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Genentech Purges Top Executives and Shuts Down Research Units

For those not familiar with Genentech’s history, this may help position the company:

“SOUTH SAN FRANCISCO, Calif.—September 25, 1998—Genentech, Inc., (NYSE: GNE) announced today that it received approval from the U.S. Food and Drug Administration (FDA) for Herceptin (Trastuzumab), a unique new approach for treating one type of metastatic breast cancer and the first monoclonal antibody for use in this disease. The new biological drug is expected to be available through the oncology medical community in October.”

This was the company that led the way in the development of monoclonal antibodies to treat disease. They were experts in developing safe, effective biologically derived drugs. I visited the South San Francisco site twice during 2003 - 4, heading up the supply chain for OSI Pharmaceuticals developing a drug for non small cell lung cancer.

They were a class outfit.

Then, in 2009, they were fully acquired by Roche, a company with no background in manufacture and distribution of biologics - but they had big pockets.

Since, Genentech has gradually withered away, until this announcement.

Fierce Pharma said this:

Genentech vice presidents Vishva Dixit, M.D., Man-Wah Tan, Ph.D., and Todd McDevitt, Ph.D., are among the casualties in another round of layoffs at the South San Francisco subsidiary of Roche.

The departures are part of a restructuring of the Genentech Research and Early Development (gRED) group, a company spokesperson said in an email. Genentech did not reveal how many positions are affected, but the spokesperson said that “targeted adjustments” are being made to “ensure our capabilities and investments are aligned with our core therapeutic areas and portfolio priorities.”

The layoffs were first reported by Endpoints News, which cited an internal communication stating that Genentech was shutting down its physiological chemistry and infectious disease teams and reducing staff in other groups. The publication cited an email sent by Aviv Regev, Ph.D., the head of the gRED group.

Dixit, who has served at Genentech for 29 years, headed up the physiological chemistry unit. Tan, who has been at the company for 16 years, leads the infectious disease group, while McDevitt has been the chief of the cell therapy unit for the last three years.

“We are deeply grateful for their leadership, ground-breaking discoveries, and the impact of their work,” Genentech’s spokesperson said.

Along with the cutbacks, Genentech pointed out that it is still hiring for positions within gRED.

“These positions reflect the capabilities, expertise, and areas of science that are most critical to advancing our portfolio and delivering transformative medicines to patients,” the spokesperson added.

Layoffs are nothing new at Genentech. Last year, the company handed pink slips to at least 489 employees, with many of the changes handed down by Roche in a global manufacturing reshuffle and its incorporation of Genentech’s inclusion and belonging team into a broader unit run by the Swiss-based company. In April of 2024, a 3% workforce reduction by Roche affected 436 Genentech employees.

“To stay ahead in a fast-moving industry and continue to deliver world-class science and medicines, we must continually evolve how we work,” the Genentech spokesperson said on Thursday. “This requires making difficult decisions to focus our resources on the work that creates the highest impact for patients.”

What should we make of this?

This is more from the Big Pharma playbook discussed yesterday:

”Find a rare disease where patients are desperate to save the lives of their loved ones.

• Engage with patient advocacy groups who campaign strongly for the drug to be approved for sale.

• Set the price at anywhere between $400K and $3 million.

• Hope the drug gets approved.”

The only way the drug gets approved is by lobbying from patient advocacy groups and pharma trade associations, then power sales and marketing if an approval is achieved.

There is a positive side

This is all symptomatic of the disease that has Big Pharma caught in the 1980s and 1990s - patenting molecules when they didn’t know how to make the drug. Now we are beginning to witness the slow, painful death of the big pharma patient.

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The Drug That Was Supposed to Rescue Sanofi's Pipeline Just Failed

This is taken from LinkedIn, shared here as a sample of what is happening across all of the Big Pharma companies. Sanofi is around #10 in the world.

“Sanofi has dealt a significant blow to its late-stage pipeline after an independent data monitoring committee recommended halting the Phase III MOBILIZE trial for riliprubart (SAR445088), its investigational antibody candidate for chronic inflammatory demyelinating polyneuropathy (CIDP).

The decision was based on a pre-planned interim analysis concluding the drug was unlikely to demonstrate sufficient efficacy — a so-called futility finding — with no safety concerns identified.

CIDP is a rare autoimmune neurological disease in which the immune system attacks the myelin sheath protecting peripheral nerves, causing progressive muscle weakness, sensory loss, and in severe cases, wheelchair dependency.

The MOBILIZE trial enrolled approximately 140 patients with refractory CIDP — those who had failed standard treatments including intravenous immunoglobulin (IVIg) and corticosteroids. Analysts had previously projected riliprubart could generate peak annual sales of around €500 million by 2033.

The setback compounds an already turbulent period for Sanofi. Following multiple clinical failures in asthma and COPD, former CEO Paul Hudson departed in February 2026. His successor Belén Garijo now faces the task of rebuilding pipeline momentum — and this failure is a difficult start. Competitors argenx and Takeda, who dominate the CIDP treatment landscape, will view the news as a clear competitive advantage.

Not all hope for riliprubart is lost. A separate Phase III trial, VITALIZE, continues — testing the drug in IVIg-responsive CIDP patients as a simpler subcutaneous maintenance alternative. Sanofi is now evaluating whether MOBILIZE's failure should alter that trial's course. Financially, the company says the shutdown carries no material one-time costs and reaffirmed its full-year 2026 guidance.”

Same Old, Same Old Playbook

The playbook is the same for all big pharma companies:

• Find a rare disease where patients are desperate to save the lives of their loved ones.

• Engage with patient advocacy groups who campaign strongly for the drug to be approved for sale.

• Set the price at anywhere between $400K and $3 million.

• Hope the drug gets approved.

As I’ve said many times, Big Pharma outsourced all its drug development assets during the 1980s and 1990s, see:

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Big pharma’s 40-year love affair with outsourcing everything must end, otherwise investors will take their money elsewhere.

Why—three main reasons

• Pharma manufacturers divested their physical storage, logistics and distribution skills and assets to the wholesaler network. Through consolidation, this network is now dominated by three major corporations – McKesson, Cardinal, and AmerisourceBergen. Pharma manufacturers’ crucial link with the users of its products has been lost.

• Outsourcing drug development and commercialization activities to Contract Research Organisations (CROs) and Contract Development and Manufacturing Organisations (CDMOs) has created a highly complex network of third-party contractors working on a fee-for-service basis. These tactical, arms-length relationships have resulted in the following:

  • Clinical trial sponsors and product license holders must pay cash for any innovations they may want to introduce into their products, putting a drag on innovation.

  • Time-to-market is in the hands of the contractor network, as lead-times are stipulated in contracts, and they are conservative, to say the least.

  • The high contractor switching costs and disruption involved in changing supply sources means clinical trial sponsors and product license holders become locked-in and hostage to price escalation.

  • Each contractor involved is a different company, and some are even in competition with each other.

Outsourcing early-stage development of drugs has resulted in:

• Early-stage development deprived of the investment needed to create a sound platform on safety, efficacy, and quality.

• These small companies do not have the skills, funding or critical mass required to develop new drugs.

• The small companies have to depend on convincing investment analysts that they have a wonder drug, so that a big pharma company buys or partners with them - BioNTech and Moderna fit the mould.

Do investors know the issues?

I suspect the investors familiar with the outsourced model think it was always a good idea to reduce risk and save costs. They should think again.

As demand has dropped, Moderna’s supplier of the drug substance, Lonza, is going to see a big hit on its projected profits. Their investors will not be happy as orders are cancelled and profits drop - see the account of the demand drop here:

WATCH: Moderna tosses 30 million COVID-19 vaccine doses because 'nobody wants them’

Sit tight folks, the tide is changing!!!

Best, Hedley

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Letting this speak for itself:

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Here are just a few pieces of news relating to layoff’s in Biotech companies. Remember, Biotech is supposed to be the new engine room of drug discovery and innovation:

BioNTech made €19B in 2021. This quarter: €118M

“The German mRNA specialist BioNTech made a fortune through its alliance with Pfizer. BioNTech launched “Project Lightspeed” in January 2020, days after the SARS-CoV-2 genetic sequence went public. It received €375M from the German government to accelerate development and production. Pfizer declined U.S. government support in the form of Operation Warp Speed R&D funding to preserve scientific independence. Yet the U.S. government placed a $2 billion advance-purchase order for 100 million doses in July 2020, with hundreds of millions more to follow. That purchase guarantee, combined with emergency use authorization in December 2020, helped turn Comirnaty into one of the best-selling pharmaceutical products in history. Comirnaty generated roughly €36B in BioNTech revenue across 2021 and 2022.”

Biotech layoffs gather pace as industry downturn persists

“At least five dozen biotechnology companies have laid off employees so far this year [2023] in a sector-wide contraction that has reached large and small drugmakers alike.

Brought on by enduring funding challenges, the consolidation has resulted in roughly 3,200 biotech employees losing their jobs between Jan. 1 and early April, according to data collected by BioPharma Dive.

While the workforce reductions aren’t a new development — more than 100 biotech companies conducted layoffs last year — the pace of announcements has accelerated, suggesting the industry hasn’t recovered from 2022’s market downturn.

Biotech layoffs are easing, but is the worst over?

BioNTech is one of the most recent companies to announce cuts, but the pace of job losses is slowing.

“There have been over 40 rounds of layoffs announced this year as of April 30, compared to more than 50 in the last four months of 2025, according to one industry tracker.

At the beginning of the year at least one analyst predicted that industry reductions would trend downward in 2026. But similar optimism last year proved misplaced when job losses rose 16% year over year amid unanticipated market turbulence in the U.S., including tariff threats, most-favored-nation pricing proposals and continuing cost pressures from the Inflation Reduction Act.

So far, many of this year’s cuts were driven by familiar industry pressures, such as investigational drug failures, strategic reprioritizations and efforts to improve operational efficiency.”

Where will the next Blockbuster Drug come from?

This is the question investors and pharma boards are asking. Now the COVID feeding frenzy is over, there is nothing in the pipeline. Big Pharma companies below are spending $billions on underfunded and under resourced Biotech’s:

I’d recommend subscribers keep an eagle eye on the pharmaceutical press, to keep up-to-date with the patent cliff looming over the entire industry.

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[first published November 2022]

It’s not a secret—Fierce Pharma is reporting it!

FiercePharma is reporting horrific FDA findings at facilities manufacturing the SARS-CoV-2 injections. In spite of this proven substandard manufacture, they are still pumping out products that are potentially adulterated—which means they should cease production immediately. Let’s take a look at some of what Fierce Pharma has published, including copies of the reports FDA issued:

Moderna's new booster launch tripped up by production issues at Catalent plant

“On Tuesday night, the FDA released (PDF) a Form 483 notice it had sent to Catalent, citing 12 observations from a lengthy August inspection of its Bloomington, Indiana, site. The massive facility is among the largest in the portfolio of contract manufacturing powerhouse Catalent. Most of the observations had to do with quality control, record keeping and the failure to establish and follow procedures. The FDA noted a failure to address unexplained discrepancies in a batch of drug product.”

See FDA inspection report: FDA Form 483 (note: an FDA Form 483 lists all the deficiencies found by FDA Inspectors).

Rentschler slapped with FDA Form 483 citing lax manufacturing procedures

[Rentschler produces the Pfizer/BioNTech Drug Substance, aka active pharmaceutical ingredient].

“Inspectors found the facility’s simulated fill process lacked a revolutions-per-minute specification for the pump and that there was no documentation for RPM settings during drug substance dispensing. Additionally, two pieces of equipment had discolored rings below the top of the assembly, but no cause for the discoloration was indicated and no formal risk assessment or corrective action to address the discoloration had been taken, inspectors said.

The regulatory agency also cited the plant for not having lab procedures or testing to assure compliance with established specifications and standards available. Other equipment supporting manufacturing operations were not adequately validated, either, the FDA said.”

See FDA inspection report: FDA Form 483

Catalent’s Belgium operations get a second FDA scolding within 1-year span [Catalent again slammed by FDA]

“In the wake of an FDA inspection conducted between August 10 and August 18 at the Brussels plant, the company received a total of nine observations. Inspectors highlighted problems with air filters in aseptic areas, deficient changes to the HVAC system, and other equipment-related issues. Additionally, inspectors found that backup data was not being verified, and the facility lacked procedures for “receiving and control of customer designs."

See FDA inspection report: FDA Form 483

Why no action from FDA—it has the powers?

Many critical thinkers reading this won’t be surprised at the lack of action. We know that the contracts Governments and its agencies signed offered no protection for unsuspecting people who believed the historic good practices of developing, manufacturing and distributing drugs were still being observed.

All I can say is that Mother Nature has a wonderful way of bringing liars and scoundrels to book, even if it takes a very long time!

Fast forward to today: Catalent is sold to Novo Nordisk!

This time, the FDA has got them, under the new leadership of FDA, and the new ownership of the unfortunate Novo Nordisk.

FDA slaps Novo Nordisk with warning letter over former Catalent site in Indiana

“The U.S. Food and Drug Administration has issued a warning letter to Novo Nordisk regarding a former Catalent site in Bloomington, Indiana — acquired in late 2024 by the Danish drugmaker — which continues to be hit with regulatory actions.

“This warning letter summarizes significant violations of current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals,” the FDA wrote to Novo Nordisk CEO Maziar Doustdar. “Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to cGMP, your drug products are adulterated within the meaning of … the Federal Food, Drug, and Cosmetic Act.”

Among the cGMP violations, the agency’s warning letter — dated Nov. 20, 2025 and posted on the FDA’s website last week — called out Novo Nordisk’s inadequate investigations into drug product failures and discrepancies, which “often concluded that no drug product was impacted because finished sterile drug product test results (e.g., sterility, endotoxin, and environmental monitoring) were within specifications.”

The question remaining now is: “will FDA revisit the decision of the previous leadership, based on the comment in the article above:

“After quietly withholding millions of Moderna’s newly formulated COVID-19 booster doses because of manufacturing issues at a Catalent factory in Indiana, the United States has reportedly released the shots.”

Watch this space…!

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SUMMARY

· UK Government has been meeting with Big Pharma since 2001, through the Ministerial Industry Strategy Group.

· This was a ‘reciprocal’ arrangement whereby the UK Government would benefit from the profile and profitability of the pharmaceutical industry at the time.

· This is the inaugural meeting of the MISG: MINISTERIAL INDUSTRY STRATEGY GROUP, WEDNESDAY 21 NOVEMBER 2001, The Cathedral Room, Richmond House:

· Attendees include the CEO of AstraZeneca and the CEO of GlaxoSmithKline (at the time):

· Sir Richard Sykes (Industry) later became Chair of the Vaccine Task Force, following on from Kate Bingham: UK Vaccine Taskforce 2020 Achievements and Future Strategy: End of year report

· Page 27 of the above Report shows Ian McCubbin, OBE, as Manufacturing Advisor - former Senior Vice President for Global Manufacturing and Supply at GSK. He is identified as a team member.

· Ian McCubbin was previously at the 9^th July 2014 meeting of MISG, below, while still being employed by GSK:

· These are the minutes: MINISTERIAL (Bio-Pharmaceutical) INDUSTRY STRATEGY GROUP, 9th July 2014, 9.30am – 11:30am, Board Room, Richmond House, Whitehall

· Ian McCubbin is now Chair of Innovate UK Cell and Gene Therapy Catapult: Press release: Cell and Gene Therapy Catapult appoints Ian McCubbin OBE, CBE, as Chair of the Board, 14th January 2022

· These are the CEOs of the nine UK Catapults funded by Innovate UK: Our Team: Meet the Catapult CEOs

· Innovate UK is a council of UK Research and Innovation.

· Further details can be presented on request.

· Also available and free to access is A step-by-step guide to the SARS-CoV-2 Injections Fraud and MY CURRICULUM VITAE—AND WHY IT IS IMPORTANT IN STOPPING THE SARS-CoV-2 INJECTIONS.

The Covishield Scandal (2025)

Words could not begin to explain the misery endured by the vaccine injured in the UK - and the rest of the world, which is still to be revealed.

You will find me in there, as a supply chain expert, commenting on the supply chain malfeasance.

NO FURTHER WORDS REQUIRED

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Trevor Mundel, President, Global Health, BMGF

Trevor Mundel, President, Global Health at the Bill and Melinda Gates Foundation has been employed by the #BillGatesFoundationCrooks for 11 years.

Here is Mundel speaking at the John Hopkins University March 2014:

Trevor Mundel: Global Health Needs Innovation

Quotes from the article:

“Mundel alluded to a new malaria eradication strategy by the Gates Foundation that addresses the vast asymptomatic reservoir of people. Mass drug administration will be key, he said, enormously difficult though that will be given the breadth of the malaria epidemic.  “We need all your keen insights in order to make this fly,” he added.

Mundel also highlighted the Gates Foundation’s other focus areas, including neglected infectious diseases, enteric and diarrheal diseases, pneumonia and, of course, polio.”

“Mundel described the Gates Foundation’s relationship with Hopkins as “broad and deep.” In terms of grants—not only those from a purely technical academic research perspective, but also very practical applied work in the field—Johns Hopkins ranks as the No. 1 institution the Gates Foundation works with, he said.”

As subscribers, you will be aware of the role John Hopkins played in the global scaremongering campaign.

Here we have Mundel speaking more recently:

Developing COVID-19 therapeutics: An investment that needs to happen

One of the questions posed is:

“Have there been public-private initiatives like COVID-19 Therapeutics Accelerator before?”

The lies spill out as they do for every question he answers (here by omission):

“Yes, there are comparable examples going back to the Second World War. Pharmas worked with governments to accelerate the identification and development of antibiotics based on Alexander Fleming’s initial discoveries from the late 1920s. This collaboration played a critical role in saving the lives of wounded soldiers.”

He missed out the fact that it took 15 years to bring penicillin to market, and Fleming was just one party in the effort, read more here:

Quote: “The paper explains that while Alexander Fleming discovered strong evidence that a mould he found in a culture dish on return from holiday was killing bacteria, he lacked the skillset to isolate the active ingredient within the mould.

It took over ten years before a team at Oxford University, headed up by Howard Florey, was able to isolate the active ingredient…”

…Read the official story from Bob Gaynes:

The Discovery of Penicillin—New Insights After More Than 75 Years of Clinical Use

This is Mundel using the myth that Big Pharma has propagated to make people believe medicines can be developed and manufactured “by accident” - eg 9 months.

Finally, this speaks to Novartis’ approved gene therapy product, given the thumbs up from FDA August 2017. Read the shocking truth here:

GENE THERAPY AND ITS SUPPLY CHAINS ARE NOT WELL UNDERSTOOD

Quote - this is the warning on the Label:

“WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES

• Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving KYMRIAH. Do not administer KYMRIAH to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab, or tocilizumab and corticosteroids

• Neurological toxicities, which may be severe or life-threatening, can occur following treatment with KYMRIAH, including concurrently with CRS. Monitor for neurological events after treatment with KYMRIAH. Provide supportive care as needed

• KYMRIAH is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS”

The viral vector is manufactured by the same company that manufacturers the AstraZeneca/Oxford University jab, Oxford Biomedica, think on…

…check out:

AstraZeneca didn't develop the COVID vaccine, Oxford Biomedica did, with a little help from its friends

In May 2017, a paper was published by Robert P. Gaynes, MD.

Titled The Discovery of Penicillin – New Insights After More Than 75 Years of Clinical Use. It presents a dramatic re-interpretation of the penicillin story. It explains in detail how Governments, pharmaceutical companies, physicians, regulators, universities and other key stakeholders worked together collaboratively to bring penicillin to market.

This is in direct contradiction of the commonly held perception that penicillin, and its role in fighting infection for patients globally, was an accidental finding.

The paper explains that while Alexander Fleming discovered strong evidence that a mould he found in a culture dish on return from holiday was killing bacteria, he lacked the skillset to isolate the active ingredient within the mould.

It took over ten years before a team at Oxford University, headed up by Howard Florey, was able to isolate the active ingredient. They were able to make enough to produce small quantities for pre-clinical and clinical trials, which resulted in increased evidence that the compound could beat infection.

They lacked the skills, however, to make the kind of quantities that would be required to service the enormous market awaiting this breakthrough treatment. In June 1941, Florey and his fungal expert colleague Norman Heatley, travelled to the United States.

They meet with Charles Thom and Andrew Jackson Moyer, both with the US Department of Agriculture (forerunner to US FDA). Moyer suggested changes to the manufacturing process that resulted in “exponentially greater amounts of penicillin” being produced.

This led to successful mass production of penicillin to satisfy the demands of the World War II. The article comments

“Unprecedented United States/Great Britain cooperation for penicillin production was incredibly successful.” Moyer applied for a patent of the manufacturing process in 1945, which was granted in 1948.

The paper explains “The Fleming Myth” was down to an article in The Times following an interview with Fleming, but Florey and his staff refused to comment.

This myth has become hard coded into the industry psyche, perpetuating a public illusion that medicines are ‘discovered’ through serendipitous findings of a new molecular entity.

Our vitally important message here is that until a medicine can be manufactured to the scale necessary to supply the projected patient population, if does not exist.

Note also that the patent was awarded to Moyer in 1948 for the manufacturing process – there was no patenting of the molecular compound.

WHAT DOES THIS MEAN FOR THE FUTURE OF MEDICINES?

There is good news, and there not so good news.

On the plus side, it tells us that if Fleming, Oxford University and the USDA (Moyer) had been working together as soon as the discovery was made by Fleming, it would have taken roughly a quarter of the time to get to market. Imagine that!

The not so good news is that pharmaceutical companies don’t want you to know that—not good for the business of creating patent monopolies to market the bones out of and create blockbusters ($1Bn+ sales).

Rest easy though, there is more good news. The penicillin myth, and much, much more, is covered in my book Medicines for the 21st Century: Safe, Better, Cheaper.

Slightly more less than good news, it’s not published yet…

…but it will be soon! More good news to finish with!!!

[This is a re-post from May 2023]

More shocking revelations from Truth for Health Foundation Whistleblower podcast

As already mentioned, I’ve teamed up with Dr Lee Vliet, President and CEO of the Truth for Health Foundation.

Last week’s Whistleblower Report, FDA Malfeasance Exposed: Director Peter Marks Ignores Safety was another great session lifting the lid on what big Pharma has in store for us. It begins:

“FDA’s CBER Director, Peter Marks, seems focused on seeking power as a global leader promoting gene therapy mRNA shots for all humanity rather than on his US-taxpayer job to protect the safety of vaccines being manufactured for Americans.

He was recently in London to promote gene therapy mRNa shots (deceptively called “Advanced Therapies”) at the World Congress of global elites and has been a major player on the world stage to push “warp speed” use of mRNA gene therapy technology for all vaccines, for humans and animals. Marks, 57, Director of FDA’s CBER Department, has played a key role in nearly every major vaccine-related decision since the United States COVID-19 outbreak began.”

So, while we are all fighting to stop the shots, Big Pharma and its enablers are merrily cruising along, creating new, lucrative markets for its poison jabs.

This is something I prepared earlier

This is something I’ve covered before, highlighting the conferences that were debating the ins and outs of every aspect of gene therapy you could think of, written in highly scientific language, such as:

“Leveraging non-Coding RNAs to Establish the Next Wave of RNA Therapeutics.”

Trust me, it’s a load of mumbo jumbo aimed at conning investors into buying shares—the sky’s the limit!

Take a look in and decide for yourself if you’d like to invest in this lot :O)

INSIDE PHARMA

While the world is fighting mRNA jabs, pharma embraces them with open arms—oh, and pockets!

The gold rush carries on apace There are so many questions to be answered on the safety, efficiacy, and quality of the Pfizer and Moderna mRNA jabs. Who would blame you for believing that those two companies will be keeping their heads down until the dust clears…

Read more

4 years ago · 12 likes · 16 comments · Hedley Rees

What’s coming down the pipe?

Well, we have this:

11th International mRNA Health Conference

By golly, it’s been going since 2013:

1st International mRNA Health Conference

…and we have this:

Gene Therapy Development & Manufacturing 2023, 13 - 14 June 2023 | London, UK

“Join over 250 scientific leaders engaging in scientific discussions on the latest strategies and technologies to accelerate gene therapy production.”

…and this:

Helping to advance the next pillar of medicine, January 30 – February 2, 2024.

“Advanced Therapies Week is the destination to form partnerships, by day, and by night.”

We’ve got to get ahead of them to stop them

The takeaway from this is that the cosy relationship between regulators and stakeholders in the development and supply of these jabs, or any other kind of medicinal products, must be stopped. Then, we are starting to get ahead of them, so’s as to cut them off at the pass (been watching too many cowboy films…!).

Be back soon.

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What happened

Tracy Beth Høeg, acting director of the FDA’s Center for Drug Evaluation and Research (CDER), announced on 15 May 2026 via X: “Today marked 6 months as head of CDER at FDA & today I was fired.” She told outlets she was first asked to resign, refused, and was then dismissed. She said the order came from “someone way above their pay grade,” suggesting it originated outside the FDA itself.

Context

Her firing came just days after FDA Commissioner Marty Makary resigned, amid reported White House unhappiness with his tenure. The departure was part of a broader shake-up — the acting head of the biologics division (Katherine Szarama) and the FDA Chief of Staff also departed simultaneously.

Possible reasons

No official explanation was given, but reporting points to a few factors:

• She had recently clashed with FDA staff over the approval of Sanofi’s type 1 diabetes drug Tzield, blocking a label expansion that staff supported — creating friction

• She was a Makary ally, and his resignation may have triggered a wider clean-out of his appointees

• Her unconventional background (sports medicine physician and epidemiologist, no prior drug regulation experience) had drawn scrutiny

Her replacement as acting CDER director is Dr. Michael Davis, the former deputy director. Høeg was the fifth person to lead CDER in under a year, reflecting the ongoing leadership instability at the agency.

What was she doing on NAMs

During her six months heading CDER, Høeg was involved in driving the FDA’s NAMs agenda (Use of New Approach Methodologies in Drug Development), which was one of the more substantive policy areas under her tenure. Key things she was associated with:

Draft Guidance on NAMs (March 2026)

CDER issued a draft guidance in March 2026 titled “General Considerations for the Use of New Approach Methodologies in Drug Development.” This was the primary deliverable under her watch — a validation framework for sponsors wanting to use NAMs (organoids, organs-on-chips, in silico modelling, 2D/3D in vitro systems) in place of, or alongside, animal studies in regulatory submissions. It set out four core principles: context of use, human biological relevance, technical characterisation, and fit-for-purpose.

Broader Strategic Direction

This guidance fed into a wider FDA roadmap to reduce animal testing announced in April 2025 — before Høeg became CDER director — with the goal of making animal studies “the exception rather than the norm within three to five years.” Høeg carried that agenda forward through the draft guidance.

Congressional Context

Separately, a bipartisan FDA Modernization Act 3.0 was moving through Congress during this period, which would require FDA to formally update its regulations to replace references to “animal testing” with “nonclinical testing” — consistent with what the draft guidance was already encouraging in practice.

So NAMs work was one of the more constructive things happening under her leadership, even as her tenure was otherwise controversial. Given my supply chain and CMC background, the NAMs shift has significant implications for nonclinical development strategy and IND-enabling packages — the draft guidance is worth reading if you haven’t already.

I’m concerned that the fda is losing good leadership (Makary, Prasad, Høeg, Tidmarsh) due to political lobbying.

The recent departures aren’t random — they follow a recognisable pattern of political appointees clashing with industry interests and then being removed. Vinay Prasad left after intense criticism from drugmakers, patients and investors. Høeg explicitly said she “didn’t give in to any pressures to approve drugs when it wasn’t appropriate” — and was fired shortly after blocking the Sanofi Tzield label expansion against staff recommendation. Whether that specific decision was right or wrong, the optics of a drug regulator being removed after refusing an approval are deeply problematic.

The Structural Problem

The FDA has always faced regulatory capture risk — the revolving door between industry and agency is well documented. What’s different now is the speed and visibility of the churn. CDER has had five directors in under a year. That kind of instability makes it almost impossible to:

• Maintain institutional memory on complex review decisions

• Defend scientifically grounded positions against external pressure

• Retain career scientists who see political appointees overruled or removed

The Counterargument

Some of the departed figures were themselves controversial — Prasad and Høeg were both aligned with RFK Jr. and held heterodox views on vaccines and established therapies. Critics would argue the FDA needs stability and scientific orthodoxy restored, not just defended from industry.

The Net Effect

Regardless of where individuals stood politically, the constant leadership turnover hollows out the agency’s capacity. Industry may win individual battles through lobbying pressure, but a weakened FDA ultimately increases regulatory unpredictability — which is bad for everyone, including industry. From a pharma supply chain and CMC perspective, regulatory uncertainty at CDER translates directly into delayed approvals, inconsistent guidance, and harder planning decisions for sponsors.

It’s a systemic problem that goes beyond any one administration.

The world cannot go on with this amount of churn in what is, from my professional observations and experience, an FDA returning to its former gold standard status.

Someone needs to tell President Donald Trump!

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The Elevidys story

There is a moment in the Elevidys story that tells you everything you need to know about the state of pharmaceutical regulation. It is June 2024. Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy has just failed its pivotal Phase 3 trial. The FDA’s own clinical reviewers, pharmacology team, and statisticians have all concluded that the drug does not work — or at least that the evidence does not establish that it does. And yet Peter Marks, Director of the FDA’s Centre for Biologics Evaluation and Research (CBER), overrules all three of them, grants full approval, and expands the label to cover non-ambulatory patients — those whose disease has already progressed to the point where they can no longer walk.

The drug costs $3.2 million per patient. Within a year, teenagers are dying from acute liver failure after receiving it.

This is not a story about one rogue regulator. It is a story about a system that has been engineered — piece by piece, over many years — to make this kind of outcome not just possible, but predictable.

A pattern hiding in plain sight

Elevidys was not the first time Sarepta had navigated this particular route to market. In 2016, the company’s exon-skipping therapy eteplirsen was approved for DMD by Janet Woodcock at the FDA, again over the objections of her own review staff, again on the basis of a surrogate endpoint rather than demonstrated clinical benefit. The agency’s advisory committee had voted against approval. The chief medical officer at the time resigned in protest.

Sarepta had learnt something important from that episode: the FDA could be moved. Patient advocacy groups, wielding the moral weight of dying children and the political optics of denying them hope, combined with a company willing to fight publicly and loudly, could shift the regulatory outcome. The scientific consensus inside the agency was not, it turned out, the deciding factor.

By the time Elevidys arrived — first as an accelerated approval in June 2023, then as a full approval in June 2024 — the playbook was well established.

The accelerated approval problem

Accelerated approval was designed as a compassionate pathway. It allows drugs to be approved on the basis of surrogate endpoints — biomarkers or measures that are thought likely to predict clinical benefit — on the condition that confirmatory trials are run and real-world benefit is subsequently demonstrated. It was a reasonable idea, born from the AIDS crisis of the 1980s and the urgent need to get promising therapies to dying patients faster.

What it has become, in too many cases, is a mechanism for getting drugs to market on thin evidence and keeping them there even when the confirmatory data disappoint. Elevidys was approved on the basis of micro-dystrophin expression — the ability of the therapy to produce a shortened but functional form of the dystrophin protein. When the Phase 3 EMBARK trial results landed, the primary endpoint — a composite functional motor score — was not met. The drug produced the protein. Whether that helped patients move, breathe, or live longer remained unproven.

Peter Marks had the authority, and the obligation, to take that evidence seriously. Instead, he converted the accelerated approval to full approval and broadened the patient population. His own agency’s scientists had told him not to.

Three deaths, and a reckoning

The consequences arrived in 2025. In March, a teenage non-ambulatory boy died from acute liver failure less than two months after receiving Elevidys. In June, a second teenage non-ambulatory patient died the same way. In July, a third death — this time a 51-year-old patient in a clinical trial using the same AAVrh74 viral vector that underpins Elevidys. Sarepta’s share price collapsed 42% on the second death.

Liver toxicity is a known risk with adeno-associated virus gene therapies. It was in Elevidys’ prescribing information. What was not in the label — and what the deaths made unavoidable — was a black box warning for acute liver failure and death.

Vinay Prasad, who had succeeded Marks as CBER Director in May 2025, was unsparing in his assessment. Marks, he wrote on X, had “overturned 3 reviewers to approve a gene therapy that seems to be killing children and blowing their livers up.” The language was intemperate, perhaps, but the underlying charge was accurate.

On 18 July 2025, the FDA placed a clinical hold on Sarepta’s limb-girdle trials, revoked the company’s platform technology designation, and requested a voluntary suspension of all Elevidys shipments — including for ambulatory patients, where the deaths had not occurred. Sarepta refused. The company argued, not unreasonably, that the safety signal was in non-ambulatory patients and that ambulatory patients were being denied a therapy that might benefit them. Three days later, under pressure, Sarepta relented — citing the need to maintain a “productive and positive working relationship with FDA.”

That phrase deserves a moment’s reflection. A company that had initially defied a federal regulator’s safety request ultimately complied not because the science demanded it, but because the commercial relationship required it. The agency, meanwhile, was being torn apart from the outside: rare disease advocates, political figures, and media voices mounted an intense campaign against Prasad for being too restrictive. He resigned. Then returned ten days later. Commissioner Makary subsequently resigned too.

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What this tells us

It would be convenient to lay all of this at the feet of Peter Marks. He made poor decisions, repeatedly, in the face of clear scientific advice. But the system that allowed him to do so — that in fact incentivised him to do so — is the more important subject.

The accelerated approval pathway creates perverse incentives. Companies invest heavily in patient advocacy, knowing it moves regulators. Regulators, in turn, face enormous public pressure to approve therapies for conditions where no alternatives exist, and enormous reputational risk if they are seen to deny hope to desperate families. The scientific staff who do the careful work of reviewing evidence find themselves overruled by senior officials who are navigating political, commercial, and media dynamics that have nothing to do with the data in front of them.

This is financialisation applied to regulation. The same forces that have hollowed out pharmaceutical manufacturing — the prioritisation of speed, return on investment, and market positioning over slow, careful, evidence-based development — have now reached deep into the regulatory apparatus itself. The FDA is not immune to the industry’s pathologies. It is shaped by them.

A different playbook

Peter Marks, now outside the agency, has been calling for a new regulatory framework for gene therapies — one based on process validation rather than product-by-product clinical packages. There is something to be said for the idea. But it is worth noting that the man proposing a new system is the same man whose decisions under the old one led to three deaths and a crisis of institutional credibility.

The structural reforms needed go further than any one approval pathway. They require insulating scientific reviewers from political override. They require post-approval surveillance that is robust enough to catch safety signals before they become fatalities. They require honest reckoning with the limits of surrogate endpoints — and with the commercial interests that make surrogate endpoints so attractive to everyone in the room except the patient receiving the therapy.

The Elevidys story is not finished. Sarepta’s AAVrh74 vector has since received a new FDA platform technology designation. The regulatory rehabilitation is already underway.

The children who died cannot be rehabilitated. They deserved better from a system that was supposed to protect them.

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Open letter to Dr Robert Califf, FDA Commissioner

This is an open letter on my PharmaFlow website, dated June 9, 2024. It outlines communications I had been having with FDA staff at the FDA’s Center for Biologics Evaluation and Research (CBER):

“Dear Dr Califf,

This is an open letter in follow-up to a question I have submitted to the FDA’s Center for Biologics Evaluation and Research (CBER). The question is repeated below:

Dear FDA,

My question relates to FDAs release of the Moderna booster vaccine, reported in a Fierce Pharma article dated September 21, 2022, titled:

Moderna’s new booster launch tripped up by production issues at Catalent plant: reports

This is a short excerpt:

On Tuesday night, the FDA released (PDF) a Form 483 notice it had sent to Catalent, citing 12 observations from a lengthy August inspection of its Bloomington, Indiana, site. The massive facility is among the largest in the portfolio of contract manufacturing powerhouse Catalent. Most of the observations had to do with quality control, record keeping and the failure to establish and follow procedures. The FDA noted a failure to address unexplained discrepancies in a batch of drug product (DP).

The detailed findings of highly experienced inspectors, although redacted in parts, paint a picture of deep systemic failure at the Bloomington facility. Each of the 12 observations in the 18 page report demonstrate critical non-compliance with cGMP.

Even more surprisingly, the article reveals that the Bloomington facility had received a previous Form 483 during August 27, 28, 31, September I, 2, 2020, stating:

The first sign of trouble at the Bloomington plant came in September of 2020, when the FDA cited (PDF) the company for a lack of procedures to prevent contamination.

You will no doubt appreciate that contamination of biological products is an instant ‘red flag’, given that these vaccines are ‘sterile injectables’. Contamination renders the products non-sterile, presenting serious risk to patients. Surely, this was an important ‘early warning’ that was missed by the FDA?

At the very least, one would expect the FDA to exercise its powers, such as issuance of a consent decree, to provide greater reassurance that the Form 483 inspection report observations were remediated to FDAs satisfaction. You will remember that FDA deployed a consent decree when Johnson & Johnson’s McNeil failed to remediate quality issues from 2007 – 2011, as detailed by Warren Adis, Hagan School of Business, Iona College, below:

McNeil, a Johnson & Johnson Subsidiary: FDA Case Study.

Finally, my question above ended:

I wish to better understand the decision-making process within the FDA that authorized resumption of production at the Bloomington facility, given the extensive Form 483 issues identified, such as shipping products prior to quality release.

I look forward to your urgent response to my question.

Yours sincerely,

Hedley Rees

Managing Director, PharmaFlow Ltd.

I had no way of contacting Dr Califf as I do not reside in the US, and therefore have received no reply.

My last post referenced an open letter to the interim Chair of UKs MHRA, Professor Grahame Cooke, where I did receive a reply, after 3 months, that left me none the wiser, see:

Why am I sharing this now?

Global country regulatory authorities (eg FDA/EMA/MHRA/TGA) have many questions to answer as to why they failed to exercise their legal powers during the COVID plandemic.

The above, and many other questions, are still absent from the public domain.

No harm in asking questions, eh?!

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DISCOVERY RESEARCH ‘FINDS’ A MOLECULE

In most industries, supply chains are created as part of a new product development program. The developers work together, consulting product end-users, producers, and distributors to ensure the physical supply chain they put together can deliver what is required by consumers.

For reasons we shall go into later, pharmaceutical new product development does not follow the customary approach of other industries. Rather than beginning with a consumer and working upstream to the beginning, the process begins with a patented compound and moves forwards.

This results in supply chains ‘evolving’ with the passage of time, rather being designed and planned with the consumer in mind.

The ‘R’ of R&D (Discovery Research) discovers (or finds) molecules using advanced technologies such as molecular modelling. Once it is confirmed a patent is in place, promising compounds are handed to ‘D’ (Development).

PRODUCT DEVELOPMENT HAS TO FILE IT WITH THE REGULATORS

Development is a completely new team of specialists responsible for building a supply chain for pre-clinical testing initially. That means proving the test compound that will be produced by the supply chain is safe to study in humans. For small molecule products (made by industrial chemistry), around 5 – 10 kilograms of compound will be produced.

Figure 5 shows a typical small molecule product supply chain for the production of the active pharmaceutical ingredient (API).

Figure 5. Production of API for preclinical testing

The production process is devised by a ‘route scout’ (process chemist). Their job is to convert a laboratory process that had only ever produced small gram quantities, into a process that can yield much larger quantities. The skill involved is about making the process as efficient and ‘manufacturable’ as possible.

A small-scale pilot plant is normally used at this stage, as the volume is not sufficient to justify occupation of commercial-scale plant. Figure 5 shows

Sources of raw and starting materials will be selected by the scientists working on the project. In this case, there are intermediate chemicals involved. Intermediate stages are not always required; it depends on the chosen route of synthesis.

Once produced, the API is transported for safety testing at one or more chosen Contract Research Organisations (CROs).

Even though this appears to be a simple supply chain, there is already an array of suppliers and service providers involved, often spanning the globe. Remember, raw, starting materials and intermediates are sourced primarily from China and India, so ex-Asian countries are operating a long way from home.

For Western companies, this puts a limit on due diligence in selecting sources, and oversight when selected sites are in operation. It also adds significantly to lead-time and complexity.

FROM SAFETY TESTING TO STUDIES IN HUMANS

If it looks like the results support moving to studies in humans, the company will fill out and submit an Investigational New Drug application (IND), a Clinical Trial Application (CTA) in UK/EU.

The IND must include all the details about the supply chain and safety data. If approved by the Regulatory Authority (RA), the company will be awarded an IND and is designated a clinical trial sponsor (CTS).

The CTS will plan to produce product for the first stage of clinical trials - phase I studies in healthy volunteers. The compound being studied is known as ‘test material’.

This is the beginning of an application to market the product, known as a New Drug Application (NDA) or Biological License Application (BLA) in the US, and Marketing Authorisation Application (MAA) in UK/EU.

The programme of work that needs to be carried out by the CTS to prove quality, safety and efficacy is laid down by the RA in the Common Technical Document (eCTD). The details of the end-to-end supply chain have to be specified in Module 3 of the eCTD.

THE COMMON TECHNICAL DOCUMENT (eCTD)

The eCTD is the template that must be used to submit a licence application to market a drug. This format has been agreed by RAs globally following regulatory collaboration and the work of the International council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Below is the agreed pyramid structure providing an overview of what is required:

Figure 6. Common Technical Document (electronic)

The three modules are at bottom of the pyramid:

• Module 3: Chemistry, manufacturing & controls (CMC or Quality)

• Module 4: Nonclinical Study reports

• Module 5: Clinical Study Reports.

The sections above the modules provide overviews and summaries.

Module 3 is titled ‘Chemistry’. This is short for ‘chemistry, manufacturing, and controls’ (CMC). The CMC section of the dossier is where all the details about suppliers, manufacturers, material and product specifications, test procedures, etc must be declared.

To gain approval from FDA, the production facilities making the active pharmaceutical ingredient (API) and drug product (DP) must undergo a thorough physical inspection by suitably qualified inspectors. These are known as pre-approval inspections (PAIs).

There is an amount of regulatory flexibility when it comes to standards in the supply-chain for producing preclinical test material, given the early stage of development. For trials in humans, however, production in the supply-chain must comply with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).

The clinical trial supply chain, Figure 7, shows the extension of the supply-chain stages into production of the dosage form and clinical trial kits, to be shipped into storage awaiting call-off from study site locations.

Each additional stage is likely to be in different parts of the world, with a number of different service providers at each stage.

Figure 7. Production clinical trial supply chain

When the time comes to submit the regulatory filing (NDA/BLA/MAA, the Regulatory Authority mandates that all data are collected and submitted using the eCTD format.

WHO WAS THINKING ABOUT THE SUPPLY CHAIN TO MARKET?

You may be surprised to learn that no-one is thinking about the supply chain that will be required to support a market launch—all the thought and effort went into collecting the data required by the RA to award an approval.

Food for thought?

A MAJOR BREAKTHROUGH FOR TYPE 1 DIABETICS

In 1921, on a shoestring budget at the University of Toronto, several young scientists began investigating a possible treatment for Type 1 diabetes. They found that by grinding up and purifying animal pancreases and then regularly injecting the material, they could treat Type 1 diabetes in dogs.

After first testing the drug for safety by injecting themselves, the scientists treated a 14-year-old boy with Type 1 diabetes. His recovery was almost miraculous, going from death’s door to good health in a matter of weeks.

By 1923, the scientists had won the Nobel prize and the treatment had entered mass production in collaboration with Eli Lilly and Company and the Swedish organisation Nordisk.

The scientists patented the drug and sold it to the University of Toronto for three dollars, (one dollar for each researcher), thinking that this was the best way to ensure that affordable treatment would be available to everyone who needed it.

TYPE 1 DIABETICS TAKEN HOSTAGE BY BIG PHARMA

With a fast forward to the future, fast-acting ‘analog’ insulins were pioneered with Lilly’s ‘HumaLog’ in 1996, but when Novo Nordisk entered the market four years later with its own analog insulin, ‘NovoLog’ prices did not decrease due to competition.

Instead, Lilly and Nordisk followed each other closely in an exponential price increase. When HumaLog was first introduced, it cost $21.

At the time of writing (2019), HumaLog cost [$295.35] per vial and NovoLog costs [$296.27].

The older ‘human’ insulins like ‘Humalin’ are less expensive, but far less effective in treating Type 1 diabetes—yet even these primitive insulins have increased dramatically in price since their introduction in 1982.

THE TRAGIC CASE OF ALEC RAESHAWN SMITH

The HPR article ‘How Insulin Became Unaffordable’ recounted the tragic case of Alec Raeshawn Smith whose body stopped producing insulin when he was 24—he had become a Type 1 diabetic.

The article goes on: ‘For two years, Smith managed his condition relatively well. But it wasn’t easy financially. On May 20, 2017, Smith turned 26, ageing out of his parents’ insurance.’

He didn’t qualify for government assistance with his insulin payments, and when he went to pick up his insulin in early June, the bill was over $1300 without insurance. He couldn’t afford the medicine that day and decided to ration his remaining insulin until he was paid. He didn’t tell his family.

On June 25, Smith went to dinner with his girlfriend where he complained about stomach pains. It was the last time anyone saw him alive. He called in sick to work the next day. On June 27, Smith was found dead in his apartment.

RIP Alec Raeshawn Smith.

Our hearts go out to his mother, Nicole Smith-Holt, his family, and all those who knew and loved him. Impossible not to shed a tear over this sickening tragedy, nor wonder how the executive boards within those companies sleep at night.

SARS-CoV-2 INJECTIONS JUST PART OF THE GAME

This is stark evidence of the game big pharma companies have been playing for decades. The game is holding patient populations hostage to their essential medications, then price-gouging.

If they are not essential, they create that perception with sales & marketing muscle, and price-gouge again.

The counter is to stop ‘easy to get’ patents that create the monopolies to price-gouge.

More on that soon…

Hedley

[First posted June 2024]

The Rock Solid Evidence provided by FDA

As subscribers may know, I have been in communication with the FDA’s Center for Biologics Evaluation and Review on the topic of facility inspections that unearthed deep manufacturing issues in facilities producing the SARS-CoV-2 injections drug substance (DS) and drug product (DP). This relates to Pfizer/BioNTech and Moderna.

FDA has been incredibly cooperative, and that is the way I have known them to be ever since me and my company, PharmaFlow, began working with them in 2010.

Yes, through this whole debacle, there has been interference at the top, but the inspectors in the field have still been doing their highly important work identifying issues.

This is what I’ve found out, beginning with a response to my FOIA:

“Dear Mr. Rees,

Thank you for speaking with me earlier today about your Freedom of Information Act (FOIA) request # 2024-5142. Please find attached the FOIA response from the Center for Biologics Evaluation and Research (CBER).

For your convenience, I did also find this document web posted via our CBER eFOI reading room and the file sharing platform box.com (https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/biologics-electronic-reading-room-efoia) and I believe it can be directly accessed here: https://fdahhs.ent.box.com/s/xaaal1mghm0wxl56iqeenyk2t396zueh/file/1525382845444

Sincerely,

Elizabeth Sly, M.S.

Branch Chief, ALFOIB

Phone:  240.402.8001

Email: Elizabeth.Sly@fda.hhs.gov

Access Litigation and Freedom of Information Branch (ALFOIB)

Division of Disclosure and Oversight Management  (DDOM)

Office of Communication Outreach and Development (OCOD)

Center for Biologics Evaluation and Research (CBER)

U.S. Food and Drug Administration (FDA)

This is a screenshot of the response letter:

This is a screenshot of the first page of the Establishment Inspection Report (EIR):

It states that a previous inspection in April/May 2019 resulted in the issuance of a three-item Form [FDA] 483.

What is an FDA Form 483? Here are frequently asked questions. The first two Q/As are:

Q: When is an FDA Form 483 issued?

A: An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant. Observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.

Q: What is the purpose of an FDA Form 483?

A: The FDA Form 483 notifies the company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.

If you think that’s not good news, wait until you hear this:

This is the Establishment Inspection Report that FDA provided:

Establishment Inspection Report FEI: 1222181. Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC. EI Start: 07/19/2021. Andover, MA EI End: 07/23/2021

It is 86 pages, so you may not have time or inclination to read it all, so I’ll pick out the key points.

The Signature Page at the end identifies the inspectors and their commitment to their findings:

• Kathleen R. Jones, Biologist, CBER/OCBQ/DMPQ/MRB1

• Ekaterina Allen, CSO, CBER/OCBQ/DMPQ/MRB2

• Anissa Cheung, CSO, CBER/OVRR/DVP

• Debra M. Emerson, CSO, Team Biologics

These are screenshots of discussions with management following the inspections. Some of it is redacted, but there is enough in there to indicate how bad things were, eg:

“Operators were observed kneeling on the floor and reaching under a cart to plug into an electrical outlet, placing MBRs (Batch Manufacturing Records) and printed SOPs (Standard Operating Procedures) and pens on top of SUMs being used in manufacture.”

More like that and worse below:

This would have been passed up the FDA chain of command

There can be no doubt that this will have been passed up the chain of command at FDA.

Did it land on the desk of Peter Marks M.D., PhD., Director - Center for Biologics Evaluation and Research (CBER).

The same Peter Marks that is pushing ahead with gene therapy for rare disease:

With Duchenne decision ahead, FDA’s Marks pushes for speedy gene therapy approvals

“In rare diseases, we need something now, not later,” said Peter Marks, head of the FDA office that reviews gene therapies, at a conference held Friday.

Peter Doshi, Senior Editor at the BMJ, has this evidence

Peter Doshi, Senior Editor at the BMJ, is in possession of this evidence, following this post below:

Hopefully, he will find it useful.

Will be back with more soon.

Regards, Hedley

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The Final Conclusion

[first published November 2024].

The Ministerial Industry Strategy Group (MISG)

If you live in the UK, or even if you don’t, did you know there had been a high-level meeting between UK Government Ministers and Global Big Pharma companies running, at least once a year, from 2001 to 2015?

This is screenshot of the inaugural meeting:

These are the Minutes:

MINISTERIAL INDUSTRY STRATEGY GROUP, WEDNESDAY 21 NOVEMBERq 2001, The Cathedral Room, Richmond House

You may not have time to click into the minutes (although they speak volumes), so I’m going to share some of the more telling bits. This is the Big Pharma opening:

“Welcome and Introductions

Tom McKillop (CEO, AstraZeneca) welcomed everybody to the first meeting of the Ministerial Industry Strategy Group. He said that the Pharmaceutical Industry Competitiveness Task Force (PICTF) had been a very successful exercise for both government and industry, and it was important to keep the momentum going. He pointed out that as well as the MISG, there was an Industry Strategy Group (ISG) which brought together senior officials from government and industry on a quarterly basis.”

Are you wondering why the CEO of a pharmaceutical company is Chair of such a high level government meeting? I did too when I first found these minutes when investigating what had gone on with SARS-CoV-2 injections. It didn’t take too long to work it out. The then Labour UK Government wanted to get a foot onto the pharmaceutical ladder to bring prosperity to Britain, and Kudos to itself.

Fast-forward to 2014, and we find the MISG has been re-branded as ‘Bio-Pharmaceutical’ only (with more than a hint of ‘genetics’ creeping in):

This time, Government is at the top, instead of industry…

…and it’s a heavyweight team of ministers on the case, eh? Rubbing shoulders with Big Pharma and its trade associations in no small measure.

Then there are two Guests - one of which is Ian McCubbin, who I met at GSK House in Brentford in 2012. It wasn’t a successful meeting in terms of me getting supply chain management consultancy work with GSK, but he did agree to buy four copies of my Wiley book for some of his staff…

…little did I know he was to become the the supply chain guy on the Vaccine Task Force working under Sir Richard Sykes. Today, he is also a Sir, and non-executive chair of the Cell & Gene Therapy Catapult based in Stevenage.

[Note: all of this is in the archives for paid subscribers with a deeper interest]

The following year was the final meeting, June 2015. Three names stand out. Pascal Soriot, Patrick Vallance, and Dr Ian Hudson.

The first two names will be familiar to you. The now Sir Pascal Soriot, CEO, AstraZeneca, and Sir and Lord, no less, Patrick Vallance. Need I say more?

The third is Dr Ian Hudson, CEO, MHRA, who later went to work for the Bill & Melanda Gates Foundation in 2019 - just in time for COVID!

These are the meeting minutes:

MINISTERIAL (Bio-pharmaceutical) INDUSTRY STRATEGY GROUP MINUTES

Attendees are listed as follows:

Government

• George Freeman MP Parliamentary Under Secretary of State for Life Sciences, DH and BIS

Industry

• Pascal Soriot CEO, AstraZeneca (Co-chair)

• Steve Bates CEO, BioIndustry Association (BIA)

• Alison Clough Acting CEO, ABPI

• Gary Hendler Senior Vice President & Global Corporate Officer Eisai Co Ltd

• John Kearney President of ABPI (General Manager UK & Ireland, Amgen)

• Jean-Christophe Tellier CEO, UCB

• Patrick Vallance President, Pharmaceuticals R&D, GSK

• John Young Group President Global Established Pharma Business, Pfizer Inc

Officials

• Rachel Cashman Head of Clinical & Scientific Policy & Strategy, Medical Directorate, NHSE

• Will Cavendish Director General for Innovation, Growth & Technology, Department of Health

• Professor Dame Sally C Davies Chief Medical Officer and Chief Scientific Officer, Department of Health

• Andrew Dillon Chief Executive, NICE

• Dr Ian Hudson Chief Executive, MHRA

• Tim Kelsey National Director for Patients & Information NHS England

• Peter Knight Deputy Director, Research Contracting, Information, Intelligence and Stakeholder Engagement, Department of Health

• Dr Nicole Mather Director, Office for Life Sciences

• Ruth McKernan CEO, Innovate UK

• Jonathan Mogford Director of Policy, MHRA

• Professor Sir Mike Rawlins Chair, MHRA

Government, with just one attendee, seems a bit outnumbered by industry, but what an array of the great and the good in UK health, science and regulation!

Now, the apologies in the minutes are probably the most interesting piece, as it reveals who else has been in on the meetings in more latter years, as follows:

Apologies

• Professor Sir John Bell Chair of OSCHR

• Sir John Chisholm Chair, Genomics England

• Sir Malcolm Grant, Chair, NHS England

• Rt Hon Jeremy Hunt MP Secretary of State, Department of Health

• Rt Hon Sajid Javid MP Secretary of State for Business, Innovation and Skills

• Jo Johnson MP Minister of State for Universities and Science, BIS

• Professor Sir Bruce Keogh National Medical Director, NHS England

• Ian McCubbin Senior Vice President NA, Japan and Global Pharma, GSK

• Haruo Naito CEO, Eisai Co Ltd

• Lord O’Neill Commercial Secretary, HM Treasury

• Fleming Ornskov CEO, Shire

• Professor Sir Mike Rawlins Chair, MHRA

• Professor Sir John Savill CEO, Medical Research Council

• Nick Seddon Prime Minister’s Office, No. 10

• Stephen Whitehead Chief Executive, ABPI

Returning to the original hypothesis

This is the hypothesis we began with in PART 1:

“The SARS-CoV-2 injections scam was perpetrated by Big Pharma companies such as Pfizer, AstraZeneca, Novartis, GSK, Sanofi et al, working in collaboration with its contract development and manufacturing organisations (CDMOs) and contract research organisations (CROs).

Part of the collaboration was to agree shortcuts in drug development, manufacture and distribution, that led to significant harm, including death, for some (innocent) people receiving the injections.”

Not only am I claiming that this hypothesis has been proven in the previous posts, but there is also a deeply concerning twist in the tale that emerged along the way, for me personally and professionally. This is the twist 👇👇👇

I was unknowingly and unwittingly part of what became to SARS-CoV-2 injections scam.

It’s a long story, and I haven’t been able to articulate it properly to those with the power to act, because it has been so difficult to cut through the ‘noise.’ Also, there’s the ‘controlled opposition’ in the US. But, here goes, anyway:

When my first book for Wiley, Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics, published in 2011, I became regarded as a visionary and thought leader in the industry. Along with that, I was vocally very active, especially on LinkedIn (10,000+ pharma connections) exposing the terrible impact of outsourcing all physical activities in drug development and manufacture to CDMOs and CROs. They kicked me off LinkedIn in the end. However, that’s another story.

In 2013, UK Government, via the Office for Life Sciences, asked me to consult to a gene therapy company, Oxford BioMedica, on the manufacturing supply chain for Novartis’ Kymriah (See FDA package insert and side effects) and this below:

Oxford BioMedica Wins Significant Funding via a Competitive Award from UK Government’s Advanced Manufacturing Supply Chain Initiative

You won’t see my name on there, but I spent 6 months working with them on putting the bid together and recruiting Cranfield University and ther Heart of England NHS Foundation Trust onto the project.

Also on the project was UKs Cell & Gene Therapy Catapult. We worked independently of each other. Its mission was to grow gene modified cell therapy (CAR T) in the UK, beginning with this project. Their interest was in growing themselves, rather than the manufacturing supply chain!

After the UK grant was awarded, c. end 2013, I was involved in a high-level Government meeting to discuss the future of medicines in the UK. GSK was represented by Roger Connor who later moved on to become President, GSK vaccines. During the meeting, I offered a few ‘helpful’ comments on some of their ideas and was shot down in flames.

At the end of it, they decided to set up the Medicines Manufacturing Industry Partnership (MMIP):

“The Medicines Manufacturing Industry Partnership (MMIP) represents the voice of medicines manufacturers in the UK. It was established jointly by the government and the biopharmaceutical industry in 2014 to ensure that the UK is recognised by the global medicines industry as a world-class advanced centre for medicines manufacturing.”

The MMIP has been operating ever since, while linking up with the cell & gene therapy catapult:

Anyway, back to the plot. That meeting was the first and last time I was involved in UK Government policy wrt to medicines manufacturing in the UK.

Fast-forward to 2020, and there was Oxford BioMedica developing and producing the adenovirus vector for AstraZeneca jabs! MHRA was approving a brand new OXBOX set of manufacturing facilities at breakneck speed without ever visiting the site:

Oxford Biomedica receives MHRA approval for the first two manufacturing suites in Oxbox

It was obvious they had driven a coach and horses through GDMP, and not in a small way! Also, the rolling review licencing process was fraudulent, as it missed out completely the chemistry, manufacturing & controls (CMC) aspects of drug safety (supply chain).

Ever since, I have been building an evidence base with my INSIDE PHARMA Substack, which is now free until people know what has gone on. Alison Wright has a brilliant Substack, exposing fraud everywhere you look, including the Chair of GSK, Sir Jonathan Symonds CBE.

Hope this has not been too long, only you need to know this to understand the whole SARS-CoV-2 scam is a 100% pharmaceutical industry project because big pharma companies were going down the pan in a big way, as their last chance saloon CAR T, gene modified cell therapies using CRISPR, proved to be a damp squid…

Previous posts below:

An Evidence-Based Assessment of the Source of the SARS-CoV-2 Injections Scam: PART 1

A program aimed at getting to the bottom of the Who, What, Where, When, and the Why, of the SARS-CoV-2 injections scam

An Evidence-Based Assessment of the Source of the SARS-CoV-2 Injections Scam: PART 1, Addendum

Adding Novartis to the list

An Evidence-Based Assessment of the Source of the SARS-CoV-2 Injections Scam: PART 2

Adding Glaxo, Dominic Cummings and Sir Richard Sykes to the mix

An Evidence-Based Assessment of the Source of the SARS-CoV-2 Injections Scam: PART 3

Contract Development and Manufacturing Organisations (CDMOs) Collude with Big Pharma Companies

An Evidence-Based Assessment of the Source of the SARS-CoV-2 Injections Scam: PART 4

The Many Business Interests of Moncef Slaoui, of Operation Warp Speed & GSK Fame

An Evidence-Based Assessment of the Source of the SARS-CoV-2 Injections Scam: PART 5

UKs Vaccine Task Force to Supply the World with SARS-CoV-2 Jabs...

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