Author: Mahmuda Khatun
Editor: Dr Chih Wei Teng
The exponential growth of regenerative medicine (RM) has attracted many venture businesses and companies seeking to discover newer therapeutic interventions that mitigate human suffering; creating employment opportunities and increasing workers productivity (4). This growth is fuelled by high levels of private and government
Image credit: www.bugnion.eu
investment as evidenced by an increase in global financing to $9.8 billion (1) and the Australian government investment of AU$5.6m in RM skills development programs in May 2018 (2).
Of the many challenges that await the bio entrepreneur, including safety, regulatory science, standardisation, manufacturing, cell viability, talent & suitable workforce shortages (5), the internationalisation process stands apart. Internationalisation is a challenge rarely discussed in detail except perhaps for the market size of different jurisdictions and their respective regulatory frameworks. In other words, internationalisation is one challenge for which most biotechs are the least prepared.
It is essential to understand that developing viable products and having a clear business model or strategy are not the only prequalifications for entering the international market. Developing a qualified workforce with appropriate management skills, including cross-cultural communication, to implement the business plan is essential before entering the global market. The purpose of this blog is to enlighten the importance of both technical and soft skills for biotech start-ups, which need to be balanced when shaping the workforce before entering into the global regenerative marketplace.
A biotech’s strategy will dictate the company structure and functions needed for Internationalisation. Whether the structure will include scientists from research, technicians from manufacturing facilities, or personnel from sales and marketing having the right mix is critical for achieving its goal. To be more specific, if the biotech plans to manufacture overseas with a contract development/manufacturing organisation (CDMO), then researchers team with a broad range of skills, ranging from the necessary technicians to PhD-level personnel are required to interface and project manage. If the biotech chooses to be vertically integrated with its own manufacturing facilities, personnel with strong process engineering, quality control, production technology, and project management skills are essential. Personnel should also have good knowledge of GMP (or Good Gene, Cellular, and Tissue-based Products Manufacturing Practice [GCTP]) as well as manufacturing experience and medical and pharmaceutical expertise (6).
When it comes to sales, marketing and customer services for a global market, having a talented and diverse team with experience in consultative selling, good communication skills, and effective customer relationship management skills are essential criteria. This critical element was recently illustrated in a webinar co-organised by the BioMelbourne Network and CCRM Australia. During this webinar, “International Market Entry – Some Shared Insights”, guest speaker Dr Paul Brennan, Managing Director of leading Australian regenerative medicine company Polynovo Limited, shared his journey in introducing, developing and promoting the product named ‘Novo Sorb BTM’, a biodegradable temporising matrix, used for regeneration of lost dermis via a surgical application. This unique product is currently marketed in 12 countries, including Australia, New Zealand, USA, Singapore, Malaysia, Germany, Austria, Switzerland, Saudi Arabia, Israel, South Africa, and India. Polynovo has plans to expand its availability to Taiwan, South Korea, Finland, Norway, Benelux, France, and Kuwait throughout 2021. When articulating his internationalising strategy into the global market, Paul specifically touched on developing a team that possesses several characteristic traits such as passion, commitment, nimbleness, openness, focus, up to date, respect and empathy. The need to mitigate cultural, language, traditional barriers are significant, and even more now with Polynovo’s product being marketed in so many countries.
Internationalisation necessitates working in a diverse workplace with people having different mindsets. Having a clear understanding of high context societies (establishing relationships and trust) is paramount. Low-context societies (business-like and formal) more effortlessly adapt communication styles and build the right relationships with international colleagues. Moreover, the ability to understand, learn, and appreciate cultural differences will help improve cross-cultural communication, teamwork, capabilities, flexibilities, responsiveness, trust, and royalty among local suppliers and partners. In any business, disputes will arise, leading to negotiation. A team with the right ‘soft skills’ including interpersonal influence, adaptive thinking, emotional intelligence and resilience that is better able to deescalate situations and work towards a win-win situation effectively is an asset.
To sum up, human resources are the primary building blocks of a company (7). Focusing on technical skills and balancing the workforce with soft skills is one of the primary considerations for bio entrepreneurs. The impact of this consideration was evidenced during the Covid-19 pandemic. The lack of personal interaction and restricted travel made it a challenging time for bio entrepreneurs. Many companies turned towards IT-based solutions, including video conferencing or more sophisticated customer relationship management systems to provide continuity in their international business. However, IT solutions are merely multi-lateral communication vehicles, rapid data analysis tool with dashboards, tailored to each business function. Without an effective workforce with effective soft skills and a good cross-cultural understanding, biotech companies will not be able to build new relationships and maintain and grow existing relationships with the customers.
- Medicine AfR. Advancing Gene, Cell, & Tissue-Based Therapies ARM Annual Report & Sector Year in Review 2019 2020, Mar 20th [Available from: https://www.regenhealthsolutions.info/wp-content/uploads/2020/03/2019-ARM-Annual-Report-Sector-Year-in-Review.pdf.
- Connect M. Regenerative Medicine Opportunities For Australia October 2018 20q8, Oct 10th [Available from: https://www.mtpconnect.org.au/images/MTPConnect%20Regenerative%20Medicine%20Report.pdf.
- markets Ma. Regenerative Medicine Market by Product (Cell Therapies (Autologous, Allogenic), Stemcell Therapy, Tissue-engineering, Gene Therapy), Application (Wound Care, Musculoskeletal, Oncology, Dental, Ocular), Geography – Global Forecast to 2025 2020, Sep [Available from: https://www.marketsandmarkets.com/Market-Reports/regenerative-medicine-market-65442579.html.
- Hussain A, Rivers PA. The economic value of investing in regenerative medicine. Journal of Health Care Finance. 2009;36(2):45-54.
- Polak DJ. Regenerative medicine. Opportunities and challenges: a brief overview. Journal of The Royal Society Interface. 2010;7(suppl_6):S777-S81.
- Nishigaki F, Ezoe S, Kitajima H, Hata K. Human resource development contributes to the creation of outstanding regenerative medicine products. Regenerative Therapy. 2017;7:17-23.
- Finegold D, Frenkel S. Managing people where people really matter: the management of human resources in biotech companies. The International Journal of Human Resource Management. 2006;17(1):1-24.