Articles By Ed Miseta

91. FDA's Hamburg: Focus Remains On Innovation, Partnerships, And Quality 12/19/2013

    Margaret Hamburg is now four and a half years into her tenure as commissioner of the FDA. That makes her the second longest serving individual in that position. Four and a half years might not seem like a long time, but some agency changes under her rule are noteworthy. For one, the budget of the agency, during that timeframe, has grown from $2.7 billion to $4.2 billion. She casually shrugs off the achievement, joking that it takes a long time to learn how to do the job.

    Hamburg’s comments came at the 2013 FDA/CMS Summit held in Washington D.C. in December. Her keynote presentation, which ran just under 30 minutes, was noteworthy in that it gave insight into what she sees as the most significant accomplishments of the department, and where the focus will be going forward. Quality and innovation were themes that came up throughout.

92. Johnson & Johnson Subsidiary Submits FDA Application For New Drug To Treat Castleman Disease, A Rare Blood Disorder 12/9/2013

    Clinical trials conducted by Janssen Research & Development, LLC points to evidence that its experimental drug, siltuximab improved symptoms and shrank growths in patients with Castleman disease, a rare blood disorder that causes enlarged lymph nodes. This condition can lead to a multitude of symptoms and weaken the immune system, making it hard to fight infection.  Infections in people with Castleman can be very serious and even fatal. No other approved therapies currently exist for the disease.

93. NovoNordisk Drug Demonstrates Superior Blood Sugar Control 12/9/2013

    NovoNordisk, the Denmark-based global leader in insulin production announced the results of its phase 3 trials of IDegLira, its new diabetes drug, at the World Diabetes Conference of the International Diabetes Federation. The results of the study indicate superior glycemic control and weight loss combined with a low incidence of hypoglycemia in adults with Type 2 Diabetes uncontrolled on basal insulin.

94. Acquisition Expands Phase I Capabilities 12/3/2013

    Clinical research firm PRA has announced it will be acquiring privately-held specialty research firm CRI Lifetree. CRI’s focus has been on early stage patient population studies with a focus in Human Abuse Liability (HAL), addiction, pain, psychiatry, neurology, pediatric and infectious disease services.

    With three Clinical Pharmacology Centers and over 200 beds, combined with over 20 years of clinical experience, CRI is one of the largest providers of patient population Phase I and confined Phase II-III services in the United States. 

95. FDA Presents Regulatory Challenges For Finished Dosage Manufacturers 12/1/2013

    As president of contract manufacturer Oso Biopharmaceutical Manufacturing, there are many concerns that might keep Milton Boyer awake at night. For example, he believes that, for most CMOs, every customer is always ready to leave. Therefore, manufacturers need to have a steady stream of new clients ready to fill the void. There are also cost pressures in the industry, concerns over hiring talented personnel, and internal problems that could arise and potentially derail any relationship. But when talking to Boyer, you get the feeling that no topic consumes more of his time than concern over the current regulatory environment.

96. WIB Profile: Best Practices For Buying, Selling, And Maintaining Used Laboratory Equipment 11/27/2013

    In this Women In Bio (WIB) profile article, Dawn Hocevar, director of national development for BioSurplus, discusses her job, trends in the market for used lab equipment, and best practices to keep in mind when shopping for used equipment. She also discusses what WIB can do for young women entering the pharma and biopharmaceutical industries.

97. How To Cut Clinical Time And Cost With CRO Continuity 11/27/2013

    Roxanne Tavakkol has a lengthy track record in the pharmaceutical industry. Currently the VP of Regulatory and Scientific services at clinical firm TKL Research, she began her career on the sponsor side of the house and has been involved in over 10 NDA registrations in her 20-year career in pharma. This experience has instilled in her the importance of solid data and streamlined data collection process in clinical trials.  

    “When FDA reviews an application for a registration, the primary concern to them is the risk/benefit to the patients,” she says. “That is not news to the pharmaceutical industry. We all know the quality of the data will ultimately determine whether or not a drug is approved. But I do think a lot more attention is now being paid to how the choice of a CRO can affect that the quality of the data.”

98. At Ferring Pharmaceuticals, Peptides And Proteins Make Significant Advances 11/15/2013

    Dr. Keith James joined Ferring Pharmaceuticals as VP of Therapeutic Innovation in early 2012. In December 2012 he was promoted to president of the Ferring Research Institute and SVP of R&D for Ferring Pharmaceuticals. Prior to joining Ferring, Dr. James spent 29 years working for Pfizer, with significant time spent in discovery research. At the 2013 Oligonucleotide & Peptide Based Therapeutics Congress he will speak on recent progress and future prospects in the peptide and protein therapeutic space. I recently spoke with Dr. James to get an overview of the potential in this market.

99. Open Cell-Free Protein Synthesis Technology Is Ready To Assist With Peptides 11/15/2013

    Dr. Aaron Sato has more than 10 years of research experience in antibody protein and peptide engineering. As the VP of research at Sutro Biopharma, he leads the team in the use of their bacterial extract system to produce high-value protein therapeutics, such as ADC, biospecifics, and naked antibodies. At the 2013 Oligonucleotide & Peptide Based Therapeutics Congress he will speak on his company’s open cell free protein synthesis technology. I recently spoke with him to better understand his company and technology.

100. Overcoming Challenges In The Development Of Peptides And Oligonucleotide Therapeutics 11/7/2013

     At the 2013 Oligonucleotide & Peptide Based Therapeutics Congress, Dr. Hanjo Hennemann, co-founder and chief science officer of Nexigen, will speak on Overcoming Delivery Challenges in Peptide and Oligonucleotide Therapeutics. Dr. Hennemann is a founding member of Nexigen GmbH and has served as managing director and head of research since the company’s founding. Previously he was principal investigator at the research center caesar, Bonn, where he established the basis for the technology and the foundation of Nexigen. We spoke with him about the potential for peptides in the treatment of cancer and other diseases.