Dr. Michael D. Ruff has recently been appointed vice president of pharmaceutical development at
Metrics, Inc. He recently received his clinical doctor of pharmacy degree from the Shenandoah University Bernard J. Dunn College of Pharmacy.
Dr. Ruff completed his Pharm.D. degree shortly after becoming the ninth person in the world to earn the new Certified Pharmaceutical Industry Professional (CPIP) credential, awarded by the International Society for Pharmaceutical Engineering’s Professional Certification Commission and is the first competency-based international certification for pharmaceutical professionals. Those who qualify for the credential demonstrate global competency through education, experience and rigorous examination.
Dr. Ruff has been with Metrics for 11 years, where his responsibilities have included providing formulation development, clinical trial material manufacture and consultation services to clients. “In his many years here at Metrics, Mike has consistently demonstrated a personal commitment to excellence, including his pursuit of continuing education that allows him to remain at the forefront of industry knowledge and technology,” said
Phil Hodges, president. “We congratulate Mike on earning his doctorate.”
Dr. Ruff has been a member of ISPE since 2005 and is a registered pharmacist with more than 20 years’ experience in developing new chemical entities with a focus on oncology, central nervous system and anti-viral drugs. He holds several U.S. patents for pharmaceutical applications and has authored numerous technical papers. He also is a member of the American Association of Pharmaceutical Scientists.
The FDA has approved
Amgen's Nplate, the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). Nplate, the first FDA-approved peptibody protein, works by raising and sustaining platelet counts, representing a novel approach for the long-term treatment of this chronic disease.
The FDA approval of Nplate was based on efficacy and safety results from two Phase III studies of adult patients with chronic ITP, including both splenectomized and non-splenectomized patients. The overall response rate for Nplate was 83% of treated patients, and platelet counts were raised and sustained in these six-month studies. Additionally, patients treated with Nplate were able to reduce or discontinue their use of concomitant ITP medications and emergency medications.
Chronic ITP is a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events. Recognized as an orphan disease, chronic ITP affects an estimated 60,000 adult patients in the U.S. and is considered an unmet need by the FDA.
“Until now, patients suffering from chronic ITP have had limited available treatment options, many of which are often unsuitable for long-term use due to side effects and tolerability issues,” said David J. Kuter, M.D., Chief of Hematology, Massachusetts General Hospital, Boston. “Nplate represents the first long-term treatment for adult chronic ITP patients, providing a new treatment approach for this chronic disease.”
Said Roger M. Perlmutter, M.D., Ph.D., Amgen's executive vice president of R&D, “The FDA approval of Nplate is the result of more than 15 years of research and represents an important biotechnology milestone as it is the first FDA-approved peptibody protein, an innovative platform for delivering targeted therapies.”
Nplate was also approved for ITP by Australia’s Therapeutic Goods Administration (TGA) in July 2008. Amgen has filed for regulatory approval of Nplate in the European Union (EU), Canada, and Switzerland and these applications are currently under review. Nplate has also received orphan designation for ITP in the EU (2005), Switzerland (2005) and Japan (2006).
Amgen is continuing to study the long-term efficacy and safety of Nplate for which there is more than three years of follow up safety and efficacy data.
Scott Neilson has been appointed to the position of chief operating officer of
AAIPharma. Mr. Neilson will be responsible for the company's global drug development services operations, reporting to chief executive officer and president
Dr. Ludo Reynders.
Mr. Neilson is an accomplished leader with over 25 years multi-functional experience in all phases of drug development on a global basis. During the past 10 years he has led the turnaround of two of the top six Global Central Laboratories, dramatically improving market share, revenues and profitability, according to an AAIPharma statement. He has also held senior operations positions in clinical research and has a broad spectrum of functional experience including finance, regulatory affairs, human resources and business development. His experience spans pharmaceuticals and CROs, having worked at MDS Pharma Services, LabCorp, Covance and SmithKline Beecham (now GlaxoSmithKline).
“As a company, we have made significant progress across the major lines of business over the last three years,” said Dr. Reynders. “Scott’s appointment underscores our commitment to continuing this progress and our goal of a global leadership position in the markets we serve."
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