DIA Biosimilars 2013

Awards & Advancement

Intarcia creates vice president and global head of regulatory affairs

Thursday, July 18, 2013 10:02 AM

Biopharmaceutical company Intarcia Therapeutics has hired Dr. Eddie Li to the newly created position of vice president and global head of regulatory affairs. Li brings more than 20 years of experience in regulatory affairs to Intarcia and will be a member of the executive team overseeing the advancement of ITCA 650 (continuous subcutaneous delivery of exenatide) toward successful registration in key markets around the world. ITCA 650 is the company's diabetes drug candidate currently in global phase III clinical trials for the treatment for type 2 diabetes.

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Cenduit: Now with Patient Reminders

Flint D. Besecker joins Kinex as chief financial officer

Tuesday, July 16, 2013 11:00 AM

Kinex Pharmaceuticals, a specialty biotech focused on the development and commercialization of next generation oral therapies for cancer diseases, has appointed Flint D. Besecker to its executive team as chief financial officer and executive vice president. Besecker will have primary responsibility over all non-scientific aspects of Kinex, reporting to Kinex's chief executive officer, Dr. Johnson Lau. Flint has been an investor and board director of Kinex since 2011.

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CRF Health – eCOA Forum

Aesica appoints two business development managers

Monday, July 15, 2013 01:32 PM

Aesica, a global contract development and manufacturing organization (CDMO), has appointed Sven Thomas and David Ross business development managers. They will ensure potential customers are aware of how their manufacturing and development needs can be supported.

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Marken appoints general manager, China

Thursday, July 11, 2013 08:15 AM

Marken, a global clinical supply chain solutions provider, has appointed Joan Yan general manager for its Beijing office.  Yan will be responsible for the logistics operations in China and the new depot facility recently commissioned for the GMP storage and distribution of drug product and ancillary materials.

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KJT Group names director of Health Outcomes

Wednesday, July 10, 2013 04:19 PM

KJT Group, a life sciences market research and insight consultancy firm, has named Arun Changolkar, Ph.D., M.B.A., director of Health Outcomes Research,  its life sciences research and consulting organization.

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Celsion reappoints Jeffrey W. Church CFO

Tuesday, July 9, 2013 01:34 PM

Biopharmaceutical Celsion has announced Jeffrey W. Church, senior vice president, will resume the role of chief financial officer, a position he held prior to his promotion to senior vice president in July 2011.  In this position he will retain responsibility for corporate investor relations.

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Icon appoints Professor Brendan Buckley chief medical officer

Tuesday, July 9, 2013 10:33 AM

Global CRO Icon has appointed professor Brendan Buckley chief medical officer. Professor Buckley will be Icon’s lead medical expert, representing the company’s position on scientific, ethical and medical governance matters and provide guidance and oversight to the medical and scientific groups across Icon.

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Alliance for Biosecurity elects new co-chairs

Wednesday, July 3, 2013 02:24 PM

The Alliance for Biosecurity, a collaboration among pharmaceutical and biotechnology companies, has elected Anders Hedegaard, president and chief executive officer of vaccine-focused biotechnology Bavarian Nordic, and Elizabeth Posillico, Ph.D., president and chief executive officer of antibody therapeutics developer Elusys Therapeutics, its new co-chairs.

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MicroConstants expands biomarker testing and analysis services

Wednesday, July 3, 2013 02:23 PM

MicroConstants, a CRO specializing in regulated bioanalysis and DMPK, has appointed Doinita Serban, Ph.D., director of biomarker research to oversee the expansion of biomarker testing and analysis services for preclinical and clinical diagnostic research. Doinita's experience with biomarker assay development, validation and profiling of disease panels, coupled with the implementation of the Luminex platform, will enable MicroConstants to broaden its biomarker analysis capabilities to include additional assay formats, such as multiplex immunoassays, gene expression and profiling assays.

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The Royal Liverpool University Hospital achieves highest level of accreditation

Wednesday, July 3, 2013 02:20 PM

The Covance-Royal Liverpool University Hospital Clinical Research Unit (the Royal)—has become the first National Health Service (NHS) facility in England to be granted Medicines and Healthcare products Regulatory Agency (MHRA) standard and supplementary phase I accreditation.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

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October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
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September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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