A meeting was recently held in Lindau, Germany, to discuss the changing face of pharma and biotech, and how companies can best prepare to face the challenges ahead.
“I would like to use the key word echoed throughout Barrack Obama’s successful Presidential campaign last year: change,” said Thomas Taapken, Chief Financial Officer of Biotie Therapies, Finland, in an opening address to attendees of the 2nd Vetter Drug Management Leadership Conference: New Pathways in the Pharma Landscape, held on 2324 September in Lindau, Germany.
Reactions to the turbulent times facing the pharmaceutical and biotech industries can be seen on a daily basis, the most obvious being the recent spate of mega mergers. “More and more people are looking for answers in a constantly shifting industry,” noted Peter Soelkner, Managing Director of Vetter, Germany.
It has been necessary for industry to adapt significantly to change, which has been brought on by factors such as the economy, changing patient needs, intensifying regulations and security threats, to name a few; as a result, the traditional pharmaceutical company business model has become virtually redundant. “We are seeing fewer fully integrated companies,” explained Taapken. “What we are seeing is the forging of more and more partnerships between pharmaceutical firms and companies along each stage of the value chain. It is these partnerships that will drive the success of this industry moving forward,” he added.
The importance of partnerships was discussed by Taapken, who was the meeting moderator, and reiterated by speakers at the conference, which featured an impressive line-up of presentations. The conference sought to provide a picture of the current challenges faced by the pharmaceutical and biotech industries from the regulatory, supply chain and partnership aspects, through to the patient’s perspective and needs.
“Sharing information and views at conferences, such as this, is important so that we can better understand the needs of our customers. Our industry is becoming more and more globalized and it is becoming increasingly important for partner companies, such as ours, to support pharmaceutical and biotech companies at an international level,” explained Soelkner. He made particular reference to Vetter’s new site in Chicago, US, which is expected to open on 1st December 2009 (www.pharmtech.com/vetterchicago).
The conference, which was attended by 64 executives, representing Vetter’s key client base of global pharma and biotech companies, provided insight into the end-user perspective, regulatory changes in Europe and the US, supply chain management, outsourcing, CMO management, industry trends, the value of partnership, and behind the scenes at Vetter.
Changes in the regulatory environment for drug products, for example, have added significantly to the complexity of the drug review and approval process. Barbara Jentges, Managing Director of Phact GmbH discussed some of the key challenges facing industry and explained how the European registration processes were set to change with the eCTD becoming mandatory for electronic submissions for the Community procedures in January 2010. Although this will point towards a more efficient procedure for regulatory document submission, Jentges outlined that the implementation of an eCTD infrastructure requires the commitment to workflow and process changes as well as the adaption to additional requirements. We will be speaking with Barbara Jentges about what this will mean to industry and how companies can adapt to make the process as smooth as possible in an upcoming issue of Pharmaceutical Technology Europe. In addition, a full interview with Barbara Jentges by Pharmaceutical Technology’s Angie Drakulich can be accessed at www.pharmtech.com/jentges
Robert Handfield, Professor of Supply Chain Management at North Carolina State University, US, provided some valuable insight into the multiple challenges associated with clinical trials and the management of the extremely complex supply chain for clinical trial materials as well as the regulatory requirements. He highlighted some of the key concerns amongst supply chain managers and clinical operations personnel, and explained the criticality of good planning, execution, performance evaluation and review of processes and performance. A full interview with Robert Handfield by Pharmaceutical Technology’s Patricia Van Arnum can be accessed at www.pharmtech.com/handfield
Isabelle Controt’s presentation on the effective management of and collaboration with CMOs made for fascinating listening. Calling upon her experience as Head of CMO Management at F. Hoffmann-La Roche and discussing the challenges faced by a global pharmaceutical company, Conrot emphasized the importance of communication and accountability. She explained that the definition of roles and responsibilities for the drug manufacturer and the CMO was absolutely crucial and, although it sounds like a simple concept, is one of the biggest reasons for project failure. Isabelle Conrot will be discussing ways that companies can minimize risks and increase the chances of a successful partnership in an upcoming issue of Pharmaceutical Technology Europe.
Solid, communicative partnerships and standing strong in the face of change were key messages that resonated throughout the conference. In fact, the formation of more elaborate partnerships was predicted by the meeting’s panel as being key to the future survival of companies. Peter Soelkner discusses some of these key challenges and explains how Vetter is working with its partners to succeed in this constantly evolving market at www.pharmtech.com/soelkner
“I picked up a copy of the Financial Times just before coming to this conference and the first page announced the development of a chip by a Swiss pharmaceutical company. The chip was designed for implantation into the shoulder of patients that will alert them if he or she has forgotten to take their medication. This concept would have been completely inconceivable 10 years ago,” said Taapken. “I believe that our market will witness an increasing number of changes in the coming years. As such, we must change the way that we work and develop new pharmaceuticals and introduce new processes to bring these products to life. We need to be ready,” he insisted.
Peter Soelkner discusses Vetter’s commitment to its clients and the 2nd Vetter drug management leadership conference
Q&A with Peter Soelkner, managing director of Vetter Pharma International
Q&A With Compliance Expert Barbara Jentges
Managing the Clinical Trial Materials Supply Chain
Vetter to open new US facility