LucasPye BIO: Enabling Next-Gen Drug and Biologics Development
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LucasPye BIO: Enabling Next-Gen Drug and Biologics Development

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Tia Lyles-Williams, Founder and CEO, LucasPye BIOTia Lyles-Williams, Founder and CEO The notion of building a legacy that inspires others to do the same has always been a key tenant in business leadership. A manifestation of this can be observed through the story of Tia Lyles-Williams and her work in the field of biologics development and drug discovery.

“We help pharma companies get their products to market in record time while driving down the associated financial expenditures”

Circa 1953, Dr. Percy Lavon Julian founded his research firm and became the first African-American to own and lead a biotechnology/ biopharmaceutical company. Sixty-five years later, Dr. Julian’s legacy was picked up by the passionate and driven Tia Lyles-Williams when she started her company LucasPye BIO in 2018. As a biology and chemistry graduate from the prestigious Howard University, Tia has always been a go-getter who snatches opportunities that would expand her horizons through firsthand experiences. She took part in internship and work-study programs at some of the top research centers across the U.S. It is during this time that Tia was offered a job at the renowned Walter Reed Army Institute of Research (WRAIR), which became her stepping stone into the world of biopharmaceuticals. Over the years, Tia has worked at several innovative firms in the realms of drug manufacturing and biologics development, gaining the critical firsthand experience of cell line development and research as well as clinical trial management. Subsequently, in 2018, Tia took the leap and started LucasPye BIO with an aim to deliver continuous quality and innovation in drug development and manufacturing.

Mitigating Drug Development Challenges through Innovation

At the helm of LucasPye BIO, Tia quickly realized that technological advancements were transforming the drug development space into an arena similar to Silicon Valley—the technological playground of the world. To this end, she started analyzing the prevalent gaps in the existing tech-driven drug discovery and research operations in CDMOs and narrowed down the problem to the cumbersome manual documentation and disorganized communication channels. As these challenges often led CDMOs to fail in their promise of delivering products that can reach commercial markets faster, Tia, with her team of highly competent experts, will be the first CDMO to utilize MasterControl, an e-documentation platform which enables the real-time tracking of all drug development project-related tasks.

Furthermore, LucasPye BIO ensures that all the proprietary information is shared securely via MasterControl’s e-documentation platform’s protected network, preventing loss and potential abuse of sensitive data. At the same time, by converting all bioprocessing documentation into electronic files, the company enables its clients to co-release products. This helps pharma companies reduce the time taken for a product to be released for cGMP-use in clinical trials and commercial markets from nearly 90 days (current industry standard) to four hours.
“We help pharma companies get their products to market in record time while driving down the associated financial expenditures,” says Tia. Owing to this benefit, LucasPye BIO’s clients can remain on track for their scheduled goal and gain additional profits.

As a leader, I let my team know that I trust them and their expertise to establish a sense of autonomy and accountability


A Portfolio that Delivers Superior Products

As the first CDMO with a Commercial Life Science Co-Working/Wet Lab Facility—named HelaPlex, LucasPye BIO thrives on bringing innovation into everything that they do. To this end, the company has garnered access to superior mammalian, gene vector, viral vector, and bacterial cell line technologies that enhance drug development processes for clients. Furthermore, to deliver best-in-breed product development services, LucasPye BIO starts every client engagement with an in-depth assessment of the customer’s demands, in order to understand their needs and business objectives. Regardless of where a client is in their drug development journey, LucasPye BIO stands as an extension of their team and ensures that the right partners guide them throughout their project. “One of the key tasks that we perform in every collaboration is establishing a definitive strategy for every stage of the drug development process,” adds Tia. And, while the timeline helps the company keep track of the progress, LucasPye BIO leverages its partner network of leading organizations in the pharma and tech landscapes to aid its clients in performing downstream processes such as the removal of unwanted impurities among others. Additionally, the company simulates engineering runs to ensure that every technical process of a project delivers superior efficiency and multiple process characterization tasks that assess whether any of the steps need revision before the product enters large-scale manufacturing. Upon completion, LucasPye BIO files the investigational new drug (IND) documentation and connects clients with their partners to conduct human clinical trials.

Apart from these services, the company provides dedicated software solutions to help its clients track the progress of their drug development process via mobile and web-based applications. “With our Bioprocess Tracker, clients will be able to understand if any non-conformance incidents have occurred,” states Tia. This remote-tracking capability enables LucasPye BIO to get a product market-ready within two to four hours. On the other hand, LucasPye BIO’s software-based mobility allows all relevant parties—manufacturing operators, quality control analysts, environmental safety personnel, and more—to communicate with each other and remain up-to-date on the progress of a project, thereby taking a proactive approach to minimize delays.

Currently, the company is helping a customer revise their process development strategy to align their downstream processes with the cell line operations better and deliver high-quality products. And, at the core of this success is LucasPye BIO’s team, which has extensive (collectively 100 years) firsthand experience in handling the prevalent challenges in drug development processes.
A Workforce Dedicated to Delivering Superior Products

From an organizational standpoint, the work culture that Tia strives to instill is one that fosters transparent and productive relationships across the whole company. “As a facilitative leader, I let my team know that I trust them and their expertise to establish a sense of autonomy and accountability,” adds Tia. To drive this point home, Tia recounts instances of inviting team members with expertise in packaging to a client conference call for a project that required highly specialized product packaging.

LucasPye BIO’s team takes pride in having one of the most diverse workforces in the corporate and biotech realms across the U.S. In fact, 50 percent of the company’s C-suite seats are occupied by women, and over 85 percent of those seats are held by People of Color. “Our C-suite is a worthy illustration of how committed we are in driving diversity and inclusion within our organization,” adds Tia. LucasPye BIO is one of the first companies to pay their entry-level (no experience req.) manufacturing employees a salary of USD $50K instead of the industry standard of USD $38K.

A Track Record of Excellence

In 2019, Tia was able to spread her message on the innovation in drug development to a broad audience (comprising potential investors and partners) with her win at Delaware Valley University’s inaugural Spark Bowl awards. This win, along with the company’s drive for continuous innovation, has helped LucasPye BIO raise USD $5M with a commitment of USD $45M. Presently, LucasPye BIO is working with Black Pearl Global Investments to gain additional funding for their future endeavors. LucasPye BIO is also a member of Ben Franklin Technology Partners’ Greater Philadelphia Regional Integrated Medicine Alliance (PRIMA) Network—a virtual partnership designed to bolster the region’s biotech and pharmaceutical technology ecosystem.

Concurrently, by leveraging its collaboration with the Jefferson Institute for Bioprocessing ( JIB), LucasPye BIO will be training its employees on the emerging technologies and processes in the biopharmaceutical realm. Additionally, LucasPye BIO’s collaboration with JIB allows it to offer next-gen process development services to its clients. Similarly, with Celltheon, a San Francisco-based cell line company, the company is currently working on a viral vector production platform inclusive of stable cell lines for gene therapy manufacturing and novel CHO Cell expression systems for high-titer recombinant protein production.

In the coming months, Tia will be attending the Interphex NYC Conference in July 2020 as a key speaker, aiming to spread awareness on the use of remote tracking and e-documentation processes in drug development. Tia has also been selected to present LucasPye BIO at BIO International Convention 2020. Besides, the company is planning to utilize the USD $50M fund (1/3 of total start-up cost: $150M) to initiate planning and construction for a 60,000 square feet bio-manufacturing facility and enhance its CDMO service offerings even further. At the same time, to overhaul its current operations, the company is undertaking customer recruitment campaigns and offering incredible complementary development services to potential new customers.
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LucasPye BIO

Company
LucasPye BIO

Headquarters
Philadelphia, PA Area

Management
Tia Lyles-Williams, Founder and CEO

Description
Pennsylvania-based LucasPye BIO offers bio-manufacturing services that financially support new biologics discovered by life science entrepreneurs, biopharmaceutical firms, and non-profit organizations bio-manufacturing services. The company is set to become the first CDMO to utilize MasterControl, an e-documentation platform which enables the real-time tracking of all drug development project-related tasks. With its e-documention platform, LucasPye BIO ensures that all the proprietary information is shared securely via MasterControl’s e-documentation platform’s protected network, preventing loss and potential abuse of sensitive data. At the same time, with the first-of-its-kind Commercial Life Science Co-Working/Wet Lab Facility—named HelaPlex, LucasPye BIO thrives on bringing innovation into everything that they do. To this end, the company has garnered access to superior mammalian, gene vector, viral vector, and bacterial cell line technologies that enhance drug development processes for clients