IMPALA Podcast Series
IMPALA Podcast Series – Subscribe via Spotify so you never miss an episode!
Sharon Havenhand and Jeremy Jones are the hosts of this new IMPALA Podcast Series, where they invite guest speakers to join them in discussing key topics from the IMPALA space and share the impact it is having across the biopharmaceutical industry.
Check out the episodes below:
- In this episode Sharon and Jeremy are joined by Timothe Menard, Co-Founder of IMPALA and Mike Pelosi, Co-Chair of IMPALA’s Strategic Steering Committee and Co-Lead of the Education Work Product Team. Listen as we discuss what IMPALA is and what they are trying to achieve.
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You’ll also get the chance to hear more about the current IMPALA work products, Tim and Mike’s vision for the future of IMPALA before they wrap up with how you can get involved!
Episode 2: The Data Driven Quality Professional
- In this episode Sharon and Jeremy are joined by Mike Pelosi, Co-Chair of IMPALA’s Strategic Steering Committee and Co-Lead of the Education Work Product Team, Joanna North, Co-Lead of the Education Work Product Team and Roshan D’Souza, Member of the Education Work Product Team.
- Listen as they delve into the industry-leading initiatives of the IMPALA Education Work Product Team and learn about what’s key to becoming a Data-Driven Quality Professional in the dynamic world of biopharma.
Episode 3: Introduction to Data Basics
- In this episode Sharon and Jeremy are joined by Mike Pelosi, Co-Chair of IMPALA’s Strategic Steering Committee and Roshan D’Souza, Chair of IMPALA and Member of the Education Work Product Team.
- Listen as they take it back to the basics and answer fundamental questions such as:
What exactly do we mean by Data?
How are we using Data we are generating?
Has data replaced Oil as the most valuable resource in the world?
They also discuss the emerging world of Generative AI and its application in the BioPharma Industry.
Don’t miss out on these valuable insights, tune in now!
Publications
An Open-Source R Package for Detection of Adverse Events Under-Reporting in Clinical Trials: Implementation and Validation by the IMPALA (Inter coMPany quALity Analytics) Consortium
April 2024 – Therapeutic Innovation & Regulatory Science
Authors: Björn Koneswarakantha, Ronojit Adyanthaya, Jennifer Emerson, Frederik Collin, Annett Keller, Michaela Mattheus, Ioannis Spyroglou, Sandra Donevska & Timothé Ménard On behalf of the IMPALA (Inter coMPany quALity Analytics) Consortium
Roche/RQA Collaboration: Impact of the Certificate in Data Basics eLearning in the Pharmaceutical Industry, Including the Launch of IMPALA Consortium
May 2023 – QUASAR – a Journal of RQA
Authors: Timothé Ménard, Sharon Havenhand
Cross-company collaboration to leverage analytics for clinical quality and accelerate drug development: The IMPALA industry group
July 2021 – CPT Pharmacometrics & System Pharmacology
Ménard T, Young K, Siegel L, Emerson J, Studt R, Sidor L; IMPALA Industry Group. CPT Pharmacometrics Syst Pharmacol (2021).
Author: Timothé Ménard et al.
Completed Work Products
Disclaimer: All work products published by the IMPALA Consortium are released “as is.” It is the user’s responsibility to validate any information/product. Any express or implied warranties, including those to the accuracy or completeness of any information published are disclaimed. In no event shall IMPALA be liable for any direct, indirect, incidental, special, exemplary, or consequential arising in any way out of the use and/or publication of this product.
Open-source Package for Clinical Safety reporting
The IMPALA Clinical Safety Reporting Work Product Team has developed an open-source R (statistical analysis software) package called {simaerep} that calculates the probability of under-reporting of adverse events for all clinical trial sites in a given study using only patient-level AE and visits data. {simaerep} is available publicly on github (https://openpharma.github.io/simaerep/). It follows general good practices and standards for R packages, has a high unit test coverage which is tested by an automated pipeline which creates a validation report that is attached to the latest release.
Read more about the package here.
Work Product Team Leads: Ronojit Adyanthaya and Björn Koneswarakantha
Conferences
Case study – Leveraging analytics for remote clinical quality oversight
This case study, presented at the 2nd APEC – Asia-Pacific Economic Cooperation Roundtable Dialogue, discusses opportunities for Post-Pandemic Regulatory Innovation Convergence, such as how analytics can help detect and mitigate issues faster, reduce the burden of retrospective, time-consuming traditional QA activities and ultimately accelerate approval and patient access to innovative drugs. View the full presentation here.
RQA Workshop on Data Analytics
The goal of the RQA Workshop Work Product Team was to engage with Industry and Inspectors in an open dialog on how Data Analytics can be used to speed up Drug Development. The workshop took place at the RQA Conference in Brighton in November 2022, and resulted in lively discussion and wide-ranging ideas.
View the summary, write-up, and video here.
Work Product Team Leads: Joanne Donald and Timothe Menard
DIA Global 2023
The DIA Global Meeting held in Boston from June 25-29, 2023, brought together professionals from the pharmaceutical industry, regulatory agencies, and research organisations. IMPALA was grateful to have a great delegation of members and to have three sessions to showcase some of the work products the Consortium is focusing on. It also afforded the group a chance to connect in person for collaborative exchange and conversation. Click for details on the different sessions where IMPALA was represented.