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ProSciento Receives 2023 Innovation Award from The Liver Coalition of San Diego

SAN DIEGO, October 17, 2023 – ProSciento, Inc. is pleased to announce that they are a recipient of the 2023 Innovation Award from The Liver Coalition of San Diego, champions for liver health and patient support in the region. The Coalition’s Annual Liver Excellence Gala, which has celebrated liver disease pioneers since 2011, takes place at the Don Room El Cortez San Diego on Sunday, October 29, 2023.

Since its inception in 2017 by the Coalition’s Medical Advisory Council, the Innovation Award has recognized leading companies and organizations advancing liver disease treatments. Previous awardees include Eric Dube and Retrophin (now Travere Therapeutics) in 2019, Joseph Panetta and Biocom in 2018, and Steven Mento, PhD, and Conatus Pharmaceuticals in 2017.

“The selection of ProSciento as this year’s recipient underscores our commitment to recognizing scientific innovation in the treatment of liver diseases, especially nonalcoholic steatohepatitis (NASH),” commented Gabriel Schnickel, MD, Chair of the Liver Coalition of San Diego’s Medical Advisory Council. “With its data-centric clinical methodologies, the NASH PASS initiative, and the establishment of the NASH Roundtable Forums, ProSciento has embodied the spirit of scientific discovery, patient engagement, and clinical excellence.”

“ProSciento is dedicated to advancing the clinical development of improved treatment solutions for individuals with metabolic conditions such as MASH/NASH,” said Dr. Marcus Hompesch, Chief Executive Officer of ProSciento, Inc. “We consider scientific research and patient engagement to be fundamental aspects of our mission and are deeply honored to have been presented with this year’s Innovation Award. This honor will further solidify our resolve to actively champion the interests of patients and continue our science-driven efforts in the pursuit of new therapeutic alternatives.”

To learn more about the event, go to https://livercoalition.org/liver-excellence-gala/.

About the Liver Coalition of San Diego

The Liver Coalition of San Diego was formed by medical professionals, patients, and caregivers to promote liver health and support the needs of those affected by liver disease in San Diego County. The coalition is a member of the Global Liver Institute’s Liver Action Network. The Innovations Award was created in 2017 by the coalition’s Medical Advisory Council to recognize innovation in the local biotech/pharmaceutical sector advancing the treatment of liver disease. You can learn more about the Liver Coalition of San Diego at https://livercoalition.org.

About ProSciento, Inc.

ProSciento is the leading provider of clinical research and patient engagement solutions for metabolic continuum diseases with unparalleled expertise in diabetes, obesity, and steatotic liver disease. As a full-service clinical research organization (CRO), ProSciento works with clients across the globe to design and conduct multinational clinical trials, from early clinical development planning through phase III. With two decades as a leading scientific contributor to metabolic continuum research, ProSciento has built trusted relationships with clients, partners, and patients, supporting the development of therapeutics and devices that make an important difference in the lives of individuals with metabolic diseases. For more information, please visit www.prosciento.com.

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

For general 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.

ProSciento Prepares to ‘Step Out’ Against Diabetes as a Sponsor for the American Diabetes Association Event in Southern California for a 19th Year

SAN DIEGO, September 16, 2023 – ProSciento, Inc., the leading clinical research organization (CRO) for metabolic diseases, celebrates its 19th year as a corporate sponsor of Step Out: Walk to Stop Diabetes, hosted by the American Diabetes Association (ADA). ADA Step Out Walks brings together thousands of walkers in events across the nation to raise awareness, support research, and fund programs for individuals affected by type 1 and type 2 diabetes.

This year ProSciento is also pleased to be the Living Red Sponsor for the Step Out event in Southern California. The ADA’s Living Red initiative recognizes and supports individuals living with diabetes (Red Striders) participating in the events, recognizable in their distinct red jerseys.

The Southern California event takes place Saturday, September 30 at Rainbow Lagoon, 400 East Shoreline Drive in Long Beach. Look for ProSciento’s tent in the Wellness Village and come by to visit our photo booth and meet our representatives.

About ProSciento, Inc.

For general 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.

ProSciento to Present Patient Access & Engagement (PAE) at the NASH Paris Meeting 2023

SAN DIEGO, September 1, 2023 – ProSciento, Inc., the leading clinical research organization (CRO) for metabolic diseases, will present scientific data related to its Patient Access & Engagement (PAE) platform at the NASH Paris Meeting taking place September 7-8, 2023.

The scientific poster titled “Participant Feasibility: Direct Engagement with Patients to Impact MASH Trial Design and Site Selection” evaluates data from ProSciento’s Patient Access & Engagement (PAE) platform, presented at this year’s NASH Paris Meeting. The poster evaluates the data from pre-study participant feasibility campaigns for 12 metabolic dysfunction-associated steatohepatitis (MASH) study protocols utilizing a database of 29,879 individuals with comorbidities related to the prevalence of MASH/MASLD. The resulting insights held significant value in demonstrating study feasibility, identifying participation barriers, aiding in site selection decisions, enhancing patient enrollment and retention, and ultimately improving overall efficiency.

View the poster on ProSciento’s website at https://prosciento.com/publication-library/posters-registration/?id=116258.

About ProSciento, Inc.

For business development inquiries, please contact:
Casey Ustick
Vice President, Global Business Development, ProSciento, Inc.
bd@prosciento.com

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

New Liver Disease Nomenclature Announced

June 24, 2023

Announced at the EASL Congress 2023, steatotic liver disease (SLD) is selected as the overarching term for the aetiologies of steatosis. Nonalcoholic fatty liver disease (NAFLD) is now defined as metabolic dysfunction-associated steatotic liver disease (MASLD), and nonalcoholic steatohepatitis (NASH) is now defined as metabolic dysfunction-associated steatohepatitis (MASH).

This change in terminology reflects the importance of addressing the underlying metabolic factors that contribute to MASLD and MASH and the importance of diagnosis based on affirmative rather than exclusionary criteria.

As clinical research experts focused on the continuum of metabolic diseases, ProSciento recognizes the significance of these changes. We are committed to supporting further advances in MASLD and MASH scientific research, therapeutic development, and biomarker discovery.

Additional details about the new nomenclatures are available in the multinational liver societies’ websites:

ProSciento Appoints David Sockolof as Chief Financial Officer

SAN DIEGO, February 1, 2023 – ProSciento, Inc., a leading specialty clinical research organization (CRO) exclusively focused on metabolic diseases, today announced the appointment of David Sockolof to the role of Chief Financial Officer (CFO). Mr. Sockolof joins ProSciento with an extensive track record in leading finance and business operations at global clinical research companies, including leadership roles at Labcorp Drug Development and PRA Health Sciences.

“It is an honor to join a company at the forefront of clinical research for critically needed, often life-saving therapeutics for metabolic diseases, a mission that holds great significance to me personally as father of a child with type 1 diabetes,” said Mr. Sockolof. “I look forward to supporting the continued growth of ProSciento and its innovative programs for patient access and engagement, leading change towards a future where the voice of the patient is at the heart of clinical research.”

“David’s knowledge of the clinical research industry and his passion for patient care are clearly evident in his collaborative, values-driven leadership style, which we consider vitally important for our corporate culture,” said Dr. Marcus Hompesch, ProSciento’s Chairman and Chief Executive Officer. “His appointment as CFO further strengthens our executive leadership at an exciting time of growth for our team, our services, and our differentiators. David’s deep understanding of the industry and experience in guiding financial strategy will be invaluable as we continue to expand our science-driven and metabolic disease-focused CRO services globally and expand our patient access and engagement platform.”

Mr. Sockolof’s career in global finance and operations spans more than 20 years with deep experience in corporate growth strategies within the clinical research industry. His most recent role was as Executive Director of Resource and Process Optimization at Labcorp Drug Development where he provided leadership in financial forecasting, expense management, and global resource management. Prior to his position at Labcorp, Mr. Sockolof held a number of leadership roles at PRA Health Sciences, including Vice President of Finance and Business Operations and, prior to that, Director of Business Operations. During his tenure at PRA, his contributions were instrumental in the company’s evolution from a mid-size company to a leading global CRO, including the implementation of strategic financial frameworks and improved systems for proposals and pricing, project finance and global vendor management. He received his MBA from George Washington University.

About ProSciento, Inc.

ProSciento is the leading specialty clinical research organization (CRO) focused on progressing clinical research and science that provide patients with better treatments, devices, and diagnostics for metabolic diseases. ProSciento works with biopharma companies and leading researchers worldwide to support clinical research programs and biomarker research. Founded in 2003, ProSciento has conducted more than 350 clinical trials for diabetes, NASH and obesity and supported the development of 19 approved metabolic drugs and devices on the market globally. For more information, please visit www.prosciento.com.

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

ProSciento Hosts 6th NASH Roundtable Forum in Washington, DC

October 31, 2022 ‒ ProSciento, Inc. will host the 6th NASH Roundtable Forum on November 5, 2022, in Washington, DC, during the AASLD The Liver Meeting, bringing together leading experts to facilitate advances in science, clinical research, and patient care for nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).

NASH Roundtable forums are held twice a year, each focusing on a topic of importance to the medical and scientific community. The upcoming 6^th Forum will facilitate a discussion on serum and imaging-based non-invasive testing, including regulatory considerations, within NAFLD/NASH clinical research. Moreover, the level of evidence in favor of replacing liver biopsy with non-invasive tests for clinical research and trials, as well as the major remaining challenges, will be analyzed.

Steering Committee:

Vlad Ratziu, MD, PhD, Professor of Hepatology at Sorbonne Université and Pitié-Salpêtrière Hospital, Paris, France
Arun J. Sanyal, MD, the Reno Vlahcevic Professor of Medicine at Virginia Commonwealth University School of Medicine, USA
Rohit Loomba, MD, Professor of Medicine, Director of Hepatology, at University of California at San Diego and Founding Director of the UCSD NAFLD Research Center, USA
Marcus Hompesch, MD, President and CEO, ProSciento, Inc., and Editor-in-Chief, Endocrinology, Diabetes & Metabolism, USA

Keynote Speakers:

Alina Allen, MD, Assistant Professor of Medicine in the Division of Gastroenterology and Hepatology and the Director of the NAFLD Clinic at Mayo Clinic Rochester, Minnesota, USA
Prof Quentin M. Anstee, PhD, FRCP, Professor of Experimental Hepatology, Faculty of Medical Sciences, Newcastle University, UK
Jeffrey V Lazarus, PhD, Co-director of the Viral and Bacterial Infections Programme at the Barcelona Institute for Global Health (ISGlobal), Barcelona, Spain, and Senior Scholar at the CUNY Graduate School of Public Health and Health Policy, NY, USA
Richard Torstenson, PhD, Senior Regulatory Affairs Director at AstraZeneca, Sweden

For additional information about the 6^th NASH Roundtable Forum, please contact: nashroundtable@prosciento.com.

To be notified of future publications from the NASH Roundtable, please visit: https://nashroundtable.com/contact/.

About the NASH Roundtable™

The NASH Roundtable™ was established in 2018 as a platform to stimulate collaboration and build consensus towards validated biomarkers and endpoints and to support the development of effective and safe treatments. Today, the Roundtable consists of distinguished physicians, researchers, and clinical development experts from three continents brought together by their common commitment to steward advances in science, clinical research, and therapeutics for fibrotic diseases.

ProSciento to Present NASH PASS® Registry Data at EASL NAFLD Summit 2022

SAN DIEGO, September 15, 2022 – ProSciento, Inc., a specialty clinical research organization (CRO) focused exclusively on metabolic diseases, will present data related to the NASH PASS (NASH Patient Access and Screening Strategies) registry at the NAFLD Summit of the European Association for the Study of the Liver (EASL), being held in Dublin and online from September 15-17.

The NASH PASS registry is a research database from a growing and well-characterized population that is a powerful tool to analyze and inform study design development, facilitating enrollment for NAFLD clinical trials. The result of this analysis helps better understand this population, increasing access to it. It also provides a pathway for further research and educational opportunities in earlier identification of the NAFLD patient population.

Poster presentation details are as follows:

Abstract #: P07-04
Title: NASH PASS®: a Registry to Inform Study Design and Accelerate Patient Enrollment
Authors: Alejandra Macias Pulido, Heidi Guthrie, Marcus Hompesch, Michelle Mazuranic

The data presented demonstrate the NASH PASS registry as a platform to model study design criteria in a community-based population to favorably accelerate clinical development programs. ProSciento’s experience applying this model has resulted in expedited study start-up of interventional clinical trials by more than 1 month on average, reduced screen failures by 15-30%, and increased enrolment rate to more than double compared to industry average.

NASH PASS is a cross-sectional diagnostic study and registry-based IRB-approved clinical research protocol with detailed prospective data collection on subsets of participants. Individuals at high risk for developing NAFLD or NASH are invited to undergo comprehensive screening to determine disease status. Participants can be followed for up to 10 years. NASH PASS data was utilized to analyze baseline characteristics of individuals at high risk for developing NAFLD. Sample t-tests were performed to compare differences among Type 2 diabetic (T2DM) and non-diabetic participants.

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 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:
Casey Ustick
Vice President, Global Business Development, ProSciento, Inc.
bd@prosciento.com

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

ProSciento Prepares to ‘Step Out’ Against Diabetes as the Living Red Sponsor for the American Diabetes Association Fundraising Event in Southern California

SAN DIEGO, September 10, 2022 – ProSciento, Inc., a specialty clinical research organization (CRO) focused exclusively on metabolic diseases, is pleased to announce that it is this year’s Living Red Sponsor for the American Diabetes Association (ADA) Step Out Event in Southern California, taking place Saturday, September 17 in Los Angeles.

Each year, ADA Step Out Walks bring together thousands of walkers in events across the nation to raise awareness, support research, and fund programs for individuals affected by type 1 and type 2 diabetes. The ADA’s Living Red initiative recognizes and supports individuals living with diabetes (Red Striders) participating in the events, recognizable in their distinct red jerseys.

Look for ProSciento’s tent in the Wellness Village and come by to visit our photo booth and meet our representatives.

More information about the event can be found at https://donations.diabetes.org/site/TR/StepOut/StepOutContent?pg=entry&fr_id=13515.

About ProSciento, Inc.

ProSciento is a metabolism-focused 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 clinical trial enrollment inquires,
Please visit www.myproscientostudy.com or contact:
Tel: +1 (866) 308-7427
hello@myproscientostudy.com

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

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.