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AUTOLOMOUS LTD are a relatively new Private Limited Company . They have been trading for 2 years. (AUTOLOMOUS LTD was incorporated on 6 February 2019 as a Private Limited Company in UK). They operate in the Business and domestic software development sector. Autolomous' approach focuses on collaboration and adding value to all manufacturing efforts within advanced therapies.(Mark Lowdell is one of co-founders)
Autolomous provides manufacturers with ways to scale their operations, by deploying a fully integrated and digitised supply chain ecosystem.
They streamline the management of manufacturing data, by integrating siloed information into one digital platform: AutoloMATE®.
Advent Bioservices is one of their industry partners.
On October 7, Autolomous announced the achievement of ISO 9001:2015 and ISO 27001:2013 certification, an important milestone for the company.
I believe that achieving ISO 9001:2015 and ISO 27001:2013 certification is important for the assessment of the GMP application for the Sawston facility. (and one of the reasons for the delay)
Thanks sharpie510!
flipper44,
IMO it's for Marketing Authorization Application to European Medicines Agency (EMA) for Glioblastoma Immunotherapy, SITOIGANAP.
biosectinvestor,
Note:
Amy Barone, MD, US Food and Drug Administration, is the first speaker this morning at the first Annual Conference on CNS Clinical Trials.
She was a speaker and one of the Special Invited Guests at the 2020 Think Tank on Neuro-Oncology Clinical Trials. (November 6, 2020)
Dr Bala,
Thanks for sharing a zip file of the entire Volume 22, Issue 10 (October 2021) of Lancet Oncology.
3 sessions about the use of External Controls in Glioblastoma trials at the first Annual Conference on CNS Clinical Trials, Co-Sponsored by SNO and @ASCO, being held virtually today and tomorrow, starts at 11am EDT.
There is still time to register: https://bit.ly/SNOASCO
flipper44,
Jennifer N. Caudle DO interviews Roger Stupp MD on Future Directions in the Management of GBM.
Video originally published on PracticeUpdate.com on 10/30/2017.
https://www.practiceupdate.com/content/future-directions-in-the-management-of-gbm/58004/45/1/3
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166173113
Mike Scott
Chief Operating Officer at Advent Bioservices
6 hours ago.
I share my communication with MHRA.
SecureInvest,
Agreed. Thanks!
Thanks ATLnsider. I agree with you, biosectinvestor, H2R, kabunushi and SecureInvest. Advent will operate the facility as a CDMO. The CERTIFICATE OF GMP COMPLIANCE will be owned by Northwest Biotherapeutics.
Update:
Patient, 54 years old, with Glioblastoma recurrence.
August 23,
Excellent! Thanks ATLnsider.
ae kusterer,
We'll know soon!
ATLnsider,
I check the database every day.
Correction:The database was updated on September 09(not 10), 2021.
ATLnsider,
July 28 was the inspection date for Aspire.
GMP Certificate was issued by MHRA on September 7, 2021
The database was updated on September 09, 2021.
Brain Tumor Social Media. Live chat 1x/month, Sundays, 5p PT/8p ET.
From Maria Quiban's instagram:
May 31
Recruiting, recruiting, recruiting...
Mike Scott
Chief Operating Officer at Advent Bioservices
42 minutes ago.
branster,
Northwest Biotherapeutics is the only TITANIUM SPONSOR.
P.12 https://www.abta.org/wp-content/uploads/2021/09/2021-ABTA-NC-ProgramBooklet_Final.pdf
Nicomac Europe?
branster,
Final ABTA National Conference program is online today.
Linda Powers will not be presenting during the program.
P.14
marzan,
I hope certification on or before September 14. (90 working days+ weekends+ 2 holidays (IMO) since the application was filed May 7, 2021)
Without a doubt, this will be an important milestone in the pathway to approval of DCVax-L.
Navigating regulations: novel cell therapy platforms and their path to clinical manufacturing
Cell & Gene Therapy Insights 2021; 7(5), 831–845
10.18609/cgti.2021.083
PUBLISHED: 11 AUGUST 2021
EXPERT ROUNDTABLE DISCUSSION.
Nina Bauer
Moderator
Head of Commercial, Gene Editing and Novel Modalities, Merck KGaA
Natika Calhoun
Senior Regulatory Consultant, Merck KGaA
She previously served as the site Head of Quality for MilliporeSigma’s viral vector manufacturing site in Carlsbad, California, USA, where she was responsible for leadership of the Quality unit, and for preparing the facility for commercial and inspection readiness to support its first FDA and EU licensed products, which resulted in successful FDA and EMA inspections.
Anthony Davies
Founder and CEO, Dark Horse Consulting
Matt Muldoon
Senior Director Supplier Management, Allogene Therapeutics
ATLnsider,
Thank you!
Some personal information about Linda Powers and her father was published in the Brain Tumour Magazine: World Edition 2020/2021.
Published on Oct 29, 2020
sharpie510,
thanks for sharing the patent news.
and Marvin Bergsneider about Linda Liau:
The full agenda for the 3rd Glioblastoma Drug Development Summit has officially been released!
WEBINAR: I Had Brain Surgery, What's Next?
Linda Liau
August 26
ae kusterer,
Information about the Phase 3 trial for MDNA55 and the use of an ECA was first posted on ihub November 9, 2020.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159379704
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159380673
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=160124042
CaptainObvious,
Not NWBO’s equipment but rather property of the Royal Free Hospital Centre for Cell, Gene and Tissue Therapeutics in London, IMO.
From LinkedIn (2017)
flipper44,
ABTA : August 10
branster,
I wonder why it took 6 days to get an answer while you got one within hours. Obviously something changed in the past week.
branster,
I asked ABTA for more information about the National Conference.