Breaking barriers and building bridges are worthy ambitions for any successful leader. Tia Lyles-Williams, CEO and Founder of Philadelphia based – LucasPye BIO, takes this one step further in her mission to adapt, create and innovate within the Biotech / Biopharma sector.
Dynamic, practical and an exuberantly passionate industry leader, Tia Lyles-Williams’ distinctive style mirrors that of her start-up organisation, LucasPye BIO – an organisation which disrupts the traditional image of the biotech / biopharma industry in both the way it operates and its cultural and ethical approach. We catch up with this innovative entrepreneur to discover more about her inspiration and drive to succeed together with the game changing techniques of Lucas Pye BIO.
To start off with, could you briefly introduce us to the world of LucasPye BIO and what it does?
If you’ve heard of the acronym CDMO, you’ll be familiar with our role. We’re a Contract Development Manufacturing Organization. In simple terms we’re a medicine manufacturer. We make medicine for biopharmaceutical companies – generally prescription drugs used to treat serious viruses and/or diseases such as Cancer, Rheumatoid Arthritis, Hepatitis, Crohn’s Disease, Hemophilia, Lupus, etc. Recently, we were recognised as 1 of the Top 10 CMOs in 2020 by Pharma Tech Outlook Magazine.
What are your main operational challenges and how is LucasPye BIO overcoming these?
High costs and the length of time taken for biopharmaceuticals to reach a commercial market. On average it takes 15 years! Coupled with this, the industry has been extremely slow to digitise its manufacturing operations. Paper documentation is still the norm; only responding to digital methods when new regulations dictate. Time-consuming manufacturing processes, such as having to clean, steam and re-clean stainless steel equipment adds to lengthy time delays.
We’ve also found that Big Pharma controls access to the market. Essentially, they can limit new drugs from entering the market by purchasing any new drug and then shelving it – either because it may be similar to drugs they already have on the commercial market or similar to those they may be developing and under review for approval by the FDA (The Food and Drug Administration – the U.S. governmental agency responsible for reviewing, approving and regulating medical products, biopharmaceutical drugs and medical devices).
These are areas where LucasPye BIO aims to make a real difference. We see it as our mission to change the way biopharmaceuticals are manufactured and developed for FDA approval.
We’re actively changing this by fast tracking the timeline for clinical development of drug products from an average of 15 years down to between six and seven, thus cutting the time taken to reach the commercial market by more than 50 percent.
We’re revolutionising digital automation processes through the implementation of electronic documentation and mobile apps in the form of digital trackers. With our ‘BioProcess Tracker’, clients will be able to quickly view data & analytical results collected from bioprocessing operation, read/review & respond to non-conformance incidents, and respond to alerts that require their response & signature to release their product for use in Human Clinical Trials and/or the Global Commercial Market. It also enables a whole range of associated parties – manufacturing operators, quality control analysts, quality assurance personnel, etc. to communicate with each other and update themselves on the progress of the operations in accordance to their clinical development timeline, which in itself is a significant time saving software application.
We’ll actually be the first CDMO to use ‘MasterControl,’ an e-documentation & digital quality management platform which enables real-time tracking of all drug development & bioprocessing operations. We’re achieving further savings through the use of disposal equipment via the PALL Biotech Single-Use Equipment Platform – including Adherent Cell Bioprocessing Equipment to cost-effectively manufacture viral/gene vector-based drugs. LucasPye BIO is a definite gamechanger; helping biopharmaceutical companies get their products to market in record time while driving down financial expenditure.
An innovative forward thinking start-up organisation obviously relies upon a radical and ambitious leader at its helm. On a personal level you could also be described as not only a unique pioneer, but perhaps atypical of a biotech / biopharma CEO. What have been your motivational and inspirational drivers?
Traditionally, the biotechnology and biopharmaceutical industry is regarded as a Caucasian-male oriented profession. I’m following in the footsteps of Dr. Percy Lavon Julian, research chemist and scientist who overcame racial prejudices and hardship barriers to become the first African-American owner of a biopharmaceutical company, as well as a large employer of minority races. Sixty-five years on, I’m proud to recognize myself as the first African-American female CEO owning and leading an organization of this type.
I’ve received inspiration from family support through an aspiration to offer a better quality of life for minority communities, and my ultimate aim of rebuilding the African-American Middle Class Community by providing employment, training and above industry standard wages for my employees.
LucasPye BIO has a reputation for investing in its staff, and has a diverse workforce dedicated to excellence. Can you tell us more about the culture across the organisation?
I’ve worked hard to instill a work culture which fosters transparency and productivity, and I let my team know I trust them and their expertise. This has been instrumental in establishing a sense of autonomy and accountability. LucasPye BIO is a truly diverse organisation, in fact one of the most culturally diverse across the U.S. Currently 50 per cent of the C-suite seats are occupied by women and over 85 per cent of these seats are held by African-Americans. That in itself is a wonderful testament to our commitment in driving diversity and inclusion.
We also recognise the importance of staff retention, incentives and our corporate responsibility for building communities. LucasPye BIO provides transportation and paid-training to staff, as well as paying entry level manufacturing employees – those with no prior industry experience – an above average salary. We hope to repeat this business model internationally, encouraging and incentivizing a ‘can do’ approach, empowering those from minority ethnicities to “aim higher” in regards to their career prospects, which will in turn improve the quality of life and wealth-generation opportunities for their respective families.
You’re clearly an inspirational role model, setting a high benchmark for LucasPye BIO in the biotech and biopharma industry? Where do you go from here? What’s next for LucasPye BIO?
The last year has been an eventful one. I’ve been fortunate to be able to spread the brand message on innovation within drug development to a broader audience and win a fine array of awards for excellence. As a result, I’ve been able to bootstrap our costs, raise funding via friends/family, pitch competitions & venture capital investment – including $5M in Venture Capital from Black Pearl Global Investments & a commitment of $45M in Venture Capital from their respective Venture Capital Partners. We plan to perform an equity-crowdfunding campaign in Q2-2021 as well.
We’re forging exciting partnerships and collaborations designed to bolster biotech and biopharmaceutical technology throughout the region. We’re currently collaborating with Jefferson Institute for Bioprocessing (JIB) & Celltheon Corporation to execute our customers’ project requirements for Bio-Development & Cell-Line Development Services.
But I would say the most exciting development will be the planning and construction of a 60,000 Sq. Ft. Large-Scale Bioprocessing Facility which will enable us to enhance our CDMO service offerings even further. We’re also building the 1st Commercial Life Science Co-Working / Wet Lab Facility – HelaPlex to provide a viable direct-pathway for Start-Up Life Science Companies & Small Biopharmaceutical Companies to successfully enter the global commercial market. Hand in hand with this, we’re overhauling our operations, recruiting and offering incredible complementary development services to potential new customers.
Further information on the pioneering work of LucasPye BIO and contact details can be found at https://www.lucaspyebio.com/