MHRA runs an innovation accelerator webinar—otherwise known as a sales pitch!
Roll up, roll up, get your gene therapy advice here...
My invitation
Last week, I receive an email from MHRA inviting me to register for an upcoming webinar titled “MHRA webinar on Innovation Accelerator.” On further inspection, I learned that other organisations were part of the ‘acceleration’ process
Before reading further, you must know what this is likely to cost you, see below—40 different fees they can get you on:
Statutory guidance: Current MHRA fees, Updated 20 November 2023
Registration now open for the upcoming MHRA Webinar on Innovation Accelerator: 7 February 2024
There was the Regulatory Advice Service for Regenerative Medicines (RASRM).
Working in partnership
Apparently, they are working closely with others and will continue to engage with those involved in regenerative medicine, including researchers, the British Society for Gene and Stem Cell Therapy, which says it is “Supporting progress & translation of gene & cell therapies”
Then there’s another partner, the Cell Therapy Catapult (‘gene’ word omitted?).
The CGTC pops up regularly, such as here below:
Key milestones in UK Government's excursion into gene therapy
Oxford Biomedica (OXB) plants the seed This is how Oxford Biomedica describes itself on its website: “Oxford Biomedica is an innovative leading viral vector specialist focused on delivering life changing therapies to patients. Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering the genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy, or gene-modified cell therapy).”
Here is the Chair of the CGTC:
The Cell and Gene Therapy Catapult (CGT Catapult), an independent technology and innovation organisation, announces today the appointment of Ian McCubbin OBE, CBE, to its Board of Non-Executive Directors as Chairman, effective 1st February 2022. With over 30 years of experience in the pharmaceutical industry and as a pharmacist by training, Ian has worked for industry leading companies including GlaxoSmithKline (GSK).
Since retiring from GSK and in response to the global COVID-19 pandemic, Ian led the manufacturing activities of the UK Government’s Vaccines Task Force (VTF) between February 2020 and June 2021. As part of the VTF he also helped to support the due diligence team involved in vaccine selection. Ian retired from GSK in 2017 where he was Senior Vice President of North America, Japan and Global Pharma Supply within the Global Manufacturing & Supply (GMS). In this role, Ian was responsible for 17 factories and 7,000 employees globally whose role within GSK was to supply the new product and pharmaceutical sales pipeline.
GSK? Vaccine Task Force? Cell & Gene Therapy? Hmmm.
Oh, and here they are, working with the Human Tissue Authority.
Then there’s the Health Research Authority (HRA), (with its tenticles firmly in UK NHS), which recently held a regenerative medicine event hosted by the Cell Therapy Catapult to look at changes and discuss issues with the sector, regulators and representative bodies. Additionally in 2012, the MHRA hosted an event on the regulation of regenerative medicine.
Then, the House of Lords chimes in:
As set out in the Government Response to the House of Lords Inquiry a Regenerative Medicine Expert Group (RMEG) is being established to develop an NHS regenerative medicine delivery readiness strategy and action plan. This group will build on existing initiatives so that the NHS is fully prepared to deliver these innovative treatments. The group will be supported by the Department of Health; members will be drawn from a number of groups and organisations, including the HRA. The remit of the Regenerative Medicine Expert Group will include a role to monitor the effect of regulation on the development of regenerative medicines in the UK.
Medicines: get scientific advice from MHRA
More dots for joining
Also: GlaxoSmithKline: former chairman denies knowledge of $3bn US deal:
“The company admitted in its settlement with various American authorities that it had been offering lavish holidays and hospitality to targeted doctors and encouraged the prescription of unsuitable anti-depressants to children. GSK also paid for articles to appear in medical journals lauding its products, and hired "independent" doctors to promote the treatments.”
As you will know, Sykes was Chair of the Vaccine Task Force after Kate Bingham made a hash of it. He was Chair through the crucial period of launch of all three SARS-CoV-2 injections.
Also see: Joint Committee on Vaccination and Immunisation, Protocols for vaccine manufacturer engagement, with JCVI sub-committees, JCVI Secretariat, August 2015 – injection manufacturers met with JVCI!
Then we have this: Health Minister visits Cell and Gene Therapy Catapult ahead of Life Sciences Council Meeting at 10 Downing Street
Difficult not to conclude that UK had numbers of fingers in the SARS-CoV-2 injection pie…hope you all don’t mind me pitching in :>)
I wrote last week about Jacinda Ardern’s sister who used to work in Audit and Quality Control for GSK in Basel and now works in NZ cybersecurity with ‘clients’ in Switzerland. It’s one big club and we ain’t in it, Hedley!
If gene therapy worked, it would need no marketing...the same with all drugs.