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Successful start-up formation is one of the key ingredients to building a bio-economy, as noted in the Department of Science’s (DST’s) most recent strategy paper. Biotech start-ups require eco-systems to thrive, a fact noted by 100s of hubs across the world, who compete for talent and investment, in their own endeavors to advance bio-economic development.

Over the last 3 years, the CPGR applied part of its resources to creating a biotech start-up ecosystem. The process started in 2016, with providing space and other resources to a food testing start-up, Tokeid Biotech. The decision was based on the notion that we had built a unique infrastructure, with concomitant capabilities (including human resources, SOPs, quality management systems); and, that this could be leveraged to support entrepreneurial ventures. In 2017, we followed with creating a subsidiary, Artisan Biomed, to use CPGR capacity to implement, develop, and offer Precision Medicine solutions for the South African and African health sectors.

These activities are linked to one of CPGR’s strategic goals (SG5, Table 1), i.e. to render investments made into businesses, through public or private means, successful. Another key consideration is to support the creation of an increasing number of businesses that will make use of, and grow, CPGR capacity, in turn benefiting the entire ecosystem (‘a rising tide lifts all the boats’). All activities put a strong emphasis on tackling socio-economic challenges, e.g. job creation or improved provision of medical services.

Table 1: CPGR vision, mission, strategic goals

Initially, we put a strong focus on providing access to infrastructure, resources and capabilities, considering this a main catalyst for start-up creation. Over time, we realised resource provision alone is not enough an ingredient to build a successful biotech start-up support ecosystem.

I’ll elaborate in the following how our outlook has changed in the process of 3 years.

In 2017, CPGR entered discussions with a team of entrepreneurs, Michael Fichardt and Dr Nick Walker, who promoted the idea of creating a bespoke biotech incubator, emulating successful models in other countries (e.g. IndieBio). The team garnered further support from CiTi, South Africa’s oldest incubator organisation, leading to the formation of a new venture, OneBio, in early 2018. The following months were characterised by an iterative process of business development, stakeholder engagement, and fund raising.

This post is not a detailed description of OneBio’s success story but, rather, a reflection on observations we made through the involvement in different types of incubation programs, with respect to the needs and wants expressed by South African and African entrepreneurs; and the value CPGR can add at various steps in the process. These observations were made over the course of 12 months. So, it’s likely that the views expressed below will further evolve over the coming months.

Conceptually, start-ups we have engaged with are passing through a series of stages, as schematically shown below (Figure 1):

Figure 1: Start-up development phases

  • University education: although not exclusive, most individuals who consider the creation of a biotech start-up are University educated. This is where an increasingly in-depth ‘hassle’ with a science or medical discipline as well as related technological aspects occurs. An issue is that the common performance indicators at University (e.g. # of publications, # of patents, or # of graduates) are not metrics that necessarily prepare, align with, or qualify for becoming an entrepreneur. A common misconception is that publication or patenting track record preconditions a University, or one of its departments, or a student, for success with start-up creation (consider the lack of reproducibility, in general, of published data as one of the key problems in this respect). Nevertheless, at University, entrepreneurial ideas, concepts, plans, or prototypes, are formed and a need for start-up support emerges. At this stage, CPGR’s support is indirect, through services and trainings offered with respect to Genomics and Proteomics technologies, as well as in Bioinformatics. This is based on CPGR’s own involvement in over 1000 projects since its own formation, executing more than 700 successfully.
  • Pre-incubation: in 2018, we designed a one-week ‘boot camp style’ program, to engage with prospective entrepreneurs in a structured fashion, ending in a pitching contest. A first program was held in collaboration with the UWC, towards the end of 2018. The program is aimed at exposing entrepreneurs to key concepts, with relevance to building start-ups. It’s also where existing ideas, concepts, or plans are shaped and modified, or new ones are conceived and developed. A value CPGR can add here is helping to stratify start-ups through exposure to relevant concepts and provision of feedback. Importantly, the exposure to concepts, and the competition in the program, gives prospective entrepreneurs an opportunity to reflect on the right course of action (including an opportunity to pause or shelf a plan). So, the effect of stratification is two-fold: for entrepreneurs, to attain clarity with respect to their future goals; for the incubator (and, prospective future investors), an increased sincerity of start-up execution. Pre-incubation participants may or may not proceed to the next phase. Participation is not a necessary condition for incubation.
  • Incubation: in early 2019, OneBio launched its first fully-fledged incubation program, with funding from SAIS. The incubation program runs over 6 months, with a modular, intensive curriculum. Participants have access to basic lab infrastructure as part of the program. However, the focus of the program is fundamentally on developing the entrepreneurs, endowing them with the skills they need for succeeding with their plans. Through ongoing interaction, it has become clear that value added by the CPGR goes beyond mentoring. Next to assistance in finding the right technical solution, key support offered is for projectisation and productization (more on this in the addendum). At the end of a successful incubation program, start-up teams should have clarity with respect to business model, product, customers, market; in sum, they should have increased their investment-readiness considerably.
  • Acceleration: What follows the first 3 stages is an intensive period of development work, where start-ups either enter an IP-heavy track (e.g. a venture that is focused on developing a new drug) or focus on product development (e.g. a start-up that develops a medical device or a diagnostic service or a health app). At this stage, start-ups should have secured investment. What is needed here, and is offered by the CPGR, is ongoing assistance with projectisation and productization. But, what will be more important in this stage, is access to quality managed environments; access to businesses and markets; and an infrastructure framework that goes beyond the provision of lab or office space, e.g. offering a sample and data management framework. The latter is of importance given the increasing convergence of wet- and dry-lab components in life science and biomedical innovation. Here, infrastructure is just a necessary underpinning. What is crucial in this stage are management systems that ease the start-ups’ ability to do more R&D, develop a product, or introduce a new offering into the market. At the end of this stage, a start-up should have reached an IP, product development, revenue, or investment milestone.

Support offered by the CPGR can be structured as shown in the following schematic (Fig 2):

Figure 2: CPGR start-up / entrepreneurial support

A key aspect of building an ecosystem is integrating a diversity of system players. This post has a narrow focus on a few who have intensively dealt with biotech formation and incubation over a course of 2-3 years, including OneBio, CiTi, and CPGR.

However, there are other important stakeholders who should be considered, such as Universities (e.g. UWC); scientific councils (e.g. CSIR); technology transfer offices (e.g. Innovus); public funding agencies (such as TIA); government departments (such as the DST); other incubators (e.g. Savant); and, private investors (e.g. SME Fund). In addition, the CPGR hosts DIPLOMICS, a large-scale infrastructure coordination program, initiated by the DST, offering a possible avenue for expanding current incubation activities across South Africa. Notably, the CPGR is in the process of forming partnerships with organisations in other African countries, to extend its current activity base across the continent.

CPGR has always followed a holistic and cooperative approach in designing and executing its business functions. Taking such a view is crucial in South Africa, where value chains are often incomplete, hampering investment decision making and start-up development. This applies in particular to the biotech sector, owing to intrinsic complexities, long development cycles, and investor inexperience with the sector. Support for entrepreneurs and startups is thus part of a bigger capacity development agenda CPGR is busy developing (Figure 3).

Rallying local players, to build an effective biotech start-up activity base in South Africa has been part of OneBio’s success over the past 2 years. The company has contributed to making the local ecosystem more attractive, to entrepreneurial talent and investors; CPGR will work alongside them to further boost the local biotech startup ecosystem in the future.


Addendum

Projectisation

CPGR employs an internally developed framework (Figure 4) for assessing and assisting with projects. The framework structures activities into four domains (digital, funding/IP, science, wet lab) and related categories, as shown below. Also considered are quality management and user needs, the latter with increasing relevance to product development projects.

Figure 4: CPGR project management framework

The framework was developed to guide conceptualisation and planning, making sure that all possible project relevant activities and tasks are adequately covered, given available time, budget, and resources.

For example, under ‘data management’, it considers

  • Type of data (e.g. molecular, image, meta)
  • Data sources (e.g. public, private)
  • Data processing (e.g. computing power)
  • Data transfer (e.g. bandwidth)
  • Data storage (e.g. hot/cold)
  • Data security (e.g. PoPi, GDPR)
  • Data access (e.g. policy framework)

Under ‘molecular assay’, it considers, in detail, what laboratory workflow best suits a research question or a product development goal. Careful consideration would be given to balancing funding with technical feasibility.

Productization

Product development is a specific type of a project. While all the above highlighted criteria may apply, product development, in a life science or medical context unfolds in a particular manner.

Of note here are the following considerations:

Firstly, biotech or medical product development is typically a long-term process, often running over the course of several years. This process is costly and risky, owing to inherent biological complexity as well as to design or execution issues common in biological and biomedical research[1]

Several organisations, such as the US National Academy of Sciences, have addressed this topic, producing guidelines (Figure 5) to assist researchers and entrepreneurs in their endeavors[2].

Figure 5: Translational omics framework

Secondly, we can use quality management systems that support the development of medical products. Of note here is ISO 13485, a standard developed to govern in-vitro diagnostic products and medical devices. The ISO standard was traditionally deemed ‘European’ but the FDA has recently endorsed ISO 13485, for the regulation of medical devices, in a step that has been seen as a move towards stronger global harmonization.

ISO 13485 employs a customer-centric view in guiding product development (shown in Figure 6, left, at the example of a waterfall approach) and uses elements of design thinking and iterative development, lending itself neatly to ‘lean productization’ in a start-up (Figure 6, right).

Figure 6: ISO 13485 waterfall development & design control [3]

About OneBio

ONEBIO provides life science startups with funding, business support, lab facilities and office space; access to networks; mentorship; and connections to resources, international markets and large corporate partners, both in Africa and internationally. Lead by Michael Fichardt and Nick Walker, the incubator builds on the unique experience of CiTi and CPGR in successfully providing incubation and biotech support services, respectively, in (South) Africa.

ONEBIO will support projects at the convergence of laboratory work and computational science, and likely to be solving African problems related to the health, food and environment sectors. Through its work, ONEBIO will build and nurture a connected continental innovation ecosystem and move Africa towards the center of global biotech innovation.

About CPGR

The CPGR is a non-profit company located in Cape Town, South Africa, based on an initiative by the Department of Science and Technology (DST), and financially supported by the Technology Innovation Agency (TIA). The CPGR combines state-of-the-art information-rich genomic and proteomic (‘omics’) technologies with bio-computational pipelines to render services and support projects in the life science and biomedical arena in (South) Africa, all run in an ISO 9001:2015 certified and ISO 17025 compliant quality management system.

Among others, the CPGR has recently launched an accelerator program to stimulate the creation of South African start-ups based on ‘omics’ technologies and set up Artisan Biomed to develop and implement Precision Medicine solutions in (South) Africa. The organization uses the open-source Baobab LIMS for sample and data tracking; and, it has recently implemented a DRAGEN platform to enhance the development and execution of high-speed/high-volume NGS data-sets. CPGR also hosts DIPLOMICS, a large infrastructure program initiated by the DST. In December 2017, CPGR entered into a partnership with the Sunflower Fund to enhance stem cell donor typing in Africa.

In support of Genomics capacity development in Africa, CPGR has launched an iScan system for high-end genotyping studies in early 2018. In April 2018, CPGR announced a new partnership to form a bespoke African biotech incubator, OneBio.

Information about the CPGR can be obtained at www.cpgr.org.za and www.cpgr.org.za/blogspot.  

Artisan Biomed

South Africa has a unique burden of disease profile, challenged by one of the world’s highest TB and HIV prevalence and an increasing shift towards Non-Communicable Diseases (NCDs), a trend caused by increasing urbanization and life style changes. This increase in ‘Western’ diseases is complicated by a lack in understanding of the contribution of the African ‘genome’ to disease development owing to a historical focus on Caucasian populations for biomedical research and development. Cutting edge diagnostic solutions are presently not available to the majority of (South) Africa’s population, mainly due to a lack of capacity (infrastructure, expertise) and financial resources.

Cutting-edge Genomics expertise is available in South Africa through the CPGR and can be used to develop and implement applications with advanced clinical utility in areas such as oncology, reproductive health, pediatrics, pharmacogenetics or nutrigenetics, contributing positively towards a population health paradigm for its citizenry. The corresponding data can be captured in a systematic manner, laying the basis for future discovery and medical innovation.

To bring Precision Medicine to Africa, CPGR has formed Artisan Biomed, Pyt Ltd. Artisan Biomed aims to develop Precision Medicine solutions by developing and implementing three distinct solutions: (i) provision of precision disease & health management services; (ii) translational research services; (iii) development of tailored medical solutions for people of African descent.

Information about Artisan Biomed can be found at www.artisanbiomed.co.za


[1] Ioannidis JP & Khoury MJ (2011) Improving validation practices in “omics” research. Science, 334: 1230 – 1232.

[2] Micheel, C. M., Nass, S. J., & Omenn, G. S. (Eds.). (2012). Evolution of translational omics: lessons learned and the path forward. National Academies Press.

[3] Images obtained from https://www.einfochips.com/blog/medical-device-design-guide-for-medtech/ and

https://blog.innokasmedical.fi/blog/applying-design-thinking-lean-start-up-and-agile-methodologies-to-medical-device-design-and-development