Drug Development – The 6 Most Critical Reasons Why Drugs are Delayed When Planning and Conducting CTA/IND Enabling Studies

Drug Discovery and Development, Drug Safety, Life Sciences, Pharmaceutical, Pharmaceutical Regulation , Preclinical,
  • Wednesday, November 21, 2018

Bringing a drug from discovery to market is an expensive and time-consuming business. Every drug that fails comes with a cost which could be both reputational and financial. Keeping your development program on track is therefore critical to success.

In this webinar, our featured speaker will explore the 6 most critical reasons why drugs are delayed when planning and conducting Clinical Trial Application (CTA)/Investigational New Drug Application (IND) enabling studies. Having gathered input from a wide-ranging group of senior drug development scientists, this webinar will use clinical examples to explore what drug developers misjudge or simply overlook when seeking to bring small or large molecules out from the lab and into the clinic.

Speaker

Robert Turcan, PhD, Head of Regulatory Affairs and Program Management, Envigo

Robert Turcan is Head of Regulatory Affairs and Program Management at Envigo.  He and his team work directly with customers to provide wide ranging scientific and regulatory support throughout product development, and provide advice and support in the design and execution of non-clinical development programs.

He is passionate about helping drug developers progress novel therapeutics from the lab to First-in-Human clinical trials and beyond to market adoption.  His many years of drug development experience in both small and large molecules enable him to design programs that balance regulatory needs, scientific robustness and safety assessment efficiency, liaising with the on-site scientific community to help customers understand and interpret results.

Robert has a PhD in Drug Metabolism from the University of Surrey.  He has been with Envigo for the last 3 years, and despite his youthful appearance brings decades of previous experience from large pharmaceutical developers.

Message Presenter

Who Should Attend?

Directors of small to medium-sized biotech companies and Senior Scientists developing small or large molecule drugs

What You Will Learn

Join this webinar to:

  • Gain insights into the common causes of delay in safety assessment programming
  • Understand the key considerations to successfully design and execute a FiH enabling package
  • Balance toxicology study design with appropriate analytical methodology and metabolism insight

Xtalks Partner

Envigo

Envigo provides mission-critical products and research services for pharmaceutical, crop protection, and chemical companies as well as universities, governments, and other research organizations. Our company is founded on the principle that research partnerships depend on unmatched expertise, unwavering dedication to customer service and shared goals. Envigo is committed to helping customers realize the full potential of their products and research which contribute to enhancing the lives of people and animals as well as protecting the environment.

With over 3,300+ employees serving over 65 countries with a network of more than 25 operating facilities worldwide, Envigo provides comprehensive scientific expertise and a full service offering in non-clinical research and development, research models and services, regulatory consulting, and analytical support to our customers. Envigo is a privately held global company with corporate headquarters in New Jersey.

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