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I suspect that Northwest Bio will first take advantage of a more favorable route in the UK, and may have applied for the Innovation Passport, which is the entry point for the Innovative Licensing and Access Pathway (ILAP). Nineteen applications were filed in only the first few months of the year, yet to date, only about a half dozen have been publicly announced. (some may have been denied)
hyperopia,
5 months ago I asked MHRA if Northwest Biotherapeutics had applied for ILAP. Here's their reply:
Dear XXXXX
Thank you for the email. Concerning your question below we do not release this information as it is considered commercial sensitive.
Asian Hall of Fame’s ceremony to honor inductees for their lasting legacy.
By Taylor Torregano Los Angeles PUBLISHED 7:45 PM PT Nov. 12, 2021
LOS ANGELES — The annual Asian Hall of Fame ceremony will be held Saturday, November 13 to induct 10 icons for their legacy, philanthropy and inter-racial equity.
The global organization aims to advance equality by elevating Asian contributions and combat Asian hate. When it needed a CEO, Maki Hsieh answered the call to elevate Asian excellence and advance racial equity, while focusing on philanthropy.
The position was a serious change of pace for Hsieh, who spent most of her career in corporate America, but everything came to a screeching halt when her only sister suddenly passed away.
"That made me realize that I wanted to do something for the community and leverage all of my talents and all of my friends to make the world a better place, since she was no longer here," Hsieh said through tears. "So that was really important.”
Every year, a ceremony is held to induct a new class that is carefully selected for their lasting legacy and major contributions to society. This year, Dr. Linda Liau is one of the 10 inductees.
Dr. Liau is a deeply passionate University of California Los Angeles Health neurosurgeon who pioneered a brain cancer vaccine. She also holds the first Asian female chair of a major neurosurgery program.
"Every day is an opportunity for a new discovery, or a new sense of hope for our patients,” Dr. Liau said.
She is part of another minority as a physician scientist. That means Dr. Liau spends half of her time in the OR, removing brain tumors, and the other half is spent in a lab researching to find a cure for the cancer. “Quite frankly I think we need more of that because we really need to get the science to the patients," she said.
Dr. Liau is doing her part to encourage the next generation, training a class of residents she hopes will one day fill her shoes.
Hsieh said stories like hers are the crux of the Asian Hall of Fame because it is hard not to respect people like Dr. Liau when you hear how hard they are working to make a difference.
"Ultimately our goal is to overcome violence. Our goal is to overcome unconscious bias against Asians," she said. "We believe that with inter-racial respect and cross cultural narratives, we can create more understanding.”
As with music, humanity is a universal language if we just focus on what unites us rather than what divides us. To learn more about the Asian Hall of Fame, or to watch the ceremony, visit: https://www.asianhalloffame.org/.
In January 2015, Califf was appointed Deputy Commissioner of the United States Food and Drug Administration's Office of Medical Products and Tobacco, "second in scope only to being commissioner".[4][6] In February 2015, Califf was cited as a possible successor to Margaret Hamburg, the outgoing Commissioner of the Food and Drug Administration.[16] and in September 2015, President Barack Obama nominated him to be the next FDA commissioner.[1] In February 2016, the US Senate confirmed Califf as commissioner of the Food and Drug Administration by a vote of 89-4. Dr. Califf stepped down from the post of FDA commissioner on January 20, 2017.[2]
With regards to the 'Specials' license Is there a limit on the number of patients that can be treated under compassionate use or is it unlimited
abc1212,
IMO, it is not limited. I believe a “capacity plan” should be in place.
In the UK ATMPs may be manufactured under a UK ‘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.
ATMPs manufactured as ‘Specials’ must meet the expectation of 2003/94/EC [1] and Guidance Note 14 [2] and may be released by the Quality Controller (QC) of the manufacturing facility as opposed to the Qualified Person (QP).
[1] COMMISSION DIRECTIVE 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. 222-226 (2003)
We know quite a bit about what Advent has been doing, which isn’t necessarily to support our business.
MI Dendream,
I don’t agree. It’s a good thing that Advent Bioservices is working so hard to get the GMPc, MIA, MIA(IMP) and ‘Specials’ Licenses. The day the licenses to manufacture DCVax products at Sawston are issued by the UK Medicines and Health Products Regulatory Authority (“MHRA”)to Northwest Biotherapeutics contract manufacturer and operator of the facility, Advent BioServices, a legal and regulator-approved revenue machine can start.
Here is a reply from Richard Parker, Senior GMDP Inspector MHRA: Nov.1, 2021
Dear XXXXX
Thank you for your email.
You are correct that a facility manufacturing an ATMP must have a current GMP Certificate to manufacture either an IMP(material for clinical trials) or an MA product.
If the facility is in the UK or EU it must also hold either a Manufacture Import Authorisation MIA or a Manufacture Import Authorisation for Investigational Medicinal Products MIA(IMP) depending on what product is being manufactured. If in the UK the facility/company must apply to the MHRA for an MIA or MIA(IMP) and this process could take 90 days, during which time an inspection will also be carried out at the facility. Depending on the time taken to close out the inspection and issue the GMP certificate/s this may be longer than 90 days especially if there are any issues found at the inspection. This application can be made at the same time as the MA application so long as there is an intention to manufacture product at the manufacturing site. However, it should be noted that the processes are independent of one another and an MIA and or GMP Certificate must be in place for the manufacturing facility before the Marketing Authorisation can be granted.
If the facility performing the manufacture is outside of the UK but in the EU it is a the current time the responsibility of the competent authority in that country to carry out such an inspection and issue the manufacturing authorisations, which are recognised by the UK.
If the site is a third country then MHRA would carry out an inspection of that facility and issue a GMP Certificate only. The marketing authorisation applicant must highlight that this is the case so that an inspection can be arranged if required.
Further guidance and application forms can be found on our website:
As chair of the UCLA Department of Neurosurgery, Dr. Linda M. Liau is the first Asian-American woman, and only the second woman, to chair an academic neurosurgical department in the United States. #AsianExcellence #AsianFame2021
With her focus on helping patients combat glioblastoma, the most aggressive & lethal kind of brain tumor, she's the first person to have developed a vaccine for brain cancer.
Her innovative medical breakthroughs have saved the lives of many patients who have come from around the world for care. In 2018, Liau was elected by her peers to the National Academy of Medicine, one of the highest honors in the fields of health and medicine.
Her innovative medical breakthroughs have saved the lives of many patients who have come from around the world for care. In 2018, Liau was elected by her peers to the National Academy of Medicine, one of the highest honors in the fields of health and medicine.
"The official virtual Asian Hall of Fame 2021 Induction will livestream this Saturday, November 13, 2021 6:00 p.m. PST on the Asian Hall of Fame YouTube Channel that you can access from the Asian Hall of Fame website. I hope you will be able to watch."
Under Dr. Linda Liau’s picture was listed the reasons for her induction which included “Brain Cancer Vaccine Neurosurgeon”. What makes this important is that this is a very bold statement that the vaccine is efficacious because in the Asian community saving face is done at all costs which could not happen with a failed vaccine. This is a preemptive declaration by the Asian community that this vaccine is successful way beyond any reasonable doubt and that Dr. Linda Liau is owed the recognition she deserves for that at the right venue.
Doc logic,
I asked Asian Hall of Fame why Linda Liau was initially announced as a World- Renowned Neurosurgeon and very recently as a Brain Cancer Vaccine Neurosurgeon.
Here is the reply:
Nov.11, 2021 Good afternoon and thank you for reaching out to Asian Hall of Fame.
Dr. Linda Liau is a world-renowned neurosurgeon and a neuroscientist; her brain cancer vaccine is a specific highlight that is a proud accomplishment.
We also have limited space on our collateral and “world-renowned neurosurgeon and neuroscientist” did not fit the space. Thank you!
Advent Bioservices updated their current job openings. They no longer advertise the GMP Production Scientist position in both London and Sawston. Just Sawston. https://adventbio.peoplehr.net/JobBoard/
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.
Flipper44,
25 GMP Inspectors as of October 2021 Recently I had correspondence with 10 of them.
Inspector 1
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.
Inspector 2
Please note that I work part-time.
Inspector 3
I am currently on maternity leave and will not read your email.
Inspector 4
I am currently out the office on annual leave. I will have limited access to emails.
Inspector 5
Thank you for your email, I now work part time.
Inspector 6
Thanks for your enquiry. I have passed this on to our ATMP inspectors as I do not work in that area.
The quote creates confusion, a PAI is not applicable in the UK. To clarify here is a quote from Norman Gray, Senior GMP Inspector at MHRA.( https://ispe.org/people/norman-gray)
Nov.1 - email from Norman Gray: "MHRA do not perform pre-approval inspections as per the FDA".
I found an interesting paper about regulatory requirements in the GMP production of an epithelial cell graft for ocular surface reconstruction.
I think many of the regulatory requirements outlined in the manuscript apply to the Sawston Facility.
The Cells for Sight (CFS) Stem Cell Therapy Research Unit, based at UCL Institute of Ophthalmology, delivers somatic cell based and tissue-engineered therapies to patients suffering from blinding eye diseases at Moorfields Eye Hospital. The following manuscript is based on their experience in the conception, design, construction, validation and manufacturing within a GMP manufacturing facility based in the United Kingdom. The paper was written before BREXIT. However, the regulations and principles still have a broad relevance in and outside (EU) the UK.
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
They've only relatively recently advertised this position in both London and Sawston
I noticed that too. All other vacancies are for 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.
Trust me, the changes were made on the exact date you see on the Wayback Machine.
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.
Irish News
Irish celebs throw support behind mum-of-four with aggressive cancer
‘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.
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
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.
Today, National Brain Tumor Society published an article about ONC201.
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.
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
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.
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.
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#boardappointmenthttps://t.co/Hu9BTalUhc
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#boardappointmenthttps://t.co/Hu9BTalUhc
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
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.
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.
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.
EMA March 4, 2021
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
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/
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.
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/
April 26,
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/
June 25,
buginthebrain (Katy Gurney) DCVax #3 today and feeling hopeful
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/
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