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From Bench to Bedside and Back Again: Strategies for Effectively Leveraging Pre-Clinical Data to Accelerate R&D

Available on-demand
60 Minutes

The drug discovery process is complex and time-consuming, with an average development time of 10+ years and hundreds of millions to billions of dollars spent to receive regulatory approval. As recently as 2015, researchers concluded that anywhere from 50-80% of pre-clinical animal (in vivo) research data was irreproducible,1 representing a monetary loss of more than $28 billion. For an industry renowned for advancing human knowledge—it’s shocking to realize that 90% of in vivo study data is captured and recorded either on paper, disparate legacy software like spreadsheets, or other in-house developed systems.

This lively discussion will feature experts from both sides of the informatics and IT canyon, focusing on the best ways to achieve maximum value and effectiveness of the in vivo research process.

Discussion will include: 

  • Current in vivo study management practices and processes. How did we get here? 
  • Best practices for capturing reproducible and accurate in vivo data to reduce failure in clinical trials – the most expensive phase of drug development. 
  • Opportunities to streamline in vivo study management, reducing costly human errors and maximizing already constrained resources. 
  • The importance of change management programs and strategic implementation of modern research tools and methods- including best practices for measuring your organization’s current tech stack.
  • How implementing standardized, traceable data management in the pre-clinical environment not only encourages collaboration but can enable new insights from both the bench and the bedside.

1 The Economics of Reproducibility in Preclinical Research 
Freedman LP, Cockburn IM, Simcoe TS (2015) The Economics of Reproducibility in Preclinical Research. PLOS Biology 13(6): e1002165.


chuck donnelly

Chuck Donnelly

Co-founder of RockStep, Chuck has a degree in Computer Science. Prior to RockStep, Chuck was Director of Computational Sciences at the Jackson Laboratory (JAX), where he led work on intractable computational problems for numerous disease areas, including cancer and diabetes. Chuck’s work at JAX was funded by the NIH, HHMI, and JAX. Prior to JAX, Chuck was in the Space Astrophysics Group at UC Berkeley where he directed development of software systems for NASA orbiting platforms, worked on the Space Shuttle ground control, and led development of software for imbedded systems, and algorithms for radio astronomy. 

Chuck has published articles and papers in peer-reviewed journals, and presented at conferences around the world. As CEO, Chuck brings a wealth of business experience, leadership, and management experience to the RockStep team.

Amy Huff

Amy Huff

Amy Huff is the Senior Director of Global Operations at Charles River Laboratories.  Before joining the Digital Operations team, Amy Huff was the Director of Operations at the Reno, Nevada site and was responsible for site vivarium-based Technical Operations, In-Vivo Training, and Animal Care Operations.  She has previously, and continues to, help lead Operations across Charles River with a focus on digitalizing laboratory practices for data collection and animal health records.

Amy has spent 19 years with Charles River and earned her MS in Management and Leadership, and a Bachelor of Science degree in Integrated Animal Science.

Michael Hayward

Michael Hayward, PhD

Over the last 15 years I’ve been working at contract research organizations specializing in in vivo pharmacology and animal models of human diseases, currently I’m the Senior Director of In Vivo Pharmacology at The Jackson Laboratory. My experience in animal model studies includes several years contributing to a large scale phenotyping project of over a hundred mutant mouse lines for a commercial client. I’ve focused most of my scientific management in the therapeutic area of CNS, pain, metabolic diseases and NASH, vasculogenesis, endometriosis, rheumatoid arthritis and oncology. I’ve had significant technical experience working with traditional small molecule therapeutics as well as mRNA, mAB, stem cell and CAR-T and worked with commercial clients ranging from large pharma to start ups and virtual biotech companies.

Szczepan Baran

Szczepan Baran

Szczepan is a scientist and veterinarian turned “technology geek.” He is passionate about transforming the delivery of innovative medicines to patients through digital technologies and data enablement while pushing the scientific envelope and reimagining patient engagement.  Szczepan currently serves as a Chief Scientific Officer at VeriSIM Life. Before joining VeriSIM Life, Szczepan served as a Head of Emerging Technologies within Comparative Medicine at Novartis, held multiple start-up and faculty positions, and served on numerous boards. Currently, he serves as an ad hoc member of the National Academies on the NHP Model Systems Committee and a member of the NIH Advisory Committee to the Director (ACD) Working Group on Catalyzing the Development and Use of Alternative Methods to Advance Biomedical Research. 

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60 Minutes