2월 18, 2021 By Steve Grossman (9 minute read)
When it comes to a viral vector Contract and Development Manufacturing Organization (CDMO), what sort of qualities should they possess? It’s expected they would have the scientific, technological, and regulatory expertise to navigate the rapidly growing and everchanging viral vector industry—but how should a CDMO approach a partnership with another company?
This week’s blog post features an expert in building and maintaining a viral vector partnership. We explore everything from building rapport with a viral vector company, to the pain points companies experience in the viral vector space. Whether you find yourself on the market for a CDMO or re-evaluating your current CDMO relationship, we hope this interview reveals the proper foundations necessary to sustain a healthy partnership with a viral vector CDMO.
Interviewer: Hello, Steve! Thanks so much for joining me today. How are you?
Steve Grossman: Doing well, thank you. How are you?
Interviewer: I’m doing just fine—I’m excited for the weekend. So, first off, I want to hear a little bit about yourself—your background, your role, and what got you into the viral vector space.
SG: So, my experience really spans several complex solution product areas of both large and small companies. From international technical sales and support for a laboratory equipment company, to rare disease project management and research, pharmacy software, manufacturing software, and supply chain software.
I landed at Thermo Fisher Scientific through a project I was leading at a rare disease foundation where I volunteer. We partnered on an iPSC project (stem cells) with experts here at Thermo Fisher and another foundation. I got to know some of the great people on the research side here and was lucky enough to find a job opportunity in viral vectors. It was a solid fit for my skill set and would enable me to make something positive happen for both rare disease and common disease communities.
I’m now a Senior Business Development Executive—which means I help “quarterback” a customer’s project from initial inquiry, through scoping, proposal, and initial project kick-off. I interact with early stage and emerging organizations in addition to current customers. They are in the process of looking to get projects going from the clinical phases to commercial production using viral vector related cell and gene therapies.
Interviewer: That’s a great story—being involved with a foundation that’s trying to combat a rare disease must really give you a drive to help companies who are also fighting other rare diseases.
SG: For sure—I love what I do. I help companies make a difference in patients’ lives.
Interviewer: Awesome, passion for the patient is crucial. So, let’s talk about the customer. When you’re engaging a potential or current viral vector customer, how important is the approach and why?
SG: Connecting on a level that is personal yet scientific, driven by project execution, and clear business goals is key. Whether it’s the first discovery call or the work statement execution at the end, there needs to be a mutual agreement on both sides on what we can achieve and how we’re going to achieve it working together. Even with the selection cycle for the CDMO—there must be a mutual understanding of how we can both make this happen. Mutual agreement is key for a successful customer/vendor partnership.
Interviewer: Interesting, so for the vendor, it sounds like they need a more consultative approach to building that type of mutual relationship.
SG: Absolutely. When you take a consultative approach, you can’t show up and just push science down someone’s throat. The first questions that our team typically start off with are simply:
Because that really tells you a lot about what’s happening. Sometimes, that perfect world is something we can’t achieve right now but is something we can maybe work toward in the future. A consultative approach is honest and transparent.
That type of honesty with the client goes a long way. They remember how you treat them and associate you—the vendor—with honesty. As a vendor, it’s important to say things like: Okay, so we—both of us—can’t do that right now, however, why don’t we try this instead?
Because there are so many things that Viral Vector Services can do for a customer, and it’s just as important to set the expectations for the handful of things that we may not be able to do, right now. Our customers really appreciate our candor when they recognize we are working in their best interest.
Interviewer: What a great approach. Let’s dig in more to building rapport—it seems like rapport is at the foundation of a healthy and sustainable partnership. How do you achieve that?
SG: When it comes down to it, it must be the right subject, at the right time, with the right person, at the right level. That sounds simple but trying to coordinate all those pieces is often challenging and my team really excels at this type of coordination. Especially when there are so many complex parts to a project in the viral vector space. So again, when you establish a mutual understanding and agreement from the start, you want to make sure you have the right people there to probe and offer solutions. Whether that’s someone who is deep in the science or someone who has the skillset to clearly develop and scope a project, you want to have the right team in the room. Once we get close to an agreement, our team and leadership recognize the tipping points where senior-level people might need to act. Customers appreciate this responsiveness and value our ability to more-or-less flatten the decision process and reduce bureaucracy.
Interviewer: Excellent. I’d also like to talk about the viral vector space holistically for a moment. In this ever-growing industry, I can imagine there’s numerous pain points customers experience—from the science to the business-side of things. In your experience, what are some common pain points, particularly new and emerging companies go through in the viral vector space?
SG: As you know, the combination of the acceleration of science and scientific technology, in addition to information processing technology, can be a lot to handle for a new and emerging company. We’re seeing more new biotech organizations take advantage of these technological advances and create lean business plans deploying virtual strategies and tactics via outsourcing. Being able to rely on a vendor like us, who has such a broad set of tools and capabilities, can help them truly build their foundation, or simply fill in the gaps.
For example, sometimes prospects might not recognize critical details for what they might need in a vector manufacturing project or maybe how to scope some type of advanced analytics. We roll up our sleeves to try and help them understand what fits with their business and scientific goals and then link that to their strengths and weaknesses. It is our intention to help them amplify their strengths and find ways to turn perceived weaknesses into strengths, so their project is a success.
That’s one thing. Then you have disruptions like COVID-19, plus the rapid expansion of the cell and gene therapy industry. These market forces might make it challenging for early stage companies to meet their timelines. Capacity is always a concern for both early stage and established biotech’s, and the industry has grown and evolved very significantly in the past year.
Furthermore, the startups and even their investors, may not recognize that timelines have changed. Other elements that historically were fairly predictable, like supply chain and third-party testing, can contribute to a decent amount of variability in timelines and how you can execute your projects.
Regarding regulatory hurdles, as the industry is evolving, the regulations surrounding these new processes create uncertainty in some cases. While regulatory agencies are doing a great job in communicating their stance and helping accelerate the approval of products related to getting viral vectors to market, it’s crucial to have experience in regulatory filings with either in-house or outsourced expertise for when regulations change.
Luckily, for all parties involved, Thermo Fisher leadership has the right kind of vision and mindset and is investing in the right places. Everything from expanding scientific facilities, increasing technical capabilities, and investing in the best people. When you combine the right scientific, business, and regulatory capabilities with best-in-class talent, it increases the ability to solve even the most complex problems.
Interviewer: Interesting. Let’s dig in more since the cell and gene therapy markets are driving the need for innovation in the viral vector space. Say for a moment, you’re engaging with a new and emerging company or even a large pharma partner looking to pivot into cell and gene therapy, who need guidance in the complex manufacturing processes of viral vectors. As their viral vector manufacturing partner, what advice would you give this company?
SG: Make sure you do your gap analysis, understand where the market is now, and where it’s possibly going—again, people, science, technology, and capacity. Make sure you understand what you do well and clearly understand your unique business value, so a CDMO can partner with you in the key areas to meet your business goals and help patients.
We have worked hard to create a broad offering in this space. When we reflect on the amazing things that we can do now in addition to integrating these efforts, the future makes everyone on our team excited. We believe in the motto, “start here, stay here”—they’re not just words. They’re at the core of what we do and as long as we can mutually identify your strengths and challenges, we can help you.
Interviewer: Excellent. Before we wrap up, I’d like to touch on how you make customers feel. What does your team do to go that extra mile? In other words, what mechanisms do you have to make a customer feel like they’re the priority?
SG: Being able to relate to the customer regardless of whether they are early stage or more established is crucial. As previously mentioned, the experiences of our Viral Vectors Service team members and I span both entrepreneurial businesses and Fortune 100 businesses, just like many of our customers. So, many of us have walked in the same shoes and as such, this fosters a richer, more honest dialogue. When a customer asks us something, we’ve probably experienced the same or similar pain points they’re going through. So being relatable on multiple levels helps everyone.
Interviewer: Established company capabilities, but with an early stage relatability.
Interviewer: Well Steve, I really appreciate you taking the time to have this conversation today. I think it’s going to be very helpful for customers, prospects, and even our own teammates. As a last question, do you have anything else you’d like to add about what makes a good viral vector partner?
SG: Again, I can’t stress it enough—it goes back to mutual understanding. Mutual goals, people, science, and technology are key— as well as vendors and customers maintaining a robust discourse and a regular communication cadence to help successfully execute their project. Also, it’s helpful as a vendor to have the mentality of seeing both sides of the project and that there’s a corporate cultural fit with the customer. Lastly, never losing sight of everything being ultimately about the patient. If we all think about the end goal—i.e., the patients who will benefit from our hard work—having that late-night call, early morning Teams video chat, or working through some tough analysis makes everything worth it. By working both smart and hard with our partners, we can do great things for the patients.
Interviewer: Excellent—thanks, Steve this was great.
SG: My pleasure—anytime.
To learn more about how Thermo Fisher Scientific makes customers feel like a priority, download 5 Ways Your Viral Vector Manufacturing Partner Should Make You Feel.