Outsourcing-Pharma (OSP) recently spoke with ProSciento CEO Marcus Hompesch (MH) about the company’s work, how COVID-19 has impacted the industry, and what might lie ahead in metabolic disease research and therapeutic development.
OSP: Could you please share the ‘elevator presentation’ description of ProSciento, who you are, what you do, areas of specialty and what sets you apart from the competition?
MH: ProSciento is a leading specialty clinical research organization (CRO) exclusively focused on metabolic diseases, including nonalcoholic steatohepatitis (NASH), diabetes and obesity. Building on 17 years of experience and more than 305 metabolic clinical projects conducted, ProSciento provides full-scope clinical research services for multinational, early development clinical trial programs.
ProSciento’s focused experience and track record in designing and conducting clinical research programs for metabolic diseases include:
- Clinical development contributions to 16 metabolic drugs and devices on the market today
- More early phase (phase I/II) type 1 and type 2 diabetes clinical studies than any other US provider
- Clinical studies completed within every medically relevant glucose-lowering drug class
- Role in validating new diabetes drug and device classes
- Only provider in the US to utilize Automated Glucose Clamp technology
ProSciento is also differentiated and recognized for its programs to address the distinct challenges in NASH clinical drug development, including the strategic NASH PASS patient access platform and NASH Roundtable. NASH PASS is a unique patient access program that leverages
- a science-driven clinical protocol to identify and diagnose NASH patients and (2) a NASH biobank designed to enhance medical knowledge related to fatty liver disease progression, validate diagnostic biomarkers, and accelerate clinical research.
- The NASH Roundtable, established in 2018, is a forum of leading researchers and clinical development experts from three continents. They meet biyearly to collaborate and build momentum towards validated NASH biomarkers and endpoints and to support the development of effective and safe treatments.
OSP: Why is metabolic diseases an important therapeutic area to focus on?
MH: Diabetes, obesity and related metabolic diseases, including nonalcoholic steatohepatitis (NASH), continue to be significant medical problems in the US and worldwide.
According to the recent National Diabetes Statistics Report published by the CDC, 34.2m individuals in the US (10.5% of the population) have diabetes (90 to 95% of which is type 2 diabetes), while an estimated 88m (34.5% of the US population) have prediabetes. According to CDC data published in February 2020, the prevalence of obesity in the US has increased from 30.5% in 1999/2000 to 42.4% in 2017/2018, while the prevalence of severe obesity increased from 4.7% to 9.2% in that same time frame.
Obesity-related conditions, including type 2 diabetes, heart disease, and stroke, are some of the leading causes of preventable, premature death.
According to data published by the American Liver Foundation and leading researchers, NAFLD is present in an estimated 24% of the US adult population, while an estimated 20% of those individuals (5% of the adults in the US) have NASH, which is now recognized as the leading cause for liver transplant. Today there is no FDA-approved drug to treat NAFLD or NASH, but there are many pharma companies with compounds in development.
OSP: How has the pharma development industry’s work on such diseases evolved?
MH: The complexities of metabolic disease and the growing understanding of disease phenotypes and their translation into more personalized medicines has fundamentally dialed up the expectation that a modern world CRO is confronted with. Scientific competence is a must, as is being able to contribute and lead a discussion on the translation from bench to bedside research.
An increasingly relevant key success factor for clinical research organizations will be the ability to develop and deploy science-driven patient access strategies, particularly in clinical research for complex or underdiagnosed diseases, such as NASH in metabolism.
ProSciento has been a leader in science-driven CRO services for metabolic diseases since its inception, so we are constantly looking at how we leverage the more than 17 years of expertise in metabolic clinical research to contribute scientifically, to move the field of science-driven clinical research forward, and to accelerate the drug and device development efforts toward new, improved treatments for patients.
OSP: Could you please provide a bit more detail about the projects the funding from 1315 Capital will enable you to launch/expand?
MH: Funding from the recent agreement with 1315 Capital will support continued development of ProSciento’s patient access strategies and services in metabolic diseases, as well as the expansion of ProSciento’s site network and CRO services in geographies of interest. ProSciento is also further expanding its business development and operational teams.
OSP: Could you please share more detail about NASH PASS?
MH: ProSciento’s NASH PASS is a clinical research and patient access platform, leveraging more than a decade of NASH therapeutic and operational expertise, and designed to overcome enrollment challenges inherent in NASH clinical trials with science-driven methodologies and services. NASH PASS is highly differentiated in its approach and utilizes a proprietary clinical study protocol and algorithms; the program provides healthcare providers and clinical trial sites the tools, methodology, and support to diagnose and monitor at-risk patients for the progression of fatty liver disease and NASH.
NASH PASS also provides qualified principal investigators and diagnosed patients the opportunity to participate in clinical trials investigating new NASH drug candidates. For companies with NASH compound pipelines, the NASH PASS data is used to model and optimize inclusion and exclusion (I/E) criteria, substantially improving patient access and enrollment timelines, and streamlining site selection for NASH clinical trials.
OSP: Is there anything else you’d like to share about the company?
MH: When someone asks what makes ProSciento unique, the obvious answer is our science-driven therapeutic expertise and longstanding experience in metabolic clinical research. That is certainly what differentiates ProSciento within the CRO industry.
However, I would be amiss if I didn’t also mention our people. We truly have a tremendous team working for ProSciento. There is a culture of always looking for a better way and building sustainable community; this was more evident than ever during the initial impacts of COVID-19 and the speed and professionalism with which our team enacted the safety and precautionary measures for patient care and clinical trial continuity.
The team recognizes and takes pride in the work we do to directly impact the lives of patients. I also attribute this culture of teamwork to our middle management, as well as administrative and support staff, many of whom have been with ProSciento for a decade or more. In fact, nearly 17% of our staff have been with us for more than 10 years, and although our company has continued to grow, there is still a wonderful sense of caring and community, which is particularly profound during these challenging times.