Patrick Anibaldi, Abbott: Patrick Anibaldi has 15 years engineering experience working on Abbott’s 7 different divisions of medical device portfolios. In addition, to working on a variety of products, Patrick also has experience wearing multiple hats in the areas of Quality, Supply Chain, R&D, and Sterilization. Patrick’s current mission is to improve the sustainability of medical device sterilization to ensure safe and effective supply of medical devices to patients around the globe.
Stephen Anisko, FDA: Stephen Anisko is a Lead Reviewer for the CDRH OHT4 Sterility Devices team. He is a chemical engineer with over 20 years of experience in the pharmaceutical, biotechnology and medical device industries. His professional focus has been on design and development of commissioning, qualification and validation programs in an industrial setting. In his current role at CDRH, he is responsible for the scientific review for medical device submissions in support of the TPLC model. Prior to joining the Agency, Stephen has held positions both as a technical consultant and in house staff focused on a wide range of Validation, Quality Systems and Compliance related projects. He also has had over 10 years of hands-on direct experience maintaining the validated status of a gamma irradiated terminal sterilization process for commercial pharmaceutical product.
Daniel Badali, Triple Ring Technologies: Daniel Badali, Ph.D., is a physicist with a broad background in scientific computing and software development. He currently leads the technical development of Triple Ring Technologies’ dose map modeling tool, which has been used by companies from startups to Fortune 500 to streamline the sterilization validation process. As a Staff Scientist at Triple Ring Technologies, he has worked on the development of medical devices in the photonics, imaging, and radiation spaces. Daniel was awarded a Ph.D. for his research in radiation physics at the Max Planck Institute for Structural Dynamics in Germany, and previously studied at the University of Toronto.
Mark Bogs, ICU Medical: Mark Bogs is the Senior Director of Sterility Assurance at ICU Medical and is responsible for supporting pharmaceutical moist heat terminal sterilization, medical device Gamma, E-Beam, X-Ray and Ethylene Oxide sterilization, and aseptic manufacturing across global ICU Medical sites and third party manufacturing. He has 30 years industry experience in start up aseptic filling operations, established aseptic filling operations for small volume parenterals and Blow Fill Seal, and Ethylene Oxide, Gamma and E-Beam radiation sterilization. Mark has been a board member of PDA Midwest snce 2018, serving as chapter President Elect from 2020-2021, and serving as chapter President from 2022-2023.
He has previously held Global Quality Director roles at Pfizer, Hospira, and Hollister and site QA/RA Director roles at Catalent Pharmaceutical, Dentsply Pharmaceutical, and LifeWatch. He has operations experience as the Manufacturing Manager at the start up of an aseptic pharmaceutical site at Dentsply Pharmaceutical and as the Plant Manager of an Ethylene Oxide sterilization plant for Sterigenics in the Chicagoland area. He began his pharmaceutical career at Abbott Laboratories Hospital Products Division as the Manufacturing QA Supervisor for the Small Volume Parenteral aseptic filling and finishing operation in North Chicago, IL.
Mark holds a BS in Chemistry from Purdue University and an MBA in International Business and Finance from Loyola University of Chicago.
Kristen Bozzelli, Baxter: Kristen Bozzelli is a Senior Manager of Regulatory Affairs at Baxter Healthcare Corporation. She has twenty years of experience in the medical device industry, including Clinical and Regulatory Affairs roles working with a variety of devices. Kristen holds a B.S. in Biology from University of Southern California, an M.A. in Molecular Biology from University of California, Santa Barbara, and a Certificate in Regulatory Affairs from San Diego State University.
Jason Canaway, STERIS Applied Sterilization Technologies: Jason Canaway is the Vice President of Sales for STERIS Applied Sterilization Technologies. Jason leads the AST Americas Sales Organization and also heads the Americas STERIS Labs Organization. Jason has 10 Years of commercial experience working with Customers in the sterilization industry. He has had the experience to partner with some of the largest Medical Device, Labware, and Single Use Bioprocessing Customers in the world helping to bring their products to their patients in need safely. Jason has significant experience working with Customers to understand irradiation technology and has assisted Customer leadership in long term strategic plans to transfer technologies best suited to their products. Jason holds an MBA from the University of Massachusetts and Bachelor of Science from the University of New Hampshire.
Eric Crawley, Abbott: My name is Eric Crawley and I hold a Bachelor’s Degree in Biological Science from California Lutheran University which I received in 2004. I have worked at Abbott Laboratories since 2005, initially working as a lab technician performing environmental monitoring, bioburden testing, LAL testing and dose audits. I transitioned into a role more focused on Sterilization in 2006, performing EO cycle validations, dose audits, dose mapping, E-beam equipment qualifications and sterilization related CAPAs. I am currently a Senior Sterilization Engineer in Abbott’s Assurance of Sterility Task Force, having worked in the Sterilization industry for nearly 16 years, with a focus on Radiation Sterilization, working to develop strategies for new products and for transitioning existing products into more sustainable sterilization modalities.
Samuel Dorey, Sartorius: Samuel has a strong focus on the radiation application work covering a wide range of applications including radiation effects on SUS for biopharmaceutical processes. Samuel is also deeply involved in promoting and facilitating the application of alternative ionizing radiations to gamma. He is the co-chair of the BPSA X-ray-committee, whose objective is to focus on the irradiation sterilization future in the form of X-ray, as increasing capacity constraints impact delivery for the growing single-use market. He is one of the lead authors of the 2021 BPSA technical guide, titled “X-Ray Sterilization of SUS”. He’s also member of the ASTM E61 and of the Panel of Gamma and Electron Irradiation. Samuel is also part of the Team Nablo initiative to conduct and spread-out specific material compatibility upon the different irradiation modalities. He is one of the lead panelists with the Emerging Technology Team (ETT) at the FDA and BARDA to discuss technology proposal on X-ray sterilization of Single-Use bioprocess equipments for biopharmaceutical manufacturing since 2021. He is also the authors/co-authors of ~20 pear reviewed articles on gamma/X-ray/Ebeam impacts on plastic materials. Samuel is Principal Scientist, Materials and Irradiations, within Sartorius Product Development. He received a PhD in Polymer Science from the Mulhouse University, France.
Chris Dugard, FDA: Chris Dugard began his career with FDA in 2013 when he participated in an ORISE fellowship at FDA’s National Center for Toxicological Research focusing on analytical chemistry techniques around silver nanoparticles. He has been with FDA/CDRH since 2014 where he started as a reviewer with what was then the Division of Surgical Devices. He joined the Infection Control Devices Team - which eventually split into the Sterility Devices Team and PPE/Disinfection team in the Office of Surgical and Infection Control Devices in - 2016 where he focused on sterilizers and their associated accessories. In 2021, he accepted a position as the Team Lead for the Sterility Devices Team.
Ludovic Eychenne TRAD: Ludovic Eychenne is a nuclear engineer at the french company TRAD Tests & Radiations. He graduated in Engineering Physics from the National Institute of Applied Sciences (INSA) in Toulouse, France. He has acquired knowledge in physics of materials and electronic components, nanotechnologies and instrumentation, test and measurement. He also completed the specialization in atomic engineering offered by the National Institute for Nuclear Science and Technology (INSTN) of the French Atomic Energy and Alternative Energies Commission (CEA). This specialization allows students to acquire skills in nuclear reactor physics and pressurized water reactor functioning.
For the end of his studies, he worked on the validation of neutron physics in the Monte Carlo calculation code RayXpert®. Today, he carries out studies on the effect of radiation for all of TRAD's clients.
Leo Fifield, Pacific Northwest National Laboratory: Dr. Leo Fifield received his PhD in Chemistry and Nanotechnology from the University of Washington. He is a senior materials scientist at the DOE’s Pacific Northwest National Laboratory in Washington state where he leads research to understand the effects of ionizing radiation on polymer materials.
Sreekanth Gutala, FDA: Dr. Sreekanth Gutala is a Sr. Scientific Reviewer/Chemist in Sterility Devices Team, Division of Infection Control and Plastic Surgery Devices in Office of Surgical and Infection Control Devices of CDRH, FDA. Dr. Sreekanth Gutala started his career in FDA in the year 2009 after having 20 years of experience in private sector which includes major pharmaceutical/medical device companies at different roles. He worked for United States Pharmacopeia (USP) as a Director, Reference Standards Laboratory for USP- India office and managed several scientists in a day to day operations while working for USP-India Office.
At present in FDA, Dr. Sreekanth Gutala is serving as a Total Product Life Cycle (TPLC) reviewer of medical devices to evaluate post market compliance issues and premarket device submissions to ensure that the product is safe & effective before the product is in interstate commerce in USA.
Dr. Sreekanth Gutala reviews a wide variety of devices with a specialization in sterilizers, sterilization accessories, personal protective equipment, protective barrier negative pressure enclosures, medical air cleaners/purifiers, washer disinfectors and sharps containers etc. to name a few. Sreekanth Gutala serves as subject matter expert and possess an extensive experience in the review of sterilization, cleaning and disinfection processes and aseptic fill for medical devices.
Dr. Sreekanth Gutala served as acting Team Lead and acting Asst. Director on several occasions. In this role, Dr. Gutala supervised several reviewers in the team, set goals, guided, trained the new team members, interacted with the firms to troubleshoot scientific and regulatory inconsistencies Dr. Gutala is also serving as FDA Primary/Alternate Liaison and Technical Expert for several ISO/AAMI consensus standards such as AAMI/ ST/ WG63, Sterilization residuals, AAMI/ ST/ WG96, Compatibility of materials subject to sterilization, AAMI/ ST/ WG86 Quality systems for device reprocessing WG, AAMI/ ST/ WG43, Hospital Steam Sterilizers, AAMI/ ST/ WG09, Aseptic processing and actively participates in AAMI / Industrial standards meetings.
Dr. Gutala received a Bachelor of Science degree in Biology/Chemical Sciences, Master of Science degree in Chemistry and Ph.D. in Chemistry from prestigious universities and world-renowned national laboratories/institutes which is under Ministry of Science and Technology, Government of India. Dr. Sreekanth Gutala possess several training certifications to his credit and published 28 scientific articles which includes prestigious peer reviewed international journals, national / international scientific meetings, and workshops.
Matthew Hammond, Amgen: Matthew Hammond is a Process Development Senior Principal Scientist at Amgen, where he leads a team of materials scientists providing technical subject matter expertise for the Single-Use Systems, Chromatography Resin, and Filter raw material categories. He has more than a decade of experience tying the attributes of raw materials to relevant biomanufacturing process outcomes, helping to ensure consistent supply of medicines to patients, with optimal yield, quality, and compliance. Dr Hammond holds a PhD in Materials Science from UC Santa Barbara and a BS in Chemistry from Harvey Mudd College.
James Hathcock, Pall Biotech: James Hathcock, PhD is Senior Director of Regulatory and Validation Strategy at Pall Biotech, which includes responsibility for the characterization strategy to support the safe and successful end-user implementation of technologies enabling pharmaceutical manufacturing. He currently leads the BPSA initiative on X-ray qualification for single-use disposables, the BioPhorum Community of Practice for Extractables and leachables, and the ASME-BPE task group on single-use biocontainers; and has previously served as an expert manel member for USP <665> & <1665>. He is an active member of ASTM, ASME-BPE, PDA, ISPE, BPSA. Since joining Pall in 2008, James has led material and performance qualification of medical and biotech components, as well as relevant technical packages supporting regulatory filings. Prior to joining Pall, James served as professor of hematology at the Mt. Sinai School of Medicine in New York City, where he directed the protein purification laboratory related to drug characterization and discovery. James enjoys coaching his daughters’ Lego Robotics team (NYC champions), reef tanking, and biking.
Timo Neumann, Merck: Timo is a project manager for materials and membrane technology at MilliporeSigma. He has worked in the life sciences for more than 5 years. Previous to his position as Project Manager he worked in Research and Development for microbiological culture media at MilliporeSigma. Timo holds a B.S. in Biotechnology from the Mannheim University of Applied Sciences and an M.S. in Biotechnology from RWTH Aachen University. Timo is a member of the Bio-Process Alliance (BPSA) working group on the qualification of X-ray sterilization for Single Use Assemblies.
Aftin Ross, FDA: Aftin Ross is senior special advisor for emerging initiatives in the Office of Strategic Partnerships and Technology Innovation (OST) at the FDA’s Center for Devices and Radiological Health (CDRH). In this role, she provides leadership and coordination within the Center on a range of emerging public health issues including medical device cybersecurity, respiratory protective devices, personal protective equipment (PPE), and incident response. Aftin has had leadership roles in CDRH incident response to potential shortages related to ethylene oxide sterilization site closures, COVID-19, device-related infections, and natural disasters such as the 2017 Atlantic hurricanes. Regarding ethylene oxide sterilization, she has led and participated on teams responsible for mitigating sterilization-related shortages, planning Agency panel meetings, generating innovative policy approaches for reducing EtO use and increasing the use of EtO alternatives. She also participates in interagency forums on EtO sterilization.
Aftin earned a B.S. in mechanical engineering from the University of Maryland Baltimore County where she was a Meyerhoff Scholar. She completed her graduate work at the University of Michigan earning a master’s and PhD in biomedical engineering. After her graduate work, she completed a post-doctoral fellowship as a Whitaker International Fellow at the Karlsruhe Institute of Technology in Karlsruhe, Germany. In 2016, she completed the National Preparedness Leadership Initiative, an executive education program in the Harvard School of Public Health and Kennedy School of Government and in 2019 she became a certified Six Sigma Green Belt.
Randy Schwarz, Pacific Northwest National Laboratory: Randy has a master's degree in nuclear engineering from the University of Washington and a second master's degree in computer science from Washington State University. He has developed graphical user interfaces for nuclear applications over the last 30 years and is currently employed as a nuclear engineer at Pacific Northwest National Laboratory in Richland, Washington state, USA.
Roger Snyder, Department of Energy: Roger E. Snyder was named Manager of the U.S. Department of Energy’s (DOE) Fermi Site Office (FSO) in August 2022. As Manager, Mr. Snyder is responsible for providing operational and institutional stewardship and oversight of the Fermi National Accelerator Laboratory (FNAL), also known as Fermilab, one of DOE’s world-class national laboratories.
Mr. Snyder has been Site Office Manager for DOE at Pacific Northwest National Laboratory since August 2011. Mr. Snyder previously served as Acting Site Office Manager for DOE at Fermilab and at Princeton Plasma Physics Laboratory.
Mr. Snyder joined DOE in 1990 as part of the Defense Programs Technical Intern Program. Since then he has worked in NNSA, EM & Science at the HQ, Operations Office & Site level. Most recently, he served as the Deputy Manager for the DOE National Nuclear Security Administration’s (NNSA) Los Alamos Site Office (LASO), overseeing over $2 billion annually in programs and projects as well as providing stewardship for the more than 2,000 facilities on over 23,000 acres comprising Los Alamos National Laboratory.
Over his over 32-year career with DOE, Mr. Snyder has served at or detailed to 14 DOE locations including headquarters, labs, and plants. Mr. Snyder is a Stanford and DOE Level 3 certified project manager. He received a B.S. in Engineering from the University of Illinois and a M.S. in Engineering from the University of Maryland; graduated from Stanford University with an Organizational Mastery of Project Management, from George Washington University with an Advanced Masters in Project Management, and completed Contracting Officer Training at the Defense Acquisition University, as well as nuclear power training at MIT, and executive training at Harvard.
Mr. Snyder is designated a Senior Technical Safety Manager (STSM) and is presently acting as the Central Technical Authority (CTA) for the Office of Science. Mr. Snyder also engages regularly with academia and students as an accreditor for the ABET (Accreditation Board for Engineering and Technology) and previously served as the Chair, Washington State University Engineering Advisory Board.
Ping Wang, Janssen: Ping Wang is a scientific director from Janssen R&D. He has been leading Janssen R&D’s effort in the evaluation, selection and qualification of single use systems for the past 15 years. He holds a MBA degree, and a Ph.D. degree in pharmacy.
Cody Wilson, IBA Industrial: Cody Wilson is the Business Development Director and a Product Manager at IBA Industrial. He has extensive experience integrating electron beam accelerators into systems for various applications and is an expert on radiation interactions and effects. He currently focuses on accelerator-based systems for medical device sterilization and phytosanitary applications. Cody is a member of several working groups developing sterilization standards and industry guidance.