In Conversation with Tia Lyles-Williams, Founder and CEO of LucasPye BIO and HelaPlex

Tia Lyles-Williams, the founder & CEO of LucasPye BIO (LPB) and HelaPlex, is on a mission to lower development and manufacturing costs for emerging life science companies while bringing greater diversity to the life science industry.

LPB, which was founded by Lyles-Williams in 2018, is the only large-scale biologics Contract Development Manufacturing Organization (CDMO) in Pennsylvania. LPB currently offers a wide range of services to its clients, including proprietary cell line development, bioprocess development, consulting, and cGLP small scale bioprocessing. The company’s unique approach includes the revolutionary digital transformation of development and manufacturing processes and a deep, profound, and authentic commitment to social change unique to the biopharma/biotech space.

Lyles-Williams is a life science industry pioneer. She is the first Queer, African-American woman to own and lead a biotech/biopharma large-scale manufacturing organization. And LPB is only the second African-American owned and led biotech manufacturing company ever, following in the footsteps of Dr. Percy Lavon Julian, who 65 years earlier started Julian Laboratories.

LPB is the first biotech/biopharma company to have 50% of its C-suite executive team seated by women and 85% seated by people of color. Lyles-Williams’ vision is to see this level of diversity mirrored by established life science companies and strengthened by increasing the number of startups founded by women, LGBTQ individuals, and people of color.  

HelaPlex, which is LPB’s sister company, is a commercial co-working space for life science startups and virtual biotechs; along with LPB, HelaPlex will play a critical role in nurturing and developing life science entrepreneurs and companies from underserved groups and communities. 

This is an exciting time for LPB, Lyles-Williams, and her executive leadership team. 

In Q4 2021, LPB will open a brand new, state-of-the-art, 60,000 square foot cGMP bioprocessing facility in an underserved Philadelphia community. With this new facility coming online soon and a novel, digital CDMO approach, we thought it a fantastic time to chat with Lyles-Williams about LPB, HelaPlex, and how her companies are poised to disrupt the life science industry on multiple levels.

Tell us about your journey to becoming only the 2nd African-American to own and lead a biotech manufacturing company?

Well, it’s been a long road. I just made 20 years in the biotech industry this year.

I majored in biology at Howard University and did an internship at Howard University Cancer Center helping to enroll patients in clinical trials and working with their internal review board. I interned with NIH and the Walter Reed Army Institute of Research, which turned into a full-time job. After a few years at Walter Reed, I went corporate and started my biotech career with Human Genome Sciences, which is now GSK.

I got sick—I have a chronic condition myself—and had to take some time off. Once I was feeling better and was cleared to return to biotech, I joined AMGEN, then worked for Baxter BioScience (now Takeda), and then the first CDMO I worked for was Avid Bioservices in California. In between that time I earned my Masters in Entertainment Business from Full Sail University & a Masters in Regulatory Science from University Southern California (USC). When I came back to the east coast, I worked for Lonza; and my last job was at Jazz Pharmaceuticals in Philadelphia. 

Once my contract was up at Jazz Pharma, I took that as a sign to start my own company. I had been working on the idea since 2014.

LucasPye Bio is a unique name. What are its origins?

Most traditional biotech companies are named after a white, male scientist who started the company. So I chose to name the company after my maternal and paternal grandmothers’ maiden names. Since I’m the first African-American woman to lead a large-scale biotech manufacturing organization, I named the company after two African-American women. 

My paternal grandmother is still living so she can see what we’re doing. My maternal grandmother died in 1992, but her siblings, my maternal grandfather and their respective children are still alive so they can see the name on our facility.

What are LucasPye BIO’s core competencies and what makes your company different from other CDMOs?

We’re able to manufacture and develop processes for cell and gene therapies, monoclonal antibodies, recombinant proteins, viral and gene vectors for traditional suspension cell and adherent cell manufacturing processes. 

What makes us stand out is that we are the first biotech to have a full, electronic system for everything via MasterControl software. That means no more fireproof rooms to meet FDA regulations to hold files for 21 years; everything will be in the Cloud. 

We’re also the first to have two proprietary mobile apps that allow our customers to track the manufacturing process at a high level. BioProcess Tracker, which works similar to the Dominos Pizza Tracker, allows our customers to follow the process, get daily statistical data, and release their drug products to the next facility or to the market within two hours. With the MasterControl software and our proprietary apps, we can co-release drug products for use in human clinical trials and/or the commercial market with our customers. 

All of our competitors take 60-90 days to release drug product for use in human clinical trials and/or the commercial market. Currently, they scan their paper documentation into PDF format, email it to the customer, and then the customer utilizes the documentation to re-release the drug product via their quality system for use in human clinical trials and/or the commercial market. The customer’s internal drug product release operations can take an additional 60-90 days. 

Our BioSupply Tracker makes us the first biotech and/or CDMO that can track its vendors in real-time…like Amazon. We can see what’s going on internally and bill our customers in real-time based on when we actually put things into use. Right now, biotech is the last industry to control the supply chain; we just take it as things are given to us. There is no rhyme or reason; it’s up to the biotech companies to determine how they’re going to track and enter items into their supply chain system. 

At LucasPye we are creating this system. We applied for an SBIR grant to test our system. Artezio and Adalo are jointly building the system on our behalf per our specifications, while Pall Biotech and MasterControl will help us test out our apps initially with LucasPye BIO customers.  

What is your company’s mission?

Our company’s mission is to bring down the cost barriers for startups entering the industry; reduce costs to patients; and last but not least, to bring high-quality, high-wage jobs to underserved communities.

Bringing better jobs to underserved communities is super important to us. The average starting manufacturing operator salary with no experience and no college degree is $38K; we are starting ours at $50K. We are doing that so people have a living wage and have a real opportunity for supporting their family with healthcare, paying for their kids to go to college, or paying for Little League. All this adds up.

If you’re not paying your employees enough, they are only working for you literally just to survive or for the benefits. Most of the time they’ll need to have a second or third job. What a lot of people don’t know is that the people actually making the drugs on the floor are, nine times out of ten, are black and brown people while white people are in senior leadership roles. This has got to change, everyone deserves an opportunity to grow and stretch their talents and professional capabilities – including being paid a REAL living wage. 

Our new facility will be up and running in Q4 2021 and we’re working with the City of Philadelphia and the Philadelphia Chamber of Commerce to locate our new cGMP facility in an underserved community and to hire a number of our team members from that community. 

One of LucasPye’s goals is to cut customer development and manufacturing costs and time-to-market by 50%. How will you achieve this?

Most of my competitors charge a premium, sometimes 20% to 30% above market price for their single-use consumables and raw materials. We don’t charge premiums because of a unique partnership with Pall Biotech that brings down our costs. 

Also, most of our competitors overstock the hell out of their equipment and overcharge their customers for shit they don’t even use because they have no control. If we use a bag of sample tubes, we can charge our customers in real-time according to what they actually use with our BioSupply Tracker. Our competitors wind up charging their customers for two bags of sample tubes even if only one and a half or one bag is actually used. 

Single-use, automated technology, the digitization of the manufacturing process, our partner network, and our deep development and manufacturing experience will enable us to consistently cut down the clinical development process from 15 years to 6-7 years. Big Pharma has been exercising this practice for years. The difference between Big Pharma and life science startups is that Big Pharma has unlimited access to capital and often has their own cGMP bioprocessing facilities. With our business model, life science startups will have a real opportunity to compete and/or outcompete Big Pharma for significant market share of the biotech industry, including their market share for their respective treatment indications. 

You are also the CEO of LucasPye BIO’s sister company, HelaPlex. Explain the relationship between these two organizations and how it can help bring more diversity to the life science industry?

HelaPlex is a commercial coworking/wet lab space for medical devices, HealthTech and MedTech software, and biologic drugs. HelaPlex exists to better prepare startup companies in these areas. As we’re going out recruiting customers for LucasPye BIO, we’re seeing a significant gap in knowledge concerning the clinical development process, how to work with regulatory, and how to ensure data and pre-clinical material tested in animal studies are more likely to get accepted by the FDA.

We’re shifting pre-clinical development operations down into HelaPlex. Each company at HelaPlex will have a dedicated project manager, a dedicated mentor, and will receive a laptop with LucasPye’s apps/software platform for easy transfer of data into our MasterControl software system. We’re also giving them the opportunity to create their prototypes using cGLP and cGMP certified equipment in a FDA-regulated (managed) environment. This is how we can cut down on the time to market; these startups can now provide investors with something they can touch, see, and feel; and, investors can see the data. We help startups do this at a much lower cost.

HelaPlex also helps startups develop the business side of things as well. Companies at HelaPlex will learn about pricing and how to speak the language and appeal to investors. 

It costs between $7 and $15M to do pre-clinical work. We think we can shave about $10M off of this cost with the HelaPlex program and LucasPye’s approach. HelaPlex helps startups pre-validate their data, de-risk investment for their investors and is a feeder program into the LucasPye BIO CDMO system. 

How do you feel about being the first Queer, African-American owner of a large-scale biotech/biopharma manufacturing company?

There’s definitely a lot of pressure, especially as a Queer, black and brown member of the community. I need to make sure I can include these groups to get to the next chapter after COVID. A lot of people in my community have lost their jobs, so they need stable work and re-tooled skills. I want to keep people abreast of why the work I’m doing is important.

Due to discrimination, black and brown people and people of color are not afforded the opportunity to be hired into leadership roles. Up until five or six years ago, there were no formal education programs for biotech. You came into the industry through traditional science like pre-med, pre-vet, chemistry, or biology. You either came into the game as a scientist, or for many black people, you had a high school diploma and/or at least an undergraduate degree and worked from the bottom up. You could have a long career, but not have the opportunity to move into leadership roles nor have an opportunity to be paid high-salary like your caucasian peers. 

I have a member of my team that is about 30 years older than me that helped set up the clinical development program for a Big Pharma company. She did not have a college degree. When the recession hit in 2008, she was let go and since then she has not had full-time employment; since then she’s always been brought on as a temp and they pay her as an entry-level person. They have her sit and work on a team of “senior” white professionals, who earn higher wages than she does, but have less experience and expertise. When the project is over they let her go every time. This is what goes on.

We’re looking forward to working with Jopwell, which is a workforce company focused on advancing the careers of black, latinx, and Native American students and professionals. And we’re purposely going after black and brown people that are three and four levels below on the title and salary scale; they have the skills to do the work, and we’re going to give them the opportunity.

Our collaboration with the Jefferson Institute for Bioprocessing (JIB) includes training our operators. We’re going to work with the unemployment office and other workforce development programs, including organizations like the Science Center and Steppingstone Scholars in Philadelphia to hire our staff. We’ve made a commitment to our particular area of Philadelphia to hire a specific number of employees from the neighborhood surrounding where our new facility will be built. 

Some of my team members still work for other employers, and once people see the picture of our C-Suite Team as majority African-American and 50% women, they’ll get it. 

There’s a lot of pressure, but my team and I are up to the challenge.  

What are a few lessons learned/pieces of advice you’d like to share with other entrepreneurs that have just started or are looking to start a new life science company?

Don’t underestimate your sales process and your ability to attract customers. Make sure you allow yourself time to get through your process and have enough funds saved up for at least six months to a year. When you’re starting a business, and you’re talking to customers, it takes time for them to get to know you and do due diligence on you. You need the funds to match this lead time.

Also, be ready for a lot of opposition, especially if you’re a person of color in the tech or biotech industry. When people see you in a leadership role, there are going to be a lot of haters that will try to disqualify you. It still happens to me. You can’t let them knock-down your confidence. 

Be strong mentally, be ready for a lot of criticism, and have an outlet to help you manage your mental/physical health.