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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA Container Closure Performance and Integrity Conference

June 13-14, 2018, Bethesda, MD

Committee & Speaker Biographies

  • Lei Li

    Lei Li, PhD

    Eli Lilly and Company

    Dr. Lei Li currently serves as an engineering advisor at Delivery Device and Connected Solutions, Eli Lilly and Company. Dr. Li’s has 9 years of experience in pharmaceutical and medical device industry, with focus on API and drug product packaging and cold-chain distribution development for biologic products. His current responsibilities include designing and evaluating container closure systems for pipeline molecules, supporting clinical development, tech transfer, and product commercialization. He is a frequent speaker at PDA conferences and author of peer-reviewed articles and book chapters on CCI test methods. Dr. Li received his Ph. D. in Analytical Chemistry from West Virginia University; prior to joining Eli Lilly, he worked at GE Plastics as an analytical and material scientist.

  • Dominick DeGrazio

    Dominick DeGrazio

    Janssen R&D, LLC

    Dominick DeGrazio is a Senior Associate Scientist in Large Molecule, Drug Product Development at Janssen R&D, Malvern, PA.

    Dominick graduated from Franklin and Marshall College in 2012 with a degree in biochemistry and neuroscience. Thereafter, he joined the Analytical Laboratory at West Pharmaceutical Services performing extractable and leachable testing for various parenteral packaging systems. He later transitioned to Wests’ Global R&D group where he implemented a strategy for assessing the compatibility of primary packaging components with biologic drug products. In 2014, Dominick joined the Analytical Development group within Oncobiologics Inc., a biosimilar start-up, where he was responsible for developing and validating multiple characterization assays for a range of molecular candidates. In 2015, Dominick shifted into his current role at Janssen R&D focused on early and late phase biologics formulation development. 
  • Paul Harber

    Paul Harber

    Parenteral Supply Chain, LLC

    Paul Harber is founder of Parenteral Supply Chain, LLC. PSC, as it is known, collaborates with clients devoted to all facets of the distribution of parenteral products.

    Paul Harber was a Principal with Modality Solutions, LLC. He completed work with a variety of companies in the Life Science areas. The scope of work has ranged from validation of active and passive shippers for numerous pharmaceutical clients as well as the installation and qualification of the Transport Simulation Lab located at BioConvergence. In 2014, project work with NGOs in the evaluation of cold chain operations at Ebola vaccine clinical trial sites in Zone 4 countries was a personally rewarding addition to scope of work.

    Paul Harber was a founding member of the PDA Pharmaceutical Cold Chain Interest Group. Paul co-authored for the Parenteral Drug Association (PDA) Journal of Pharmaceutical Science and Technology Technical Report No. 39 (PDA TR#39). PDA TR#39 is widely used by both industry professionals and regulators as the definitive reference source for best-demonstrated practices in transport validation. For 16 years, the scope of Paul’s work at Eli Lilly and Company focused on the qualification of both active and passive shippers in support of clinical and commercial transportation of temperature labile products. He had major roles in defining and specifying the cold chain components and practices necessary to support the commercialization of four Lilly products worth over one billion in annual sales. Paul was the interface to all regulatory agencies on issues of transport package qualification. Paul has provided tech transfer support to implement numerous changes and improvements across the supply chain in support of the Lilly API supply strategy. As a team member on the internal Lilly CM&C teams, Paul made major contributions in the selection and justification of primary packaging as well.

    Paul is the 2008 recipient of Eli Lilly Engineering Excellence Award, a peer selected award acknowledging lifetime engineering achievements at Eli Lilly and Company.

  • Marc Hogreve

    Marc Hogreve

    Sartorius Stedim Biotech GmbH

    Marc Hogreve has been working for Sartorius since 2006, were he is today Senior Engineer for Integrity Testing Solutions. He earned his engineering degree at the “University of Applied Sciences and Arts” in Goettingen. Marc started his career as project leader in the field of development for lab equipment for cell culture and microbiology.

    As of 2011, he has been working as an engineer for integrity testing solutions with a focus on single-use systems for fluid management. As a subject matter expert in that area he is working on Sartorius’ global container closure integrity strategy for single-use systems. As part of task forces in several organizations like ASTM, BPSA or PDA he is supporting the creation of standards and best practices for the container closure integrity of single-use systems.

  • Isabel Tejero

    M. Isabel Tejero del Rio, MD, PhD


    Dr. Tejero was born in Spain where she trained as a physician. Moved to the United States where she got a PhD in Integrative Physiology. Worked as family physician in Spain, and in cardiovascular research in the States, reaching the position of Research Assistant Professor at GWU. She joined the Office of Compliance at CDRH in 2009, where she currently a Lead Consumer Safety Officer in the Front Office. She has several years of experience working with combination products both from a regulatory-policy perspective and as an expert reviewer of premarket applications and post-market compliance actions.

  • Steve Badelt

    Steven W. Badelt

    Suttons Creek, Inc.
    Steven W. Badelt, PhD. is a seasoned expert in combination products, engineering management, business development, and systems engineering.  He has over 20 years of experience in the design and launch of combination products and medical devices, including auto injectors, insulin-pumps, implantable defibrillators, connectivity, and patient management software.  Steve is Founder and Managing Partner of the consulting firm Suttons Creek, Inc., which has served as the device team for pharma on over 40 programs.  In his spare time, Steve advises several startups, serves as a Graduate Professor at Loyola Marymount University, and is an Emeritus Ambassador for the International Council on Systems Engineering.
  • Daniel Bantz

    Daniel L. Bantz

    West Pharmaceutical Services, Inc.

    Daniel Bantz brings experience in product performance testing to West’s pharmaceutical systems and components to his position as Packaging and Performance Technology Manager.  He’s competent in fluidics systems development, combination product testing and risk assessments.  Daniel implements testing technologies meeting ever-changing regulations in conjunction with customer needs.  He earned an associate’s in Electromechanical Technology from Allegany College of MD, a bachelor’s degree in Business Management from the University of Northwestern St. Paul and an MBA in Operations and Technology from Aurora University.

  • Jon Bell

    Jon Bell

    Fulcrum PDC

    Jon Bell is the co-founder and Managing Partner for Fulcrum PDC, a New Jersey based consulting firm started in 2010 that is dedicated to helping medical product companies develop meaningful products for the pharmaceutical, life science and device global markets.

    Jon has more than 30 years of experience exclusively in the development and commercialization of medical devices and combination products. As an Engineer, he has been extensively involved in bringing innovative new medical products to the market using his diverse career experience in R&D, Business Development and Operational roles. Jon spent nearly 20 years at BD in R&D supporting their drug delivery device business. In addition to his role as a senior project leader, he led the assessment of new and emerging medical technology as part of BD’s license and acquisition ventures, focusing on evaluating market, technical and manufacturing viability for each potential opportunity. Following BD, Jon was the VP of Operations for a medical device start-up company.

    Jon’s primary responsibilities at Fulcrum PDC include project management, design controls execution & documentation, implementing/updating quality systems, evaluating device & combination product concepts, product design and human factors/usability engineering, as well as presenting customized training workshops for clients covering such topics as device & combination product development, design controls, risk management and human factors/usability. He provides engineering, quality systems and regulatory support to a diverse group of clients ranging from the largest pharmaceutical and medical device corporations to aspiring start-up companies.

    Jon received his BS in Mechanical Engineering from Illinois Institute of Technology and an MS in Biomedical Engineering from Rensselaer Polytechnic Institute. In addition to medical device patents, he has been a team member recipient of several nationally recognized medical product design awards.

  • Philippe Bunod

    Philippe Bunod

    Pfeiffer Vacuum SAS

    Philippe Bunod currently serves as a product manager for integrity test solution, Pfeiffer Vacuum in Annecy-France. Philippe has 23 years of experience in vacuum engineering and industrial leak detection in many industries; automotive, medical, electronics, pharma. His current responsibilities include developing and promoting of CCI testing methods for pharmaceutical and medical industries.

    Philippe Bunod received his Ph.D. in Solid State Physics from Grenoble-Joseph Fourier University; prior to joining Pfeiffer Vacuum, he worked at Cyberstar S.A. as physicist to develop crystal growth equipments.

  • Allison Dill

    Allison L. Dill, PhD

    Eli Lilly and Company

    Allison Dill, Ph.D. is a Senior Research Scientist in Delivery and Device Connected Solutions at Eli Lilly and Company, Indianapolis, IN. She received a BS in Chemistry and Biology from Indiana University, and worked for 4 years as an analytical chemist in Product Research and Development before attending graduate school. She received her Ph.D. in Analytical Chemistry from Purdue University, studying imaging mass spectrometry for disease state characterization. While at Lilly, she has been responsible for the analytical control strategy of many solid oral and parenteral dosage forms and has contributed to several regulatory submissions. Her recent contributions have focused on enabling the delivery of the early phase portfolio within a complex global network with responsibility for the analytical control strategy of both the active pharmaceutical ingredient and the drug product. She is now focusing on the CCI strategy for multiple molecules with a concentration in on-line high voltage leak detection for 100% inspection.

  • Carolyn Dorgan

    Carolyn Dorgan, BBME, MS


    Mrs. Dorgan serves as a Senior Lead Reviewer and Combination Products Team Lead in the General Hospital Device Branch in CDRH’s Office of Device Evaluation.  Within the Agency, Carolyn serves as the Agency’s standards liaison for over nine international standards, is part of the team developing three device specific guidance documents, participates on the Pediatric Steering Committee, and is a member of the Pediatric Extrapolation Review Committee. Prior to joining the FDA, Carolyn worked in the medical device industry for 5 years as an engineer. Carolyn earned her Bachelor’s Degree in Biomedical Engineering from the University of Minnesota and her Master’s Degree in Technology Commercialization from the University of Texas.

  • Carole Langlois

    Carole Langlois

    Sartorius Stedim Biotech

    Carole Langlois started her career in 1996 with Abbott Laboratories in Chicago, US. In 1998, she joined Sartorius Stedim Biotech in Aubagne, France where she is today Senior Product Manager for Single Use Fluid Management Technologies. Carole has 20 years of experience in the Pharmaceutical and Biopharmaceutical industries and has been involved in many industrial projects for the integration of single-use systems (SUS) in Form, Fill & Finish processes. As of 2012, she has been working on the container closure integrity strategy for SUS. Carole is a member of the PDA and of the BPSA task force for integrity testing and leading the ASTM E55 WK51754 on integrity testing of SUS.

    Carole Langlois has a Biotechnology university graduation from Polytech Marseille and an Executive Master of Business Administration (MBA) from Kedge Business School Marseille.

  • Corinne Lengsfeld

    Corinne S. Lengsfeld, PhD

    University of Denver

    Dr. Lengsfeld is a Professor at the University of Denver and currently serves as the Vice Provost for Research and Graduate Education. She received her bachelors, masters and Ph.D. degrees from the University of California at Irvine in 1992, 1993, and 1997 respectively. She specializes in interdisciplinary research in meso and micro-scale fluid systems. She has worked with Professor Ted Randolph (University of Colorado Boulder) and Prof. John Carpenter (University of Colorado Anschutz Medical Campus) for more than 20 years to investigate the impact of fluid dynamic phenomena on macromolecular therapeutic stability. Specifically, she has studied the impact of fluid dynamics on small molecule, protein, siRNA and plasmid DNA in drug processing, drug shipping and transport and drug aersolization systems. She has focused her effort on identifying problems and proposing cost effective solutions utilizing both experimental and computational fluid dynamic simulations.

  • Gary Mills

    Gary J. Mills


    For the past 30 years Gary has been a practicing engineer in the biotech industry.  His experiences have focused on the development, technical transfer and commercialization of parenteral drug product manufacturing processes. Gary has been involved with the commercialization of three therapeutic proteins, two complex generics, one contrast agent and an auto-injector device.  He has also contributed to the start-up and commissioning of four new biopharmaceutical facilities.  He has designed numerous downstream manufacturing processes that range from cell culture harvesting through purification and aseptic filling, as well as inspection, packaging and CIP/SIP operations.

    In Gary’s current position as Associate Director, Drug Product Development at TESARO he is responsible for the oversight of clinical drug product manufacturing at TESARO’s contract manufacturers.  His previous work experiences have been with Moderna Therapeutics, Momenta Pharmaceuticals, MassBiologics, Wyeth, Shire/TKT, Genzyme and Molecular Biosystems.

    Gary received his Master of Science Degree in Engineering Management from Northeastern University and his Bachelor of Science Degree in Chemical Engineering from the University of Massachusetts, Lowell.

  • Sarah Mollo


    Sarah Mollo serves as Biocompatibility Consultant and Lead Reviewer in the General Hospital Device Branch in CDRH’s Office of Device Evaluation. Within the Agency, Sarah serves as the Agency’s standards liaison for over multiple international standards, is part of the team developing three device specific guidance documents, and sits on the Biocompatibility Policy Forum. Prior to joining the FDA, Sarah was a post-doc at Harvard University. Sarah earned her bachelor’s in Microbiology and Cell Science from the University of Florida and her doctorate in Immunology from the University of Alabama at Birmingham.

  • Alexandre Mura

    Alexandre Mura

    Confarma SAS
    Alexandre Mura holds a Bachelor degree in biotechnology and microbiology, as well as a Master degree in business. Alexandre Mura led the Microbiology department at Confarma France for 3 years, followed by 1 year Head of the R&D department. In 2016, he developed and qualified an innovative equipment for Microbial Challenge Testing using an Aerosol System. Since 1 year, Alexandre Mura is Site Head of Confarma France.
  • Coralie Richard

    Coralie A. Richard, PhD

    Eli Lilly and Company
    Coralie Richard, PhD is an Associate Senior Consultant Engineer in Delivery and Device Connected Solutions at Eli Lilly and Company, Indianapolis, IN.

    She spent her early life in France and came in the USA in 2008 to pursue her PhD in Organic Chemistry at the Georgia Institute of Technology.   Her graduate studies focused on synthesizing polymers for electrochromic and solar cell devices. After graduate school, she joined Celanese in Kentucky, developing aesthetically pleasing plastics for the automotive and consumer spaces.  She joined the Materials and Packaging Engineering team at Eli Lilly in 2017.  In this role, she supports the material characterization analytical laboratory, with a focus on the mechanisms of drug-container interactions.  Her experience encompasses a wide variety of bioproducts across the various stages of development.  In addition, her recent contributions have included a thorough examination and alignment of the team’s external sourcing strategy.
  • Suzette Roan

    Suzette M. Roan, JD

    Sanofi US

    Suzette Roan joined Sanofi as Senior Director, to Global Regulatory Affairs – Devices in September 2017. Prior to Sanofi, Suzette was with at Biogen for 3 years in Regulatory Affairs CMC where she led the combination product regulatory team responsible for the development and commercial combination product portfolio. Before Biogen, Suzette was with Pfizer for 19 years, with roles in Analytical Development, Outsourcing and Regulatory CMC where she gained experience in outsourcing analytical testing activities, auditing contract laboratory facilities, qualification and control of polymer and elastomer materials, including leachables and extractables for inhalation products. She has experience with pulmonary inhaler, prefilled syringe, autoinjector and on body delivery systems.

    Suzette holds a BS in Chemistry from the University of Connecticut, a MS in Management from Albertus Magnus College and a JD from the University of Connecticut School of Law. She is an active member of ISO/TC 84 working groups, PDA TR73-2 development committee and is currently chair of the Combination Products Coalition Marketing Submissions working group.  

  • Pooja Sane

    Pooja Sane, PhD

    BioMarin Pharmaceutical Inc.
    Pooja Sane received her M.S. from Northeastern University in 2009 followed by a Ph.D. in Pharmaceutical Sciences from the University of Connecticut in 2016. Her academic research involved several projects on lyophilization with a focus on investigating the variation in the heat and mass transfer during freeze-drying and understanding the mechanisms involved in the reconstitution times of high concentration proteins. She joined BioMarin Pharmaceuticals as a Formulation Scientist in 2016 where she has been primarily involved in designing a freezing process and container closure combination for a Gene Therapy Project.
  • Oliver Stauffer

    Oliver P. Stauffer

    pti - Packaging Technologies & Inspection

    Oliver Stauffer received his Bachelors of Science degree from the University of Michigan and completed his MBA at Georgetown University. He began his career in analytical and R & D laboratories, with a focus on sensory technologies, physio-chemical measurement and test method development specific to package testing.

    Stauffer joined PTI in 2005 as a member of the research and development team working on non-destructive testing of high-risk pharmaceutical packaging. In 2006, he joined the sales team as applications engineer for PTI Inspection Systems. He held the position of International Business Development Manager for PTI through 2010, followed by COO through 2015, focusing on global quality solutions for package inspection that provide the highest level of measurement accuracy and reliability. During his time with PTI he has developed several technology platforms, measurement methodologies, and technology patents. In 2016, he was appointed as CEO.

  • CAPT Alan M. Stevens


    CAPT Stevens supervises the FDA premarket review branch responsible for evaluating a majority of the drug delivery devices used within the United States, which includes devices like syringes, autoinjectors, nasal sprays, catheters, intravascular ports, and infusion devices. In addition, a majority of the device components of combination products approved for use in the U.S are evaluated by the General Hospital Devices Branch (GHDB). Prior to becoming branch chief, CAPT Stevens spent 10 years as an engineering reviewer in GHDB and 3 years as a compliance officer in CDRH’s Office of Compliance working on post-market safety issues for drug delivery devices.  CAPT Stevens received his B.S. in mechanical engineering in 2003 and master’s degree in reliability engineering in 2012, both from the University of Maryland.