Bio Innovation Conference | 2020 Recap
Presented by Maryland Life Sciences, a division of the Maryland Tech Council, the Bio Innovation Conference is driving the future of life sciences in Maryland. This conference provides a forum for professionals from industry, academia and government to discuss trends and insight into Maryland’s burgeoning life sciences industry and topics related to funding, structuring, commercialization and government relations.
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2020 Recap

Postdoctoral Researcher Session – Mid-Atlantic Career Opportunities

 

Moderator:

  • Steven M. Ferguson, CLP, NIH Office of Tech Transfer

Speakers:

  • Stephen Auvil, Executive Vice President, Programs, Maryland Technology Development Corp. (TEDCO)
  • David Ihrie, Chief Technology Officer, Center for Innovative Technology (CIT)
  • Omar Mencin, DBA, Senior Director of Investments, Investment Group, Ben Franklin Technology Partners
  • Randy Ribaudo, Ph.D., Co-Founder of SciPhD; and ex-NIH and ex-Celera

 

Whether it’s an industry or government job, or whatever it is you want next, there’s a lot of things you can do as a graduate student. The first is making sure that you know what the career options are available to you. And there’s a lot of resources out there to really figure out career options.

Once you understand the career options that are out there, it’s gaining the credentials that you need in order to be a competitive candidate. So sometimes that means getting some leadership experience, so joining the committee for your postdoc or grad student organization or volunteering to lead the journal club for your department or doing some kind of above and beyond your science, doing some kinds of things like that to make sure that you’re gaining team skills and leadership skills that that complement the research skills that you’re getting in your labs.

Networking is very important, and it doesn’t have to be this scary horrible thing that you have to do. It’s really just having good conversations with people and asking good questions. So for example, in an informational interview. ask what’s on their to-do list both long-term and short-term projects, because that gives you a really good view of what those that job does on a day to day basis.

And then the last one that I really wanted to point out is something that many of us are struggling with is that to realize that everyone’s struggling during the pandemic. To think about next steps, struggling with worrying about whether they’re getting enough work done. You can’t get into the research labs as much as you would like to and so is that going to hurt your long term career outcomes. And I want to assure you that everyone’s in the same boat. And everyone’s getting jobs. So, it’s okay if your research is slower than you want it to be. Take care of yourself. Take care of your resilience. Take care of your wellness and make sure that you’re ready for the next step. So it’s gaining career knowledge, gaining good credentials, and leadership skills. Build your networks and take care of yourself.  

 

QUESTION: So many scientists that currently work in academic and federal laboratories will need to be thinking about careers in industry. So what are some of the key skill sets that biotech and pharma companies look for when they bring in new scientists into their companies?  

The first thing that they look for is, do you know the science? So you’re going to have to make sure that you convince them that you understand the nuances of the science, the pathways that are involved in the kinds of work that they’re doing. I know many hiring managers who run oncology divisions of major pharmaceutical companies, and what they’ll tell you is, I don’t have time to train a scientist on the science they need to know. That’s 10 years of your life or you’ve learned that and they can’t train somebody for that. They do have experts who can train you on a particular assay, a particular technical skill that you don’t have, they don’t worry about that so much, but that is only the first step in your candidacy for a job. First, establish that you know what they’re doing.

The next thing they tell you in the same breath is, once I know that they know the science, there is no way that I’m going to welcome them into my group, my high functioning team, unless they also have the business and social skills that are necessary to integrate well into that environment and this is where a lot of people fail. The notion that your science is enough to get you the job is just not true, it is in some ways the most important for technical jobs because it’s your ticket to be considered. But these people who run divisions in biotech and pharmaceutical companies and related kinds of organizations, spend an inordinate amount of time building what they call a high-performing team, a team that can meet deadlines. You have a tremendous amount of pressure from upper management to deliver projects and products on time to satisfy investors, to satisfy corporate objectives. So they have to know that you can work in this cross-functional environment, that you’re a good listener, you’re not a dominant person, that you can work with other people, you can be deferential, you can take constructive criticism, you can give constructive criticism in a way that is empathetic.

There is a whole wide variety of business and social behaviors that you have to be able to demonstrate. During the interview process and even on your cover letter and targeted resume that show that you can be a good contributing team member, because the worst thing that can happen is that you poison that team dynamic, because that can really slow down a team.

 

QUESTION: How can postdocs and other scientists connect up with TEDCO funding companies, and what are some of the other TEDCO programs and resources that might be relevant for early stage.

TEDCO was created by the state of Maryland, and it’s funded by the state of Maryland. Its goal is to support entrepreneurs and to support the innovation ecosystem. We do that through a variety of ways including supporting technology transfer, supporting entrepreneurs by providing resources, and then also providing funding to help companies grow, primarily in the state of Maryland. So as a postdoc, you can start a company, or we can try to connect you with one. It’s about networking. We currently don’t have sort of a formal matching program where we can match scientists with other scientists or scientists with business folks to try to build tools around that for companies.

Another thing I would recommend is talk to your colleagues if you’re interested in starting a company or you’re interested in getting engaged with another company. Let folks know. If you keep it to yourself then nothing’s going to happen.

So if you’re a postdoc in one of the major research universities in Maryland or in a federal lab, we have funding programs available. We also have entrepreneurial support programs. We have things like networking advisors so a lot of entrepreneurs, they get out and they think the first thing I need is money but they also need advice. We’ve got a startup orientation where you can get online and ask questions and learn about what does it take to become an entrepreneur. And, we also have a lot of online resources for folks as well.

 

QUESTION: What does the Center for Innovative Technology offer in terms of career opportunities for early stage scientists?

In many ways, CIT is the equivalent in Virginia to what TEDCO is in Maryland. We’re an extension of the state government and operate as not-for-profit. We run grant programs for university researchers and so forth. We connect with the entrepreneurial community and make equity investments in early stage companies.

I think a good way to get involved in various programs in Virginia…there are a number of different clusters so if we’re looking at Northern Virginia, certainly the Inova healthcare system has very active program, and we make investments there. In Richmond, we work with VCU, and there’s a cluster of innovation and funding sources, going around there. Similarly, in Charlottesville, the University of Virginia is very active and many of our companies come out of that area,

Don’t be afraid to explore sort of adjacent industries. Everybody likes to focus on their specific verticals or specific areas of scientific expertise, and in a lot of ways those skills translate into different areas that you might not think of.

 

QUESTION: The Philadelphia/New Jersey area has always been an active one for both pharma and tech. What opportunities do you see with Ben Franklin funded companies in the region for new scientists and what kind of advice or suggestions might you give.  

We are a Pennsylvania-wide organization, Ben Franklin Technology Partners. We’re economic development in our mission but we operate like a venture capital fund investor. We’re very active. We do anywhere from 25 to 40 deals a year. We have a portfolio that is similar to what TEDCO has, around 200. That’s about 50% in the healthcare and digital health what we call sort of healthcare IT types of companies and then the rest of it is kind of between…different types of technology companies. region. We partner very closely with local universities here. We’re very close to University of Pennsylvania and Drexel. We work with the Drexel Culture Center. We have a wide range of investments between $25K and $50,000, up to a million. Most of ours come in around $200,000. On the early stage, I would say we’re probably one of the most active here in this region. We make a lot of connections to angel investment groups and venture capital companies.

 

QUESTION: What is the value of having grad students and postdocs exposed to entrepreneurship and commercialization training, and having these folks have it early in their career rather than waiting?

At NIH’s graduate school, we have programs and a couple classes. One is business development for scientists.

We have a program at CIT where students pretend they’re a startup company that is licensing the technology and they have to put together a business plan and do a pitch meeting to ask for funding. We’ve had students work with CIT and end up working with other granting agencies or end up actually part of the biotech community. So, being part of the training and exposure gives you some different role models and different career pathways where you proceed as a scientist, rather than just assuming that you’re going to be an academic professor.

I had a class on the business aspects, and we talked about the time value of money, the net present value and that sort of thing. These things were very basic to business folks, but as somebody who never had any business classes I always thought this is really relevant stuff. Getting exposure to entrepreneurship training is really the nuts and bolts of business. It’s not the full MBA but it’s the basics of business. I’d venture to say that if you’re not going into academia, you’re going to want to understand a little about the business the industry.

 

QUESTION: In terms of development, what are things that people shouldn’t do or what are some career pitfalls?

Number one, not doing career development. Like waiting for the last six months and then hoping you’re just going to land a job. So start preparing. You don’t have to do a lot your first year as a postdoc but start building your network, like one or two people that year. Think about a visit with a career counselor or something like that.

Another thing we’ve seen that is detrimental is that folks stay in labs that don’t support them. So if you’re in a lab that’s just not working for you, find some support to move labs, so that you’re not feeling trapped. Also, publishing at least something during your postdoc years is very important. And then the last one. There are so many, so many resources out there on how to build a resume…use them.

Identify jobs that you’re really excited about and develop a targeted resume that really speaks to that job. Identify the skills that you’re good at and gain accomplishments for those skills. Identify the skills that you’re not particularly good at and work with an outside the lab to try and find those abilities to gain those experiences and accomplishments.

Postdoctoral Researcher Session – Mid-Atlantic STEM, Innovation & Entrepreneurship 

 

Moderator:

  • Jack Pevenstein, Ph.D., P.E., NIST Tech Transfer Advisor, Senior General Engineer, Federal Laboratory Consortium, Mid-Atlantic [FLC-MA] Regional Coordinator

Speakers:

  • John P. Holden, Director of Economic Development and Tourism, Stafford County Va.
  • Rebecca A. Styn, PhD, Erie Management Group, Director of Community Investment, Erie, Pa.
  • Robel Worku, Economic Development Specialist, Montgomery County Economic Development Corporation

 

The Mid-Atlantic region is loaded with opportunities for scientists, engineers researchers, and bench researchers who have an interest in careers beyond the bench. And it is an interesting mix that the Mid-Atlantic region is the most densely populated in terms of federal laboratories and technical facilities, and it’s also loaded with state and local governments that are deeply concerned about promoting economic and professional opportunities for scientists and engineers and related fields.

Once you get finished with your fellowships, with your postdoc, opportunities with your short-term research activities, you’re going to be looking for more permanent career situations. Some of you will stay with the bench. Some of you may want to stay with the federal government. Others of you may want to explore opportunities in innovation and Technological Entrepreneurship. An important point is, learn to network. Networking isn’t done by sending out CVs and resumes, networking is done person-to-person. 

The second major point we want to stress is that the Mid Atlantic states, and their various municipalities, are actively encouraging economic and career opportunities that are driven by technological innovation, and the opportunities are growing rapidly in this area. The Mid-Atlantic region desperately wants to attract a highly skilled workforce, a young dynamic workforce, a workforce that’s plugged into 21st century technology of all kinds. And finally, this area has world class academic institutions that you can rely on for further training, where you can rely on for collaboration.  

Opportunities in Pennsylvania

I thought I’d give like a highbrow overview of Pennsylvania overall and talk a little bit about Erie as we move forward in this session. Today, there are over 250 institutions of higher education throughout the state of Pennsylvania that are currently working on research talent development. And we have a network of incubators and accelerators within this area that also provide support. We have a strong incubator program through both Gannon University and what’s known as Ben Franklin Technology Partners, which is a statewide initiative supporting and collaborating with many entities. It has four chapters across the state.

Though this year, we have gone virtual given obviously the pandemic situation so statewide, our Department of Community and Economic Development also launched a KIZ program (Keystone Innovation Zone), and as a means to drive innovation and support and entrepreneurship in and around Pennsylvania, through their colleges and universities. Qualified companies are eligible to receive up to $100,000 per year in tax credits, which can be used to support growth and expansion in our Commonwealth. So there’s currently 29 zones throughout the state of Pennsylvania, And Pennsylvania is in the top 10 states for technology growth potential. We are home to two of the top six NIH funded research institutions, the University of Pittsburgh and the University of Pennsylvania. And last year, we received the fourth largest amount of NIH funding in the United States. Obviously we have other great institutions like Carnegie Mellon, and they also boast a nascent company called Carnegie Foundry which supports innovation and robotics. We have major healthcare systems including UPMC and Allegheny and there’s just a wealth of opportunity here. 

NIST Opportunities

At NIST, we have a program that we call the Entrepreneurs in Residence Program. We have three people there who have had extensive experience in all manner of technology transfer activities, entrepreneurship activities related to the legal aspects of developing a startup company. It’s for people who want to explore the entrepreneurial space, the startup space, talk to people about what it’s like to start their own company, on a one-on-one basis. We’re very big on the idea of paying it forward, giving of our knowledge and giving up our resources in terms of networking to help you.

 

QUESTION: What talent or skill sets are most needed?

Data analytics is huge, and that spans multiple industries and fields. A lot of the new software or hardware they create has a lot to do with analyzing a massive quantity of data using artificial intelligence or machine learning technology. So they’re always looking for folks who can process a large amount of data and make sense of it. I think one of the most interesting titles I’ve seen out there is with product managers. And a lot of what the product managers have been doing is trying to figure out how to use a lot of the data that they’re synthesizing and trying to operationalize and make the product better so I’ve seen a lot of that happening here

There’s a lot of opportunity in research and development in PA and also in data analytics. PA is home to cyber especially up in the northwest corner of Pennsylvania. Gannon just launched what’s called the AI Hack, which is part of their university so I know that’s growing. And then manufacturing is key here. There’s a ton of opportunities that they’re looking to expand and grow.

I’m going to give you my take on technology transfer, and why I think it’s important, and how it moves into other fields related to technology entrepreneurship. People with technical backgrounds, no matter what level they are generally, have the knowledge and the ability to undertake technology transfer. And when we talk about technology transfer, we’re not only talking about simply the transfer of knowledge from one party to another. We’re talking about the marketing of the knowledge, we’re talking about the ability to take technical knowledge and make people aware of how that can solve problems to better their lives. Every federal laboratory, and there are some 330 of them throughout the country, is required to have a technology transfer office, and the federal technology transfer mission is mandated by a number of federal laws.

The Foundation for Advanced Education and Sciences at NIH offers graduate level tech transfer classes.

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.

Life Sciences Track – Expanding Progress and Opportunities in Gene and Cell Therapy

 

Moderator:

  • Jeff Galvin, CEO and Founder, American Gene Technologies

Speakers:

  • Dawn Driscoll, MBA, Ph.D., GAICD, Chief Executive Officer, Cell Therapies Pty Ltd
  • Bill Enright, CEO, Vaccitech
  • Jon Rowley, Ph.D., Founder and Chief Product Officer, RoosterBio, Inc.

 

QUESTION: Tell us about RoosterBio

Our goal is to radically simplify the incorporation of living cells into tomorrow’s therapeutic products. We are not a therapeutics company, we are actually a tools company, and we supply cell banks and bioprocess media into the cell therapy and gene therapy field from which therapeutics are made. So they’re the cellular starting materials and the ancillary materials in manufacturing. So, we’ve taken the traditional media business model that was actually pioneered right here in Maryland and turned that business model on its head and focused it on the manufacturing and the product development. Our mission is to really fuel the rapid commercialization of scalable regenerative cures.

 

QUESTION: Tell us about Cell Therapies

We are a full service contract development and manufacturing organization. We’re fully licensed by the TGA, which is the Australian equivalent of the FDA, to produce cells for immunotherapy…various immunotherapy applications so we have a broad license for T-cell manufacturers in both clinical trial as well as commercial applications. And there’s really interesting quirk in Australia versus the US, where we’re required to have manufacturing inspections very early on in the development process, so we’ve already obtained those licenses so when clients come to us, they know that they’re coming to an organization that has basically de-risked the entire process and been through the process with a regulator.

American Gene Technologies is a clinical stage immunotherapy company, and we are really focused on using the T-cell side of the immune system to prevent disease or cure diseases, where we know T-cells are going to be important. We’re focused primarily right now in chronic infectious diseases like Hepatitis B, Human Papilloma Virus, as well as in oncology, so we’ve got multiple programs running in the clinic right now. The big news out of American Gene Technologies right now is obviously that we have been approved by the FDA to start a clinical trial for an HIV functional cure. And we’ve been working on this for a while. And we have a lot of preclinical data which is giving us significant confidence about our ability to actually cure HIV and a functional cure basically would be. And I’m pretty confident about it because we have really put together a dream team of HIV clinicians scientists and folks that are very experienced at it.

 

QUESTION: What can the Maryland stem cell research fund do to help accelerate cures in this field?

They’re already doing a lot. They’re funding a lot of basic translational research within the universities. Just a couple years ago, they put together funds specifically to help industry, which is to fund both product development as well as clinical trials that are being run in Maryland. And so there’s lots of opportunity there. We’re a small company here in Maryland and have grown over the last few years, and we’ve benefited from two of their two grants, specifically on the product development side and we successfully have launched two products based off of the funding that came out of there.

So they are actively helping the small companies here which is really great.

With workforce development, one thing that’s happening with lots of great companies that are moving to the area, the talent is getting slim. So the workforce development aspect, I think it would become an interesting area for them to expand into.

We’re finding it easier to get sort of entry level folks but a little bit harder to get experienced Ph.Ds.

 

QUESTION: When we were prepping for this session, I was surprised to hear about some of the projects Cell Therapies is working on with companies in the United States. Could you just tell us a little bit about those ones. You know the products that you’re working with.

There’s two fairly high profile projects and clients that we have which are very highly public knowledge, and I have my clients approval to talk about this publicly. The first being a company based in Boston that is developing various gene therapies for rare disorders. And we’re doing a lot of their product development and bringing those products into clinical trials in Australia for that company, and that’s been great because of their non-cancer applications. So, our team gets to become immersed in the biology of another disease state and really the biology of a different type of cell from what we work with most frequently. Another high profile client is Novartis. We are in the end stages of tech transfer and we’ll be launching manufacturing for Australia and quite a few other countries in this region. We’ve been pretty thoroughly road tested by some of the biggest companies in the world. We’re quite comfortable working remotely.

 

QUESTION: What are the major characteristics of MSCs that you think will be useful in the future in terms of treating different diseases, and you know sort of what’s the broadness of that platform.

Cell therapy developers have been figuring out how to take them outside the body, ex vivo, to expand them. And then just overwhelm the site of injury so you can infuse them and they will then home to the site of injury. A bunch get stuck in the lungs. So unless you’re treating a lung disorder like RDS, that might be a bug in some indications, it’s a feature. Some are directly injected into the site of injury. And, from my from my understanding, no one has really found a dose that is too high so you can really use a ton of these cells and overwhelm that site and really get that tissue regeneration starting. And then within a couple of weeks, you don’t see anything there, but the function of transplanting can last for months.

Life Sciences Track – Biomanufacturing in Maryland: Building a global footprint and maximizing the local ecosystem

 

Moderator:

  • Curran Simpson, Chief Operations and Technology Officer, REGENXBIO

Speakers:

  • Sean Kirk, Executive Vice President, Manufacturing and Technical Operations, Emergent BioSolutions
  • Tom Spitznagel, Ph.D., Senior Vice President, BioPharmaceutical Development & Manufacturing, MacroGenics
  • Aaron M. Vernon, VP, Engineering & Supply Chain, Autolus, Inc.

 

QUESTION: Maryland is now sort of being referred to as a strategic location for manufacturing, in general, so could you describe what is it about the area that you feel fits the category strategic location, maybe we’ll start with you.

We have a desire to enhance our overall collaborative effectiveness with not only HHS, BARDA, and other agencies, but also the FDA and the Department of Defense. Biodefense preparedness was really the origin of Emergent, so we’ve had a lot of great success and it just so happens that we’ve acquired products that came along with facilities, two of which happened to be here in Maryland. So to your point, through acquisition and organic growth we’ve ended up firmly rooted in the Maryland area.

Maryland’s real estate prices are reasonable compared to other biotech hubs like Boston or San Francisco. Maryland still has a substantial advantage over there even if you build within the city of Rockville for example it’s still highly discounted compared to other areas. One of the things in why we built our manufacturing facility in our actual corporate headquarters is to showcase manufacturing. It’s a way of advertising. 

Compared to Boston, it was still a much better cost basis for us to come to Maryland but also it came down to the talent. It has a substantial kind of cluster of people in particular biologics. But even more so in the last several years, cell gene therapy in the area is a pretty good cluster.

 

QUESTION: How do you deal with the necessary operational speed in Maryland? What are the advantages of being here and what are some challenges that you see the local area as it relates to employment, providing opportunities which.

We’re hiring over 300 people to support our efforts across our three manufacturing plants, and our product development facility is in Gaithersburg. The competition can be a bit stiff here and the talent pool is a bit undersized to serve all the different needs that exist amongst these companies and many others. I believe that much could be done to improve the overall personal income tax structure and other things that are sometimes a challenge to get people to overcome when they’re relocating here from, say the North Carolina area or other areas. Of course, some aspects of living here are actually less expensive than some of the other competitive markets. We’ve worked with the Chamber of Commerce and others in the past and we’re continuing to look to explore mechanisms to enhance the attractiveness of the greater Maryland area to the overall talent pool and get the numbers of candidates up to serve all of our needs.

 

QUESTION: Could you share some success stories around recruitment and in onboarding of new employees? What areas or techniques have you used to attract and retain employees and what can Maryland do to help support the next generation of companies that are involved in manufacturing?

We’ve been very successful recruiting directly out of college. That’s one area that does have a lot to offer, a lot of local colleges with talented individuals. And a lot of companies won’t give these people the time of day, so we were actually quite successful in scooping those people right out of college and training them and getting them, a rewarding and fulfilling career within manufacturing, and that’s worked quite well for us.

After that second or third year people leave. And, on one hand, we’ve decided we can live with that. If we can get a good two or three years out of them, that’s sort of a minimum but what we really try to focus on is, can we get them to the next part of their career, either into a more supervisory role within manufacturing which, honestly, the options are limited if you’re not expanding your capacity. But more importantly, getting them into development and things like that and we’ve, actively tried to do that and it’s still a work in progress.

Rockville has a lot to offer. Within just amenities, the street from us has 20-30 restaurants. One of the things we find is that a lot of our younger manufacturer employees are living in the cities, so Rockville does have more of a centralized location for that worker base.

 

QUESTION: Did you consider Frederick or Hagerstown? Obviously, the lower cost of living and potentially the real estate pricing being more affordable.  

So being in closer to the DC area you have access to BWI, Reagan, Dulles, whereas going out to Hagerstown, for example, it’s severely limited in terms of the logistics and the cost and complexity would go up so that’s one of the reasons we wouldn’t go much further west in in Maryland. We did absolutely consider Frederick. Part of the reasoning also was to be located in the middle of the Rockville cluster as our US headquarters.

 

QUESTION: Cell therapy is an interesting area. Have you thought about the sort of ideal profile of employees in terms of academic training. Are you looking for people with advanced degrees, associate’s degrees or all of the above?

With very early stage clinical, you’ve got many more people with advanced degrees who are touching the product but that’s not sustainable especially not in a large scale. Certain roles that are associate’s degree and more of our manufacturing is probably in the four-year degree. When we’re talking shop floor, that wouldn’t require an advanced degree.

 

QUESTION: How do you manage that growth in terms of people in onboarding and training and also considerations for the academic level that you’re recruiting for.

We are hiring at virtually every level in the organization. It’s challenging. The pace of hiring is challenging, we have stood up some focused training and education methodology to get people on board and onto the floor or into the labs, and we’re moving at warp speed. I’m wondering how much stress this is going to put on the state of Maryland. So, the state of Maryland has long been dependent upon folks who are government employees but reside in the state of Maryland for income tax base. And as the government reassesses how it operates in a paradigm going forward, I’m curious as to if it may actually lead more individuals using the government as an example to relocate to the state of Virginia, where the overall tax structure is lower, creating downstream tax deficiencies in the tax base for the state of Maryland.   

 

QUESTION: Have you considered as part of the substantial growth you’re going through things like apprenticeships or on-the-job training programs to bring people in who might not have science degrees but also could be cross trained in the manufacturing?

Yes, we have a variety of different programs that are kind of sprinkled in throughout the organization and have apprenticeships and internships in a variety of different areas ranging from engineering to manufacturing. We’re looking at ways to continue to build them out and to improve the effectiveness of them if you will.

 

QUESTION: Historically, there have been initiatives in Maryland where labs have been set up to demonstrate for students how manufacturing works, how to put together valves, how to run bio reactors, etc. Is that something that Maryland should continue to invest in? I know that historically that has been developed and then kind of fallen away and then come back. Is that something that you feel that for example Montgomery College could do more to sustain?

It’s great that we have a cluster now in particular manufacturing, But there’s more jobs that we need to hire for than there are people available right now. So I do think that this is an area where companies can work together and work with the state to be able to do a little bit better job of helping to pipeline.

 

QUESTION: I imagine the facility you’re putting together will have a fairly high level of automation associated with it. Where do you find automation engineers in the Maryland area? What are the creative ways to find this rare skill and retain that that skill?

I wish I had a good answer to that, I think that the best I could say is that, not just in Maryland, I would say all around the country there’s probably not as good automation engineers and we’re all going through this. I think one of the things that is really exciting for automation engineers is the intention to be paperless on the shop floor and to run an almost fully digital supply chain.

 

QUESTION How important is the commute? When everything goes back to normal, do you feel like that is an impediment for further growth for you, or is it something that just people deal with and you tend to recruit, maybe less from remote more remote areas.

 We haven’t seen commute time be the final deciding factor. Surprisingly, we haven’t seen that be a big driver in either inability to attract people, or the ability to retain people.

 

QUESTION: One question I would ask around recruitment since that’s going to be front and center for you as the facility comes together. Do you think we are now in a position where people look at us as a hub, and that there are multiple opportunities so the resistance to relocate has gone down or am I just imagining that?

Today, we’re kind of on the precipice thing. People will feel like the DC area is another place like San Francisco like Boston where they could just be here for a long time. And if they have to, they can find opportunities, big companies, small companies and take different roles.

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.

 

Postdoctoral Researcher Session – Welcome & Keynote + Technology-focused Careers Beyond the Lab Bench  

 

Introduction by:

  • Jayan Rammohan, Ph.D., NIST Post-Doc Association

Moderator:

  • John A. Fraser, CLP, RTTP; Assoc. VP, Research (Ret), Florida State University; Past President, AUTM

Speakers

  • Walter Copan, Ph.D., Under Secretary of Commerce for Standards and Technology and NIST Director
  • Ernesto Chanona, Senior Manager, Office of BioHealth and Life Sciences, Maryland Department of Commerce
  • Javier Atencia, Ph.D., Entrepreneur, founder of PathOtrak, LLC; former NIST Post-Doc;  Research Professor, UMD
  • John Curry, Ph.D., Entrepreneur, founder, acting CEO, CTO, Parman Tech, LLC; former Senior NIST Scientist

 

NIST is known by many as America’s innovation agency because we focus as part of our core mission on innovation and competitiveness. Some of the industries of the future focus areas of this which include structural biology engineering biology, advanced communications IoT quantum science and engineering and artificial intelligence, all these domain areas have massive career opportunities associated with them, whether in academia, in the federal sector in the private sector, or elsewhere.

A couple of pieces of pieces of advice I can offer you from my journey, everybody’s journey is somewhat different. Number one, find out what the core program is all about. Find out what it’s about and get into it. It might not be a perfect program, but you will learn some business ideas and theories which will be helpful. Maybe just as important, it’ll help you to prepare emotionally for what you’re getting into, and it’s going to help you to meet people that will be able to help you in one way or another down the line.

Number two, if your goal is to have a business that’s any more extensive than a single lemonade stand outside of your house, you’re going to need a team, and this team is going to be made of people who know things that you do not know, and there are plenty of things that you do not know. At the very beginning, that team might be one person who is working part-time, but that team is going to play a strong part in your successes or failures as an entrepreneur.

Number three, funding is very important. If you’re coming out of the NIST venue, then obvious places to look are TEDCO and also the NIST SBR program. One of the most difficult questions you’re going to face is where are you going to conduct the work of your business, especially if it’s a technical work. So for most startups that are right at the very beginning, there’s just not enough money to pay for commercial space that you’re going to need.

Find people who have already started down the path that you are contemplating and get to know those people. Learn as much as possible from them, because they know things or have had experiences that can really educate you.

Be honest with yourself about whether you have the sustainable drive to do this for the next 5 to 10 years. And it’s not just the length of time but inevitably you’re going to go through real challenging points, real difficulties that are going to make you say, this is never going to work. And you just simply have to have a drive and a desire to get you through those rough patches. And when you do get them, it’s amazing how fast they disappear in the rearview mirror, but they will happen to you. So be prepared.

Be prepared for change because our career journeys will almost inevitably lead us to certain junctures where you just feel that it’s time to move on. It’s a new passion that takes on. It’s a reason to leave where you are currently. And, so for a postdoc early career people having this opportunity to learn one on one another, to reach out to mentors, was an absolutely essential part of the journey.  

 

QUESTION: Do you have advice on green cards?

Going through the immigration process can be pretty challenging. One word of advice for anyone out there who has an I-485 in progress, reach out to your Congressperson and let them know what’s happening. But before you do that, you need a really compelling reason why they should be paying attention to you. I was at the Cancer Research Institute on a fellowship, and I needed to be a permanent resident. I needed to be able to receive it to open up my postdoc slot.

Senator Van Hollen was my representative, and I explained my situation and my green card was in the mail. It took nothing at all, but I made it very clear that I had a time issue.

 

QUESTION: How can postdocs moved from a lab to tech transfer?

Apply for a tech transfer fellowship program. There are some inside the NIH and other government agencies. NIH has tech transfer classes that are open to the community.

 

QUESTION: Do you have advice for a person with a lot of experience but doesn’t want to move into an entry position. And they haven’t experienced enough for a senior position in industry.  

It’s all about building relationships based on your background and on your interests. You may need a stepping stone to get to a more senior level role, but as soon as you build those relationships with the kinds of companies that you respect, you will find that new doors start opening up within your network.

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.

Life Science Track – Vaccine Development: Driving Partnerships in Maryland 

Moderator:

  • Marian Ewell, Sc.D., Chief Scientific Innovations Officer, The Emmes Company

Speakers:

  • Subhendu Basu, Ph.D., Chief Operating Officer, Adaptive Phage Therapeutics
  • Syed Husain, Senior Vice President, CDMO Business Unit Head, Emergent BioSolutions
  • Helen Montag, Senior Director, Corporate Partnerships, Johns Hopkins Technology Ventures
  • Sally Mossman, Ph.D., VP, Head of R&D Center, US, GSK Vaccines

 

So, today’s discussion we’re going to be focused primarily on COVID-19 vaccine development, but I think a lot of this discussion and the comments can be broadly applied to other vaccines, as well. 

TOPIC: So the first broad topic that we have is what are the some of the unique challenges for developing a COVID vaccine. So I’d like to start with what type of vaccines are in development.

There are really two overarching challenges in developing a COVID-19 vaccine: One is urgency, and the other is scale. In terms of urgency, we really needed a vaccine yesterday or at least as soon as possible. And for scale, we’re looking at an enormous challenge of needing to vaccinate the entire world’s population. 

We are really lucky that there’s a very diverse range of vaccine candidates in development, and they have various strengths in terms of addressing those overarching challenges as some of the candidates in development are representing very cutting edge technologies things like mRNA vaccines, like the ones from Moderna or Pfizer. And those are very exciting because they’ve been able to those companies have been able to develop design a vaccine candidates very quickly and get them into clinical trials, breaking records for how quickly they could get these into first in human testing.

On the other hand, those new platforms have never gotten to the point of being a licensed vaccine and they face challenges on the scale dimension, trying to set up manufacturing capabilities in the moment and then getting ready to distribute vaccines for which the formulation still got to be optimized. On the other hand, do you have more well established platforms represented, including the one from GSK in partnership with Sanofi Pasteur. And for many of these well-established platforms, it takes a bit longer to be able to design and develop a vaccine candidate and get them into the clinic for technical reasons. On the other hand, when it comes to scale, we have the infrastructure set up and experience with manufacturing vaccines and these platforms. So I’d say overall it’s fantastic to have such a broad range of different vaccine candidates in the pipeline. We really need as many shots on goal as possible, and ultimately will likely need more than one successful vaccine, just given the sheer numbers of people that will need to be vaccinated across the world.

 

QUESTION: What do you think realistic timelines are for developing a vaccine, and how can we sort through kind of what’s realistic for media hype kind of surrounding this?

I think everyone’s pulled together; The bureaucracies have been cut down and supply chains are being pried open. But there is the biology, and biology has its own timeline and it can be compressed. So, we can recruit all the patients we need, people are lining up. You know, this is the duty the clinical trials will proceed. But at the end of the day, if you’re looking at a one dose or a two dose vaccine. And then ultimately determining if it certifications. You need to have the incidents happening and then it’s going to take some time to actually establish that and this is beyond safety. I can see a vaccine coming on which is emergency-use authorized earlier, based on early efficacy. And hopefully, middle to end of next year.

Sure I mean I think you can add you can accelerate the process to be able to get to the point of entering the clinic. And we have certainly seen cases of that. There’s certainly efforts to manufacture millions of doses at risk while those clinical trials are underway, but it’s very difficult to dramatically accelerate an effective clinical trial process. I know that a lot of the trials being pursued are using adaptive trial designs and then really novel aspects of that for you. Even if you have a successful candidate coming out, I wouldn’t want to minimize the challenges of manufacturing and distributing the vaccine at the end. I think that’s when you know we haven’t faced something on this scale.

 

QUESTION: What type of a bar do you think they will need to pass in terms of immunology? What level of protection, what type of duration, why type of protection?  

I don’t know if we know what is a protective response. We’ve fallen back to historical knowledge. So everyone’s assuming that you need an antibody neutralizing data, which is reasonable to actually protect. But there is literature coming out that indicates that a T-cell response, And then you overlay on top of the anecdotal evidence that individuals have been infected are getting reinfected that throws a wrench in a classic understanding of the biology and what is actually protected for this vaccine. So the question is, is it masking, is it just behaving more like a common cold virus where you get repeated infections, but you don’t have a long-lasting immunity. Are you going to be able to have a classic traditional vaccine immunity we get, you know, two doses, and then protected for three years. Honestly, I don’t think we know the answer to that until we advance some of these vaccines through the clinic and do a longer follow up. 

We have to make sure that we test in a way that that meets the public trust so that once the vaccine is developed people will be willing to take it.

One aspect here is an it takes into account the last two topics Overall from an acceleration standpoint. The exciting thing is, the industry has come together. So everything that would happen sequentially. People are very open to, and they’re working on, ways to bring it to do everything in parallel. Certainly there’s always a cost risk to that but you know these are the types of things that have been kind of put to the, to the side.

That’s one of the most important elements and it certainly puts people in a situation, out of their comfort zone. But I think the way everyone’s working together, including the government including the regulatory bodies, kind of putting all their knowledge and horsepower on the table to attack this together. I think that gives a lot of merit to the fact that it will be accelerated.

 

QUESTION: Once we get a candidate that makes it through the safety and efficacy testing, how do we get the scale-up and manufactured to really quickly deliver that vaccine candidate to the population?

It’s all about doing it in parallel, as much as possible and in advance. It’s essentially putting everything on an all-hands-on-deck fashion and really assessing the state of the process on the supply chain and getting the facilities ready at a rapid pace. To start, essentially immediately going into large scale manufacturing but I think it. It all comes under this at risk umbrella and there’s going to be decisions that are going to be made that are being made based on phase appropriate information. There may need to be still some modifications that are made down the road. But this is where the sooner you can bring in the regulator’s into it as well. Then it’s kind of an, it’s a very transparent at risk type of process which, you know, I think is kind of makes it sound easier said than done. But, um, you know the transparency is very important here.

 

QUESTION: What about this administration’s idea of involving the military to get the vaccine delivered and administered.

One of the significant efforts that have been that has been put in place is the formation of Operation Warp Speed. Emergent has had an opportunity to directly interact with Operation Warp Speed, and when you look at the construct of it, there’s a scientific element focused on innovation, the science behind the vaccine, the manufacturing aspect of it, and then there’s a very strong logistical aspect to it as, as well. It all goes into this all hands on deck, and it also starts to look at everything from a parallel standpoint, so they’re already thinking about the distribution in parallel to when the manufacturing is happening. Their support has helped us accelerate timelines from a supply chain standpoint, and given their expertise in this from a logistical standpoint, it’s a great add, and I think it can only help us. Now, before we have a vaccine, they also are bringing in expertise. That is very critical.

I don’t think we give them enough credit. It’s amazing what they can do, especially because they are unencumbered by return to shareholders and shareholder value. We wouldn’t have penicillin if it weren’t for the US military. And this was in the 1920s, so when we had the influenza pandemic and the military driving penicillin. It was the military, and you know they get stuff done. And then from a distribution perspective, it’s bar none. I think we’re lucky that the military is actually stepping into this, and I’m encouraged, because they will get it done. So, I think it’s a great idea to leverage the military.  

Well I think we’ve, we’ve heard, but probably amplifying the fact that there are a lot of government nonprofits foundations and private companies that are all partnering together on this work. We’ve partnered with several government agencies conducting vaccine research at NIH National Institute of Allergy and Infectious Diseases, the Walter Reed Army Institute of research, BARDA the biomedical Advanced Research and Development Authority. We’re also working with foundations and nonprofits like Bill and Melinda Gates Foundation, the Henry Jackson foundation, and others. Historically, the governments and NGOs have played a big role in vaccine development and in really preparing for emerging infectious diseases.

From a public private partnership standpoint so many merchants have a long track record and history with working with the government and its and its agencies I mean when you look at COVID-19 right now in our collaborations with them. I mean we have collaborations on the product side where they are supporting the development of our therapeutics that we have in development. And then on the cdmo side, the public private partnership to proactively reserved capacity to pave the way for a proven us supply chain for these vaccine candidates as well as expand capabilities as well. It kind of it comes to a spotlight right now during the pandemic. But there have been years and years of investment and collaboration and preparedness, as well as solving other public health threats as well.

 

QUESTION. What unique aspects of Maryland are furthering these partnerships?

We certainly have a broad array of universities that are actively involved in trying to work closely with all the industry partners in the state. It’s a small state, but we are close to the federal government so we have the advantage of knowing really knowing each other. It’s kind of a small network.

Life Sciences Track – Pandemic & Risk Mitigation: A focus on preparedness & resiliency

Moderator:

  • Linda Segal, Principal, The McCormick Group

Speakers:

  • William Hearl, Ph.D., Founder and CEO, Immunomic Therapeutics, Inc.
  • Anne Lindblad, Ph.D., Former President & CEO, The Emmes Company, LLC
  • John Trizzino, Executive Vice President, Chief Business Officer and Chief Financial Officer, Novavax

 

Preparedness is a big challenge for any organization. And for us, I think the way we kind of looked at it is almost along lines with how we prepare for bad weather in the winter. And we made it possible for all our employees to be able to work from home, because we anticipated there would be cases where we would have severe weather where we would just prefer our employees to be safe and be home and be able to work. So, we outfitted everybody with the appropriate types of laptop computers so they could always have them at home. Set up the VPN situation so that we could work, and we’d had a video conferencing system on a kind of a basic level, install that originally.

And so, I think the way to do it is we’ve always taken the point of view that the health of our employees is the most important thing, as is taking care of their families. So with that philosophy in mind, I think, knowing that we gave everybody the ability to work from home, we instituted that and then once it became clear that the pandemic was expanding. Of course we have laboratory experiments, and having a CME in wet lab activities. We worked out a circumstance to allow people to come in, do their work, and then go home on shift so the building was never, never crowded and there was never a case where people had to work in close proximity. So we were able to endure that period of time very well because of the commitment of the employees and the tools we had kind of given them in advance. That turned out to be very useful for this circumstance. 

One of the things I think for any company that’s important is just to have a really strong foundation. And so I see that as building and maintaining a company in a culture that really values transparency and trust. And that really helps you change as you need to change as an organization when things happen that are unexpected. So, I think from the very beginning, Emmes has always encouraged leadership and self-discipline, at every level of the company and this allows people that freedom to make choices and decisions without waiting so that helps them move faster when things are changing. Preparing for change and making change is easier than managing that change.

Just being really clear that our employees and our clients come first, and making sure that people are staying safe and able to communicate is paramount. Security is crucial here because we have offices in India and Canada and the US and now I have to add in everybody’s homes and that changes the paradigm with security. We have to worry about GDPR and HIPAA, and we need to make sure that we can stay compliant with those important regulations. And so having the tools and having the security is one thing but making sure staff is trained to use them effectively is actually part of the challenge too and making sure they know where to get help so they can be as efficient as possible.

I think one of the most important things we did was to encourage our employees who are already doing this to really communicate with clients, because the face of our clinical trials were rapidly changing. Making sure our clients knew what we were doing to maintain this the safety of the patients, making changes to protocol helping through the regulatory processes, etc. And then, you know, in hindsight Another important thing we did is we started a weekly 30 minute touch base on COVID and on corporate happenings with our employees and we continue to have incredible participation. It’s totally voluntary. But people really want to stay connected as a community and so we learned from that people needed help on, you know, managing being home alone, and not having that that camaraderie. And others with families that were trying to manage children and so by having our HR department help with special seminars and support groups I think also helped just the mental status of our employees to adapt to that change.

 

QUESTION: How has COVID affected clinical trials, especially the recruitment for those trials.

It’s been interesting. It wasn’t a total shutdown which we were sort of expecting that maybe nobody could recruit, but we found that many of the sites pivoted as well, and were very innovative so the best way to think about is that it’s all about innovation. I think this is a good thing for our clinical trials community. I think it really challenged us. We found that the FDA, long ago had guidance on risk-based monitoring and use of remote monitoring or centralized statistical monitoring and this really forced many organizations to actually implement these things a lot faster. We tend to be a little late adaptors because we’re risk adverse, we want to make sure we have the best clinical trials, but having to accommodate places where you cannot do on-site monitoring, you have to think of different ways because the quality of that data is essential to getting the answers to the questions that you started out with for recruitment. We found that some sites totally shut down, and were on pause, while other sites kept going, and they had instituted safe practices for seeing their patients but also sort of hybrid approaches that required that we go to the ethics committees with revisions to protocols that allowed patient reported outcomes, telephone interviews, and replace them in-clinic visits. And so there was a very fast need to make those changes and get them approved in the protocol so they could be instituted so that we didn’t lose out on any safety information for ongoing clinical trials. And so as we think about the future, I think we’re going to see more hybrid models than maybe we have in the past. And I think this might be very good for speeding recruitment into clinical trials to the future so as bad as COVID is, I think it’s been an opportunity for all of us to rethink how we do our business and maybe do a better in the future.

 

QUESTION: So I would have thought that maybe you would have had a problem recruiting, but it doesn’t seem like that’s the case.

No, not at all, I think, in fact, just the opposite. I think there was a high degree of interest. I think in the US there were potentially some challenges regarding the multiple 30,000 subject trials but even there, there’s a high degree of interest in pursuing those clinical trials. Even with the clinical research organizations as well as the individual sites, a high priority was being placed upon these trials starting as quickly as possible and simply based upon the availability of material and regulatory approvals.

 

QUESTION: What changes do you see that the market is predicting based on this pandemic and, and how long we may be in this state, and what talent pools? Do you think it will help with whatever changes are happening?

There’s a uniqueness to what we’re what we’re doing here at Novavax that I think from a talent pool standpoint, we’ve grown dramatically from the beginning of the year, bringing some over 150 people into the organization in that period of time. Everyone across the organization wants to contribute to the cause.

Montgomery County and this region has a tremendously valuable talent pool to tap into and so that’s been a success for us. Even on the infrastructure side, so whether it’s HR or finance, we have attracted some significant folks and the additional work that’s had to be done in those areas to build up that infrastructure has allowed us to tap in to those human resource needs and the regional talent pool. So, again, our experience may be slightly different than some others. But the region has allowed us to accelerate on all of those fronts because of the resources available here.

 

QUESTION: Have any of the talent that you’ve been needing been very different from what you would normally recruit for?

There’s going to be a huge backlog of trials that are likely to be launched in 2021. So once a vaccine is widely available, there’s going to even be larger growth just because there’s this pent-up demand. So I think that’s going to put a lot of pressure on our labor market to find attract and maintain talented staff to support these studies within biotechnology. And I think about our talent needs so I think about our experience we were really privileged to be working with the National Institute of Allergy Infectious Diseases and our staff were able to receive that protocol back, way back in the March timeframe and get the first patient in within four days. So we got the system up and ready and randomized, and that’s a new record for us. And I think what that speaks to is just staff being able to work collaboratively and innovatively so that we can maintain quality and rise to these occasions

I agree with the other panelists I mean the enthusiasm of our staff, wanting to make a difference, you know to human health in this pandemic is huge. And so finding talent that has that passion that’s willing to work remotely, collaboratively, and innovatively it means you need the people that are confident and self-starters. We can provide a lot of support, but it’s also going to come from a sort of the fire in the belly of our staff, because that’s really what makes a difference for us. What has been good about remote staff is, even though there’s a wealth of talent here, it opens the door globally.

 

QUESTION: What are some lessons learned?

I think we have to keep doubled down on managing remote workforces and managing by productivity, not by time in a chair, you know with being able to share screens, you can be virtually next to each other.

A long time ago I heard it takes seven touches you know in advertising to really bring a message home and that’s seven different ways to figure out how to connect with people. So that’s something that’s a work in progress. And where we’re concentrating is what we think is happening to our clinical trials community of hybrid trials, more direct-to-patient, maybe more virtual trials which have a lot of using electronic health records maybe sightless trials, etc. and making sure we’re prepared with all the technology we need and privacy and security as well, so that we can launch those kinds of trials as well. We do some of that now, but I think it’s going to become more predominant in our field. We need the best and the brightest to continue to work on technology because I think this will make trials less expensive and it could aid recruitment so we can recruit faster, which means we can get answers faster and hopefully better treatments to patients faster.

Now, I think the, my, my thoughts about heading into next year are that we just really need to kind of stay the course and as we had the ability to integrate more in person, activities, we’ll do that but I think the biggest issue is we have to be cognizant of the potential for a COVID spike. We need to keep our eyes open to the things that are going on in the public health arena at the moment with respect to the virus and not drop our guard until we’re sure that we are completely out of the woods. And so that’s why leaders such as Dr. Fauci have been so important to the dialogue. All people forget that Dr. Fauci is 80 years old, and he’s been around for every major pandemic that this country has seen since HIV. And the man has dedicated his life to making sure that we have a safe environment for our country. And so I look forward to hearing more from Dr. Fauci and implementing his recommendations for my company, and hopefully for our region to keep us safe.

 

QUESTION: Do you have a target for when you would like everyone back in the office when there’s a vaccine and when there is community immunity?

If I find that I’m in front of my computer a whole lot longer during the day these days than I ever was in the office in Atlanta. That’s an interesting statement because that’s one of the things we worry about with our employees is burnout. And so it’s part of trying to bring that awareness because people are putting many more hours in, and you know I’m interested in getting their fresh bright perspectives and if you’re burned out you don’t get that from them. As a company leader, you want your folks very refreshed, so we’re pushing ours to take time away from the office and unplug and finding we have to do that a lot more now in this remote workforce than we did when it was in brick and mortar.

 

QUESTION: What is your approach to becoming involved in nonprofit causes in your community?

Drew Parnell, who is on our scientific advisory board, is an advocate for Moveable Feast. We’ve given strong financial support to Moveable Feast as requested by an employee, and they are providing meals. For me personally, I’m a very big advocate of one of the local charities that provide support to cancer families of connections for cancer support.

We joined Montgomery County’s Corporate Volunteer Council because what it brought to us was the ability to offer a wide array of opportunities for employees to participate in giving back to the community. We’ve been doing some book drives, there’s opportunities using Amazon to make it really easy for employees who choose to donate to the local area or a specific cause a homeless shelter.

We really appreciate the help of Montgomery County for pointing us in different areas to give our employees choices, as well as people know that’s as a nonprofit revenue generating company and I think the effort that we’re putting forth right now with coronavirus vaccine is focused on a global response. We work with CEPI, the Coalition for Epidemic Preparedness and Innovations, and the funding support that we’re getting from them requires some global equitable allocation of product, as we’ve heard in the past about influenza pandemics and you know where is the product being made available what our coordination with CEPI puts us in a position of being able to make sure that we’re part of that global allocation process.