Committee & Presenter Biographies

Ilias Amara holds an engineering degree in mechanical and industrial engineering from the Arts et Métiers ParisTech (Paris, France) engineering school.

He is a PhD candidate and has completed an industrial thesis at F. Hoffmann - La Roche Ltd (Basel, Switzerland) in collaboration with the University of Basel and the FHNW Muttenz (Switzerland). His research focuses on the development of an innovative technology for the detection, characterization and chemical identification of visible particles in liquid drug products as well as the development of new protein like particle standard.

He is currently working at Roche (Basel, Switzerland) as a Process Engineer in the medical device & packaging development department.

Dr. Ashwinkumar Bhirde is a senior research scientist at the Office of Biotechnology Products (OBP), CDER\FDA. Dr. Bhirde has a bachelors and master’s degree in chemical engineering. Dr. Bhirde has a PhD in chemistry from the University of Connecticut. Dr. Bhirde is a primary chemistry, manufacturing, and control reviewer for biotechnology products in OBP. Dr. Bhirde’s regulatory research involves evaluating the pre and post market quality of protein drug products including biosimilars with emphasis on particulate detection, identification and characterization. He is an FDA liaison for USP chapter <788> Particulate Matter in Injections. Dr. Bhirde has participated in cross-lab studies evaluating NIST developed particle standards in the visible and submicron size range.

Employed since 2020 as a data scientist at Novo Nordisk specializing in computer vision and deep learning. Master’s in Mathematical Modelling and Computing (2022) and bachelor’s in Electrical Engineering (2019), both at the Technical University of Denmark. The master thesis regarded unsupervised anomaly detection in freeze-dried products in AVI systems.

Antonio Burazer joined Takeda in 2010 where he has overseen visual inspection and secondary packaging processes at a multi-product manufacturing facility in Vienna, Austria. In 2019 he transitioned to Global Quality, taking over responsibility for visual inspection and particle life cycle management globally for Takeda. He is engaged in collaborating with experts across the industry and strives for continuous improvement, guided by the ultimate goal to achieve zero particles in parenteral products.

Roy T. Cherris has over 40 years of process and QA experience in microbiology, microscopy and inspection. He is a founding member and Senior Advisor of Bridge Associates International consultancy. He is also CSO of InQuest Science providing expert database applications for monitoring particulate matter and physical defect control in the Pharma industry. Roy has studied forensic microscopy extensively at the McCrone Research Institute in Chicago and is a respected SME in the field of visual inspection systems and investigative microscopy for particulate source identification and mitigation. Roy chaired the PDA task force for TR-79 Difficult to Inspect Parenteral products and is an active member of the USP Expert Panel for Visual Inspection of parenterals.

 

Mary Lee Ciolkowski is a Sr. Principal Scientist in the Analytical Development organization of Bausch + Lomb and has 20+ years of experience spanning R&D through product launch and on-going manufacturing support. Mary Lee is an SME in the characterization of sub-visible and visible particles in pharmaceutical dosage forms during development and drug product quality control/stability studies. This includes support of particle-related root-cause analyses and investigations at US and global manufacturing sites. Mary Lee also supports visual inspection training and ensuring compliant visual inspection systems are implemented at manufacturing sites.

Rukman De Silva, PhD is currently working as a Policy Lead in the U.S. Food and Drug Administration (FDA)/ Center for Drug Evaluation and Research (CDER)/ Office of Pharmaceutical Quality (OPQ)/ Office of Policy for Pharmaceutical Quality (OPPQ)/ Division of Internal Policies and Programs (DIPAP), Branch II. In 2007, Rukman De Silva received his PhD in Chemistry from Dartmouth College, NH, specializing in protein chemistry. After a short postdoctoral fellowship at Dartmouth College, in 2008, he joined FDA/CDER/OPQ/Office of Biotechnology Products (OBP). At OBP, he conducted chemistry manufacturing and control (CMC) review and inspectional activities related to biological products submitted to the FDA. In 2022, he joined FDA/CDER/OPQ/OPPQ/DIPAP, Branch II, where he conducts FDA policies and programs development activities related to pharmaceutical quality.

Dr. De Silva has received several awards including FDA/CDER team excellence awards in 2015 and 2019. He has been an invited speaker in multiple conferences in the area of visible and subvisible particulates testing in past few years. He has published in peer reviewed journals on the subject of subvisible particulate testing in biotherapeutics. Dr. De Silva also serves as a Journal of Pharmaceutical Sciences Editorial Advisory Board Member since 2018.

After achieving a Master’s Degree in Mechanical Engineering, Mr. Frasson worked for several international companies in the automation industry.

He joined Brevetti C.E.A. in the year 2000 as Mechanic Systems Design Manager.

From 2004 he undertook the technical management of the company and later on in 2007 he began the restructuring of Brevetti C.E.A.’s production and the expansion of the entire range of products by introducing new vision’s technologies.

In the same period, he was coordinating and supervising a special department dedicated to the pharmaceutical process analysis through the development of artificial vision systems using also neural algorithms.

On 2010 he became responsible of the whole operations process and in February 2014 he has been appointed as the General Manager of Brevetti C.E.A. Company.

Zhengqi Gao received his BS and MS in the School of Microelectronics from Fudan University, Shanghai, China, in 2018 and 2021, respectively. Currently, he is pursuing his PhD at the Department of Electrical Engineering and Computer Science, Massachusetts Institute of Technology, MA, USA. His current research interests include design automation for photonic integrated circuits and machine learning.

Casey Jarvis has worked as a research scientist at MVA Scientific Consultants for five years isolating visible and sub-visible particles under an ISO 5 clean bench. Her background in chemistry and forensic science provides a strong foundation for investigating and characterizing foreign materials found in products and packaging. Casey specializes in chemical analysis using light microscopy and microspectroscopy techniques, such as FTIR and Raman microspectroscopy.

Conor Kennedy works in Merck's Global Engineering Solutions Group as their Subject Matter Expert on Automated Visual Inspection. He graduated from the Pennsylvania State University in 2017 with a degree in Mechanical Engineering and started at Merck in the Automated Vision Inspection Group at Merck’s West Point site. After starting at Merck, he started attending Drexel University to get his master’s in electrical engineering due to his focus on control systems and Machine Learning. He began developing Deep Learning models during him time working in the West Point vision group and has continued to work with Merck’s vendors on Artificial Intelligence.

Christian Kolić is a Product Manager Inspection Machines for Körber Pharma Inspection in Germany, Markt Schwaben. Christian has over 20 years’ experience in inspection of pharmaceutical products.

In his current role as product manager, he is responsible for further development and maintenance of the product portfolio and manages activities such as preparation and coordination of market and technology analyses, development and project management for the implementation of new product and service ideas.

Rob Miller has been with Pfizer Global Technology and Engineering, Sterile Injectables Technology as a subject matter expert and group leader in visual inspection since 2019. Prior to this he worked within Pfizer Global Quality supporting the sterile injectables network and responsible for internal policy associated with visual inspection. He is responsible for supporting Pfizer’s sterile injectable network with internal guidance, policy and best practices related to manual and automated visual inspection. In addition, he reviews site inspection processes for compliance and directs strategic initiatives to the Pfizer network. Rob has a BS in Electrical Engineering, an MS in Engineering Management and a Graduate Certificate in Applied Statistics.

Sai Teja Neeli holds a PhD in Chemical Engineering from University of Tulsa, Oklahoma. Currently, working as a Senior Process Engineer at Catalent Pharma Solutions in Bloomington, Indiana. Sai is part of automated inspection team which primarily focuses on automated inspection machine (AIM) recipe development and performance qualification activities for syringe and vial products.

Felix Riehn holds a Master of Science degree. He joined Körber Pharma in 2014 and has worked in business development, strategic marketing and product management. After 4 years in the Swiss headquarters, he joined the world market leader 'Körber Pharma Inspection', better known as 'Seidenader'. As head of product management he is in constant exchange with pharmaceutical manufacturers and drove innovations such as 'Switch 75' or 'Deep Learning'.

Andrea holds a degree in Physics from Padua University and a Master's in Nuclear Engineering.

As a researcher at the National Research Council (C.N.R.), he developed several optoelectronic and nuclear scientific instruments for Magnetically Controlled Fusion Research. He also set up international collaborations with UWA Madison (USA) and Garchin IPP (DE).

After ten years of activity in research, he moved to the industrial sector to develop optical and vision controls for industrial application as CEO of a small-medium company. This experience drove him into the pharmaceutical field, where he started to develop several control applications with vision and spectroscopy tools.

He then joined a leading company as R&D Manager, for which he developed an innovative inspection technology for the inspection machines.

Since 2008 he has been with Stevanato Group first as Pharma Inspection Product Development Manager. Here, he works to develop new automation and inspection products dedicated to the pharmaceutical customers of the Group.

Tobias Tvarnø holds a Masters degree in Computer Science from University of Copenhagen since 2019. He specializes in Machine Learning and Algorithm design. Tobias has worked in several fields as a Software Developer during and after his studies and has since 2020 held a position as a Data Scientist for Novo Nordisk.

Romain Veillon is Director Vision Technology at GSK, in Global MSAT Manufacturing Technologies. As global expert he is leading Visual Inspection performance and expertise network on multiple sites.

He now focuses on Quality Integration Lead, New Technology Development, Validation Strategy, Capability assessment, Asset Management programs, Technical Watch, Performance Improvement and Develop Equipment strategy within network. He manages a network of vision experts to develop visual Inspection expertise within GSK Vaccines. Romain is now focusing in digitalization and innovation management with new AVI-LT asset deployment.

Romain has developed expertise in new AVI equipment qualification and Deep Learning deployment.

Last past 24 years he has worked in parenteral manufacturing, he has gained experience at Sanofi Pasteur, E Lilly and GSK, in support to production and secondary operations projects for filling and freeze-drying.

He also developed innovative vision systems with some academic collaborations and regular presentation to PDA conferences.

In 2017, Romain developed a PDA course "Mastering AVI". Since 2018 Romain is Interest Group Leader for Visual Inspection in PDA Europe. Since 2019, Romain co-led a taskforce to prepare a point to consider document for AI applied to Visual Inspection.

In 2020 Romain received PDA James P. Agalloco Award for educational training.

Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 28 years of experience in the field of process design and process modeling and is a certified Black Belt in Lean Six Sigma. Rick has spent the past twenty-one years at Merck focusing on the visual inspection processes for parenteral products. During this period he led a team of engineers responsible for optimizing existing automated and manual inspection processes and developing new inspection systems. Rick's current role includes providing a global strategy and process support for visual inspection and glass breakage management for Merck manufacturing sites around the world.

Brady Wern is a Lead Process Engineer at Catalent Biologics with 8 years of pharmaceutical experience, including validation, facility and process design, construction management, and AIM development. He has been developing automated inspection recipes for over 2 years and serves as the site’s subject matter expert for automated inspection engineering and validation in addition to overseeing other inspection technologies. Brady holds a BS in Mechanical Engineering from the Rose-Hulman Institute of Technology.

Linda Wildling did her PhD and Post-Doc research at the Institute for Biophysics at the University of Linz in the Cell Communication in Health and Disease field. In 2011 she joined Takeda Pharmaceuticals and worked in several positions within Takeda Site Quality and Production. She has broad experience in Pharmaceutical development, Auditing, Regulatory & CMC, and Contract Manufacturing management, including sterile production and lyophilized products.

Linda works in Digital within Takeda Manufacturing as Head of Digital Innovation Success Management. To drive digital innovation, she is also leading the project AI-enabled, automated inspection of lyophilized products in sterile pharmaceutical manufacturing. She is the Co-Lead of Takeda´s Global Visual Inspection Program - Visual Inspection in Parenterals and Particles Management.

Jeffrey Williams is a Manager in Drug Product Processing Engineering for Catalent Biologics and has nearly a decade worth of experience spanning R&D, validation, and manufacturing roles including more than 5 years in the pharmaceutical and medical device industry. Jeff is responsible for the primary and secondary process engineering technical teams at Catalent Biologics’ facility in Bloomington, Indiana. In particular, Jeff’s team focuses on implementation of automated visual inspection systems throughout the facility and vision recipe development. Jeff holds a BS in Mechanical Engineering and a MS In Mechanical Engineering from the University of Maryland, College Park.