Clinical Leader Newsletter - Biosimilar Approval: A Regulatory Perspective

Clinical Leader Newsletter | February 16, 2015   The U.S. Biosimilar Approval Pathway: Policy Precedes Science — A Regulatory Perspective By Dr. David Shoemaker, Senior Vice President, R&D With the passage of the Biosimilar Price Competition and Innovation Act (BPCIA) in 2009, the U.S. created new pathways for development and approval of biosimilar and interchangeable products (Section 351(k) of the Public Health Service (PHS) Act (42 U.S.C. 262)) in the hopes of creating a low-cost alternative to expensive, innovator-marketed biologics whose patent terms were expiring. Featured Articles Pharma, Mobile Health, And Patients: How Stakeholders Can Better Advance Clinical Trials   By Ed Miseta, Chief Editor, Clinical Leader Clinical trials are evolving. The cost, along with issues surrounding patient recruitment and retention, are forcing many sponsors and CROs to rethink the conduct of trials. One innovation that will certainly have an impact will be mobile health technologies. Best Practices For Successful Bioanalytical Methods Transfer By Roger Hayes, Ph.D., Vice President and General Manager of Laboratory Services, MPI Research From bench to bedside, developing a new drug requires many years and many hands. Each step must be taken carefully to ensure the quality and integrity of the process. This is of special importance in bioanalytical methods transfer. Improving Clinical Trial Operations Through Analytics By Comprehend Systems, Inc. Conducting clinical trials today is a complex set of activities that amasses huge volumes of data from multiple systems. These varied systems — utilized to track patient information, manage inventory, capture patient images, enter medical records, detect issues and perform other functions — must efficiently provide trial stakeholders with a comprehensive understanding of trial performance across the entire clinical portfolio at multiple global sites. Harmonizing Anatomic Pathology And Histology Services By Dr. Paul Kirchgraber, M.D., FCAP, Covance Central Laboratory Services, and Dr. Steven G. Brodie, Ph.D., FACMG, NeoGenomics Laboratories, Inc. The number of oncology clinical trials stands well above those in other therapeutic areas: almost four times those in the cardiovascular sector and well beyond neurology. Not only does oncology both lead and grow, most major pharmaceutical companies are involved in it to some degree. Q&A With Dr. John Harrison: Part 3 — Focus On Raters   By Heather Bilinski, Associate Director of Marketing, CRF Health This is the third part in the four-part series written following a Q&A session with Dr. John Harrison. During our conversation with Dr. Harrison we discussed the current problems with Alzheimer's clinical trials and the reasons behind the very low success rates for treatments. Resources Managing Clinical Trial Risk: It's A Tough Job, But One Person Has To Do It By Michael Macri and Sherry Merrifield, inVentiv Health Clinical Since the U.S. Food & Drug Administration published its guidance on risk-based monitoring approaches to clinical trials, sponsors have demonstrated a mixture of interest in, and trepidation toward, focusing their oversight activities on those areas that present the greatest risk to human safety and data integrity. Cloud-Based Regulatory Document Management: 10 Questions You Can't Afford NOT To Ask! Question 2   By Matt Walz, Chief Strategy Officer, NextDocs The goal of this question, especially when considering the implementation of a cloud-based system, is to instill the understanding that the vendor audit should change when considering an alternative to an on-premises solution. Most Popular News • The Philippines Clears CEL-SCI For Patient Enrollment In Phase III Head And Neck Cancer Trial • AmerisourceBergen's World Courier Expands Global Presence With Melbourne Distribution Facility • LYSOGENE, UMM and AU Collaborate On IND-supporting Preclinical Studies In GM1-gangliosidosis • Medidata Teams Up With Garmin To Optimize Clinical Trials Through Mobile Health Technology • Cold-Chain Packaging Service Raises The Bar In Healthcare Logistics Sponsor   Chief Medical Officer East May 4 And 5, 2015 Battery Wharf Hotel, Boston, MA This conference is designed specifically for CMOs, but certainly heads of R&D, clinical operations/development/outsourcing, and vice presidents of medical affairs would also greatly benefit from attending the program. Clinical service providers and investors are encouraged to attend, as conversations with CMOs are very much welcomed. Use code LSL15 for 15 percent off registration. Featured Product Cardiovascular Clinical Research At Worldwide Clinical Trials you benefit from outstanding expertise in the field of cardiovascular research. Our global cardiovascular team incorporates experience in the practice of cardiology, advanced scientific research with novel chemical entities, and more than 20 years of conducting complex global cardiovascular clinical studies. • Request Information Worldwide Clinical Trials Upcoming Training CRO Oversight: Risk Assessment And Action Planning Date: Monday, February 23, 2015 • Time: 1:00 pm to 2:30 pm EST CRA Oversight: A Risk-Based Approach Date: Monday, March 2, 2015 • Time: 1:00 pm to 2:30 pm EST Subscribe Today   For insight on how pharma and biopharm executives can improve how they run their businesses, subscribe to Life Science Leader magazine.     © Copyright 2015 Vertmarkets, Inc, 5340 Fryling Rd Suite 300, Erie, PA 16510. All rights reserved. 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