July 26, 2019 | "Central to improved patient outcomes lies within the diagnostic arena, which continues to reinvent itself and define new business models for driving cost-effective and improved patient outcomes," says Albine Martin, Executive in Residence at Johns Hopkins University and Biohealth Innovation. "Significant disruption is occurring via the advancement of point-of-care technologies (PoCT). While point of care diagnostics holds great promise for targeted and timely therapeutic interventions, mobilizing PoCT from lab to patient is ever so challenging due to multi-matrixed technology expertise that must be delivered as a cost-effective and easy to use end-products. However, with cost-effective patient outcomes as a key priority we must coalesce across multiple disciplines to advance, finance, and support translational pathways for point-of-care testing."
With a background that includes the development of risk prognostic tests like the Digene HPV Test (Qiagen) and Companion diagnostics for patient stratification, Martin has a profound understanding of advancing early stage innovation and early identification of key early imperatives that must be contemplated for the ultimate development of diagnostic tests that have had a significant and measurable impact on patient outcomes.
"Generating results in a non-laboratory places a higher bar on product performance but holds great promise to bring healthcare closer to patient especially within resource limited environments for timely and improved patient outcomes. The opportunity for dissemination of targeted therapies in tandem with broader geographic accessibility is unquestionable support for advancing rapid and cost-effective diagnostics," she says.
Martin is now applying this journey to support clinicians, inventors, and entrepreneurs both at Johns Hopkins and Biohealth Innovation, seeking to advance innovations within a translational framework.
On behalf of Diagnostics World News, Emily Le spoke with Martin about the biggest hurdles in translating early stage innovation from the lab to the market, the most common mistakes startup companies make in their early development, and how companies can distinguish themselves in a dense diagnostic arena.
Editor's note: Emily Le, a conference producer at Cambridge Healthtech Institute, is planning a track dedicated to Commercialization of Diagnostic Tests at the upcoming Next Generation Dx Summit in Washington, D.C., August 20-22. Martin is moderating a panel for the track. Their conversation has been edited for length and clarity.
Diagnostics World News: What are some of the biggest hurdles in translating early stage innovation from the lab to the market?
Albine Martin: Setting aside early stage financing the development of early and disciplined milestones which require the company/inventors to make go/no go decisions along the development pathway of bench to market. Having now worked across numerous programs this remains a very challenging aspect of the commercialization plans.
You work with a lot of startup companies. What are the most common mistakes you see they make during their early development stage?
They operate under a "survival mode" mind-set vs a "success mode". This ties to my earlier point that planning must be done with the discipline of defining short-term deliverables but within the context of the long-term roadmap. One must map the trail to reach the Summit and use Base-Camps that represent those critical milestones and inflection points.
Is there a favorite or interesting business model that you came across from your years of experience with diagnostic startup companies that you would like to share?
I am involved with a company that was directed to prioritize early interactions with potential customers, collaborators or commercial partner in tandem with its technical and scientific goals. The ability to secure that first commercial partner was predicated on implementing a business/science driven culture early in the inception of the Company. This formula has provided a highly disciplined environment where scientific milestones are measured within the context of customer needs and timelines. The latter can be a very challenging cultural change but over times defines the paradigm for the "operating ethos" of the Company with a common roadmap and shared vision for strong teamwork. Real customers bring a harsh but invaluable change to a culture that is built on strong science but translated towards core customer and/or unmet medical needs.
In the very dense diagnostic arena how should one differentiate themselves from others to score the attention of investors and early funding organization?
Indeed, diagnostics is being redefined from determining if someone has a disease to leveraging rapidly emerging technology landscape driven by big data and point of care disruptive technologies. The rapid rate of technology advancement is therefore redefining our traditional definition of diagnostics to include, point of care/self-diagnosis, risk prediction, prognosis, response to targeted drugs, digital health which focuses on early triage of patients and aims to prevent disease through early risk stratification., Differentiation has to now be defined relative to:
- How a new Dx changes patient outcome. Minimal improvements are hard to gain payer interest.
- How does the Dx save/impact health care cost, or another driver so Dx is now undergoing economic modeling just like drugs.
- Direct impact on therapeutic intervention (strong driver) as Pharma will often be interested in supporting earlier stage programs if tied to expansion and accessibility of therapeutic interventions especially within underserved "centralized" testing geographies.
There is no "formula" for successful translation of PoCTs and I am currently focused on mentoring and developing strategies for disruptive innovation which encompasses the principles discussed above. Certainly securing early stage funding for proof-of-concept and developing the "matrixed" teams is a critical aspect for establishing the foundation for innovation that can ultimately benefit patients globally.