Theorem Clinical Research

Bristol-Myers Squibb

TransCelerate releases update on risk-based monitoring initiative

Thursday, January 30, 2014 10:43 AM

In its continued effort to modernize and streamline the way clinical trials are conducted and monitored, TransCelerate BioPharma has providing the first update to its position paper outlining a methodology for risk-based site monitoring (RBM) released in June 2013.

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Transcelerate Biopharma recognizes CCRC, CPI certification for good clinical practice

Wednesday, January 15, 2014 11:19 AM

The Association of Clinical Research Professionals (ACRP) has learned that TransCelerate Biopharma now recognizes certification through the Certified Clinical Research Coordinator (CCRC) and Certified Physician Investigator (CPI) programs of ACRP's affiliate, the Academy of Clinical Research Professionals, as evidence of Good Clinical Practice (GCP) training.

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Molecular Profiles joins consortium to drive pediatric formulation development

Thursday, January 2, 2014 10:30 AM

A collaborative pharmaceutical project focused on improving the pathway for developing pediatric formulations has been given the go-ahead after successfully securing an innovation grant.

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AstraZeneca to acquire Bristol-Myers Squibb share of diabetes alliance assets

Friday, December 20, 2013 11:00 AM

AstraZeneca will acquire the entirety of Bristol-Myers Squibb's interest in the companies' diabetes alliance for $2.7 billion, and up to $1.4 billion in regulatory, launch and sales-related payments. AstraZeneca also has agreed to pay various sales-related royalty payments up until 2025 and may make payments up to $225 million when certain assets are subsequently transferred.

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Taigle, SAFE-BioPharma partner

Friday, December 6, 2013 01:00 PM

Taigle, an Irvine, Calif.-based technology company, has partnered with the SAFE-BioPharma Association, which manages the global SAFE-BioPharma digital identity and signature standard. 

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Bristol-Myers Squibb Foundation awards four grants

Friday, November 15, 2013 01:13 PM

The Bristol-Myers Squibb Foundation marked World Diabetes Day and the third anniversary of its Together on Diabetes initiative by announcing four new grants focusing on the link between type 2 diabetes, depression and distress.

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PhRMA to open Middle East and Africa regional office at DuBiotech, UAE

Wednesday, October 9, 2013 02:09 PM

Pharmaceutical Research and Manufacturers of America (PhRMA) plans to establish its Middle East and Africa regional office within Dubai Biotechnology and Research Park (DuBiotech), a free zone dedicated to facilitating and fostering the growth of the life sciences industry in the UAE and a member of Tecom Investments, a developer and operator of business parks.

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Ambrx names Peter Kiener chief scientific officer

Wednesday, August 28, 2013 02:42 PM

Ambrx, a clinical stage biopharmaceutical company, has appointed Peter Kiener, Ph.D., chief scientific officer. Kiener has experience in the development of next-generation biologic therapeutics, including multi-specific, antibody based biologics, while president, chief executive officer and cofounder of Zyngenia.

Kiener led Zyngenia through its early stages of development, including validating the technology platform, identifying and advancing lead programs and securing Series A funding. Previously, Kiener was the executive vice president and global head of biologics R&D at MedImmune, AstraZeneca's biologics arm. He built protein and antibody engineering capabilities and oversaw the submission of multiple INDs and NDAs. Over the previous 18 years, Kiener held multiple positions at Bristol-Myers Squibb, 10 of which were spent working on biological therapeutics.

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Ashfield names Michael Burman VP Medical Call Center

Monday, August 19, 2013 08:48 AM

Ashfield, part of United Drug, has named Dr. Michael Burman vice president of its Ivyland, Pa-based Medical Call Center. Ashfield Medical Information, formerly Alliance Healthcare, is a provider of medical information and pharmacovigilance call center services to healthcare, biotech and device companies.

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inVentiv Health Clinical expands executive team

Friday, August 9, 2013 02:02 PM

CRO inVentiv Health Clinical has appointed Dawn Anderson president of phase II-IV development, Martin Birkhofer chief medical officer and Richard Shimota chief financial officer.

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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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