LA BioStart Biotech Entrepreneur Boot Camp Day #1
By: Skylar Björn
Tags: Biotech Startup, Innovation, Biotech, Bioscience, Biotechnology

Background information on what this biotechnology boot camp was: 🧬🦠

As stated on the LA BioStart website: “The Cal State LA BioStart Bioscience Entrepreneurs Boot Camp is a five-week, intensive training program that prepares emerging bioscience entrepreneurs to launch their own bioscience ventures. The boot camp is a collaborative project of Cal State LA, the Biocom Institute and the Los Angeles Cleantech Incubator. With investment from the U.S. Economic Development Administration, the training is offered at no charge to eligible participants.”

I was accepted into LA BioStart’s third cohort over the summer of 2018.☀️

👉 Here is a link to the cohort I was in: (I am “Skylar Björn” in Summer 2018) https://labiospace.calstatela.edu/biostart/cohorts/

Before the first day: 🎀

This boot camp was about 30 miles from me and the traffic in Los Angeles is terrible, so it was over an hour drive there. Once on campus, I remember having trouble finding the room too. When I found it, I walked in and all the attendees had nametags on the table while they waited for the speaker to present.

The topic of day #1: July 16, 2018 🌀

The presenter mainly lectured about the stages of starting a biotechnology company.

Information from day #1: 📝

Questions 🧐❓

1️⃣ Why is it important to implement the commercial process early on?

⏩ Just because you have great science does not mean you will be successful.

2️⃣ What is the life science industry?

⏩ Diagnostics, pharmaceuticals, biotech, MedTech, digital health/wearables.

Research steps involved in starting a biotechnology company 📚

Biopharmaceutical research and development process is long and requires significant investment — with potential for high returns if successful.

▶️ A lot of scouts are always talking to researchers to see what new discoveries could be of interest.

1️⃣ Discovery and development — pre-clinical research: (4.5–6.5 years) 🧐🔬

▶️ Research for a new drug begins in the lab.

▶️ Drugs undergo lab and animal testing to answer basic questions about safety.

▶️ Extremely expensive to do any research in non-human primates.

▶️ Is this safe for humans?

▶️ Pre-IND meeting: must have a minimum amount of data that will influence the rest of the design of studies I need to do.

Pre-IND package: FDA only responds to what you ask, so you need to ask the right questions.

▶️ Much stronger in saying we had a pre-IND meeting with the FDA; not all INDs get approved to go into human studies.

▶️ Once you get the green light to practice on people, getting healthy volunteers is faster and less expensive.

2️⃣ Clinical Research: (7–7.5 years) 💉

▶️ There are 3 phases in clinical research.

▶️ Understand the maximum tolerated.

▶️ Risk profile varies on the demographic; ex: a young versus an old person.

▶️ The smaller the population the higher tolerance for risk and vice versa.

▶️ There are a variety of ways to conduct researches.

▶️ Design of study, CRO you are using, how are patients being taken care of.

▶️ The clinical site is where you actually conduct your studies.

▶️ Pivotal studies are phase 3 studies, these are the most expensive.

▶️ She was at a migraine meeting and they had 1,000 patients.

▶️ Cardiovascular has about 10,000 patients.

▶️ NDA BLA — submit these to FDA if it works.

3️⃣ FDA Review: (1–1.5 years) 📑

▶️ If not done after approval, then still under monitoring.

▶️ You have to update the information to the FDA, and then the FDA evaluates it.

▶️ Pre IDE- for medical devices

▶️ Denovo - 5–10k

▶️ Post-market follow up varies on years.

▶️ An oral drug can have a major impact on certain parts of the body.

▶️ If it is a new material that has never been used, additional studies may need to be done.

4️⃣ Post-approval research and monitoring 🧐📋

It takes $1–2 billion for a biopharmaceutical company, which includes the cost of failures.

▶️ Startups tend to not have enough money, so they do not always have another chance.

▶️ It is so expensive to develop products; there are opportunities for liquidation depending on how much the value of the production is done can exit.

▶️ Expenses are very expensive.

▶️ Software is way different.

▶️ You will need to bring in experts since no one is an expert in everything.

Sometimes products are not approved which can delay it 6 months to a year; stock prices tend to tank when you hear this.

▶️ More difficult from phase 2–3.

▶️ There are 2 sides: risk and reward.

▶️ Studies are a lot more expensive.

▶️ You may need to scale up for the phase 3 study.

▶️ When trying to exit with a larger company there are different components with the deal structure; could be when you reach certain milestones.

▶️ With royalty, what percentage would you get of sales?

▶️ You typically tend to license this product from academia like UCLA.

Biopharmaceutical vs. Medical Devices 🔬🧪

Biopharmaceutical: 💊

▶️ Always have to have clinal studies.

▶️ Way more expensive.

▶️ Tend to be higher priced and larger markets.

Medical Devices: 🧬

▶️ The life cycle is way shorter.

▶️ Tend to make a version, then over time develop and make new versions.

▶️ Doing product [outer atoms]are more attractive

Nanotech is slow since there is not much regulatory so it would cause other companies to take risks.

▶️ SBIR funding

▶️ How much skin in the game does the management team have?

Reasons for failure in the biotech industry 🧨

The hardest point where most companies fail is when they do not choose the right process of approval.

▶️ Young entrepreneurs may not choose the right CMOS and often fail. What you are looking for dictates the CMOS and there are tons of CMOS out there.

Bridging the gap between R&D and commercial interests 🤔 ❇️

Funding/investors 💸

▶️ Entrepreneur grants and scholarships.

$5–10 million to get to first in human studies, sometimes $15 million.

▶️ Nothing turns off investors more than saying you are going into a billion-dollar market when it is not one.

▶️ She would score people and see if they should be funded or not.

▶️ What would bug her is that she would hear how people raised like $30 million but had done no work.

▶️ A company has one shot at getting it right.

▶️ Mistakes at launch are expensive, if not impossible, to correct and it can impact sales for years to come.

What to think about in development 🛠

▶️ When making devices they are getting feedback on how studies should be designed.

▶️ It is really a mindset than the need to hire more people.

▶️ How are you addressing their pain points?

▶️ How hard is it to gain access to that patient?

The biggest challenge is that every second literally counts.

▶️ You need to make things convenient for the patient; understanding these things helps lead to commercialization.

▶️ The point of entry in the patient population that has an unmet need.

▶️ The payer dictates how the products are used.

▶️ The focus is not on approval, but on reimbursement and coverage.

▶️ No one may want the product because it may take another few years of research and what if it can’t be commercialized.

Payers: private payers- such as Blue Cross; also the government: such as Medicare, etc.

▶️ Sometimes with devices, they can start as self-pay.

▶️ Information gathering during the pilot study.

▶️ To be the first line you need the head to head studies, botox is 3rd and 4th line.

What people will ask 🤓

▶️ People tend to ask who your competitors are.

Competitors are not now, but what are coming downstream; so pay attention to all of that.

▶️ You better have a very clear idea of how your product is better.

▶️ Look at technical vs. commercial fit.

4 pillars of focus in a successful product 🏅

1️⃣ Approvability

2️⃣ Manufacturability

3️⃣ Reimbursabilitly

4️⃣ Commercializability

⏩ These are the four key areas to decrease risk and increase the probability of success.

▶️ Successful product development goes beyond obtaining regulatory approval.

▶️ You have to look at the cost of commercial scalability.

▶️ Get something that is very scalable moving forward.

Going international 🌎

▶️ When they think of global approval they tend to do the U.S. And Europe.

▶️ In Europe all they need is a CE mark which is very easy; although sometimes when approved no one will buy it.

Things to remember 🧠

It is all about the money — Botox made doctors a lot of money since they could bill a procedural code, so then on top of that they can markup the product.

▶️ Psychiatrists almost lose money writing prescriptions.

▶️ You take a product every single day that lasts some hours, but they never heard of one that you need 21 injections that last 3 to 4 months.

▶️ Most often in small startup companies, they bring in different consultants with specialties in different areas.

▶️ They never bring the group of consultants together since it is too expensive so they have one-on-one meetings.

Integrated product development & commercialization 🖌

▶️ Business development and licensing, product development strategy & project management, regulatory CMC, and more.

▶️ You can go through all those things and if you don’t have money it will be very hard to move forward unless you are extremely wealthy with the ability to fund yourself.

▶️ Large molecules are much more expensive.

▶️ A CRO can’t do the manufacturing side of things.

What types of things are commercial value-driving? 🚙

▶️ Even when trying to raise money, they expect you to have a business plan and strategy; such as how is the market, how are patients being treated, will barriers change over time - do a SWOT analysis; show a fundamental understanding in the market.

What to think about and realize upon launching a biotech company 🚀

▶️ How are you addressing pain points for stakeholders?

▶️ What is your initial target product profile?

▶️ What do you think you want to be when you grow up?

▶️ Business development licensing

You will sometimes talk informally to people who may be interested in the technology.

▶️ The testing product profile.

▶️ They talked to 5–7 key opinion leaders and 5 out of 7 were interested, etc.

▶️ Talk to people that you want to invest money in your company.

Starting a life science business is not difficult, it is obtaining the funding that is.

▶️ As a startup, you don’t want to hire a lot of people since you cannot afford it.

▶️ Outsource a lot of what you do since it is very easy to cut off.

▶️ You want a board.

▶️ As an entrepreneur, you have to be willing to do anything and everything.

Investors, advisors, and other key stakeholders evaluate both the jockey and the horse; such as a jockey who does not know how to get the best out of the horse will not win.

▶️ They are looking for people who have been there and done it before.

▶️ You have to show that you are willing to learn and listen.

▶️ You need to stand out aside other investment options for the investor.

▶️ Who do you know that you can connect with that will help you out?

You need to do homework when it comes to investors to see what they have invested in already.

▶️ You understand what you want and what the investors are looking for.

▶️ For women, look for groups in which women are the decision-makers since they are most likely looking for companies in which women are in the C-suite.

▶️ She often contacts female VC’s not for funding but for advice as a first-time female CEO.

▶️ Initial investments are easier to get since investors have to start investing.

▶️ Does the management team have the ability to maneuver through the unknowns?

▶️ You cannot guarantee that things will be successful.

▶️ You need to be willing to be able to change course.

Kill fast, kill early; but it is really hard for founders to do this.

▶️ Know when to engage with experts.

▶️ You are a salesman, you need to know when to pitch.

▶️ Understanding risks, what irritates VC’s, and investors, in general, is saying there is no risk with your company.

▶️ Knowing how to meet the unmet need.

▶️ Investors have a flock herd mentality and can be very fickle.

They say VC’s all have ADD, especially once they start looking at their phones and step out to take a call.

▶️ Highlight your best data.

▶️ They all like stories, it’s all about a story; kind of tell a story in terms of what you are doing.

▶️ The main thing is focusing on the main thing.

4 major things compromise LA’s bioscience economic development master plan 🗞

1️⃣ Bioscience commercialization

2️⃣ Bio lab development

3️⃣ Bioscience talent development

4️⃣ Marketing & branding

Random: 💫

▶️ The eye is a very isolated organ, so some companies start out in the eye before expanding.

LA is known for Hollywood, but not as much as innovation, etc.

▶️ MedTech: can be all sorts of things in MedTech, it is very broad.

▶️ Wearables/digital health: software for healthcare.

▶️ Greater and greater integration of these areas.

▶️ The process is the product.

▶️ At first people in life sciences were older, but now younger tech people are speeding up the process.

▶️ Genetics and genomics in the life science industry.

▶️ A lot of companies are outsourcing manufacturing.

▶️ CROS- contract research organization; tons of different ones, can be work on humans, etc.

▶️ ****CMOS AND CROS******

▶️ So many different types of commercialization: which journals to choose, people to endorse you, PR agencies, press releases, what is your marketing mix, how are you going to brand, IP lawyers, corporate lawyers when starting a company and when doing fundraising, etc.

▶️ A lot goes into running the life science industry

After the first day: 😜

The boot camp provided lunch everyday so there was always a buffet style meal to eat everyday, and I ate a lot. We then all got our headshots taken for the LA BioStart website by a photographer.

Key takeaways: ✅

1️⃣ Biopharmaceutical research and development process is long and requires significant investment — with potential for high returns if successful.

2️⃣ 4 pillars of focus in a successful product 🏅: approvability, manufacturability, reimbursability, commercializability

3️⃣ Starting a life science business is not difficult, it is obtaining the funding that is.

Tips: 🏁

1️⃣ The hardest point where most companies fail is when they do not choose the right process of approval.

2️⃣ It takes $1–2 billion for a biopharmaceutical company, which includes the cost of failures.

3️⃣ Startups tend to not have enough money, so they do not always have another chance.

4️⃣ $5–10 million to get to first in human studies, sometimes $15 million.

5️⃣ The payer dictates how the products are used.

6️⃣ Initial investments are easier to get since investors have to start investing.

7️⃣ A lot of companies are outsourcing manufacturing.

Thank you for reading! 😄🎊🎊🎊

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