Renexxion - Ireland
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  • ​Naronapride (ATI-7505)
    • About Naronapride (ATI-7505)
    • Mechanism of Action
    • Development Status
    • Chemistry and Manufacturing
    • Regulatory Developments
  • Knowledge Centre
    • Gastrointestinal Dysmotility in Cystic Fibrosis (CF)
    • Gastroparesis
    • Chronic Idiopathic Constipation
    • Irritable Bowel Syndrome
    • PPI non-responsive GERD
  • News
    • Press >
      • ​Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Completion of Enrollment of the Global Phase 2b Study Evaluating Naronapride in Gastroparesis (MOVE-IT)
      • Renexxion Ireland Ltd. Announces Issuance of Fifth New U.S. Patent Covering Novel Crystal Isoform of Naronapride
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Expansion of the Phase 2b MOVE-IT Study of Naronapride in Gastroparesis and Dosing of the First United States Patient
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce FDA Clearance of the Investigational New Drug Application for Naronapride to Treat Gastroparesis and Subsequent Expansion of the Ongoing Phase 2b MOVE-IT Study to the United States
      • Renexxion Ireland’s European Partner, Dr. Falk Pharma GmbH, has Elected PPI-non-responsive Symptomatic GERD as the Second Naronapride Indication to Develop and Commercialize in their Licensed Territories
      • Renexxion to Present at the Oppenheimer 34ᵗʰ Annual Healthcare Life Sciences Conference
      • Renexxion Ireland Ltd. Announces FDA Clearance of Investigational New Drug (IND) Application for Naronapride to Treat PPI-Non-Responsive Symptomatic GERD
      • Renexxion Ireland has Completed a Successful Pre-IND Consultation with the United States FDA for Development of Naronapride for Patients with PPI-non-responsive Symptomatic GERD
      • Renexxion Ireland Announces Issuance of Two U.S. Patents Covering a Novel Crystal Isoform of Naronapride
      • ​Renexxion to Present at the Oppenheimer Healthcare Private Company Showcase​
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Initiation of Phase II Study of naronapride in patients with gastroparesis
      • Renexxion Announces Opening of Investigational New Drug (IND) Application for Naronapride for the Treatment of Gastrointestinal Dysmotility in Cystic Fibrosis Patients
      • Gastrointestinal Biotech Company Renexxion Ireland Announces $100M Investment Commitment
      • Renexxion Ireland Announces Issuance of a New US Patent covering Naronapride, a Clinical Stage Potential Best-in-Class Prokinetic Agent for Gastrointestinal Disorders
      • Renexxion Ireland Ltd. Announces a Licensing and Collaboration Agreement with Dr. Falk Pharma GmbH
  • Contact

​Our Leadership Team


Picture
Andrew E. Mulberg, MD, FAAP, CPI
Head, Global Regulatory Affairs
Andrew is currently an Executive pharmaceutical leader leading strategy and operational aspects of drug and biological development for NDA and BLA submissions for pediatric and adult rare diseases, cystic fibrosis, gastroenterology and hepatology. He is currently Senior Vice President, Regulatory Affairs at Neurogene Inc, a company devoted to gene therapy approaches to management of neurodegenerative and neurodevelopmental disorders in children and adults. Formerly, he served Senior Vice President, Global Regulatory Affairs at Amicus Therapeutics from 2016-2020 and responsible for the approval of Galafold (migalastat) for the treatment of Fabry disease in adults. He has been involved in the registration planning for AT-GAA, a novel enzyme replacement therapy for Pompe disease in infants, children and adults.  He served as Division Deputy Director of Gastroenterology and Inborn Errors Products, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA) since 2010-2016.  Before joining FDA, Andrew was Portfolio Leader in Established Products responsible for worldwide leadership of Internal Medicine products in Johnson and Johnson from 2000-2010.  Andrew is a graduate of Columbia College of Columbia University and of the Mount Sinai School of Medicine.  He completed his residency in Pediatrics at the Children’s Hospital of Philadelphia followed by a Pediatric Gastroenterology Clinical Fellowship and a Post-Doctoral Fellowship in Cellular and Molecular Physiology at New England Medical Center.  Andrew is Adjunct Professor of Pediatrics at the University of Maryland School of Medicine and has served as Attending, Pediatric Gastroenterology and Nutrition at Cooper University Hospital in New Jersey caring for children with gastrointestinal diseases.  He is Principal Editor of Pediatric Drug Development: Concepts and Applications published in 2011 and 2013.  He is a member of Alpha Omega Alpha Honor Medical Society, American Gastroenterological Association and the North American Society for Pediatric Gastroenterology and Nutrition.
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  • Home
  • Company
    • Our Vision
    • Our Leadership Team
  • ​Naronapride (ATI-7505)
    • About Naronapride (ATI-7505)
    • Mechanism of Action
    • Development Status
    • Chemistry and Manufacturing
    • Regulatory Developments
  • Knowledge Centre
    • Gastrointestinal Dysmotility in Cystic Fibrosis (CF)
    • Gastroparesis
    • Chronic Idiopathic Constipation
    • Irritable Bowel Syndrome
    • PPI non-responsive GERD
  • News
    • Press >
      • ​Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Completion of Enrollment of the Global Phase 2b Study Evaluating Naronapride in Gastroparesis (MOVE-IT)
      • Renexxion Ireland Ltd. Announces Issuance of Fifth New U.S. Patent Covering Novel Crystal Isoform of Naronapride
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Expansion of the Phase 2b MOVE-IT Study of Naronapride in Gastroparesis and Dosing of the First United States Patient
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce FDA Clearance of the Investigational New Drug Application for Naronapride to Treat Gastroparesis and Subsequent Expansion of the Ongoing Phase 2b MOVE-IT Study to the United States
      • Renexxion Ireland’s European Partner, Dr. Falk Pharma GmbH, has Elected PPI-non-responsive Symptomatic GERD as the Second Naronapride Indication to Develop and Commercialize in their Licensed Territories
      • Renexxion to Present at the Oppenheimer 34ᵗʰ Annual Healthcare Life Sciences Conference
      • Renexxion Ireland Ltd. Announces FDA Clearance of Investigational New Drug (IND) Application for Naronapride to Treat PPI-Non-Responsive Symptomatic GERD
      • Renexxion Ireland has Completed a Successful Pre-IND Consultation with the United States FDA for Development of Naronapride for Patients with PPI-non-responsive Symptomatic GERD
      • Renexxion Ireland Announces Issuance of Two U.S. Patents Covering a Novel Crystal Isoform of Naronapride
      • ​Renexxion to Present at the Oppenheimer Healthcare Private Company Showcase​
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Initiation of Phase II Study of naronapride in patients with gastroparesis
      • Renexxion Announces Opening of Investigational New Drug (IND) Application for Naronapride for the Treatment of Gastrointestinal Dysmotility in Cystic Fibrosis Patients
      • Gastrointestinal Biotech Company Renexxion Ireland Announces $100M Investment Commitment
      • Renexxion Ireland Announces Issuance of a New US Patent covering Naronapride, a Clinical Stage Potential Best-in-Class Prokinetic Agent for Gastrointestinal Disorders
      • Renexxion Ireland Ltd. Announces a Licensing and Collaboration Agreement with Dr. Falk Pharma GmbH
  • Contact