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Anyone have up to date info on Kat?
ATLnsider,
Thanks for your efforts! Much appreciated! I agree that the slide from Dr. Liau's presentation is very telling.
10baggerz,
Thanks for sharing!
thermoo,
Thank you!
Wen Study:
A Randomized Double-Blind Placebo-Controlled Phase II Trial of Dendritic Cell Vaccine ICT-107 in Newly Diagnosed Patients with Glioblastoma.
https://clincancerres.aacrjournals.org/content/clincanres/25/19/5799.full.pdf
They need to hire people to be start the process to get GMP certified. That process can be a while.
I have the impression that the facility at Sawston is ready to start next month.
Advent BioServices in Cambridgeshire are recruiting two Lab Technician Apprentices
https://www.findapprenticeship.service.gov.uk/apprenticeship/-561247
The purpose of the Technician Scientist Apprentice is to support the batch manufacturing of the company’s commercial products, to support the delivery of Advanced Therapeutic Medicinal Products (ATMPs) as both ”Specials” and as Investigational Medicinal Products (IMPs).
Possible start date
11 Jan 2021
Date posted
01 Dec 2020
Closing date
17 Dec 2020
Positions
2 available
Just to let you know that the start of the treatment process has been delayed slightly due to the manufacturing company's need to schedule in some maintenance within their facility during December. It has now been rescheduled from December to start in January.
flipper44,
Good post! Thank you!
Why hide this?
To keep as much blind integrity as possible.
I know it’s common to talk anecdotally about success stories in the GBM trial, but the person who haunts my memory is a British patient (who was a stage actor) that bravely/humbly discussed entering this placebo controlled trial. Those of you who have been here for years will remember him.
2nd Annual Glioblastoma Drug Development Summit
December 8-10
Hear What Past Attendees Have Said
"The conference carried a great balance of topics from a scientific, clinical, and patient perspective. The organisation was excellent
in successfully delivering some great and diverse topics from eminent speakers."
- Northwest Biotherapeutics
I’m so sorry to hear this news:
“Lance Wood passed away at the age of 53 on Thursday, November 12, 2020, in Danville, Calif., following a six-year battle with Glioblastoma.”
https://www.legacy.com/us/obituaries/timesdispatch/name/lance-jon-wood-obituary?n=lance-jon-wood&pid=197141467
Lance Wood enrolled in the DCVax-L trial before his first surgery (Nov.2014). His baseline visit MRI after surgery revealed progression/ recurrence. He was crossed over to the compassionate arm at that time.
His personal blog – “Brain Cancer: Beating The Odds”.
https://www.facebook.com/beatingodds/
Despite the heaviness in our hearts due to the loss of our deeply loved husband and father, we are proud to know that Lance touched so many lives.
I struggle to find the words to express the magnitude of life that was our Lance! His confidence, laughter, and quick wit were his gifts to all of those that he loved.
During his courageous battle with GBM, Lance inspired so many. Fighting fiercely, he took GBM to war for six years, beating the odds, and far surpassing the 12-month life-expectancy.
I feel blessed and fortunate to have spent 27 years by his side. At 53 years of age, Lance is leaving this life with three beautiful children who are reflections of his life. They will continue his journey, allowing Lance’s legend never to die.
Melinda Kunz Wood
Bright Boy,
Thank You. Here is a picture:http://www.the-get.com/custom/upload/files/EStreet2.jpg
Left to Right: Les Goldman, MeiLi and Robert Hefner
ATLnsider,
Thank you! Excellent work! Here is the list of the External Studies that Linda Liau has listed in her presentation on Nov.6, 2020.
http://my.fit.edu/~bsubrahm/Liau_Talk_UAB_11062020.pdf
Study Gilbert 2013
Study Gilbert 2014
Study Stupp
Study Weller
Study Wen
Good post flipper44! Thank you! Same thought. For me it looks like all the puzzle pieces fall together. Especially after a member of the “Working Group” (FRIENDS OF CANCER RESEARCH) was so kind to address some of my queries about the use of an External Control Arm in a randomized control trial.
Link:White Papers
Publication Date
November 12, 2019
CHARACTERIZING THE USE OF EXTERNAL CONTROLS FOR AUGMENTING RANDOMIZED CONTROL ARMS AND CONFIRMING BENEFIT
https://friendsofcancerresearch.org/sites/default/files/Panel-1_External_Control_Arms2019AM_2.pdf
Interesting talk today about the use of an External Control Arm (ECA).
KOL Call on MDNA55 for the Treatment of Recurrent Glioblastoma (rGBM)
December 11, 2020, 11:00am EST
Incorporation of an ECA in a Planned rGBM Registration Trial
Amy McKee, M.D. VP, Regulatory Consulting Services
Parexel BIOTECH
Summary
First randomized hybrid control arm with an ECA component for a
registration trial inoncology
Trial design retains many elements preferred by FDA for a registration trial
? Large proportion of patients randomized
? OS endpoint
? All data elements required for ECA
Keys to FDA’s acceptance of trial design
? Significant unmet medical need
? No substantive change in SOC for rGBM over the time period
covered in the ECA
? Near-contemporaneous ECA by limiting to last 5 years
? Large effect size demonstrated in Phase 2b study
? Buy-in and, in fact, encouragement from FDA statistical
review group
Engaging a first class CRO was one of the last steps required
for initiating enrollment in the U.K. After an extensive RFP
process, the Company selected PAREXEL International. PAREXEL
is a leading international CRO with unparalleled expertise in
managing international clinical trials. Over the past 30
years, they have developed significant expertise in oncology,
including glioblastoma. Headquartered near Boston,
Massachusetts, they operate in 71 locations throughout 54 countries
around the world, and have over 14,000 employees.
I agree that the 99 would be sufficient. NWBO has no plans to include the 99 in the primary though, as Medicinna did when getting prospective approval from the FDA.
Medicenna Therapeutics, Corp. (NASDAQ: MDNA, TSX: MDNA), a clinical stage immunotherapy company, will use a hybrid external control arm in a phase 3 registrational trial in recurrent glioblastoma, an aggressive form of brain cancer. The hybrid external control arm will reduce the number of patients required to be assigned to the control therapy in the trial, will provide rigorous scientific data, and will enable speedier development of the product. The phase 2 single arm trial preceding this phase 3 study was also enhanced by a synthetic control arm and estimates of the treatment effects based on the synthetic control arm were part of the briefing information provided to the FDA for justification of the use in phase 3.
thermoo,
Thanks for the update!
Conference Day One Wednesday, December 9
IMMUNO-ONCOLOGY & THERAPY
10.20 AM
Linda Liau
Chair of Neurosurgery
UCLA
Optimize the Role of Immunotherapy for Treatment of
Glioblastoma
• Outline the historical and current understanding of the mechanisms of
immune responses against glioblastoma
• Discuss the common challenges of designing and evaluating clinical
trials of immunotherapy for glioblastoma
• Elucidate the considerations of timing, sequence, and tumor/patient
heterogeneity in developing combination immunotherapy/vaccine trials
for glioblastoma
10.50 AM
Fahar Merchant
President & CEO Medicenna Therapeutics
Ruthanna Davi
Vice President, Data Science
Acorn AI a Medidata company
MDNA55, an IL4-Guided Toxin in Recurrent GBM: Phase 2b
Results & Use of an External Control Arm in a Registration Trial
• Updated results from the Phase 2b clinical trial: results show improved 2-year survival rate and long-term tumor control (progression-free survival)
• Use of a propensity matched External Control Arm (ECA) demonstrates potential utility for go/no go decisions and reduces risk in a registration trial
• Presentation of a novel hybrid-design incorporating an ECA in a planned recurrent GBM registration trial
Ruthie Davi, PhD is a Statistician and Vice President, Data Science at Acorn AI, a Medidata company, and has a background in pharmaceutical clinical trials with more than 20 years working as a Statistical Reviewer, Team Leader, and Deputy Division Director in the Office of Biostatistics in the Center for Drug Evaluation and Research (CDER) at FDA. At Acorn AI, Ruthie is part of a team creating analytical tools to improve the efficiency and rigor of clinical trials, an example of which is the development of Synthetic Control Arms. Ruthie holds a Ph.D. in Biostatistics from George Washington University.
Sentiment,
Thanks for sharing the information. Much appreciated and all so logical!
Dr Bala,
Thank you for posting these slides!
Note: af few questions (and answers) about DCVax-L and Northwest Biotherapeutics at the end of the Q&A session.
Nghiemphu, Phioanh [Leia] M.D. 10:35 PM
please attend the 2 pm “Updates on Experimental Therapies” to learn about current trial for DCVax-L
Help Joel Live Longer.
Today:
Hello all,
Just to let you know that the start of the treatment process has been delayed slightly due to the manufacturing company's need to schedule in some maintenance within their facility during December. It has now been rescheduled from December to start in January.
Regards
Ian, Steph and Joel
Nov.2020
Louise McNamara is now in a new apheresis service design consultancy role for Advent Bioservices.
Greater Cambridge Shared Planning
Question 2. Please submit any sites for employment and housing you wish to suggest for allocation in the Local Plan. Provide as much information and supporting evidence as possible.
Form ID: 40341
Respondent: Carter Jonas
Agent: Carter Jonas
Site details (greatercambridgeplanning.org)
https://consultations.greatercambridgeplanning.org/form/40341#tab-40341-1
Site 40341 map (scambs.gov.uk)
https://gismaps.scambs.gov.uk/connect/analyst/mobile/#/main?mapcfg=HELAA_Public&queryTable=%2FNamedTables%2FHELAA%20Sites%20Final%2011082020&queryColumn=Jdi_number&queryValues=40341
Current and most recent land uses (greatercambridgeplanning.org)
Proposed future uses (greatercambridgeplanning.org)
Suitability – site features and constraints
(greatercambridgeplanning.org)
Availability (greatercambridgeplanning.org)
Deliverability (greatercambridgeplanning.org)
Viability (greatercambridgeplanning.org)
Supporting evidence (greatercambridgeplanning.org)
286 Aerial Red Line Boundary Plan.pdf (greatercambridgeplanning.org)
https://consultations.greatercambridgeplanning.org/download/attachmentform/3042
286 Concept Master Plan.pdf (greatercambridgeplanning.org)
https://consultations.greatercambridgeplanning.org/download/attachmentform/3043
286 Red Line Boundary Plan.pdf (greatercambridgeplanning.org)
https://consultations.greatercambridgeplanning.org/download/attachmentform/3044
Land to the north of Mill Lane, Sawston
Landscape and Visual Overview & Green Belt Assessment Prepared by CSA Environmental on behalf of Carter Jonas
4632_01_Landscape Overview_Redacted.pdf (greatercambridgeplanning.org)
https://consultations.greatercambridgeplanning.org/download/attachmentform/3045
Northwest Biotherapeutics – Advent Bioservices
LAND NORTH OF MILL LANE, SWASTON
OUR VISION
J0024088_NW Bio_Masterplan Vision_200224_Redacted.pdf (greatercambridgeplanning.org)
https://consultations.greatercambridgeplanning.org/download/attachmentform/3047
Local Plan Site Promotion SUBJECT Land at Mill Lane, Sawston – Transport Technical Note DATE 30 January 2020 CONFIDENTIALITY Public
Land at Mill Lane, Sawston_Transport Technical Note.pdf (greatercambridgeplanning.org)
https://consultations.greatercambridgeplanning.org/download/attachmentform/3048
Greater Cambridge Local Plan – Issues & Options Consultation Representations (February 2020) NW Bio – Mill Lane Site, Sawston
NW Bio - Greater Cambridge IO Response Final 20200224.PDF (greatercambridgeplanning.org)
https://consultations.greatercambridgeplanning.org/download/attachmentform/3049
Land North of Mill Lane, Sawston
DRAFT DEVELOPMENT SCHEDULE
225 Dwellings (exact mix to be determined)
Public Open Space 0.6BHa approx.(not including woodland)
Woodland 0.54Ha
Total site area 6.83Ha
NW Bio are promoting the Mill Lane Site, Sawston for the development of up to 225 residential dwellings, some of which could provide the essential housing for key employees of the Vision Centre. The need that NW Bio have identified for adequate nearby housing for personnel who must be “on call” for the Vision Centre (similar to doctors being “on call” for a hospital), and the fact that this need will be a significant factor in the pace at which NW Bio and Advent BioServices can hire personnel and grow the operations in the Vision Centre, clearly highlight the intrinsic links that there are between economic and housing growth in Greater Cambridge.
1.0 Who We Are
NW Bio is a biotech company developing novel therapies to mobilise a patient’s own immune system to treat a wide range of cancers more effectively than current treatments and without the toxic side effects of chemotherapy drugs. Our lead product, DCVax®-L, is just finishing the last stage of clinical trials (Phase III) treating patients with Glioblastoma brain cancer, the most common and lethal primary adult brain cancer. This trial was selected by the NIHR for its priority portfolio, and DCVax®-L was the first product to receive formal designation as a “Promising Innovative Medicine” from the UK Ministry of Health. We have treated over 20 diverse types of cancer in our clinical trials and compassionate use programs, and our aim is to enable our DCVax® immune therapies to become widely available to cancer patients.. The advanced manufacturing facility we and our partner Advent BioServices are developing in the Vision Centre on the former Spicers site will produce these immune therapies and other novel therapies for the UK, Europe and worldwide.
Advent BioServices provides advanced manufacturing services for healthcare companies developing innovative medicines, including personalised therapies made from a patient’s own immune cells to treat cancer, and therapies made from a patient’s own stem cells to treat other diseases. Advent is one of only a small number of companies worldwide who are experts in the highly specialised process/ technology development and advanced manufacturing of these living cell products. The demand for these specialised development and manufacturing services is growing at an enormous rate, as more and more of these therapies are entering clinical trials. Advent’s headquarters is located in the Vision Centre on the former Spicers site just across the A1301 roadway from the Mill Lane Site and the village of Sawston. Advent also has administrative offices in London and laboratory facilities at the Royal Free Hospital in London. Advent has already been staffing its headquarters and the advanced manufacturing and technology development facility in the Vision Centre with local talent from the surrounding area, and plans to continue doing so as the facility develops further. Advent is developing apprenticeship programs for a wide range of positions and skill levels, and has reached out to local schools in the Sawston area to further develop such programs together. Advent has also been recruiting at local career fairs and plans to continue doing so.
Up to 450 new jobs over a wide range of skill levels, from apprentices and school leavers through to PhDs and senior managers, will be created in the advanced manufacturing and technology development facility that NW Bio and Advent BioServices are developing in the Vision Centre (as described above). Hiring has already been under way for over a year, and will continue in phases over the next several years. A key factor that will affect the pace at which personnel can be hired for these jobs will be the availability of housing quite nearby to the Vision Centre. It is essential for a number of key personnel to live near the Vision Centre because tending to living cells and tissues for medical products often requires unpredictable and varied hours (e.g. when tumour tissue is delivered from a hospital in the evening). The Mill Lane Site, located just a 10 minute walk from the Vision Centre on the other side of the A1301 road, is ideal for the nearby housing that is essential. The employment opportunities created by the Vision Centre will have a significant positive impact on the local Sawston economy and wider South Cambridgeshire economy.
Kaizenman,
February 2020
link is now inactive.
Northwest Biotherapeutics (NW Bio) along with our partner, Advent Bioservices, is building one of the premier advanced manufacturing facilities in the world, in the Vision Centre on the former Spicers site. This facility will produce personalised immune cell therapies for cancer and other diseases, as well as regenerative medicine cell therapies. The development of the Vision Centre also includes large training facilities to provide specialised job training for this advanced manufacturing.
We hope that our presence in Cambridge will contribute to the local, regional and national economy and that our innovative technology can change the lives of cancer patients in the UK.
The Vision Centre
The Vision Centre in Sawston is fully operational and is currently being fitted out with three ‘cleanroom’ suites, to be used by NW Bio as well as by other organisations that work in advanced cell manufacturing. Once complete, the Vision Centre will play a crucial role in allowing life-saving treatments to reach patients across the rest of Europe.
Land North of Mill Lane
Northwest Biotherapeutics acquired a site to the east of our existing Vision Centre in Sawston, with one possibility being to develop this for housing, some of which could be utilised by staff at the Vision Centre. Due to the nature of advanced manufacturing, blood and biopsy samples can arrive at any time, meaning we must have staff in close proximity to ensure the safe delivery, storage and processing of sensitive materials.
We are promoting the site through the Greater Cambridge Local Plan process and will be consulting with the community. Our aspiration for the site is that it will enhance our offering at the Vision Centre and support the services and other commercial and public facilities already in Sawston.
Our vision for the site at Sawston is one of partnership and growth with the community in and around the village, with employment opportunities at the Vision Centre being an importantpart of the Sawston local economy going forward, just as Spicers was in the past.
When do you think large scale and efficient manufacturing needs to be considered when a therapy is being created by companies?
Dr. Marks: Simple: it is never too early. Best to contemplate the path toward scale up early on, as sometimes success in this space comes very quickly, and it is a shame when manufacturing scale up must hold a product back from reaching the market.
https://www.cellandgene.com/doc/dr-peter-marks-advancing-cell-and-gene-therapies-presentation-at-meeting-on-the-mesa-a-q-a-0001
Consultation: Greater Cambridge Local Plan Issues & Options 2020
The closing date for receipt of comments is 24 February 2020 at 5pm.
Question 24. How important do you think continuing economic growth is for the next Local Plan?
Form ID: 50599
Respondent: NW Bio and its UK subsidary Aracaris Capital Ltd
Agent: Carter Jonas
• Question 24
• Supporting information
How important do you think continuing economic growth is for the next Local Plan?
Very important
Please add any comments and ideas
Very important. Continued economic growth is vital for the next Local Plan in order ensuring that Greater Cambridge continues to be recognised as a centre for research and high technology employment, with the significant and varied employment opportunities that this creates for residents. The Mill Lane Site, Sawston is owned by Northwest Biotherapeutics (NW Bio), a biotechnology company developing novel immune therapies to treat cancer. NW Bio’s DCVax®-L immune therapy for Glioblastoma brain cancer is in the NIHR's Priority Portfolio and was the first product to receive PIM designation as a Promising Innovative Medicine by the Ministry of Health. NW Bio currently has offices in London but is planning to develop a head office in Sawston, where they are working together with Advent BioServices to develop the Vision Centre on the former Spicers site. Advent is one of only a small number of companies in the world that specializes in technology/process development and advanced manufacturing for cell and tissue therapies for cancer and other diseases. The Vision Centre is located across the A1301 (a 5 or 10 minute walk) from the proposed residential site on Mill Lane. The Vision Centre is an advanced manufacturing facility that will produce cell therapy products for the UK and for export to the European Union and worldwide. The development of the Vision Centre will involve the creation of up to 450 new high-value jobs across a wide range of skill levels in phases over the next few years. A key factor which will affect the pace at which personnel can be hired for these jobs will be the availability of housing nearby to the Vision Centre. A proportion of Vision Centre employees will have to live close to the site because producing and managing living cell products requires unpredictable and varied hours (e.g. when tissues are received from hospitals for processing at any time of the day or evening). The jobs at the Vision Centre will be for a range of employees, from school leavers through to PhD level, with a private apprenticeship programme also under development. This will result in increased employment and learning opportunities within Sawston and South Cambridgeshire as a whole which will have benefits for social inclusion. As a result of these requirements NW Bio are promoting the Mill Lane Site, Sawston for the development of up to 225 residential dwellings, some of which could provide the essential housing for key employees of the Vision Centre. The need that NW Bio have identified for adequate nearby housing for personnel who must be “on call” for the Vision Centre (similar to doctors being “on call” for a hospital), and the fact that this need will be a significant factor in the pace at which NW Bio and Advent BioServices can hire personnel and grow the operations in the Vision Centre, clearly highlight the intrinsic links that there are between economic and housing growth in Greater Cambridge.
https://consultations.greatercambridgeplanning.org/document/forms/37625/5
flipper44,
Thank you!
Mike Scott - Chief Operating Officer at Advent Bioservices.
9 hours ago:
"Congratulations to one of our fabulous colleagues who has been awarded a prestigious ISCT scholarship. Well done Alejandro!"
Congratulations to the 2021/ 2022 Awardees
ISCT is pleased to announce the awardees of the ISCT Europe Master Programme Scholarship to enroll in the 2021/2022 Master in Manufacturing of ATMPs at the University of Granada/ Andalusian Network for the design and translation of Advanced Therapies.
Specialization as Qualified Person:
Alejandro Barquero, MPharm, MSc
Advent Bioservices Ltd
Sawston, United Kingdom
Alejandro Barquero holds a Master of Pharmacy and an MSc in Advanced Therapies & Biotechnological Innovation. After working in the community pharmacy and research laboratories, he decided to step into the blooming ATMP industry, having a first rewarding experience working in QC for Catapult Cell & Gene Therapy. In 2019 Alejandro joined Advent Bioservices Ltd, biopharmaceutical CDMO specialized in ATMPs, where he has been working as part of the Quality Assurance team ever since.
At the time of completing this Master Degree programme with a specialization as Qualified Person, Alejandro looks forward to being in the position to meet the statutory requirements to assume a QP role within his organization and help in the development and commercialization of ATMPs.
https://isctglobal.org/page/EUScholarshipProgram2021
Perhaps you meant Cognate? nwbo owns no US manufacturing.
There are likely not many folks with mfg scale that would need this software yet in the US. Probably a pretty short list.
sentiment_stocks Thursday, 02/13/20
Poor Shenel (the girl on the right) was diagnosed with GBM, which LL removed. LL did the removal right before SNO last year.
She's so happy that it's been about 12 months since her surgery, with no sign of it coming back (yet). She said that LL had indicated she removed most of it. It was pretty small. She has two young children.
Anyhow, one knows that her odds of it not returning are pretty small, despite the almost complete removal of it.
So I take some comfort in thinking that perhaps the recurrent trial will be an option for her, should she need it.
Her message might benefit a few people here,
"Take that time for yourself, feel the sunshine on your face. Find joy, peach, and self love because you only live once."
shenellmalloy
Nov 17, 2020
shenell Malloy:
Throwing it back to a couple weeks ago when I was celebrating love and LIFE! This is my happy dance to show how grateful I am to live another day and receive the best news ever today....STABLE, no new tumor growth! All my hard work and dedication to health and wellness is working!!! This last year has been stressful and scary with everything going on in the world but I’ve tried my best to remain calm, hopeful and positive through the madness. So happy to get the reassurance today that my truth is and will continue be I AM HEALED! Thank you for all your love, good energy, and prayers being sent my way. Believe in miracles and yourself because I am walking proof of this power!
https://www.instagram.com/p/CHq4s2njiD5/
Thanksgiving is on my birthday this year, so any time before that day would be wonderful!
They recently appointed a US based director too https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159238850
Do you think there could be any ownership/financial links between LP and Autolomous?
CMS advises Autolomous on fundraising | Corporate M&A | United Kingdom | International law firm CMS
International law firm CMS has advised Autolomous, a developer of innovative software for cell and gene therapy manufacturers, on its seed funding round led by a US-European investor consortium.
The funding will enable Autolomous to build its capacity to meet rapidly increasing customer demands across Europe and the US, expand the functionality of its software solutions platform, AutoloMATE, and complete the establishment of its fully integrated ecosystem.
Theo Godfrey, Corporate partner at CMS UK, comments: “We are delighted to have successfully advised Autolomous on its first round of funding. It has been a great opportunity to work with an incredibly smart, ambitious and forward-looking team and we wish them the very best as they look to deploy this funding optimally. As a member of equIP Life Sciences, our accelerator programme focussed on start-ups in the life sciences sector, Autolomous will continue receive our support as the company develops.”
Alexander Seyf, CEO of Autolomous adds: “It has been a great pleasure to work with a top tier law firm like CMS, whose advice is often out of reach for start-ups. Theo and his team have been a great help to us. The CMS equIP Life Sciences Programme has allowed us to access lawyers who understand the needs of a start-up in the cell and gene therapy space and the scale of what we’re trying to achieve. With our legal foundations firmly in place, we can now concentrate on the commercial opportunities that will follow.”
https://www.companynewshq.com/company-news/legal-company-news/cms-advises-autolomous-on-fundraising-corporate-ma-united-kingdom-international-law-firm-cms/
AUTOLOMOUS.
10 months ago:
AUTOLOMOUS
Happy and Excited to announce that we have been working with Advent Bioservices on developing & deploying our AutoloMATE eBMR solution.
We look forward to continuing our partnership with Mike Scott and the Advent Team.
AUTOLOMOUS
Autolomous' 1st year in review:
1. Build a industry leading team.
2. Develop, validate and deploy the AutoloMATE-eBMR, 9 months.
3. Secure Clients, Academic x1, CDMO x1, Commercial Manufacturer x1 ( to be announced)
4. Build strategic partnerships, multiple PoCs in progress.
Boosting Capabilities in Gene and Cell Therapy Bioprocessing
By Vivienne Raper, PhD
November 17, 2020
A new company has been founded to supply software for managing cell & gene therapy manufacturing.
Autolomous, founded in February 2019, has already secured four different clients whom they hope to assist with digitizing and streamlining their workflows.
“There’s a gap around handling manufacturing data in cell and gene therapy manufacturing,” explains Kwok Pang, the company’s co-founder and COO. “So, what we’re doing is providing that missing piece of the puzzle to help drive efficiency across the supply chain.”
Autolomous will be presenting its technology at a “Dragons-Den”-style event at the 17th Annual bioProcessUK Conference 2020, taking place online in December. They claim their software provides an end-to-end view of the manufacturing workflow, which includes the status of manufacturing equipment, operators, the facility and the starting material which, for CAR-T products, is the blood obtained from patients at the point of care.
According to Pang, the AutoloMATE platform is the first to incorporate all these aspects of workflow within a single digital platform. “We believe that all aspects need to be accounted for to provide efficient, reliable, scalable manufacturing,” he says.
These management and quality assurance data can be communicated across the supply chain, Pang explains. The company has already integrated their software with equipment from Chemometec and Beckton Dickinson.
“Our major differentiator is that we have good connections to the industry, and we’re industry led in terms of responding to its future and current demands,” says Pang, who has 18 years’ experience working in advanced therapies.
His three co-founders (Alexander Seyf, Mark Lowdell and Alexis Blain) also have lengthy experience in either advanced therapies or using software solutions in non-life science industries.
Their aim is to simplify the vast amount of data produced during personalized therapy manufacturing, where a different product batch is needed for each patient.
“Prior to joining Autolomous, I worked at the UK’s Cell and Gene Therapy Catapult,” he says. “So, I saw first-hand the challenges of operating and scaling a manufacturing facility and managing its data.”
The company currently has customers in the U.K., the Netherlands, and the U.S. They expect to announce the identity of their U.S. collaborator later this month.
Survivor2012,
Thank you!
Just posted:
Joel Danziger : Treatment Update.
The start of the treatment process has been delayed slightly due to the manufacturing company's schedule. Its being rescheduled from December to the New Year.
Joel Danziger : Treatment Update.
It’s been a very difficult couple of months trying to weigh up the pros and cons of the different types of Dendritic Cell Vaccine treatments on offer, both here and in Germany. We’ve had detailed consultations with Professor Ashkan, at King’s College Hospital; with the Cambridge based bio tech company who manufacture the vaccine; and with IOZK, the German clinic who offer their version of the vaccine.
We’ve come to the conclusion that the UK based offer is the best option for Joel. This is in terms of minimising disruption to his university life as well as there being very promising results from recent clinical trials, in terms of prolonging life. The first stage of the manufacturing process has now started and Joel has a number of appointments with King’s College Hospital London starting in early December for the second stage of manufacturing.
This is all rather scary given that we haven’t raised all of the funds needed. But time is of the essence, whilst Joel is currently stable. So, we therefore need a further BIG push on the fundraising to be able to complete Joel’s treatment.
Thanks again for all of your support and please continue to help us to HelpJoelLiveLonger.
10baggerz,
Thank You!!
Facebook- Ian Runacres( Joel Danziger's dad)
Ian Runacres
September 11, 2019 ·
The most shocking thing that could happen to a parent. My son, Joel, has just been diagnosed with brain cancer. We were given the news yesterday, following the removal of a tumour, last week. Joel will soon be starting lengthy chemo and radio therapy, to try to keep the cancer at bay. Today, Joel has set up a Just Giving page, for the Teenage Cancer Trust. There's a branch at the Christie Hospital, where he will be attending. If you'd like to help, then this is a nice way of showing it.
https://www.justgiving.com/fundraising/joel-danziger?fbclid=IwAR3SQSQPpqK_Nss-Vw1pIHxaL9woam5Nx1AUnbJgm0g9Q25mob97P38Psd8
Ian Runacres
May 3, 2020
I’m conscious that I haven’t posted an update about Joel’s brain cancer for a while and I know that some people feel a bit awkward about asking. Also, Joel is quite private about it all, so I don’t like to keep going on about it on social media, too much, however I thought a quick update might be appreciated. Joel is currently on his last round of 6 months of chemotherapy, plus he’s self injecting a daily immune boosting drug, as a covid19 precaution. The current debate is whether to continue for another 6 months with the chemo, as his compromised immunity is a big issue with covid19, plus the chemo is only about 20% effective anyway. Joel is keen to carry on, though. We’ve also been exploring what might come next, as the treatment he’s had to date is effectively only palliative. The most promising treatment is called Dentritic Cell Vaccine. Basically it’s a personalised cancer killing vaccine is made from residual tumour. There is some evidence that it prolongs life, (years, but not decades). So, we’re trying to find out if there’s enough of Joel’s tumour left, following the NHS histology and, if so, whether it’s been frozen properly. Even then the cost is jaw-droppingly expensive. Something like £200k to £250k, it seems. So, we have quite a bit to consider, even if it’s possible. Hopefully we should find out over the forthcoming weeks. In the meantime Joel worries that each headache is an indication of the tumour growing back, which is very scary for him. Having said that, he’s reconfirmed his place at Kings to do English, this autumn and has his accommodation secured. I just hope he can make it and I hope that lockdown restrictions don’t jeopardise his plans. Until then, we’ll keep wandering along the Mersey, as you can see.
Ian Runacres
August 13, 2020
It's now almost a year since my son Joel was diagnosed with Glioblastoma - the most lethal of all brain cancers. Life expectancy is only 18 months on average. Almost no one survives beyond five years.
The NHS have been absolutely amazing over the last year and Joel has had surgery to remove as much of of the tumour as possible. This was followed by intensive radiotherapy, chemotherapy and immunotherapy. The NHS have continued Joel's treatment all through the covid restrictions, but it is now all concluded and was only really palliative anyway.
We've done loads of research and the only proactive treatment recommended by leading oncologists and neurosurgeons is called Dendritic Cell Vaccine. This is a personalised cancer killing vaccine manufactured from your own residual tumour tissue. Trials have shown positive efficacy in prolonging life. But, it is prohibitively expensive at around £400,000.
We are therefore trying to raise the funds ourselves. If you are able to donate please do so via Joel's Go Fund Me page:
http://gofundme.com/helpjoellivelonger
please post the replay or transcript of the 11/18 @ 8 am Cognate meeting with EDGE. thanks.,
“We work with innovative companies that develop technologies to take living cell tissue from patients and change those in a way to treat a disease,” Will James said.
“We might take living tissue and genetically modify it to better fight cancer,” he said during the online meeting. Or, he said, “It might involve taking white blood cells in a tumor and multiplying those and returning them to the patient to better fight cancer.”
AN INTERVIEW WITH J. KELLY GANJEI, CEO AND CHAIRMAN OF THE BOARD, COGNATE BIOSERVICES, INC
NICOLA AMBLER AUG.14, 2018
What is the one thing you’d recommend clients do when evaluating a CMO partner?
Having been on the other side of the table, as a company in development, I would evaluate, in person, what efforts are being made to address commercialization and try to understand the mindset of those who are responsible for making and releasing your product. Developing, and maintaining a commercial mindset is not easy to achieve, and is highly critical, especially in context with the rapid development cycles we’re witnessing today. Products must be manufactured with a higher level of compliance at earlier stages and elements like simplicity, closed systems, modular automation and validation are more important earlier on. If you’re going to develop a product with a CMO that doesn’t have a commercial mindset, you’re most likely going to have to go back to the drawing board when you’re seeking FDA approval. To summarize, face to face relationships are critical.
https://www.phacilitate.co.uk/article/preparing-commercialisation-right-cdmo