Read the summary and watch or listen to the interview here: https://www.crowleylawllc.com/podcasts/drug-development-with-ray-sison-supply-chain-operational-logistics-regulatory-expectations/
Voiceover: Welcome to the From Lab to Patient, Garage to Market podcast with your host, Phil Crowley. In each episode, we discuss professionals serving the tech startup market and key issues impacting these companies. You can find this show on all major platforms, including YouTube, LinkedIn, Facebook, Apple Podcasts, Spotify, and on our website, CrowleyLawLLC.com. Now, here’s your host, Phil Crowley.
Phil Crowley: Welcome, and thanks for tuning in to our podcast. We bring you experts knowledgeable about technology, biotech, artificial intelligence, and other advancements to help smooth your pathway to success. At the end of today’s discussion, I’ll ask my guest to share recommendations and insights to help you further develop and succeed with your company.
Meet Ray Sison of SCx CMC Solutions
Phil Crowley: My guest today is Ray Sison, managing partner of SCx CMC Solutions. His company focuses on taking innovative developments from the lab to market, managing the crucial steps required to bring products to consumers. Ray, thanks for joining us today.
Ray Sison: Phil, thank you for having me. When we met last year at the BioNJ event, you left a great impression. I’m happy to be here.
Phil Crowley: Fantastic. Ray, can you tell our audience about SCx CMC Solutions, what it does, and how it helps its clients?
Ray Sison: SCx is a consulting firm specializing in drug product development and supply chain management. I’ve been consulting since 2011 and working in the industry since the early ’90s. In this iteration of my consulting career, I’ve brought together best practices I’ve learned over the years with a skilled team to assist early-phase biotech startups. These companies often face challenges with funding, forecasting budgets, and transitioning from raising capital to executing business plans.
We’ve found a niche in helping these early-stage companies, though we also support late-stage development. It’s about building long-term relationships and ensuring our consultants deliver real value to our clients.
Challenges for Young Companies
Phil Crowley: What areas do you find young companies often need help with but might not realize during the product development phase?
Ray Sison: Like many startups, raising capital has been particularly challenging recently. I’m optimistic the environment will improve soon, but it’s still essential to focus on the basics. I tell clients that the FDA approves a finished drug product—not just a business plan, clinical data, or correspondence. Early on, we define a target product profile to guide development and ensure the product aligns with regulatory and market needs.
Having a clear drug product development plan alongside your clinical plan shows investors you understand the costs and timelines involved. Investors want to know not just how much funding is needed but when it’s required at each stage of development. This clarity can make a big difference.
Phil Crowley: That makes perfect sense. From my experience mentoring investigators at institutions like Weill Cornell, uncertainty about development costs is a significant hurdle. Many academics, for example, are unaware that running a Phase 3 clinical trial can cost $100,000 or more per patient. With thousands of participants, the price quickly reaches tens of millions of dollars. Could you speak more about navigating the FDA process and your role in helping companies along the way?
Navigating FDA and Academia
Phil Crowley: The FDA process is complex. How do you assist companies in getting from the lab to filing an Investigational New Drug (IND) application?
Ray Sison: You raised two points—working with academia and navigating FDA expectations. Let me start with the FDA. Recently, I was involved in a pre-IND meeting where we faced challenges due to unresolved issues in our dosage form. One thing I always emphasize is that the FDA wants a clear, well-thought-out plan. They’re not there for real-time discussions but to evaluate proposals. You need to state your plan and ask specific, structured questions like, “Do you agree with our approach?”
The FDA also expects a defined drug product, indication, and target population. They won’t engage meaningfully without these specifics. Many biotech startups, led by clinical experts, focus heavily on efficacy but often lack the industrial pharmacy expertise required to develop the actual drug product. That’s where we step in to bridge the gap.
As for academia, tech transfer offices often provide minimal guidance, leaving consultants to piece together details from research papers. Academia and industry operate differently, with distinct goals, which can create challenges. For example, academic labs aren’t typically equipped to meet the regulatory and documentation standards required for commercialization.
Phil Crowley: As someone on the board of Stevens Institute of Technology, I’ve seen brilliant researchers underestimate the effort required to operationalize their discoveries. They often assume the market and industry will naturally adopt their technology, not realizing the complexity of creating a reliable, scalable product. It’s one thing to source materials for lab tests and quite another to establish a supply chain for clinical trials or global distribution. Your work seems essential in helping these companies understand those challenges early.
Ray Sison: Exactly. Operationalizing discoveries requires a shift in focus—from pure science to systems and logistics. Supply chain management, for example, is distinct from drug product development. Negotiating supply agreements or navigating licensing requirements involves entirely different skill sets. Early-stage companies must recognize when to bring in specialized expertise to address these areas.
As companies grow, their organizational structures evolve to include functions like supply chain management, finance, and compliance. Founders often wear many hats initially, but over time, they need to delegate responsibilities to experts. Consulting has given me exposure to diverse companies and approaches, which keeps me adaptable and able to offer relevant insights.
Phil Crowley: Great point, Ray. Let’s pause there for now.
Phil Crowley:
I want to ask you about teamwork because I believe it’s a key success factor for smaller companies. Let me take a moment to introduce Crowley Law. We’re a boutique law firm focused on helping innovators in life sciences and other technologies take great ideas from the lab to the market, or from the garage to the marketplace, enriching lives.
I’m a former research physicist who transitioned into law after realizing it was taking too long to get things out of my lab. Now I have the opportunity to work with passionate people developing products that use technology to improve lives. Our firm offers big firm experience with the care and attention of a small firm. Please check us out at CrowleyLawLLC.com, where we provide free resources relevant to technology-based businesses. Feel free to contact us if you have questions—we’re here to help.
Ray, I want to get back to you. You raised an issue I mentioned in my free ebook, The Top 10 Causes of Failure for Technology Startups and How to Avoid Them. One of those causes is not having a multifunctional team. You described very well the need to cover all the bases, so teams don’t develop products with blind spots, especially when moving from discovery to development. There are many more steps involved, like dealing with manufacturing challenges, particularly with fragile proteins. What are some key mistakes you’ve helped your clients avoid?
Ray Sison:
Yes, building a multifunctional team is critical. It’s about doing a gap analysis early on to ensure you’re covering all areas appropriate for your project’s stage. Here’s an example: if you’re moving into a clinical trial and you’ve got a great team of PhDs who developed the drug, you might miss the expertise needed in clinical labeling, packaging, and regulatory requirements. Clinical operations have a very different skill set than what’s typically in your CMC (Chemistry, Manufacturing, and Controls) or clinical team. A small company often has to solve this by bringing in the right expertise. A mistake many make is pulling people out of their core competencies to handle tasks like clinical supplies and logistics, which can be a steep learning curve. It’s much more cost-effective to bring in the right consultants to fill those gaps.
Phil Crowley:
It sounds like it’s useful to bring in appropriate outside consultants when the company doesn’t have the expertise. One of the key questions for founders and leadership is figuring out who those experts are. What should developers of drugs consider when looking for the right consultants—before hiring someone full-time for a specific task?
Ray Sison:
Finding the right consultant is just like finding the right development partner, CDMO, or CRO. It always surprises me how thorough people are when buying a car but less so when hiring a consultant. Do the same due diligence. Understand exactly what you need, set clear criteria, and give everyone the same information—what you need, what they’ll deliver, and by when. Finding a consultant should follow a formal process, just like selecting any other business partner. Even if you lack expertise in an area, a structured process helps you make informed decisions. I always tell clients to get multiple bids and interview candidates carefully to find the best fit. And don’t expect one consultant to do everything. If you need diverse skills, assemble a team of experts. It’s more efficient than relying on one person for everything.
Phil Crowley:
That reminds me of the saying in quality circles: “If you don’t take the time and resources to do it right the first time, where will you find the time and resources to do it again?”
Ray Sison:
That’s absolutely true. And that leads me to the importance of leadership. As a founder, you need to inspire your team, align them with your vision, and create synergy. Even if some of your team members are consultants, they need to understand your work style and expectations. It’s not just about having a great idea, but also about leading others to execute that vision.
Phil Crowley:
We’ve seen a shift in the biotech business over the past 5-10 years, with many companies starting as virtual firms and outsourcing key functions to consultants like you. From a governance standpoint, it makes sense for founders to recruit directors with experience in drug development. This allows them to ask the right questions and ensure the company’s plan is sound.
Future of Biotech and Pharma
Phil Crowley:
If you had a crystal ball, Ray, what changes do you see in the biotech and pharma sectors over the next 5 to 10 years?
Ray Sison:
I’m actually quite optimistic. We’re moving past COVID, and there’s a big push to bring resources back to the U.S., especially around supply chains. Biotech startups will have more options for local contract manufacturers, making it easier to scale production. The contract manufacturing and development space has always been fragmented, but with more companies entering the market, there’s more flexibility. Onshoring will create more choices, although it also means you’ll have to sift through a lot of options to find the right partner. But overall, it’s a positive trend, particularly for those in biotech.
Phil Crowley:
It’s great to hear that there’s more potential for local resources. Do you see the shift continuing in the next few years?
Ray Sison:
Yes, absolutely. For example, in places like Philadelphia, Boston, and San Francisco, the number of CDMOs is growing, and they’re offering expertise in gene and cell therapies as well as more traditional manufacturing. With increased funding, biotech startups will be able to deploy resources effectively to develop their products.
Final Thoughts and Recommendations
Phil Crowley:
Ray, do you have a few key recommendations for aspiring innovators in the biotech and pharma spaces to help smooth their path to commercializing products?
Ray Sison:
It really depends on the person, but here’s what I’d suggest. First, develop strong business processes. Starting a company, especially a consulting business, is no different from any other—there’s a lot of behind-the-scenes work. You need processes in place for everything: financial management, vendor selection, etc. These processes create discipline and muscle memory.
Second, as a founder, understand that you are the leader. People will look to you to inspire and guide them. You may be technically brilliant, but you’ll need to learn to engage with investors and influence others.
Lastly, surround yourself with the right people. Recognize when others excel in areas where you may not, and delegate accordingly. Leadership is about extracting the best from your team. A successful leader knows how to empower others to shine.
Phil Crowley:
Ray, thank you for your time today. It’s been a pleasure having you on the show.
Ray Sison:
Thank you. I had a great time.
Voiceover:
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