Intravenous Infusion: From Preclinical Challenge to Clinical Reality

Clinical Trials, Life Sciences, Pharmaceutical, Pharmaceutical Regulation , Preclinical,
  • February 05, 2014

Preclinical studies for drug candidates should reflect as closely as possible the clinical regimen with respect to route, duration and frequency of treatment, and even patient age when pediatrics is concerned. Oral and parenteral routes of administration, including intravenous infusion, are obviously well established for both large and small animal species and there is a wealth of literature, including guidance documents, to help investigators develop their methods and procedures.

However, new methods are continuously developed in order to meet regulatory and sponsor requirements for the preclinical safety assessment of increasingly complex drug candidates, including biotech products. Regulatory pressure to improve animal welfare based on the 3R’s (Replace, Reduce & Refine) philosophy must also be taken into account. The challenge for preclinical scientists is to develop methodology that can be applied with the animal model of choice, whether adult or juvenile, whilst maintaining the highest ethical standards. Intravenous injection or infusion (or even both) are the principal routes of administration for biotech products and technological advances are helping investigators move away from traditional tether and jacket systems. Some of this technology is as important in the preclinical facility as in the hospital and clinic.

During this webinar, the speakers discuss:

  • Preclinical and clinical perspectives on how to use increasingly intricate and sophisticated procedures for intravenous injection or infusion
  • New ideas on attending to animal welfare

Speakers

Stéphane Milano, Chief Scientific Officer, WIL Research – Europe

Stéphane Milano, Chief Scientific Officer, WIL Research – Europe
Stéphane Milano is the CSO at WIL Research Europe –Lyon, France where he has worked since 2003. In this role, he provides strategic scientific leadership for European operations as appropriate to the Executive Management Team. As part of his responsibilities, Stéphane is in charge of WIL Research’s Safety Pharmacology and Discovery Services in Europe.

Previously, Stéphane worked as Research Associate for Jouveinal Laboratories, Parke Davis and Pfizer in GI and A&R therapeutic areas. He holds a Ph.D. in Pharmacology, from the University of Marseilles, France where he researched the neurophysiology and pharmacology of the autonomic functions. He has authored more 40 scientific papers and abstracts. Stéphane has also filed two patents on the use of recombinant gastric lipase for treating functional dyspepsia and Modified PAR receptors for selecting compounds. He is an active member of the Safety Pharmacology Society since 2003.

Edward Marsden, Associate Director, WIL Research – Europe
Edward Marsden is an Associate Director and Head of Reproductive and Developmental Toxicology at WIL Research Europe – Lyon, France, where he has worked since 1994. He is responsible for both the scientific and technical staff, specialising in DART and juvenile toxicology studies and for planning future methods and developments in these fields. Previously, Edward worked in the UK for five years where he trained as a reproductive toxicologist with another major contract research organisation. He is a EUROTOX Registered Toxicologist, a council member of the European Teratology Society and member of the British and French Toxicology Societies. In addition to preparing numerous posters for presentation at scientific meetings, Edward is author/co-author of a number of publications and chapters from books including “The Minipig in Biomedical Research” and “Teratogenicity Testing, Methods and Protocols”.

Tim Vanderveen, Vice President, Center for Safety and Clinical Excellence
Tim Vanderveen is Vice President of the Center for Safety and Clinical Excellence. He is responsible for ensuring CareFusion’s commitment to education and innovation. Prior to this, he was the Director of Clinical Affairs, Medication Management Systems, for ALARIS Medical Systems. In addition, he was on the faculty of the College of Pharmacy at Medical University of South Carolina and was Director of the Division of Clinical Pharmacy. He also had a faculty appointment in the College of Medicine and was on staff at the Charleston VA Hospital.

Tim’s clinical practice was in nutritional support, and he co–founded one of the first multi–disciplinary nutrition support teams. During his academic tenure, his research, speaking and publication interests were closely tied to drug therapy in patients receiving parenteral and enteral nutrition. He received his BS and MS degrees from Purdue University School of Pharmacy and his PharmD degree from the Medical University of South Carolina.

Edward Marsden, Associate Director, WIL Research – Europe

Edward Marsden is an Associate Director and Head of Reproductive and Developmental Toxicology at WIL Research Europe – Lyon, France, where he has worked since 1994. He is responsible for both the scientific and technical staff, specialising in DART and juvenile toxicology studies and for planning future methods and developments in these fields. Previously, Edward worked in the UK for five years where he trained as a reproductive toxicologist with another major contract research organisation. He is a EUROTOX Registered Toxicologist, a council member of the European Teratology Society and member of the British and French Toxicology Societies. In addition to preparing numerous posters for presentation at scientific meetings, Edward is author/co-author of a number of publications and chapters from books including “The Minipig in Biomedical Research” and “Teratogenicity Testing, Methods and Protocols”.

Tim Vanderveen, Vice President, Center for Safety and Clinical Excellence

Tim Vanderveen is Vice President of the Center for Safety and Clinical Excellence. He is responsible for ensuring CareFusion’s commitment to education and innovation. Prior to this, he was the Director of Clinical Affairs, Medication Management Systems, for ALARIS Medical Systems. In addition, he was on the faculty of the College of Pharmacy at Medical University of South Carolina and was Director of the Division of Clinical Pharmacy. He also had a faculty appointment in the College of Medicine and was on staff at the Charleston VA Hospital.

Tim’s clinical practice was in nutritional support, and he co–founded one of the first multi–disciplinary nutrition support teams. During his academic tenure, his research, speaking and publication interests were closely tied to drug therapy in patients receiving parenteral and enteral nutrition. He received his BS and MS degrees from Purdue University School of Pharmacy and his PharmD degree from the Medical University of South Carolina.

Who Should Attend?

VPs, Directors, and Managers in the following areas:

  • Preclinical/Clinical Pharmacology
  • Preclinical/Clinical Safety
  • Preclinical/Clinical Research or Clinical Development
  • Preclinical/Clinical Operations
  • Drug Development Research & Development
  • Toxicology

Xtalks Partners

WIL Research

WIL Research provides world-class research and development services for Pharmaceutical and chemical organizations. The company combines scientific expertise with an eagerness to truly listen and understand client needs. With more than 64,000 square meters of laboratory space and offices in North America, Europe and Asia, WIL Research offers extensive resources over a broad range of services. Areas of expertise include general toxicology, developmental and reproductive toxicology, juvenile toxicology, neurotoxicology, inhalation toxicology, infusion toxicology, genetic toxicology, pathology, safety pharmacology, ecotoxicology, environmental fate, immunochemistry, analytical/bioanalytical chemistry and ADME. The experts at WIL Research can also help with worldwide regulatory and compliance issues. The more than 1,300 team members, many with advanced degrees, have completed thousands of projects, often pioneering new techniques along the way. These skilled researchers use their scientific knowledge and their advanced listening skills to develop customized solutions that match the specific requirements of each project.

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