Online Extras

Chinese biotech companies are emerging as serious competitors in the global market as the country's drug development landscape claims industry attention once more.

The industry-wide shift towards RBx is not only reducing risk, but improving oversight and boosting proactive, predictive decision making, writes Cluepoints' CCO, Patrick Hughes.

Dave Li explores the current information on the commercialization of advanced therapy medicinal products.

Clinical research must deploy innovative, disruptive approaches without disrupting patients.

Findings from analyzed data from approximately 300 web survey responses representing over 200 global individual sponsor and provider organizations

Simon Jones and Gordan Alexander, both of Prisym ID, explore the added complexity to the labeling of trial supplies that new regulations to EU 536/2014 will bring, specifically Annex VI.

With more than 174,000 new cases expected to be diagnosed this year, explore emerging areas and future challenges prostate cancer treatment is facing.

Erin Finot, Global Head of Immuno-Oncology at IQVIA Biotech, discusses the immense challenges to overcome before advanced therapies become more widespread.

Michael Keens, COO of Firma Clinical, explores the beginning of patient centricity, common misconceptions related to its implementation, and offers steps to improve the ability to achieve patient centricity within drug development.

Taking a closer look at the skills expected from the Principal Investigator beyond the expected technical skills.

Global experts collaborate to form the Addressing Lupus Pillars for Health Advancement (ALPHA) Project in order to combat challenges in lupus drug development.

Basheer Hawwash, Principal Data Scientist at Remarque Systems Inc., writes of the potential artificial intelligence, more specifically machine learning, has to transform clinical trials.

With the world of gene therapy still rapidly evolving, an Interactive Response Technology system might help a sponsor navigate new and complex steps throughout the supply chain.

Linda Reuter, CIP, Director of BRANY IRB, discusses the Revised Common Rule that now requires informed consent to begin with a concise and focused presentation of key information that will help the patient better understand the reasons why they might or might not want to participate in the research.

Irina Petrova, Director of Clinical Operations for OCT Clinical Trials, explores why U.S. companies are turning to Russa after having secured approval for 108 trials there in 2018.

MyStudies, introduced by the FDA, bridges data streams to real world evidence by facilitating the collection of real-world data directly from patients in conjunction with a variety of data sources.

As pharma businesses shift their focus away from ‘blockbusters’ to treatments for rare diseases, clinical trial design must also go through a period of change and should consider response-adaptive over traditional randomized controlled trial designs.

Amid the recently released ICH E8 (R1) draft guidelines further supporting RBM strategies, practical methods for integrating critical-to-quality (CTQ) factors within the operational execution life cycle of a clinical trial are presented.

Cathleen Dohrn, Senior Scientific Director for Continuum Clinical, describes the momentous challenges in clinical trials presented by low awareness of nonalcoholic steatohepatitis.

Catch up on all the latest happenings in the industry from the past month.

A look at three contemporary trends that though integrated cautiously at first, may open up a reimagined world of clinical research.

Penelope Manasco, CEO of MANA UBM, answer thorny questions about adopting electronic investigator site files in clinical research.

David M. Kronfeld, the Head of Real World Data Innovation for Medidata, writes of Mercy Hospital in Joplin, Missouri, that despite seeing over 600 new cancer patients each year, it has historically had very limited access to clinical trials

Crystal Stone and Amanda Coogan of Remarque Systems discuss how an RBM approach can help enhance the safety and efficiency of clinical trials.

Abby Abraham, Vice President, Data Analytics, and RBM for OmniComm Systems, writes about a new survey that highlights gaps in the conversation surrounding the industry’s adoption and implementation of risk-based approaches to monitoring.

At some point in every organization’s life, they come to realize that their data environment isn’t set up for success. Adrian Cottrell, PhD, VP of clinical, medical, and regulatory tech for GlaxoSmithKline writes about when his company came to that very conclusion in 2017.

The latest happenings in clinical trial news when it comes to people and business.

Drug development in oncology continues to evolve, Sarah Alwardt, VP of Data, Evidence, and Insight Operations for McKesson, discusses the shift to highly personalized therapies, including new modalities like cell and gene therapies.

Sudhakar Bangera and Latha MS discuss how in the past medical devices in India were clubbed with regulations for new drugs, biologicals and vaccines, but how new regulations are bringing new and more devices to the area.

Cancer therapy development has advanced to researching targeted immunotherapies and moving into gene-specific therapies. Some companies, however, are focusing on reviving cytotoxic therapies that were too toxic for patients when administered generally. Bill Newell, Chief Executive Officer of Sutro Biopharma, sits down with Moe Alsumidaie to discuss the use of a cell-free protein synthesis approach.