PharmaLex Talks

Summary:
A lot of statistical work within pharmaceutical companies is repetitive and this costs money and resources, especially if it’s done within GxP environments where there is often a need for double programming, extensive data quality control and meticulous follow-up of procedures. The podcast explores requirements and ways  to  develop fully automated solutions and processes to address this repetition and improve overall business efficiency.

Speaker:
Davor Josipovic is senior manager statistics and data science at PharmaLex, focusing on developing innovative solutions for questions the pharmaceutical industry faces, using applied mathematics, probabilistic modelling and machine learning.

Links:
General page:
https://www.pharmalex.com/pharmalex-departments/data-science-in-pharmaceutical-industry/

Custom solutions:
https://www.pharmalex.com/software-login/

A strong quality culture in the biopharmaceutical industry is one in which all participants in the organization understand patient safety and how their roles impact patient safety risks. It is one where decisions are prioritized based on patient safety first. From a GMP perspective, that means not only abiding by the formal law but knowing the applicable current best practices, understanding the risks a company’s processes and products pose to patients and implementing effective quality risk management practices.

About the speaker:
Londa Ritchey is Quality Director with the Quality Management and Compliance group at PharmaLex.

There are unique considerations and nuances to the US Food and Drug Administration’s (FDA) pre-submission process for medical devices that companies need to consider. Known as the Q-submission (Q-sub) program, these pathways are a way of communicating with the regulator to obtain their feedback on particular topics that are germane to both the manufacturer and the regulator.

About the speaker:
Mohammad Asad is the Regional Sales Manager – Asia Pacific at PharmaLex, where he draws on his consulting and industry experience in Australia, the US, and Singapore and on his engineering analytical background to help start-ups and large companies alike bring new and novel technologies to market.

With pharmaceutical companies increasingly turning to outsourcing partners to support maintenance of marketed products, efficiency and reliability are imperative. Digitalization, in particular automation and AI, plays an integral role in streamlining processes and enhancing that outsourcing relationship.

Timm Pauli is Vice President and head of R&D informatics at PharmaLex, where he combines his informatics and systems expertise with his experience in the pharmaceutical industry. Timm has been with PharmaLex for more than 8 years in a series of senior roles. Before joining PharmaLex, Timm worked in various technology-driven R&D roles at leading pharmaceutical and healthcare companies. Timm has a degree in medical informatics.

Jim Nichols, Chief Product Officer, brings over 20 years’ experience with compliant software solutions for regulated processes to Phlexglobal. Jim has served in senior management positions at Liquent, Thomson Reuters and DitaExchange. He has a Bachelor of Science in Mathematics from The Pennsylvania State University.

This podcast introduces the concept of strategic product development as part of an integrated strategy to bring new drugs to the patients that need them. This holistic approach helps to save time, reduce overall development costs, and identify and mitigate risk throughout the product lifecycle. 

Introduction:
The ICH-Q2 and ICH-Q14 together describe the development and validation activities proposed during the life cycle of an analytical method to assess the quality of medicinal products. But what is it that defines the quality of a reportable value? The podcast explores how Bayesian statistics makes it possible to take an observation made during the validation of the analytical procedure and predict the uncertainty around any future result, and in so doing bridge the gaps that exist in the guidelines.

About the speaker
Bruno Boulanger, Ph.D., is Global Head Statistics and Data Science at PharmaLex, where he draws on his many years of experience in several areas of pharmaceutical research and industry including discovery, toxicology, CMC and early clinical phases. Bruno has authored or co-authored more than 100 publications in applied statistics. He organizes and contributes to Non-Clinical Statistics in Europe and, in 2010, set up the First Applied Bayesian Biostatistics conference.

Brad Carlin is a statistical researcher, methodologist, consultant, and instructor.  He currently serves as Senior Advisor for Data Science and Statistics at PharmaLex, an international pharmaceutical consulting firm.  Prior to this, he spent 27 years on the faculty of the Division of Biostatistics at the University of Minnesota School of Public Health, serving as division head for 7 of those years.  He has also held visiting positions at Carnegie Mellon University, Medical Research Council Biostatistics Unit, Cambridge University (UK), Medtronic Corporation, HealthPartners Research Foundation, the M.D Anderson Cancer Center, and AbbVie Pharmaceuticals.   He has published more than 185 papers in refereed books and journals, and has co-authored three popular textbooks: “Bayesian Methods for Data Analysis” with Tom Louis, “Hierarchical Modeling and Analysis for Spatial Data” with Sudipto Banerjee and Alan Gelfand, and "Bayesian Adaptive Methods for Clinical Trials" with Scott Berry, J. Jack Lee, and Peter Muller.  From 2006-2009 he served as editor-in-chief of Bayesian Analysis, the official journal of the International Society for Bayesian Analysis (ISBA).  During his academic career, he served as primary dissertation adviser for 20 PhD students.  Dr. Carlin has extensive experience teaching short courses and tutorials, and won both teaching and mentoring awards from the University of Minnesota. During his spare time, Brad is a health musician and bandleader, providing keyboards, guitar, and vocals in a variety of venues.

Under the Medical Devices Regulation economic operators – that is manufacturers, the authorised representative, importers and distributors – all face new roles and obligations. While some of these responsibilities existed under the Medical Devices Directive, workload will be impacted. From requirements around Eudamed, to having a person responsible for regulatory compliance, to ensuring certain obligations are properly followed through to complaint management, the roles of all economic operators are affected and require careful consideration by companies with devices in the European market.

Clare Huntington is Director and Head of Medical Devices / IVD UK at PharmaLex

Clare leads the UK and EU teams and consults on industry-wide issues including drug/device combination products, clinical trials, device classification and regulatory submissions, and post-market requirements. Clare has worked in a variety of roles in the medical device space during her career, including the MHRA, a Clinical Research Organisation, as an EU Authorised Representative, as well as industry, leading the regulatory affairs activities. This has given her a broad understanding of the EU regulatory landscape which enables her to provide comprehensive advice to clients that covers the full product life-cycle. 

The next frontier in outsourcing is the management of established marketed products, which provide the opportunity to sustain revenue, keep maintenance costs low and ensure compliance of mature products.

A recent survey of senior pharmaceutical and biotech executives explores why IPD programs are becoming an increasingly important strategy to successfully bring a new drug to market. 

To find out more, we speak with Frédéric Pailloux, Senior Director, Head of Integrated Product Development & Consulting, at PharmaLex.