Biotechnology Entrepreneurs Research Articles

Lean Start-up: A Comprehensive Case Study in the Establishment of Affordable Laboratory Infrastructure

Historically, innovation in the biotechnology sector has relied to a large extent on the expensive infrastructure provided by universities or large pharmaceutical companies. This prohibitive start-up expense is the basis of why garage-style biotechnology entrepreneurs are exceedingly rare as compared to their software and high-tech counterparts. Recent consolidation among pharmaceutical companies and the release of next generation research equipment has produced an affordable surplus in the secondary equipment markets, reducing the barrier to entry posed by equipment expenses. We examine the biotechnology start-up Ichor Therapeutics, Inc., and review strategies that the founding team has successfully employed to establish an affordable laboratory, reduce research expenses, and promote communication among team members.

Indian entrepreneurship in biotechnology comes of age

Biotechnology is one of the fastest growing, knowledge-driven industries in India and is expected to play a key role in shaping India’s rapidly developing economy. Since its inception in 1986 the Department of Biotechnology (DBT) has been guiding to foster growth of Indian biotechnology with a range of initiatives. Indian biotechnology industry registered over 3.0 billion USD revenue generation in 2009–10, which constitutes about 2 % share of the global biotechnology market. More than 300 companies are engaged in different biotechnology sectors in India, majority of which are clustered in western and southern regions. Biopharmaceuticals is the largest biotechnology sector in India with about 62 % market share. Bioservices ranked second due to the upward trend in a range of service oriented research activities. Bioagriculture recorded highest growth in 2009–10 and is dominated by insect resistant transgenic cotton. Bioindustrial, which deals with production of enzymes for different industrial uses, is the smallest biotechnology sector in India with 6 % revenue share.

A general model for training the next generation of Biotechnology entrepreneurs based on recent experience of USA-UK-South Africa collaborations

Preparing students for future entrepreneurial activity in the biotechnology industry is an important issue in many parts of the world because most countries seek to reap the benefits of investments in university-based teaching and research through the development of a knowledge-based economy driven by a highly skilled work force. The current generation of biotechnology students will begin their professional lives in a globalized society. This means that flexibility, creativity and critical thinking are essential personal skills that need to be cultivated by students at universities in order for graduates to be competitive in the job market of a fast-moving world. It is no longer sufficient for universities to teach students to be passionate about science and to enjoy learning and discovering new things. Biotechnology students, in particular, need to be trained to identify the connections between science and its commercial applications.

Editorial: The Biotechnology Entrepreneurship Boot Camp: From Lectern to Printing Press

This issue of the Journal of Commercial Biotechnology focuses on the proceedings of the Seventh Annual Biotechnology Entrepreneurship Boot Camp held in conjunction with the Biotechnology Industry Organization (BIO) annual conference in Washington, DC in June, 2011.The Biotechnology Entrepreneurship Boot Camp was launched for the 2005 BIO Industry Organization’s Annual Meeting in Philadelphia. The Boot Camp was originally designed as a program for CSOs but is now expanded in scope and design to address a broad range of issues for entrepreneurs more generally. The Boot Camp was created in response to the growing need in the managerial, scientific and academic community to learn about the necessary elements and skills to transform technology and invention into a viable company. The insight and energy required for entrepreneurial success can be developed by anyone motivated to do the following: think strategically, select projects and plan for expeditious and cost-effective management, understand the requirements of all the involved stakeholders, and oversee the essential components of the commercialization process. The Boot Camp travels from year to year to each of the BIO Annual Meeting venues – a veritable “moveable feast.” Previously, the Boot Camp was offered at BIO’s annual meetings in Chicago in 2006 and 2010, Boston in 2007, San Diego in 2008, and Atlanta in 2009. The creation of the syllabus, the recruitment of faculty, and the faculty’s extensive preparation suggested that wherever possible there should be core faculty, i.e., a portion of the faculty from the Philadelphia Boot Camp who would volunteer from year to year. This approach has the added benefit of improving the presentations and the material from year to year as the faculty themselves identify what works, as well as how to teach together. Each year, additional faculty members are recruited from the host region. Over the seven years of the boot camp, over 500 entrepreneurs have attended and taken away a broad spectrum of insights from the faculty. The Boot Camp was founded and co-chaired by Professors Arthur Boni of the Tepper School of Carnegie Mellon University, Stephen Sammut of the Wharton School and Burrill & Company, and Jeffrey Libson, Partner, Pepper Hamilton LLP and Lecturer at Wharton School Health Care Management Program. The law firm, PepperHamilton has also served as the Boot Camp’s sponsor since its inception.

Roles of histone deacetylases in epigenetic regulation: emerging paradigms from studies with inhibitors

The zinc-dependent mammalian histone deacetylase (HDAC) family comprises 11 enzymes, which have specific and critical functions in development and tissue homeostasis. Mounting evidence points to a link between misregulated HDAC activity and many oncologic and nononcologic diseases. Thus the development of HDAC inhibitors for therapeutic treatment garners a lot of interest from academic researchers and biotechnology entrepreneurs. Numerous studies of HDAC inhibitor specificities and molecular mechanisms of action are ongoing. In one of these studies, mass spectrometry was used to characterize the affinities and selectivities of HDAC inhibitors toward native HDAC multiprotein complexes in cell extracts. Such a novel approach reproduces in vivo molecular interactions more accurately than standard studies using purified proteins or protein domains as targets and could be very useful in the isolation of inhibitors with superior clinical efficacy and decreased toxicity compared to the ones presently tested or approved. HDAC inhibitor induced-transcriptional reprogramming, believed to contribute largely to their therapeutic benefits, is achieved through various and complex mechanisms not fully understood, including histone deacetylation, transcription factor or regulator (including HDAC1) deacetylation followed by chromatin remodeling and positive or negative outcome regarding transcription initiation. Although only a very low percentage of protein-coding genes are affected by the action of HDAC inhibitors, about 40% of noncoding microRNAs are upregulated or downregulated. Moreover, a whole new world of long noncoding RNAs is emerging, revealing a new class of potential targets for HDAC inhibition. HDAC inhibitors might also regulate transcription elongation and have been shown to impinge on alternative splicing.

Separating hype from reality in the era of the affordable genome

Early adopters of new technologies often pay more than people willing to wait for prices to drop, but few have seen the cost of their purchase plummet like Dan Stoicescu. In 2008, Stoicescu, a successful biotechnology entrepreneur, became the second person to purchase his entire genetic sequence.

Coherence as an Alternative to Strategic Complementarity at an Entrepreneurial Firm

Organisational change processes are complex, idiosyncratic, and seemingly nonstochastic. Theories of strategic complementarity present change as the evolution of systems of mutual reinforcement among heterogeneous elements within the firm. This paper combines theories of strategic complementarity and entrepreneurial sense-making to develop an alternate heuristic of entrepreneurial adaptation as a search for coherence. Within a framework of narrative rationality, I define coherence as inference or search for the best explanation. A case study of organisational change at an entrepreneurial biotechnology firm provides the backdrop for the modeling exercise. A constraint satisfaction model reveals coherent systems of heterogeneous organizational elements. The model recapitulates organizational structuring observed at the firm. The success of the organization despite violating the primary heuristic of complementarity suggests that strategic theories of fitness must be applied with caution in entrepreneurial contexts. This paper contributes to the study of fitness generally and the specific application of fitness regimes in entrepreneurial contexts, specially when high uncertainty and resource scarcity limits strategic analysis and implementation.

Biotechnology entrepreneurship - where no research has gone before

Many researchers have a scientific interest in taking their translational studies from bench to bedside. They want to take their ideas and see how far they can go towards bringing medical solutions to as many patients as possible. However, it can be frustrating when the clinical development of their work is beyond the scope and capabilities of their university or hospital. Even for those institutions with research beds, studies are usually limited to small, pilot studies. Even for those institutions with the necessary financial support, the manufacturing, regulatory, and legal essentials are not in place to evolve such studies to larger, later-stage human trials. This is nothing new. What is new is the rising tide of researchers turning to the for-profit world. Either directly - by starting their own companies, or indirectly - by working with existing pharmaceutical and biotechnology companies, researchers are moving more and more technologies towards the marketplace. Biotechnology Entrepreneurship: From Science to Solutions provides a real-world introduction to starting and growing life science companies, as well as useful material for medical researchers interested in getting their technologies to as many patients as possible.

Emerging Indian entrepreneurship in biotechnology and National Innovation System: exploring linkages and prospects

The recent expansion of Indian biotechnology industry backed by strong R&D allocations sets the upward movement of the industry on a new growth trajectory intertwined with innovation and entrepreneurship. This is most likely to take off Indian biopharma industry from 'bio-generics' and 'bio-similars' to a higher pedestal where it may develop 'proprietary processes', carving a new niche for the growth of the sector, giving further push to R&D-intensive activities. The issue is how National Innovation System (NIS), which could provide initial manpower and financial support to the sector, responds to the growing specialisation of the Indian biopharma and help evolve new strategies to sustain the growth in the high-end biopharma sector.

Collaboration – a competitor's tool: The story of Centocor, an entrepreneurial biotechnology company

Biotechnology companies have relied on alliances for survival and growth since their inception. This history of Centocor illustrates the pivotal role collaborations played for pioneers in the industry. Five years after its founding Centocor had become a competitive and profitable diagnostics company based on partnerships with research institutes and larger health care companies. In 1992, however, Centocor faced collapse, brought on by a departure from collaboration and going it alone in the development and marketing of the company's first therapeutic. What saved the company and enabled it to prosper in therapeutics was a reversion to the old strategy of collaboration.

Networking: The “Missing Link” in Public R&D Support Schemes

ABSTRACT This article reviews the support tools available for young biotechnology firms in Israel and points out the need to expand these tools to the area of networks. Such a service would be of specific importance to biotechnology entrepreneurs who have a relatively low starting point in terms of relevant social capital, limited business, and managerial experience. If public support schemes are to support innovation they must broaden their range of services and not focus solely on R&D.

The formation of subsequent inter-firm R&D partnerships between large pharmaceutical companies and small, entrepreneurial biotechnology firms – how important is inter-organisational trust?

This paper analyses the role of inter-organisational trust in pharmaceutical biotechnology, an industry characterised by a strong dual market structure. Our main finding is that repeated ties in pairs of large pharmaceutical companies and small, entrepreneurial biotechnology firms, which indicate inter-organisational trust, have a negative effect on subsequent partnering. An explanation for this result is found in specific conditions for R&D partnering in this high-technology dual market structure. Partnerships between a small number of very large companies and a large group of dependent small companies are not characterised by mutual dependence and inter-organisational trust.

European asymmetries: a comparative analysis of German and UK biotechnology clusters

This paper updates to 2006 material first gathered in the late 1990s. Though Germany has about the same number of firms as the UK its biotechnology economy is far weaker, with many small firms employing few people, relatively low venture capital investment and little interest being shown by pharmaceuticals companies in licensing intellectual property. The reverse is the case in the UK even though the investor euphoria at the time of the first comparative study has not returned. A new policy of ‘entrepreneurship outsourcing’ has become visible in the UK as venture capital perceives a better business climate for biotechnology entrepreneurship in the USA. Recent developments of this kind may add to debilitating European problems, loosening more proximate links within national and regional innovation systems widely perceived as highly important elements in biotechnology cluster performance. Copyright , Beech Tree Publishing.

Strategic Considerations for Innovation and Commercialization in the US Biotechnology Sector

This paper examines the importance of alliances as an innovation strategy utilized by US biotechnology firms. In doing so, the role of alliances with universities vis-à-vis alliances with industrial companies is emphasized. The biotechnology sector is dominated by few large and many small firms. The small firms are research focused or technology developers. Several large firms are now integrated biopharmaceutical companies. Very few small firms can survive without strengthening their relationships with universities, biotechnology or pharmaceutical or other large companies. These relationships range from licensing agreements, export–import connections to various forms of alliances for R&D, product development and marketing. Large firms supplement in-house R&D by acquiring research products and/or new technologies from small firms as well as universities. A survey of US biotechnology companies is used to show the emergence of alliance relationships, which continue to highlight university linkages, emphasize connections of biotechnology firms with other biotechnology entrepreneurs, and an ongoing effort to build a synergistic relationship with pharmaceutical or other large companies. Most linkages are not confined to the local area; the main locational attribute is the science base or the labour market.

Technological Entrepreneurship and Capability Building in Biotechnology

The question addressed in this paper is whether and how intermediate developed countries (IDCs) can profit from the possibilities opened by globalisation to set off processes of capability building in advanced technological sectors. While most debates have taken place in the Information and Communications Technology (ICT) field, the paper addresses the case of biotechnology. It is argued that, given the specific characteristics of biotechnology, opportunities may emerge for technology-intensive entrepreneurial initiatives in countries that have developed a reasonable science base and built the capacity to connect to and plug into international biotechnology networks. The exploitation of these opportunities requires strategies that combine good indigenous scientific competences and a pool of skilled human resources, with transnational linkages, and that rely on firms’ abilities to find a position in globally coordinated ‘knowledge value chains’. The paper conducts a first assessment of the viability of this approach, drawing on empirical research on ‘distant networking strategies’ adopted by Portuguese new biotechnology firms.

What is “Business Development”? — The Case of Biotechnology

"Business development" (BD) is an often used, but not well defined, term in the business world. Taking a strategy-as-practice perspective as a background, we explore the daily activities of BD in the German biotechnology industry. We show how BD tasks are defined and how they are fulfilled, what resources are used for this function and how it is organized. We compare our results with insights from the strategic management literature and show that business development is an example of what a modern type of planning might look like, but that it may be misleading to see the BD function in biotech firms in the same way as the dynamic capability the literature assumes. By doing this analysis, we contribute to an understanding of how entrepreneurial biotechnology ventures operate, and how they do their "strategizing" and "organizing" work.

Innovation and Entrepreneurship in Biotechnology, An International Perspective: Concepts Theories and Cases

Innovation and Entrepreneurship in Biotechnology, An International Perspective: Concepts Theories and Cases

Innovation and Entrepreneurship in Biotechnology, an International Perspective: Concepts, Theories and Cases

Innovation and Entrepreneurship in Biotechnology, an International Perspective: Concepts, Theories and Cases Damian Hine and John Kapeleris Edward Elgar Publishing, Cheltenham, UK; ISBN 0 851 199 056 8; April 2006; 272 pp

Brazilian high-tech entrepreneurs' perceptions and attitudes towards venture capital

This paper approaches entrepreneurship from a cultural perspective, analysing the entrepreneurs' cognitive world. A web-questionnaire captured the perceptions and attitudes towards venture capital held by Brazilian information technology and biotechnology entrepreneurs, which is further subdivided into incubated and non-incubated groups. The paper is organised in three parts. First, it explores the expectations held by entrepreneurs in seeking venture capital. Results show that the main reason for seeking venture capital is to 'establish partnership for strategic planning'. However, there are contrasting perceptions within the paired sample groups. Second, entrepreneurs' beliefs and feelings towards venture capital were examined. Data indicates that entrepreneurs generally hold overall favourable beliefs towards venture capital. Third, the analyses of the consequences of venture capital anticipated by entrepreneurs show that sample groups emphasise different positive impacts. Furthermore, reduction in managerial flexibility is the most significant worry expressed in entrepreneurs' assessment of venture capital outcome.

Crisis management in entrepreneurial biotechnology companies: an explorative case study

Biotechnology startup companies are often based on little more than a technology with the potential to contribute to the development of innovative products in the future. Failure of this technology leads to a life-threatening crisis for these firms; managers must react quickly to ensure survival of their companies. The existing literature does not provide information on how biotechnology startups successfully escape technology breakdown crises. In this work, we present an in-depth case study of a biopharmaceutical startup company that suffered and successfully escaped a technology breakdown crisis. We illustrate its project acquisition strategy as well as management of financial, organisational, human and social resources after the breakdown. Our findings have implications for managers of entrepreneurial biotechnology firms.