NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

I think Mark Lowdell, Professor of Cell & Tissue Therapy University College London, has interesting comments about the optimization of the manufacturing process during the clinical trial in the next video (Dec.2015).

An interview on Cell Therapies with Dr Mark Lowdell, UCL, RFH.

Ahead of the Cell Therapy Manufacturing & Gene Therapy Congress 2015 in Brussels, we sat down with Dr Mark Lowdell, Director of Cellular Therapy & Biobanking at Royal Free London NHS Foundation Trust to talk about the state of the cell therapy industry.

This is also interesting IMO: An interview with Mark Lowdell: On cost effective patient specific therapy.

The subject is still current, see agenda ISCT.

September 12-14,2018 Chief Scientific Officer Mark Lowdell, Ph.D.,was chairman of 2 Sessions at International Society of Cell and Gene Therapy (ISCT) European Regional Meeting in Florence, Italy.

The second session was titled “Manufacturing: Closing the Process,”

http://www.isct-eu2018.com/concurrent-session-spotlight/

This session highlights the importance of engineering closed processes in ATMP manufacture early in product development and the downstream effects this has on successful delivery of early phase trials and then translation to market access. Increasingly we are seeing ATMPs obtain marketing authorisation after small registration trials which has meant that the optimisation time for manufacturing improvements during phase 1 and 2 trials is lost. Consequently these process developments need to be done during pre-clinical work-up and doing so reduces cost and complexity of the early phase trials too. This session has been developed in partnership with the International Society for Extracellular Vesicles in recognition of the fast pace of EV trial development and the novel challenges associated with closed system manufacture and downstream processing.

I also notice that there is an important link between Prof.Mark Lowdell and J.Kelly Ganjei.

Mark Lowdell

CSO and Founder at InMuneBio.
London, United Kingdom

J. Kelly Ganjei: Director at InMuneBio.

Professor Mark Lowdell, PhD
CSO/CMO
Prof. Lowdell has been a Chief Scientific Officer and Chief Manufacturing Officer since the formation of the Company in September 2015. Prof. Lowdell is Professor of Cell and Tissue Therapy at University College London, where he has led a translational immunotherapy group since 1994. Since February 2009, Prof. Lowdell has also been Director of Cellular Therapy at the Royal Free London NHS Foundation Trust. He received his PhD in clinical immunology from London Hospital Medical College, University of London in 1992 and is a qualified immunopathologist.
https://www.inmunebio.com/index.php/en/about/management

J. Kelly Ganjei
Mr. Ganjei has been a director since September, 2016]. He is Chief Executive Officer of Cognate BioServices, Inc., a position he has held since 2011. Mr. Ganjei has over 20 years of experience within the life science, venture capital and IT sectors and has lead companies through various stages of development ranging from virtual start-up to mid-cap restart, exponential growth and public exit. Prior to joining Cognate, Mr. Ganjei was Principal at an SBA venture capital firm where he instrumental in supporting deal flow with a specific focus on regenerative medicine, immunotherapy and cell therapy investment opportunities. While in this role, he was the key driver of several other strategic deals for various portfolio companies. Previously, Mr. Ganjei was Chief Executive Officer of Remegenix, Inc., a company he co-founded, and Vice President of Business Development at TissueGene, Inc., where he was instrumental in closing several funding tranches and was responsible for developing the global informatics infrastructure for the company and its affiliates. He also served as Product Marketing Manager for LabVantage, where he was the key technical sales and marketing lead for that firm’s life science software product offering globally and was responsible for the design of all life science product initiatives. He began his career at the National Institutes of Health. Mr. Ganjei has published numerous scientific, peer-reviewed papers and has been a speaker and presenter at various business forums. Mr. Ganjei received his B.S. in Microbiology from the University of Maryland College Park in 1995.
https://www.inmunebio.com/index.php/en/about/directors