The technology of monoclonal antibodies has been developed since the 1990s and is attracting more and more attention in China during the 21st century. The first monoclonal antibody product was introduced by the Chinese local producer in 1999, and presently seven products are listed, of which three are humanized products. There are several technical constraints that are affecting the development of monoclonal antibodies in China: limitations to the number of drug targets, restricted biological diffusion, limitations to administration routes, and species-specific issues, as well as China’s own limitations in production and R&D capabilities. This article provides suggestions relevant for the Chinese development of monoclonal antibodies. In the long run China is expected to catch up with its own technology roadmap.

Full details at the Journal of Commercial Biotechnology

To make basic research transcend the walls of a university for the benefit of the society, technology transfer processes such as patenting, market analysis, and economic assessment are essential. Therefore small dedicated units, called technology transfer offices, have emerged during the last four decades. The emergence is a manifestation of a general political intention to make basic research have direct impact on society – to focus on application and publication, and not just the latter. The process is, however, not straightforward and different universities have different way of doing it.

University of Southern Denmark has recently implemented a highly extrovert and progressive science-based communicative strategy providing an adequate framework for a “grass-roots moving” among researchers. By working on four frontlines we aim to ensure high degree of transparency in the technology transfer activities, to demythologize pseudo-idealistic and inadequate perceptions on the role of e.g. patents, to scout early-stage business opportunities, to map the competence landscape of the university and to ensure a three-faceted political alignment.

We here present what we would call the SDU-model of doing technology transfer anno 2012. Despite the short timeline in which it has been implemented we already harvest the early fruits of the model, which encourage us hereby to present the model, its underlying strategy, its rationale and its perspectives. We believe that the model are unique with respect to the holistic four-frontline focus, addresses some of the major challenges of academic technology transfer and we are confident that universities worldwide could benefit from it or a context-dependent modified versions hereof.

Full details at the Journal of Commercial Biotechnology

Today’s pressure on pharmaceutical companies reflects greater pressures throughout the entire healthcare ecosystem as payers, patients, and providers wrestle with escalating costs and drive  healthcare systems around the world away from being cost-based to becoming value-based.  For pharmaceutical companies, this means not only a greater emphasis on creating value, but seeking new ways to capture value as well, particularly at a time when drugs will need to demonstrate they provide benefits commensurate with their costs and governments and payers squeeze down prices.    The challenge for drugmakers, broadly speaking, is to both find new ways to create value and capture value.

Full details at the Journal of Commercial Biotechnology

Full details at the Journal of Commercial Biotechnology

Abstract – In this article, we address the issues that are involved when developing a strategy for commercializing a discovery that is novel, useful, and non-obvious to someone skilled in the art.  Patent(s) may be used as one means of providing a competitive advantage, and in addition this method is quite common as a means to monetize the intellectual asset.  Alternatively, a more “open-source” method may be employed as is more typical in dealing with software products or services – thereby opening up the field to collaboration and widespread use.  However, other means must then be developed to monetize the asset whether it involves a “hardware” component, software, or both. We argue that to answer these questions, one needs to be very strategic in framing the business model that would be most successful in commercializing the particular discovery keeping in mind that wide dissemination of the innovation is the objective. We focus on issues prevalent for innovation in biopharma, medtech, and medical IT, where high risk, long life cycle, capital-intensive investments are required for commercial introduction.

Full details at the Journal of Commercial Biotechnology

Full details at the Journal of Commercial Biotechnology

On February 19, 2013, the U.S. Supreme Court heard oral argument in Bowman v. Monsanto – the first case to directly present the question of how the Exhaustion Doctrine should apply to patents relating to biotechnology and digital technology inventions.  The Petitioner, Vernon Hugh Bowman, asserts that the Exhaustion Doctrine should be extended to advanced agricultural technologies where the technology itself is contained in genetically modified seeds that may be reproduced through successive generations of seeds without limitation, and that companies like Monsanto can instead rely on remedies found in contract law to protect its commercial interests.  The Respondent, Monsanto Corporation, supported by the U.S. Government, (not surprisingly) disagrees, contending that an extension of the Exhaustion Doctrine of this magnitude would undercut effective patent protection for inventions that may reproduce perfectly over generations, undermining R&D in innovative technologies.  
During the Bowman v. Monsanto oral argument on February 19th, the Justices focused on the broad scope of the exception sought by the Petitioner to patent rights for GM seed as an extension of the Exhaustion Doctrine to biotechnology and digital technology inventions, and did not appear persuaded either that the only reasonable use of the soybeans by Bowman was to plant them or that right holders would find effective modes of protection through contract law.  The Justices noted that this was the first case to present the intersection of the Exhaustion Doctrine and effective protection for inventions that may be reproduced across generations – that intersection to be the issue of greatest interest to the Court in  Bowman v. Monsanto, where the Court may be unlikely to create a sweeping exception to patent rights for biotechnology or digital technology inventions that has not been contemplated by the Congress.

Full details at the Journal of Commercial Biotechnology

This work quantifies the highest risk activities and interdependencies in cell therapy new product development (NPD).  A simulation model based upon an activates based and information driven  approach of the Design Structure Matrix (DSM), using Latin Hypercube sampling methods with discrete event simulation evaluated the interdependencies between critical development tasks.  Input data was collected from quarterly financial reports of cell therapy developers and developmental milestones as reported in company press releases and publications.  .

Successfully planning and managing development processes is problematic in an emerging industry lacking precedents and standardised technology platforms.   Methods of understanding and reducing developmental uncertainty and risk are needed to aid resourcing decisions.  A particular requirement is to understand the impact of process and clinical development, in this highly regulated sector.

Results from the model quantify the probability and impact of process iterations and failures that impact cost and duration of cell therapy NPD.  High impact areas quantified are the interdependence of Phase 1 clinical trials and investment, the scaling of the manufacturing process from Phase 1 to Phase 2 and Phase 2 to Phase 3.  The model also allows for the calculation of the probability of NPD success for given resource levels, time constraints and market conditions.  An application comparing alternative regulatory approaches indicates that the current favoured strategy of targeting an orphan indication gives little benefit for the tested clinic al indication because of reduced clinical trial recruitment rate.  While specifically developed for cell therapy NPD this modelling approach has potential application across the wider biotechnology industry.

Full details at the Journal of Commercial Biotechnology

This chart shows the pharmaceutical drugs with the most patents still in force. The drugs with the most active patents

I will be in Pittsburgh from April 4-5th to give  a talk at Carnegie Mellon’s business school, Tepper, and at