Chiltern has appointed Dr John Andrews to the role of director of regulatory affairs for the Americas.
The California-based contract research organisation (CRO) said that Dr Andrews will be responsible for assisting clients with strategic decisions in their approach to develop drugs, biopharmaceuticals and medical devices.
In his new role, Andrews will also be in charge of expanding the company's regulatory affairs department in North and South America.
"With FDA tightening its requirements for new applications and its scrutiny on clinical study safety results, it has become imperative for sponsors to devise unassailable development strategies, in partnerships with their CROs, in order to attain the best possible study outcome, within a predetermined timeframe," Andrews commented.
Patheon is also planning to make some senior management changes following the resignation of its director George Ploder .
The company said its Board of directors is currently in the process of finding a suitable successor to Ploder.
In other news, Hill Top Research , a clinical research services firm, has named Tim Burke executive director of CRO Clinical Operations.
Burke will oversee the development of multi-centre clinical trial management and clinical monitoring services for the company, as well as manage the day-to-day clinical operations activities.
In his new position, he will also be responsible for assuring regulatory compliance of contract research projects.
Burke was previously senior project director at Kendle International, another CRO.
Ohio-based Hill Top Research has five clinical sites located throughout North America where it provides safety, efficacy, sensory, data management, project management and microbiology services for health care companies.
US firm Albany Molecular Research (AMRI) has announced that Prasad S. Raje has assumed leadership responsibility for the company's manufacturing in India and has moved from Syracuse, New York to offices in Mumbai.
Dr Raje joined the company in 2002 as in the chemical development department and subsequently led all technical and commercial operations at the company's Syracuse Research Centre.
Prior to joining AMRI, Dr Raje was a senior research scientist at Abbott Laboratories, near Chicago.
His appointment was announced just as the company completed the acquisition of two pharmaceutical manufacturing sites in Aurangabad and Navi Mumbai, India for $11m (€8m) in cash.
The plants currently manufacture a range of pharmaceutical intermediates and bulk active ingredients.
AMRI also has obtained additional land in Aurangabad and plans to invest around $15m to expand and upgrade its manufacturing capabilities over the next three years.
Meanwhile, Parexel's technology subsidiary Perceptive Informatics revealed last week the appointment of Wade Wirta as vice president of its worldwide Clinical Interactive Voice Response Systems (IVRS) operations.
Wirta was previously director of Pfizer's Supply Chain Informatics group where he was responsible for the IT strategy for supply chain products and services for all phases of clinical drug development.
On the other side of the Atlantic, Microdosing and Phase O studies specialist Xceleron appointed its first chief operating officer last week.
The UK-based company chose Bernard Chan to fulfil the role.
Dr Chan was most recently director of biological manufacturing development at UCB for the past four years.
He also co-founded Eden Biopharm, an international development and manufacturing consultancy.
Also in the news recently, Charles River Laboratories ' CEO James Foster has been named one of the New England regions' Entrepreneurs of the Year by Ernst & Young.
Foster was awarded the honour in the biotech category, joining 14 other regional business leaders chosen for their outstanding leadership withing their industry sector during an awards ceremony held in Boston, Massachusetts recently.
All award recipients were selected by an independent panel of judges composed of past Ernst & Young Entrepreneur Of The Year alumni and given to businessmen who have demonstrated excellence and exceptional success in such areas as innovation, financial performance, and personal commitment to their businesses and communities.