Around the World in 120 Days: Latin America 101 - Opportunities South of the Border

Tuesday, June 17 2014
8:00 am – 10:00 am

Location: MassBio, 300 Technology Square, 8th Floor, Cambridge, MA

South America, Mexico, and Central America are among the leading life sciences emerging markets in the world. Our experts will discuss the latest trends and cover topics ranging through market distinctions, business development, new product launches, clinical trial management, and CROs servicing companies in the region.

You should attend this Forum if you or your company would benefit from learning the latest trends in these dynamic markets. Key discussion points will include:

  • The role and importance of Private Public Partnerships (PPPs) in Latin America. How to materialize PPPs.
  • The role of patients when introducing new and innovative therapeutics in the region
  • The importance of including strong government affairs expertise from the start in your local team
  • Which big pharma/biotechs are striking deals with regional companies and why?
  • What are the barriers (IP, export control, etc.) to entry that U.S. companies need to consider/overcome in order to have successful product launches?
  • What do American companies need to do to partner with regional players and expand their markets?
  • What are the market distinctions among countries and subregions?
  • What are the pros/cons to conducting clinical trials in the region?
  • Are the market opportunities for U.S.–based CROs?

You will leave with a deeper insight and appreciation for these dynamic markets less often factored by life science companies.

Speakers:

  • Jorge G. Guerra, MD, FACP, Executive Director, JG Guerra ClinOps Management, and Director, Business Development, CIDAL (Center for Investigation & Training in Latin America)
  • Federico Lerner, MD, Senior Director of Operations - Latin America, PRA International

Moderator:

  • Pedro Arboleda, MS, MBA, Director, Strategy, Monitor Deloitte

 

 

Bios:

Pedro Arboleda – Director, Strategy, Monitor Deloitte

Pedro Arboleda is a Director at Monitor Deloitte successfully leading life sciences and health care-related commercial strategy projects since 2001 for leading pharmaceutical, biotechnology, medical devices, and health care payer companies as they seek new customers and markets in North America, Europe and emerging economies, such as Mexico, Brazil, and China.

Pedro is currently focused on advising clients on strategic options related to engaging national governments as changes in national health care systems in US and emerging economies take hold, creating complex corporate / marketing strategy and license-to-operate issues. Work has included critical commercial strategy, advocacy, outreach, and stakeholder engagement advisory support. Pedro’s work has been cited in The Economist magazine’s 2007 and 2009 Special Reports. Pedro received an MBA from Cornell University in 1997, a Masters in Latin American Studies from Stanford University in 1995, and a Bachelors of Science in International Relations from Georgetown University in 1991.

Jorge G. Guerra, MD, FACP, Executive Director, JG Guerra ClinOps Management, and Director, Business Development, CIDAL (Center for Investigation & Training in Latin America)

Dr. Guerra’s clinical research and business career spans three decades in leadership roles at global biopharmaceutical companies Merck & Co. and Biogen Idec. He currently provides consulting services to diverse organizations on the entire spectrum of clinical operation functions. He serves as the Chairman, Board of Advisors at TrialNetworks, and is a member of the Board of Advisors at the non-profit organizations SAFE-Biopharma and CISCRP (Center for Information & Study on Clinical Research Participation).

Among his previous roles, Dr. Guerra served as Vice President, Clinical Research Operations - Global Trial Management at Merck & Co. During his twenty-four years at Merck, his major accomplishments included significant contributions to the global execution of all its development programs (small molecules and vaccines); a substantial increase in the participation of emerging markets, particularly Latin America, in clinical research; the successful deployment of several new processes and IT tools; and a lead role in the Site Selection & Patient Recruitment initiative that reduced the median enrollment cycle time by 6 months in both phase 2 and 3 trials.

As Senior Vice President, Global Clinical Development Operations at Biogen Idec, Dr. Guerra was responsible for clinical trial management, clinical data management, clinical business operations, medical writing, country management and field operations, operational excellence and analytics, and Asia-Pacific development strategy. He managed six simultaneous pivotal programs (biologicals and small molecules), four of which ended in regulatory filings. Under his oversight, the company underwent successful sponsor and site inspections, which led to the approval of the blockbuster drug TECFIDERA (dimethyl fumarate). Coincidental with the end of his tenure, Biogen Idec was ranked as the top sponsor in Center Watch’s 2013 Global Sponsor and Investigator Site Relationship Survey. 

Dr. Guerra received his medical degree and trained in Internal Medicine at Universidad Peruana Cayetano Heredia in Lima, Peru. He completed his postgraduate training in Clinical Tropical Medicine and Medical Statistics & Epidemiology at the Hospital for Tropical Diseases and the London School of Hygiene & Tropical Medicine, England.  Before joining the pharmaceutical industry, he served as Associate Professor of Medicine and clinical investigator at his alma mater University Hospital. Dr. Guerra is also the author or co-author of 47 published articles and several book chapters.

Federico Lerner, MD, Senior Director of Operations - Latin America, PRA International

Dr. Lerner oversees all operations for PRA’s Product Registration group in Latin American. During his 17 years in the biopharmaceutical industry, Dr. Lerner has held several executive and senior management positions. Prior to joining PRA, Dr. Lerner was Senior Director for two large global CROs, as well as a manager of phase I services for Edyabe CRO, where he also held the positions of quality assurance and training program coordinator. He was co-investigator for Cartesius Analytical Unit and Miguel Servet Clinical Pharmacology Unit in Sao Paulo, Brazil. He has held several teaching positions at major universities in Argentina and Brazil and published several per review articles in both basic and clinical research.

Born in Buenos Aires, Argentina, Dr. Lerner attended Buenos Aires University Medical School prior to moving to Brazil in 1998. He received a degree in Clinical Pharmacology from Sao Paulo University, and after completing a research program at Cartesius Analytical Unit in clinical pharmacokinetics, moved into the CRO industry. Dr. Lerner is a member of the American College of Clinical Pharmacology, the Drug Information Association, the American Society of Pharmaceutical Physicians and the Argentina Medical Association.

Rogério Vivaldi, MD, MBA, President & CEO, Minerva Neurosciences Inc.

Dr. Rogério Vivaldi is chief executive officer and president of Minerva Neurosciences, Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat patients suffering from neuropsychiatric diseases. Over the past 20 years Rogério has been involved in commercializing around 20 pharmaceutical products addressing a wide range of unmet medical needs, mainly within the Rare Diseases therapeutic area. He most recently served as senior vice president and head of the Rare Diseases business unit at Genzyme, a Sanofi company. Prior to that he led the establishment of Genzyme's business operations in Brazil and served as president of Genzyme Latin America. During his 17 year tenure at Genzyme, he spearheaded the company's patient-centric approach to product development and marketing and he has extensive experience in building relationships with government and regulatory agencies and patient advocacy organizations.

For 18 years Rogério also owned a private medical practice specializing in diabetes and endocrinology care. He received his medical degree from Rio de Janeiro University (UNIRIO) and completed his residency in metabolism and endocrinology at Rio de Janeiro State University (UERJ) and his fellowship at Mount Sinai Hospital Center in New York, Department of Genetics with an emphasis on Gaucher's disease. He completed his M.B.A. at Coppead, Rio de Janeiro Federal University (UFRJ). Rogério was the first Brazilian medical doctor to treat a patient in Brazil with enzyme replacement therapy for Gaucher's disease in 1992.

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