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Phone :
+1 (858) 366 - 8608
Address :
NovaRhythm Biosciences, Inc
9311 SE Maricamp Rd #1007
Ocala, FL 34472 USA
Email :
info@novarhythmbio.com

Corporate Strategy

Program Status

From Late-Stage Preclinical to First-in-Human

SAR-297871 enters NovaRhythm’s portfolio as a late-stage preclinical asset supported by extensive prior data packages from Sanofi, including medicinal chemistry, pharmacology, toxicology, and human tissue studies. NovaRhythm’s development plan focuses on efficient de-risking and rapid translation to human proof-of-mechanism.

DEVELOPMENT ROADMAP
(IND → PHASE 1)

Step 1 – IND-Enabling Activities

  • – CMC (Chemistry, Manufacturing & Controls)
  • – Final preclinical safety and toxicology work
  • – Regulatory engagement and IND preparation

Step 2 – IND Submission

  • – Submission of Investigational New Drug (IND) application
  • – Regulatory review and clearance to proceed with clinical trials

Step 3 – Phase 1 Clinical Trial

  • – Single and multiple ascending dose study in healthy volunteers (or relevant population, as finalized with regulators)
  • – Primary endpoints: safety, tolerability, pharmacokinetics
  • – Secondary / exploratory:  pharmacodynamic signals, early cardiac biomarker assessment

Step 4 – Phase 2 Readiness & Strategic Options

With Phase 1 safety and PK established, NovaRhythm plans to:

  • – Design focused Phase 2 trials in AF patients to evaluate efficacy and dose optimization
  • – Drive strategic partnering or transaction opportunities with larger cardiovascular or pharma partners interested in AF innovation

J. Kevin Buchi

BOARD MEMBER AND M&A ADVISOR

Mr. Buchi previously served as Chief Executive Officer of BioSpecifics Technologies Corp. and of TetraLogic Pharmaceuticals Corporation. From 1991 to 2010, Mr. Buchi served as the Chief Financial Officer at Cephalon Pharmaceuticals and from 2010 to 2011 became the Chief Executive Officer to complete the $6.9 Billion acquisition of Cephalon by Teva Pharmaceutical. Subsequently, Mr. Buchi served as Corporate Vice President, Global Branded Products of Teva Pharmaceuticals Industries Ltd from 2012 to 2013. Mr. Buchi is currently on the Board of Directors of Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) and of Benitec Biopharma (NASDAQ:BNTC). Mr. Buchi has a B.A. in chemistry from Cornell University and a Masters in Management from Kellogg Graduate School of Management at Northwestern University. He is also a Certified Public Accountant.

Paul E. Miller, Ph.D.

BOARD MEMBER, CEO & FOUNDING PARTNER

Dr. Miller is the Founder and CEO of Consulting Life Sciences, a biotech consulting and brokerage firm he launched in 2007. From 2009 to 2023, he served as Co-Founder and Chief Corporate Development Officer of AnaBios Corporation, a company focused on advancing translational science through the use of primary human tissues in preclinical research. With over 40 years of experience in both science and business, Dr. Miller’s research background spans a wide range of fields, including cancer biology, immunology, protein secretion, gastrointestinal function, genomics, cardiology, pain and itch therapeutics. He also spent 20 years in the cultural arts industry before fully integrating his scientific knowledge with his business expertise in the biopharmaceutical sector. Throughout his career, Dr. Miller has led the development and commercialization of innovative services for preclinical contract research organizations (CROs), helping streamline drug discovery and safety testing—efforts that generated over $80 million in revenues.

Najah Abi Georges, Ph.D.

BOARD MEMBER, CSO & FOUNDING PARTNER

Dr. Abi Gerges has over 30 years of experience in cardiovascular research and 26 years in preclinical R&D. He is a seasoned leader in drug discovery. He spent 16 years at AstraZeneca and 10 years at AnaBios, where he currently serves as Senior Vice President of Research Alliances. Dr. Abi-Georges has authored more than 59 peer-reviewed publications and has been instrumental in developing several first-in-class therapies, including Tagrisso, Zeposia, Velsipity, and APD418. Known for his deep expertise in cardiovascular drug development and safety, he is widely respected across the pharmaceutical industry and regulatory agencies.

Cooley M. Pantazis, M.D.

BOARD MEMBER, CMO & FOUNDING PARTNER

Dr. Pantazis is a board-certified pathologist and has served as the Medical Director of Laboratory Services at Advent Health in Ocala, Florida, since 2015. Formerly, he was a tenured Associate Professor and Director of Surgical Pathology at the University of Kansas Medical Center. In 2005, he founded Hemacon Laboratories, a molecular hematopathology reference lab focused on diagnosing bone marrow and blood cancers. With over 40 years of experience in both medical practice and research, Dr. Pantazis has authored more than 75 peer-reviewed publications. His expertise includes animal cancer models, laboratory test development, and molecular cancer diagnostics, and he remains actively involved in research collaborations.

J. Kevin Buchi

M&A ADVISOR

Mr. Buchi previously served as Chief Executive Officer of BioSpecifics Technologies Corp. and of TetraLogic Pharmaceuticals Corporation. From 1991 to 2010, Mr. Buchi served as the Chief Financial Officer at Cephalon Pharmaceuticals and from 2010 to 2011 became the Chief Executive Officer to complete the $6.9 Billion acquisition of Cephalon by Teva Pharmaceutical. Subsequently, Mr. Buchi served as Corporate Vice President, Global Branded Products of Teva Pharmaceuticals Industries Ltd from 2012 to 2013. Mr. Buchi is currently on the Board of Directors of Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) and of Benitec Biopharma (NASDAQ:BNTC). Mr. Buchi has a B.A. in chemistry from Cornell University and a Masters in Management from Kellogg Graduate School of Management at Northwestern University. He is also a Certified Public Accountant.

Shashank Upadhye, J.D. LLM

IP ADVISOR

Mr. Upadhye is a partner at Upadhye Tang LLP and a nationally recognized pharmaceutical IP and FDA strategist with nearly 30 years of experience helping pharmaceutical companies maximize asset value and investor returns through integrated patent and regulatory planning. He previously served as Chief Legal/IP/FDA Counsel at Apotex, Sandoz/Novartis, and Eon Labs, where he guided numerous drug products from development through approval and commercialization, bringing deep operational and executive-level insight. Shashank specializes in designing robust patent portfolios, exclusivity strategies, and FDA regulatory pathways that enhance competitive positioning, extend franchise life, and unlock long-term enterprise value. He is the author of the leading treatise Generic Pharmaceutical Patent and FDA Law and is widely recognized as a trusted advisor to pharmaceutical companies, executives, and investors on high-stakes IP and regulatory strategy.

Peter R. Kowey, M.D.

FDA & REGULATORY ADVISOR

Dr. Kowey is a leading American cardiologist and medical researcher. He serves as Professor of Medicine and Clinical Pharmacology at Jefferson Medical College of Thomas Jefferson University and holds the William Wikoff Smith Chair in Cardiovascular Research at the Lankenau Institute for Medical Research. A recognized expert in cardiac rhythm disorders, Dr. Kowey has authored or co-authored over 400 scientific papers and received more than 150 research grants. He has played key roles in numerous clinical trials and co-edited three major textbooks on cardiac arrhythmias. Dr.Kowey is a fellow of multiple prestigious organizations, including the American Heart Association and the American College of Cardiology. He also serves on the editorial boards of Heart Rhythm Journal and the Journal of Cardiovascular Electrophysiology, and reviews manuscripts for 25 scientific journals. He has consulted for over 60 international pharmaceutical companies, chaired multiple data and safety monitoring boards, and served as an advisor to the U.S. Food and Drug Administration.

Cooley M. Pantazis, M.D.

CHIEF MEDICAL OFFICER & FOUNDING PARTNER

Dr. Pantazis is a board-certified pathologist and has served as the Medical Director of Laboratory Services at Advent Health in Ocala, Florida, since 2015. Formerly, he was a tenured Associate Professor and Director of Surgical Pathology at the University of Kansas Medical Center. In 2005, he founded Hemacon Laboratories, a molecular hematopathology reference lab focused on diagnosing bone marrow and blood cancers. With over 40 years of experience in both medical practice and research, Dr. Pantazis has authored more than 75 peer-reviewed publications. His expertise includes animal cancer models, laboratory test development, and molecular cancer diagnostics, and he remains actively involved in research collaborations.

Najah Abi Georges, Ph.D.

CHIEF SCIENTIFIC OFFICER & FOUNDING PARTNER

Dr. Abi Gerges has over 30 years of experience in cardiovascular research and 26 years in preclinical R&D. He is a seasoned leader in drug discovery. He spent 16 years at AstraZeneca and 10 years at AnaBios, where he currently serves as Senior Vice President of Research Alliances. Dr. Abi-Georges has authored more than 59 peer-reviewed publications and has been instrumental in developing several first-in-class therapies, including Tagrisso, Zeposia, Velsipity, and APD418. Known for his deep expertise in cardiovascular drug development and safety, he is widely respected across the pharmaceutical industry and regulatory agencies.

Paul E. Miller, Ph.D.

CHIEF EXECUTIVE OFFICER & FOUNDING PARTNER

Dr. Miller is the Founder and CEO of Consulting Life Sciences, a biotech consulting and brokerage firm he launched in 2007. From 2009 to 2023, he served as Co-Founder and Chief Corporate Development Officer of AnaBios Corporation, a company focused on advancing translational science through the use of primary human tissues in preclinical research. With over 40 years of experience in both science and business, Dr. Miller’s research background spans a wide range of fields, including cancer biology, immunology, protein secretion, gastrointestinal function, genomics, cardiology, pain and itch therapeutics. He also spent 20 years in the cultural arts industry before fully integrating his scientific knowledge with his business expertise in the biopharmaceutical sector. Throughout his career, Dr. Miller has led the development and commercialization of innovative services for preclinical contract research organizations (CROs), helping streamline drug discovery and safety testing—efforts that generated over $80 million in revenues.