Ensuring Regulatory Compliance of Biologics
Join us at this special half day event and find out how we are supporting the rapidly developing biopharmaceutical market.
September 26, 2018, 08:30
September 27, 2018, 13:30
SGS is pleased to present a two day, two location roadshow in Ireland where we will discuss current regulatory issues, biosimilars testing, biosafety testing, extractables and leachables, QA benchmarking and data integrity. Join us and learn how we can help you advance from molecule to medicine.
Locations and dates
Kildare – Palmerstown House and Estate, Johnstown
- Wednesday, September 26, 8:30 am-1:30 pm
Cork – Maryborough Hotel and Spa, Douglas
- Thursday, September 27, 8:30 am-1:30 pm
|9:00 am||Welcome (Eugene Kirwan)|
|9:15 am||Current regulatory issues in Ireland (IDA representative)|
|9:30 am||Biosimilars, the analytical pathway (Mark Rogers, Ph.D.)|
|10:10 am||Considerations for biosafety testing of cell and gene therapies (Richard Adair, Ph.D.)|
|11:20 am||Extractables and leachables testing in single use systems safety evaluation/qualification (Andreas Nixdorf, Ph.D.)|
|12:00 pm||Understanding the role of QC laboratory operational excellence: an overview of recent FDA quality metrics research (Nuala Calnan, Ph.D.)|
|12:20 pm||Data integrity from a corporate IT perspective (Michael Spalding)|
Closing statements (Eugene Kirwan)
Mark Rogers, Ph.D.
Dr. Rogers has been with SGS for nearly eight years since joining the company via an acquisition (M-Scan) in 2010. Mark received his Ph.D. in analytical chemistry from Westminster University in 1985. His work has appeared in over 35 peer-reviewed publications, including Nature, and he has one patent. His post-doctoral work, at Imperial College, London, was followed by a lectureship, specializing in diabetes in the endocrinology department at St. Mary’s hospital. Mark joined M-Scan, USA in 1990, where he remained as Vice President until its acquisition by SGS. Since joining SGS, Mark has held several roles, including Head of North American Biologics and VP of SGS USA. Today, he is the global technical director for the SGS Life Sciences group.
Andreas Nixdorf, Ph.D.
Dr. Nixdorf studied organic chemistry, focusing on mass spectrometry and computational chemistry, at the University of Bielefeld in Germany. After receiving his doctorate in 1997, he worked in different scientific and managerial positions in the life sciences, until he joined SGS in 2007.
From 2007 to 2010, Andreas was responsible for project management, regulatory consultancy and pharmaceutical customer service at SGS Institute Fresenius GmbH. He introduced an extractables and leachables testing services to SGS in 2008. Andreas arrived at his current position in 2010.
With over 20 years’ experience in the life sciences, Andreas is a frequent speaker at events and international conferences (PDA, ECA, VDI, BioInnovation, CPHI, Smithers RAPRA, IQPC, Vonlanthen Group, Chinese Medical Device Association and others) on the topics of medical devices, single use systems and finished packaging safety evaluation. Andreas wants to motivate experts in the life sciences industry and organizations to work together to achieve more effective cross departmental collaboration, so they can improve regulatory requirements for the safety testing of plastic materials used to produce medical products.
Richard Adair, Ph.D.
Dr. Adair obtained an honours degree in immunology at the University of Edinburgh in 1994. For the following four years, he worked as a clinical research manager at Procter & Gamble Technical Centres Ltd, based in Staines. He also managed clinical research trials in numerous international locations, including the USA and the People's Republic of China.
Richard spent six months training at the healthcare R&D world headquarters in Cincinnati, Ohio in 1997. He returned to academia in 1998 to obtain a PhD in virology at the MRC virology unit in Glasgow, where he studied the US22 gene family of human cytomegalovirus (HCMV).
In March 2002, Richard undertook an NIH funded post-doctoral position at Children’s National Medical Center in Washington, DC, studying the regulation of gene splicing of the UL37 gene of HCMV. In 2005, he returned to the UK to take a position as an investigative scientist at the MRC virology unit, where he worked on hepatitis C gene regulation.
In 2007, Richard joined Vitrology Limited (which became SGS Vitrology Limited in 2012) as virology manager. In 2016, his role was expanded to virology manager and virology technical support manager, involving him in both operations and business support.
Nuala Calnan, Ph.D.
Dr. Calnan has over 20 years’ experience in the biopharmaceutical industry across operations, new product introduction, facility start-ups, manufacturing and, more recently, research and consultancy. She works closely with industry, helping organizations to deliver quality excellence and enhance quality outcomes for the patient. Her work focuses on designing metrics that matter to the patient and the business to drive site performance, developing good data governance programs and implementing behavior-based quality through cultural excellence programs.
Nuala led a recent Irish Industry research study examining product recall and quality defect data at the Irish medicines regulator, HPRA. She is currently a member of the St. Gallen University led team, which was awarded a research grant by FDA to examine the role of quality metrics in driving enhanced quality performance in both site and QC Laboratory operations. She co-leads the ISPE Quality Culture Team, which published the recent ISPE Cultural Excellence Report, and the ISPE/ PQLI Task Team on Knowledge Management. She was also lead editor of a recent knowledge management book: A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry, CRC Press 2017.
Nuala is currently an adjunct research fellow with the Pharmaceutical Regulatory Science Team at DIT, Ireland, where she teaches and leads a number of regulatory science research projects at master's and PhD levels.
Michael Spalding has dedicated his 35 year career to the delivery of IT solutions for the life sciences contract testing industry. After receiving a BS in physics, Michael joined the family business, Northview Laboratories, an independent US-based medical device and pharmaceutical contract testing lab. He spent the first year working as a bench chemist experiencing the testing side of the business, and then worked at Northview in various IT roles for the next 20 years, where he computerized business and laboratory operations. As head of IT for Northview, a life sciences only company, Michael applied a holistic IT strategy, supporting all aspects of IT in a regulated environment, including infrastructure, lab application support, validation and CSV/Part 11.
Michael joined SGS upon the acquisition of Northview in 2006. During his tenure with SGS, Michael held several roles within IT and life sciences, including Global LIMS Program Manager and IT Manager for Life Sciences in the US. In his current role as Global Head of IT for Life Sciences, Michael acts as the interface between SGS corporate IT and the life sciences business, communicating unique Life Science IT requirements and coordinating corporate IT support. He holds specific ownership of SGS’s global life sciences IT systems including LIMS. In addition, he has overall responsibility for ensuring compliance of life sciences IT systems with data integrity and Part 11 regulatory requirements.