Nelum Panditharatna

Trainee Production Scientist

Company Name: Advent Bioservices Full-time
Dates Employed :Mar 2021
Location: Cambridgeshire, England, United Kingdom
https://www.linkedin.com/in/nelump/

Mike Scott
Chief Operating Officer at Advent Bioservices & Visiting Professor, Anglia Ruskin University

22 hours ago

We are hiring!

Join our progressive, friendly and expanding team in Cambridge.

1. QA Officer
2. QC material specialist
3. Laboratory Systems Administrator

https://adventbio.peoplehr.net/JobBoard/

It is worth pointing out that if early-stage research is not funded, there will be nothing coming out at the other end of the pipeline, and currently we are not allocating available money effectively. Just 25% of the NIHR £40 million, which was announced following the sad passing of Dame Tessa Jowell, has so far been committed to brain tumour research. Brain tumour sufferers just do not have the luxury of time. Even after significant attention has been given to the brain tumour and brain cancer space, it is still the case that brain tumours kill more children and people under 40 than any other cancers.

The potential for significant improvement to survival rates is very real. New methods of treating brain tumours are being developed, but it is a very difficult and tricky pathway. Proper Government focus and targeted funding into brain tumour research will accelerate the discovery of effective treatment. Not only would that give thousands of families real hope and reduce mortality rates, but it will also support UK plc as a world leader in this, as will the other areas of research and development raised during the debate.

forumreader35 Thursday, 04/11/19 09:21:53 AM
Re: None 0
Post #
222208
of 300388

Select Novel Approaches to Glioblastoma—Part 2
Published in Oncology and Expert Opinion / Interview · April 10, 2019

Interview with
Steven Brem MD
Interview by
Aman Shah MD

https://www.practiceupdate.com/content/select-novel-approaches-to-glioblastoma-part-2/76518

Dr. Shah: So, we spoke earlier in part one of this program about some of the new research that you’re doing with DNA vaccines and conjugates with Pseudomonas toxin. Could you tell us some other interesting research you’re doing on novel therapies in neuro-oncology?

Dr. Brem: Yes. We just completed a study with Tocagen, which is a viral therapy, which will also stimulate the immune response and also uses a novel form of chemotherapy where it takes an antifungal drug that is converted genetically to an oncolytic drug. So it’s a very clever approach, and that’s a large multi-center study and that’s being analyzed right now. And we learned at this meeting that their plans to roll out a new trial through the NRG for newly diagnosed using viral therapy and we’ve heard of the poliovirus, we’ve heard of the many viral studies coming from multiple centers in Boston, Houston, and so on, and about viral therapy. And whatever the virus is, they all are oncolytic. They kill the new glioma cell, liberate new antigens, or neoantigens, which are then recognized by antigen presenting cells.


We’ve also been very active in the DCVax, which was started at UCLA but now extended to Penn and other sites. And the interesting thing of that trial, which we reported some preliminary data, is that a large percentage of the patients are now living beyond 3 years, so that is a unique approach in that the patients own tumor creates their very individual vaccine looking at their own panel of antigens. So we’re excited by that approach and we’ll be hearing more about that in the future.

Dr. Shah: Okay, so my understanding of the DCVax is that you have to take the tissue out and then generate something against the dendritic cells within that admixture.

Dr. Brem: Yes.

Dr. Shah: Could you tell us a little bit more about where that therapy stands as of now and what kind of efficacy we're getting?

Dr. Brem: Well, a very large multi-national study was concluded and so that is going to…as the data matures, that will be going to FDA. We hope that that gets approved. We don’t know, but it’s an exciting study.

Dr. Shah: Okay, so talking about getting tumor cells out and generating something against it. It seems that you are also either working on or are involved with CAR T cells in glioblastomas, so please walk us through how that works.

Dr. Brem: Well, that is an exciting effort. It’s being led at the Abramson Cancer Center by Donald O’Rourke and his team, Zed Binder. I’m involved in that group, and it has just been funded by the Abramson Cancer Center as a translational center of excellence, so there’s a huge effort underway with neurosurgery and the Parker Institute, Abramson Cancer Center, Carl June’s Laboratory, many other laboratories trying to develop the next generation of CAR T cell. So we are…we just published a first-in-man phase I human trial that showed biological activity. And now because we’re dealing with a tough foe, the glioblastoma, we’re working on potentiating this by taking down some of the tumor defenses, looking at checkpoint inhibitors, combining it, supercharging the CAR T cell vaccine in a combination therapy, so that will be the next generation. That’s the future.

Dr. Shah: So, my understanding is that perhaps part of the reason why PD-1s have not been as promising in glioblastomas is glioblastomas somehow seem to not be very rich in T cells when you sample them, so there’s something stopping them.

Dr. Brem: There’s stromal barrier and there are inhibitors like TGF-ß, IL-6, the TNF-a, there’s cytokines. Also, we’ve been very interested in looking at macrophage polarization. And I’m part of a group that published this year in Nature Communications led by Yi Fan, who presented at this meeting, showing that if you block IL-6, you could redirect the macrophage from a tumor-suppressing state, the M2 state, to the M1 immunostimulatory state, so we hope to partner with pharma on that and develop the clinical trials based on that discovery.

Dr. Shah: That is fascinating, and of course, the CAR T cell strategy makes perfect sense because you create them in vitro and then put them in.

Dr. Brem: Yeah, so ultimately, we feel by attacking the tumor microenvironment as well as creating a vaccine directed to the antigens on the tumor, we’re going to have really a new class of therapy.

The closed system provides consistent yields and requires only three hours of technician time during the week-long process (see figure). MicroDEN leverages the benefits of a polystyrene culture surface, similar to the manual method, to provide for removal of non-adherent cells. Up to 25 million DCs can be reproducibly generated per unit, an equivalent or greater yield than manual production.

So your saying the flaskworks device takes about 7 days to produce one vaccine? In how much space?

What % of the time to make the vaccine does the flaskworks device represent? I assume there are other steps?

About how long does it take to make the vaccine once advent has the resected tumor?

The current gold-standard method for generating DCs from monocytes has 11 laborious manual steps involving 15 hours of technician time. Steps include static culture and stimulation with cytokines contained in culture media using multiple T-flasks or well plates.

To address this manufacturing dilemma, market-leading Corning entered into an agreement with Flaskworks to commercialize MicroDEN, an automated fluidic system that allows for differentiation of monocytes into DCs utilizing continuous perfusion of differentiation media.

“Using an automated, perfusion-based process such as MicroDEN for dendritic cell production eliminates six manual steps, reduces the risk of contamination, and efficiently produces repeatable results in less time,” said Elizabeth Misleh, senior product line manager, bioprocess, at Corning Life Sciences. “It also eliminates the variability that can result from different levels of technician proficiency.”

The closed system provides consistent yields and requires only three hours of technician time during the week-long process (see figure). MicroDEN leverages the benefits of a polystyrene culture surface, similar to the manual method, to provide for removal of non-adherent cells. Up to 25 million DCs can be reproducibly generated per unit, an equivalent or greater yield than manual production.

Where are you finding this information?

About This Project
Problem

Due to the rise of personalized therapies, the demand for Dendritic cells has increased. However, the process for generating Dendritic cells has remained laborious, error-prone, and time intensive.

Solution

Flaskworks has produced a device, MicroDen, that revolutionizes the process. MicroDen is compact, easy-to-use, efficient, affordable, and 10x more productive than current methods and devices.

Leadership

President & CEO

Jennifer Rossi

Founder

Shashi Murthy

Nicola Nuttall

Just to update you, we had a meeting with Mr D'Urso, Laura's new Neuro-oncologist in Manchester this evening.
Her new scans were discussed in the MDT meeting by the finest medical minds and the consensus was...they don't actually know what the scan is showing.
Apparently the Multi Disciplinary Team don't often see people with GBM doing so well, 28 months after diagnosis and so we're in unchartered waters now really.
It's looking less likely to be a meningioma, could be inflammation as it's close to the original surgery site or it could be another tumour. Theoretically, it doesn't look like a glioma (but it didn't last time either so we're taking that with a pinch of salt!)
So we have 3 options; we can wait to see if it grows any bigger, Mr D'Urso could do a biopsy or he could just operate to remove it (both would involve fairly similar surgeries with the same elements of risks.)
It won't be 'till the pathology is reviewed that we will know what we're actually dealing with and what other treatment might be required.
Laura's leaning towards having it removed sooner rather than later so we'll keep you updated with the plan going forward.
Thanks for all the messages of support, we really do appreciate it x

In the first year of Project Orbis (June 2019 to June 2020), a total of 60 oncology marketing applications were received, representing 16 unique projects, and resulting in 38 approvals. New molecular entities, also known as new active substances, comprised 28% of the received marketing applications.

I'm of the belief that NWBO can approach the FDA to be considered in these programs, but it's up to the FDA to agree. I would suspect that the company may not yet know if they've been selected. I would think they would announce it if they were in the programs.

FDA RTOR combined with Project Orbis would be the best, most efficient & expedient path forward for DCVax-L approval in the US, UK, Canada & Germany.

I believe & hope that this is the pathway that NWBio has chosen.

Regulatory Perspective on Cancer Drug Development in a Global Setting

R. Angelo de Claro (FDA, USA)

Even during the COVID-19 pandemic, FDA Oncology Center of Excellence (OCE) has remained highly active on several initiatives consistent with its mission to advance patient-centred regulatory decision-making through innovation and collaboration. Project Orbis, a global collaborative program launched in 2019, reported 38 approvals in its first year. Current Project Orbis partners include the regulatory health authorities of Australia, Brazil, Canada, Singapore, Switzerland, and the United Kingdom. FDA OCE reported the initial experience with the Real Time Oncology Review (RTOR) program which facilitates earlier submission of datasets to support an earlier start to the FDA application review. The median approval time was 3.3 months (range 0.4-5.9 months) for the initial set of 20 marketing applications that used RTOR (February 2018 to April 2020). Other regulatory achievements include the issuance of 17 guidance in 2020 on many aspects of oncology drug development, including the broadening of eligibility criteria for cancer clinical trials. Patient-centred efforts include Project Community which introduces the work of the FDA to underserved communities and Project Facilitate which is a single point of contact call centre to health care providers through the expanded access request process. To facilitate interactions across multiple programs, OCE switched to virtual platforms to continue the attention on cancer drug development and to assure patients with cancer that they have not been forgotten.
https://cddf.org/wp-content/uploads/2021/03/2021-CDDF-Spring-Conference-Report_Final.pdf

Kwok Pang
Chief Operating Officer at Autolomous
3 hours ago

Very proud that the Autolomous team has demonstrated our ability to deliver an "end-to-end" integration strategy. 8 integrations in 18months, across the entire manufacturing value stream, together with the development of #AutoloMATE-CLOCK and AutoloMATE-Assist, Autolomous will empower CGT manufacturers to safely scale advanced therapy manufacturing while maintaining control and increasing transparency.

We have more #innovative integrations in development to address unique #CGT challenges we have identified with our clients, towards our joint mission to scale manufacturing and drive down costs of goods.

Autolomous
3 hours ago

Autolomous has created its 1st integration with a #LIMS platform, samples (IPC, EPC, Final Product) can now be created in #AutoloMATE and processed in LabWare LIMS. Results can be automatically pass back into AutoloMATE-eBMR , reducing risk of transcription errors , increasing both efficiency and data integrity.

The integration can be expanded to cover material & consumable management and sample/ drug product storage management, linking the eBMR with both warehouse and QC activities.

>>The drug works by binding to mature amyloid plaques and dissolving them. The loose amyloid beta proteins are then removed from the brain through the blood vessels.

"When amyloid protein is removed from the brain through the blood vessels, it has to pass the blood-brain barrier, and that can cause a leakage in the barrier," Apostolova

https://www.newsmax.com/t/newsmax/article/1013680/16

Eli Lilly releases detailed results on Alzheimer’s drug, as data divide researchers.

By Matthew Herper and Adam Feuerstein March 13, 2021

Orig. Dx 06/2008 grade 2 Oligo- Astrocytoma

Recurrence in 2010 grade 3 Anaplastic Astrocytoma. 33 treatments of radiotherapy, then watch and wait. Good up til Halloween 2019. then progression to GBM. Crani’s 3&4 the next two days, then another round of 30 radiotherapy treatments along with 30 days of temodar followed by 7 shunt related surgeries in 2020 while watching and waiting.

Nov. ‘20 mri suggested recurrence and dec’20 scan confirmed. Offered Avastin or hospice. Chose hospice at the time while also reaching out to Dr. Liau @UCLAJCCC for any possible help. After 3 days in and an email sent to @UCLAJCCC i received as call from the aamazing @SDGNP and began the recruitment process for the trial. Next thing I knew, I was headed to California son Jan. 10th to enroll and begin the pre trial requirements. Luckily, I was a good fit and performed well senough to be included in this phase one double blinded trial that guaranteed me the @DCVAX_L and either the drug, pembrolizumab, or a placebo.

I have now had 3 infusions of the pembrolizumab/placebo snd 2 of 3 rounds of the personalized dendritic cell evaccine.I have had little to no reaction to the infusions or the vaccine shots outside of extreme fatigue. I return to UCDLA for my final round of shots of the Cancer vaccine on the 25th.I should be starting Avastin infusions locally next week and i received my 2nd Phizer Covid shot on Friday the 19th.

After all of this is taken care of, we will be working with Dr. Liau to determine next steps for the trial. There is the possibility that she will recommend pulling me out of the trial and prescribe the trial drug, pembrolizumab to me off label. I have complete trust and faith in Dr. Liau and will follow her recs.

From here on out, If the going gets tough and the side effects become unbearable, i know right where I need to be. For right now, I am lying next to our soon to be 9 yr. old ( 1 more hr) lol and am looking forward to celebrating her birthday all day tomorrow along with Cammie, Ashton, and Claire. Thank you all again for the continued love & support. It’s what keeps me going and gives me hope of a cure In the not too distant future. Love always - Matt

GHK Companies - https://ghkco.com/

Anyone know anything about these guys? They list NWBO as an investment and their description of NWBO seems recent.

Bright Boy Friday, 12/11/20 02:38:25 PM
Re: Papa9x post# 338390
Post # 338421

I really appreciate your comments. Means a lot to me to think that I've made a small contribution to the world we live in. AND you and I are definitely on the same page in knowing that encouragement and recognition are the fundamental, creative energies that make the world a better place.When in China in the mid 80's with my friend and partner, Robert A. Hefner III, I witnessed his efforts in advising Deng Xiaoping in exploration and development, transportation, distribution and marketing of China's natural resources(mainly oil and natural gas)and most importantly encouraged Deng to unleash cottage industries throughout China which when implemented was the foundation for capitalism , changing China forever. So yes, I understand and appreciate the power of encouragement and the way that it helps all of us "believe that we are respected for our contributing capabilities and important to the process!!" So thank you and I will seriously consider the book and if I write it, I'll ask you to personally review before I submit it to any publisher. And, by the way , Les Goldman is and has been a great friend of ours and a tremendous supporter of Robert's during the early years of developing the domestic natural gas industry and all the hurdles that he faced in Wash. DC as he fought to develop the Natural Gas Policy Act providing clean and affordable energy to America while Big Oil did everything within their power to suppress and deny that opportunity. So this ain't Les or Robert's first rodeo with Northwest and their championing a new technology that WILL change the world forever and for the better !!! Cheers and have a great weekend. And none of us need worry about the success of Northwest!!! We are in very experienced and great hands!!!!


Bright Boy Sunday, 12/13/20 10:53:39 AM
Re: Evaluate post# 338691
Post # 338787

Robert has been an investor and supporter of Team Northwest for a number of years. He's not officially involved with the company, but when asked, he's been willing to share his experiences to further the work that Les and Linda are doing. He believes in the technology and the positive impact on humankind. Through Robert and others involved, Northwest and DCVax-L are discussed at the highest and most influential levels in the world. Having been in the "David and Goliath" scenario more than once in his career, he realizes the importance of understanding that "right is not might"!!! "Ego does not drive"!!"No room for arrogance"!!! and "The Art of Compromise" is a very valuable tool !!! One of the best descriptions of Robert can be found in his book,"The GET". If you google Robert, you'll find a link to "The Get". IT's worth a quick read and one of the most important takeaways is that in ,many cases throughout history, if we had listened to the simple and yet brilliant suggestions/concepts of some of the brightest and best instead of believing the critics from on high, we would be light years ahead in advancing civilization through peaceful means and as it relates to Robert's intellect and commitment to a hydrogen based economy, chances are we might already be there!!! Thank you for your question and I hope my answer helps. Cheers, BB

Bright Boy Sunday, 12/13/20 01:32:16 PM
Re: Sojourner55 post# 338818
Post # 338829

Beautifully stated!!! AND one of Robert's favorite quotes is Winston Churchill's ,"The positive thinker sees the invisible, feels the intangible and achieves the impossible "

Bright Boy Friday, 03/12/21 05:27:28 PM
Re: Papa9x post# 361516
Post # 361533

OMG, after a compliment like that from Dr. Bala, I'm going to have to runout a buy a new cowboy hat at least a couple of sizes bigger!!! That's what I/we love about this board !!! So many very, very intelligent contributors!! And when we receive a compliment, it's like receiving an A+ from the toughest professor at every college in the world!!! And yes, my family and the Hefner family have been involved in some very exciting, world changing, breakthrough technologies over the last 121 years !!!! Robert Hefner III is one of the great visionaries of our time, of any time for that matter. He is and has been an advisor to many world leaders on subjects ranging from energy to our microbial world that encompasses most of the phylogenetic diversity on Earth. Robert has been involved with Northwest for a number of years and is very close to the leadership team AND very knowledgeable with regard to the technology as well as the skill sets of the leadership team. To have Robert involved as a significant investor should give everyone a great deal of confidence in Northwest and DCVax-L and should likewise create a lot of speculation/excitement among our board as to how many world leaders, world business executives...... that he has shared the potentials for DCVax-L and DCVax Direct !!! Robert is honest, straightforward and a man of his word!!! I'll bet we've done a hundred deals in our lifetime without signing a single "commitment document" as Robert is the personification of the belief that"If your word's no good, your paper isn't either!!" Oh, almost forgot, Robert's father was in the same fraternity at Stanford that I was a member during my time at Stanford, DU, loving referred to as Delta Palm Tree !!!

Among the more notable investments are what we believe to be a revolutionary BioTech company finalizing a Phase III trial for personalized vaccines for one of the most lethal forms of cancer, glioblastoma, by using cells of the patients.

Current Investees & Partners

Northwest Biotherapeutics, Inc. A leading BioTech Pioneer in the development of personalized immunotherapy vaccines for solid tumor cancers. As of October 5, 2020, NWBO locked down all data for its 331 patient, four country, 14-year long Phase III trial of its flagship vaccine, DCVax-L, for glioblastoma patients. More recently, the company acquired from Corning Incorporated a breakthrough new technology, Flaskworks, that NWBO believes will scale up the capacity and lower production costs of its vaccines. The build out of its UK manufacturing facility should be completed in the coming months. www.nwbio.com

Hi everybody it’s Matt here. I don’t post on Facebook often, as I don’t want to inundate everyone with too much info. Well, i just want to keep everyone updated from my perspective and I feel that I owe it to everybody for all the support, texts, emails, phone calls, and cards. I want everyone to know it is truly amazing and it ifts my spirits and it encourages me to keep pushing and to keep fighting, especially for ashton, Claire, and Mara. That’s why I want to just give you a quick update to let you know how it’s going and where we go from here. Today I had my second round of the DC VAX dendritic cell vaccine that will hopefully train my good cells to attack and kill the cancer cells in my brain and around my brain stem.i am currently in observation for another hour before I can be released. I hope to enjoy a late lunch with my mom and dad and hopefully meet up with my good friend Randy. We will then catch a 7 AM flight out of LAX to return home. Before this trial started, I promised my baby girl, Mara, that no matter what I would be home for her birthday. She turns nine on Sunday. I cannot wait to see her, tickle her, and cuddle with her. I believe Cammie will appreciate any small break that I can give her and rightfully so!This little French horn playing mama of 5, if you include me and Lucy, Is a force to be reckoned with. I love you dearly Cammie. In the meantime, I will hopefully be starting Avastin Infusions in Rockford next week. These infusions will happen every two weeks-for as long as I can handle the side effects. Avastin isn't chemotherapy but is a monoclonal antibody manufactured in a lab that prevents development of new blood vessels, including ones that are feeding the cancerous tumor. I am still in the mindset that I’m not going to accept What has historically been the fate of those diagnosed with glioblastoma. Although I will likely succumb to this unrelenting disease, I will die knowing that I loved my family with all my heart and that Dr. Liau and her team at UCLA are one patient closer to finding the cure. Bye for now- With all my love - Matt

Matt returned to Cali yesterday and he has had a handful of appts today along with his infusion.
Our family just finished a zoom appt with Dr Liau. She said that the symptoms that sent Matt to ER March 1st/2nd could have been caused by response to cancer vaccine, which could mean that the vaccine is doing its job. MRI shows more"enhancement" but Dr. can't say if it's tumor growth, inflammation, infection, or scar tissue. All of these things look the same in an MRI. The next MRI isn't scheduled until April and even that one might be too soon to differentiate. If the vaccine is working, it is common to have increased swelling. Swelling will likely continue to increase with each vaccine and should eventually improve over time. Dr. Liau said the main goal right now is to treat symptoms. He will start Avastin infusions to help reduce swelling and prevent tumor growth. Matt appears to be having focal seizures. Dr recommended increasing anti-seizure med for prevention. They had one trial participant contract Covid so she is urging extreme caution because fighting Covid and the immune response caused by the cancer vaccine would be a lot for his body to handle.

There no recording if you click the link

Anonymous Attendee 10:23 PM
Can you discuss where you are with DCVax? Wasn't this invented and developed at UCLA?

Nghiemphu, Phioanh [Leia] M.D. 10:31 PM
Please see recordings of Part 1 of our conference at https://www.uclahealth.org/braintumor/patient-education

Al Musella 11:34 PM
Why do so many phase 3 trials fail after having success in phase 2?

Nghiemphu, Phioanh [Leia] M.D. 11:59 PM
There are inherent bias when enrolling in patients in small phase 2 trials, which is why therapies are usually not approved unless show efficacy in phase 3.

Brad Silver 12:30 AM
When was chemo changes from 21/7 for 2 years to 5/23 for 1 year?

Nghiemphu, Phioanh [Leia] M.D. 12:40 AM
This may have been addressed in part 1 of our conference. We never really used 21/7 dosing.

Brad Silver 12:31 AM
Does UCLA suggest clinical trials elsewhere for patients?

Nghiemphu, Phioanh [Leia] M.D. 12:40 AM
As best as we can but there are thousands out there and we usually refer patients to clinicaltrials.gov website.

Anonymous Attendee 12:47 AM
I have a few questions about this trial at UCLA: Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma
This trial with Merck’s Keytruda coupled with DC VAX L has been ongoing for about 14 months.
How many patients are enrolled to date?
Is there radiation or chemotherapy (temozolomide or avastin to help reduce swelling and prevent tumor growth)?
What has UCLA learned from this trial to date?
Can someone from the UK participate in this trial?
Why is the name of the vaccine “ATL-DC vaccine” and not DCVax-L? Are both generic the same?

Nghiemphu, Phioanh [Leia] M.D. 12:54 AM
As long as a patient can come to UCLA to have surgery for tumor resection and come to UCLA every 6 weeks for pembrolizumab or placebo infusion, they can be enrolled into this trial. It is ongoing and we are still enrolling patients. We do not have results as it is still too early. The vaccine names are different but it is the same vaccine.

Anonymous Attendee 12:54 AM
Are you aware of changing endpoints over the course of a clinical brain tumour trial here at UCLA? And must the participant be informed about a changed endpoint?

Nghiemphu, Phioanh [Leia] M.D. 12:57 AM
Most of our current trials do not always change endpoints. Participants would be informed if there are procedural changes to the trial because of the changed endpoints.

Anonymous Attendee 01:13 AM
As part of an industry-wide review, the FDA persuaded PD-1/L1 players Merck & Co., Bristol Myers Squibb, Roche and AstraZeneca to remove four indications on the labels of cancer drugs, after the failure of post-marketing studies.
The expert panel will discuss data on three indications for Merck’s Keytruda, two for Roche’s Tecentriq and one for Bristol Myers’ Opdivo.

Is that an issue for the ongoing combo trial keytruda and dcvax-l?

Nghiemphu, Phioanh [Leia] M.D. 01:19 AM
these treatments are supported by the clinical trial and not affected by the FDA panel which have to do with FDA provisional approvals. Neither vaccine nor pembrolizumab are indicated for brain cancer.

Apr 9 2021 12:05AM
SY22.OD. Progress from Personalized Cancer Vaccine Trials
On Demand

Link to register for below zoom meeting is within the attachment:-

Biomedical Engineering Seminar - Linda M. Liau FRIDAY, APRIL 9, 2021, 11:45AM – 2PM

https://www.bme.utah.edu/calendar/?trumbaEmbed=view%3Devent%26eventid%3D147261822

Nicola Nuttall:

Scan shows Laura has a new tumour. Possibly a meningioma (brain lining) Could be benign but we won't know till next weeks MDT meeting. Chances are she’s going to need another brain surgery though. Thanks for all the support, it means so much to us.

Regulatory Perspective on Cancer Drug Development in a Global Setting.
R. Angelo de Claro (FDA, USA)

Even during the COVID-19 pandemic, FDA Oncology Center of Excellence (OCE) has remained highly active on several initiatives consistent with its mission to advance patient-centred regulatory decision-making through innovation and collaboration. Project Orbis, a global collaborative program launched in 2019, reported 38 approvals in its first year. Current Project Orbis partners include the regulatory health authorities of Australia, Brazil, Canada, Singapore, Switzerland, and the United Kingdom. FDA OCE reported the initial experience with the Real Time Oncology Review (RTOR) program which facilitates earlier submission of datasets to support an earlier start to the FDA application review. The median approval time was 3.3 months (range 0.4-5.9 months) for the initial set of 20 marketing applications that used RTOR (February 2018 to April 2020).
Other regulatory achievements include the issuance of 17 guidance in 2020 on many aspects of oncology drug development, including the broadening of eligibility criteria for cancer clinical trials. Patient-centred efforts include Project Community which introduces the work of the FDA to underserved communities and Project Facilitate which is a single point of contact call centre to health care providers through the expanded access request process. To facilitate interactions across multiple programs, OCE switched to virtual platforms to continue the attention on cancer drug development and to assure patients with cancer that they have not been forgotten.

RWE: technical perspective
Sinan Bardakci Sarac (DKMA, DK)

Q&A and Discussion

• Ultimately, drugs are developed for use in the real world. Does the lecture suggest that yet RWD will be excluded from regulatory process?
And what are the thought on using historical data from previously, or even contemporaneous, performed trials?
? What is relevant is that the data are of good and reliable quality. Pre-planned collection of RWD registries, following a specific protocol and pre-discussed with the regulators, could be acceptable.
? Indirect comparisons between trials remain difficult, and one tries to avoid this. And historical data would be hampered by the recent changes in cancer biology understanding

Mark Lowdell sure does have his fingers in a lot of pies.

Dr. Mark Lowdell
UCL Medical School, UK

Biography

Professor Mark Lowdell PhD FRCPath FRSB is the Professor of Cell & Tissue Therapy at University College London and Director of the Centre for Cell, Gene & Tissue Therapeutics / Honorary Consultant Immunologist at Royal Free Hospital London. He is a qualified diagnostic immunopathologist as well as holding MHRA Qualified Person status for the release of ATMPs for clinical trials. He held the post of Vice President (Europe) of the International Society for Cell & Gene Therapy for two terms from 2014-2018. Mark has over 25 years’ experience in adoptive immunotherapy of cancer and has targeted the role of the innate immune responses; especially the role of natural killer (NK) cells, although his experience includes a variety of adoptive T cell therapies (cancer and viral infection) as well as dendritic cell vaccines and CAR-T cells. He has focused particularly on translational research and established the first academic GMP facility in the UK for the production of human cells as medicines in 2003. Professor Lowdell has held and holds numerous appointments to academic and government advisory boards in the UK and overseas. Recently he was a member of the UK Government Regenerative Medicine Expert Review Group.

Jonathan Gillham

Experience

Head Of Quality Control
Company Name: Advent Bioservices Full-time
Dates Employed: Mar 2021 – Present
Employment Duration: 1 mo
Location Cambridgeshire, England, United Kingdom


Company Name: Autolus Ltd.
Total Duration: 1 yr 10 mos

• Title Director Quality Control
Full-time
Dates Employed Nov 2019 – Nov 2020
Employment Duration1 yr 1 mo
• Title Associate Director Quality Control
Dates Employed Apr 2019 – Nov 2019
Employment Duration 8 mos
Location Stevenage, United Kingdom
• Title Quality Control Manager
Dates Employed Feb 2019 – Mar 2019
Employment Duration 2 mos
Location Stevenage, United Kingdom

Autolomous has had a great start to 2021 with 3 new projects, an exciting opportunity for a Project Manager #PM to join the team and help us help #cellgenetherapy manufacturers bring more therapies to patients

Please contact Info@autolomous.com for more details

1 hour ago:
Nicola Nuttall

Thanks to @kkir& our Gracie, we now have a website http://doingitforlaura.com It tells our story but more importantly has tips & suggestions for people dealing with the horror of a #glioblastoma diagnosis. Hopefully we can save time for other families #GBM @BrainTumourOrg pls share.

IOZK
UPDATE:
Professor Van Gool is our consultant at IOZK and we’ve now been going out there for a week roughly every month/6 weeks for 17 months, 13 of those have just been the standard electro-hyperthermia & Newcastle disease virus and 4 trips have also included the dendritic cell vaccinations. This is still pretty expensive, but the GoFundMe fund-raising has made this possible.

As well as the dendritic cell vaccinations we have also had tumour analysis done at CeGat, they then designed 2 neo-peptide vaccinations which were then made and administered at IOZK

We go out to Germany for 5 days every 6 weeks and Laura has an hour of treatment every day. It doesn’t have any significant side effects, and the only real discomfort is the amount of blood taken on the first day. Laura lies on a water bed and radio waves are applied to the area of her brain where the tumour was, the NDV is just a simple injection

Joan Lappin CFA

$NWBO 8K today borrrowing $$$ instead of issuing shares. Some folks are optimistic enough to lend them capital, hardly the situation for a firm with a failed Phase 3 trial. Sawston revving up. Charles River Labs buying Cognate to get a foot into door of personalized vaccine mfg.

I am an enthusiastic and collaborative researcher with extensive basic and translational biology knowledge, especially in advanced molecular biology, genetics and immunology. I have experience in basic research on T cell modulation and translational antibody development targeting T-cell for onco-immunology applications. During the last 10 years I have gained a variety of laboratory skills when working with a team-oriented spirit and managing pioneering projects. I have an organized and structured thinking that allows me delivering time-sensitive and goal-oriented projects.

About
Results-driven CEO/CFO. 25+ years' business/operational finance experience. Develop global financial strategy, raise capital, manage investments, create sustainable value, implement efficiencies and internal controls, M&A integration, problem solve and IR. M&A experience includes acquisitions and divestitures.

Armed with quantitative and analytical skills, I am well-equipped to address pressing challenges and capitalize on opportunities. Managed teams of 100+ in economically volatile environments, Accustomed to solving multiple issues creatively and under extreme pressure. I actively anticipate when to implement changes in direction, prioritizing and delegating tasks, and motivating others to achieve targeted objectives in a timely and efficient manner.

Key strengths include:
FINANCE
• Lead continuous evaluation of short/long-term strategic financial objectives
• Optimize management of capital sources and their uses
• M&A
• Investor Relations (manage relationships with financial markets; lenders; investors; etc.)
• Timely, accurate analysis of budgets, financial trends and forecasts
• Audit, budget and financial forecasting
• Strategically enhance financial performance and business opportunities
• Seek and negotiate capital raising transactions
• Ensure effective internal controls, compliance with GAAP and applicable regs governing financial and tax reporting
MANAGEMENT/LEADERSHIP
• Develop strategic plan
• Hire, motivate and direct teams of men and women
• Create new organizations and deploy work force
BUSINESS DEVELOPMENT
• Design strategies to achieve, sustain and recapture market leadership and growth
• Expand geographic footprint/wholesale and retail franchise operations in appropriate global markets
• Launch new product lines
• Increase manufacturing capabilities
• Improve brand name recognition
COMMUNICATION
• Liaise with media in connection with PR strategy

Chief Financial Officer
Company Name:Advent Bioservices-ltd Full-time
Dates Employed: May 2018 – Present
Location: London, England, United Kingdom

As Chief Financial Officer of Advent, I am responsible for all financial aspects of the business. Further, I develop and implement strategic initiatives and use financial metrics and tools to drive innovation. My day-today responsabilities also include risk managment and the growth of our operations and expansion of our services into new sectors of the industry.

Help Joel Live Longer.

Updates (19)
Elisa Bonaminio, Organisator

Just a brief update to let you know that unfortunately Joel’s vaccines are currently on hold due to Covid precautions. We were delighted that four vaccines have been manufactured, but unfortunately the clinic at King’s Hospital who hold the licence to administer them is closed due to the number of Covid patients in the hospital. Professor Ashkan has assured us that as soon as the clinic reopens, when the Covid numbers have reduced, Joel will start receiving the treatment. This will consist of weekly vaccines for three weeks and then the fourth one will be a month later. We are very grateful that Professor Ashkan was able to ensure that Joel had the treatment preparations prior to the clinic closing, as they have not been able to take on any new patients for DCVax since. We are hoping he will start to receive the vaccines from the beginning of April.

His alias was born about 2 weeks ago & he is probably a reincarnation of someone we all know from the past, now using a different alias.