Theorem Clinical Research

Awards & Advancement

Panacea Pharmaceuticals engages Accelovance for clinical development

Wednesday, February 11, 2015 12:46 PM

Panacea Pharmaceuticals, based in Gaithersburg, Md., and Accelovance, a CRO headquartered in Rockville, Md., have established a clinical development services agreement to develop and advance Panacea's oncology immunotherapy pipeline. Accelovance will support Panacea's clinical development strategies by offering scientific/medical and regulatory experience, in addition to providing CRO support through project management, clinical monitoring, data management, biostatistics and safety services for Panacea's clinical trials.

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Quest Diagnostics

Certara promotes Amin Rostami to senior vice president of R&D, chief scientific officer

Thursday, February 5, 2015 01:41 PM

Certara, a global biosimulation technology-enabled drug development and drug safety consulting company, has promoted Amin Rostami, Pharm.D., Ph.D., to senior vice president of R&D and chief scientific officer at Certara. Professor Rostami previously was co-founder and vice president of R&D for Certara’s Simcyp Business Unit.

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Cord Blood Registry forms scientific and medical advisory board

Thursday, February 5, 2015 01:17 PM

Cord Blood Registry (CBR) has announced the establishment of a scientific and medical advisory board (SMAB). Composed of internationally renowned stem cell experts, the SMAB will provide input and guidance to help advance CBR's mission to expand the scope of newborn stem cell therapies that may be available to patients and their families. The founding members of the SMAB are Dr. Charles Cox, Dr. Mahendra Rao, Dr. Leslie Silberstein and Dr. Alan Trounson. Rao will be the inaugural chairman of the SMAB, and he also will be acting as CBR's chief clinical and regulatory advisor.

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Lycera names Paul Sekhri president and CEO

Thursday, February 5, 2015 12:58 PM

Lycera, a biopharmaceutical company developing breakthrough medicines to treat cancer and autoimmune disease, has named Paul Sekhri president, CEO and a member of the board of directors, effective immediately. Sekhri brings more than 25 years of operational experience in the life sciences industry, including business development and strategy, general management, drug development, and commercial strategy.  He succeeds Kathleen M. Metters, Ph.D., who currently serves as senior advisor to the company.

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Inovio appoints Mark Gelder vice president, clinical development

Thursday, January 29, 2015 01:09 PM

Inovio Pharmaceuticals has appointed Mark Stephen Gelder, M.D., as vice president, clinical development. Gelder will be responsible for planning and executing Inovio's clinical development strategy for its immunotherapies against human papillomavirus (HPV)-caused cervical cancer and dysplasia. He will report to Dr. Mark Bagarazzi, Inovio's chief medical officer.

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Dr. Robert Califf named FDA deputy commissioner for medical products and tobacco

Thursday, January 29, 2015 11:02 AM

FDA commissioner Margaret A. Hamburg, M.D., has appointed Robert Califf, M.D., a global leader in cardiology, clinical research and medical economics, as FDA deputy commissioner for medical products and tobacco.  

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Chiltern earns five spots in PharmaTimes Clinical Researcher of the Year finals

Thursday, January 29, 2015 10:47 AM

Chiltern, a global CRO, has earned five nominations in the PharmaTimes Clinical Researcher of the Year finals for the project manager, clinical research associate (CRA) and new CRA categories.

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INC enhances clinical delivery focus with executive leadership promotions

Thursday, January 22, 2015 01:38 PM

INC Research Holdings, a, global phase I to IV CRO based in Raleigh, N.C., has announced the promotions of Alistair Macdonald and Michael Gibertini, Ph.D., to key roles within the C-suite.

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Dr. Paul Janssen Award for Biomedical Research issues 2015 call for nominations

Thursday, January 22, 2015 01:05 PM

The Dr. Paul Janssen Award for Biomedical Research has opened its 2015 call for nominations. This prestigious award recognizes individuals whose scientific research has made, or has the potential to make, significant contributions toward the improvement of human health.

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Continuum Clinical adds Medical Communications executive, expands global presence

Thursday, January 22, 2015 01:00 PM

Continuum Clinical, a healthcare research and communications company, has added U.K.-based industry veteran Elaine Ferguson to its leadership team as the global practice lead, medical communications. The move expands Continuum Clinical’s Medical Communications practice, while also adding to the company’s global presence.

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March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

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Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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