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Ashwini Bhisikar
Technical Key Account Manager. at Datwyler Pharma Packaging- Keynote 1: Aseptic Manufacturing in Times of Covid-19: Supply Chain, People, Management
- Container Closure Components
Ashwini has completed Graduation in Biotechnology from Nagpur University and MBA in Biotechnology & Marketing from International Institute of Information technology Pune, India in the year 2010. While working with Pharma Clients she developed immense interest in Packaging Technology and pursued Graduate Diploma in Packaging Technology from Indian Institute of Packaging Mumbai in 2012.
She has experience in the techno-commercial business of primary packaging materials like Vials, Ampoules, and Prefilled syringes along with strategy building for packaging machines in the allied pharma industry. She has an experience of working with pharma packaging companies like; Schott Kaisha, ACG Pharmapack & West Pharma.
She was exposed to Japanese culture for 2 years while staying in Japan and have performed social activities on the community level.
Ashwini joined Datwyler Pharma Packaging in 2018 and works as a Technical Key Account Manager. In her current profile, she delivers technical support to the business and customers and also leads and supports the in-house customer-oriented technical projects.
She is a passionate runner and likes doing yoga.
Jia Min Boo
Technical Account Specialist at West PharmaceuticalsJia Min, Boo is from Singapore and holds a Bachelor's degree in Material Science Engineering from Nanyang Technological University in Singapore.
She joined West Pharmaceuticals Singapore since July 2013 as a Technical Account Specialist. In her role, she provides technical support to pharma companies in the AP region, providing product recommendations, technical training and advice to ensure smooth and easy uptake of West’s wide product portfolio as required for customer’s drug product application.
Richard Denk
Senior Consultant Aseptic Processing & Containment at Skan AGRichard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Senior Consultant Aseptic Processing & Containment. Richard founded 12 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2015. Richard is member of the PDA Ptc Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard has spent more than 20 years with the subject on Aseptic Processing and highly active / highly hazardous substances and has developed the containment pyramid.
Derek Duncan
Director of Product Line Europe at Lighthouse InstrumentsDr. Duncan began his career at the DutchInstitute for Atomic & Molecular Physics in Amsterdam. He moved into industry holding Product & Application Development positions. Currently, at LIGHTHOUSEsince 2003, Dr. Duncan is responsible for developing applications for process monitoring and finished product inspection. These include using headspace analysis for 100% container closure integrity testing, lyo chamber moisture mapping, and automated media fill inspection.
Somasundaram G.
Senior Technical Consultant, APAC at Merck KGaASomasundaram Gopalakrishnan, works as Senior Technical Consultant for Asia Pacific in Merck Life Sciences under the Process Solutions division based in Singapore. He does consultation with Biopharmaceutical customers for Regulatory compliance, Training and Process Unit Operations. Previously, Somasundaram was leading the Technology Management for S.E.A and Oceania handling a team of Technology Managers working closely with customers in Product Applications and training customers in best practices. Somasundaram has worked in different functions within the organisation for the last 18 years in Technical Service, Filter Validation Lab, Product Marketing, Commercial role and Business Development areas. He also worked in Quality Control (Microbiology), and Academic experience in Microbiology.
Somasundaram graduated with a Master Philosophy in Food & Industrial Microbiology, and Post graduate in Business Management.
Tobias Goettler
Head of Product Management & Marketing - Product Group Pharma Liquid at Syntegon Technology GmbH- Keynote 1: Aseptic Manufacturing in Times of Covid-19: Supply Chain, People, Management
- Manufacturing: Filling Specifics
Tobias Goettler holds a Diploma in Engineering from the Technical University of Nuremberg and a Master’s Degree in Management from the University, Hagen. In 2009, he joined Syntegon Technology (formerly Bosch Packaging) as a process engineer for filling- and CIP/SIP- systems. After additionally six years as product manager for the business field ampoules and filling systems with global product responsibility, Goettler has been Head of Product Management & Marketing for the Product Group Pharma Liquid since June 2020. His main responsibilities include market analysis, the development of the product portfolio including initiating of new products, as well as general business development.
Yves Grossenbacher
Business Development Manager at Ypsomed AGYves Grossenbacher is Business Development Manager with Ypsomed Delivery Systems since late 2017.
His main regional responsibilities at Ypsomed include market development for Ypsomed Delivery Systems in Europe, Asia, LATAM, and MENA.
Yves has been with Ypsomed since 2012 in several commercial roles within Ypsomed’s Diabetes Care/insulin pump business. He has worked closely with patients, nurses, and doctors to build up a deep diabetes market understanding and was involved in the successful launch of the mylife YpsoPump in Switzerland. Yves graduated in 2017 from the University of Applied Sciences in Bern with a degree in Business Administration.
JungWoo Han
Senior Engineer at Janssen Vaccines, South KoreaJungWoo Han has near 10 years of experience in the pharmaceutical industry. He is a Senior Engineer at Janssen Vaccines, Incheon, South Korea. He has graduated with a BS in Biochemistry from Temple University. He started his career in Teva Pharmaceuticals in the USA on generic product development and launch in Global Technical Operations as a Process Engineer. He has led more than five (5) projects on process validation, product launch and optimization and improvement on process robustness. He joined Janssen as Senior Engineer and continued his career on new product launch, new equipment setup, and various process modeling activities. In this PDA conference, he will present regarding the Time Pressure Filling system case study while introducing a new product at Janssen.
Minuk Kim
Principal Scientist, Drug Product at Samsung BioepisMinuk Kim is a Principal Scientist for Samsung Bioepis responsible to develop autoinjector at DP group, PD team. He joined Samsung Bioepis in 2013.
Christian Kollecker
Director Aseptic Technologies of Harro HöfligerChristian Kollecker is working in the aseptic and liquid filling business for over 11 years and has experience in project and product management, as well as a strong focus on sales and business development.
Christian Kollecker is working at Harro Höfliger as Director Aseptic Technologies. In this position, he is worldwide responsible for all projects regarding liquid filling applications and aseptic requirements for customized equipment solutions.
In this position, he is supporting and consulting his customers during product development until the final production scale-up. Following the credo “from lab to production”, all kinds of aseptic projects are handled by Christian and his team at HH to find solutions for customer-specific equipment and needs.
During his engagements in different companies, he gained experience in various pharmaceutical manufacturing areas like parenteral device handling and manufacturing, product development, and integrated machine solutions as well as different countries and cultures all over the world.
He holds a graduate degree in industrial engineering from a German university as well as an Open University degree.
Henry Lu
Manager at OpTek LimitedHenry currently serves as the micromachining manager at OpTek Systems’ Asia Pacific regional office, located in China. A graduate of Aston University, UK, he has worked at Corning China, Johnson & Johnson UK, and SC Johnson and Son Taiwan. Henry specializes in pharmaceutical industry, and is a regular speaker at CCIT events on the topics concerning CCIT positive control.
Brett Marshall
Head of Quality Assurance at Zuellig PharmaBrett Marshall is the Corporate Head, Quality Assurance for Zuellig Pharma based in Singapore, the largest healthcare services group in Asia. Based in Singapore, Brett has reporting lines from Quality Assurance Heads in 13 Countries and oversight of Clinical Reach Operations in another 4 Countries. Brett is passionate about Quality 4.0 and how the QMS of the future, enabled by digitization, will bring more effective Quality Risk Management in increasingly complex life science supply chain and regulatory landscape.
Originally from Melbourne, Australia, Brett has a Bachelor Degree in Transport & Logistics Management from RMIT. He has over 25 years’ experience in positions of Executive Management, Logistics & Supply Chain, Business Process Transformation and Quality Assurance, more than 15 years in the Pharma Industry, and has spent nearly 25 years in Asia living in Indonesia, Thailand, the Philippines, Bangladesh and now Singapore.
Jana-Cathrien Müller
Sales Manager at Atec Pharmatechnik GmbHJana-Cathrien Mueller works since the beginning of 2020 as a sales manager at Atec Pharmatechnik GmbH, Germany. Atec manufactures pharmaceutical processing equipment, such as formulation systems, vessels, CIP/SIP systems, clean room lifts, component processing systems (stoppers, caps, combi-seals etc.), and sterile transfer solutions.
Previously, Jana-Cathrien Mueller worked for GEA Group as project engineer and manager for pharma and healthcare solutions, mostly in API processing.
Jana-Cathrien Müller is holding a master degree in Biotechnology and Process Engineering.
Wenzel Novak
Glob. Sen. Director Business Development MDS of Gerresheimer Bünde GmbH- Keynote 1: Aseptic Manufacturing in Times of Covid-19: Supply Chain, People, Management
- Safety Syringes, Autoinjectors, Pens and Wearables
Wenzel studied biology and did his Ph.D. in physics at the Max-Planck-Institute for Neurochemistry in Munich.
As head of the laboratory in a Swiss biotech-company, he worked on Keratinocytes for wound healing.
In charge of project management and as head of the production for pre-sterilized syringes, he designed the manufacturing area, built up the process and quality systems, and operated the start-up phase of production.
He took the role as Chief-Innovation-Officer at a pharmaceutical equipment supplier, developing new methods of sterilization and filling processes. Two years in the USA, he developed the market for cell- and gene therapy equipment.
In 2018, he returned to the same primary packaging manufacturer, left 13 years ago in a new global senior role for business development.
DeokSeok Oh
Manager in Technical Operations at Janssen, Johnson & JohnsonDeokSeok is a manager of the aseptic & sterilization team in the Technical Operations department at Janssen Vaccines Incheon site and is responsible for aseptic processing and New Product Introduction supporting. DeokSeok has about 15 years of experience in the Quality & Aseptic area and diverse experiences in a project which are plant construction projects, new-line projects, and overseas projects before joining in J&J. DeokSeok has also diverse inspection experiences including Korean (MFDS), UK (MHRA), and WHO.
DeokSeok has been a PDA member since 2007.
Serena Panighello
Senior Scientist/SG Lab Analytics at Stevanato Group S.p.A.Serena Panighello is a senior scientist at SG Lab Analytics. Her role is mainly related to the study of glass corrosion mechanisms and container-drug interaction consultancy. She is involved on the advanced analytical services that SG Lab offers to the Pharma customers to understand the containers properties and performances with respect to the customer needs and to mitigate and reduce the risk of interaction of containers with the drugs. She earned a PhD in Chemical Sciences at Ca' Foscari University of Venice (Italy) within a joint research program with the National Institute of Chemistry, Ljubljana (Slovenia). During the PhD she was awarded with the Paul Award for the best presentation at the New Researchers Forum during the SGT (Society of Glass Technology) annual Conference in Durham (UK).
Morgan Polen
Contamination Control Expert at MicroriteMorgan Polen is a subject matter expert on contamination control, airflow visualization, and particle monitoring in cleanrooms with over 35 years of industry experience.
He is a member of the ISO Technical Committee 209 (Cleanrooms and Associated Controlled Environments) and a board member of IEST and has been instrumental in drafting and editing international cleanroom standards and best practices. He has extensive experience in working on cleanroom projects in the United States, Canada, Mexico, Germany, Malaysia, Taiwan, South Korea, Singapore, Thailand, China, Philippines, India, and Turkey and is a valuable resource in addressing contamination control in critical environments for the electronics, aerospace and healthcare industries.
As a key member of Microrite’s Expert Contamination Control team, Morgan is instrumental in the development of proactive contamination control strategies through pragmatic risk assessment, troubleshooting contamination issues, and helping with FDA 483/warning letter remediation activities.
Matthias Poslovski
Technical Sales Director of Optima pharma GmbH- Keynote 1: Aseptic Manufacturing in Times of Covid-19: Supply Chain, People, Management
- Manufacturing: Filling Lines and Barrier Systems
Mr. Matthias Poslovski, a graduate mechanical engineer, has been with the Optima Group since 1998. He began his career with Optima as the sales manager of the former division Inova pharma systems GmbH. From 2000 until 2002 he managed the Optima division of Kugler whose expertise was in non-sterile filling and packaging technology. Today, Mr. Poslovski holds the title of Vice President Sales Turnkey of the OPTIMA pharma GmbH. His responsibilities encompass the overall support of technical sales worldwide.
Brigitte Reutter-Haerle
Vice President Product Management & Marketing at Vetter Pharma International GmbHBrigitte Reutter-Haerle is Vice President Product Management & Marketing for Vetter. In this role, she is responsible for both existing and new product and service offerings that support Pharma & biotech companies as well as marketing and public relations activities. She joined Vetter in 1996, serving in the company’s sales and marketing function and later transferring to corporate marketing. She began her career in 1983, holding various positions in the sales organizations of companies including Hilton International and TNT Express Worldwide.
Brigitte joined PDA in 2005 and has been Vice-Chair of the Marketing Advisory Board since March 2019. She has also been a leader of PDA’s Pre-Filled Syringe Interest Group/Europe since 2007, and served on various committees, including as Chair of the PDA UPS Program Planning Committee. In 2014, Brigitte received the PDA Distinguished Service Award and, in 2017, the PDA Europe Service Appreciation Award for her long-standing commitment. The awards were in recognition of special acts, contributions, or services that have helped build on the success and strength of PDA
Ms. Reutter-Haerle earned a BA and a degree in business administration from Baden-Wuerttemberg Cooperative State University.
Christian Scherer
Executive Vice President – Sales / Business Unit Inspection Machines at Seidenader Maschinenbau GmbHBorn 1984 in Germany, technical apprenticeship at Seidenader Maschinenbau GmbH (2001 - 2004). Visited University of Supplied Science in Munich from 2005. Graduated in 2009 as Dipl.-Ing. (Business and Engineering). Spending one semester in Seidenader's subsidiary "SV Research - Harrisburg/USA" and at the University of Plymouth / England.
Mr. Scherer then took on the role of Area Sales Manager at Seidenader Maschinenbau GmbH in Markt Schwaben,
Business Unit Inspection Machines from 2009 to 2015.
Since then, Mr. Scherer has led the team at Seidenader Maschinenbau GmbH as the Executive Vice President - Sales with responsibility for the sales and marketing department of the Seidenader Business Unit Inspection Machines.
Rico Schulze
GMP Inspector at Office of the Stateminister of Saxony, GermanyRico is a registered pharmacist from Germany. He holds an additional degree in Economics. Before working for the Ministry of Social Affairs and Consumer Protection of the German Federal State of Saxony, he used to work as GMP and GDP Inspector with the Local Inspectorate in Dresden. For around 20 years, Rico performed GxP inspections worldwide. Now he is involved in legislative processes on both EU and German national level.
Oliver Stauffer
CEO of PTI - Packaging Technologies & InspectionOliver 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.
Sheena Wang
Senior CMC Reviewer, Office of New Drug Products (ONDP) at U.S. FDA | Center for Drug Evaluation & Research (CDER)Dr. Sheena Hailin Wang is currently a senior CMC reviewer in the office of new drug products (ONDP) in the Center for Drug Evaluation and Research (CDER) and has been with the agency since 2013. She has reviewed many ANDA and NDA submissions for injectable drug products including complex drug substances and products manufactured with nanotechnology. Sheena has been involved in the guidance development for Inspection of Injectable Products for Visible Particulates.
Prior to joining FDA, Sheena worked at Novartis Vaccine and Diagnostics where she was a formulation development scientist and process/product development lead with expertise in protein formulation and nanoemlusion preparation.
Sheena is trained in chemistry from Peking University and received her Ph.D. in Pharmaceutical Sciences from the University of North Carolina at Chapel Hill with focus on process engineering and particulate sciences.
In addition, Sheena is a member of the Visible and Subvisible Particulate Matter Expert Committee of the United States of Pharmacopeia.
Tobias Wetzel
Area Sales Manager at Bausch + StröbelTobias Wetzel joined Bausch + Ströbel in 2010, after completing his degree in business administration he took the position as Sales Engineer in 2013.
Since 2020 he is mainly covering the Korean and South-East-Asian markets as Area Sales Manager.
Tobias is responsible for sales as well as for project management for various pharmaceutical applications, from small table top machine up to high-speed customized filling lines.
Lyndon Wild
Senior Director of Commercial Operation at SHL MEdical AGLyndon Wild is the Senior Director of Commercial Operations at SHL Medical, leading the organization’s business development initiatives within the APAC region. Prior to joining the commercial team, Lyndon spearheaded SHL’s complex manufacturing operations for almost 4 years (2016-2020). He brings over twenty years of professional experience in Director-level roles within pharmaceutical, medical devices, and medical packaging industries.
Yu-Jung Yang
Assistant Manager - Global Drug Product Expansion at Celltrion Inc.Yu-Jung Yang serves as Assistant Manager – member of the Global Drug Product Expansion (GDPE) Division at Celltrion Inc. She joined Celltrion in 2016, and worked as a member of the DP global commercial manufacturing operations division until 2019. She was responsible for aseptic filling & lyophilization process including implementation and improvement of Celltrion’s DP manufacturing standards, deviation investigations, and compliance to international regulatory requirements, especially for aseptic technique improvements. In 2017, she also joined the PFS (Pre-filled syringe) project and participated in the design of a new syringe filling line including commercial isolation technology. In 2019, she joined the GDPE division focusing on the PFS project. She is responsible for the isolator project and supports the syringe filling line including installation, qualification and establishment of manufacturing standards. In addition, as a member of GDPE she supports the overseas expansion of Celltrion’s manufacturing operations.
Jose Zanardi
Senior Manager, Engineering Vision Technology at Syntegon Technology K.K.Zanardi is Senior Manager at Syntegon Technology (formerly, Bosch Packaging Technology), where he is responsible to oversee projects related to Deep Learning applied to automated vision inspection at the Center of Competence for Vision Technology, located in Japan. Previous to his present position, he was project manager for platform development of automated inspection machines, later on, Manager of the R&D Department, and also responsible for vision technology applications in customer projects.
Before joining the Bosch Packaging division, Zanardi worked at Bosch Corporate Research where he was responsible for the Japanese branch of that unit.
He has a doctoral degree in materials science, with a specialty in the spectroscopic characterization of defects in semiconductor materials.
Cathy Zhao
Director of Scientific Insights Lab at West Pharmaceutical Services, Inc.- Keynote 1: Aseptic Manufacturing in Times of Covid-19: Supply Chain, People, Management
- Container Integrity at Deep Freeze Temperatures
- Container Closure Components
Cathy Zhao (Formal Name Xia Zhao) has over 18 years of experience in the medical/pharmaceutical industry. She is currently the Director of Scientific Insights Lab in West Pharmaceutical Services, Inc, and leads SIL to differentiate West products and services. Prior to this role, she held various positions in West, such as Global PPS Research Director. Prior to West, Cathy worked for BD as a Principal Materials Scientist. She received her Ph.D in polymer chemistry from City University of New York and her BS in Polymer chemistry from the University of Science and Technology of China. Cathy is the inventor of many US and European patents, and is an active presenter in conferences.