Novel Alternative Methods (NAMs) refer to Non-animal methods, models and
technologies used to answer complex questions about human health and disease. These include in
chemico (biochemical), in vitro (cell-based) and in silico (computer-based) approaches.
Resource Tag: Sustainablity Driven R&D
Clinical Trials Carbon Footprint Project
Our project aims to standardise the carbon footprint evaluation of clinical trials with a focus on Decentralized Clinical Trials.
LGBTQIA+ Inclusivity in Pharma
Why your business will deliver more when you foster greater LGBTQIA+ inclusion in the workplace and how to get there
This workshop is focused on LGBTQ+ inclusion in the workplace and includes a presentation on the importance of LGBTQ+ inclusion, highlighting key statistics, terms, and challenges faced by LGBTQ+ individuals, especially in life sciences.
Participants are welcomed to engage in small group discussions through case studies that address real-life LGBTQ+ challenges and propose solutions for a more inclusive environment.
The session concludes with an interactive Q&A and a call to action, offering resources for continued learning.
Speakers
- Dr. Covadonga Palacio Gutierrez, Analytical Scientist, Roche Analytical chemist with a strong focus on mass spectrometry working in the Extractables and Leachables (E&L) group within the Hyphenated & Special Technologies (HST) at Roche. My main task is the validation of the methods used for E&L determination, analysis of routine E&L samples and coordination of requests. I also look for ways of improving the way we work with focus on lean work and automation. In addition, I’m a core member of the OPEN network at Roche and I focus on making Roche a more inclusive place to work for every employee.
- Vincent E. Gaillard,Group Global Medical Director, Roche A trained anesthesiologist and emergency physician, Vince has more than a decade of experience in Pharma industry, working in Medical Affairs at country and global levels, contributing to the further development of oncology medicines, crafting medical education and collaborating with global experts in diverse disease areas. For the past 4 years, Vince has been an outspoken core member of the OPEN Switzerland network, Roche’s LGBTQ+ employee resource group, advocating and educating on all kind of queer topics. Additionally, he co-created, trained trainers for, and led global workshops on Allyship, trying to improve the world around him a little bit every day through kindness and empathy.
- Steinar Halldorsson, Senior Scientist, Roche Steinar is a Senior Scientist working in the early stage research and development of Roche Pharma. Steinar has more than ten years of experience in the field of Structural Biology that spans academia and industry. His passion though is culture, diversity, equity and inclusion. Steinar is a part of the People Leadership Circle within Lead Discovery of Roche where he shapes culture and people leadership within his department. For the last six years Steinar has been involved in LGBTQ+ working groups both within his work and outside where he has taken on various roles including facilitation, event management and policy shaping.
This webinar is part of a series of D&I webinars sponsored by AbbVie.
Pistoia Alliance Annual Report 2023/24
The Power Leaders Have over Employees’ Mental Health
Join us for an enlightening webinar where we delve into the profound influence leaders have on the mental well-being and performance of their team members through their management approaches. Throughout the session, we’ll dissect various management styles, highlighting both exemplary and detrimental practices. By examining these examples, we aim to elucidate the significant impact management styles wield on employee mental health and subsequent workplace performance.
Speaker
Iain Hadwin, Senior Manager, BMS
Unlock the Future of Non Animal Models
Join us for an enlightening webinar as industry leaders Eurofins and InsilicoTrials shed light on cutting-edge approaches to revolutionize toxicity studies. In this dynamic session, we will explore the transformative power of in vitro assays and in silico predictive analysis, replacing traditional animal models with ethical, efficient, and scientifically advanced alternatives.
Key Highlights:
- Eurofins In Vitro Assays: Discover the realm of in vitro assays with Eurofins, where experts unveil the versatility and precision of toxicity signature/prediction analysis. Learn how these advanced methods provide reliable insights into toxicity without relying on animal testing.
- InsilicoTrials In Silico Predictive Analysis: Delve into the future of predictive analysis with InsilicoTrials as they showcase the immense potential of in silico methods. Explore how computational modeling can accurately predict toxicity outcomes, revolutionizing the way we approach pre-clinical studies.
Speakers
- Alastair King, Ph.D. Head of Biology, Eurofins
- Luca Emili, InSilico Trials
Strategic Priorities Update February 2024
Join us for this inaugural update on the newly formed Strategic Priorities of the Pistoia Alliance, followed by a 30 minutes Q&A with our panelists
Agenda
Dr Becky Upton, President of the Pistoia Alliance
- Introduction
Dr Christian Baber, Chief Portfolio Officer, Pistoia Alliance
- Strategic Priorities Overview
- Harnessing AI to Expedite R&D
- Delivering Data-Driven Value
Thierry Escudier, Portfolio Lead, Pistoia Alliance
- Accelerating Use of Real-World Data
- Sustainability Driven R&D
Advancing Research: Reducing Animal Models in Experiments
“Advancing Research: Reducing Animal Models in Experiments” addresses the pressing need to reduce reliance on animal models in scientific research, particularly in light of the FDA Modernization Act 2.0. The event encompasses an overview of the current research environment, exploring innovative alternatives such as virtual control groups, organ-on-a-chip technology, and in-vitro methods.
AGENDA
- Overview of the Current Environment
- Virtual Control Groups
- Organ-on-a-Chip Technology
- In-Vitro Method Alternatives
- The Validation of Alternative Approaches
- Poll and Q&A
Pistoia Alliance Clinical Trials Carbon Footprint Project
A recently released white paper of the Health Systems task force of the Sustainable Market Initiative estimated the global clinical trial footprint to equal up to 100 million tons of greenhouse gas emissions a year. This is leading to environmentally conscious behaviors and increasing awareness around clinical trials specific impacts and leading the pharma industry to a need for measuring carbon footprint at a corporate level to meet corporate long-term sustainability objectives.
The collaborative Pistoia Alliance initiative is providing an opportunity for members from different companies for building a model in standardising the evaluation of carbon footprint. The rationale and objectives of this project will be detailed during the webinar
Agenda
- Pistoia Alliance-Industry collaborative intiative to standardize carbon footprint evaluation of Decentralized clinical trials – Thierry Escudier & Dalila Nafi, Pistoia Alliance
- Understanding Sustainability and clinical research – Jason Lanier, Janssen
- Joining the dots and trade offs for sustainability in clinical trials – Carly Santer, Bayer
- Saving the planet One site visit at a time- a tool to calculate the impact of clinical research associates’ travel – Aparna Srivistava, Syneos Health
- Q&A
Extracting Adverse Event Incidence Rates for Predictive Toxicology
Drugs can cause unwanted undesirable effects called adverse reactions, or side effects. In addition to lack of drug efficacy, safety issues caused by these reactions are a major reason for clinical trials to fail. Identifying adverse reactions in preclinical stages can help to reduce the risk associated with drug development and improve patient safety.
In-vitro and in-silico predictive toxicology models can be used to identify adverse reactions at an early development stage. However, they require reliable, quantitative data on adverse event incidence rates for calibration and training. While a great deal of clinical and regulatory information on adverse drug events is publicly available, the data itself is often unstructured, limiting its accessibility. The variety of ways in which the relevant information is reported provides a challenge for data extraction at scale.
Using a test set of 865 FDA-approved small molecule drugs, we demonstrate a workflow for extracting adverse reaction incidence rates from clinical trials, drug labels and literature. To ensure statistical robustness and comparability between drugs, we identify patient numbers and the monotherapy status of the underlying trials. Using a combination of public and proprietary natural language processing tools, we supplement the extracted incidence rates with dosage, route of administration and formulation data. To compare the results from clinical trials with data from post-market reports, we perform a disproportionality analysis using FAERS data. In this webinar, we will present our approach to solving the challenges in data collection and summarize the top results from both search strategies, using gastrointestinal toxicity as an example.