Biosimilars Latam 2017 speakers

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Daniel Alvarez

Pfizer USA

Senior Director- Asset Lead Biosimilars Research Development Unit

Daniel Alvarez, M.D. Senior Director. At Pfizer Inc. is currently a Development Asset Lead in the biosimilar program at Pfizer and has worked in the biosimilar space since 2012. Daniel joined the pharmaceutical industry in 2005, and held previously positions of increasing responsibility at Schering Plough and Wyeth. He has worked in Ph1-4 clinical trials in development in the areas of HIV, Hepatitis C, Psoriasis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and opioid induced constipation. He has participated as the medical expert in regulatory with Enbrel in the EU and Japan. Daniel serves in the Immunosafety Council, the Pfizer Hepatic Injury Council and is member of the Hepatic Injury Advisory Panel. He is one of the Pfizer representatives in the Translational Team and previously also in the Hepatotoxicity Working Group, both part of the Predictive Testing Safety Consortium under the umbrella of the C-PATH Institute in collaboration with the FDA. He also was the Pfizer clinical representative in the PML consortium.

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Julio Sánchez y Tépoz

Cofepris, México

Comisionado Federal

 Graduate in Law from the Escuela Libre de Derecho of Puebla, Mexico; with studies in Economic Development from the Complutense University of Madrid, Spain. He has mainly worked in the administration of regulatory bodies such as the Federal Commission of Economic Competition, the Federal Consumer Protection Agency and the Commission for the Protection against Sanitary Risks (COFEPRIS), where he has held various positions. In 2011, Sánchez y Tépoz joined COFEPRIS as Chief of Staff to the Federal Commissioner. He was responsible for implementing the institution’s comprehensive administrative simplification program. In July 2012, he was appointed Health Promotion Commissioner within the institution. In charge of being the central contact with the regulated industry, directing generic drug entry projects, releasing innovative molecules and designing processes to improve customer service. On March 7, 2016, President Enrique Peña Nieto appointed him Federal Commissioner for Protection against Sanitary Risks (COFEPRIS).

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Guillermo Caletti

Boehringer Ingelheim, México

Head of Clinical Operations

 Guillermo Caletti is Head of Clinical Operations for Mexico, Central America and Caribbean at Boehringer Ingelheim, and has over 20 years’ experience in the field of clinical research. He is Medical Doctor with clinical specialty in Gastrointestinal Surgery, with a Diploma in Clinical Pharmacology and a Master Degree in Sciences focused on Clinical Research. He has been working for Pharmaceutical firms, Contract Research Organizations and Clinical Sites as decision making executive leading initiatives to foster Clinical Research in Mexico and Latin America as a whole. His experience in Clinical Research includes clinical trials for Drug development and Medical Devices in all relevant therapeutic areas.

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Juan Luis Fuentes

Sandoz, México

Legal & Compliance Head

 Venezuelan lawyer, specialized in corporate, commercial and labor law, with more than 16 years of experience in corporations, both family and multinational companies, in consumer/retail/wholesale, distribution, services, franchise systems and since 2009 in the pharmaceutical industry, especially within the area of Legal services, litigation, intellectual property and Compliance. In 2003 he succeeded in establishing all the legal framework for trademarks, contracting and procedures of a recognized pharmacy chain in Venezuela, in 2006 he joined Brinks Venezuela, as the main responsible for consultancy, litigation (civil, criminal and labor) and collective bargaining, managing to make significant changes to the labor processes in the company and reduce litigation in more than 50%, in 2009 enters Roche Venezuela as Legal and Chief compliance Manager, where he had the opportunity to implement the compliance program within the organization, especially the Policy for interactions with healthcare professionals; in 2012 joins Novartis Venezuela to create the Legal and Compliance Direction, which organized as an area of corporate services for all Group Divisions (Oncology, OTC, vaccines, Sandoz Alcon), including not only legal and Compliance, but communications ( internal and external) and public affairs, repositioning the company’s image as a healthcare partner among main stakeholders, structure that remains until now; since January 2015 is responsible for the area of Legal and Compliance to Sandoz Mexico, where he had the opportunity to relaunch the entire compliance program based on self-management, efficiency and risk management, and establishing a new level of legal services in the area positioning as a reliable as a business partner. 

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Juan Pablo Acosta Martinez

Sartorius, Mexico

Business Development Manager Biosimilars and Senior Application Specialist Purification

 Juan Pablo has more than 10 years of experience in bioprocess development. He started his career in Sartorius as a Project Manager responsible for all project activities in the field of Virus and Contaminant Clearance. Later he became the Manager of the Process Development team in Europe working closely with end–user process development groups to help them create and optimise their processes early on in development. In his current role Juan Pablo is part of the Latin American organization focused on the development of complete biosimilar platforms as well as heading the local Purification team.

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