Key Considerations for the Successful Development of a Biologic: Seven Steps to Success (Part 2 of 3)

Drug Discovery & Development, Drug Safety, Life Sciences, Pharmaceutical, Preclinical,
  • Tuesday, December 04, 2018

Understanding the biology of your therapeutic is key to effectively and efficiently progressing it from first principles, through safety assessment studies and into clinical trials. The unique characteristics and specific biology of each large molecule therapeutic makes it impossible to design a “one size fits all” approach to non-clinical development, requiring instead a design tailored to each molecule.  For efficient development strategies, this should include a thorough understanding of disease and therapeutic biology as well as ensuring that the most appropriate studies are conducted to progress each molecule.

Despite the need for unique approaches for each novel biologic, there are seven key steps that should be considered when developing biologics through non-clinical development in order to ensure effective and efficient progress.

This 3-part webinar series reviews the key considerations for design and conduct of a development plan for a monoclonal antibody (mAb) product. Focusing on the development of a therapeutic mAb, the presenters will review and discuss key considerations on the journey from target identification and underlying disease biology, addressing key questions for successful safety assessment, through to successful delivery of a phase I clinical study to illustrate the seven steps to effective biologics safety development.

Part 2 of 3: In Vivo Efficacy and Critical Preparatory Tasks for Nonclinical Safety Assessment

Join featured speakers for the second in this series of webinars in which Envigo’s experts will build on the topics discussed in part one as the candidate mAb progresses further along the development pathway. Part two of this series explores in vivo efficacy (including considerations for delivery by inhalation), as well as some of the tasks required to progress non-clinical safety assessment including tissue cross-reactivity studies to identify potential toxicity concerns and strategies to ensure delivery of appropriate bioanalytical methods.


Kathryn Bailey, Senior Study Scientist, Envigo

Coming soon…

Message Presenter

Steve Jordan, Principal Scientist, Envigo

Steve is an in vivo pharmacologist with twenty years’ experience of providing biological expertise and delivering discovery and safety pharmacology studies to internal project groups at AstraZeneca and external pharmaceutical and biotechnology companies at a global contract research organization. He has a BSc honours degree in Pharmacology and an MSc in Forensic Science at Kings College, University of London. Steve has been with Envigo for over eight years and leads the Discovery Pharmacology Group, which is a dedicated team within the Pharmacology Department.

Message Presenter

Simon Moore, Director of Inhalation Science and Engineering and Toxicology, Envigo

Simon joined Envigo in 1999 as an inhalation study analyst and was promoted quickly within the Aerosol Technology and Analysis section. When the section expanded and divided in 2003 into inhalation chemistry and aerosol technology, Simon was promoted to the role of Head of Aerosol Technology with managerial responsibility for the aerosol technologists. In 2009, he took managerial responsibility for the inhalation engineering services group. In 2016, he was promoted to his current title. In July 2017, Simon took on the additional responsibility of being part of the Toxicology Operations Management as a Team Leader of the inhalation study management team with line management responsibility for Study Managers and Trainee Study Managers in the Inhalation Studies Group.

Simon obtained his degree from the University of Dundee in Chemistry (1996) and gained his PhD in Heterogeneous Catalysis from the University of Glasgow (2000) using high-pressure gas flow and chromatography.  Simon lectures at the University of Surrey as part of the MSc Toxicology course on inhalation dosing, techniques and methodology, is the Vice Chairman of the Association of Inhalation Toxicologists, a committee member of the British Standard Institution on Nanotechnologies and has produced over 100 publications.

Message Presenter

James Lawrence, Principal Scientist, Envigo

James joined Envigo in 2011, and is now Principal Scientist for the Immunoassay section of the Biomarkers, Bioanalysis and Clinical Sciences Department. He is responsible for managing the scientific aspects of all pre-clinical, clinical and discovery immunoassay projects within the department.

Prior to joining Envigo James had 18 years of experience with immunoassays and biomarker analysis. After graduating with a degree in Biochemistry from the University of Greenwich in 1998 he has developed and run immunoassays at a diverse range of companies such as R&D Systems, Covance, Microscience, Emergent BioSolutions, Veeda Laboratories, Icon and Oxford Biomarker Services.”

Message Presenter

Who Should Attend?

Virtual to medium sized biologics developers, with relevant job titles including:

  • Principal scientists
  • Drug developers
  • Heads of large molecule/biologic development
  • Safety assessment/toxicologists

What You Will Learn

Join this webinar to learn about considerations for:


  • in vivo efficacy (including aerosol generation and inhalation delivery)
  • Tissue cross-reactivity 
  • Biomarker assays


Xtalks Partner


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.

Register below for Part 2 of the series

About Part 1:  Therapeutic Biology and Species Selection

About Part 3: Nonclinical Safety Assessment and Phase I Clinical Design Considerations

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