Adam Walker — GMP, Sepsis & 900k NHS Doses a Year

**Adam Walker (host):** My namesake, Adam Walker, is a pharmaceutical quality leader, Qualified Person and innovation specialist with extensive experience in GMP manufacturing, aseptic processing and medicine supply within the NHS and the wider pharmaceutical sector.

He's Head of Development and Innovation at the North East and North Cumbria Medicines Manufacturing Centre, where he leads projects focused on building the new generation of NHS pharmaceutical manufacturing facilities. Alongside his NHS role, Adam is co-founder of Help Me GMP, a widely followed educational platform delivering free, practical Good Manufacturing Practice training and industry insights to pharmaceutical professionals worldwide.

He's also involved in emerging technology initiatives, exploring blockchain-enabled medicines and supply chain transparency. Adam is passionate about improving patient safety, strengthening medicine resilience and making complex pharmaceutical topics accessible to the next generation of industry professionals.

**Adam Walker (guest):** I'm an NHS pharmacist by trade — qualified all the way back in 2003 — and very quickly realised that clinical pharmacy wasn't the right fit for me. During a summer placement in my last year of university, I went to work at a small Specials manufacturing facility called The Specials Lab, just over the River Tyne from where I grew up. That was my first introduction into technical services — the pharma manufacturing side of things.

Even though it was just a summer placement, I really felt welcomed into the organisation, learnt the basics of Good Manufacturing Practice, was involved in the manufacture of some Specials, and realised that was the right fit for me. After my foundation training at the Freeman Hospital in Newcastle I was drawn towards technical services — the order of GMP struck a chord with me compared with what I viewed as the disorder of organic systems like patients. The best way I could help patients was by staying a bit further away from them in the clean rooms, preparing those critical medicines.

**Adam Walker (guest):** The term 'Special' comes from a special clinical need — where a patient has a condition that isn't fulfilled by a marketed medicine with a full product licence. This is UK-only legislation. Facilities holding a Specials licence are authorised to manufacture and put unlicensed medicines onto the market, but they're manufactured in licensed premises, so full GMP applies without the regulatory oversight you get with a fully marketed product.

To operate under a Specials licence you have to be really focused on Quality Risk Management and the impact on the patient. Products tend to have a very short shelf life and small batches — often a batch size of one — which limits your ability to sterility-test before release. On one end of the scale you've got Section 10 Exemption preparation of chemotherapy from licensed starting materials with an eight-day shelf life. At the other end you've got fully licensed product from Accord, GSK or Eli Lilly. Specials lives in the middle.

**Adam Walker (guest):** My permanent role is Head of Development and Innovation for the North East and North Cumbria Medicines Manufacturing Centre — a brand-new facility we're building that should go live in early 2027. It's one of four aseptic pathfinder hubs nationally and it's a real step change for the NHS in the way ready-to-administer products are prepared.

A lot of hospitals have small aseptic facilities within them, but as they age the capital to keep them to the required standard is getting harder to find while the standards themselves demand more. The new Annex 1 of the GMP guide grew from around 16 pages to well over 80. NHS England made available money to invest in a hub-and-spoke model — the Seaton Delaval site will manufacture medium-sized batches of chemotherapy and IV antibiotics, treating patients from the Scottish borders down to South Tees and across to Whitehaven. We're targeting around 150,000 chemotherapy doses and up to 750,000 antibiotic doses a year.

**Adam Walker (guest):** When a patient presents at A&E with suspected sepsis, the target is one hour from door to needle. If a nurse has to spend 12 to 15 minutes making that dose in a busy A&E environment, that's not the best use of their time. They can simply go to a fridge, grab a ready-made bag with assured quality, hang it up and give it to the patient.

The secondary benefit is that nurses have more time to care for patients. Nurses don't enter nursing to prepare medicines in a treatment room — they enter nursing to nurse. Ready-to-administer antibiotics release time back to patient care, and products like ready-made Furosemide help patients who present with fluid on their lungs and are struggling to breathe.

**Adam Walker (guest):** The real push for me came from a personal experience. My mum was diagnosed during my pre-registration year with Grade Four bowel cancer — metastatic, with secondaries in liver, lung, bone and peritoneum. She enrolled on the FOLFOX study back in 2003 and had a remarkable response to that chemotherapy. Because of that, she got an extra nine years. She was at my wedding. She met my first son.

That is only because of the fantastic surgeons the NHS has and the chemotherapy. Making sure people get the chemotherapy they need, making sure people get the time to make those memories, is why I get up in the morning.

**Adam Walker (guest):** Fiona Cruickshank and Brian Doherty shone a light on this path as an option for pharmacists. Later I joined a spin-out called SCM Pharma, whose tagline was 'Novel, difficult and dangerous' — intravenous aerosols, needleless injection systems, sterile ampoule fillers for non-aqueous flammable products. I learnt about large-scale manufacture and commercialisation there.

At Newcastle there were two or three real key people: Alison Beeney, who literally wrote the book on aseptic standards within the NHS — the QAPS 'Yellow Guide'; Anne Black, a Regional QA Specialist Pharmacist focused on ATMP manufacture and deployment; and Dave Caulfield, Head of Quality at Newcastle and my QP sponsor. And I have to mention Kyle Wynn, my close friend and business partner. Kyle is now Head of Production at the North East and North Cumbria Medicines Manufacturing Centre where I'm Head of Development and Innovation.

**Adam Walker (guest):** Kyle and I have launched the Help Me GMP YouTube channel and www.whatisgmp.com. The mission is to create access to good-quality GMP information and training in an accessible, easy-to-learn format that will help the next generation enter the GMP space.

Our organisation is about to grow from around 30 people up to 150. Going into an interview for those entry-level roles fresh out of school without knowing what a change control or a deviation is would be daunting. The channel builds a library on YouTube, TikTok, Instagram and Spotify so people can absorb the information in the way the next generation actually learns.

**Adam Walker (guest):** We use some generative AI to voice some content, but everything is curated. We take a GMP approach to the content we manufacture: Kyle is Production, he creates the script and content, and I do the QA — I listen, edit and tweak before anything goes out. We're approaching about 150 videos on YouTube and well over 1,700 subscribers, which for a niche subject is doing okay. YouTube doesn't pay — this is an expensive hobby.

**Advice to your younger self:** Don't be afraid to open your mouth. If you've got something you're passionate about, just stand up and say it.

**Top qualities when building a team:** Honesty — especially as a QP you need the full answer without anything hidden. Being able to get on with people and talk without fear of retribution. And dare to dream — the phrase 'we've always done it like that' drives me mad. Regulations change; there's always a better way.

**Favourite thing outside work:** Riding — and working on — my motorbike. Engines, cars, F1, engineering. Plus the Help Me GMP videos: nice weather, out on the bike; raining, video editing.

**Number one golden rule:** Be willing to accept that you don't get things right every time. Don't punish yourself for failure — use it as a lesson.

**Adam Walker (guest):** LinkedIn is the best place if it's career-related, or reach out via the Help Me GMP YouTube channel for anything GMP.

**Adam Walker (host):** It's been an absolute delight to welcome you onto the podcast today, Adam. You've made me smile and enlightened my day in equal measure.