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Sentiment,
IMO the pre-specified trigger number for the interim analysis of efficacy was 198 events, comprising 80% of the 248 events required to reach the primary endpoint (PFS) of the Phase III trial.
In December 2013, we announced that the number of events required to trigger the first interim analysis of the Phase III clinical trial had been reached. This milestone is measured by "events," which are defined as either a tumor recurrence or a death. With the current trial size, the pre-specified trigger number for the first interim analysis is 66 such events, comprising 60% of the 110 events required to reach the primary endpoint of the Phase III trial. The interim analysis will be conducted by an independent Data Monitoring Committee, or DMC, with assistance from the independent clinical research organization, or CRO, managing the trial. In March 2014, we announced that the DMC has conducted a review of the safety data, and recommended that the trial continue as planned. As we also announced the DMC’s interim analysis of efficacy data remains outstanding. With the current trial size, a second interim analysis will occur when 88 events, comprising 80% of the total 110 events, have been reached.
Flipper44,
The change to IDHwt was in the fifth cIMPACT-NOW update (May, 2020).
cIMPACT-NOW (Consortium to Inform Molecular and Practical Approaches to CNS Tumor Taxonomy) was created to convey timely updates and provide recommendations for future WHO publications.
See my post : https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164968664
The latest round of revisions to the WHO classifications for brain tumors will officially be published later this year, and leaders of the process to update the classification have just published a review article that previews the updates. (June, 29 : https://academic.oup.com/neuro-oncology/advance-article/doi/10.1093/neuonc/noab106/6311214)
When the full updates are published by the WHO (in a publication known as “the Blue Book,” expected later this summer or early fall), NBTS will provide a more detailed overview of the changes with leaders from the WHO CNS group who developed the classifications as well as key neuro-oncologists who can explain how these changes impact patients.
Actually there were at least two references to what seemed to be a UK still outside of the ORBIS program with one being the one you mentioned
Dr June Raine CBE, Chief Executive, Medicines and Healthcare products Regulatory Agency said:
With Project Orbis, we are working to ensure that patients receive earlier access to promising, life-saving cancer treatments. We know that the earlier we can treat patients, the better their outcomes. Through international cooperation, innovation in regulation, and working with others across the whole health system, the MHRA is cementing the UK’s global position at the centre of life sciences and healthcare access.
learningcurve2020,
§312.7 Promotion of investigational drugs.
(a) Promotion of an investigational new drug. A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.
National Brain Tumor Society
Conquer and Cure GBM: A #GBMDay Panel Discussion.
Virtual Glioblastoma (GBM) Awareness Day panel discussion yesterday at 12 PM EDT, moderated by New York Times Pulitzer Prize-winning investigative reporter Eric Lipton and featuring Dr. Susan Chang, director of the Division of Neuro-Oncology at the UCSF Department of Neurological Surgery; Dr. Richard Pazdur, director of the U.S. Food and Drug Administration's Oncology Center of Excellence; Dr. Ned Sharpless, director of the National Cancer Institute; Adam Hayden, patient and advocate and member of the National Brain Tumor Society Board of Directors; and David Gelles, former caregiver and senior broadcast producer of CNN's The Situation Room with Wolf Blitzer.
Thanks Survivor2012!
NWBO particpated in this:
https://braintumor.org/your-voice/head-to-the-hill
My amazing MD brain tumor family!! THIS is why we fight every day!
— Mary Dunn (@MaeveNY) May 4, 2021
Thank you @ChrisVanHollen for mtg with us tday and for your continued support to all Marylanders &especially for being a long time supporter of the Brain tumor community @nbtstweets #GoGrayInMay #Head2Hill #btam pic.twitter.com/hGo3tPQZC5
The other person I try to follow is Jessica Oldwyn, but she's been especially quiet of late. I'm hoping she's still doing okay... do you have any updates on her status? I know she was never on DCVax-L; although I'd hoped that she'd have been able to get into the UCLA combo trial.
jessica_oldwyn
Celebrating the 11th anniversary of my very first brain surgery with my girl! Picnic on the patio, and a doggie spa day. Emma taught herself to calm me down with my seizures, with zero training. She used to run or walk with me everywhere I went, the doctor, the grocery store, every park. Now, she’s too old, with little old bones, to be putting those kinds of steps in, but I wouldn’t be here with out her. Since I can’t drive, I’m pretty isolated, but with her love, I never feel alone, and I always feel cherished. Cheers to many many more years hopefully without more brain surgeries, and to a selfless soul that I owe my heart, sanity, and gratitude to.
https://www.instagram.com/p/COMA18Ml4wt/
Yes I agree they may be trying to address the new GBM classification. They may have had some advanced warning since they were scrambling to try to get IDH patient status before data lock. I am thinking Duffy may have given them a heads up.
MAY 2020
GBM refers only to IDHwt, H3wt astrocytomas
Summary
Identification of the underlying genetic and epigenetic alterations in an increasing number of tumors of the nervous system is contributing to a more clinically relevant classification. In the following article, the 7 cIMPACT-NOW publications, which adumbrate the upcoming 5th edition of the WHO Classification of Tumours of the Central Nervous Sytem are summarized.
The fifth edition of the World Health Organization (WHO) Classification of Tumors of the Central Nervous System (CNS) (WHO CNS5) was recently released and summarized by Louis et al in this issue of Neuro-Oncology.1 This builds on the 2016 WHO CNS tumor update which for the first time incorporated molecular data with histology in classifying CNS tumors, as well as the subsequent work of the Consortium to Inform Molecular and Practical Approaches to CNS Tumor Taxonomy (cIMPACT-NOW). The changes in WHO CNS5 group tumors into more biologically and molecularly defined entities with better characterized natural histories, as well as introducing new tumor types and subtypes, especially in the pediatric population. Most importantly, these updated classifications will enable clinicians to have a better understanding of the prognosis and optimal therapy for patients with specific CNS tumors. It will also allow more homogeneous populations of patients to be enrolled into clinical trials, facilitating the evaluation of novel therapies.
Matt Henkel
April 9, 2021
Matt here.... I hope everyone had a great Easter with family. It has been awhile since my last update. In this time, I have met with my Neurosurgeon,Dr. liau, and also my neuro-oncologist, Dr. Cloughesy, both at UCLA. I set up appts with both, as I wanted to have the benefit of hearing my situation and having a plan moving forward.
The plan: I have pulled out of the clinical Trial I was participating in. I did so Because while in it, I received all 3 dcvaxx shots and was left to wonder if I was also getting the trial drug, keytruda , or a placebo.today, I couldn’t tell you either way. Extreme fatigue and cognitive fog is what is hampering me right now, which can easily be attributed to the start of Avastin infusions. What’s Coming up....
2nd round of Avastin on the 15th. Back to UCLA on the 19th with my sister, Sarah, and our niece, Lauren Tarr. I’m looking forward to spending time with both of them. I will return home to hospice and Avastin infusions every other week. The Avastin is being offered Palliatively, so It is allowed on hospice . I’m hoping I am allowed to monitor the tumor with mri and if some treatment becomes available while I am still around, I can explore it, snd make hospice wait on me again. Thank you all for the continued thoughts and prayers as our family continues down this dark and unknown path.
All my love - Matt
Cammie Henkel
April 24, 2021
I saw this quote today and it spoke to me. Joy and Sorrow are never separated. When we are overwhelmed with grief we discover what true friendship is all about. If we try to avoid sorrow, we may never taste joy.
When I use the word grief it doesn’t have to mean a loved one dying. My family has been grieving for a year because a year ago my kids lost the experiences in life with their Dad. Matt is here with us but Brain Cancer is not easy to see. The brain controls all and losing functions of the brain big or small has terrible side effects. Matt lives a complex life because he is unable to do all the things he loves but wants so badly to do them which leads to overwhelming emotions.
Many have asked why Matt pulled out of the trial in California and there isn’t one reason but many little reasons. He received the most important part and the traveling became exhausting for him. The painful reality of it is his brain has been cut more times than a lot of people on this earth which leaves for many deficits.
With the help of so many great family and friends I was able to work most of the year. Today was my last day at school as I have taken FMLA and cut my year short. My sweet kiddos showered me with love and I am blessed to have a great substitute filling in. I will spend my days focused on my family and Matt. Thanks to some great people and the help of my Dad we will be trying to enjoy every little second together next week on a beach in Florida. Hoping the memories of this trip will give us the energy and positivity we need to continue this battle. With my leave from school and the focus on my family and the request of our teenagers I will be signing off for a couple months to be more in the moment. I know you all are invested in this journey and I appreciate that so much so please reach out through text anytime to check in on Matt. Sending you all giant hugs.
Cammie Henkel
May 19, 2021
Matt's 13 year battle with brain cancer has come to an end. He died peacefully at home surrounded by family a short time ago. For the sake of our 3 kids we would appreciate some time to grieve privately. Please pray for healing for me, the kids, and our extended families. Thank you for coming on this ride with us .
To the best of my knowledge, this(slide 23) is the first public dissemination of the inner workings of the NWBO DC VAX L phase 3 SAP. Please correct me if I am wrong.
"Gilbert 2014 randomized study subjects at an earlier timepoint then the other studies, and all analyses will be conducted both including and excluding this study."
... not sure where the 40k is coming from then ... really thought I read this though (maybe I'm confusing that number with a different investment I had last year or something, thought I couldn't have sworn it was NWBO) Well, wishful thinking then I guess ...
As of March 26, 2021, there were approximately 40,000 holders of record of our common stock. Such holders may include any broker or clearing agencies as holders of record, and in such cases exclude the individual stockholders whose shares are held by such brokers or clearing agencies.
Dr. Liau was not a proponent of utilizing DC therapy on idh mutation patients in her compassionate care cases at UCLA and would refer them to other trials, because she believed idh mutation was almost akin to something other than GBM altogether. (Ahead of her time, but the neuro-oncology world is coming ‘round to this.)
"There are some very exciting changes that are coming down the pipeline. For the WHO 5th 2021 edition (CNS Tumor Classification Scheme)
gliobastoma is only going to be used for IDH wild-type tumors there's no more IDH mutant GBM."(Nancy Ann Oberheim Bush, MD, PhD)
Thank you ATLnsider!
In their May 2019 report, their expert investigators have identified only 4 innovations with such disruptive potential in the entire oncology space, that are being followed.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150041706
The Patient-Centered Outcome Research Institute (PCORI):
The PCORI Health Care Horizon Scanning System’s (HCHSS’s) purpose is to conduct horizon scanning of new and emerging health care technologies and innovations with high potential for disruption to the current standard of care to better inform patient-centered outcomes research investments at PCORI. The HCHSS provides PCORI with a systematic process to identify and monitor technologies and innovations in health care that are in PCORI’s priority areas of interest and to create an inventory of interventions that have the highest potential for disruption to the current standard of care in terms of patient outcomes, health disparities, care delivery, infrastructure, access, and/or costs. It will also be a tool for the public to identify information on selected new health care technologies and interventions.
Any investigator or funder of research will be able to use the PCORI HCHSS to select potential research topics. The health care technologies and innovations of interest for horizon scanning are those that have yet to become part of established health care practices. These health care interventions are in late stages of research and development or very early phases of adoption except in the case of new applications of already-diffused technologies. Consistent with the definitions of health care interventions provided by the National Academy of Medicine (formerly the Institute of Medicine)and the Federal Coordinating Council for Comparative Effectiveness Research, PCORI is interested primarily in innovations in drugs and biologics, medical devices, and procedures within its selected priority areas of interest for horizon scanning.
Highlights
DCVax-L is an immunotherapy made from activated dendritic cells derived from the patient’s monocytes obtained during pheresis and then loaded with patient-derived tumor antigens that were obtained from the patient’s tumor during surgery. The therapy is intended as an adjunct to standard initial therapy for newly diagnosed glioblastoma multiforme (GBM).
Most of the 8 stakeholders commenting on this topic agreed that DCVax-L has potential to improve outcomes, quality of life, and overall health of patients with GBM. Because DCVax-L is anticipated to be costly relative to standard of care, it also has potential to disrupt health care costs for patients and payers. DCVax-L’s high cost might also increase disparities because copayments even for insured patients could be high and uninsured and underinsured patients could have difficulty accessing DCVax-L.
Recently, IMO.
Jean Davis is now CIO and Head of Special Projects at Northwest Biotherapeutics
Responsible for overseeing the Company's Information Technology initiatives including overseeing the internal and outsourced personnel and ensuring security and controls are in place.
As Head of Special Projects, coordinates audit efforts as the Audit Liasion, oversees the Sarbanes Oxley Efforts and the Company's ICFR Compliance Program, coordinates international tax efforts, as well as assists on other projects and company initiatives as needed.
Autolomous has been selected by Bio-Techne to support their GMP cellular manufacturing center.
Bio-Techne Further Enhances Its Gene Engineering & Cell & Gene Therapy Manufacturing Capabilities
Published: Jun 10, 2021
MINNEAPOLIS and LONDON, June 10, 2021 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH), a leader in developing innovative tools and technologies for cell and gene therapy research and manufacturing, has partnered with Autolomous to implement a first of its kind electronic batch record system, AutoloMATETM, at Bio-Techne's GMP cellular manufacturing center.
Through this partnership Bio-Techne will be able to offer state of the art electronic records to therapeutic companies utilizing its non-viral gene delivery system, TcBusterTM, or contract cellular manufacturing services alongside working with Autolomous to integrate further its analytical and manufacturing technologies within their platforms.
"Improving process control during the manufacture of novel cell-based therapies will further ensure that patient products meet the highest quality standards resulting in safer therapies," commented Dave Eansor, Bio-Techne's Protein Sciences Segment President.
"Adding this level of precision to our process monitoring represents another milestone as we deliver best-in-class gene editing and manufacturing capabilities to our clients."
"This is an excellent development for Autolomous as we seek to extend our portfolio of users across Europe and the USA and the diversity of products we can support.
Implementation at Bio-Techne's GMP manufacturing facility will showcase the flexibility of our solutions and its ability to support a variety of Cell & Gene Therapy Manufacturing workflows. This will be our first deployment in the USA which is particularly exciting for us", said Alexander Seyf, CEO of Autolomous."
https://www.biospace.com/article/releases/bio-techne-further-enhances-its-gene-engineering-and-amp-cell-and-amp-gene-therapy-manufacturing-capabilities/
Raymond Chan Ph.D. Product Manager at Bio-Techne
10h ago
Amazing to see this ground-breaking trans-Atlantic CGT manufacturing collaboration. Congrats Kwok and to our CGT team for making this happen. Wonderful to connect the innovation here in the UK with our new GMP manufacturing site.
Mike Scott
Chief Operating Officer at Advent Bioservices & Visiting Professor, Anglia Ruskin University
5h ago
Congratulations to you all.
Lindsey Clarke
Global Product Marketing & Commercial Strategy, Cell & Gene Therapy at Bio-Techne
10h ago
Another exciting collaboration we can talk about this week! Our GMP cell manufacturing capabilities will be further enhanced with the ability to provide state of the art e-batch records thanks to Autolomous!
marzan,
I have asked UCSF if there is a recorded version available.
I got a reply:
Hi xxxxx,
Unfortunately, the recordings are only available to UCSF personnel.
Best,
Teresa
And if its actual treatment arm demonstrates a very obvious separation from all other contemporaneous and historical ndGBM trials, why don’t you think that is evidence enough of efficacy?
around min. 28.00
Slide: Large RCTs for newly diagnosed GBM (2013-2020)
Linda liau:
So..uh ..so one potential concept is to test.. you know.. statistically….use these control arms to test a new therapeutic and if you see..you know..if your new drug or therapeutic is way out here..then perhaps that will give you enough signal to say that there is efficacy.. uh..in your new therapeutic without having ..you know .. enroll another 400 people in the control arm..
What’s the application number or publication number?
At least two new employees at Advent Bioservices since early June.
Mike Scott
Chief Operating Officer at Advent Bioservices
4 days ago:
“We are growing our workforce at a rate of knots.”
reg2015,
Today's "Round Table discussion" was focused on particular GBM patient cases.
See post dr Bala:
Case 1 of this presentation from SNI Digital dealt with the case of how to treat a particular GBM case in a 63 year old. It deals with resection + chemotherapy + radiation in this case. It does not deal with immunotherapy. They are dealing with Case 2 now. I am going to exit since I have to attend another meeting.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164222784
I see you all are ignoring the part where that oncologist and the rest of them seem out of the loop on where if anywhere DCVAX is still being manufactured for trials /compassionate use.
Title: 2020 UCLA Brain Tumor Virtual Conference
Date & Time: Dec 04, 2020 9:00 AM - 5:00 PM
Location: Zoom webinar
https://digest.dgsom.ucla.edu/digest/posting-view?digest_id=3022&posting_id=4808048#:~:text=2020%20UCLA%20Brain%20Tumor%20Virtual%20Conference%20Title%3A%202020,Dec%2004%2C%202020%209%3A00%20AM%20-%205%3A00%20PM
I would not be surprised if NWBO requested that since they have actively hidden even the scraps like the endpoint changes from us as long as they could.
That's my impression too.
Dr Bala,
Yes, I saw you as an attendee at the follow-up meeting after the lecture.
I got the link on Wednesday (from Teresa Pan). So, no problem to enter.
Next presentation ( A Round Table discussion ) on Saturday June 5:
SNI Neurosurgery World Education Summit-FREE-Helping People Throughout the World
A virtual conference with leading neurosurgeons from around the world. Interactive practical round table discussions, case reviews, & presentations.
3:05 PM - 4:00 PM
Room A- Glioblastoma, Gliomas. How should I treat?
A Round Table discussion of how neurosurgeons from around the world manage Adult Gliomas and Glioblastomas, so you can decide what is best to do.
Syed Ather Enam, MD, PhD
Jinsong Wu, MD, PhD
Linda Liau, MD, PhD, MBA
Ian Lee, MD
Vinay K. Puduvalli, MD
Ignatius Esene, MD, PhD, MPH
Rashid Jooma, MBBS
Ahsan Ali Kahn, MD
Cleopatra Charalampaki,MD, PhD
https://www.airmeet.com/e/eb100470-a2c3-11eb-92cf-8dceb6528f42
for instance:
May 19
Endpoint selection: Median PFS & OS may not capture the true efficacy of immunotherapy.
June 3
Endpoint selection: Challenges with PFS endpoint.
May 19 (slide large RCTs for newly diagnosed GBM)
footnote made invisible
June 3
Footnote no longer hidden.
….and … and…
She does sometimes repeat use old slides.
Thank you biosectinvestor for the additional information.
I would like to add that Linda Liau talked a lot (and enthusiastic) about the UCLA SPORE in Brain Cancer research project during her lecture yesterday. (UCSF - Resident Research Day Lecture)
Someone has a very specific public statement where this is made quite clear. I do not have it, but that shorts keep coming back on this nonsense point that they KNOW is false, speaks to how easy they think it is to deceive retail.
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.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=162535567
Update Laura Nuttall
Our daughter, Laura was diagnosed with brain cancer in Autumn 2018 when she was just 18.
She was given a prognosis of roughly 12 months and told to go away and make memories. She bravely endured a craniotomy to remove the largest tumour and then started a gruelling program of radiotherapy and chemotherapy.
But then we found an innovative new immunotherapy treatment available only in Germany and with the help of our friends, community and the wonderful people who donated through GoFundMe, we were able to take Laura out to Cologne on a regular basis and to our delight, her immune system responded to the treatment.
Laura remained well, well enough to go back to university in Manchester and start a degree in Politics, Philosophy and Economics.
Fast forward 2.5 years and although still really healthy and free of symptoms, a routine MRI scan revealed regrowth on the site of the original tumour.
Laura had a second surgery at the end of March and now the plan is for 2 further dendritic cell vaccinations and a course of a checkpoint inhibitor called Pembrolizumab. None of this is available on the NHS of course so we are faced with the enormous challenge of raising a further £80k.
We appreciate that Laura's had a great deal of support already and we're so grateful to everyone that has raised funds for her. It really has made the most incredible difference and I honestly don't think that she'd be here without it. She's used the last few years wisely, studying and working as an ambassador for The Brain Tumour Charity and helping out in the community.
We think Laura is an incredibly special girl who deserves the luxury of getting old and we will do everything we can to give her that opportunity.
Thank you so much for your support
Nicola, Mark, Laura and Gracie xxxx
https://uk.gofundme.com/f/doing-it-for-laura-2021
Nick119, I got the link and password yesterday. I think registration is closed.
Nick119, are you planning to record Linda Liau's lecture tomorrow?
Gary, I wish you a speedy recovery.
I am not aware that Keytruda was used in that trial.
After treatment with Multikine and the SOC, the patients enrolled in our study can take any medicine if their tumor recurs. We therefore considered the possibility that the introduction in late 2016 of Keytruda and Opdivo, two new cancer immunotherapy drugs for recurrent head and neck cancer, might be responsible for the lower than expected death rate in our study. We do not think that this is the case based on the following: 1) The use of Keytruda and Opdivo as a treatment should already be accounted for in the SEER database results which were evaluated since these drugs were used in the U.S. for patients with recurring disease. 2) Our study was enrolled in 20+ countries and these drugs were not available in many of those countries during the time patients were enrolled and treated in our study. In most of those countries Keytruda and Opdivo are still not available, even today. 3) Keytruda and Opdivo show a survival benefit of about 3 months in head and neck cancer once the initial treatment has failed and the tumor recurs. Any patient who received a 3-month survival benefit from Keytruda or Opdivo would already have passed on since the patients in the Phase 3 study entered/completed treatment between 3.5 and 9 years ago. Therefore, the delay in reaching 298 events in the Multikine Phase 3 study should not be due to Keytruda and Optivo.
https://www.businesswire.com/news/home/20200226005869/en/CEL-SCI-Corporation-Issues-Letter-Shareholders
Prof. John Smyth
https://cddf.org/about-cddf/organisation/board-members/prof-john-smyth/conflict-of-interest-disclosure-prof-john-smyth/
He moderated the panel discussions at past 2021 CDDF events.
CDDF 12th Spring Conference on Current and Future Challenges of Innovative Oncology Drug Development
8 – 10 February 2021 – Virtual Conference (moderator Marnix Bosch)
CDDF Multi-Stakeholder Workshop: Endpoints in Cancer Drug Development
26 – 28 April 2021 – Online Workshop
I don't think anyone here has followed these events. IMO, a missed opportunity.
New job for J. Kelly Ganjei
President & Chief Executive Officer at AmplifyBio.
Battelle Creates AmplifyBio to Develop Next-Gen Therapies; Lou Von Thaer Quoted
May 4, 2021
Battelle announced Monday that it is launching a new company that will perform research and development of next-generation therapies, including cell and gene therapies (CGT). The new company called AmplifyBio is backed by Battelle and outside investors with experience in pharmaceutical markets and life sciences.
“For decades, Battelle has found new ways to innovate, AmplifyBio is a $200 million start-up with the backing of respected investors who will help us to move quickly and intelligently in this rapidly developing field of research,” commented Lou Von Thaer, president and CEO of Battelle and a 2021 Wash100 Award recipient.
AmplifyBio’s mission will be to speed up the development and research of next-generation therapies by creating and optimizing new technologies and working to solve the problems of scaling complex treatments to help as many people as possible.
“This is why Battelle exists—to happen to the world,” Von Thaer added. “We see a need, we see opportunities, we search for partnerships, and we keep Battelle at the leading edge of discovery for the benefit of humanity. I’m excited to see where the team takes AmplifyBio and proud to support its growth through our continued involvement.”
AmplifyBio plans to purchase a building and surrounding land on the Battelle campus. The 210,000-square-foot facility has state-of-the-art laboratory space and equipment to facilitate accelerated research into novel cell and gene therapies that AmplifyBio desires. The company will also perform research contracts for commercial clients.
J. Kelly Ganjei has been named president and CEO of AmplifyBio and is currently completing his leadership team. Ganjei has previously served as CEO of Cognate BioServices. He possesses over 26 years of experience in the life science and information technology sectors.
“There is great potential for advanced medicines to help so many patients across a diverse set of conditions, but there is no shortage of technical problems to solve across this sector,” Ganjei said.
“The earlier in their development lifecycle, we can help these products, the better the outcome for everyone,” “Combining the strength of Battelle with our investors will uniquely position us for rapid growth and the potential to help millions of people around the world,” Ganjei added.
https://www.executivegov.com/2021/05/battelle-creates-amplifybio-to-develop-next-gen-therapies-lou-von-thaer-quoted/
New job for Kevin Duffy.
Kevin Duffy
Associate Director - Field Medical Affairs - Oncology
Company Name: Regeneron
Full-time
Dates Employed : May 2021 – Present
Location Weston, Florida, United States
https://www.linkedin.com/in/kevin-duffy-9519831/
ae kusterer,
Good find! Thank you for sharing.