Miguel A. Lopez Toledano
Medical Director, CMDA at Neurelis, Inc.- Claim this Profile
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Bio
Experience
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Neurelis, Inc.
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United States
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Medical Director, CMDA
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Oct 2023 - Present
United States
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Director Project Management
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Feb 2022 - Oct 2023
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Medical Science Liaison
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Jul 2020 - Mar 2022
Florida, United States
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Senior Pharmaceutical Project Manager/Scientific Affairs
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Jul 2019 - Jul 2020
West Palm Beach, Florida Area
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Micelle BioPharma
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United States
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Pharmaceutical Manufacturing
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Scientific Affairs / Project Management
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Aug 2018 - Jun 2019
Riviera Beach - Responsible for Scientific Affairs, reporting to the CEO. Creation of SOPs and processes for publication planning, grant writing, and evaluation, signing official for grant submission, contacting and contracting Key Opinion Leaders, developing internal and external communications, scientific publications and assistance to meetings and supporting marketing related-activities, as well as in the scientific evaluation of new business opportunities. - Responsible for Clinical and Pre-Clinical… Show more - Responsible for Scientific Affairs, reporting to the CEO. Creation of SOPs and processes for publication planning, grant writing, and evaluation, signing official for grant submission, contacting and contracting Key Opinion Leaders, developing internal and external communications, scientific publications and assistance to meetings and supporting marketing related-activities, as well as in the scientific evaluation of new business opportunities. - Responsible for Clinical and Pre-Clinical Development. involving the design of the protocols for pre-clinical studies (GLP for toxicity and non-GLP for proof of concept, with key interactions with the most important key opinion leaders in the specific areas in different sites in the US, Canada, Europe and Asia)and then design and implementation of early phase and proof of concept clinical trials (Phase 1 and 2). - Key role in assisting and coordinating phase III protocol writing, investigator brochure, and scientific reports in all regulatory communications with the FDA - Project Leader to track clinical, manufacturing, and laboratory activities for Investigational New Drug (IND) and provided clinical support to generate the FDA End of Phase 2 meeting briefing package Show less
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Sancilio and Company
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Senior Scientist/Project Manager
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Apr 2014 - Aug 2018
Riviera Beach, FL, USA - Project management and coordination between CDMA, Formulation, Analytical and manufacturing. - Key role in phase II clinical trial in Sickle Cell Disease (orphan condition, 67 patients), including idea generation, protocol development, implementation, execution, on-site monitoring and data analysis and interpretation. - As Pre-clinical Study Lead, successfully managed 8+ preclinical trials under GLP or in collaboration with High Education Research Institutions. - Responsible of SCI’… Show more - Project management and coordination between CDMA, Formulation, Analytical and manufacturing. - Key role in phase II clinical trial in Sickle Cell Disease (orphan condition, 67 patients), including idea generation, protocol development, implementation, execution, on-site monitoring and data analysis and interpretation. - As Pre-clinical Study Lead, successfully managed 8+ preclinical trials under GLP or in collaboration with High Education Research Institutions. - Responsible of SCI’ Scientific Affairs, involving the creation of SOPs and processes for publication planning, grant writing and evaluation, acting as the company’s signing official for grant submission, contacting and contracting Key Opinion Leaders, developing internal and external communications and supporting marketing related-activities, as well as in the scientific evaluation of new business opportunities in collaboration with the Business Development team. - Author of two publications in peer-reviewed journals and four abstracts at scientific meetings. Formal teaching includes the implementation and delivery of the course “Drug Development and Regulation” in collaboration with Florida Atlantic University for 2 consecutive years. Show less
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University of Miami
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United States
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Higher Education
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700 & Above Employee
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Affiliated Assistant Professor
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Apr 2011 - Mar 2016
Miami, FL, USA Affiliated Assistant Professor at the Psychiatry and Behavioral Sciences in the Leonard M. Miller School of Medicine - Collaboration in the study of non-coding RNA involvement in BDNF expression and its application on neurodegenerative disorders.
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Florida Atlantic University
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United States
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Higher Education
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700 & Above Employee
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Research Assistant Professor
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Feb 2011 - May 2014
5353 Parkside Drive, Jupiter, FL, 33458 - Strong expertise in the fields of neural stem cells, neurodegenerative disorders and cancer, resulting in a total of two publications in high impact journals, three meeting communications and one patent. - Formal teaching included the implementation of the course “Research in Neuroscience” and participation in several seminars. - Mentoring and supervising of a total of eight undergraduate and graduate students.
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The Herbert Wertheim UF Scripps Institute for Biomedical Innovation & Technology
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Biotechnology Research
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100 - 200 Employee
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Staff Scientist
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Oct 2010 - Feb 2011
Jupiter, FL. USA - High level expertise in the fields of neurogenesis, imaging, RNAi and AAV gene expression in vivo in several mouse models of Alzheimer’s disease, resulting in a total of three meeting communications and four publications in high impact journals such as The Journal of Neuroscience and Nature Biotechnology. - Collaboration with other scientist in the fields of neurogenesis, RNAi, clinical depression and cancer, and several scientific collaborations in research projects of more than USD… Show more - High level expertise in the fields of neurogenesis, imaging, RNAi and AAV gene expression in vivo in several mouse models of Alzheimer’s disease, resulting in a total of three meeting communications and four publications in high impact journals such as The Journal of Neuroscience and Nature Biotechnology. - Collaboration with other scientist in the fields of neurogenesis, RNAi, clinical depression and cancer, and several scientific collaborations in research projects of more than USD 3,000,000 in lab grant funding.
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Research Associate
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Aug 2008 - Sep 2010
Jupiter, FL, USA - High level expertise in the fields of neurogenesis, imaging, RNAi and AAV gene expression in vivo in several mouse models of Alzheimer’s disease, resulting in a total of three meeting communications and four publications in high impact journals such as The Journal of Neuroscience and Nature Biotechnology. - Collaboration with other scientist in the fields of neurogenesis, RNAi, clinical depression and cancer, and several scientific collaborations in research projects of more than USD… Show more - High level expertise in the fields of neurogenesis, imaging, RNAi and AAV gene expression in vivo in several mouse models of Alzheimer’s disease, resulting in a total of three meeting communications and four publications in high impact journals such as The Journal of Neuroscience and Nature Biotechnology. - Collaboration with other scientist in the fields of neurogenesis, RNAi, clinical depression and cancer, and several scientific collaborations in research projects of more than USD 3,000,000 in lab grant funding.
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Delegación del Gobierno de la Junta de Andalucía en Sevilla
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Spain
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Government Administration
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300 - 400 Employee
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Researcher - Assistant Professor
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Nov 2006 - Dec 2007
Cádiz, Spain - Exceptional technical expertise in the fields of neurogenesis, histology, imaging, microscopy and molecular biology applied to the neuroscience filed, resulting in a total of two publications in high impact journals, seven meeting communications and one patent. Collaboration in research projects of more than 50,000 €. - Formal teaching included different subjects in “Physiology” for the School of Medicine and Nursing, and the supervision of two graduate students under the “Erasmus”… Show more - Exceptional technical expertise in the fields of neurogenesis, histology, imaging, microscopy and molecular biology applied to the neuroscience filed, resulting in a total of two publications in high impact journals, seven meeting communications and one patent. Collaboration in research projects of more than 50,000 €. - Formal teaching included different subjects in “Physiology” for the School of Medicine and Nursing, and the supervision of two graduate students under the “Erasmus” program. Show less
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Columbia University Irving Medical Center
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United States
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Hospitals and Health Care
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700 & Above Employee
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Postdoc
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2001 - 2006
Manhattan, New York, NY, USA - Groundbreaking applications of neural stem cells expertise to the Alzheimer’s disease field, resulting in a total of four publications in high impact journal, six meeting communications and the opening of a new field of study in the understanding of the disease. In this period, I collaborated in research projects of more than 1,500,000. $ funding - This period of time provided a total of four publications in high impact journals.
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Hospital Ramón y Cajal
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Research
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500 - 600 Employee
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Graduate Student
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Jan 1993 - Jun 2001
- Pioneer in the isolation and characterization of neural stem cells in murine and human brain samples, as well as the mechanisms of neural stem differentiation, resulting in a total of eight publications in high impact journals and thirteen meeting communications. - This period of time provided a total of eight scientific publications in high impact journals.
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Education
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Universidad Complutense de Madrid
Ph.D., Neurosciences -
IMQ Iberica Business School and Fundacion UNED
Master of Business Administration - MBA, Business -
Universidad Complutense de Madrid
Certificate of Pedagogic Aptitude (Certificado de aptitud pedagógica), Education in Biology and Geology -
Universidad Complutense de Madrid
Bachelor, Biology -
Instituto Bachillerato Butarque
BUP, Ciencias -
Colegio Calderón de la Barca
EGB