Benefits of operating within an innovation hub ecosystem
Supply Chain Innovation is Needed for Clinical Impact
In 2022, the global market for biologics was valued at more than U.S. $460 billion and is expected to grow at a 10.3% compound annual growth rate (CAGR) from 2023 to 2030. The rising prevalence of cancer, genetic diseases, and autoimmune diseases, coupled with the approval of several disease-modifying therapies of these conditions, is driving the growth. Despite this, however, biological drug access remains constrained by high cost and payer complexities. Unsurprisingly, biologics represent only 2% of all U.S. prescriptions but 37% of net drug spending.
As biologics continue to flood the drug discovery pipeline, translation into widespread clinical impact will require more efficient uses of capital with minimal idle time, lower cost of goods, and improved patient access. Our founders believe that a new paradigm in contract development and manufacturing organization (CDMO) is necessary to meet the rising healthcare needs. Unfortunately, in a heavily regulated industry, change takes a very long time and not too many new CDMO ideas have emerged in the last 25 years. However, if the business environment, underpinning technologies, and stakeholder alignment are working together in an innovative way, accelerated change is more likely.
Wheeler Bio announced the grand opening of their state-of-the-art drug substance Current Good Manufacturing Practices (CGMP) facility inside the Ziggurat building (Echo Investment Capital) in Oklahoma City, OK in October of 2023.
A Home Base at the Heart of the Nation
We have often been asked – why choose Oklahoma City as Wheeler Bio’s home? Oklahoma, as with many rural states in the United States, has no shortage of significant healthcare challenges, but OU Health and the formidable regional life sciences cluster are transforming the future of healthcare. We planted Wheeler Bio’s flag in Oklahoma City to leverage the current momentum. We recognized that doing business in a progressive, hyper-connected, and cost-effective environment like OKC would allow us to be more creative, daring, and experimental in our approach to disrupting the CDMO industry. The future of healthcare is to ensure patients have access to highly trained medical experts, skilled healthcare professionals, dedicated scientific researchers and the latest emerging technologies and advanced medicines. Our core assets (state-of-the-art process development and small scale CGMP manufacturing) are located inside the Oklahoma City Innovation District (OKCID), a geographically centralized hub that is equidistant from major coastal biopharma ecosystems and just up the I-35 corridor from the North Texas biopharma cluster (BioNTX). Our company was founded by a team of industry veterans in discovery, CMC, and venture, with a mission to bridge the discovery-to-clinic gap (a.k.a., “valley of death”) for our clients. By improving the integration of discovery-development workflows (Portable CMC™), connecting clients with an aligned venture syndicate, and partnering with the regional ecosystem, our clients can reach first human trials faster than ever before.
The answer to this question also lies in the city’s strategic investments in the biotech sector over three decades. With a trained workforce, established biotech institutions, and a burgeoning community of local venture capitalists, Oklahoma City provides a conducive environment for Wheeler Bio to thrive. The ease of doing business in Oklahoma City, a top spot for North American business-friendliness, further solidifies the city as a prime growth hub.
Formidable Biosciences Ecosystem and Ready Workforce
The Greater Oklahoma City’s biosciences cluster has made significant progress over the last two decades in becoming one of the region’s top growth sectors, employing about 31,000 people and spending $316 million annually on research and development. Over 75% of all NIH funding in Oklahoma flows into the 1.3 square mile area that constitutes the OKCID, so we knew we wanted to be proximate to all these thought leaders and skilled professionals. In 2021, the U.S. Economic Development Administration awarded the cluster a $35 million grant through its Build Back Better Regional Challenge to help expand Oklahoma City’s role as a national hub for drug development, testing and manufacturing. Additionally, in 2019, OKC voters approved, as part of a large public works initiative, $71 million for a new development called Convergence which will be completed in late 2024 and host tenants from a broad spectrum of industry sectors, including biopharmaceuticals.
“Situated in the heart of our downtown, closely aligned with and near the OKC Innovation District and greater healthcare ecosystem, Wheeler Bio is, by design, positioned to seamlessly connect customers with exceptional development and clinical resources.” – Christian Kanady, Founding Partner and CEO of Echo
As biomanufacturing is always on the critical path to clinical impact, innovation isn’t just a buzzword or a nice-to-have; it’s an imperative. This is especially true for CDMOs, which have become intricately involved in the drug development process and must be more responsive, more agile, and more capable than ever before in scaling up and delivering clinical materials from an ever-evolving pipeline. Improving patient access to this pipeline is also critical, CDMOs need to continuously improve their business processes to ensure best outcomes for their clients.
Wheeler Bio: Merging Discovery and Development
Wheeler Bio is a trailblazing biomanufacturing company on a mission to expedite the translation of therapeutic innovation into clinical efficacy. Our visionary business model and proprietary manufacturing technology integrate drug discovery with development in a way that uniquely caters to start-up biotechs and emerging biopharma companies. These venture-backed companies, driving the forefront of early- stage medicine, often struggle to access high-quality contract manufacturing services promptly. Our novel approach integrates upstream process development in parallel with drug discovery, offering a swifter, more streamlined path for drug developers.
Oklahoma’s Biotech Potential: A Unique Perspective
Comparing Oklahoma City to Boston, a global biotech powerhouse, we at Wheeler Bio believe wholeheartedly in the latent potential within the city. Oklahoma City boasts existing institutions with untapped capacity, exemplified by the Stephenson Cancer Center’s top-tier ranking in patient accruals for early clinical phase research. The collaborative ecosystem, facilitated by a more intimate scale compared to Boston’s multiple universities, streamlines interactions and accelerates progress. The alignment of key components and stakeholders fosters an environment primed for innovation, evident in our partnership with Alloy Therapeutics.
Empowering Biotech Startups Through Innovation
Wheeler Bio’s disruptive business model targets medicinal entrepreneurs, catering to the unique needs of start-ups and emerging biopharma companies. Unlike large biologics CDMO companies, which prioritize long-term contracts, we focus on providing flexible solutions for smaller, critical batches. Our alignment with customers’ long-term product economics ensures shared objectives and risk mitigation. Our partnership with coastal, discovery CROs reinforces this mission, channeling novel drugs from Boston- based research to Oklahoma-based antibody expression and production, and ultimately through to commercial scaling.
Wheeler Bio’s stunning, purpose-built CGMP facility at ‘The Zig’ features 50L and 500L scale drug substance production. Wheeler’s Portable CMC™ development and manufacturing platform supports up to 32 rapid IND filings per year.
Wheeler Bio is deeply committed to giving back to Oklahoma City’s Innovation Hub. Our engagement extends beyond our dedication to mission; it’s about nurturing the ecosystem that fuels our innovation. We actively collaborate with local partners and institutions to enhance workforce training in biomanufacturing, ensuring a steady pipeline of skilled professionals. By advocating for policies that attract venture capital and support R&D, we aim to bolster early and growth-stage Oklahoma-based companies, driving economic diversification. Reshoring supply chains plays a role in fortifying national resilience. Through these efforts and more, we seek to empower the entire Oklahoma City Innovation Hub, propelling it toward premier growth in innovation and technology.
Building the Future: Wheeler Bio’s Forward-Thinking Infrastructure
Wheeler Bio’s commitment to innovation extends to our facility designs. Our recently launched “Facility of the Future,” within the “Ziggurat” building at the heart of the Innovation Hub, showcases scalable drug substance manufacturing, analytical method development, quality control labs, and integrated digital systems. Our focus on Pharma 4.0 principles underscores the dedication our team has to driving efficiency, automation, and process transparency. This infrastructure, coupled with a collaborative, accountable organizational structure, forms the backbone of our commitment to transformative biomanufacturing.
Shaping Tomorrow’s Biomanufacturing Landscape
Two commissioning runs were completed recently at Wheeler’s new facility using Wheeler’s Portable CMC™ antibody process platform, and the first client orders for CGMP drug substance batches have already been received.