Business and People April 2013

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-04-01-2013, Volume 22, Issue 4

Industry news focusing on the people and organizations who work in the clinical trials profession.

People

• INC Research, LLC (Raleigh, NC and Port Adelaide, Australia) announced the promotion of Garth Tierney to Executive Vice President, Asia/Pacific, responsible for driving the strategic development and overall growth of the company's Asia Pacific clinical research operations. INC also announced that James Taylor has joined the company as Vice President, Clinical Development.

Josef von Rickenbach

• Clinical Network Services (CNS) (Brisbane, Australia), a CRO offering integrated development services in the planning, implementation, and delivery of Phase I and II trials, announced that it has appointed ex-Therapeutic Goods Administration toxicologist, Douglas Francis, PhD, as Senior Regulatory Toxicologist to the company's BioDesk product development planning and regulatory affairs service.

Paul Kennedy

• AAHRPP (Washington, DC) President and CEO of the Association for the Accreditation of Human Research Protection Programs, Marjorie A. Speers, PhD, announced that she intends to retire at the end of this year, or when a successor has been named. Speers has led the organization since its founding in 2001, establishing AAHRPP as a champion for quality research and rigorous human research protections worldwide.

Suzanne Gagnon, MD

• Idis (Princeton, NJ) announced the appointment of Suzanne Gagnon, MD, as Chief Medical Officer. Gagnon takes on the responsibility for leading global medical affairs and providing strategic medical and regulatory leadership across all business divisions. She will also oversee global quality assurance and compliance.

• Venn Life Sciences (Dublin, Ireland) appointed Paul Kennedy as Non-Executive Director to the board.

• Premier Research (Philadelphia, PA) announced the addition of four clinicians to key leadership roles in its pediatric and rare disease clinical trial research disciplines. Susan P. Tansey, MBCHB, MRCP, CCST, was named Medical Director, Pediatrics. Ilze Balode, MD, was named Senior Project Manager at Premier Research Europe, based in Latvia. Alison Sampson, PhD, has been named Project Director at Premier Research Europe, based in the United Kingdom. Mary Kay Seeland has been named Director, Clinical Planning and Study Start-Up, based in the United States.

Acquisitions

• PRA (Raleigh, NC) announced that it has acquired privately-held ClinStar, LLC, a clinical research organization managing Phase I-IV clinical research trials in the Russian Federation, Ukraine, Belarus, and the Baltic States. Through its operations in the region, ClinStar provides clinical development services to a wide range of pharmaceutical and biotechnology companies.

• BioClinica, Inc. (Newton, PA) announced that JLL Partners and Ampersand Capital Partners, two middle market private equity firms, have completed their acquisition of BioClinica and CoreLab Partners and have combined the two companies under the name BioClinica.

Alliances

• Xceleron (Germantown, MD), a company in the design and execution of novel clinical investigations using ultra-sensitive analytical technology, has announced a partnership with Kinetigen, a clinical pharmacology consulting firm specializing in pharmacokinetics. The partnership aims to offer drug developers simpler and more robust early clinical investigations.

• InVentiv Health, Inc. (Burlington, MA) announced that it has taken an equity stake in Mytrus, Inc., a company working in virtual clinical trials and technologies such as electronic informed consent to improve trial efficiency.

• Theorem Clinical Research (King of Prussia, PA) expanded its Medidata services partnership by obtaining accreditation for Medidata Balance and Medidata Rave Targeted Source Document Verification services.

Awards

• National Institutes of Health (NIH) (Washington, DC) Director of the Clinical Pharmacology Program, Juan J. L. Lertora, MD, PhD, received the 2013 Pharmaceutical Research and Manufacturers of America (PhRMA) Foundation Award in Excellence in Clinical Pharmacology. The award program, now in its 15th year, honors former foundation grant recipients for outstanding career achievements.

• PAREXEL International Corporation (Cambridge, MA) Chairman and CEO, Josef von Rickenbach, received the Massachusetts Biotechnology Council's Henri Termeer Innovative Leadership Award. The award recognizes an industry executive who has a strong presence and commitment to growth in Massachusetts, actively supports community-based organizations, contributes to science education to prepare the future workforce, and creates a positive work environment that fosters motivation and collaboration. It is named for longtime President and CEO of Genyzme, Henri Termeer.

• ERT (Philadelphia, PA) announced it has been awarded Omega Management Group's NorthFace ScoreBoard (NFSB) Award for consistently delivering outstanding customer service. The award is presented annually to the companies who, as rated solely by their own customers, achieved excellence in customer satisfaction during the prior calendar year.

Company News

• Aptuit, LLC (Greenwich, CT) President and Chief Operating Officer, Stuart Needleman, announced that the company has formed the Aptuit Scientific Advisory Board (SAB) comprised of scientific experts from within the company. The SAB will regularly meet to assess Aptuit's current and long-term scientific capabilities and objectives and will recommend actions.

• Theorem Clinical Research released two site-level reference booklets for clinical research sites that explain and condense critical International Conference on Harmonization guidelines related to good clinical practice for the conduct of trials. A third booklet was previously released and intended for sites seeking to understand the International Organization for Standardization's requirements for medical device trials, "Little Advisor ISO 14155:2011 for Medical Device Trials." All three are available online.

• ERT (Philadelphia, PA) along with pulmonary researchers at the Johns Hopkins University School of Medicine and University of Washington, announced an expansion to the Early Intervention in Cystic Fibrosis Exacerbation Study. An additional 12 investigative sites are now enrolling patients to the randomized study, which was initiated in February 2012. Supported by the National Institutes of Health and the Cystic Fibrosis Foundation, the study will compare standard care to an intervention arm.

• CDISC (Austin, TX) launched the Essential Standards to Enable Learning (ESTEL) initiative of the Learning Health Community (LHC). The CDISC-led ESTEL initiative is the first of several that have grown out of the May 2012 Learning Health System (LHS) Summit, sponsored by the Joseph H. Kanter Family Foundation, which convened a critical mass of key stakeholders representing over 80 organizations across the healthcare spectrum, and achieved multi-stakeholder consensus on a set of 10 LHS Core Values that will underpin a national-scale LHS. The ESTEL initiative of the LHC was launched by CDISC specifically to concentrate on the identification of a minimal set of standards to enable an LHS.

• Pharmaceutical Product Development, LLC (PPD) (Wilmington, NC) announced its bioanalytical operation has been certified by Brazil's Agencia Nacional de Vigilancia Sanitaria, validating that PPD meets the agency's biopharmaceutical safety guidelines and allowing the company to conduct bioanalytical work on its clients' compounds that will be marketed in Brazil.

New Facilities

• IMARC Research (Cleveland, OH), a contract research organization based in Fairview Park, OH, has announced that it is moving its entire operation to a new location at 22560 Lunn Road in Strongsville, OH. IMARC's new space in Strongsville is 23,000-square feet—which is more than a 300% increase over the company's existing space on Mastick Road in Fairview Park, OH. Now with 26 employees, IMARC has experienced double-digit growth over the past two years. This continued growth is expected to create the need for additional staff over the next 12 to 18 months.

• Cenduit, LLC (Durham, NC), global provider of patient randomization and clinical supplies management services, has announced the expansion of its Durham, NC, headquarters and its office in Basel, Switzerland. The expansion adds space to the company's headquarters and triples the size of its office in Basel.