The Next Big Thing in Cancer Care

The webinar is moderated by Dr. Peter Yu, Physician-in-Chief, Hartford HealthCare, ASCO President for 2014-2015 term
The program features:

Drugging the Undrugable

  • Dr. Lillian Siu, Professor, University of Toronto; Chair, Program Committee, ASCO Breakthrough 2023

CAR-T and Adoptive Cell Therapies

  • Dr. David Lebwohl, CMO, Intellia

Therapeutics Precision Oncology, AI and Next Generation Multiomic Technology

The FDA and Clinical Trials

In America, the FDA (Food and Drug Administration) was established as a federal agency in 1906 with the Pure Food and Drug Act. Since then, they have protected the health of Americans by ensuring the safety and efficacy of medication, medical devices and biological products. 

Regarding clinical trials, the FDA evaluates the data on an investigational drug and decides whether it is safe enough to become available to the public. To do that, they need to be sure that the medication works and that the benefits outweigh any possible risks. 

Clinical Data Management: Past, Present and Future

Clinical Data Management (CDM) is an integral part of clinical trials and enables clinical trial staff to extract valuable, accurate, high-quality data during the clinical trial process. The final results of a clinical trial are only good if the data collected is reliable. Incorrect data can result in the wrong conclusions being made which can be a risk to participants and can tarnish the reputation of Contract Research Organisations (CROs) and clinical trial sponsors. 

Types of Clinical Data Management

Clinical Data Management (CDM) deals specifically with the information that is collected during the clinical trial. Its aims are to ensure quality, data, integrity and compliance with regulations and protocols. 

There are many clinical data management systems available and it can be difficult to select one to utilise. Comparing a few allows for an informed decision to be made. Look out for features like 

Contract Research Organisations and the Different Roles They Play

A Contract Research Organisation (CRO) provides research services to the biotechnology, pharmaceutical and medical device industries through a contract agreement. CROs have various functions and specialities. Ultimately, they operate as a hired agent that carries out specialised tasks for a trial sponsor. Any data that a CRO collects should be unbiased and meet the regulatory requirements which are then used in a participant-driven approach to drug discovery and device design. 

Contract Research Organisations: Market and Trends

The Contract Research Organisation (CRO) industry is constantly changing and growing due to various key factors like a growing healthcare sector, research funds, a growing patient population worldwide and an increase in government support for research and development (R&D). According to the latest research, the global demand for Contract Research Organisation’s market size and share is expected to exceed around the US$65.5 billion mark by the year 2028.

The biotech landscape: market trends, priorities, predictions, and pathways to FDA approval

Hi, everyone.
Arsalan Arif here with Endpoints News.

Thanks for joining us today for The Biotech landscape: Market trends, priorities, predictions, and pathways to FDA approval.

We're sponsored by Novotech, the leading Asia-Pacific biotech CRO.

I'm excited to moderate today's expert panel.

Joining us today, we have Fred Cohen, co-founder and chairman of Monograph Capital Partners in San Francisco.

Jeanne Novak, the CEO and president of CBR International Corp in Boulder, Colorado.

The Future of Contract Research Organisations

Contact Research Organisations (CROs) have undergone many changes over the past few years, thanks to the COVID-19 pandemic and technological advances. There are even more changes for CROs in the future. One of the biggest changes will be how CROs respond to unforeseen emergencies, such as the unprecedented COVID-19 pandemic. As well as the ongoing advancement of technology and new medical treatments. 

The future of CROs includes: 

Technology Instead of Labour 

Subscribe to