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Looks like MHRA had a busy June, took it easy over the summer, and for one reason or another, They’ve experienced a 120 day lull in certifications.
One really can’t tell why. MHRA probably started doing more inspections again after their people came back from holidays, you’d think there would be an uptick in certifications by now.
Please note that I will be leaving MHRA in early January 2022 and will also be on holiday between 27th October and 3rd January inclusive.
Please note that I work part-time.
I am currently on maternity leave and will not read your email.
I am currently out the office on annual leave. I will have limited access to emails.
Thank you for your email, I now work part time.
Thanks for your enquiry. I have passed this on to our ATMP inspectors as I do not work in that area.
There has been a lot of confusion about the certificate and licensing process by MHRA in the UK on this board.
I never said the cGMP cert will be an issue. Nor even that the PAI will be an issue. The first will come in time (likely Q1 2022). The second will only happen if a BLA/MAA ever happens. Exwannabe https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166579199
Nov.1 - email from Norman Gray:
"MHRA do not perform pre-approval inspections as per the FDA".
Within Europe, the manufacture of medicines is regulated by European Medicines Agency, who decrees that each EU member state is required to elect a competent authority to oversee licensing of manufacturing facilities ratifying their compliance to Good Manufacturing Practices (GMP). GMP is a quality system for ensuring that medicinal products are manufactured consistently and to defined standards thus ensuring medicines are as safe as possible. GMP has historically been employed in the production of small molecules, proteins, vaccines and monoclonal antibodies [4]. However, in 2004, the European Commission ratified the Tissues and Cells Directive (EUTCD; [5]) which re-classified gene therapy, somatic cell therapies (which includes stem cell therapy products) and tissue engineered products as ATMPs (Advanced Therapy Medicinal Products) and imposed their manufacture (i.e. expansion or modification) to apply to the same GMP principals. Two Directives lay down the principals and guidelines of GMP for medicinal products, Directive 2003/94/EC which is concerned with medicinal products of human use [6] and 91/412/EEC intended for veterinary use medicines[7].
One potential confusion within the field of cell therapy manufacturing is what regulations applies to human tissue and/or cells isolated from tissue used for direct transplantation or as part of a medicinal product. As previously mentioned, the EUTCD was issued in 2004 and one of its aims was to clarify these definitions. Where whole tissues intended for human application, are donated from the living or deceased, the consent, procurement, processing, testing, storage and disposal of that whole tissue is governed by EUTCD with UK enforcement provided by the Human Tissue Authority (HTA). Where individual cells, isolated from whole non embryonic human tissues, are expanded or modified to make a cell based medicinal product then their manufacturing and quality control testing, would fall under the ATMP Directive 2009/120/EC [8] and the regulating authority would be the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA are the competent authority within the UK, whose remit covers the regulation of medicines, devices, blood and 2 Advanced Therapy Medicinal Products (ATMPs) for human application. In the UK, manufacture of veterinary products is regulated by the Veterinary Medicines Directive (VMD). In addition to ensuring medicines are manufactured to GMP, the MHRA also issues authorisations allowing the distribution of safe and tested medicines on the market (termed a marketing authorisation; MA), or authorises their use within a clinical trial, the medicine in this case is termed an Investigational Medicinal Products (IMP). Facilities manufacturing medicines intended for release to the market must be granted a manufacturing license (MIA) by their competent authority, whilst facilities manufacturing IMPs must also obtain a separate MIA IMP license.
In the UK, in addition to the above-mentioned manufacturing licenses (MIA or MIA IMP), ATMPs may be manufactured under a UK ‘Specials’ or a hospital exemption license for an unmet clinical need i.e. where no alternative licensed product is available. Cells for Sight have experience of manufacturing ATMP ‘Specials’. Here, a bona fide, unsolicited request from the patient’s surgeon, in the form of a prescription, is required to commence the manufacturing process. The legal responsibility for use of the ATMP in this case rests with the surgeon. The main difference between the two types of licence are; that the holder of a ‘Specials’ license can manufacture an ATMP for any EU member, whereas a hospital exemption holder may only manufacture ATMPs for their own hospital’s patients. ATMPs manufactured as ‘Specials’ must meet the expectation of 2003/94/EC [6] and Guidance Note 14 [9] and may be released by the Quality Controller (QC) of the manufacturing facility as opposed to the Qualified Person (QP).
At CFS, we manufacture ATMP MIA-IMPs generated from expended stem cells to produce novel cell-based and tissue-engineered products. Medicinal products must be certified by a QP prior to release. The QP plays an integral role in medicine manufacture and must take final responsibility for the release of that product for human or animal use. The QP must ensure the product is safe by ratifying it has been manufactured to GMP and in accordance with the marketing authorisation (for products released to the market), or in accordance with an IMP Dossier (IMPD) and Product Specification File (for IMPs).
Irrespective of the type of medicine being produced, and the type of license a manufacturing facility holds, the principles of GMP must always be applied in order to ensure medicines are consistently produced, of the highest quality, safe and effective for the end user. Under the EU regulations, ATMPs, which are classified as sterile medicinal products, must be manufactured within a cleanroom to ensure no contamination is transferred to the recipient. There are many requirements of a cleanroom in order for it to be ‘fit for purpose’ and the following section describes these in detail.
https://discovery.ucl.ac.uk/id/eprint/1478655/1/Daniels_Regerative%20Medicine_revisions_accepted%20track%20changes.pdf
tunnelvisionofplenty,
Thanks! Great job!
They've only relatively recently advertised this position in both London and Sawston
The Wayback Machine doesn't necessarily capture the exact date the changes were made, but it was sometime between 10/16 and 10/28 that they started advertising for London.
flipper44,
I believe they have given a reasonable estimate.
Take a look at Advent Bioservices website for vacancies. They are looking for a GMP Production Scientist. Location: London and Sawston.
https://adventbio.peoplehr.net/JobBoard/
https://adventbio.peoplehr.net/Pages/JobBoard/Opening.aspx?v=137f6dd8-8b68-4cdf-97fe-c56226d470f0
I think they will be manufacturing in aseptic suites in London at least until the end of the year.
biosectinvestor,
They need GMPc, MIA, MIA(IMP) and UK "Specials' License. Lots of work to do!
exwannabe,
Not Kings College, London.
Advent Bioservices
Room 1/458, 1st Floor
Royal Free Hospital
Pond Street
London
NW3 2QG
https://ct.catapult.org.uk/sites/default/files/publication/2018%20GMP%20Manufacturing%20Report_FINAL.pdf
100% sure!
Updated 1min. ago. No change!
Usually between now (03.00 PM) and 05.00 PM. ( 1hour after US markets are closed).
biosectinvestor,
Same story here (NOT DCVax-L)
Help Jamie Fight Brain Cancer
https://www.gofundme.com/f/help-jamie-fight-brain-cancer?utm_campaign=p_cp+share-sheet&utm_medium=copy_link_all&utm_source=customer
With Jamie's permission, we are undertaking this fundraising campaign and appealing to you to donate whatever you can so that Jamie can access additional treatments that can help to prolong her life, specifically, a ground-breaking new immunotherapy treatment called DCVax which is expected to cost in excess of a staggering €200,000.
DCVax creates personalised immune therapy made from each patient's own dendritic cells. Dendritic cells are a type of immune cell that function to help the body's immune system recognise and attack tumour cells. Our hope is that this treatment will significantly prolong Jamie's life so she can spend time with her young family.
October 27
8 days ago we set up this fundraiser with a goal of helping our friend Jamie to access an extremely costly brain cancer treatment in Germany... We were so worried that we might not raise enough funds, or that it would take too long, but we have reached our target of €200,000.
‘There is a treatment in Germany that is promising in treating this and can significantly prolong her life with her young family. It’s €200,000 so her friends have set up this GoFundMe,’ Aoife continued.
Of the €200,000 Jamie requires for the surgery abroad, the appeal has so far raised €171,731 with 4,200 people donating towards the ground-breaking new immunotherapy treatment called DCVax.
sentiment,
IOZK Cologne and CeGat Tubingen are partners in the search for the best personalized treatment.
Ethan's family calls it DCVAX treatment but it's NOT our DCVax-L.
March 21,
So today’s the day.
We set off for Köln in 2 hours for our first DC Vax treatment and I’m feeling hopeful for my son and anxious about the journey navigating Covid.
Treatment starts tomorrow finishing on the 1st April so we travel back on 2nd April ready for Easter.
We had a positive review of our diagnosis report Wednesday from CeGat where our personalised peptides are being made.
They have identified a very fragile component to the structure of Ethans tumour that doesn’t have the ability to repair and there are chemotherapy, compounds and repurposed drugs that can attack this
Saskia the geneticists is consulting with oncologist at university hospital in Tubingen Germany and my oncologists here in the UK and I have a call next week with them after they have discussed and hopefully there is some additional way to treatments- I’ll still be doing DCvax first and then personal peptides but hopefully we have an important finding to attack and bridge the gap until immunotherapy is doing it’s job.
Much love and thanks to you all
March 25,
DCVAX Treatment started today thankyou so so much to everyone for your continued support for Ethan's ongoing treatments. the enormity of what you have helped us do is overwhelming
ALOT of blood was taken today for the Dendric Cell Vaccination,
BUT It was ok as they have magic freezing spray here in Germany, Ethan is NOT a fan of a cannula, something he is having fitted at least 2-5 x a week now
Newcastle disease virus is then injected for 6 days whilst the blood is being prepared, NDV is a oncolytic virus that is only taken up by certain cells --- in our case tumour cells changing the structure and breaking them down causing a immune response, re activated dendric cells are then put back in last day teaching the body to fight the tumour cells - Science is amazing, and the best bit is no nasty effects unlike chemo, maybe mild flu symptoms
Love my boy so much even with his hat hair we have cabin fever here in quarantine but He amazes me with his continued determination and perseverance with his daily Physio, a very slow and painful process.
Here he is having IV Vit C & Hypothermia treatment after his Newcastle disease injection - these make the treatment more effective,
thankyou all
much love
Nikki
Ethan got ONC201.
January 30, 2021
This week I have ordered Ethans 1st immunotherapy ONC201 - 3mnths supply from Germany, in 3 months ONC206 will be available, treatments are changing all the time.
YEARS OF SCIENTIFIC PROGRESS LEAD TO HOPE FOR GLIOBLASTOMA PATIENT.
By National Brain Tumor Society | Published November 4, 2021
https://blog.braintumor.org/years-of-scientific-progress-lead-to-hope-for-glioblastoma-patient/?src=readmore&id=5774
Yes!
My prayers and positive thoughts are with Ethan and his family.
Ethan, who is 17 yrs old, was diagnosed with a Brain tumour in October 2019.
3rd Craniotomy on January 20, 2021.
Ethan has had his first 2 injections of CeGat peptides on June 26 and another 2 injections a week later.(4 injections each session) (CeGaT GmbH-Paul-Ehrlich-Straße 23-D-72076 Tübingen-Germany https://www.cegat.com/)
CeGaT’s CancerNeo selects neoantigens that can be used to create a personalized vaccination. The family of Ethan usually calls it DCVAX but it's not our DCVax-L.
A recent emergency MRI gave the news his tumour had grown to the other side of his brain.
A New Hope for Ethan
September 16
Hey everyone.
Sorry for the radio silence. It’s been an extremely difficult and heart wrenching month. Unfortunately Ethan has deteriorated and we were admitted to Southampton as an emergency at the end of August.
An emergency MRI gave the news we didn’t ever want. His tumour had grown to the other side of his brain which is what had been giving him more symptoms.
As a result his chemo has been stopped and no more treatments are available on the NHS and we have been put on a supportive cocktail of medications to help eliviate Ethans pain and symptoms.
After receiving news from the last scan showing the tumour had shrunk this blow has been even harder. There are no words to express how devastated and completely heartbroken we have been as a family and we have needed private family time to absorb the news and rebuild ourselves to carry on the fight.
Ethan has now been home for just over a week. And has been more comfortable and stronger at home and enjoyed a few visits from his friends.
OT have been amazing in getting him a bed and a device to help him get down the stairs so we could bring him home and keep him in the comfort of his own room.
We have had a really difficult decision as to whether Ethan should carry on with his treatment in Germany and after consultation with his Doctor in Germany we have decided to add some additional treatments in Germany with his 6th peptide.
As I write this we are travelling through France on the 13h drive to get him to Tubergin in Germany for treatment tomorrow. We will then head home after on a late crossing back, with Ethans increasing disabilities and pain we thought driving to Germany was the best option for safety and to keep Ethan comfortable.
Your kind words, love and support have always helped us find strength throughout this difficult journey and for that we are extremely grateful we appreciate you giving us this opportunity to keep fighting for our beautiful boy.
Much love
Nikki
Everest in Sight? pic.twitter.com/M9limqicJw
— Michael Bigger (@biggercapital) November 4, 2021
Everest in Sight?
Appreciate the publicity, but really, who is this guy, seems pretty irrelevant
The more improbable, the more bandwidth required to decode and that is the information you want to focus on… As how you interpret it is up to you. I use a simple framework to do so. It works for me
— Michael Bigger (@biggercapital) November 3, 2021
Joseph M. Burnett
President & CEO
Mr. Burnett joined us as our Chief Executive Officer and President in November 2017. Prior to joining ClearPoint Neuro, he served as Vice President and General Manager of Neuro Diagnostics and Therapy at Royal Philips, a publicly traded global health technology company, since March 2016. Prior to serving in such role, Mr. Burnett was the Senior Vice President and Business Leader of Image Guided Therapy Devices at Royal Philips and General Manager of Volcano Corporation (a Royal Philips company) from February 2015 to March 2016. Before Royal Philips' acquisition of Volcano in February 2015, he held various positions at Volcano from November 2004 to February 2015, most recently as Executive Vice President and General Manager of its Coronary & Systems Business Unit. Prior to joining Volcano, Mr. Burnett served as an R&D Engineer and Product Manager at Guidant Corporation from August 1999 to November 2004 and worked as a Bio-Medical Engineering Researcher at Duke University from May 1998 to May 1999. He holds an MBA from The Fuqua School of Business at Duke University and a B.S.E. degree in BioMedical Engineering from Duke University.
Election of New Director.
On November 2, 2021, the Board of Directors (the “Board”) of ClearPoint Neuro, Inc. (the “Company”) increased the size of the Board from seven to eight members, and, with the recommendation of the Corporate Governance and Nominating Committee of the Board, appointed Linda M. Liau, MD, PhD, MBA to fill the newly created directorship, effective immediately. Dr. Liau will serve as a director of the Company until the 2022 annual meeting of stockholders and until her successor is duly elected and qualified or until her earlier death, resignation, disqualification or removal.
Dr. Linda M. Liau is a Professor of Neurosurgery and the W. Eugene Stern Chair of the Department of Neurosurgery at the David Geffen School of Medicine at the University of California, Los Angeles (“UCLA”). She is the Co-Director of the UCLA Brain Tumor Center, and Principal Investigator and Director of the NCI-designated UCLA Brain Tumor SPORE (Specialized Program of Research Excellence). Dr. Liau is internationally recognized for her achievements in understanding the immunology of malignant brain tumors and pioneering the use of dendritic cell-based vaccines for glioblastoma. Clinically, she has developed novel ways to map brain function during awake brain tumor surgeries using functional MRI (fMRI) correlates and specializes in surgery for brain tumors in eloquent areas. She received her BS and BA degrees from Brown University. She received her MD degree from Stanford University School of Medicine, a PhD degree in Neuroscience from UCLA and an MBA from the UCLA Anderson School of Management.
In accordance with the Company’s Non-Employee Director Compensation Plan, Dr. Liau will be entitled to receive a $40,000 annual retainer for service as a Board member as well as a supplemental annual retainer in the event she is appointed to serve as a member of a committee of the Board. In addition, in connection with her appointment to the Board and pursuant to the terms of the Company’s Non-Employee Director Compensation Plan, Dr. Liau will receive an equity grant valued at $120,000, consisting of a stock option and restricted stock award. The shares subject to such stock option and restricted stock award will vest on the first anniversary of the grant. Further, on the day following each annual meeting of stockholders in which she is elected or is then serving as a director, Dr. Liau will receive an equity grant valued at $120,000, consisting of a stock option and restricted stock award. The shares subject to such stock option and restricted stock award will vest on the earlier of the first anniversary of the grant date or the day immediately preceding the next annual meeting of stockholders.
Dr. Liau shall be entitled to the benefits of the same insurance, indemnification, reimbursement and other policies generally applicable to non-employee directors of the Board. Related thereto, the Company has entered into its standard form of indemnification agreement with Dr. Liau (the “Indemnification Agreement”). The Indemnification Agreement provides, among other things, that the Company will indemnify Dr. Liau under the circumstances and to the extent provided for therein, for certain expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by her in any action or proceeding arising out of her service as a director of the Company.
The foregoing description of the terms and conditions of the Indemnification Agreement is only a summary and is qualified in its entirety by the full text of the Indemnification Agreement, the form of which was previously filed as Exhibit 10.2 to the Company’s Current Report on Form 8-K, filed on June 28, 2021, and is incorporated herein by reference.
There are no arrangements or understandings between Dr. Liau and any other persons pursuant to which she was appointed as a director of the Company. There are no family relationships between Dr. Liau and any director, executive officer, or any person nominated or chosen by the Company to become a director or executive officer. There are no related person transactions (within the meaning of Item 404(a) of Regulation S-K promulgated by the Securities and Exchange Commission) between Dr. Liau and the Company.
Vikinginvest,
you are correct. Wrong timezone. My fault, sorry!
Margin Buu,
you are correct. Wrong timezone. My fault, sorry!
correction:
Tweet: 04:05 PM
Dr. Linda M. Liau, internationally renowned neurosurgeon and accomplished researcher in the field of neuro-based biologics and drug delivery joins ClearPoint Neuro Board of Directors #CLPT #lindaliau #Nsgy #boardappointment https://t.co/Hu9BTalUhc
— ClearPointNeuro (@ClearPointNeuro) November 2, 2021
Tweet: 03:05 PM
Dr. Linda M. Liau, internationally renowned neurosurgeon and accomplished researcher in the field of neuro-based biologics and drug delivery joins ClearPoint Neuro Board of Directors #CLPT #lindaliau #Nsgy #boardappointment https://t.co/Hu9BTalUhc
— ClearPointNeuro (@ClearPointNeuro) November 2, 2021
antihama,
I will respond to your post and the original post of Dan88 (https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166566358 - https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166577282 ) and the reply of Exwannabe (https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166577616) with a new additional post later. I got information from MHRA inspectors (written correspondence) about the whole process.I think it is useful information for all members. I expect some additional information from the MHRA inspectors in the next couple of hours or days, so please give me some time to respond.
Irdpdx77,
Wishing you a full recovery. My thoughts are with you and thank you for your contribution.
JerryCampbell,
Per Form 10-K,
On December 14, 2018, we sold most of the U.K. property to an unrelated company. However, we retained a lease-back of the approximately 87,000 square foot manufacturing facility and adjacent areas for 20 years with a renewal option for another 20 years on favorable terms, and we retained ownership of a 17-acre parcel of property that we did not sell. Under the long-term lease of the 87,000 square foot facility, the annual rent is approximately $0.6 million, with rent reviews for potential increases (which are capped) only once every five years. Additionally, we will pay certain service charges of approximately $45,000 per year for the first 3 years, and approximately $55,000 per year for the next 7 years, and up to a potential maximum of approximately $110,000 per year for the remaining 10 years.
newman2021,
EMA (European Medicines Agency) paper was published on March 5, 2021.
For the United Kingdom, as of January 1, 2021, European Union law applies only to the territory of Northern Ireland (NI).
So, GMP certificates issued by the UK authorities was a big issue that is now resolved.
It means that the GMP certificate for Sawston, issued by MHRA (the UK Medicines and Health Products Regulatory Authority), will be accepted in the EU as confirmation of GMP compliance. The GMP certificate, issued by MHRA, will serve as supporting information once the EMA starts the Marketing Authorisation Process for DCVAX-L.
EU accepts MHRA Inspections!
March 5, 2021
The EMA has now updated its question and answer document on the implementation protocol. Of particular interest is question and answer 14.3 (“How will the manufacturing and import authorisations, GMP certificates and GMP non-compliance statements for sites in Northern Ireland be issued and made available and will the same apply GMP certificates issued by the UK authorities for sites in other locations?) Here it was added or clarified that according to the provisions of the previous agreement between the EU and the UK, both sides recognise the results of GMP inspections of the other party.
National documents from the UK authority such as GMP certificates and inspection reports for locations in the UK will continue to be accepted in the EU as confirmation of GMP compliance in connection with regulatory submission and/or import applications. The same applies to inspections in third countries. The GMP certificates issued here can at least serve as supporting information in regulatory submissions.
14.3. How will the manufacturing and import authorisations, GMP certificates and GMP non compliance statements for sites in Northern Ireland be issued and made available and will the same apply GMP certificates issued by the UK authorities for sites in other locations?
Manufacturing and Import Authorisations (MIA) as well as certificates of good manufacturing practice (“GMP certificates”) and GMP non-compliance reports issued by UK Authorities after the end of the transition period for manufacturers located in Northern Ireland will continue to be made available in the EudraGMDP database by the UK competent authorities and will be recognised in the EU/EEA. The European Commission decision of 16/10/2020 (C(2020) 7126 final) foresees that from 1 January 2021 the UK authorities will have partial access to EudraGMDP database (write access via Gateway submissions for information in relation to sites located in Northern Ireland).
GMP certificates issued by UK competent authorities after the end of the transition period for sites located in the rest of UK (i.e. Great Britain) and in other third countries will be considered as GMP compliance information from a third country regulatory authority (please see question 8.2 of EC/EMA Notice to Stakeholders on the Withdrawal of the United Kingdom and EU rules for medicinal products for human use and veterinary medical products) and therefore will no longer be included in EudraGDMP database.
According to Annex on Medicinal Products, included in the Trade And Cooperation Agreement, the EU and the UK shall recognise the outcomes of GMP inspections carried out by the other Party in their territories. As such, the EU will continue to accept GMP documents (e.g. GMP certificates and inspection reports) issued by the UK authorities for sites located in Great Britain for the purpose of confirming GMP compliance in the context of regulatory submission and/importation requirements.
The agreement applies to GMP inspections covering manufacture of medicines for human and veterinary use, including biological and immunological products for human and veterinary use, advanced therapy medicinal products, active substances for human and veterinary medicinal products and investigational medicinal products. The agreement also foresees a possibility to recognise inspections carried out by the UK authorities in other third countries. Therefore, applicants and Marketing Authorisation Holders can continue to submit GMP certificates issued by UK authorities for sites located in third countries as supporting information for regulatory submissions which will be considered as part of the evaluation, as appropriate Further guidance on the application of this agreement will be published at a later stage.
https://www.ema.europa.eu/en/documents/other/questions-answers-stakeholders-implementation-protocol-ireland/northern-ireland_en.pdf
Comment from Alejandro Barquero, Quality Assurance Officer at Advent Bioservices (Sep 2019 – Apr 2021)
Congratulations to all the team!! The hard work finally pays off!
Mike Scott
Chief Operating Officer at Advent Bioservices & Visiting Professor, Anglia Ruskin University
10 minutes ago
Delighted to announce that we have been granted an HTA licence. Thanks to our amazing Team for their hard work preparing for this.
Our state-of-the-art cryostore has a large capacity for storing cells and tissue in LN2, -80C and -20C. Please get in touch if you are interested in easy access off-site storage of your precious clinical or research material. info@adventbio.uk
https://www.linkedin.com/in/mike-scott-103064a0/detail/recent-activity/
March 2021
Katy Gurney
Blitzing the bug with immunotherapy
Fundraising for Brainstrust
Story
In June 2019, at the age of 29, I was diagnosed with a high-grade brain tumour. I had awake brain surgery to reduce the tumour, followed by seven weeks of radiotherapy and a year of chemotherapy. Frustratingly, this is where the standard treatment ends and the waiting begins for the tumour to recur.
Fortunately, there is a cutting-edge new immunotherapy treatment being trialled by Northwest Biotherapeutics called DC Vax-L. This is not yet available on the NHS, nor covered by any private insurance, although trial results to date have been very promising. The treatment is expensive, and whilst my family and I are self-funding the majority ourselves, we are asking for help, not least because the results will then go to help others.
For some time now I have been involved with Brainstrust. This is a small, wonderfully supportive charity, and they have agreed to work with me as I embark on fundraising challenges such as runs, bake-offs, cycles, auctions, hikes, BBQ’s and much more.
Thanks to Brainstrust, all donations will go to my treatment. Any excess funds not required for my treatment as well as all the Gift Aid will be kept by Brainstrust. This will support them so that they can continue to provide amazing support to others living through uncertainty with this disease.
If you would like to get involved in any of these fundraising ideas or have any new ones, please shout! Or if you would like to donate please use the link below. Every penny is a wonderful gift.
Lots of love
Katy x
https://www.justgiving.com/fundraising/bug-in-the-brain?fbclid=IwAR16856XnXf_yjmGf6wbGK1JMziCGXaHNHVxkysfoOG4qTrQrls_PyoedpU
March 23,
buginthebrain (Katy Gurney)
Since being diagnosed with a high grade brain tumour in 2019, I’ve completed the standard treatment plan (op, radio and chemo). Now, the normal procedure is to watch and wait for the tumour to recur... which, at the ripe age of 31, I’m not ready to do...????
Fortunately, there’s a promising new immunotherapy treatment called DCVax, but it’s very expensive and this is why I am asking for your support...
Together with Brainstrust, we will be finding exciting ways to fundraise money, which will help to fund my treatment. Any excess funds, along with Gift Aid, will help support Brainstrust so that they can continue to provide amazing support to others living through uncertainty with this disease.
You’ve all been so generous with your love, time and money already, but if you’d like to get involved there are a few ways you can:
that they can continue to provide amazing support to others living through uncertainty with this disease.
You’ve all been so generous with your love, time and money already, but if you’d like to get involved there are a few ways you can:
1 - Share this message with anyone who might be interested.
2 - Help me with fundraising ideas or fundraise yourself.
3 - Make a donation via the link in my bio ????#dcvax #braintumourawareness #cancerawareness #recurrence
https://www.instagram.com/p/CMxb_3_BotV/
buginthebrain (Katy Gurney)
First stage of the ADCV process Complete ??6 hours hooked up for Leukapheresis, a procedure in which white blood cells / leukocytes (involved in the body's immune response) are separated from the red cells which are then circulated back into my system. Next step - combining these cells with the cancerous protein from my frozen tissue - the aim bring to make a mega tumour blitzing vaccine
https://www.instagram.com/p/COIwbjYgtbC/
buginthebrain (Katy Gurney)
DCVax #3 today and feeling hopeful
NICE (The National Institute for Health and Care Excellence)
DCVax-L for treating newly diagnosed glioblastoma multiforme [ID836]
Consultees
Companies sponsors
Northwest Biotherapeutics (DCVax-L)
Others
Department of Health and Social Care
NHS England
Welsh Government
Patient carer groups
Brain Tumour Charity
Brainstrust
International Brain Tumour Alliance (IBTA)
Professional groups
Association of British Neurologists
Association of Cancer Physicians
Cancer Research UK
Royal College of Physicians
Royal College of Radiologists
https://www.nice.org.uk/guidance/indevelopment/gid-ta10143
Brainstrust
https://brainstrust.org.uk/
The Bug in the Brain Fundraising Committee welcomes you to a special charity auction to raise money for brainstrust and their dear friend Katy Gurney.
In conjunction with The Auction Collective, we will be hosting a dinner and auction at Wild by Tart on the 1st November 2021.
Guests will enjoy an evening of entertainment, a black-tie dinner and an unmissable auction featuring carefully curated lots.
Guests will be invited to bid on handpicked works from renowned artists, such as Jacky Tsai and Freddy Paske as well as extraordinary experiences, fine jewellery and much more. In addition, there will be an online Timed Auction, so that those who can't make dinner can also join the bidding fun.
This event will also highlight the incredible work of Northwest Biotherapeutics, in the hopes that their pioneering DCVax®-L programme will become more widely accessible in future.
Katy’s story
In June 2019, aged just 29, Katy was diagnosed with a high-grade brain tumour.
For the last 2 years she has battled the tumour, undergoing 7 hours of awake brain surgery, followed by a year of rigorous radiotherapy and chemotherapy.
Standard treatment has now come to an end for Katy and the bug in her brain. Now her only viable option is a life-saving treatment called DCVax®-L, not yet available on the NHS or covered by insurance.
brainstrust
brainstrust provide personalised support and build resources that help people with a brain tumour and their loved ones live the life they want to after diagnosis.
They work with people in the clinical setting to secure the best possible care for people with a brain tumour and campaign to solve real issues, because they understand the challenges faced by the brain tumour community.
https://theauctioncollective.com/viewing-rooms/bug-in-the-brain/
flipper44,
Content hasn't changed, IMO. Just some very minor design changes.
Lykri - do you think HTA is part of the GMP application process or separate, even though I saw Flipper post that the inspections can be somewhat in tandem .. ??
Dear XXXXX,
GMP licensing/certification is not overseen by the HTA and I am not sure of the requirements in gaining a GMP licence.
The Medicines and Healthcare products Regulatory Agency oversee matters relating to GMP.
I have attached a link below to their website for your information.
I hope this is helpful.
Kind regards,
Adam.
MHRA - Medicines and Healthcare products Regulatory Agency - GOV.UK (www.gov.uk)
Adam Whittaker
Regulation Manager
Human Tissue Authority
2nd floor, 2 Redman Place, London, E20 1JQ
Direct: 020 7269 1965
General: 020 7269 1900
Email: Adam.Whittaker@hta.gov.uk
Web: www.hta.gov.uk
I got a second message today that a new inspection report has been published on Mon, 10/25/2021 - 14:04 for Advent Bioservices Ltd on the HTA website.
Thanks.
Oct.22
Report sent to proposed DI for factual accuracy: 25 August 2021
Report returned from proposed DI: 25 August 2021
Final report issued: 26 August 2021
Report sent to proposed DI for factual accuracy: 25 August 2021
Report returned from proposed DI: 26 August 2021
Final report issued: 20 September 2021
Completion of corrective and preventative actions (CAPA) plan Based on information provided, the HTA is satisfied that the establishment has completed the agreed actions in the CAPA plan and in doing so has taken sufficient action to correct all shortfalls addressed in the Virtual Regulatory Assessment Report.
Assessment Report. Date: 25 October 2021
The establishment’s agreement with the courier for the transport and distribution of tissue and cells does not stipulate the required timeframe to report serious adverse events to the establishment, as set out in Directions 001/2021.
I got a message that a new inspection report has been published on Mon, 10/25/2021 - 12:41 for Advent Bioservices Ltd on the HTA website.
https://www.hta.gov.uk/professional/establishments/advent-bioservices-ltd
https://content.hta.gov.uk/sites/default/files/2021-10/2021-08-16%2022694%20Advent%20Bioservices%20Ltd%20Application%20Assessment%20Final.pdf
Oct.22,
Compliance with HTA standards Although the HTA found that Advent Bioservices Ltd (the establishment) had met the majority of the HTA’s standards that were assessed, four minor shortfalls were found against standards for Governance and Quality, and Premises, Facilities and Equipment.
Compliance with HTA standards
Although the HTA found that Advent Bioservices Ltd (the establishment) had met the majority of the HTA’s standards that were assessed, three minor shortfalls were found against standards for Governance and Quality, and Premises, Facilities and Equipment.
If I am not mistaken this trial did not even start life as full-fledged Phase 3 trial but I will leave that for shareholders who have been invested longer than myself let alone some others to discuss.
17 MAY 2012
Northwest Bio Provides Update On DCVax® -L Brain Cancer Trial
Amendment Accepted By FDA, Enhancing and Upgrading the Trial
41 US Clinical Trial Sites Now In Operation
BETHESDA, MD, May 17, 2012 — Northwest Biotherapeutics (OTC.BB: NWBO) (NW Bio) announced today that it now has 41 clinical trial sites open and recruiting across the United States in its ongoing clinical trial of DCVax®-L immune therapy for Glioblastoma multiforme (GBM), the most lethal form of brain cancer. This is ahead of the Company’s previous projection of 40 sites by the end of Q2, 2012. The Company plans to continue adding clinical trial sites in the US and Europe, and expects to have at least 60 sites open and enrolling by the end of Q3, 2012.
The Company also announced that the FDA has accepted an amendment of the clinical trial, which does not make any change in the treatment regimen, which leaves all data collected to date intact for use in the trial’s overall results, and which includes the following:
• Designation as a Phase III trial
• Expanded and enhanced statistical endpoint analyses
• Addition of another cohort of patients which can potentially
expand the application of DCVax®-L, and which increases the
trial to up to 300 patients
• Addition of interim analyses for efficacy
A description of the trial protocol as amended will be available at www.clinicaltrials.gov.
Linda Powers, CEO of Northwest Bio, commented, “Of course, the evolution of this trial to a Phase III trial is no assurance of the outcome, and more than one Phase III trial can often be required for a product approval unless the clinical results are particularly strong. However, we are pleased to make this transition to Phase III, and believe that the package of amendments further enhances an already strong trial, positioning the Company to realize the potential of the DCVax®technology.”
Ms. Powers added, “We are excited about the operational progress we have made on multiple fronts, through long periods of work building to these points, as described in our recent announcements. Our lead clinical trial has grown and emerged as a 300-patient, international Phase III trial involving some of the best institutions in the US, UK and Germany. We are also working on several other initiatives, and will provide reports when milestones are reached in those programs.”
https://nwbio.com/northwest-bio-provides-update-on-dcvax-l-brain-cancer-trial-2/
January 2020. Content is no longer publicly available.
Note: Maybe you can search for Jonas Carter papers!
How come "Sawston" isn't called something that powerfully describes the services?
Thanks sharpie510.
HTA Licence now on Advent Bioservices website.
CRYOSTORAGE
The Sawston facility houses a large cryostorage facility consisting of fully monitored -80 C freezers and -196 C liquid nitrogen storage with dedicated In-house liquid nitrogen production. This ensures secure and monitored cryostorage, with full contingency, to meet the needs of clients. The facility is licensed by the HTA (Licence number 22694).
REGULATORY COMPLIANCE
We operate to the highest industry standards with expertise in regulatory standards including HTA, MHRA and JACIE. We are GMP and GLP compliant and strive to reach the best quality output. We are here to help you ensure that your process complies with relevant standards.
https://www.adventbio.uk/
Lykiri
Thursday, 10/21/21 12:13:15 PM
Post 411023
For whatever it's worth.
Advent Bioservices claimed they were in the process of applying for licencing and accreditation from UK authorities including the HTA, MHRA and HFEA for the Sawston site. (https://www.sciencedirect.com/science/article/abs/pii/S1465324920303959)
And from their website:
Quote:
________________________________________
We operate to the highest industry standards with expertise in regulatory standards including HTA, MHRA, JACIE and HFEA. We are GMP and GLP compliant and strive to reach the best quality output. We are here to help you ensure that your process complies with relevant standards.
________________________________________
https://www.adventbio.uk/
HFEA = Human Fertilisation and Embryology Authority.
I was curious about the HFEA License.
Here is a reply from the Human Fertilisation and Embryology Authority:
Quote:
________________________________________
Hi XXXXX,
Thank you for contacting the HFEA.
We do not hold any record of this centre and no request has been received to pursue a licence.
We have reached out to the company to clarify the claims on their website. They had hoped to pursue a HFEA license, but at present do not have one.
Kind regards,
Alice Collinge
Information Governance and Records Manager
Human Fertilisation and Embryology Authority
020 3443 8907
2nd floor, 2 Redman Place, London, E20 1JQ
www.hfea.gov.uk
________________________________________
So I hope and expect that it is indeed their first priority to get the license for manufacturing GMP DCVax-L products in the Sawston facility soon!
ae kusterer,
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Our Stem Cell Licences | HTA MHRAhttps://lifeplusstemcells.com › licences
We hold licences through both the Human Tissue Authority (HTA) and the Medicines and Healthcare Products Regulatory Agency (MHRA). Find out more.
Advent provide us with state-of-the-art GMP manufacturing services that meet all our stringent regulatory requirements. The Advent team are highly professional and also a pleasure to deal with.
Chris Schiel, CEO and Co-Founder
www.LifePlusStemCells.com
https://www.adventbio.uk/