Autoimmune Disease Featured Articles

1. Lupus Research Alliance Enhances Clinical Trials for Patients 6/16/2017

   The Lupus Research Alliance is the largest non-profit health organization raising money for research into the cause, cure, treatment, and prevention of Lupus and its complications. The research programs funded are typically collaborations with hospitals, medical schools and universities, as well as pharmaceutical companies from around the world. While treatments are available, Farber notes they are far from perfect. This has led the Lupus Research Alliance to step up its efforts to improve clinical trials and get ned medicines to patients.

2. AMO Pharma Addresses Rare Childhood Disease 5/22/2017

   “Rare diseases are bad enough, but the ones that affect children are even more heartbreaking,” says Mike Snape, CEO of AMO Pharma, a virtual biotech focused on rare disease. “The medical need in these areas is greater than ever. They also present challenges for drug developers, especially with clinical trials.”

3. Eli Lilly Steps Up Focus On Autoimmune Diseases 10/5/2016

   Managing patients having an autoimmune disease can present special challenges for researchers, from correctly diagnosing the disease to recruiting specific patients for clinical trials. I recently spoke with Chin Lee, global senior medical director in the immunology therapeutic area at Eli Lilly and Company. Lee discusses his decision to move from academia to pharma and the challenges inherent in performing clinical trials on autoimmune disease patients.

4. NEWS ROUNDUP: Santa Claus, The Easter Bunny, And Patient Centricity? 4/11/2016

   Clinical Leader news roundup for the week of April 4, 2016, with articles on Patient recruitment via Twitter, NIH sponsors trial of anti-HIV antibody, diversity in clinical trials, INC Research partners with CISCRP, the use of apps in clinical trials, and the myth of patient centricity.

5. Clinical BioStatistician/Programmer: A Day In The Life 4/15/2013

   Statisticians play an important role in many phases of the clinical trial process, beginning at the design stage and progressing through the final analysis. By Justin Sjogren, MS, Clinical BioStatistician/Programmer

6. Toxicometabolomics For Compound Attrition To Reduce Late Stage Failures Due To Safety 4/10/2013

   Many ’omics’ technologies have now become the primary way of discovering new biomarkers, and validation of these biomarkers is a relatively new and evolving concept. By Michael V. Milburn, John A. Ryals, and Lining Guo

7. Outsourcing Perceptions From The CEO Of An Early Stage Start-Up 4/1/2013

   Leslie Williams is President, CEO, and founder of ImmusanT, Inc., an early stage company focused on peptide treatments for auto-immune diseases. Williams has over 20 years of industry experience in healthcare, management, commercial product development and marketing. Williams took time out from her managerial duties to share her perceptions on outsourcing and working with CROs.

8. Outsourcing Insights From The Executive Director Of Medical Research Operations For Purdue Pharma 4/1/2013

   Dr. Mitchell Katz, Ph.D. is the executive director of medical research operations responsible for leading activities across all clinical programs for Purdue Pharma. He has 26 years’ experience in the pharmaceutical and biotech industries, including preclinical research, pharmaceutical operations, and regulatory affairs. Katz, a key opinion leader within the clinical trial space, often speaking at key industry events such as Partnerships in Clinical Trials, and DIA. He recently shared his insights regarding outsourcing in the clinical universe.

9. Strategic Application Of Regulatory Pathways For Medical Devices 11/15/2012

   The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) signed into law by President Obama last July is a sweeping piece of legislation that, among many other provisions, enacts reforms aimed at improving various FDA regulatory procedures, including the medical device review and approval processes.  By Evan L. Rosenfeld, MD, JD, FCLM, Vice President of Medical and Scientific Affairs, Medical Device and Diagnostics, Theorem Clinical Research

10. Increased Adoption Of iPSC-Derived Human Cells For Use In Drug Discovery And Toxicity Testing 10/1/2012

    Traditionally, discovering a pharmacological therapy for a disease involves first investigating the underlying biological processes of that condition and then identifying drug candidates that interfere with those processes.  From here, the most promising compounds are advanced to pre-clinical and clinical development. The goal of this “bench to bedside” approach is to translate bench research to point-of-care patient outcomes as quickly and safely as possible. With dwindling drug pipelines, pharmaceutical companies need new approaches that can re-energize their discovery efforts. By Chris Parker, Vice President and Chief Commercial Officer, Cellular Dynamics International