Articles By Ed Miseta
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The Pfizer Approach To Clinical Outsourcing: Develop Capabilities And Align Objectives
1/29/2014
Pam Garzone, executive director of biotechnology and clinical development at Pfizer WRD (worldwide research & development), is instrumental in implementing her company’s outsourcing strategy. As the clinical team lead, she is accountable for the clinical development strategy for programs originating at Rinat, a research unit within Pfizer. Her duties include working with different functional expert groups such as biologists, clinicians, both MDs and non-MDs, toxicologists, clinical pharmacologists, and statisticians. “I ensure that everyone on the asset team is in the same boat and rowing in the same direction,” she says.
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WIB Profile: Increased Challenges For Pharma Foster Closer Partner Relationships
12/20/2013
Challenges in the pharma and biopharmaceutical industries, such as the end of the blockbuster model, the patent cliff, and rising costs, has companies relying more and more on outsourcing partners. In this Women In Bio (WIB) profile article, Laura Marquis, VP, Customer Solutions Management Group at Quintiles, discusses her job, the challenges her clients are facing, and how many of them are best dealing with those challenges. She also discusses what professional women can expect to get out of their affiliation with Women In Bio.
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WIB Profile: Cutting The Length, Cost, And Complexity Of Clinical Trials
12/19/2013
Sophie McCallum has spent almost four years with clinical solutions firm ClinCapture, currently serving as its director of operations. In this position, McCallum oversees and manages the marketing, HR, finance, and inside sales departments. She also works with the governance team to plan and implement corporate vision and strategy, develops strategic plans and direction for products and services, develops tools and controls to track company profit margins and department budgets, and analyzes business and operation procedures to increase company efficiency and worker productivity. In this Women In Bio profile, McCallum discusses her role in helping build the company, and trends she sees occurring in the clinical research space.
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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.
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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.
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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.
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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.
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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.
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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.
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Collaboration Seeks To Simplify Investigator Engagement
11/6/2013
Anyone involved in clinical work knows investigator engagement is not an easy task. Gathering real-time feedback during a trial, selecting the right investigators, and effectively engaging with sites and investigators can be a monumental challenge.
Earlier this year Invesco Perpetual, an investment firm with holdings in Big Pharma companies including Pfizer, Merck, and GSK, announced a $50 million investment in DrugDev, a data sharing platform for clinical trial doctors with an online network of more than 80,000 clinical trial doctors in 93 countries. DrugDev stated at the time that the money would be used to enhance its clinical trial technology as well as acquire companies with complementary technologies. The first of those companies is CFS Clinical. DrugDev announced it has acquired the company, a provider of business and financial management activities for trials, as part of its plan to help companies control the spiraling cost of clinical trials.