As part of our ongoing advanced manufacturing series this BioBreakfast will be looking at topics around issues relating to manufacturing for clinical trials and challenges in phase II trials.
Dr Jane Ryan – Consultant for Stakeholder Engagement, CSIRO
Craig Rogers – SVP of Asia Pacific, PCI Clinical Services
Dr Christian Behrenbruch – Chief Executive Officer, Telix Pharmaceuticals Limited
Jo Sherriff – Senior GMP Consultant, SeerPharma
Jane Ryan, representing CSIRO, will be speaking at the event on the Advanced Biotechnology Manufacturing Platform (ABMP) and their vision for addressing the unmet need in scaling-up manufacturing for clinical trials. The proposed manufacturing facility, ABMP, will enable process development and production of clinical-grade biologicals at the pilot scale to support clinical translation.
Craig Rogers, Senior Vice President for PCI Asia Pacific will be joining Jane in presenting and then both speakers will be taking part in a panel discussion together with Christian Behrenbruch, Chief Executive Officer, Telix Pharmaceuticals Limited and facilitated by Jo Sherriff, Senior GMP Consultant, SeerPharma. Areas for discussion include innovation strategies improving streamline efficiencies in increased production processes with increasingly complex manufacturing environments.
When: Monday 10 December 2018
Where: The Cube, ACMI, Federation Square, Melbourne
Cost: BioMelbourne Network Members: $65; Non-members: $130 (prices include GST)
7:20 am – Registration
7:30 am – Networking breakfast
8:00 am – Presentations and discussion
9:00 am – Close
Jane has over 30 years of international experience in the pharmaceutical and biotechnology industries where she has held executive roles in management of research and development programs as well as business development and alliance management. Jane has worked in Australia, the US and UK with companies including Peptech, Roche, Cambridge Antibody Technology and Biota Holdings. Throughout her career, she has led many successful fundraising campaigns and licensing initiatives including the awarding of a $230m US Government contract.
Jane currently chairs the Advisory Board at the ithree Institute at the University of Technology Sydney (UTS) which studies how microbes grow, live, adapt and survive. She is also Part-time Vice President of Research and Development at Reef Pharmaceuticals and advisor to Opal Pharmaceuticals. Jane was previously a Board Member of Diabetes Victoria, TechInSA, Diabetes Vaccine Development Centre, and veski. Jane is assisting CSIRO with its GMP protein manufacture initiative.
SVP of Asia Pacific, PCI Clinical Services
Craig Rogers is a registered pharmacist, toxicologist and lawyer. He has more than 20 years of experience working within the pharmaceutical industry with a specific focus on manufacture of investigational product for early phase clinical trials and regulatory affairs. Craig established PPP a TGA licensed cGMP manufacturing facility in 2008, based on his gap analysis of the services available in the local market for finished product manufacture of investigational products. He sold the business to the US-based PCI Pharma Services in March 2018.
Joining the speakers on the panel
Chief Executive Officer, Telix Pharmaceuticals Limited
Chris Behrenbruch has 20 years of healthcare entrepreneurship and executive leadership experience. He has previously served in a CEO or Executive Director capacity at Mirada Solutions, CTI Molecular Imaging (now Siemens Healthcare), Fibron Technologies and ImaginAb, Inc. He is a former Director of Momentum Biosciences LLC, Siemens Molecular Imaging Ltd, Radius Health Ltd (now Adaptix) and was the former Chairman of Cell Therapies P/L (a partnership with the Peter MacCallum Cancer Centre). Chris is currently a director of Factor Therapeutics (ASX:FTT) and Amplia Therapeutics P/L. He is
Chairman of the Monash Engineering and IT Foundation Board and is an Adjunct Professor at Monash University. Chris holds a D.Phil (PhD) in biomedical engineering from the University of Oxford, an executive MBA jointly awarded from New York University, HEC Paris and the London School of Economics (TRIUM Program) and a Juris Doctor (Law) from the University of Melbourne.
Senior GMP Consultant, SeerPharma
Jo is an experienced senior compliance engineer and senior consultant, with 20 years of experience within the pharmaceutical and life science industries. She is not only a qualified Chemical Engineer but also a specialist in development and execution of GMP validation documentation; GMP Design Reviews; and development of Quality Systems. She also has extensive experience with non-GMP facility compliance, TGA, FDA, DAWR (Biosecurity), OGTR, ARPANSA, SSBA, and Pharmacy Board of Australia, SHPA, PRASA compliance.
Jo is an experienced presenter of Validation Workshops and GMP Training, and conducts Quality Assurance Audits.