06 Oct Session D – Entrepreneurship Track

Entrepreneurship Track – The Government as a Customer

Moderator:

• Geoffrey Ling, M.D., Ph.D., CEO, On Demand Pharmaceuticals Inc.

Speakers:

• Captain Joseph Cohn, Ph.D., Chief, Research Program Division, Defense Health Agency
• Michael Ehret, Director of Business Development, ASELL
• Michael Fitzpatrick, Ph.D., President, Cellphire Inc.

QUESTION: What I want to do here is address the issue of when you build business with the government. One area that people focus on is how can I get the funding, right, because it is non-dilutive funding. However, there’s something else too and that is when you do work with the government you’re trying to do things for.

I think the beyond the funding side of things, there is that chance to work on these big programs and arguably some of these programs are such high risk that you never actually are able to get private sector funding to initiate. So, from a scientific perspective, as you get traction, you get to work on some really important work that no one else is going to work with. There’s a lot of really talented smart individuals on that. So from a small company working with the government, you almost get a free scientific advisory panel. You’ll get really good feedback on your technology that you know is unsolicited oftentimes. I think people outside the government will also want your product, and you know the guidance you’ll get will actually help you do both of those.

You’ll hear from a lot of folks that it’s completely different working with the government. Government clients are nothing like working with the private sector, and I think there’s a lot of truth to that. But ultimately, you’re reporting to somebody, you’ve got a board you’ve got investors you’ve got clients of some sort. And the same principles of being successful hold true to the government as well. You got to be a good communicator.

In spite of what you may have heard about working in the government, The government does care about schedules and milestones and budgets, those are all really important. So I think there’s some foundational things that are very similar, but there are a lot of differences. 

QUESTION: How does the government identify some of its big challenges? And then once they identify those challenges, how do they get access to you?

From the perspective of military medical research and development, a lot of what we invest in is focused on developing capabilities that will allow us to manage the challenges of the future. And the way we understand what that future environment is, is that we will be looking at a lot of the strategic documents that are developed across the DoD and across the federal government. Everything I’m going to talk about is available in the National Defense Strategy from 2018.

If you take a look at all of those strategies, they’re not necessarily all focused on medical, but each of them has elements that, if you read between the lines just a little carefully, you’ll see there are many medical challenges that we are looking at addressing now and into the future. So for example, you can see that very likely we will be in environments where we have degraded or denied communication so we limit our ability to do real time reach back, we might have challenges with air superiority right now we don’t have those challenges in the battlespace, but down the road, we make we can’t always assume we’ll have that that level of superiority and so at the end of the day this boils down to having to worry about things like logistics challenges. Also wearable sensors getting ways of understanding at a glance the health of our individual warfighters as they move through their missions. Another area that we focus on is combat casualty care that’s where you’ll find things like hemorrhage control traumatic brain injury management. Forward surgical and routine care research activities.   

I had a good idea of what the needs of the military were, but then my transition into the civilian world showed me that they weren’t unique to the military, those needs were worldwide, and an innovative idea that has a worldwide consequence can improve things. But these things need to be funded and funding is difficult especially for projects that might be considered unique to the military or might have a small threshold of customers and not be highly profitable. Getting private funding can be very difficult.

And the advantage to us has been that because what we were doing was not considered a highly marketable profitable field, the military has been able to fund us through what people consider the valley of death, or the gray zone from private funding. This is where you’re struggling to get into that phase one clinical trial or you’re struggling to get your first commercial acceptance of a product or FDA approval, and the military sees the need, has confidence in you to build that product, and then gets you through that valley of death to where you can become very attractive to private industry.

The military and other government organizations have regulatory experts who have FDA experience or civilian experience. They have patent experience, and you get them for free. You get that great advice for free.

The other thing you have to remember is beyond the military and the government as your customer, Congress is your customer as well because they’re the ones that provide the funds. So we have made an attempt to keep our congressional representatives aware of what we’re doing, not in the way of trying to direct the military to give us money or direct the military to fund our program, but we’re able to keep our congressional group advised of what we’re doing, to see the positive aspects about what we’re doing. And if a question comes up about funding, we know we have their support. And so that’s been a key to our success as well.

QUESTION: So let’s be specific here, how do they know where your interests are, where I mean specifically when and how did they get to you, or some of your people but they’re the appropriate people.

I’m going to do it from a healthcare medical perspective, because that’s really what we’re talking about right now. It’s not enough to just have a brilliant idea, there has to be a way to align what your brilliant idea is to something somebody needs on a back-end. And so, the general approach to doing that is to reach out across the services scooping up ideas and needs and then working them through a process. This can happen on the government side to make sure that there’s a strong enough demand for whatever that need is that it would allow us to then take the next step which is to determine whether or not there’s a simple way to address that need by just going into the open market. In general, the things we need in the department are not easily purchasable just off-the-shelf shrink wrapped and so what we ended up doing is looking at that need in terms of how much research we need to invest in it, versus how much product development activities we need to invest and how those two things marry up, that’s really what that lifecycle management process is so that’s the sort of thing that happens.

So the common ways of doing that are generally through a request for information, request for proposals, and broad agency announcements. So when you see these RFIs, we’re trying to gauge where that market space is and where we need to make our investments. When you see a request for proposal or request or a broad agency announcement that means we’ve already determined where we need to make our investment and then it’s over to industry, academia to work with us to better understand the great idea you have then package it up as a proposal.

QUESTION: How do I convince the government that my idea is something that it needs to fund?

You really want to engage your potential customers as early as you can. And in some cases, things like conferences and industry days let you interact with potential government clients in an informational capacity. Be very careful on procurement, once things go so far along, conversations are shut down to keep the competition fair. 

The government wants to be aware of what’s out there, so find those opportunities. Understand what you are bringing to bear, what is your product, how might it fit in? Then try to identify the government clients who you think might be interested and just see if they’re open to talk at a conference or industry day, that sort of thing. And then request feedback anywhere along the process. So, there’s this formal acquisition process and there’s opportunities to submit white papers and a lot of times clients will give you feedback on that. All those things are really important to get in kind of the head of the government client.

QUESTION: How do you understand the current state of need of the government side?

Their strategic plans are published, and they’re made publicly available. You’ve got to search them out on the web, but they are there. The other place is FedBizOpps which is a website where every federal agency lists the things that they’ve got funding for or need there.

06 Oct Session C – Entrepreneurship Track

Entrepreneurship Track –Business Resiliency for the Unexpected and Expected

Moderator:

• Murat Kalayoglu, M.D., Ph.D., President & CEO, Cartesian Therapeutics, Inc.

Speakers:

• Pete Buzy, President, Gene Therapy, Catalent
• Kazem Kazempour, Ph.D., President & CEO, Amarex Clinical Research
• Michael Ruff, President and CEO, Creative Bio-Peptides

QUESTION: Give us an example of a case where you you’ve encountered an unexpected difficult situation, how you overcame it for.

You need a lot of resiliency on the financial side. You need to be really scrappy and I think locally, a lot of entrepreneurs are scrappy as far as getting government funding, getting funding customers. I think what I learned that really helped me the rest of my career is the importance of cleanup; pulling together kind of a senior team to make it happen. And with a lot of emerging biotech companies, you may not get the perfect candidate or perfect executive, and a lot of very talented people are in pharma and stay in pharma. So you’ve got to pick and choose who you hire and that might be someone in the second part of their career. And that can be very helpful but it’s important to find the right balance. The takeaway is that it’s ungodly critical to be able to hire a very strong senior team, when you do not have the technical expertise.

QUESTION: I would like to talk about resilience from a slightly different perspective. I want to come at it from a little bit more of the personal side. And I thought maybe there are some lessons or pointers that I could bring forward that would be helpful and instructive.

So we’re all going to be confronted with challenges and stresses. What comes forward well first, is an acceptance of reality for the biotech entrepreneur that means accept the challenge, you’re going to have a challenge and you have to accept the challenge.

The second thing the literature speaks to is a deep belief that life is meaningful. I interpreted that in the biotech context as well. This is an ongoing commitment to your mission, and your mission is what gives you purpose and meaning and your mission is an important statement of your company and you want to have a company statement.

And the third thing that everybody spoke about is the ability to improvise. Improvisation means that you can regain control of a situation by taking action, and as the executive of your company, you’re the person who is in charge. So, these are the internal elements with resistance. Many of them were not part of my persona, but you can learn them. I think this is a natural kind of human response, so you want to name the challenge, you want to put words to it, you want to accept it, you want to begin to act on it.

The other thing that I would say is the nature of reality. Reality is fungible. That’s true from a physics point of view, it’s true from a metaphysical point of view, and it’s true from a personal point of view. There’s no reality except what you bring to it. And so, as the leader of your company, you can control a narrative and you can reframe the reality, and even a big disaster is not the end of your dream. I’ve had death of a partner, I’ve had bankruptcy, I had crooked CEOs, if you could name it, I probably experienced it. So, here I am. I’m still here. The disaster is not the end of your dream. Discipline is remembering what you want. So stick to your mission, stick to your dream, remember what it is you set out to do. And then continue to act upon it to bring it into reality.

The failure, the rejection, the setbacks are temporary and as bad as they seem, you need to stabilize yourself, and then get to work on it. Identify the problem, and you will prevail. You need to have personal courage. You want to support your inner work warrior, not your inner critic. We’re going to make mistakes, we’re going to make errors, you can’t dwell on them. You need to put those behind you, and you need to always be focused forward.

I didn’t wake up one day having any of these skills. I had to put myself into what were perhaps personally uncomfortable situations and kind of grow through that and move through that. 

If you want to have resilience and make a success of your company, you need to learn how to be a leader.

Another aspect relates a little bit to the current idea is, be prepared to jump to the moon. Sometimes you will not know what’s on the other side of the door. You will need to take a leap of faith. You’re going have to commit yourself to your organization. And that’s what I mean by courage, it’s a leap of faith. I think all of us that are probably starting companies have experienced that sometimes, you just have to jump, you just have to go.

QUESTION: How did you obtain financing?

I had to get on top of that and being involved in three prior companies gave me a knowledge base to be able to do that. I’m a researcher, I felt I can speak to my project, I could speak to the science but I didn’t have a lot of experience in running or being the business guy so I had to get help. One of the first things I did in forming a business was to try to meet people and try to build a network of people who would help me. The Maryland Tech Council has something called the Venture Mentor Service. I was introduced to Pam Lubell who put me into the program: It’s like, you’re on my team, others are on my team. That has been powerful for me. It’s given me a safety net. I could take a leap and felt that I had people around me.

Striking up conversations was a challenge for me, I had to force myself to do it, I would go to these business conferences and force myself to walk up to people and introduce myself. And through this now, I could walk up and talk to anybody. I’ve kind of overcome whatever fear or resistance that was but that was important. It took me about a year, but I met someone who was a scientific officer in a big company, and he came to me one day and said, we got a bunch of money we need to get rid of at the end of the year and your project seemed like they could be helpful and you know we’d like to give you a slug of dough and I’m like that sounds great. I also now have collaborators from Temple University have collaborators from UCLA and collaborator from Colorado State.

QUESTION: What do you look for to determine if you need to pivot from your original strategy. So in other words, to determine whether you’ve given your original strategy enough time.

I don’t think there’s a magic answer to that. One big piece that drives this is financing because to build capital over any biotech company, any early stage company, is critical. So, I think that really drives it quite a lot. Like for example, funding is moving toward COVID, and funding may be moving away from other things like, say, cancer so that may make the decision for you.

Also, it’s been important to follow the technology. My sense has been the technology is always evolving and expanding and I still feel I’m at the leading edge. So even though I’ve been doing this for a couple of decades, I still feel the work is at the leading edge so it needs to be kind of like a harsh analysis.

That can be a real crisis of the soul. We don’t want to give up. I would say, don’t give up, find your way forward.

05 Oct Session B – Entrepreneurship Track

Entrepreneurship Track – Human Resources as a Strategy – Building a Team to Ensure Success to Attract Investors

• Moderator:
  • Sally Allain, MSc., MBA, Head of JLABS, Washington, DC, Johnson & Johnson Innovation – JLABS

• Speakers:
  • Ellen Hukkelhoven, Ph.D., Managing Director, Perceptive Advisors
  • Claire Leurent, Ph.D., MBA, Principal, Venture Investments, Johnson & Johnson Innovation
  • Ken Mills, President & CEO, REGENXBIO, Inc.

This panel of colleagues and others across Maryland is really going to look at the topic of human resources as a strategy, building a team to ensure success, and to attract investors. What this session will discuss is how to build a team to ensure success. We’re going to focus on the key roles within startup companies, developing boards, what to look for when partnering with investors and other companies, and the shift of expertise when transitioning from an early stage company to a public company.

QUESTION. What are the key roles you see within startups and what are you looking for to invest?

It really depends on what stage the company is at, and what is important to get them to the next stage. If it’s a private company or an earlier stage company, they have a lot of preclinical data maybe from an academic really early on and so they have to make sure that data can get transferred to in-house labs and that they can plan the next preclinical experiments. Having strong scientists who have had some experience doing that is important.

One area that a little bit later stage companies who are starting to do the clinical development really struggle with is finding good clinical developers, because a lot of them are in pharma companies. A lot of the ones who’ve had experience in biotech, it’s hard to recruit those to early stage, small companies and so I think when a company does have someone who has experience and not just experience but actually success in that area, like understands how to set up clinical trial sites and how to drive enrollment and really get things moving is really important, so that you don’t get delays to those first proof of concept data sets.

I’m always thinking, what’s the probability of success? How can we de-risk that probability of technical success? Having very strong experts who have experience in that field is helpful and ideally ones who can recruit a good team underneath them because often as an investor, I don’t have visibility to the lower rank people so having someone having a strong leader in place is key.

CEO and CFO. You need a road to grow the finance, as well as to grow the enterprise. You really need somebody in charge of compliance very early. Like in data science, for example, and Chief Medical Officer may be needed for some companies early. Others can just make it as a Chief Scientific Officer.

QUESTION: What are some of the failures that you’ve seen with companies building an early stage company?

Not focusing on that clinical development part enough and not hiring the right person. Time is money and so if they make promises and are generally over-promising and under-delivering on timelines. Because of that, and those are really intertwined. And that can be very frustrating. We as investors, especially if we’re looking at public market companies, we’re usually used to getting guidance and you better get guidance on that timeline. If you didn’t, that’s a big red flag. In early stage companies, in early clinical development, they don’t know how to recruit patients well. They don’t know how to recruit the right patients. It’s also very important that you get patients who are sick enough to show a benefit but not so far gone that you can’t show a benefit because the therapy can’t do anything anymore. Walking that line can be so difficult and finding someone who’s really good at it, and has done it before and has interacted with clinicians to really guide the enrollment and not just push it through speed-wise but also the quality, is something that is really important.  

As investors, we need to have confidence not just in a person but in that person’s ability to put a team together that trusts one another.

The CEO is extremely important. It’s important that this person understands both the business and the science. You need a good manager who can hire the right CFO and the right CMO. Understanding all those aspects is really critical.

QUESTION: Early stage companies and startups, with limited budgets can only bring in certain roles into the company, versus outsourcing or using consultants. What do you think is critical? If we were to make trade-offs here. What would you trade off to potentially outsource or use a consultancy?

At the beginning, a good Chief Scientific Officer, or if we’re talking tech, CTO, the CIO, or product manager, if you’re going marketing so it depends on the company’s core. And so the other functions can definitely be consulted or it can be some time, where, when the company is really early can be advisors, sometime not paid.

You might be strapped and not have a lot of cash but you have the equity in the company. If you have articulated a strong vision, and have assembled a good team of people and advisors around them, you should be able to recruit some of these top positions and lure them in with generous equity compensation.

QUESTION: What are some of the considerations in developing an advisory board and board membership?  

It’s important to have people on the board that were able to go through strategic, more abstract exercises they’re synthesizing through. While the work is going on with management, you needed a group of people who are able to play a role that was not just approving things but also listening and providing feedback.

Fewer board members is always better. People of diverse backgrounds, people who you know maybe they had worked on different types of projects and different experiences in different ways. Five people out of the gate is a good critical mass to get enough diverse thinking, enough backgrounds of experience and sort of breadth of understanding to be able to navigate.  

QUESTION: Any advice that you offer companies in your portfolio to in regard to board advisors?

The board is basically the investors and the CEO, which is fine to some degree, it depends on who they are and they can add helpful expertise to the boardroom conversations. It’s important to get industry experts on the board early and to try to get independent board members. But not too many. You don’t need nine board members. Even from scheduling standpoint it can really be a problem. So, try to limit the number to a small handful.

I will call them up and I will ask, what are the boardroom dynamics because when we’re writing term sheets, we don’t have capacity or perceptive to take a lot of board seats I’m completely maxed out at six. If I get a red flag about the board dynamics and what may or may not happen then I might not even make the investment. So, one of the concerns that’s kind of high in my mind is, you know, if the for example if we’re coming in at a series C or D like we did with Ken Ken’s company REGENXBIO. The early investors might be at the end of their fun life, they might be and they might control the board and so they might want to sell the company for what for them is a huge step up from the price that they got to the company but for me is small and you know I see the vision of this company is becoming really large and that’s why I’m doing this late stage investment and so I’ve had that happen once or twice, and since then I’ve learned it’s really important to be present for those, you know, for those situations and take a board seat and have a little bit more control than one where that’s less of a problem. So, I think that that’s something common for for kind of the later stages crossover type round investments.

QUESTION: Should small companies bring in someone with large biopharma experience or would this be a culture clash?

The culture clash is less of an issue. You’re just pulling on their expertise and their networks for the company It’s a little bit of a transition and you need to find someone who really has that entrepreneurial drive. And there are a lot of good executives out there who actually have gone from leading organizations in pharma to wanting to go into smaller companies and lead organizations there and have been really successful because they do know how drug development is done.

QUESTION: With regard to those looking to step into the biotech equity space. What are the essential skill sets and steps that are needed to be there?

So there’s a lot of different routes. Get a job on the sell side at a major bank and get trained there because you’ve got to learn some of the business. But a lot of it is pretty easy to learn on the job. Another easy thing to do which is helpful on this, while you’re doing your postdoc or your Ph.D., there are usually programs in lots of cities that help early stage startups raise money. Build your network while you’re there trying to get a job in equity research, whether it’s the sell side first and internship at a buy side place can always also help at a fund. The other route that sometimes people go is consulting. Also, having a Ph.D. or an MD as a background is now almost a requirement.

QUESTION: Are there some thoughts you have there about what you see across the ecosystem here in Maryland with opportunities for postdocs?

The ecosystem around here is interesting; places like the NIH and Hopkins and the academic institutions. We’re actively seeking people, and we’re going to those campuses and working with a number of others in the area to communicate that there are work opportunities for postdocs in the industry.

05 Oct Session A – Entrepreneurship Track

Entrepreneurship Track – It Takes an Ecosystem

Moderator:

• Rosemarie Truman, Founder and CEO, The Center for Advancing Innovation

Speakers:

• Hansilla Alaigh, Director, External Development. Emergent BioSolutions
• Angela Graham, President and CEO, Quality Biological, Inc.
• John B. Mumm, Ph.D., President and CEO, Deka Biosciences

Emergent has established itself so well in recognizing and knowing what capabilities and competencies it has. And what else it needs in order to grow. And I think what Emergent has done well in the sense of starting off where they were in 98 and expanding to the portfolio. So, in terms of doing that, it’s like what John indicated, knowing what you have and where do you need to partner, what capabilities and competencies you need to bring in. So that awareness is extremely important and humility in that so Emergent has done that by understanding that we have this but we need this. And then at the same time to the point Angela made of being that trusted partner, and the fact that we’re in a wonderful environment and ecosystem with our government and non-government counterparts here.

I think that it’s incredibly important to grow at a pace that’s commensurate with your capacity to kind of leverage yourself right. So I think oftentimes especially with small companies, there’s a predisposition to have to go as fast as possible. And it’s not that it isn’t true, it’s just that whenever you’re making a choice, you can over-leverage yourself, you can overextend yourself, and as a small company, you need to grow in a way that’s constantly optimal.

And I think that’s an important part of building and continually, I would say vesting yourself into those relationships. Not only early on, and you may not need to reap rewards at the beginning but you’re establishing yourself as a partner to say we have these capabilities, you can come to us for X, Y and Z. And over time, then that may eventually lead to a program or project or collaboration, but I think the awareness of that we’re here and this is what we can do. And we’re willing to partner It’s the openness. Not everyone is always open to say hey I don’t have this or maybe we need to bring this element in and I think always having that helps build that trust in those relationships. And over time, you basically see the fruits of that labor, and especially with emerging right now in the COVID crisis. It took time building that trust with the government since 1998. And here we are today being part of that broad arching response to a global health pandemic, I mean that’s huge. Where it took time and trust to get to the point where we can be trusted to manufacture these vaccines with the capabilities and competencies we have so I agree with my colleagues.

I spent a number of years in Texas, I spent three years in California, various companies, and there is something profound about the waters here in Maryland. There is more of a focus. It sounds as if we are able to cultivate trust a little bit better than in other ecosystems. There’s a passion for discovery.

Maryland is cheap in comparison to Texas. This is a great place. There’s a lot of value here. There’s value in talent, there’s value in that. We’re in a very unique environment with our neighbors and our policymakers.

 The talent in Maryland is everywhere. But if you talk about regulatory talent, I can’t imagine that anywhere else is going to look like Maryland.

There is a diverse talent here, scientific expertise, regulatory expertise, manufacturing expertise, policy expertise. People are gravitating toward this area.

We have the proximity to all these all the resources that you would need in order to actually flourish.  

I think being aware of who your network is number one, and where the gaps are and how can you can fill those gaps. It’s also being able to articulate what your capabilities and competencies are outside in and inside out so being able to target what exactly are you looking for, that’s also very important. We could build relationships and that’s fantastic but what are your specific requirements, what exactly are you looking to form a relationship for?

There are a lot of resources here for whether your established company or startup. Whether it’s through the county or through the state there. And then we also have this great convener in the Maryland Tech Council. Whether you need our county resources or state resources or you just need an introduction to another company. So I think it’s about leveraging all the resources that we have here.

I think we also have the unique ability to conjure up unique collaborations because you have pharma, you have biotech, you have academic institutions. It’s also a nice opportunity for us to think outside the box. Maryland is very much an outside-thinking box state because we have these unique perspectives from all parts of the industry.  

I would just say that I always I always tell people, I think it would be very difficult for me to walk in anybody’s lab and not have something on their shelf, whether it has the Quality Biological name on it or someone else’s name on it, so you know again that’s what is unique about this area of a partnership. So we trust one another, we’ve learned to work together and understand when it’s important to say, you know what I’m going to leverage you to do this for me, that I trust you enough that we’re going to we’re going to put my label on it, so that I can then maybe because they have some capabilities that maybe are higher than ours that they can go move on to something else so you know those are to me some of the some examples I can’t give you more specific but it’s really because I haven’t had permission from people to be able to tell to tell you that I make something for them.

And again, because Emergent is very diverse in its portfolio, we can leverage innovation from other sides of the business, whether it’s vaccines to therapeutics to manufacturing and devices but you’re always thinking about different opportunities. The nice thing is Emergent is also very open to people coming to us and giving us maybe a pitch about that new innovation and capability. We’re good on feedback, we’ll provide feedback saying yes this is great but have you thought about this or maybe, this is super innovative.

And for external stakeholders and our partners, it’s very different. The government has innovation and where they want to see next- gen. You know DARPA is very different and what they understand their innovation to be. So, at the same time it’s, you have to also understand that innovation is at different phases and paces for different organizations, and I think being open minded to that and knowing how that innovation fits into your program or portfolio.