Strain Banking: How To Transform Samples into Assets

When

25th Jan 2023

Where

Webinar

SPONSORED BY

 

Date: 25 January 2023 (Wednesday)
Time: New York 09:00 | London 14:00 | Paris 15:00 | Singapore 22:00 | Tokyo 23:00 | Sydney 01:00 (26th January)
Duration: 90 minutes
Event structure: 20 minutes Biomillenia Presentation + 45 minutes Panel Discussion + 25 minutes Q&A
Registration fee: FREE – Complimentary access
Webinar on-demand: Available to view until midnight 10th February 2023 (registration is required)

 

Nature has evolved over millions of years, allowing complex microbial ecosystems to thrive, allowing tribes to evolve their unique abilities and functions. Most live biopharmaceuticals (LBPs) and probiotics are based on natural strains isolated from natural samples. Strain banking is the starting point for innovation, the foundation for successful product development. However, it is difficult to select good candidates from complex samples. What technology is available to streamline this process? What are the most important criteria for selecting the most promising candidates? How can you anticipate key issues such as intellectual property, regulatory pathways, and future commercial-scale production early? Our panel of experts will answer these questions in a roundtable format followed by a Q&A session which allows attendees to get direct answers to their questions.

  • How to generate strain banks ?
  • Generating a proprietary strain bank versus purchasing strains from existing collections: advantages and inconvenience?
  • Best practices to characterize a strain bank: how to transform a “collection” in a real “toolbox” for product development, how to characterize the strain from a genetic and phenotypic point of view and how to screen large quantities of strains to understand their function?
  • Intellectual property: how to secure your findings?
  • Production: should criteria related to production be anticipated at a very early stage/ can strain be characterized according to the “presumed” easiness to manufacture them in future ?
  • Regulatory : BSL1 vs BLS 2 strains : What differences ? What impact for the future development of an LBP or a Probiotic product ? Probiotics vs live biotherapeutic products : key regulatory differences

 

PRESENTERS/PANELISTS and MODERATOR

PRESENTERS/PANELISTS DETAILS: 

Alex Dajkovic, Head of R&D, Biomilenia, France

Alex has more than 10 years research and project management experience in microbiology after obtaining his PhD in Microbiology at the University of Kansas Medical Center in Kansas City, USA. His research projects were funded twice by the European Molecular Biology Organisation (EMBO, Heidelberg, Germany) and he conducted microbiology research at several high impact international institutions such as at the Institut National de la Santé et de la Recherche Médicale (INSERM) and Institut National de la Recherche Agronomique (INRA) in Paris, France as well as at Johns Hopkins University in Baltimore and at University of California in Irvine, USA. He obtained a degree at the medical school of Université Paris Diderot in Paris for a diploma to become a chief investigator for clinical trials. He leads the microbiology research and high-throughput screening discovery activities at Design Pharma, France.

 

Nadine Daou, U.S. Head of operations and R&D, Biose Industrie Inc., USA

Dr. Daou holds a Ph.D. in Microbiology and Molecular Biology from AgroParisTech in Paris, France. She has more than 15 years of experience in microbiology, molecular and cellular biology, with a focus in gene regulation, metabolism, and infectious disease. At Biose, she is leading live biotherapeutics program from early process development to manufacturing and more recently Dr. Daou is heading R&D and operation at Biose USA site. Prior to Biose, Dr. Daou worked at Axcella Health in Cambridge where she led the design and development of innovative strategies for improving the production of novel class therapeutic proteins as well as led and developed a discovery platform enabling several patented inventions and scientific communications and supporting IND filling and clinical trials.

 

Emma Raftis, Team Leader Microbiology-Genomics, 4D Pharma, UK

Emma Raftis is the Leader of the Microbiology-Genomics Team at 4D pharma Research Ltd. Within the MicroRx® platform, she works in the area of Live Biotherapeutic Products (LBPs) discovery. She leads a team which specialises in the isolation and anaerobic cultivation of bacterial strains. Additionally, she applies genomics-based approaches to identify the mechanisms through which LBPs benefit their hosts. Prior to joining 4D pharma Research Ltd in 2014, her previous research focused on the comparative and functional genomics of human and animal commensal bacteria. Emma completed both her BSc and PhD in the Department of Microbiology and Alimentary Pharmabiotic Centre in University College Cork, Ireland.

 

Christian Kilger, European Patent Attorney, CH Kilger Anwaltspartnerschaft mbB, Germany 

Dr. Christian Kilger is a European and German Patent Attorney. After studying genetics and biochemistry at the Ludwig-Maximilian’s University of Munich he completed his doctor degree in the laboratory of Prof. Dr. h.c. Svante Pääbo, the recipient of the Nobel Prize in 2022. Prof. Pääbo received the Nobel Prize in Medicine and Physiology in 2022 for his ancient DNA work and the elucidation of human evolution. In 2011 Dr. Kilger founded the patent law firm CH KILGER Partnerschaft with its main office in Berlin and offices in Munich as well as Buenos Aires, Argentina. The firm has represented numerous biotech, pharmaceutical and diagnostic clients in complex opposition and patent infringement proceedings and specializes in life sciences. Clients include but are not limited to Johnson & Johnson, Genentech, Chugai, Biogen Idec, Regeneron, Alvotec, Mylan, Schering, Roche, QIAGEN, Janssen Vaccines, Takeda, FEDEX, TEVA and others. 

 

J. Shawn Roach, PhD, RAC, Specialist, Regulatory CMC, Halloran Consulting Group

Dr. Roach has been working in Regulatory Chemistry, Manufacturing and Controls (Reg CMC) since 2012. Dr. Roach has a broad background in Reg CMC, spanning the development process from very early stage, including preparation & submission of pre-IND packages through all phases of clinical development up to and including initial commercialization work immediately after approval. Therapeutic modalities he has provided Reg CMC support on include live biotherapeutic products (LBPs), oligonucleotides/RNAi drugs, nanoparticles, monoclonal antibodies, and small molecules. Prior to transitioning to Regulatory CMC work, he worked in drug development as an analytical chemist at multiple startup companies in the US. Dr. Roach worked on one of the first oligonucleotide drugs to be approved, Macugen. As a post-doctoral fellow, Dr. Roach helped to develop a high throughput oligonucleotide synthesizer, the MerMade, in support of the Human Genome Project. Currently, Dr. Roach works for Halloran Consulting Group. A life science consulting firm which provides strategic regulatory, quality, clinical, and organizational support to industry leaders in the pharmaceutical, biotechnology and medical device sectors. 

 

MODERATOR DETAILS:

Maxence Desjonqueres, Head of Business Development, Biomillenia, France

Maxence has a 15-year experience of international business development in the microbiome field. He brings an overall vision on the regulatory, product development, commercialization and manufacturing landscape of live microorganism based products, including Live Biotherapeutic Products and probiotics.

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For further details please contact
Gavin Hambrook
Telephone +44 (0) 7538 368 764 or
email [email protected]

Reuben Raj
Telephone: +603 2731 9335 or
email [email protected]