Bioassays & Bioanalytical Method Development Session Spotlight: Anticipating and Assessing the Immunogenicity of Biologics—A Scientific and Regulatory Perspective

Cell-based assays are extremely challenging to use due to their innate uniqueness and the need to interpret them through complex statistical analysis programs. At the same time, FDA regulators often require the use of a NAb assay in order to test immunogenicity and demonstrate product safety – meaning this is a challenge that practitioners in this field cannot avoid. In this session Dr. Martin Lechmann, Associate Director of DMPK at Merck Serono, will provide specific case studies of methods to decrease the development time of these assays, while also increasing robustness, reproducibility, and potential for automation.

For more information on Bioassays and Bioanalytical Method Development, download the agenda.  If you'd like to join us in Berkeley, CA this October 1-3, 2012, as a reader of this blog when you register to join us and mention code XP1768BLOG, you'll save 15% off the standard rate!

Featured Session: Novel Approaches for the Detection of Neutralizing Antibodies
Featured Speaker: Martin Lechmann, PhD,Associate Director, DMPK, MERCK SERONO
About the Session: The development of reliable Nab assays is very challenging and takes a lot of time and resources until a validated NAb assay is up and running. Usually not only the development time is long but also the assay itself can last several days. Thus, cell-based Nab-assays are in general not suitable to analyze high number of samples. In addition, cell-based Nab assays are often susceptible to matrix background and special care has to be taken to assure that the neutralizing effects are attributed to antibodies. Particularly, robustness and reproducibility present major challenges. Therefore, new approaches are needed to decrease the development time and to increase the reproducibility of these assays. We will present different novel approaches with the aim to develop NAb assays that are more robust and have the potential for automation. These approaches include miniaturization of cell cultivation using Lab-on-Chip Technology and ready to assay cells.

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DDP 2010: The Future of Invasive Drug Delivery- Maximize the Value of Drug Delivery by Designing for Improved Patient Adherence

Moderator: Mathias Romacker, Principal Business Analyst, Amgen
Tomas Landh, PhD, Director, Strategy & Sourcing, Novo Nordisk A/S
Simon Exell, Director, Life Cycle Management, Devices and Formulation, Merck Serono
Gerhard Mayer, Director of Marketing and Life Cycle Management, Bayer Schering
Jonathan Rigby, Co-Founder & Vice President, Business Development, Zogenix. inc.

Where is needle-free injection going? It will only be adopted if a need is satisfied, and the need must exist. Just like humans have evolved, so has technology. Needle technology has greatly evolved over the last few decades. They’re now more robust systems that can be filled and reused by the patients.

In a large market, many systems will be available. Do they co-exist or compete? The different technologies are addressing different medical needs. They’re demonstrating that they’re meeting patient requirements. Any company could provide many different ways to provide administration. Why? Not all patients are the same, many different patients throughout the world will be using the devices.

It is important that patients adhere to their medications. This is a big problem in the market. Poor outcomes from patients not taking their medicine as prescribed have a large impact. The drug delivery industry can help find a way so that patients find it easy to take their medication, and therefore a more adherent.

Most patients are not willing to pay more for a general delivery system, tradeoffs for less expensive products are a factor, and they expect that biotech generics will begin to appear.

Q: If “the traditional drug delivery model is dead” why should a company with a new needle free technology partner with big Pharma at all?

They should still partner with big Pharma, but also develop the ability to commercialize the product themselves. They develop products within technology. The technology has a capability, you should get an ROI on your technology. You should sell your high value products.

Q: Have needle based technologies peaked or are they advancing?
Needle based systems will continue to invest. There are more proteins and products coming to the market that will make this necessary. Competitive environment is stimulating as a whole, so needle and needle-free technology will continue to expand and grow. There are more therapies coming along that could replace these therapies.

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