Publications by authors named "Segundo Mariz"

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Navigating the orphan medicinal product designation: Evidence requirements for gene therapies in Europe.
Gloria M Palomo, Tomas Pose-Boirazian, Frauke Naumann-Winter, Enrico Costa, Dinah M Duarte, Segundo Mariz

Mol Ther· June 2025

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Advancing rare disease treatment: EMA's decade-long insights into engineered adoptive cell therapy for rare cancers and orphan designation.
Maria Elisabeth Kalland, Tomas Pose-Boirazian, Gloria Maria Palomo, Frauke Naumann-Winter, Enrico Costa, Segundo Mariz

Gene Ther· July 2024

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The European landscape for gene therapies in orphan diseases: 6-year experience with the EMA Committee for Orphan Medicinal Products.
Gloria M Palomo, Tomas Pose-Boirazian, Frauke Naumann-Winter, Enrico Costa, Dinah M Duarte, Segundo Mariz

Mol Ther· December 2023

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The EMA Assessment of Asciminib for the Treatment of Adult Patients With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase Who Were Previously Treated With at Least Two Tyrosine Kinase Inhibitors.
C Mircea S Tesileanu, Sotirios Michaleas, Rocio Gonzalo Ruiz, Segundo Mariz, Babs O Fabriek

Oncologist· July 2023

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Orphan Medicinal Products for the Treatment of Pancreatic Cancer: Lessons Learned From Two Decades of Orphan Designation.
Jorn Mulder, Tobias van Rossum, Segundo Mariz, Armando Magrelli, Anthonius de Boer

Front Oncol· December 2021

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Haemophilia, state of the art and new therapeutic opportunities, a regulatory perspective.
Francesca Tomeo, Segundo Mariz, Angelo Loris Brunetta, Violeta Stoyanova-Beninska, Karri Penttila

Br J Clin Pharmacol· November 2021

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Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit-The EU Regulator's Perspective.
Maria E Sheean, Frauke Naumann-Winter, Giuseppe Capovilla, Maria Elisabeth Kalland, Eva Malikova, Segundo Mariz

Front Med (Lausanne)· August 2021

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Regulatory Standards in Orphan Medicinal Product Designation in the EU.
Stelios Tsigkos, Segundo Mariz, Maria Elzbieta Sheean, Kristina Larsson, Armando Magrelli

Front Med (Lausanne)· June 2021

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Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases.
Maria E Sheean, Eva Malikova, Dinah Duarte, Giuseppe Capovilla, Laura Fregonese, Segundo Mariz

Drug Discov Today· February 2020

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Defining orphan conditions in the context of the European orphan regulation: challenges and evolution.
Daniel J O'Connor, Maria E Sheean, Matthias P Hofer, Stelios Tsigkos, Segundo Mariz

Nat Rev Drug Discov· July 2019

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Comparative analysis of the scope of European Union paediatric investigation plans with corresponding orphan designations.
Andrea Ecker, Segundo Mariz, Frauke Naumann-Winter, Koenraad Norga, Ingeborg Barisic

Arch Dis Child· May 2018

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Establishing rarity in the context of orphan medicinal product designation in the European Union.
Stelios Tsigkos, Matthias Philipp Hofer, Maria Elzbieta Sheean, Segundo Mariz, Kristina Larsson

Drug Discov Today· March 2018

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Nonclinical data supporting orphan medicinal product designations: lessons from rare neurological conditions.
Maria E Sheean, Violeta Stoyanova-Beninska, Giuseppe Capovilla, Dinah Duarte, Matthias P Hofer, Segundo Mariz

Drug Discov Today· January 2018

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Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe.
Andreas M Farkas, Segundo Mariz, Violeta Stoyanova-Beninska, Patrick Celis, Spiros Vamvakas

Front Med (Lausanne)· May 2017

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Evolving prevalence of haematological malignancies in orphan designation procedures in the European Union.
Benedetta Polsinelli, Stelios Tsigkos, Frauke Naumann-Winter, Segundo Mariz, Bruno Sepodes

Orphanet J Rare Dis· January 2017

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Regulatory watch: The orphan drug pipeline in Europe.
Thomas Morel, André Lhoir, Eline Picavet, Segundo Mariz, Bruno Sepodes

Nat Rev Drug Discov· June 2016

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Worldwide collaboration for orphan drug designation.
Segundo Mariz, James H Reese, Kerstin Westermark, Lesley Greene, Takahiro Goto

Nat Rev Drug Discov· June 2016

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Erratum to: Establishing medical plausibility in the context of orphan medicines designation in the European Union.
Stelios Tsigkos, Segundo Mariz, Jordi Llinares, Laura Fregonese, Stiina Aarum

Orphanet J Rare Dis· October 2015

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Establishing medical plausibility in the context of orphan medicines designation in the European Union.
Stelios Tsigkos, Segundo Mariz, Jordi Llinares, Laura Fregonese, Stiina Aarum

Orphanet J Rare Dis· December 2014

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Use of biomarkers in the context of orphan medicines designation in the European Union.
Stelios Tsigkos, Jordi Llinares, Segundo Mariz, Stiina Aarum, Laura Fregonese

Orphanet J Rare Dis· January 2014

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The development and registration of topical pharmaceuticals.
Christopher J Mugglestone, Segundo Mariz, Majella E Lane

Int J Pharm· October 2012

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European regulation on orphan medicinal products: 10 years of experience and future perspectives.

Nat Rev Drug Discov· May 2011

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Orphan drugs. EU regulations.
Segundo Mariz, Jordi Llinares, Kerstin Westermark

BMJ· January 2011

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Long-term effects of pioglitazone versus gliclazide on hepatic and humoral coagulation factors in patients with type 2 diabetes.
Gabriele Perriello, Simone Pampanelli, Paolo Brunetti, Cinzia di Pietro, Segundo Mariz

Diab Vasc Dis Res· September 2007

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A lifetime modelled economic evaluation comparing pioglitazone and rosiglitazone for the treatment of type 2 diabetes mellitus in the UK.
Dominic P Tilden, Segundo Mariz, Gillies O'Bryan-Tear, Julia Bottomley, Alexander Diamantopoulos

Pharmacoeconomics· March 2007

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