Melanie Sena is community editor of Pharmaceutical Technology.

Melanie Sena

 has appointed Sean Scully as its new president. Scully has been with Fette Compacting America since the company’s inception in 1991. Most recently, he had served as the company’s Senior Vice President since 2008. As president, Scully will oversee the entirety of Fette Compacting’s business interests in the US, Canada, and Puerto Rico.
  
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Fette Compacting America appoints Sean Scully as its new president.

Fette Compacting America Appoints New President

ATHENA, the Advanced Tissue-engineered Human Ectypal Network Analyzer project team, is developing four human organ constructs, the liver, heart, lung and kidney, which are based on a miniaturized platform. Each organ component will be about the size of a smartphone screen, and the whole ATHENA body of interconnected organs would fit on a desk. The project is supported by the Defense Threat Reduction Agency (DTRA).
  
“By creating a holistic dynamic system that more realistically mimics the human physiological environment than static human cells in a dish, we can understand chemical effects on human organs as never before,” said Rashi Iyer, a senior scientist at

(LANL), the lead laboratory on the five-year, $19 million multi-institutional effort. “The ultimate goal is to build a lung that breathes, a heart that pumps, a liver that metabolizes and a kidney that excretes, all connected by a tubing infrastructure much akin to the way blood vessels connect our organs.”

Some 40% of pharmaceuticals fail their clinical trials, Iyer noted, and there are thousands of chemicals whose effects on humans are simply unknown. Providing a realistic, cost-effective and rapid screening system such as ATHENA with high-throughput capabilities could provide major benefits to the medical field, screening more accurately and offering a greater chance of clinical trial success.

Results from the project’s Vanderbilt University effort on the ATHENA perfusion system were presented at the Society of Toxicology meeting by co-principal investigator John Wikswo. The development and analysis of a human liver organ construct, that responds to exposure to a toxic chemical much like a real liver, is described in a presentation reported by Gordon A. Cain, university professor and director of the Vanderbilt Institute for Integrative Biosystems Research and Education (VIIBRE) at Vanderbilt University.
  
  The ATHENA project brings together researchers from LANL, the Vanderbilt Institute for Integrative Biosystems Research and Education (VIIBRE) at Vanderbilt University, Charité Universitätsmedizin,Berlin, Germany, Harvard University, University of California San Francisco, and CFD Research Corporation.

Successful integration of the Charité-developed liver organ construct into the VIIBRE built ATHENA perfusion system was demonstrated recently. The team expects to connect the liver and the heart constructs this winter followed by the lung and finally the kidney.
  
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The Advanced Tissue-engineered Human Ectypal Network Analyzer project team is developing realistic human organs for testing.

Desktop Human Body Developed for Toxicity Testing

, a human gene therapy company, reported the appointment of Eric Goossens as its new COO. Goossens has 15 years of experience in management and leadership for technology-based companies, including the biopharmaceutical industry.

In addition, uniQure appointed Deya Corzo, MD, as vice president, Medical Affairs for the US as of April 1, 2014. Goossens joins uniQure from Dätwyler Pharma Packaging Belgium N.V where he was site director for three years. Corzo previously worked at Celgene, as executive director, Medical Affairs/Oncology from 2012 to 2014.

uniQure appoints a new COO and vice president, Medical affairs.

uniQure Announces Management Changes

, a Freiburg, Germany-based contract research company that offers custom synthesis of APIs and fine chemicals, has announced that it successfully passed an FDA inspection.
  
  The March 2014 inspection for GMP compliance was the fourth in the 17-year history of the company. The inspection examined all quality assurance systems of the company relating to production, equipment,manufacturing facilities, materials, and quality controls. No form 483 was issued, the quality systems were considered acceptable, and the inspection was classified as no action indicated, the company reports.

ChemCon passes its fourth FDA inspection in the 17-year history of the company.

ChemCon Passes its Fourth FDA Inspection

 reported the promotion of three internal managers to head the life-science-tools and consumer health divisions as well as its allergy business unit as part of its “Fit for 2018” program.

Udit Batra, who previously managed Consumer Health, will become president and CEO of the Life Science Tools division, succeeding Robert Yates, who has left the company. Uta Kemmerich-Keil, currently CEO of Allergopharma and head of the global allergy business unit, will succeed Batra in his role as president and CEO of Consumer Health. Kemmerich-Keil will be replaced at Allergopharma by Marco Linari, who was head of the Operating Model within Merck Millipore and Performance Materials. All changes will take effect May 15.

In addition, Merck Serono President and CEO Belén Garijo will take charge of the R&D organization ad interim while the search for a permanent leader for the R&D organization is conducted. Annalisa Jenkins, who served in that role, left the company at the end of March. 

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Merck promotes internal managers to head Merck Millipore and Consumer Health Divisions.

Merck Announces Management Changes

 approved Oralair to treat allergic rhinitis with or without conjunctivitis that is induced by certain grass pollens in people ages 10 through 65 years. Oralair is the first sublingual allergen extract approved in the US.

Oralair is a once-daily tablet that dissolves after it is placed under the tongue. Oralair is started four months before the start of the grass pollen season and continued throughout the season. The first dose is taken at the health care provider’s office, where the patient is to be observed for at least 30 minutes for potential adverse reactions.

Oralair contains a mixture of freeze-dried extracts from the pollens of five grasses, including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy. Oralair is manufactured by Stallergenes S.A. of Antony, France.

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FDA approves Oralair, the first sublingual allergen extract for the treatment of pollen allergies.