Tia Lyles-Williams

Since its beginnings in the 1970s, the biotech industry has grown massively and made huge advances. Unfortunately, Black people account for just three percent of this industry.

That’s why we were excited to discover LucasPye BIO, a Black owned biotechnology/biopharmaceutical large-scale manufacturing company. LucasPye BIO is one of only seven biotech companies in the U.S. with capabilities to develop and manufacture Gene/Viral-Based Drug Products.

What inspired you to start your business?

I’ve been working in the biotech/biopharma industry for 20 years. During that time I noticed three things:

1) There weren’t/aren’t many Black people in Management, Sr. Management or Executive Management Roles.

2) The financial impact of a biotech/biopharma in a community was limitless in regards to opportunities for:

1. Generate wealth & savings for families
2. Financially support a large percentage of the local taxes, which resulted in better schools, policing, access to better food sources
3. Development of a strong and stable middle class community

3) Black people were not being included in human clinical trials for investigational treatment on diseases/viruses that severely impacted our communities the most. Therefore, I wanted to make changes.

More importantly, I wanted to make the biotech/biopharma industry more inclusive, diverse, and accessible to POCs from various skill and education levels.

I believe the biotech/biopharma industry will be similar to the former years of the U.S. Steel Industry; however, it will last a lot longer due to the continuous need for new and improved medical devices and biologic drug products.

How, if at all, has the COVID-19 pandemic affected your business plans or strategy?

The COVID-19 Pandemic, unfortunately, has had a positive impact on our business plans. It’s actually helped us to demonstrate a market need for our CDMO Services and prove our business model for:

• Outsourcing bio-development Services via strategic partnerships to accelerate our customers’ drug products into human clinical trials & the global commercial market
• Digitizing our business operations with cloud software, e-documentation & proprietary mobile/web applications.
• Partnering with a commercial co-working / wet lab facility for life science start-ups & virtual biotech companies.

In fact, LucasPye BIO will be the exclusive contract development and manufacturing partner for HelaPlex – Commercial Co-Working for Life Science Start-Ups & Virtual Biotech Companies.

What trends do you foresee in the biotech industry in the near future? 

I foresee that more biotech companies will become virtual by outsourcing their manufacturing operations. This allows a significant reduction in manufacturing costs that can trickle-down to lowering the prescription drug prices for patients.

I foresee a major overhaul on the controlled documentation systems & quality management systems. The biotech industry is one of the “last” industries that insist on using paper documentation.

This is one of the primary areas that causes the extended timelines & high-costs for commercializing a drug product. I predict that the FDA is going to mandate that biotech companies digitize their controlled documentation systems & quality management systems – one that’s inclusive for global corporate collaboration within & outside their respective companies.

I also foresee that the large-scale bioprocessing equipment utilized in our manufacturing operations will become more automated and intuitive with less interface for human interaction.

How is your company uniquely positioned to capitalize on the direction the industry is moving towards? 

LucasPye BIO will be 1 of 7 companies in the U.S. with a Biosafety Level – 2 (BSL-2) and the capabilities to manufacture Gene/Viral Vector-Based Drug Products. The future of drug products to treat diseases and viruses will be Gene Vector-Based & Viral Vector-Based Drugs. We will also be strategically located in underserved communities to help rebuild their local economies.

To be specific, our headquarters will be located in/near Philadelphia, PA.

This allows us to have a more sustainable workforce, and reduce turnover by paying above market rate, financing their education goals, and lower our operations costs by requiring our Mid-Management to Executive Management roles to work from home. We are, and were, already preparing for 40% of our workforce to work from home via our Cloud Software Quality Management System (QMS), E-Documentation Platform and Proprietary Mobile/Web Apps.

The BioProcess Tracker software application allows customers to digitally monitor the manufacturing process for their drug product, receive invoicing real-time for raw materials / consumable equipment utilized in the manufacturing process, and quickly respond to items that require their review/signature in our QMS.

The BioSupply Tracker application allows our supply chain vendors to receive Real-Time Purchases Orders (POs) with payment to restock raw materials / consumable equipment in our warehouse and complete the manufacturing process on behalf of our customers on-time. It also allows more control over the quality that we require from our vendors’ products to ensure we collectively maintain business operations per FDA requirements.

Where do you see the business in 5 years? 

There is a growing trend for DNA Plasmid Drugs (aka DNA Vectors). These drugs will be the “go-to” drugs to correct genetic codes that are “paired incorrectly” or “missing a code” to treat people & animals with immune deficiencies, neurological impairments, and/or treat people with diseases/viruses that were/are considered non-treatable.

In other words, DNA Plasmid Drugs will be the new platform for vaccinations. They are manufactured utilizing bacterial cells, i.e. E.Coli. The U.S. has less than five(5) facilities with the capabilities to manufacture DNA plasmid drugs. The majority of manufacturers with these capabilities are outside the U.S., and LucasPye BIO plans to bring back these operations to the U.S. within the next 5-6 Years.

Our expansion plans are to build an additional 6-7 facilities, including strategically placing some of our new facilities in developing countries and/or underserved communities outside the U.S., i.e. Africa. We aspire to strengthen their local economy and their healthcare system alongside their education infrastructure.

To summarize, our mission is to:

1. Lower Costs for Biotherapeutic Drugs – including prescription costs for patients.
2. Accelerate New Drugs into the Commercial Market – including lowering the barrier of entry for new drug discoverers.
3. Provide High-Quality & High-Pay Jobs to Underserved Communities

What advice do you have for aspiring entrepreneurs? 

The road to entrepreneurship is long, lonely, and hard as hell. You have to be strong mentally & physically for the “hater” & “naysayer” aerosols that will be frequently sprayed at you and your entrepreneurial goals. Being an entrepreneur is not all about money.

It’s about the opportunity to make a social impact and prove to the local communities around the globe that there are some “do-gooders” that still care about their problems, interests, and aspirations.

My advice for aspiring entrepreneurs is to never give up on your divine purpose in life, never give into the naysayers & the haters and never compromise on your mission for your company & professional aspirations.

Tony O. Lawson

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