Geoff Owen has been named senior vice president, global business development, for Quintiles’ Commercial business. Mr. Owen will lead and coordinate worldwide business development activities and will be responsible for global, multi-country and risk-based commercial partnerships. The Commercial group has 10,000 employees in 30 countries.

Mr. Owen began his career at Quintiles in the Commercial group (formerly Innovex), focusing on structuring large commercial services projects. He was a founding member of NovaQuest, Quintiles’ partnering unit, where he worked for 10 years, building financial and service partnerships with life science companies. Prior to Quintiles, he worked at The Wilkerson Group, a consultancy that provided strategy, marketing and business development advisory services to the healthcare industry.

“We have broadened our strong commercial business to respond to the urgent partnering needs of our customers," Owen said. “Quintiles’ commercial partnering model refines the more traditional contract sales organization structures and capabilities of the past in order to align incentives, manage risk, increase productivity, overcome complexity and demonstrate measurable results for products and partners.”

Cellceutix Corp. has concluded an agreement with Formatech, Inc. to formulate Kevetrin for a Phase I study. The terms of the agreement were not disclosed. Kevetrin will be presented as a lyophilized powder for reconstitution in saline solution at the time of use. The drug is being developed to treat drug resistant cancers.

"This agreement allows us to stay on track for our IND filing," said George Evans, chief executive officer of Cellceutix. "Formatech is a quality formulator and has been very flexible and responsive in meeting our needs."

"We are very pleased to have been selected by Cellceutix to participate in this exciting research effort," said Indu Isaacs, Ph.D., chief executive officer of Formatech. "We look forward to helping Cellceutix achieve its goal of reaching Phase I with Kevetrin as soon as possible."

Additionally, Formatech has selected Tracon Pharmaceuticals’ TRC102 clinical product as the next candidate for its Fillanthropy Program. Under this program, Formatech donates the services to aseptically fill and finish one lot of the drug candidate to support Tracon’s upcoming trials.

“TRC102 is a small molecule inhibitor of DNA base excision repair that shows very promising results in animal models and cancer patients when administered in conjunction with chemotherapeutic agents such as Temodar and Alimta,” said Jeffrey Bernard, Formatech’s director of business development. “This compound appears to potentiate chemotherapeutic efficacy as well as prevent drug resistance. We’re excited to play a role in the development of this beneficial compound.”

“We are pleased to be able to work with Formatech, one of the leaders in the field of drug product formulation and manufacture,” said Charles Theuer, Tracon’s president and chief executive officer. “We are deeply appreciative that their Fillanthropy Program will allow us to continue our Phase I study of TRC102 in combination with Temodar for advanced cancer patients, and to initiate a Phase II study of TRC102 in combination with Alimta for patients with lung cancer.”

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Nicholas A. LaBella Jr., MS, RPh, has joined Insmed as chief scientific officer, a newly-created position on the executive team. Mr. LaBella will oversee the scientific and regulatory analysis related to the company's ongoing strategic review. He reports to Dr. Melvin Sharoky, Insmed's chairman.

Mr. LaBella has approximately 30 years of pharmaceutical industry experience, including drug development, clinical operations and regulatory affairs. Most recently, he served as vice president of development and regulatory affairs at Cardiokine, Inc., a privately-held specialty pharmaceutical company.

"Nick's extensive track record in drug development, clinical operations and regulatory affairs should significantly benefit our strategic review process," said Dr. Melvin Sharoky, Insmed's chairman. "Nick recently served as a scientific consultant to Insmed and his counsel has been instrumental in our scientific evaluations.As we continue our review of late-stage development assets, adding Nick to the internal management team should further streamline the review process and add greater efficiency to the scientific and regulatory analysis of each asset."

DPT Laboratories has announced plans to restructure its facilities, creating three new Centers of Excellence, each focusing on a different area of expertise: Sterile & Specialty Products, Semi-solids & Liquids, and R&D.

“We feel each of these Centers of Excellence will provide our clients with access to experienced personnel who are experts in their field and who will provide comprehensive development and manufacturing services,” said Paul Johnson, president and chief operating officer of DPT.

DPT Laboratories in Lakewood, NJ is home to The Center for Sterile & Specialty Products. This center specializes in development and aseptic manufacturing of clinical trial material and commercial scale products to meet sterile requirements. The 175,000-sq.-ft. site recently underwent a multimillion-dollar transformation to provide state-of-the-art aseptic processing suites and filling equipment.

The Center for Semi-solids & Liquids in San Antonio, TX will provide cGMP pilot, clinical and commercial scale manufacturing for prescription and OTC products. The center also includes a dedicated cGMP aerosol and pMDI manufacturing facility. A multi-million-dollar investment was also made to this center to improve efficiency and increase capacity.

DPT’s Center for R&D in San Antonio provides pharmaceutical development services to include pre-formulation and formulation development as well as analytical development services. This center will perform R&D activities and support technical transfers to the applicable manufacturing center of excellence.

“We are committed to excellence and investing in our future. Our goal is to provide our clients the most efficient and the best development and manufacturing services,” said Mr. Johnson. “These strategic changes reflect our mission of providing enhancements to service, innovation, and technology for our customers as we move into our next strategic plan.”

Teva Pharmaceutical Industries has bid to acquire Germany-based generic drug manufacturer Ratiopharm, for an estimated $5.0 billion. The acquisition will provide Teva access to Germany’s generics market — the second largest in the world. Teva is currently holds fourth place in Germany's generics market, but the addition of Ratiopharm will put it at #2. Analysts suggest the takeover would move Teva's global generics market share to around 19%, widening the gap over its closest competitor Novartis's Sandoz unit, at about 11%.

Shlomo Yanai, Teva’s president and chief executive officer, said, “This is an important acquisition for Teva. This transaction is perfectly aligned with our long-term strategy in which Europe is an important pillar and growth driver. Ratiopharm will provide us with the ideal platform to strengthen our leadership position in key European markets, most notably in Germany, as well as rapidly growing generic markets such as Spain, Italy and France."

A Teva statement said the company was valuing Ratiopharm’s portfolio of 500 molecules as well as its background in biosimilars, a field where it has several products in late-stage development. The combined company’s 2009 revenues would have been $16.2 billion, and would have 40,000 employees, with 18,000 in Europe. Teva expects to pare out $400 million in operating costs within three years. The transaction is expected to close by the end of 2010.

John E. Murphy has been appointed head of clinical analytics within Quintiles’ consulting business. Mr. Murphy will help pharmaceutical and clinical scientists with strategies for translational and evidence-based medicine. He is currently directing development of a statewide clinical research data and software platform across New York to connect scientists with hospitals, physicians and patients for the analysis of disease-state, selection of study patients, point-of-care clinical information and managing follow-up and therapeutic safety.

Previously, Mr. Murphy served as senior executive advisor at Booz & Co., supporting the pharmaceutical, life sciences and health care partners’ business development activities. He also served as senior vice president Strategic Consulting Services at Pharsight Corp., where he managed scientific modeling and simulation consulting, directed a specialized CRO, and managed development of metabases used to analyze compound and clinical data. Other positions he held include, vice president and chief information officer at CuraGen Corp., chief technology officer at Predict Inc., founder, president and chief executive officer of Just Medicine, Inc., and vice president for clinical software engineering at Community Health Computing.

Marc Kamin, M.D., has been appointed vice president, Medical and Scientific Affairs, Neuroscience, PharmaNet Development Group. Dr. Kamin will advise clients in the area of neuroscience and will provide medical support to PharmaNet project teams conducting neuroscience clinical studies.

Dr. Kamin is a neurologist, certified by the American Board of Psychiatry and Neurology, and has 20 years of experience in the pharmaceutical industry. Most recently, he led the Central Trial Coordination group for Medical Affairs in Global Clinical Operations at Johnson & Johnson. Dr. Kamin has designed and managed trials in many areas of neuroscience including migraine, eating disorders, bipolar disorder, alcohol addiction, acute and chronic pain, multiple sclerosis, epilepsy, peripheral neuropathy, amyotrophic lateral sclerosis and fibromyalgia.

“We are delighted to have a physician of his caliber at the forefront of our neuroscience team,” commented Dr. Pablo Fernandez, senior vice president, Worldwide Medical Affairs. “Marc’s vast experience and valuable expertise strengthens our neuroscience service offering.”

PPD and Southern Research Institute have entered into a collaborative agreement for pandemic and seasonal influenza vaccine R&D in an effort to provide clients with a full spectrum of vaccine development services. Southern Research will transfer its seasonal assays and reagents to PPD, adding to PPD’s flu vaccine testing services. In return, PPD will help build Southern Research's preclinical flu and clinical pandemic/highly pathogenic avian influenza (HPAI) testing business through client referrals.

"This key collaboration enhances PPD’s position as the first CRO to offer a comprehensive menu of vaccine assay development and testing services to support vaccine clinical trials with faster, more cost-efficient laboratory solutions," said Christine Ding Ivan, M.D., chief medical officer of PPD. "Our agreement with Southern Research further expands our large collection of commercial vaccine assays with very important capabilities in the influenza vaccine field and enables us to expand our partnerships with influenza vaccine developers in the commercial, government and nonprofit sectors."

Nancy M. Gray, Ph.D., vice president of corporate development, Southern Research Institute, added, "By partnering with PPD, Southern Research has the opportunity to expand its client base for the well-recognized work our scientists perform in the influenza research field. By working closely with one of the world's top clinical CROs and leaders in the fields of vaccine clinical trials conduct and laboratory testing, we can provide an unmatched breadth of influenza services to our clients. Together, we will offer a full spectrum of influenza research capabilities with highly respected bench-to-market support."

“The opening of the new GVK BIO Clinical Pharmacology unit reflects our commitment to offer faster recruitment solutions to our customers. The facility has been audited by the DCGI and we have initiated our first study at the Ahmedabad facility”, said Manni Kantipudi, president, GVK Biosciences.

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