Horacio Plotkin Md Email & Phone Number | -Almost 30 years fighting rare diseases. And still going. -Biotechnology executive with proven leadership skills. Led the clinical development of three drugs approved for rare diseases (Genzyme; Enobia/Alexion; Novo Nordisk) -Started R&D at Retrophin from his kitchen, going from a one-member team to a 40+ member organization. Delineated the current R&D strategy that led to five pre-IND meetings with FDA, the timely full enrollment of a phase 2 study, and the completion of a first in human with a novel compound ahead of schedule, in less than two years; as well as the filling of 2 INDs and 4 orphan designations. -Using innovative enrollment techniques led a team to fully enroll 150 patients in a rare disease study in a record 7 months - Extensive experience in clinical trial development and management, protocol writing and supervision, including phases 1-3 and post-marketing, pharmacokinetics (PK) and drug-drug interaction (DDI) studies for biologicals and small molecules -As part of a natural history study of PMM2-CDG, discovered that those patients frequently have low cortisol levels, putting them at risk of death -Founder and first Medical Director of the Pediatric Bone Diseases Program (Omaha, NE) - Global Medical Lead for the successful BLA submission for Lumizyme for the ERT of Pompe disease (Genzyme Corporation). -Global Medical Lead for the successful BLA submission for Asfotase alfa for the ERT of hypophosphatasia (Enobia/Alexion Pharmaceuticals). -Participated and presented in numerous meetings with regulatory authorities. -Non-clinical hands-on experience with protein separation and development of methods of quantification - Hands-on experience and deep understanding of pharmacovigilance. - Hands-on experience in the development and maintenance of Disease Registries - Extensive leadership and team-building experience. - Experience in due diligence procedures. - Author of eight book chapters in medical textbooks and over 50 scientific articles. - Proven leader with excellent conflict management skills.

Horacio Plotkin Md

-Almost 30 years fighting rare diseases. And still going. -Biotechnology executive with proven lead...
Arlington, Massachusetts, United States

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Horacio Plotkin Md’s Email horacio.plotkin@ppdi.com

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Horacio Plotkin Md’s Location Arlington, Massachusetts, United States

Horacio Plotkin Md’s Current Industry Tbc Fibrous Dysplasia Foundation University Of Nebraska Medical Center

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Work Experience

Tbc

Biotechnology executive

2024-08-01 00:00:00 - Present

Fibrous Dysplasia Foundation

Member, Scientific Advisory Board

2013-01-01 00:00:00 - Present

University Of Nebraska Medical Center

Adjunt Associate Professor of Pediatrics and Orthopedic Surgery

2002-01-01 00:00:00 - Present

Novo Nordisk

VP Medical & Science

2023-03-01 00:00:00 - 2024-08-01 00:00:00

Glycomine

CMO Consultant

2022-10-01 00:00:00 - 2023-03-01 00:00:00

Selecta Biosciences

SVP and Head, Clinical Development

2019-03-01 00:00:00 - 2020-03-01 00:00:00

Moderna

Head of Clinical Development, Rare Diseases

2018-02-01 00:00:00 - 2019-02-01 00:00:00

Ppd

VP and Therapeutic Area Head, Pediatrics and Rare Diseases

2016-08-01 00:00:00 - 2018-02-01 00:00:00

Shire

Global Clinical Development Lead

2016-03-01 00:00:00 - 2016-08-01 00:00:00

Retrophin

Chief Medical Officer

2013-05-01 00:00:00 - 2016-02-01 00:00:00

Alexion Pharmaceuticals

Executive Medical Director, Clinical Research

2012-01-01 00:00:00 - 2013-05-01 00:00:00

Enobia Pharma

Sr Medical Director, Clinical Research

2010-01-01 00:00:00 - 2012-01-01 00:00:00

Genzyme

Medical Director Clinical Research

2007-01-01 00:00:00 - 2010-01-01 00:00:00

Mcgill University

Fellow, Orthopedic Surgery (Metabolic Bone Diseases)

1997-01-01 00:00:00 - 2002-01-01 00:00:00

Yale University School Of Medicine

Fellow, Endocrinology

1996-01-01 00:00:00 - 1997-01-01 00:00:00

Metabolic Research Institute

Fellow, Metabolic Bone Diseases

1993-01-01 00:00:00 - 1996-01-01 00:00:00

Jp Garrahan Hospital

Fellow, Pediatric Endocrinology

1992-01-01 00:00:00 - 1993-01-01 00:00:00

Teodoro Alvarez Hospital

Resident, Pediatrics

1988-01-01 00:00:00 - 1992-01-01 00:00:00

Skills

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Languages

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FAQ About Horacio Plotkin Md

Horacio Plotkin Md is located at
Arlington, Massachusetts, United States

Horacio Plotkin Md is a -Almost 30 years fighting rare diseases. And still going. -Biotechnology executive with proven leadership skills. Led the clinical development of three drugs approved for rare diseases (Genzyme; Enobia/Alexion; Novo Nordisk) -Started R&D at Retrophin from his kitchen, going from a one-member team to a 40+ member organization. Delineated the current R&D strategy that led to five pre-IND meetings with FDA, the timely full enrollment of a phase 2 study, and the completion of a first in human with a novel compound ahead of schedule, in less than two years; as well as the filling of 2 INDs and 4 orphan designations. -Using innovative enrollment techniques led a team to fully enroll 150 patients in a rare disease study in a record 7 months - Extensive experience in clinical trial development and management, protocol writing and supervision, including phases 1-3 and post-marketing, pharmacokinetics (PK) and drug-drug interaction (DDI) studies for biologicals and small molecules -As part of a natural history study of PMM2-CDG, discovered that those patients frequently have low cortisol levels, putting them at risk of death -Founder and first Medical Director of the Pediatric Bone Diseases Program (Omaha, NE) - Global Medical Lead for the successful BLA submission for Lumizyme for the ERT of Pompe disease (Genzyme Corporation). -Global Medical Lead for the successful BLA submission for Asfotase alfa for the ERT of hypophosphatasia (Enobia/Alexion Pharmaceuticals). -Participated and presented in numerous meetings with regulatory authorities. -Non-clinical hands-on experience with protein separation and development of methods of quantification - Hands-on experience and deep understanding of pharmacovigilance. - Hands-on experience in the development and maintenance of Disease Registries - Extensive leadership and team-building experience. - Experience in due diligence procedures. - Author of eight book chapters in medical textbooks and over 50 scientific articles. - Proven leader with excellent conflict management skills.

Horacio Plotkin Md currently works in the Tbc | Fibrous Dysplasia Foundation | University Of Nebraska Medical Center |

No Languages Available

Horacio Plotkin Md has prior
experience in the following industries:
Novo Nordisk | Glycomine | Selecta Biosciences | Moderna | Ppd | Shire | Retrophin | Alexion Pharmaceuticals | Enobia Pharma | Genzyme | Mcgill University | Yale University School Of Medicine | Metabolic Research Institute | Jp Garrahan Hospital | Teodoro Alvarez Hospital

Horacio Plotkin Md has the following professional experience:
Tbc | Fibrous Dysplasia Foundation | University Of Nebraska Medical Center | Novo Nordisk | Glycomine | Selecta Biosciences | Moderna | Ppd | Shire | Retrophin | Alexion Pharmaceuticals | Enobia Pharma | Genzyme | Mcgill University | Yale University School Of Medicine | Metabolic Research Institute | Jp Garrahan Hospital | Teodoro Alvarez Hospital

You can view Horacio Plotkin Md’s LinkedIn profile at LinkedIn URL

Horacio Plotkin Md’s work email
addresses are
horacio.plotkin@ppdi.com

Tbc | Fibrous Dysplasia Foundation | University Of Nebraska Medical Center |