challenges.
He has worked in various capacities in corporate occupational toxicology groups culminating as a Director of Occupational Toxicology in Pfizer’s Corporate Environmental Health and Safety Department. His group was responsible for evaluating the toxicity of pharmaceutical products, their intermediates and other chemicals handled in research facilities and providing hazard communication information to all research facilities worldwide.
Bob has an Sc.B. in Bioenvironmental Engineering from Brown University and a Ph.D. in Environmental Health Science from New York University. He is a Diplomate of the American Board of Toxicology, a past member and chair of the AIHA’s WEEL Committee, and a founding member of the Occupational Toxicology Roundtable and serves on that organization’s steering committee. Bob is also a member of the Society of Toxicology, American Industrial Hygiene Association, and the International Society of Pharmaceutical Engineers. He has had an adjunct appointment at the NYU Medical Center where he gives several lectures each year on regulatory toxicology, risk assessment, and industrial hygiene aspects of the pharmaceutical industry.
Partner & Managing Director, London
Boston Consulting Group (BCG)
Elliot Vaughn is a core member of the Health Care, the Operations, the People & Organization, and the Social Impact practices at The Boston Consulting Group. Since joining BCG in 2005, Elliot has focused his client work in the health care and social impact sectors. He has additional experience in the energy, financial services, media, retail, and industrial goods industries, across a broad range of topics. He leads one of BCG’s major pro bono relationships with a global NGO.
“What drives me is seeing the lasting impact of our work to drive the competitiveness of our clients. Whether we are working with commercial or social impact clients, that level of lasting result can only be sustained by BCG’s way of working with — not on — our clients.”
Prior to joining BCG, Elliot worked for five years as a public policy consultant helping clients in the health care, consumer goods, telecoms, energy, transport, and financial services industries.