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CMC helps maintain the connection in quality between the drug used in clinical studies and the marketed drug.
Manufacturers should maintain the connection in quality between the drug used in clinical studies and the marketed drug. — FDA. https://www.accessdata.fda.gov/static/cvm/cormier/spanish/CMCsandGMPs.pptx
Scott Gottlieb, M.D.
MAY 22, 2018
In contrast to traditional drug review, where 80 percent of the review is focused on the clinical portion of that process, and maybe 20 percent is focused on the product issues, I’d say that this general principal is almost completely inverted when it comes to cell and gene therapy. The initial clinical efficacy is often established early, and sometimes in small series of patients. The more challenging questions relate to product manufacturing and quality, or questions like how much you can change, or enlarge, the gene cassette that you load into a vector before the gene insert will change the conformation of the vector in ways that also fundamentally alter the entire product’s safety or performance.
There is also the question of durability of response, which often can’t be fully answered in any reasonably sized pre-market trial. For some of these products, there’s going to be some uncertainty, even at the time of approval. But these products are initially being aimed at devastating diseases, many of which are fatal and lack available therapy. In these settings, we’ve traditionally been willing to accept more uncertainty to facilitate timely access to promising therapies. This is the direction Congress gave FDA by creating vehicles like the accelerated approval pathway, or the breakthrough therapy designation, or the RMAT designation.
When we adopt these approaches to accelerating the development and approval of highly promising therapies that target unmet needs, but have some uncertainty associated with their safety or benefits, we’ve typically done it under strict approval standards. These approaches require significant post-market follow up to answer the theoretical questions that might remain about a products risk or long-term effectiveness.
https://www.fda.gov/news-events/speeches-fda-officials/remarks-alliance-regenerative-medicines-annual-board-meeting-05222018
If DCVAX was anywhere near approval, I'd think literature should be disseminated instructing surgeons to capture tumor tissue?? That would've popped up on our radar by now.
In summer 2019 the future looked bright for Joel and his family. Having received fantastic A-level results he was looking forward to going to university in September. Less than two weeks later on August 28 following a period of having severe migraine type headaches he went to the optician on the advice of his GP. The Optician saw retinal haemorrhaging and sent him immediately to hospital. Within a few days he was having emergency brain surgery to remove a golf ball sized brain tumour. Although the tumour was removed successfully, a few days into Joel’s recovery they received the devastating diagnosis of glioblastoma - the most lethal and aggressive brain cancer.
17 DECEMBER 2020
Treatment update
The first stage of the manufacturing of Joel’s personalised vaccine has now been completed. This is the extraction of antigens, (cancer proteins), from Joel’s original tumour tissue, which was transported from Salford Royal Hospital to the biotech company in Cambridge. The next stage is to introduce Joel’s white blood cells, (his ‘immunity cells’), to the antigens to start to cultivate natural antibodies. This will take place mid-January 2021, followed by the delivery of the vaccine at King’s Hospital London. All being well, Joel will be back in London to resume his English degree course in the new year.
learningcurve2020,
Anthony Davies looks ahead to the rest of 2021
January 10, 2021
Happy Eve of Not #JPMorgan: here are my in-no-particular-order Top 10 predictions for the year in cell and gene therapy, not so much as a Nostradamus impression, but hopefully more a provocation of thought…
#1 The investment and acquisition arms race in the CTx and GTx tools & technology space will continue, with valuations that baffle us all, especially for CMOs
Besides the unusually high EBITDA multiple of 23 times for the Cognate acquisition, the multiple to revenue of 7 times is exceedingly high.
Those multiples are so high taken together, they could be considered almost an outlier in comparison to other CRO and CMO acquisitions.
Business Valuations
According to Pitchbook data, business sale median valuations of publicly traded CROs range from 11.75x to 15.6x EBITDA (earnings) and 2.88x to 4.77x revenue multiples. Valuations within this range are influenced by revenue size, competitive environment, growth rates, margins, the strength of the management team, and buyer motivations.
Referring to the CRL/Cognate PR, it is noted: “Dark Horse Consulting Group, Inc. is acting as Charles River’s strategic advisor.”
Anthony Davies
Founder & CEO at Dark Horse Consulting Inc.
1 month ago:
Happy Eve of Not #JPMorgan: here are #darkhorsepredicts #genetherapy #celltherapy for the year, not so much as a Nostradamus impression, but hopefully more a provocation of thought...
#1 The investment and acquisition arms race in the CTx and GTx tools & technology space will continue, with valuations that baffle us all, especially for CMOs
#2 mRNA-nanoparticle technology will become regarded as a bona fide GTx, expand out of its world-changing year in vaccinology, and comprise the first for-real competitor to viral vector technology
#3 Regulators will continue to drop the hammer on CMC, especially but not limited to potency assays: sponsors will howl they are suddenly 'tightening up', but cooler heads will remind the CGTx field it's simply maturing to a point where regulators have always been strict
#4 What's going on with toxicity and high-dose AAV will be clarified - and it won't be good news for high-dose AAV. Capsid engineering could save the day, but only if it actually shows effectiveness of reduced doses
#5 The myth of mesenchymal stem cells being all-seeing, all-knowing, anti-inflammatory, 'smart cells', 'cells that know what disease needs to be treated and do what needs to be done' will finally die - everyone, we wish they did, but they don't work
#6 Allogeneic CAR-T, NK etc. therapies will either show a definitive CMC advantage (= consistently high doses/donor) or risk being considered insufficiently differentiated from their autologous competitors
#7 For the first time in 20 years, scale-up and consistency of Adenovirus (yes, not the Associated Virus) will become really important - and not just for viral vaccines
#8 CGTx clinical assets will become commodities, in a good way, enabling companies with rich and diverse pipelines to monetize and streamline
#9 @ScottGottliebMD
will return as FDA Commissioner, to a ticket tape parade and rows of CoVID-19-vaccinated staffers prostrating at his feet and the sound of a chorus of angels (just kidding - umm, kind of - but well done for reading this far)
And #10 (For 2022) hotel room rates in the second week of January in San Francisco drop back into the triple digit $ - I just hope there's still a #JPMorgan conference there for us to avail of them...
Dark Horse Consulting has recently added Donald Fink, former FDA CMC reviewer, to their staff.
https://darkhorseconsultinggroup.com/fdas-donald-fink-to-join-dark-horse-consulting-group-as-master-practice-expert-regulatory/
Anthony Davies
1 month ago:
Such a personal pleasure to announce this hire, Donald Fink and I first sat ‘across the table’ from each other some 15 years ago, I have admired his wisdom and skill ever since...
Donald Fink
Master Practice Expert / Regulatory at Dark Horse Consulting Group Inc.
1mo ago:
I am appreciative of the opportunity given me by Anthony Davies (AD) and Katy Spinks to join the exceptionally talented group assembled at Dark Horse Consulting. Week One and its "Off to the Races"!
After my first 2-weeks "on-the-job" I really feel as though I have landed in a good place.
Dark Horse feels like a comfortable fit for me.
Dark Horse Consulting Group Inc.
1 month ago
Today we are thrilled to announce our first new hire of 2021: accomplished FDA regulatory expert, Donald Fink, Ph.D.
His decades of experience with CMC reviews in Cell and Gene Therapy are unmatched in the industry. Read more about him here: https://lnkd.in/gMkRP-u
Sentiment,
I was lucky with my DD and I have the privilege of seeing the whole picture better now!
Good luck to all longs!
Sentiment, thank you for the information and special thanks for the transcription!
ATLnsider,
Thanks for all your contributions. Much appreciated!
About Charles River Laboratories to Acquire Cognate BioServices-
quite a few comments! Like this one:
Gerno Schmiedeknecht Head of Main Department GMP Cell and Gene Therapy at Fraunhofer Institute for Cell Therapy and Immunology IZI
Regulatory Consultant and Qualified Person
Northwest Biotherapeutics GmbH
Oct 2013 – Dec 2016
"Congratulations Mike. What a great growth story since the years we worked together in Germany!"
Reply
Mike Stella Chief Business Officer and Director at Cognate BioServices
"Thanks Gerno, it’s been a pretty incredible journey."
Update on the progress of Joel's cancer treatment start around min38.00.
tue18 Tuesday 16 February
Feb 16, 2021 by
A Bit of Everything with Ian Rothwell
https://podcast.canstream.co.uk/scr/index.php?id=70383
6pm UTC/GMT update on the progress of Joel's cancer treatment.
On Salford City Radio Tuesdays @ 6pm, A Bit of Everything. Music, interviews & events with a variety of guests on 94.4FM &
@salfordcityradio.org
Ian Rothwell #CEDAW People's Tribunal #Backto60
@Rothersonradio
6pm SCR Kate Gilbert Prof. Speaking Coach on her 'TED Talks' challenge & Ian Runacres of Dislocation Dance on his early days & an update on the progress of his son Joel's cancer treatment. +new music from Caolilfhionn Rose, Toria Wooff + Kirsty Almeida & Disclocation Dance.
6pm SCR Kate Gilbert Prof. Speaking Coach on her 'TED Talks' challenge & Ian Runacres of Dislocation Dance on his early days & an update on the progress of his son Joel's cancer treatment. +new music from Caolilfhionn Rose, Toria Wooff + Kirsty Almeida & Disclocation Dance. pic.twitter.com/mN7hRCenlB
— Ian Rothwell #ADRnow #Mediation #EDM1040 #50sWomen (@Rothersonradio) February 16, 2021
From Ian Runacres (Joel’s father) Twitter
2 dec. 2020
Yes, I think that US North West Bio license the product to the UK based Advent Biotech company $NWBO #Glioblastoma #dcvax #helpjoellivelonger
Evaluate,
Advent Bioservices is manufacturing Joels vaccine.(100% certain!)
flipper44,
Advent Bioservices
JOB VACANCY: Quality Assurance Officer
Location: Sawston, Cambridgeshire
Position Type: Temporary (6 months)
Hours: Full Time (37 hr/wk)
We are looking for an experienced and proactive Quality Assurance Officer to support the Quality Assurance team in validation, operation and management of the Quality Management System.
Responsibilities will include:
• Writing Quality documents, Standard Operating Procedures (SOPs) and policies
• Supporting the management of the controlled document system including SOPs, labelling, validation plans, change control, non-conformance, risk assessments and reviewing CAPAs
• Participate in the inspection process by the MHRA and HTA for manufacturing and storage licensing
As a team player, you will have excellent written and verbal communications skills with a meticulous and proactive approach to work.
You will have the following experience/qualifications:
• Experience in writing QA documents, especially Standard Operating Procedures, labels and forms
• Experience within a GMP facility and working in a sterile manufacturing facility
• A sound scientific understanding of cell therapies
• BSc or MSc in a life sciences subject, or comparable experience
We offer excellent opportunities for career progression along with training and the chance to be a part of a growing organisation. We also offer an attractive base salary and benefits package.
The candidate must have the right to work in the UK.
Interested candidates are encouraged to submit a CV and a supporting letter to recruitment@adventbio.uk.
Closing date for applications is 4 September 2020.
Help Joel Live Longer
17 DECEMBER 2020 by Elisa Bonaminio,
Treatment update
The first stage of the manufacturing of Joel’s personalised vaccine has now been completed. This is the extraction of antigens, (cancer proteins), from Joel’s original tumour tissue, which was transported from Salford Royal Hospital to the biotech company in Cambridge.
The next stage is to introduce Joel’s white blood cells, (his ‘immunity cells’), to the antigens to start to cultivate natural antibodies. This will take place mid-January 2021, followed by the delivery of the vaccine at King’s Hospital London. All being well, Joel will be back in London to resume his English degree course in the new year.
Any key take home messages (that may apply to NWBO, positive or negative)?
Maverick0408
Also, I wasn’t able to watch the session that Bosch moderated earlier this week (and I can’t find a recording yet). You seemed to be quite positive about it - was there anything specific to NWBO mentioned?
Harry1969
Harry1969,
Probably not fully up and running yet, but they are definitely heading in the right direction. This month Advent Bioservices hired a new GMP Production Scientist and they are recruiting two level 5 Technician Scientists.
Parvathi Raj
GMP Production Scientist at Advent Bioservices
Greater Cambridge
Feb 2021 – Present
Kelly Balsom
Advent Bioservices
Greater Cambridge Area
2 days ago
Do you know anyone interested in an apprenticeship? We are recruiting two level 5 Technician Scientists and would love to hear from anyone interested in working with us!
Help Joel Live Longer!
Steph Danziger
35 min ago
Really amazing news.
Advent Bio-Services in Cambridge have just confirmed that they’ve made 4 vaccine doses for Joel. This personalised cancer vaccine is made from Joel’s own brain tumour lysate taken from frozen tissue, following his surgery. These have been combined with his white blood cells which were recently extracted at Kings College Hospital, to cultivate antibodies.
This is such an incredible milestone. It means that Joel can now finally commence the treatment for which we’ve been fundraising since August 2020. None of this would have been possible without the extraordinarily generous and utterly incredible amount of donations that family, friends and strangers have made toward the fund, for which we are forever grateful. We will never be able to thank everyone enough for the amazing opportunity they’ve given Joel.
Obviously, this is just the beginning of a new stage for Joel. The treatment is not a cure, but research shows that it prolongs life, during which we can explore other emerging medical trials and treatments. To that end we still need to be raising funds both to continue his existing treatment and to maximise the opportunities that arise in the future. If Joel can continue to live longer then he stands a chance of making the most of life.
2 days ago
Shenell Malloy
It’s been 2 YEARS since hearing the words...YOU have Stage 4 Brain Cancer. Wow what a sentence and nightmare! I’m so appreciative to have made it through to the other side. I’m still in awe of how far I’ve come especially looking back at these pics. Today, I have never felt happier, stronger and healthier. So grateful for a second chance at life especially when my future was so uncertain and if I would even make it past 6 months. Through the fear, pain and suffering I found my strength and voice and learned the only way to survive it is to embrace it. And with the help of my family, friends and loved ones I am creating the best chapter yet.
I am also so thankful for the excellent care and successful surgery I had at #ucla on 2/8/19. They truly are my angels here on earth especially the incredible Dr. Linda Liau. I went with my gut and got a second opinion at a research hospital, not stopping until I got answers. Always advocate for yourself and get a second opinion no matter what you are facing health wise. I am living proof of the importance of listening to that bad ass inner voice inside and hope it keeps me safe until I can hold my grandchild one day and there is a cure.
flipper44,
Thanks for the additional information!
Marion Smits (Erasmus MC, NL) /CDDF Spring Conference 2021
Quote:
At present no reliable MR imaging marker of response in clinical trials for assessing high-dose radiotherapy/immunotherapy/anti-angiogenic agents.
Did anyone attend Dr. Bosch’s presentation today?
SESSION 4: ADVANCES IN IMAGING
Session Chairs: Marnix Bosch (Northwest Biotherapeutics, UK) & Catarina Edfjäll (CDDF, SE)
19:00 Radiology imaging
Marion Smits (Erasmus MC, NL)
19:20 Molecular imaging
Wim Oyen (Rijnstate Hospital Arnhem and Humanitas Univ Milan, NL)
19:40 Q&A (30')
Full study report is here:-
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3071163/
Ah; the much-referred to 23-patient Phase 2 study, which was used to demonstrate the use and possible additional survival benefit of either of the two adjuvants.
The same study was also used to demonstrate the non stat-sig additional benefit accrued by mesenchymal patients.
I'm pretty sure this is all one and the same study (though if anyone can demonstrate otherwise, I'd be happy to accept..)
ATLnsider
$NWBO #DCVax Dr Linda Liau gave presentation at American Association of Neurological Surgeons (AANS) meeting in Boston 4/25-4/29/20. Patients treated with DCVax+ Poly ICLC median survival was 54 months vs 11 months for placebo group. See page 83: https://thejns.org/downloadpdf/journals/j-neurosurg/132/4/article-p1.xml
Hopeforthefuture3,
Al Musella's Thoughts on the SNO 2020 Conference!
11. Poly ICLC + a DC vaccine in randomized trial shows a major improvement in OS and TTP. Hard to interpret the poster – they do not say if these are newly diagnosed or recurrent and they mix grade 3 and 4 but it was randomized. IF DCVAX gets approved soon, the first thing we should try is adding Poly ICLC to it
In the trial ae_kust posted the arms were
ATL-DC + placebo : 11 months
ATL-DC + PolyICLI : 54 months
ATL-DC + Resquimid : 17 months
Category: Clinical trials: Immunologic
Tumor Type: Glial Tumors
CTIM-18 - Dendritic Cell Vaccination in conjunction with Adjuvant TLR-3 Agonist administration Enhances Pro-inflammatory Immune Responses and is associated with Extended Survival in Malignant Glioma Patients
ePoster Award
Despite recent advances with immunotherapy in other tumor types, malignant glioma patients have not shown a therapeutic benefit, potentially due to the insufficient activation of an immune response. We and others have documented immune responses and extended survival following dendritic cell (DC) vaccination in small clinical trials. In this Phase II clinical trial, we randomized malignant glioma patients to receive autologous tumor lysate pulsed DC vaccination with and without adjuvant toll-like receptor (TLR) agonists. Treatment with TLRs in cancer patients has been shown to activate the innate immune response by inducing the expression of pro-inflammatory factors and cytokines. Twenty-three patients with WHO grade III or IV glioma received three intradermal injections of autologous tumor lysate-pulsed DC on days 0, 14, and 28 in conjunction with either a placebo adjuvant, TLR-7 agonist (Resiquimod), or TLR-3 agonist (Poly ICLC). We observed a difference in survival for the DC-vaccinated patients who received adjuvant Poly ICLC treatment of 54 months over adjuvant placebo (20 months) and adjuvant Resiquimod (28 months) groups (P = 0.04). The patient cohorts were balanced for WHO grade, IDH mutation, and MGMT methylation status. Mass cytometry (CyTOF) analysis of patient peripheral blood mononuclear cells (PBMCs) showed increased levels of the monocyte populations CD14+CD16- and CD14dimCD16+ after Poly ICLC treatment. In addition, gene expression analysis of the PBMC populations using single cell RNA sequencing demonstrated increased expression of pro-inflammatory genes after adjuvant Poly ICLC and Resiquimod treatment. Nonetheless, a greater fold change increase and a larger pro-inflammatory repertoire was observed in the Poly ICLC group. Overall, these findings demonstrate that adjuvant Poly ICLC increases the number of circulating monocytes and induces a large pro-inflammatory response, which may account for the survival differences observed over adjuvant Resiquimod and placebo.
Yes... and there was also this passage in the 3rd quarter Q, so these actions were already underway sometime between July 1 and September 31
Item 5. Other Information
Consulting Agreements
The Company is in the process of entering into expanded agreements with certain Scientific Advisory Board members and certain other key consultants whom the Company anticipates will play important roles in helping the Company prepare for potential applications for regulatory approvals of the DCVax-L product. The agreements are being negotiated around structures that are contingent upon major milestones and will provide substantial incentive compensation.
Dr. John Smyth
Dr. Smyth was appointed the first Chair of Medical Oncology in Edinburgh and, over the course of 30 years, has developed multidisciplinary oncology to create the Edinburgh Cancer Research Centre, combining laboratory and clinical research with teaching and training, and serving a population of 2 million. Dr. Smyth’s research expertise is in experimental therapeutics, from drug design through all phases of pre-clinical evaluation and clinical trials, with his major research focus on the development and evaluation of new anti-cancer drugs. He Chaired the Expert Advisory Group for Oncology & Haematology for the Commission on Human Medicines, and served for several years on the UK Committee on Safety of Medicines, as well as on the Scientific Advisory Group for Oncology for the European Medicines Agency (the Europe-wide regulatory body). Dr. Smyth also has extensive experience participating in the independent monitoring of clinical trials of checkpoint inhibitor drugs. His work has also focused on the affordability of cancer related healthcare.
Dr. Smyth has published over 300 papers and been involved in 47 books and chapters. He served as Editor-in-Chief of the European Journal of Cancer for a decade, from 2001to 2010. He is a fellow of the Royal College of Physicians of Edinburgh and London, and fellow of the Royal Society of Edinburgh, and is a past president of the European Society of Medical Oncology and the Federation of European Cancer Societies.
Linda Powers, CEO of NW Bio commented: “We are excited to work with such an expert Scientific Advisory Board, and gratified that these leading experts see the encouraging possibilities of the DCVax technology. The SAB members bring diverse and complementary skill sets, in addition to long experience in the field. They will be a valuable resource for the Company, both in the periodic SAB meetings and on an ongoing basis in between the meetings, as we work toward bringing DCVax therapies to patients to help provide much needed new treatment options as soon as possible. In addition, we anticipate that one or more of the SAB members may become involved in our clinical programs.”
Day 3 – wednesday 10 February 2021
SESSION 5: REGULATORY HOT TOPICS
Session Chairs: John Smyth (CDDF, UK) & Ralf Herold (EMA, NL)
15:00 Patients Preferences
Hans Hillege (Committee for Medicinal Products for Human Use, EMA, NL)
15:25 Comments-alt Q&A (30')
15:55 coffee Bio-break (15')
16:10 RWE: technical perspective
Sinan B. Sarac (Danish Medicines Agency, DK)
16:35 Q&A (30')
17:05 fire Fireside chat (30')
Flexroy,
Marnix Bosch is responsible for moderating the session.
SESSION 4: ADVANCES IN IMAGING Session Chairs: Marnix Bosch (Northwest Biotherapeutics, UK) & Catarina Edfjäll (CDDF, SE)
19:00 Radiology imaging Marion Smits (Erasmus MC, NL)
19:20 Molecular imaging Wim Oyen (Rijnstate Hospital Arnhem and Humanitas Univ Milan, NL)
12th CDDF SPRING CONFERENCE 2021
Current and Future Challenges of Innovative Oncology Drugs Development
The 12th edition takes place from 8 to 10 February 2021, virtually
Day 2 – Tuesday 9 February 2021
Session 4: Advances in Imaging
Session Chairs: Marnix Bosch (Northwest Biotherapeutics, UK) and Catarina Edfjäll (CDDF, SE)
LEARNING OBJECTIVES
• Understanding the pitfalls in the European HTA process leading to current inequality in patient access.
• Forward facing discussion on endpoints in cancer clinical trials, and on digital tools and use of artificial intelligence in cancer drug development.
• Understanding current differences in the global regulatory approval and HTA approaches, and discussing potentials for harmonization
• Awareness on novel methods for clinical oncology imaging, and discussion on their application as biomarkers in the drug development process.
• Addressing regulatory guidance: EMA regulatory strategy 2025; envisioning product development for 2025; Industry perspectives on innovation and current topics in oncology.
TARGET AUDIENCE
The target is a multidisciplinary audience of representatives from academia, EU and US regulatory bodies (EMA, FDA and national agencies), the pharmaceutical Industry, HTAs and patient advocates.
On Tuesday, Lord Hunt of Kings Heath will ask Her Majesty’s Government what steps they are taking to encourage research into (1) the causes, and (2) the treatment, of brain tumours.
The question will be answered by Lord Bethell who was last asked a brain tumour question in the Lords in November.
https://www.braintumourresearch.org/media/our-blog/blog-item/our-blog/2021/01/15/peers-mps-ministers-and-the-pm---campaigning-update
UK
House of Lords
Tuesday 19 January 2021 Meeting starts at 12.00pm.
Oral questions: Research into the causes and treatment of brain tumours
Lord Hunt of Kings Heath (Labour)
My condolences for your loss marzan.
From the link on that page, there is a time scale. The time scale suggests that LP was an MD only for a few short period recently, and just before Ms. Diehl was appointed. It looks like Guenter Rosskamp preceded and is no longer MD.
Handelsregister Veränderungen vom 05.08.2020
HRB 27978: Northwest Biotherapeutics GmbH, Leipzig, Deutscher Platz 5, 04103 Leipzig. Ausgeschieden: Geschäftsführer: Powers, Linda, Potomac / Vereinigte Staaten von Amerika, *16.10.1955. Bestellt: Geschäftsführer: Diehl, Barbara R., New York / Vereinigte Staaten von Amerika, *04.06.1945, einzelvertretungsberechtigt; mit der Befugnis, im Namen der Gesellschaft mit sich als Vertreter eines Dritten Rechtsgeschäfte abzuschließen.
Handelsregister Veränderungen vom 16.03.2020
HRB 27978: Northwest Biotherapeutics GmbH, Leipzig, Deutscher Platz 5, 04103 Leipzig. Bestellt: Geschäftsführer: Powers, Linda, Potomac / Vereinigte Staaten von Amerika, *16.10.1955, mit der Befugnis, im Namen der Gesellschaft mit sich im eigenen Namen oder als Vertreter eines Dritten Rechtsgeschäfte abzuschließen.
Handelsregister Veränderungen vom 30.11.2016
HRB 27978: Northwest Biotherapeutics GmbH, Leipzig, Deutscher Platz 5, 04103 Leipzig. Ausgeschieden: Geschäftsführer: Dr. Rosskamp, Guenter, Berlin, *04.06.1942.
Handelsregister Veränderungen vom 07.03.2013
Northwest Biotherapeutics GmbH, Leipzig, Deutscher Platz 5, 04103 Leipzig. Ausgeschieden: Geschäftsführer: Faber, Bernhard, Leipzig, *22.03.1970. Bestellt: Geschäftsführer: Dr. Rosskamp, Guenter, Berlin, *04.06.1942.
Handelsregister Neueintragungen vom 16.02.2012
Northwest Biotherapeutics GmbH, Leipzig, Deutscher Platz 5, 04103 Leipzig. Gesellschaft mit beschränkter Haftung. Gesellschaftsvertrag vom 30.09.2011. Geschäftsanschrift: Deutscher Platz 5, 04103 Leipzig. Gegenstand des Unternehmens: Erforschung neuer pharmazeutischer Produkte, Durchführung von klinischen Studien, Lizenzierung und Vertrieb dieser Produkte, sowie Erbringung von Dienstleistungen in diesem Zusammenhang. Stammkapital: 25.000,00 EUR. Ist nur ein Geschäftsführer bestellt, so vertritt er die Gesellschaft allein. Sind mehrere Geschäftsführer bestellt, so wird die Gesellschaft durch zwei Geschäftsführer oder durch einen Geschäftsführer gemeinsam mit einem Prokuristen vertreten. Bestellt: Geschäftsführer: Faber, Bernhard, Leipzig, *22.03.1970, einzelvertretungsberechtigt.
So what do we think this means for us ??????
Handelsregister Veränderungen vom 05.08.2020
HRB 27978: Northwest Biotherapeutics GmbH, Leipzig, Deutscher Platz 5, 04103 Leipzig. Ausgeschieden: Geschäftsführer: Powers, Linda, Potomac / Vereinigte Staaten von Amerika, *16.10.1955. Bestellt: Geschäftsführer: Diehl, Barbara R., New York / Vereinigte Staaten von Amerika, *04.06.1945, einzelvertretungsberechtigt; mit der Befugnis, im Namen der Gesellschaft mit sich als Vertreter eines Dritten Rechtsgeschäfte abzuschließen.
highwayman4life,
I believe Barbara R Diehl is an attorney admitted to practice in New York State.
https://opengovus.com/new-york-state-attorney/1812320#page
flipper44,
I notice that a change has occured. Linda Powers is no longer the Managing Director of Northwest Biotherapeutics GmbH (German subsidiary).
MANAGING DIRECTOR: BARBARA R. DIEHL · NO LONGER MANAGING DIRECTOR: LINDA POWERS
5 AUG 2020 – GERMAN TRADE REGISTER ANNOUNCEMENT, GERMANY
HRB 27978: Northwest Biotherapeutics GmbH, Leipzig, Deutscher Platz 5, 04103 Leipzig
. Retired: Managing Director: Powers, Linda, Potomac / United States of America, born ????. Appointed: Managing Director: Diehl, Barbara R., New York / United States of America, born ????, authorized to represent one person; with the power to enter into legal transactions on behalf of the company as a representative of a third party.
I just went by the Cognate facility in Memphis. There are significant building additions in the back of the building.
Parcel 093301 A00005 (4600 East Shelby Drive) is 7.38 acres and contains a 112,313 square foot warehouse. The Applicant currently occupies approximately 88,000 square feet and after relocating the warehouse and distribution operation to 5780 East Shelby Drive, will spend $30 million on interior construction and renovations and $17 million on new personal property. Real property improvements occupied by the Applicant (78.35%) will receive PILOT benefit on a proportional basis and new personal property will receive PILOT benefit. The redevelopment of this parcel will allow the removal of current distribution activities on the site to another parcel and the redevelopment of this parcel to create a manufacturing facility utilizing clean room operations at a significant expense.
Cognate expansion announced today.
Exciting news from Cognate! Today, we formally announce our plans to expand our facilities, doubling capacity, and increase development & manufacturing capabilities in the US, UK, & EU. Read more here: https://t.co/7HAtkLAmYv pic.twitter.com/Yde2d2DJoL
— Cognate BioServices (@CognateBio) January 14, 2021
you wrote:
Quote:
Note: af few questions (and answers) about DCVax-L and Northwest Biotherapeutics at the end of the Q&A session.
What were the questions, and what were the answers?
Did you learn anything new or worthwhile from Q&A?
exwannabe,
I’m confident Northwest Biotherapeutics has a data scientist at hand who can avoid the pitfalls of poor data or sloppy methodology.
Here is a recent webinar (June,17 2020) about Synthetic and External Control Arms in Clinical Trials: https://www.cytel.com/webinars/synthetic-and-external-control-arms-in-clinical-trials
Speaker: Dr. Kristian Thorlund
Dr. Kristian Thorlund is a Professor of Biostatistics at McMaster University and Senior Vice President of Real World Evidence at Cytel. Dr. Thorlund is a world-renowned biostatistician. He ranks among the top 1% highly cited researchers internationally in the past decade, has published several hundred peer reviewed research papers in medical and statistics journals. His research focuses on Bayesian statistical methods for evidence synthesis, innovative clinical trial designs, real world analytics, and global decision-making. His teaching and educational efforts focuses on making complex Bayesian methods widely applicable and interpretable to the global clinical research community. Dr. Thorlund sits on several clinical trial data monitoring committees and has been the principal statistician for over 50 completed clinical trials. Dr. Thorlund also frequently advises ministries of health on both discovery and delivery of health care.
Dr Bala,
Thanks, i will do that.
An ethical remark: I don't think Dr. Ashkan Keyoumars would recommend DCVax-L to his patients if he was aware of a failed trial.
I'll be glad to donate to Joel right after I see an NWBO effusive post on Kat's FB page. Let me know when to check. I, as probably many others here helped her out. Maybe her and her family can return the favor.
October 1, 2019
Four years ago I had been given 3 months to live, now i'm well enough to be allowed the simple pleasure of driving again and still tumour free thanks to DCVAX!
Kate Jason
Help Joel Live Longer
Treatment update
The first stage of the manufacturing of Joel’s personalised vaccine has now been completed. This is the extraction of antigens, (cancer proteins), from Joel’s original tumour tissue, which was transported from Salford Royal Hospital to the biotech company in Cambridge. The next stage is to introduce Joel’s white blood cells, (his ‘immunity cells’), to the antigens to start to cultivate natural antibodies.
This will take place mid-January 2021, followed by the delivery of the vaccine at King’s Hospital London. All being well, Joel will be back in London to resume his English degree course at King’s College in the new year. So, it should all be convenient for him.
Thanks again for all of your support and please continue to help us to
HelpJoelLiveLonger.
Ian, Steph and Joel X
ATLnsider,
I notice that researchers at the Dana-Farber Cancer Institute (Boston, MA) and UCLA (Los Angeles, CA), used data from a trial, listed on your table, to design an External Control Trial design for newly diagnosed GBM.
Datasets
To develop an ECT design for newly diagnosed GBM, we used data from patients receiving standard temozolomide in combination with radiation (TMZ+RT) from both prior clinical trials and RWD (Table 1). Clinical trial data were from the phase III AVAglio (NCT00943826; ref. 18) trial and two phase II trials (PMID: 22120301 and NCT00441142; refs. 19, 20). RWD was abstracted from patients undergoing treatment for newly diagnosed GBM at the Dana-Farber Cancer Institute (Boston, MA) and UCLA (Los Angeles, CA), and a previously published RWD dataset (21).