Pharma challenges & innovative collaboration

Dr. Abina Crean

Having both worked in industry (Elan & Servier Industries) and academia (Trinity College Dublin & University College Cork) for many years, and currently a Principle Investigator and Lecturer in Pharmaceutics in University College Cork, Dr. Crean brings an experienced perspective to the challenges facing the pharmaceutical sector. She also helps and supports Glantreo in applying their nanomaterials to the world of Pharma. She has kindly shared her thoughts and draws interesting comparisons with successful collaboration in EU projects.

The traditional Pharmaceutical world is continuing to wrestle with challenges, that have been highlighted for some years, these include :

• Reduced Pipeline
• Blockbusters coming off patent
• Increased Regulatory Requirements
• Growth of Generics
• Cost of the drug Development Lifecycle

Large Pharma companies have taken similar approaches to addressing the shifting environment and these include strategies such as buying earnings through M&A, development of internal generic pipeline, look to developing global markets (not just the US), development of brand biologics, diversification of their product ranges, and interest in orphan drugs and biosimilars Crucially, there is a general acceptance that traditional internal development practices needed to improve to not only fill the pipelines but to accelerate the rate at which new entities are being developed. In order to achieve this there has been a dramatic increase in innovative collaboration between large Pharma, other large Pharma & Biotech companies, with innovative SME’s and with Academic groups. Each stakeholder plays a vital role in the innovation and development process. Interestingly, the challenges that these approaches bring are similar to those experienced by large EU consortium projects. The challenges are the same and the practices employed to address them, are paralleled. Some examples are as follows:

• IP Negotiation, and the design of “Win-Win” scenarios
• Effective Portfolio and Project Management
• Metric Driven Performance Tracking
• Knowledge Management and effective sharing of information
• Communication Channels
• Cultural differences due to globally integrated project teams
• Management of dispersed Cross Functional Teams

To address the challenges listed above, companies who engage in effective collaboration in the Drug Development space, have systems and structures in place to effectively manage the continual shifting requirements in this arena. For Academics, it means an increased focus on understanding the needs / requirements / pressures of Pharma Companies. Whilst on the Large Pharma side, there needs to be an appreciation of the innovative benefits of Academic groups, and the realization that their flexibility can provide the focus and speed to the development pipeline that large Pharma find difficult to replicate.