Business and People: May 2015


Applied Clinical Trials

New faces among the Pharma Industry rise the ranks.

People News

Merck Serono, the biopharmaceutical business of Merck, today announced the appointment of Alise Reicin, MD, as Senior Vice President, Head of Global Clinical Development.  Dr. Reicin brings extensive research and early/late clinical development expertise to Merck Serono, including experience in Oncology and Immunology. She is an accomplished pharmaceutical executive with strong leadership ability, having served as a Vice President in various capacities across R&D at MSD (Merck Sharp & Dohme) for the last 10 years.

Profil Institute for Clinical Research, Inc., an early engagement clinical research organization (CRO) focused on diabetes, obesity and NAFLD/NASH, announced today the appointment of Dr. Michael Trautmann as Senior Director of Drug Development Services and Dr. Gordon Brandt as Senior Director of Clinical Development and Regulatory Affairs to its clinical development leadership team. 

Dr. Trautmann joins Profil Institute overseeing drug development services. He is working with clients globally to build strategic clinical development programs from early engagement assessment and planning and creation of compound-specific scientific advisory boards through the completion of multi-site clinical trials. Dr. Brandt joins the company overseeing regulatory services and consulting, including evaluation of IND/CTA and NDA/ANDA readiness, managing all regulatory steps from submission through clinical study reports, and representing clients at FDA and EMA meetings.

In a recent meeting in Annapolis, Maryland, the Leadership Council elected three new members by unanimous vote. These members were selectively nominated based on their involvement with the organization, executive experience in the clinical research industry, and capacity to aptly represent the interests of clinical research sites globally. The newest additions to the SCRS Leadership Council include Michael Koren, M.D., the CEO and Investigator at Jacksonville Center for Clinical Research,Fabian Sandoval, M.D., CEO and Medical Director at Emerson Clinical Research Institute, and David Vulcano, L.C.S.W, M.B.A., C.I.P, R.A.C, AVP and Responsible Executive for Clinical Research Clinical Services Group at HCA.

BioClinica announced its next stage of evolution with the appointment of Mukhtar Ahmed President of its Global eClinical Business Unit, effective immediately. Ahmed joins the company from Oracle Corporation where he served as VP and Contract Research Organizations such as Medidata. With the appointment of Ahmed, BioClinica has an opportunity to emerge out as a true third and be among its main competition. 

Gary A. Puckrein, PhD, president and CEO of the National Minority Quality Forum (NMQF), presented an award to John Castellani, president of the Pharmaceutical Research and Manufacturers of America (PhRMA), for his demonstrated leadership to increase diversity in clinical trials. On behalf of PhRMA, and in conjunction with NMQF, Castellani spearheaded the “I’m In” campaign to build awareness, start conversations, and increase diversity in clinical trials, especially among African Americans, Asian Americans, and Hispanic populations.

ERT, a global solution provider for high-quality patient safety and efficacy endpoint data collection, today announced an expansion to its Executive Management team. Andrea Valente has been named Executive Vice President and Chief Development Officer. Andrea comes to ERT with over 20 years of professional services, product development and sales leadership experience, including her most recent role as Chief Operating Officer of PHT Corporation. ERT acquired PHT in May 2015.


Business/Awards News

PAREXEL International Corporation, a global biopharmaceutical services provider, today announced that Partnerships in Clinical Trials named PAREXEL’s Drew Garty, Senior Director, Product Management, the 2015 Clinical Innovator of the Year.  The honor recognizes Mr. Garty’s leadership of the product development team for the Company’s Perceptive MyTrials® Data-Driven Monitoring solution.

PPD received a Ragan Employee Communications Award for best article series for a collection of stories highlighting employees’ personal experiences with clinical trials. The series, titled “It’s Personal to Us,” featured monthly stories highlighting PPD employees who have participated in clinical trials. The campaign’s goal was to motivate employees by sharing the personal stories of struggle, hope and triumph that their colleagues had experienced, further engaging a workforce already passionately committed to finding life-saving medicines.

Quintiles, a biopharmaceutical services company, has been named to the InformationWeek Elite 100, a ranking of the top business technology innovators in the U.S.  In compiling the InformationWeek Elite 100, the publication tracks the technology-based investments, strategies and results of some of the best-known organizations in the country.  Unique among corporate rankings, the Elite 100 spotlights the power of business technology innovation.  Quintiles was previously named to the InformationWeek 500 for five consecutive years.

Certara®, the global biosimulation technology-enabled drug development consultancy, today announced that its ClinGenuity company has been named a “Cool Vendor” in Gartner, Inc.’s 2015 Life Sciences report1. ClinGenuity was acquired by Synchrogenix, Certara’s regulatory writing company, in January 2015.

Rho, a contract research organization focused on bringing new products to market through a full range of product development services, has recently been recognized by Trust Across America-Trust Around the World, a collaborative initiative aimed at rebuilding trust in American business, by receiving the Edward Marshall Culture Award. Part of the organization’s North American Trust Award, this honor recognizes Rho for the company’s collaborative, team-based trust culture. Rho is one of 12 companies featured in a recent issue of the organization’s quarterly digital magazine, TRUST!, dedicated to helping leaders and organizations place trust on their strategic agenda.

CluePoints, a provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, today announced that the United States Patent and Trademark Office has granted a Notice of Allowance for Application No. 13/452,338, a patent which covers the company's award-winning SMART™ engine. The patent provides broad coverage for CluePoints' proprietary methodology that supports a risk-based approach to data monitoring in clinical trials. The SMART engine is central to CluePoints' CSM solution which uses statistical methodology to identify unexpected or unusual patterns in clinical trial databases.



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