US drug shortages have hit a five-year high and the availability of life-saving treatments is getting scarcer by the minute, Smeltzer tells BioPharma-Reporter.
With the Biden administration assembling a team to address these chronic problems, Smeltzer explained how drug manufacturers can cope under the pressure and get treatments to patients faster.
She says drug companies can’t afford to make large excess quantities of drugs to prepare for shortages, which leaves little room for unexpected spikes in demand.
As a ‘woman in science’ we wanted to know about her background and her path to becoming a principal consultant at CAI, a company offering multiple end-to-end services to the life sciences industry including commissioning and qualification, quality systems development, and operational performance improvement.
OSP: How did you end up entering the world of science?
Throughout my life, I have always taken the opportunity to learn new things and absorb information. While I now collaborate with gene therapy clients, I would have never thought about pursuing science as a career and I wouldn’t characterise myself as a science person! However, I am a process person, if I can visualise a process, I can make it happen – and that is how I ended up as a woman in science.
My background is in music, fine arts, photography, and liberal arts – none of which prepared me for what I do today. But from a process standpoint, each of those disciplines rely on key processes. In photography, for me, it’s 60% inspiration and 40% process.
I got into pharmaceuticals accidentally. When I left college, I realised right away that I didn’t want to be a music teacher. I also got married relatively quickly and I was determined to be an equal financial contributor to our marriage, so I took a lot of jobs, but I didn’t have a strong career trajectory. I went to work for a bank but had to leave through no fault of my own and ended up in line at a state employment agency. I was given a job as an inventory clerk for a gypsum manufacturing company and after a few months on the job applied for a vacant warehouse manager position.
As a, admittedly unexperienced, woman, they were not keen on giving me that job. So, I quit, which freaked them out. I think they thought I was going to sue them for sexism – and they ended up, however grudgingly, giving me the job. I quickly learnt the ropes, I went to transportation school, traffic school, taught myself to drive a forklift – I was determined to nail it!
It was a union environment and was ‘trial by fire’ as a manager. Ten union guys who hated me doing a job that I really didn't know how to do. So, I taught myself and very quickly fell in love with logistics. A few years later, I started my own freight brokerage. Now we get to J&J part one. I had a large customer base in the in the area and I kept trying to get the J&J business and they just wouldn't give it to me. I kept pestering them, but they never did give me any freight. Instead, they offered me a job helping them build a new logistics empire.
I accepted the J&J offer and was one of the very first people hired – but I was one woman among 300 professional men. It was another education, but it was great because I could make mistakes. I could learn things from experienced logistics professionals and was allowed to succeed and fail at J&J's expense. It was like going to college all over again. And that’s how I ended up in life sciences – by accident!
OSP: What would you say to young women who might think it's male-dominated area and believe they won’t get as far as male candidates?
I learned eventually that some of the barriers were in my own mind. I think if you look for the barriers, you find them. I decided that I was not going to let anyone stop me and I was not going to let it consume every waking moment of my day - believing people were against me because I'm a woman.
It did drive me to try to be better, faster, smarter than the others. But the one thing I took away from that experience was the recognition that there were no women to help mentor me. There was nobody to show me how to act or what to say or how to dress – simple things like that.
In the last 30 years of my career, I've made it a point to bring people along to share what I've learned and the things that I've done wrong and the things that have worked out well. I mentor people within our organisation, male and female, but typically I try to mentor women because even now, there are so few female executives to learn from.
One of my early experiences, I was out on assignment with three guys and one of the vice presidents of a company we were meeting with drove up in his limo, looked at me and said – ‘It’s so nice to see you gals getting out of the kitchen.’
The guys that were with me were thinking – oh gosh this is going to be brutal. But his comment was so over the top I just said – ‘Well thank you sir.’ That’s all I said – can you imagine! It was amazing control, and it was not me, I was channelling somebody else at that moment because I had a million responses and that's what came out of my mouth. Things are much better in the industry now, but women still need mentors and people to talk to.
OSP: I wanted to ask you about excess drug quantities and drug wastage. Could you explain how it happens – and why so regularly?
That is an outgrowth of the expanding and contracting rubber band of the supply chain. It's really been shaken up over the last few years, not just through COVID-19, although that had an enormous impact, but also the war in Ukraine and other regional conflicts.
I don’t want to sound like an old timer, although I am, but back in the day we had safety stock planning where we purchased or produced a smidge more than we needed, both for finished goods inventory and raw materials. From a US standpoint, we typically used onshore suppliers and didn’t go shopping globally.
The larger companies I worked for could afford to carry excess inventory so I would overbuy. I never wanted to be the one that stopped a batch from being created based on a mistake on my part. That practice led to excessive inventory.
The excesses of the old days led to the advent of ‘just in time’ inventory – in an effort to cut down the costs of drugs and the cost of carrying inventory. JIT focused on planning and waste reduction in the supply chain. In other words, if you needed it, you ordered it based on lead-time and more realist minimum stock quantities. We pushed the inventory carrying costs back to the supplier and contracted for drop shipments.
This was a terrific financial improvement which was further spurred on by globalisation. The advent of globalisation - If you could purchase the same materials from an alternate source, maybe not in the US or from a source with a lower cost labour base, you would simply go to where it was a lower cost. A lot of the things that drove and still drive all manufacturing, whether it's drugs or anything else, is a reduction in the cost to manufacture on a return of profit to the company.
OSP: So, it comes down to finances?
With events like COVID-19 some companies were forced to go back to the old model and then some. I have a client that ordered two years’ worth of raw materials at an exorbitant cost because they were afraid to not be able to have materials to make the drug product.
When I first collaborated with this company, I told them they would be able to do this for a while, but the finances and balance sheet would catch up with them. You cannot continue to order two years’ worth of supply, because instead of throwing made drugs, substances, and drug products away, they will end up throwing away raw materials – as they will have expired or become unusable. This is one result from the rubber band, or reactive model of supply chain.
There are new drug products coming out every day. All the companies that I work with are developing brand new small molecule, brand new biosimilars, and developing exciting new therapies. There is more demand for raw materials than ever before.
Over the past several years, our government in the US and I think other governments around the world, started pouring money into companies to get production started or to expand existing production capabilities – but that is not a fast process. It’s a process that takes years, three to seven years depending on what you’re going to make.
You have to build or modify a facility to start producing, whether it’s a drug substance or drug product. There is a time lag there and I don’t see that this will be rectified anytime soon. The raw materials needed to support production of these new facilities require a different approach to supply chain planning – old, and not-so-old methods must change to become less reactive and more predictive – and we are on that path. We are now entering a phase where predictive analytics, advanced systems intelligence are combining to help the drug companies ‘right-size’ their inventories. Of course, all of this requires a significant investment in systems and technology. The thing I worry about is when things do normalise, we end up going back to our old ways.
OSP: How can you make people see, we've been there, we've done that. And can we do it a different way?
In the past, we have been reactive. We implemented ‘just in time’ inventory and it was lovely for a while. But I think things must change and we'll have to be different, and we must plan better. A lot of the clients I work with, perform operational readiness assessments and that is where we look at their facility from multiple aspects – we call them workstreams.
From the quality department to the manufacturing or supply chain, we say, are you guys ready? Have you planned to get operationally ready? Can you do this without making mistakes that caused the disruptions? If you have a smooth start-up, you're going to be producing drug substance, drug product faster, the cycle is going to be faster to the patient.
Additionally, when working with a client I now emphasize development of robust business continuity plans to anticipate supply chain disruptions as well as plan for disasters.
OSP: From all businesses I hear the word ‘sustainability’ bandied around, does this enter your business plans?
We must ask – if we’re going to manufacture a drug substance or a drug product – do we really need rare earth minerals to be part of the process? I think it's the choices of how these products are developed that will help dictate the future. I don't know where sustainability is going to go. I really don't. I think it's just starting to creep out there. But it may be too late, and we may be past the time where we can be sustainable for some of the things that we need. It's going to cost money. Sustainability is going to cost money. So, I guess it's going to come down to the cost benefit analysis.