ProSciento Hosts the 5th NASH Roundtable Virtual Forum Focused on Digital Pathology for Histology in NASH Drug Development

June 7, 2022 ‒ ProSciento, Inc. and the NASH Roundtable™ will host the 5th NASH Roundtable Forum on June 16, 2022, as a virtual event. Consisting of leading hepatologists, endocrinologists, and clinical development experts from around the world, the forum’s goal is to discuss and steward advances in science, clinical research, and therapeutics for nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). The theme of the event: Is Digital Pathology a Game-Changer for Histology in NASH Drug Development?

The event will be moderated by Dr. Arun J. Sanyal, the Reno Vlahcevic Professor of Medicine at Virginia Commonwealth University School of Medicine; Dr. Rohit Loomba, Professor of Medicine and Director of Hepatology at the University of California, San Diego; and Dr. Marcus Hompesch, President and CEO, ProSciento, Inc., and Editor-in-Chief, Endocrinology, Diabetes & Metabolism.

Keynote presenters include:

  • Anil Parwani, MD, PhD, Vice Chair, Anatomical Pathology, and Director, Pathology Informatics and Digital Pathology, The Ohio State University, Wexner Medical Center
    Presentation: Impact of Digital Pathology/AI in NASH Drug Development: A Regulatory Perspective
  • Cindy Serdjebi, PharmD, PhD, Head of Research and Development, Biocellvia
    Presentation: How to Get Better Insights from Liver Biopsies in NASH Clinical Drug Development?
  • Mathieu Petitjean, PhD, Chief Executive Officer, PHARMANEST
    Presentation: FibroNest: Quantitative Digital Pathology image analysis and AI for Fibrosis and Associated histological features
  • Janani Iyer, PhD, Scientific Program Manager, PathAI
    Presentation: Characterization of NASH Histology Using AI-Powered Pathology

NASH Roundtable Members participating at the June Virtual Form are:

  • Elisabetta Bugianesi, MD, PhD, Professor of Gastroenterology, School Medicine at the University of Torino, Italy
  • Kenneth Cusi, MD, Professor & Chief, Division of Endocrinology, Diabetes & Metabolism, University of Florida
  • Scott Friedman, MD, Dean, Therapeutic Discovery and Chief, Division of Liver Diseases, at Icahn School of Medicine at Mount Sinai
  • Eric Lawitz, MD, Vice President, Scientific and Research Dev, Texas Liver Institute, and Clinical Prof of Medicine, University of Texas Health San Antonio
  • Rohit Loomba, MD, Professor & Director of Hepatology at University of California, San Diego, & Director, NAFLD Research Center
  • Vlad Ratziu, MD, PhD, Professor of Hepatology at Sorbonne Université and Pitié-Salpêtrière Hospital
  • Manuel Romero-Gómez, MD, Professor at University of Seville and Director of Digestive, Liver and Inflammatory Diseases Program at Institute of Biomedicine of Seville
  • Arun J. Sanyal, MD, the Reno Vlahcevic Professor of Medicine at Virginia Commonwealth University School of Medicine
  • Detlef Schuppan, MD, PhD, Professor, Hepatology & Gastroenterology at Mainz University & Beth Israel Medical Center, Harvard
  • Miriam Vos, MD, Professor, Pediatrics, Hepatology at Emory and Director, Pediatric Fatty Liver at Children’s Healthcare of Atlanta

More information about the event is available at https://nashroundtable.com/5th-virtual-forum/.

To learn more about the NASH Roundtable and its members, please contact nashroundtable@prosciento.com.

ProSciento Appoints Dr. Michelle Mazuranic as Vice President of Medical and Regulatory Affairs

ProSciento, Inc., a specialty clinical research organization (CRO) focused exclusively on diabetes, obesity, non-alcoholic steatohepatitis (NASH), and related metabolic diseases, has announced the appointment of Michelle Mazuranic, PhD, MSM, RD, as Vice President of Medical and Regulatory Affairs.

In this role, she oversees ProSciento’s medical affairs and regulatory consulting services, as well as works with clients to build strategic clinical development programs from early engagement assessment and planning through the completion of multi-site clinical trials.

“We are thrilled to have Michelle join our scientific leadership team. She is a widely recognized leader in global medical and scientific affairs, driving forward clinical development and regulatory strategies for new therapies in metabolic diseases. Michelle’s deep and highly applicable expertise, as well as her direct experience in metabolic diseases, further augments our clinical development consulting services for a rapidly growing global client base,” said Marcus Hompesch, MD, ProSciento’s CEO and Chairman of the Board.

“I’m pleased to join ProSciento’s highly respected scientific team and to have a leadership role in continuing to expand ProSciento’s global clinical development and regulatory services. ProSciento’s science-driven, therapeutically focused expertise is unique and differentiating within the CRO industry, leading to meaningful outcomes for our clients’ metabolic drug and device development programs, as well as for patients by accelerating promising IND candidates through phase II/III studies,” said Dr. Mazuranic. 

Dr. Mazuranic has extensive experience in building and leading global scientific strategies for clinical development, regulatory and medical affairs. Prior to joining ProSciento, Dr. Mazuranic served as Head of Global Medical Affairs at Gan & Lee Pharmaceuticals, where she built the department from the ground up. Prior to that, she served as Director of Global Medical Affairs for the Cardio-Renal and Metabolism Team for a seven-year tenure at AstraZeneca, where she managed strategic relationships with external scientific, academic, and advocacy group organizations and experts. Throughout her career, Dr. Mazuranic has developed and implemented activities to support global and compound-specific strategies, external scientific engagement, medical excellence, and evidence generation. Dr. Mazuranic is a licensed dietitian, completed her MS in management from Boston University, and earned her PhD in Public Health and Epidemiology from Walden University.

About ProSciento, Inc.

ProSciento is the leading specialized CRO focused on NASH, diabetes, obesity, and related metabolic diseases.  The company works with biopharma companies worldwide to support their outsourced clinical research needs with comprehensive and customized services for multinational, early development clinical trial programs. Founded in 2003, ProSciento has conducted more than 350 clinical studies for diabetes, NASH, and obesity, and has contributed to the development of numerous approved metabolic drugs and devices on the global marketplace. For more information, please visit www.prosciento.com.

For business development inquiries, please contact:
bd@prosciento.com

For media inquiries, please contact:
Abby Devine
Senior Director, Corporate Communications, ProSciento, Inc.
abby.devine@prosciento.com

For clinical trial enrollment inquires, please visit www.myproscientostudy.com or email hello@myproscientostudy.com.

Key Takeaways from the 4th Annual NASH Roundtable™ Virtual Forum

On November 18, 2021, ProSciento, Inc. co-hosted the 4th Annual NASH Roundtable™ Virtual Forum, a council of leading hepatologists, endocrinologists, and clinical development experts from around the world to discuss advances in the science, clinical research, and therapeutics for nonalcoholic fatty liver disease, steatohepatitis (NAFLD/NASH) and related metabolic diseases.  

Moderating the event were NASH Roundtable co-chairs: Dr. Marcus Hompesch, President and Chief Executive Officer of ProSciento, Inc.;  Dr. Rohit Loomba, Professor of Medicine and Director of Hepatology at the University of California San Diego; and Dr. Arun Sanyal, Professor of Medicine at Virginia Commonwealth University School of Medicine.  

Presenters included Dr. Arun J. Sanyal; Dr. Julio Gutierrez, Vice President of Clinical Research and Clinical Science of ProSciento, Inc. and Transplant Hepatologist at Scripps Health; Dr. Morten Karsdal, Chief Executive Officer of Nordic Bioscience A/S; and Dr. Lars Johansson, Chief Scientific Officer of Antaros Medical AB.  

Request access to view a video recording of the event at this link.

Presentation topics included methods of utilizing the NASH Patient Access and Screening Strategies (NASH PASS®) database and biobank for biomarker and translational research; identifying critical biomarkers for liver fibrosis; advances in imaging technologies; and the various collaborative opportunities available with NASH PASS. 

NASH PASS is a clinical research platform consisting of a database of clinical data and biobank from subjects identified as high risk for NAFLD/NASH. The data include demographics, blood work, as well as FibroScan and biopsy data from over 3,000 subjects. In addition, the NASH PASS clinical site network allows for efficient recruitment of subjects with NAFLD/NASH risk phenotypes. Given the depth and breadth of the data, as well as the flexibility and efficiency of subject recruitment, NASH PASS provides valuable opportunities for: 

  • Researchers interested in biomarker discovery and validation, endpoint determination, and the study of NAFLD/NASH as a multi-system disorder. 
  • Healthcare providers and clinical trial sites by providing the tools, methodology, and support to diagnose and monitor at-risk patients for the progression of NAFLD/NASH.  
  • Principal investigators and diagnosed patients interested in participating in clinical trials investigating new NASH drug candidates and other clinical interventions.  
  • Biopharma companies working with ProSciento to substantially improve patient access and enrollment and streamlining site selection for NASH clinical trials, as well as optimization of inclusion-exclusion (I/E) criteria, 

PRESENTATION HIGHLIGHTS: 

Utilizing NASH PASS® Biobank for Biomarker Discovery and Translational Research 

Presentation by Julio Gutierrez, M.D., Vice President of Clinical Research and Clinical Science, ProSciento, Inc., and Transplant Hepatologist at Scripps Health 

Dr. Gutierrez’ presentation focuses on NASH PASS as a highly effective collaborative research tool. Nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) are major public health challenges, and approximately 24 percent of the U.S. population will develop NAFLD.i Despite NASH being highly prevalent, drug development may be delayed because of a lack of suitable subjects enrolling in clinical trials. Rates of clinical trial enrollment have been steadily dropping since 2009, and access to individuals who meet the phenotype of NASH patients in the U.S. is limited. 

Conclusion: NASH PASS gives at-risk communities access to research. EMR data is used to prescreen subjects, and it utilizes proprietary algorithms to identify subjects with NAFLD and those with the highest risk of NASH. As a result of the optimized screening and recruitment efforts, there is an abundance of data and biological specimens.  

As a highly adaptable platform utilized at any stage, the recruitment methodology for NASH PASS is robust, and currently includes custom technology, as well as physician-to-patient, physician-to-physician, and patient-to-patient referral programs. These efforts feed into the top of the funnel of the recruitment science process, including keeping patients engaged. Data from the first 3,000 NASH PASS subjects that was presented at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting was also reviewed during Dr. Gutierrez’ presentation. 

ProSciento’s initiative for 2022 is the development of a polygenic risk model for NASH, and it currently has a tool for phenotyping patients at high risk for metabolic disease. ProSciento is pursuing addtional collaborations on the scientific side. Request access to view the recorded video of Dr. Gutierrez’s full presentation at this link or by emailing nashroundtable@prosciento.com

Biomarkers of Hepatic Fibrosis, Fibrogenesis, and Fibrosis Resolution 

Presentation by Morten Karsdal, Ph.D., Chief Executive Officer, Nordic Bioscience A/S 

Dr. Karsdal discusses how liver fibrosis is a multi-organ disease, and extracellular matrix remodeling is the common denominator in all chronic diseases. He poses the question, “How do we find patients who are progressing fast?” The answer: biomarkers of fibrosis – we need to develop a set of solutions with the liver at the center.  

Conclusion: Collagen fragments are key elements of this solution set because collagen is part of all organs and is central for tissue structure and function. When tissue modeling, the balance of tissue formation and degradation is central to most pathologies. Collagen fragments can predict death and response to treatment, as well as inform on early efficacy of clinical interventions. NASH PASS provides a platform to help understand the structure of organs and better profile patients and Dr. Karsdal highlighted the current collaboration between NASH PASS and Nordic Biosciences. Request access to view the recorded video of Dr. Karsdal’s full presentation at this link or by emailing nashroundtable@prosciento.com

Advances in Imaging Technologies for Fibrotic Diseases – A Look Forward 

Presentation by Lars Johansson, Ph.D., Chief Scientific Officer, Antaros Medical AB 

Dr. Johansson’s presentation centers around imaging and how it can help evaluate the effect of medications on different parts of the disease development. The use of PET and MRI imaging were discussed in detail. These imaging modalities can determine hepatocyte density and function. Though this technology has existed for some time, functional liver MRI using gadoxetic acid is an important development to help predict risk in cirrhotic patients. 

ConclusionClinicians should use a holistic approach using advanced imaging to understand treatment effects in fibrosis, cirrhosis, and portal hypertension by integrating imaging of liver structure and composition, liver function, ascites, liver stiffness, spleen stiffness, fibrogenesis, spleen structure and composition, and hemodynamics. These can be all integrated into a single exam to understand disease stage and progression. Combining metabolic and anti-fibrotic treatments is being tested by several companies. With imaging, we can assess the early effects of drug treatment on lowering the liver fat and improving insulin resistance, as well as downregulation of fibrogenesis and effects on fibrosis. Request access to view the recorded video of Dr. Johansson’s full presentation at this link or by emailing nashroundtable@prosciento.com

Collaborative Translational Research Opportunities Utilizing the NASH PASS® Biobank 

Presentation by Arun J. Sanyal, M.D., Professor, Division of Gastroenterology, Hepatology and Nutrition, at Virginia Commonwealth University School of Medicine 

Dr. Sanyal’s session focuses on NASH not only as a liver disease, but part of a multi-system disorder since, in most cases, approximately 70 to 85 percent of patients have one or more comorbidity. Key elements in non-invasive test (NIT) development include biological plausibility, analytical performance, clinical validity, clinical utility, and evaluating benefit versus harm. There are significant gaps in the field that need to be addressed to improve analytical performance. Dr. Sanyal also discusses the various perspectives by multiple stakeholders, which requires a strategic approach to meet everyone’s needs, including clinician, regulator, and payor. 

Also discussed are the parameters and results of the FNIH NIMBLE study2 of circulating biomarkers for NASH and activity and fibrosis stages. These data allow for the opportunity to analyze population results in more granular detail. The world of NIT has made progress in allowing information and data to be analyzed, especially when compared and paired with LITMUS.3 

Conclusion: How can we bring all these data together? One powerful approach is to use the NASH PASS platform to help expedite clinical research and help move the field forward. Request access to view the recorded video of Dr. Sanyal’s full presentation at this link or by emailing nashroundtable@prosciento.com


NASH Roundtable Members that participated in the discussion portion of this year’s forum included Dr. Elisabetta Bugianesi, Professor of Gastroenterology, School Medicine at the University of Torino, Italy; Dr. Scott Friedman, Dean, Therapeutic Discovery and Chief, Division of Liver Diseases, at Icahn School of Medicine at Mount Sinai; Dr. Eric Lawitz, Vice President, Scientific and Research Dev, Texas Liver Institute, and Clinical Prof of Medicine, University of Texas Health San Antonio; Dr. Vlad Ratziu, Professor of Hepatology at Sorbonne Université and Pitié-Salpêtrière Hospital; Dr. Manuel Romero-Gómez, Professor at University of Seville and Director of Digestive, Liver and Inflammatory Diseases Program at Institute of Biomedicine of Seville; Dr. Detlef Schuppan, Professor, Hepatology & Gastroenterology at Mainz University & Beth Israel Medical Center, Harvard; and Dr. Miriam Vos, Assistant Professor, Pediatrics, Hepatology at Emory and Director, Pediatric Fatty Liver at Children’s Healthcare of Atlanta. 

If you have any questions about the NASH Roundtable or the forums held twice a year, please contact nashroundtable@prosciento.com

1Arshad. Curr. Pharm Des. 2020:26(1):993-997
2 Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE). The Foundation for the National Institutes of Health.
3 LITMUS: Progress towards diagnosing and better treating liver disease. EASL.

ProSciento Becomes a California-Wide Sponsor of JDRF’s One Walks

SAN DIEGO, November 30, 2021 – ProSciento, Inc., a specialty clinical research organization (CRO) focused exclusively on metabolic diseases, is pleased to announce that it has become the first California-wide sponsor of JDRF’s Northern California and Southern California One Walks. Each year, JDRF One Walks across California bring together more than 10,000 walkers to raise awareness, support research, and fund programs to make a difference in the lives of individuals affected by type 1 diabetes (T1D).

ProSciento is a longtime supporter of JDRF, a global organization funding T1D research. Since 2007, ProSciento has participated in the JDRF San Diego Gala, TypeOneNation Summit, and One Walk events, contributing more than $100,000 from fundraising and sponsorship to support T1D research.

“ProSciento is delighted to announce our California-wide partnership with JDRF and this expanded opportunity to share our core values of making a positive difference in the lives of patients with metabolic diseases through meaningful clinical research and partnerships with patient advocacy groups. We want to thank JDRF for the tremendously impactful work that they are doing on behalf of the T1D and overall diabetes community, locally, regionally  and ultimately, across the country and the globe,” commented Dr. Marcus Hompesch, ProSciento’s Chairman and Chief Executive Officer.

“One Walk activities are a key strategy for raising funds and awareness about our continuing work to find a cure for type 1 diabetes. We are honored to have ProSciento join us as a sponsor in this life-changing work. Their commitment allows us to reach more people living with T1D, and their loved ones, in our efforts to expand knowledge of much needed new treatments and cutting-edge technologies under development,” commented Michelle Popoff, JDRF Southern California Chapter Executive Director.

About JDRF

Founded in 1970, JDRF is the world’s largest nonprofit funder of T1D research. Its exclusive focus is on finding a cure, and in pursuit of that goal, the organization is making daily advancements that improve the lives of those living with the disease. JDRF’s research has two core objectives: Cures by restoring the body’s ability to make insulin and stopping T1D before it occurs or providing insulin independence through replacement with insulin producing cells; and Improving Lives by keeping people with T1D as healthy as possible until cures are found by advancing new T1D resources, technologies, and therapies.  JDRF has a five-year plan for making Cures for T1D closer to reality.

About ProSciento, Inc.

ProSciento is a metabolism-focused, full scope clinical research organization (CRO), with a mission to advance the global development of therapeutics for type 1 and type 2 diabetes, nonalcoholic steatohepatitis (NASH), and obesity. ProSciento works with biopharma companies worldwide to support their outsourced clinical research needs with comprehensive and customized services for multinational, early development clinical trial programs. Founded in 2003, ProSciento has conducted more than 350 clinical studies for diabetes, NASH, and obesity, and has contributed to the development of numerous approved metabolic drugs and devices on the global marketplace. For more information, please visit www.prosciento.com.

For business development inquiries, please contact:
bd@prosciento.com

For media inquiries, please contact:
Abby Devine
Senior Director, Corporate Communications, ProSciento, Inc.
abby.devine@prosciento.com

For clinical trial enrollment inquires, please visit www.myproscientostudy.com or contact:
Tel: +1 (866) 308-7427
hello@myproscientostudy.com

ProSciento Appoints Lynn Rudolph as Vice President of Human Resources

SAN DIEGO, November 10, 2021 – ProSciento, Inc., a specialty clinical research organization (CRO) focused exclusively on metabolic diseases, today announced the appointment of Lynn Rudolph as Vice President of Human Resources. Ms. Rudolph joins ProSciento with an extensive track record of leading global team development, management, and retention programs for companies in accelerated growth phases.

“Our team, culture and corporate values are at the very foundation of what makes ProSciento successful and able to do the work we do to make a difference in the lives of patients with metabolic diseases. We’re thrilled to have Lynn in this key leadership role at a time of exciting growth and expansion of offices and services in the US and internationally, and as we continue to strengthen programs and strategies to attract new talent and support the continued growth and development of our leaders and teams,” commented Dr. Marcus Hompesch, ProSciento’s Chairman and Chief Executive Officer.

Ms. Rudolph’s career in human resources spans more than 20 years, including management of global human resource operations in highly regulated industries. Her background also includes implementing executive coaching and leadership development programs for individuals and teams. Prior to joining ProSciento, Ms. Rudolph served as the Senior Vice President of Human Resources at RW Baird, where she helped the company build its global talent strategy through innovative career and talent development programs. Before her role at RW Baird, she was Principal at Rudolph Coaching, a boutique executive coaching firm focused on delivering career development programs for emerging leaders in diverse industries. Prior to Rudolph Coaching, she was Vice President of Human Resources at PIMCO,  a global asset management company with over $2 trillion of assets under management.

Ms. Rudolph earned her BS in Psychology from Northwestern University and was awarded Columbia University’s Coaching Certification. She is also a Hogan Assessments credentialed coach.

About ProSciento, Inc.

ProSciento is the leading specialized clinical research organization (CRO) focused on NASH, diabetes, obesity, and related metabolic diseases. ProSciento works with biopharma companies worldwide to support their outsourced clinical research needs with comprehensive and customized services for multinational, early development clinical trial programs. Founded in 2003, ProSciento has conducted more than 325 clinical studies for diabetes, NASH, and obesity, and has contributed to the development of numerous approved metabolic drugs and devices on the global marketplace. For more information, please visit www.prosciento.com.

For business development inquiries, please contact:
bd@prosciento.com

For media inquiries, please contact:
Abby Devine
Senior Director, Corporate Communications, ProSciento, Inc.
abby.devine@prosciento.com

For clinical trial enrollment inquires, please visit www.myproscientostudy.com or contact:
Tel: +1 (866) 308-7427
hello@myproscientostudy.com

ProSciento Co-Hosts the 4th Annual NASH Roundtable Virtual Forum

November 1, 2021 ‒ ProSciento, Inc. and the NASH Roundtable™, with co-hosts Antaros Medical AB and Nordic Bioscience,A/S, will host the 4th Annual NASH Roundtable Forum on November 18, 2021 as a virtual event. Consisting of leading hepatologists, endocrinologists, and clinical development experts from around the world, the forum’s goal is to discuss and steward advances in science, clinical research, and therapeutics for nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).

Covering a range of topics centered around the latest research, the event will be moderated by Dr. Arun J. Sanyal, the Reno Vlahcevic Professor of Medicine at Virginia Commonwealth University School of Medicine; Dr. Julio Gutierrez, ProSciento’s Vice President of Clinical Research and Clinical Science; and Dr. Rohit Loomba, Professor of Medicine and Director of Hepatology at the University of California, San Diego. 

Presentation topics will include methods of utilizing the NASH Patient Access and Screening Strategies (NASH PASS®) database and biobank for biomarker and translational research; identifying critical biomarkers for liver fibrosis; advances in imaging technologies; and the various collaborative opportunities available with NASH PASS.

“This year’s Roundtable Forum is a unique setting of immense expertise in fibrotic diseases to truly facilitate focused collaboration and applicable outcomes to accelerate science-driven clinical research and therapeutic program developments,” said Marcus Hompesch, MD, ProSciento President and CEO, Co-chair of the NASH Roundtable, and Editor-in-Chief, Endocrinology, Diabetes & Metabolism.

NASH Roundtable Members participating at the November Virtual Form are:

  • Dr. Elisabetta Bugianesi, Professor of Gastroenterology, School Medicine at the University of Torino, Italy
  • Dr. Scott Friedman, Dean, Therapeutic Discovery and Chief, Division of Liver Diseases, at Icahn School of Medicine at Mount Sinai
  • Dr. Eric Lawitz, Vice President, Scientific and Research Dev, Texas Liver Institute, and Clinical Prof of Medicine, University of Texas Health San Antonio
  • Dr. Vlad Ratziu, Professor of Hepatology at Sorbonne Université and Pitié-Salpêtrière Hospital
  • Dr. Manuel Romero-Gómez, Professor at University of Seville and Director of Digestive, Liver and Inflammatory Diseases Program at Institute of Biomedicine of Seville
  • Dr. Arun J. Sanyal, the Reno Vlahcevic Professor of Medicine at Virginia Commonwealth University School of Medicine
  • Dr. Detlef Schuppan, Professor, Hepatology & Gastroenterology at Mainz University & Beth Israel Medical Center, Harvard
  • Dr. Miriam Vos, Assistant Professor, Pediatrics, Hepatology at Emory and Director, Pediatric Fatty Liver at Children’s Healthcare of Atlanta.

More information about the event is available at https://prosciento.com/nashroundtable/virtual-forum/.

To learn more about the NASH Roundtable and its members, please contact nashroundtable@prosciento.com.

ProSciento Expands Executive Scientific Leadership, Appoints Dr. Julio Gutierrez as Vice President of Clinical Research and Clinical Science

SAN DIEGO, July 8, 2021 – ProSciento, Inc., a specialty clinical research organization (CRO) focused exclusively on diabetes, obesity, non-alcoholic steatohepatitis (NASH), and related metabolic diseases, announces the appointment of Julio Gutierrez, M.D., as Vice President of Clinical Research and Clinical Science.  Dr. Gutierrez, a board-certified physician in obesity medicine, transplant hepatology, and gastroenterology, is a renowned specialist in metabolic clinical research and patient treatment for liver diseases. In this role, Dr. Gutierrez will lead the company’s clinical science team.

“We’re thrilled to have Julio join our scientific leadership team.  With his deep knowledge of medical research, therapeutic development, and treatment modalities for metabolic diseases, as well as his work for ProSciento as a scientific consultant and principal investigator in early phase NASH clinical trials, he is already making key contributions within our expanding clinical science team,” said Marcus Hompesch, M.D., CEO, and Chairman of the Board. “In addition to his experience and scientific acumen, Julio has an extraordinary ability to articulate science, whether speaking with our clients, peers in the field, or with patients newly diagnosed. He also has a passion for ensuring under-represented patient communities have opportunities to participate in clinical research, which is particularly important as the prevalence of metabolic diseases continues to increase.”

“ProSciento is an industry leader in combining clinical research and scientific services for metabolic disease drug and device development and a driving force in developing new, critically needed strategies and methods to address patient access and therapeutic development for NASH. Their long-standing scientific expertise, including more early phase clinical trials in type 1 and type 2 diabetes than any other US provider, is widely recognized in the biopharmaceutical industry,” said Dr. Gutierrez. “ProSciento’s efforts to drive drug development in the field of fatty liver disease with its NASH PASS program will allow us to not only speed clinical development of much-needed therapeutics, but also to increase access to clinical trials amongst underrepresented populations. It’s a privilege to join the ProSciento team of highly respected scientists, physicians, and clinical development specialists and to help continue to make considerable contributions in expanding and improving therapeutic options for NASH, diabetes, obesity, and other related metabolic diseases.”

As an outstanding subject matter expert on NAFLD, NASH, and metabolic-related research, Dr. Gutierrez is an internationally recognized clinical researcher and has published more than 90 peer-reviewed publications on liver disease. Dr. Gutierrez is a transplant hepatologist and liver cancer specialist with an active practice in Southern California. He is also the former Medical Director of Liver Transplant at St. Vincent Medical Center in Los Angeles and an Adjunct Assistant Professor at the University of California, San Diego. Earlier in this career, he was a transplant hepatologist for Sharp Healthcare and the Director of Hepatobiliary Cancer at the Texas Liver Institute, where he participated in the landmark hepatitis C virus clinical trials studying oral combinations of Direct Acting Antivirals (DAAs).

Dr. Gutierrez earned his Medical Degree from Mount Sinai School of Medicine in New York City and completed his internship, residency, and fellowship at the University of California, San Diego.  He also completed a fellowship at the University of Miami School of Medicine.

About ProSciento, Inc.

ProSciento is the leading specialized clinical research organization (CRO) focused on NASH, diabetes, obesity, and related metabolic diseases. ProSciento works with biopharma companies worldwide to support their outsourced clinical research needs with comprehensive and customized services for multinational, early development clinical trial programs. Founded in 2003, ProSciento has conducted more than 325 clinical studies for diabetes, NASH, and obesity, and has contributed to the development of numerous approved metabolic drugs and devices on the global marketplace. For more information, please visit www.prosciento.com.

For business development inquiries, please contact:
bd@prosciento.com

For media inquiries, please contact:
Abby Devine
Senior Director, Corporate Communications, ProSciento, Inc.
abby.devine@prosciento.com

For clinical trial enrollment inquires, please contact:
Tel: +1 (866) 308-7427
volunteer@prosciento.com

ProSciento Closes Growth Financing from 1315 Capital

SAN DIEGO and PHILADELPHIA, September 10, 2020 /Businesswire/ – ProSciento, Inc., a leading specialty clinical research organization (CRO) focused on non-alcoholic steatohepatitis (NASH), diabetes, obesity, and related metabolic diseases, announced today the closing of a growth financing from 1315 Capital, a healthcare investment firm that provides expansion and growth capital to commercial-stage healthcare services, medical technology and specialty therapeutics companies. SVB Leerink served as the exclusive financial advisor to ProSciento for this transaction.

The funds raised will support further expansion of the company’s CRO operations and the continued growth of ProSciento’s differentiated patient access solutions, including NASH PASS®, a novel and highly effective clinical research and patient registry platform.  

“We are thrilled to partner with 1315 Capital to implement a number of strategic initiatives, including further expansion of our services, operations and key hires in the U.S. and key global markets. 1315 Capital has an impressive track record of working successfully with growth-stage companies in the therapeutics and healthcare services sector. We couldn’t be more pleased to work with the 1315 Capital team as we enter this stage of strategic expansion,” said Dr. Marcus Hompesch, Chief Executive Officer and Chairman of the Board at ProSciento. 

“ProSciento has established an outstanding reputation as the leading provider of early stage clinical research services for metabolic diseases.  With this differentiating expertise and an experienced leadership team, we believe the company is poised for significant growth as it continues to expand its CRO operations and leverages its proprietary NASH PASS program to improve clinical study design and enrollment for NAFLD and NASH drug development,” said Matthew Reber, Partner at 1315 Capital. “Our firm seeks to make a positive impact on patients and the entire healthcare system, and ProSciento is a key addition to the portfolio. We look forward to supporting ProSciento in its continued contributions to advance clinical research for metabolic diseases.”

About 1315 Capital, LLC

1315 Capital provides expansion and growth capital to commercial-stage healthcare services, medical technology, and specialty therapeutics companies. 1315 Capital leverages experienced investors and proven operating teams to work alongside portfolio company management to rapidly grow platform companies into high value businesses that positively impact patients, physicians, and the broader healthcare system. For more information, visit www.1315capital.com.

About ProSciento, Inc.

ProSciento is a leading specialized clinical research organization (CRO) focused on NASH, diabetes, obesity, and related metabolic diseases. ProSciento works with biopharma companies worldwide to support their outsourced clinical research needs with comprehensive and customized services for multinational, early development clinical trial programs. Founded in 2003, ProSciento has conducted more than 300 clinical projects for diabetes, NASH, and obesity and supported the development of many approved metabolic drugs and devices on the market globally. For more information, please visit www.prosciento.com.

For further information, please contact:
Abby Devine
Senior Director, Corporate Communications, ProSciento, Inc.
abby.devine@prosciento.com

ProSciento Appoints Stephen Mullennix as Chief Financial Officer

SAN DIEGO, September 1, 2020 – ProSciento, Inc., a leading specialty clinical research organization (CRO) exclusively focused on NASH, diabetes, obesity and related metabolic diseases, today announced the appointment of Stephen Mullennix to the role of Chief Financial Officer (CFO). Mr. Mullennix joins ProSciento with a diverse global finance background consisting of over 25 years of operational and transactional experience in biotechnology, infrastructure, and private equity sectors.

“We are delighted to welcome Stephen to our ProSciento team as Chief Financial Officer, an appointment which further strengthens our executive leadership team. Stephen joins us at an exciting time, and his experience in guiding financial strategy, corporate development and access to capital markets will be invaluable as we continue to expand our metabolic disease-focused specialty CRO services globally, including our NASH PASS clinical research and patient registry platform,” commented Dr. Marcus Hompesch, ProSciento’s Chairman and Chief Executive Officer.

“ProSciento has cultivated exceptional scientific and operational expertise in clinical R&D for metabolic diseases, including NASH, diabetes and obesity, and has contributed to the development of many FDA-approved drugs and devices of significant importance to patients and the healthcare community,” said Stephen Mullennix. “I’m thrilled to join the leadership team to support the continued financial growth of ProSciento and its contributions in advancing new treatments and new methodologies in these critical therapeutic areas.”

Mr. Mullennix is a finance and operations executive with deep experience in corporate growth strategies within highly regulated industries. Mr. Mullennix was most recently with UroGen Pharma, Ltd., where he served as Chief Operating Officer and, prior to that, Chief Financial Officer. During his time at UroGen, he helped the company build its management team and corporate infrastructure that successfully launched its first FDA-approved drug for urothelial cancer and completed a $160 million secondary offering. Before his executive leadership role at UroGen, Mr. Mullennix was Chief Financial Officer and Senior Vice President of Operations at SolarReserve, LLC, a solar energy technology company, where he supported the company’s global expansion and oversaw multiple corporate financings. Prior to SolarReserve, he served as a Managing Director at US Renewables Group, a private equity investment fund with more than $750 million of assets under management. Mr. Mullennix has been directly involved in $3.3 billion of transactions in growth companies. He earned his MBA from the Anderson School at University of California Los Angeles and BA in Economic Geography from Dartmouth College.

About ProSciento, Inc.
ProSciento is a leading specialized clinical research organization (CRO) exclusively focused on NASH, diabetes, obesity and related metabolic diseases. ProSciento works with biopharma companies worldwide to support their outsourced clinical research needs with comprehensive and customized services for multinational, early development clinical trial programs. Founded in 2003, ProSciento has conducted more than 300 clinical projects for diabetes, NASH and obesity and supported the development of many approved metabolic drugs and devices on the market globally. For more information, please visit www.prosciento.com.

For business development inquiries, please contact:
bd@prosciento.com

For media inquiries, please contact:
Abby Devine
Senior Director, Corporate Communications, ProSciento, Inc.
abby.devine@prosciento.com

For clinical trial enrollment inquires:
Tel: +1 (866) 308-7427
volunteer@prosciento.com

ProSciento, Clinical Research Organization (CRO) Focused on Metabolic Diseases, Institutes Rapid COVID-19 Antigen and Antibody Testing at Clinical Research Unit in Southern California

SAN DIEGO, June 15, 2020 – ProSciento, Inc., a clinical research organization (CRO) exclusively focused on NASH, diabetes, obesity, and related metabolic diseases, announced today that its clinical research unit (CRU) in San Diego has implemented on-site rapid COVID-19 antigen and antibody testing for essential staff and clinical study participants.

“Most of our study participants are considered higher risk populations for COVID-19 complications, including individuals with diabetes, obesity and hypertension. We have an obligation to our study participants and staff to enact safety measures to the fullest possible extent. As such, we established an internal mandate at our CRU for on-site COVID-19 testing prior to the relaunch of essential clinical research activities,” said Marcus Hompesch, MD, ProSciento’s Chief Executive Officer. “We’re pleased to have now implemented point-of-care COVID-19 antigen and antibody testing protocols, in addition to the ancillary safety measures that will remain in place.”

In addition to testing, existing safety measures at ProSciento’s CRU include:

  • Six-foot social distancing and face covering protocol throughout facility
  • Clinic zoning restricted to 10 individuals per area with independent entrance, exit and air flow system 
  • Full personal protective equipment (PPE) for clinical staff 
  • MERV-13 HVAC airflow filtration system (HVAC system used in hospital surgical rooms)
  • COVID-19 symptom and exposure monitoring triage prior to entry for all
  • Daily medical grade sanitation of clinic  

“ProSciento’s CRU is widely recognized for its specialized methodologies and expertise in metabolic clinical research, including being the only center in the U.S. that offers high capacity automated glucose clamp procedures. At this clinic alone, ProSciento has conducted nearly 300 early phase clinical studies for metabolic diseases, including more phase I/II diabetes clinical trials than any other U.S. provider,” continued Dr. Hompesch. “With a profound focus on utilizing advanced clinical research methods, it is of critical importance that our CRU set a high bar for patient and staff safety, which now includes antigen and antibody testing.”

For more information or questions about ProSciento’s COVID-19 safety and response measures for CRU and multi-site clinical studies, please contact COVID-19@prosciento.com

About ProSciento, Inc.

ProSciento is a leading specialized clinical research organization (CRO) exclusively focused on NASH, diabetes, obesity, and related metabolic diseases. ProSciento works with biopharma companies worldwide to support their outsourced clinical research needs with comprehensive and customized services for multinational, early development clinical trial programs. Founded in 2003, ProSciento has a global network for more than 220 sites, including a state-of-the-art specialized clinical unit in Southern California, and is widely recognized for its scientific expertise, depth of services, and contributions to the development of many approved metabolic drugs and devices on the market globally. For more information, please visit www.prosciento.com.

For business development inquiries, please contact:
bd@prosciento.com

For media inquiries, please contact:
Abby Devine
Senior Director, Corporate Communications, ProSciento, Inc.
abby.devine@prosciento.com

For clinical trial enrollment inquires:
Tel: +1 (866) 308-7427
volunteer@prosciento.com