**3. Setting the scene: Nanotechnology in the drug delivery sector**

The drug delivery sector consists of different value chains related to the technology under consideration. A drug delivery system is a formulation or device "that delivers therapeutic agent(s) to desired body location(s) and/or provides timely release of therapeutic agent(s). The system, on its own, is not a therapy, but improves the efficacy and/or safety of the therapeutic agent(s) that it carries."1 These delivery devices can not only be used as carriers for drugs but can also be applied for medical imaging purposes and as carriers for food ingredients. The

<sup>1</sup> From www.drugdel.com/glossbot.htm

**20** 29 Aspects aspects during the development of

These broader discussions

nanotechnology-enabled products.

drug delivery sector, then, is an intersection of two product value chains involving the 'primary manufacturing' of the active pharmaceutical ingredient (API) and the 'secondary manufac‐ turing', i.e. the formulation (including drug delivery systems) and packaging. Both stages of manufacturing can occur within one (integrated) firm or be outsourced to contractors [24]. **<sup>21</sup>**2-3 grounded in understanding of ongoing dynamics in a domain **<sup>21</sup>**3-5 contribute to the further development of participants anticipatory competences by enhancing their insights on what happens support articulation of anticipatory strategies and decision making

**20** 32 foregrounded highlighted

**20** 26 with its associations of both promises and

Developments related to nanotechnologies more

risks

generally

**20** 26/2 7

Dynamics in the sector then come from both chains and their intersection, but also from the broader health care environment in which these chains are embedded. For embedding new drug delivery systems, enactors, e.g. business entrepreneurs, not only need to deal with business dynamics in the world of pharma, but also with broader developments in health care such as overall pressures on cost reduction of treatments, debates on reimbursement. In addition to firms, there are knowledge institutes, clinicians, patients, governmental actors and health insurers. Figure 1 offers a (simplified) overview of actors in the drug delivery sector. at the level of a domain. **21** 10 will have effects will already have effects Please replace figure 1 on page 9 with:

**Figure 1.** Organizations in the drug delivery sector

The design of a CTA workshop can take different shapes, see also [19, 21], but will often be geared toward eliciting actors' perspectives on societal embedding of emerging technologies and to stimulate broadening and enriching of understanding of dynamics in development and future introduction of these technologies. To do so the workshop can be structured around two themes which will be recognizable for participants: (1) identification of challenges, opportunities and directions for development of emerging technologies in a specific domain; (2) identification of ways to cope with challenges and opportunities of these technologies. These are broad themes in order to simulate actors to articulate linkages between emerging technologies like NDDS and aspects of societal embedding and prevent too early lock-ins into particular options or strategies. Such open-ended character will often be unavoidable consid‐ ering the emergent character of the application of technologies. It was intentionally open-

Some reduction of the open-ended character of these two discussion themes will be important in order to have a productive meeting and attract participants. In CTA workshops this is often done by means of a preparatory document which will be given to all participants, justifying and framing the meeting. To link up with interests of potential participants, such a document can identify key issues and dilemmas which will be recognizable to at least part of the participants. In addition the document will contain the scenarios about future developments. These scenarios depart from major challenges in the present situation and explore strategies to overcome them, including the possible responses of actors involved, for scenario method‐ ology see also [15, 20, 22]. In this way the scenarios help to make anticipations of future

Finally, to stimulate an open discussion and overcome possible concerns regarding confiden‐ tiality, a CTA workshop can be held under the 'Chatham House rule'. This rule is as follows: "When a meeting, or part thereof, is held under the Chatham House Rule, participants are free to use the information received, but neither the identity nor the affiliation of the speaker(s), nor that of any other participant, may be revealed" [23]. By adopting this workshop rule, the

Before I will discuss the results of the workshop discussions I will briefly introduce the drug

The drug delivery sector consists of different value chains related to the technology under consideration. A drug delivery system is a formulation or device "that delivers therapeutic agent(s) to desired body location(s) and/or provides timely release of therapeutic agent(s). The system, on its own, is not a therapy, but improves the efficacy and/or safety of the therapeutic agent(s) that it carries."1 These delivery devices can not only be used as carriers for drugs but can also be applied for medical imaging purposes and as carriers for food ingredients. The

developments concrete and can support actors in their formulation of strategies.

organizers aim to create an informal atmosphere and stimulate an open discussion.

**3. Setting the scene: Nanotechnology in the drug delivery sector**

ended in order to allow for open discussion

508 Application of Nanotechnology in Drug Delivery

delivery sector and nanotechnology.

1 From www.drugdel.com/glossbot.htm

The development and introduction of nanotechnologies plays against a backdrop of increasing difficulties of pharmaceutical companies to develop and market new drugs [25, 26]. Nano‐ technology-enabled drug delivery systems promise new solutions. The application of nano‐ technologies which has attracted the most attention is the promise of releasing drugs at a particular target. While there are other targeting approaches, nanotechnology engineered delivery systems are considered to be particularly promising. In a conventional delivery system, the drug is distributed systemically across the body, but this may not always be

3

sufficiently (therapeutically) effective or have adverse toxic effects. For targeted drug delivery there are two general approaches. Drugs can be released near the desired location in the body or drugs can be designed for active or passive targeting purposes. In both cases the application of nanotechnologies (devices and molecules) promises to contribute to targeted delivery.

related to rhetorics of nanotechnology in general and for drug delivery in particular, as well as advances at the level of materials, have created new openings for pursuing targeted drug

Anticipating Market Introduction of Nanotechnology-Enabled Drug Delivery Systems

The application of nanotechnology-engineered drug delivery systems (NDDS) is expected to be beneficial for the generation of novel pharmaceutical therapies and thereby appealing to current pressures on pharmaceutical companies to generate novel therapies. The idea of the magic bullet enabled by nanotechnologies is a powerful image. There are further expectations of the application of nanotechnologies which link up with issues in the drug delivery sector, in particular the challenge of sustaining pharmaceutical business: (1) creating new drugs or extension of patent life of existing drugs by providing new and improved formulations with respect to therapeutical effectiveness and safety; (2) enabling formulations for API's which are difficult to develop pharmaceutically, including promising new biopharmaceutical therapies such as those based on genes. In table 1 an overview of expectations of the applications of

To prepare for a CTA workshop on NDDS it is important to have a solid understanding of dynamics related to the development and introduction of these emerging technologies. To do

major findings in the pre-engagement phase. For an in-depth discussion of dynamics in the drug delivery sector, nanomedicine and pharmaceutical developments more generally, see

For the organization of the drug delivery workshop I co-operated with two (regional) branch organizations. One of them was an association of companies, including large pharmaceutical companies, who develop new pharmaceutical products. The other organization was an association of companies and organizations involved in biotechnology, including pharma‐ ceutical applications. For the former, nanotechnology was not a central topic as it was not (yet) an important theme for its members. Its members are relatively little involved in R&D activities and therefore activities in this area are limited almost by definition as many nanotechnologies are still in a pre-clinical stage. For the other the situation is somewhat different. Biopharma‐ ceutical companies are likely to be interested in nanotechnologies considering the promises

2 Mapping of dynamics linked to nanotechnologies and the drug delivery sector was completed by analyzing relevant reports, papers, conducting interviews and attending international conferences on nanomedicine. Interviews were conducted with experts in the field in order to map opportunities, challenges and dynamics. In addition, interviews were used to find out about existing activities to develop new framing conditions, rules and practices and attempts at co-

Table 2 summarizes

http://dx.doi.org/10.5772/57180

511

so I addressed the pre-engagement requirements mentioned in section 2.2

for (difficult) delivery of macromolecules such as siRNA.

ordination with respect to nanotechnologies and drug delivery systems [11].

delivery.

NDDS is presented.

also [1, 33-35].

**4. Workshop results**

**4.1. Preparing the interactive workshop**

The promise of targeted delivery is not entirely new. The concept of drug targeting is linked with Paul Ehrlich's idea of 'Zauberkugeln', 'magic bullets' introduced over a century ago. The 'magic bullet' refers to the idea of homing in on the target and being effective - in this case affecting only the diseased tissue. Work on what are now considered to be nanotechnology enabled drug delivery systems has evolved since the 1960s [27-29] – although not exclusively related to targeting. Systems which are currently labeled as 'nanovehicles' have existed for some time, such as liposomes and polymer micelles (1960s), nanoparticles and dendrimers (1970s) [30]. The connection with the term 'nano' can thus be considered as a relabeling of what was already occuring.


**Table 1.** Expectations of nanotechnology enabled drug delivery systems

Considering the history of drug delivery systems, promises of the application of nanotech‐ nologies may not be very effective in mobilizing actors. According to Boyd [27] the claim that "advances in nanotechnology are stimulating a 'revolution' in colloidal drug delivery" should be reconsidered given evolutionary developments over the last decades. Available funding related to rhetorics of nanotechnology in general and for drug delivery in particular, as well as advances at the level of materials, have created new openings for pursuing targeted drug delivery.

The application of nanotechnology-engineered drug delivery systems (NDDS) is expected to be beneficial for the generation of novel pharmaceutical therapies and thereby appealing to current pressures on pharmaceutical companies to generate novel therapies. The idea of the magic bullet enabled by nanotechnologies is a powerful image. There are further expectations of the application of nanotechnologies which link up with issues in the drug delivery sector, in particular the challenge of sustaining pharmaceutical business: (1) creating new drugs or extension of patent life of existing drugs by providing new and improved formulations with respect to therapeutical effectiveness and safety; (2) enabling formulations for API's which are difficult to develop pharmaceutically, including promising new biopharmaceutical therapies such as those based on genes. In table 1 an overview of expectations of the applications of NDDS is presented.
