YongHua Gao is Deputy Secretary-General at the China National Pharmaceutical Packaging Association. Graduated from West China Medical University, pharmacy chemistry is the major profession. 8 years work experience of pharmaceutical research, producing, and quality management in pharmaceutical factory. Since 2002, working in China National Pharmaceutical Packaging Association, responsible for the technology and research project on Pharmaceutical Packaging.More information about speaker
Dr. Klein is a regulatory, scientific, CMC Expert with 23 years (1995 – 2017) of experience as a Senior Review Chemist of new drugs in CDER/FDA where he received upon retirement the FDA Distinguished Career Service Award (2017) from the FDA Commissioner. While at the FDA, Don significantly contributed to developing FDA policies for pharmaceutical packaging, comparability protocols, and drug master files. With respect to post-approval changes, his last 12 years were dedicated to the CDER CMC post-marketing division where he was a Senior Review Chemist and a CMC Lead (2013 – 2017). In addition, Don worked with fellow FDA Experts and Industry to resolve drug shortage issues from 2005 to 2017. Prior to starting a Consulting Company (7/2019) with his wife, Lynda Taskett, Dr. Klein was a CMC Consultant at parexel (9/2017 – 6/2019). In his professional career he has either reviewed or drafted applications in the following therapeutic areas: Oncology, AIDS, Neurology, Psychiatric, Metabolic/Endocrine, Dermatology, Pulmonary, Analgesic, Radiopharmaceutical; and OTC. Don has been an invited speaker at AAPS, PDA, and RAPS Conferences and had presented several seminars (1999 – 2017) within the FDA as well as representing the FDA. He received a B.S. in Chemistry from Allegheny College (1982) and a Ph.D. in Synthetic Organic Chemistry from Emory University (1988).More information about speaker
As Principal Scientific Affairs, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This is complementing work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging.
Since 2015 Bettine is an active member of the USP Packaging and Distribution Expert Committee as well as the ISO TC76/WG 4 on elastomers. Additionally, in 2018 joined the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass).
Since January 2019 she is also a member of the PDA Board of Directors, actively supporting the role of PDA in the global pharma world. She is active in the PDA Glass Handling Task Force and co-chairing the European PDA Interest Group Packaging Science as well as the Pharmacopeia Interest Group.
In 2015 she published the book ""When Glass Meets Pharma"".
She is a frequent speaker at industry conferences and has chaired and moderated several conferences for the PDA and other formats. This is adding to numerous trainings and publications that she has provided.
Dr. Boltres is a (bio)chemist by training, with a diploma in chemistry and a PhD in biochemistry.
Automation continues to bring benefits to all areas of the pharmaceutical industry. In this session, you will hear how full traceability, digitalization and new approaches to inspection & packaging can support adherence to regulatory requirements, timely delivery of product and ultimately more patient safety.
Georg Schick is the Strategic Product Manager at Uhlmann Packaging Systems in Germany and therefore responsible for the global strategic product management for Track & Trace. Georg Schick started his career as an electrical design engineer for cartoners and end-of line equipment at Uhlmann in 1999, after he successfully graduated in electrical engineering. A further task he took over was the project management for automation of customized packaging lines. His long-term experience at Uhlmann in various fields of automation and working intensively in projects with customers are the basis for his tasks in sales and product management today. The customers trust in the wide range of Uhlmann products as well as in our experts with fundamental knowledge and that leads to long-term partnerships. One of these reliable experts with the know-how from many customer projects in automation and digitalization is Georg Schick.More information about speaker
2019 - today
Head of Product Management
Seidenader Maschinenbau GmbH, Germany
2015 – 2019
Senior Analyst Strategic Marketing
Körber Medipak Systems AG, Switzerland
2013 – 2015
Master of Science in Business Administration
FH Wedel – University of Applied Science, Germany
One of the topics brought to the forefront by the COVID-19 pandemic is deep cold storage and transport, a topic that will remain critical moving forward especially in the area of cell and gene therapy. This session addresses the challenges primary packaging systems have to maintain good container closure integrity at these deep cold storage temperatures.
Roman Mathaes is Head of Pharmaceutical Services at Lonza DPS. In this role, he is responsible for primary packaging development and testing as well as device testing, tox and technical batch drug product manufacturing and the Lonza DPS lab automation group.
In his previous role at Lonza DPS, he was a Sr. Group leader in the Analytical Department performing drug product stability studies and leading the Lonza particle core facility.
Before his assignment Roman, worked within the Roche/Genetech network Basel/San Francisco.
Roman is a pharmacist by training and holds a PhD in pharmaceutical technology.
Roman is a adjunct member of the Pharmaceutical Department University Basel and authored 30 research papers in the field of Biotech Drug Product Development.
Dr. Yusuf Oni is a Principal Engineer at Bristol-Myers Squibb Company where he is involved in all aspects of primary packaging & device development in the parenteral product development space. Prior to joining BMS, Yusuf was a Senior Engineer with the Materials Science and Technology group at BD Medical. There, he led the design and development of material solutions for various medical products and packaging applications. Yusuf is also involved in academic instruction. He was a visiting professor at the African University of Science and Technology (Nigeria) and the University of New Haven. He currently serves as an Adjunct Faculty in the Biomedical Engineering department at New Jersey Institute of Technology. Yusuf received his Bachelors of Science degree in Chemical Engineering from New Mexico Institute of Mining and Technology and a PhD in Mechanical and Aerospace Engineering (with a concentration in Materials Science) from Princeton University.More information about speaker
Sinue Gomez, Product Development Manager for Corning Pharmaceutical Technologies, currently leads the design and development of products for parenteral packaging that meet customer and industry requirements at Corning’s Research and Development facility, Sullivan Park. Sinue specializes in glass composition, processes, and properties that deliver needed product performance attributes.
Sinue earned her B.S. in Materials Science from Universidad Simon Bolivar, Venezuela, and her Ph.D. in Materials Science from The University of Connecticut. She has co-authored 14 peer-reviewed articles and has over 50 granted patents.
Jennifer L. Riter is Senior Director, Analytical Services and Integrated Solutions for West Pharmaceutical Services, Inc., Exton, PA. She joined West in August 1996 as an Associate Chemist in the Quality Control group. Jennifer has held many roles within the West organization and has experience and expertise in several areas from Technical Customer Support, Business Development, Sales and Marketing and Quality. Her most recent role is Senior Director, Analytical Services in the Scientific Affairs and Technical Services organization. Jennifer is responsible for the Analytical Services organization which has four primary areas of focus and thought leadership in Extractables & Leachables, Container Closure Integrity, Packaging and Device/Combination Product Performance and Particle Analysis.
Her experience blends knowledge of West’s components, containment and delivery systems with hands-on experience of providing technical support and analytical solutions for packaging, delivery systems and combination products to West’s multi-national customers. Ms. Riter has also spoken at several symposiums on analytical testing of parenteral packaging components, devices and combination products as well as on extractables and leachables analysis.
Ms. Riter is a member of the Board of Directors for the Lock Haven University Foundation, American Association of Pharmaceutical Scientists, Parenteral Drug Association, and Healthcare Businesswoman Association. She earned a Bachelor of Science Degree in Biology/Chemistry from Lock Haven University, Lock Haven, PA and an MBA in Pharmaceutical Business at the University of the Sciences in Philadelphia, Philadelphia, PA.
Corinne Ondo leads the sourcing of Innovation and the sourcing strategy of glass primary containers for Merck Healthcare.
Through her team, she also coordinates the procurement of secondary packaging activities for various manufacturing sites in Europe and Latin America.
Before joining Merck in 2015, she had over 20 years of international experience in the luxury business, consumer goods, automotive and oil & gas industry.
She is an engineer, graduated from French ESIGELEC Graduate School of Engineering.
Jacqueline (Jacquie) Hollands leads and develops MilliporeSigma’s initiatives and programs that meet the sustainability needs for customers. She has implemented product recycling options, such as the Biopharma Single-Use Product Recycling Program and the ech2o™ Lab Water Cartridge Recycling Program. Currently she is working on developing innovative recycling solutions for the life science industry.
Jacquie has more than 25 years of experience within the life science industry, holding positions in biological research, training, sales and sales support, as well as serving as program manager on several product development projects for detection instrumentation platforms.
Throughout her career, Jacquie has demonstrated an ability to communicate technical material clearly and effectively to all levels of audience, and to develop and implement initiatives that create positive change, efficiency and increased profitability.
Prior to her tenure with MilliporeSigma, Jacquie spent seven years in various roles in the life science industry—managing customer relationships, serving as a technical specialist and developing programs and products related to imaging and detection systems.
Jacquie holds a bachelor’s in biological sciences from Hood College and has nine years of lab experience, having performed multiple techniques in the fields of molecular and protein biochemistry, immunology and cell biology at Johns Hopkins University, Northwestern University and Oxford University.
The Container Closure Integrity (CCI) Testing Training session will establish a foundation for CCI as it relates to parenteral applications. CCI is a vast field that has elevated in importance as the parenteral space continues to evolve. Effective strategies and solutions must be deployed to successfully navigate CCI requirements and provide the highest level of patient safety. This workshop will offer practical and logical tools to apply to individual cases. The objective of the workshop is to further enhance the participants ability to be CCI experts and will cover the following agenda.
- History of CCI and its purpose today
- What is CCI specifically for the parenteral space?
- Current state of regulatory environment
- Strategies and critical factors
- Technology landscape and selection
- Validation strategies
- Sustaining quality
- Bibliography and review of resources