For the Record with Josh Ludwig, Global Director of Commercial Operations, ScaleReady – Medical Alley Association

For the Record with Josh Ludwig, Global Director of Commercial Operations, ScaleReady

Josh Ludwig leads commercial operations as the global director for ScaleReady. He closely collaborates with the EMEA commercial and leadership teams to ensure ScaleReady addresses the longstanding industry need for a truly scalable and practical solution. Josh has more than a decade of experience in commercial leadership and business development in the medical device industry with a specific focus on engaging directly with customers and achieving customer and company goals.  

Give us ScaleReady’s elevator pitch.

In short, we make the business of Cell and Gene Therapy practical and viable while significantly de-risking the future. Our product portfolio, centered around G-Rex, provides the field with the simplest and most scalable solutions in the industry. Our products allow customers to save time, reduce supply chain risks, and increase cash runways.

Our name, ScaleReady, really speaks to what we do. We enable Cell and Gene therapy programs to have a truly linear and scalable manufacturing process from the very earliest research studies through to clinical and commercial manufacturing.

The ability to quickly validate and implement manufacturing process improvements, or qualify new reagents, is the key to success. To do that in a simple, fast and cost-effective manner, you need to have confidence that your small-scale studies, products, and reagents will translate seamlessly into large-scale processes. We believe we’re the only organization that offers customers in this space product solutions that seamlessly translate from small-scale to large-scale processes.

Finally, the way ScaleReady does business is unique. While we are new, our partner company’s products are established. They’ve been in the industry for a decade or more — they’re proven. Our goal isn’t to sell as many products as we can. ScaleReady’s goal is to technically support our clients, simplify, and de-risk their processes to lead them to clinical and commercial success.

We want to make the most efficient use of our products in our clients’ manufacturing programs, so they have the best chance to treat patients and succeed long term. Ultimately, getting to the market fast with a consistent process that can scale to meet demand over time is the key to success. And we know every day counts for patients and our clients.

What is one thing the Medical Alley community might be unaware of about ScaleReady that you would like them to know?

The products ScaleReady has in its portfolio are not only commercially viable, but they are the gold standard for manufacturing T-Cells and NK cells. ScaleReady is new but its partner organizations — Bio-Techne, Fresenius Kabi and Wilson Wolf — have been effectively producing and providing tools/reagents in this space for more than a decade. This is evidenced by hundreds of peer-reviewed published articles in high-impact journals and hundreds of clinical programs utilizing ScaleReady partner technology. The ScaleReady products are already in use in CAR T drugs commercially approved by the FDA (US), EMA (Europe) and PDMA (Japan).

How have the last few years changed ScaleReady for the long term?

Our momentum, especially in the area of partnerships and tools, continues to change and grow for the better. It’s our second anniversary in January and while a lot has transpired, our vision and mission have not changed. We remain dedicated to impacting and improving the chances of success for our clients’ Cell and Gene Therapy programs through a technical partnership.

It was an interesting time to launch a company and go through the pandemic. But I am proud to say we have a strong track record of success and supply chain stability — we didn’t have any challenges providing products to our clients. We know the margin for error is razor thin and can prevent a client from successfully moving to the next stage of a clinical trial, raising capital and then treating more patients. Our Partner companies offer the safest and most secure products in the industry — and ScaleReady has proven technical acumen and process development knowledge to help clients scale without complex systems.

Our momentum is fueled by our agility. If a client comes to us with a need or problem, we find a way to provide the best possible solution right away. Not only because it supports our clients but because it supports the industry, the researchers, the healthcare providers, the patients and their loved ones. We will continue to do this.

What are some of the big milestones to come in the next few years for ScaleReady?

In the next few years, ScaleReady is looking to continue to grow our team of industry experts to keep up with the business of cell and gene therapy. The skills needed to succeed today are hard to come by. If it continues to advance to more front-line treatments, we must turn it into a streamlined, risk-free manufacturing process. There are a lot of technologically savvy people in the industry working on this and we want to continue to develop their skillsets and solutions.

Today, ScaleReady is having great success in North America and Europe, the markets we aim to serve. We’re looking to spread further internationally into markets where our Partner organizations are already established, trusted and thriving to help those manufacturers understand the power of our technical expertise and partnership in addition to the gold-standard products they already use.

One of our core beliefs is that the industry first needs to simplify, then automate. By utilizing this approach, we can provide the most automation-friendly product solutions to the market. This will allow our customers to implement automation when it makes the most sense, and when their product demand requires it. We are focused on continuing to help the industry see our platform is about simplicity, reproducibility and reliability. Other cell and gene therapy manufacturing platforms are too focused on automation for automation’s sake which leads to incredibly complex systems and a plethora of pain points, including excessive capital costs. First and foremost, the industry needs systems to communicate with each other efficiently and effectively, then remove complexity and simplify. This needs to occur before the automation of these manufacturing processes can see successful economies of scale. ScaleReady is pushing the envelope in this space by eliminating complexity to continue to help clients simplify their processes before automating what’s left. We believe ScaleReady provides products that are highly amenable to large-scale, high throughput, simultaneous automation of Cell and Gene Therapy manufacturing processes.

The Fresenius Kabi, Bio-Techne and Wilson Wolf engineers are constantly working to push the envelope on streamlining manufacturing at scale. There is so much energy being put into that space, and I am excited for the future of the ScaleReady products, partnerships and impact to come out of it.

ScaleReady is exploring in earnest automated batch record systems to help our clients work smarter, not harder, to maintain consistency and reproducibility. Additionally, we are focused on developing fluid-handling platforms around G-Rex technology to ensure it is automation friendly. As we look toward thousands of patients getting treated with these programs, we’re staying firm in prioritizing simplicity to scale. 

What does leadership look like to you?

Leadership to me is being a servant leader — one who leads through action. If you expect your team to put in extra effort or go above and beyond, you as a leader better be ready, willing and able to put in the same effort. I am proud to say every leader at ScaleReady leads through action and by doing the work alongside their team. We have an incredibly accomplished team who support clients by getting in and doing the work, technically guiding and improving processes.

I also believe strong leadership is embracing and living your organization’s values. The entire company lives ScaleReady’s values day in and day out. We work with the same urgency our clients work with to treat cancer patients in urgent need of therapies. We collaborate with clients, Partners and even competitors to further the industry for the greater good. We are authentic, agile and tenacious in everything we do because we don’t leave things up to chance, especially when we have the power to impact our clients, the industry and the lives of patients and their loved ones. We aim to elevate all stakeholders at all times. Win-Win-Win is the philosophy.

When I’m onboarding new employees (or interviewing prospective employees), one of the first questions I will ask is if they can get obsessed with cell therapy. Do they want to be an expert in the industry? Are they excited about all the potential in the industry? We want a team of leaders who are eager to push the envelope, not take “no” for an answer and work to solve even the most complex problems. Our career development at ScaleReady is designed to lift everyone as a leader and empower courageous solutions.

What is the best advice you have ever received in your career? And what’s the worst?

My mom always told me that if I’m going to do it — no matter what it is — I might as well give it my all. It may be challenging, and I might fail, but the learning and growth come from the failures and the missteps. I see the value in being agile enough to digest feedback, learn and course correct all while not slowing down. It is important to constantly challenge yourself and move quickly to overcome roadblocks or else you may get too comfortable in a stasis.

The worst career advice I got was to constantly be on the move in your career. In other words, if you have been at company X for more than 3 years, you are inherently doing something wrong. There is a sentiment that to climb, one needs to move diagonally and jump from company to company. The cell and gene therapy industry is growing at an incredibly fast pace. There are new companies, products and providers all the time that delivers incredible opportunities for people. But there is something remarkable about finding a product, solution or company you’re passionate about and seeing it through. Even if it may not be the easiest road, there’s a unique opportunity in being with a life-saving solution from beginning to end and seeing your direct impact on the success.

I started with Wilson Wolf focused on G-Rex technology almost a decade ago. In that time, I have worn a lab coat running internal experiments, answered calls from global clients, learned how to ship products to every corner of the globe, ensured we had processes in place to track and manage all necessary components of the business and throughout, we have challenged conventional wisdom and seen the product take shape and save lives — and it led me to the inception of ScaleReady and making that idea a reality for many. I am so grateful I followed the best advice I’ve ever received and that I saw the vision out. Extraordinary accomplishments come from doing ordinary things for extraordinary periods.

What have been some of the most rewarding moments in your career?

There are so many rewarding moments in my career. Nothing is more rewarding than reaching the commercial finish line and seeing products I’ve supported commercially available to cancer patients. Following the products and hearing the stories is unbelievable. I only dreamed that I’d be able to see the tremendous outcomes of our work and the impacts our products have on patients and their loved ones, so for that to become a reality is truly remarkable. Every day, week, month and year there are huge moments of success in this field, and I try not to take a single one, or the feeling, for granted.

I’d be remiss if I didn’t mention the inception of ScaleReady as a rewarding career moment as well. To start from an idea on a piece of paper with industry leaders to move to meetings and board rooms and now be a fully functional, well-staffed company is exceptional. In its two years, ScaleReady has already made such an impact on the lives of our people, Partners, providers and patients and I am so grateful to witness its enormity every day — and to have the opportunity to welcome other experts to grow their career and solutions here.

What is one personal goal for the upcoming year?

My professional goal for the year is to help as many companies as possible get to their next inflection point, help them overcome their roadblocks and find success in their work. Looking at the state of the industry and the market, it’s a tough point for organizations looking to raise money to do something new and novel. I want to help those organizations find ways to achieve more with less. I want to help their people and processes become more efficient, straightforward and effective.

There are easy, cost-effective and proven processes to help organizations today that are not complex or overly automated, but our industry is constantly changing and inundated with information. It is nearly impossible to cut through the clutter and identify fact over fiction. My goal is to Partner with organizations to help them find those tried-and-true solutions available today to help them continue their great work in a way that works for them.

In my personal life, I am focused on getting more sleep to maintain the energy to be fully present at work and home. I am the father of a kindergartener and a three-year-old and we are constantly on the move. Life is busy, it’s full of fun and joy but it’s important to find discipline in my personal life to be the best I can be in all aspects of my life.

How do you relax or decompress?

I am an avid Minnesota sports fan — go Vikings! So, I use sports to decompress and get my mind back to the present. I love playing catch or soccer with my kids or going to the gym and playing pick-up basketball. My son just finished five-year-old flag football and loved it. It was great to see him lean into the sport on the weekends over the fall. When I’m slowing down, I love spending time with friends and family. As a Minnesota native, I value the summers and time spent outdoors.

What do you enjoy most about the Medical Alley community in Minnesota?

Minnesota is a great place to grow up, raise a family and — from what I’ve experienced — start a company. We have a world-renowned network of cell and gene therapy and health organizations in Minnesota including hospitals, cancer research centers, academics and medical device companies. And the best part of the community is everyone is willing to help one another achieve their mission. Medical Alley supports people, products and organizations in a way nowhere else does. The patients and the healthcare come first in Medical Alley and it’s a special place to be surrounded by phenomenal technology, companies and the pioneers who continue to make it happen.

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