Biotechnology Management: Borderless Untraditional Careers in Life Sciences

Biotechnology is not just an innovative academic activity, but rather an intense industrial and commercial activity. Indian Biotechnology industry has crossed the 18,000 crores benchmark and its growing strong with almost 20 percent annual growth rate. India is already a World leader in vaccine production, biopharmaceuticals, industrial enzymes and biofuel production, bioremediation, hybrid seeds production, stem cell banking, and micropropogation commercialization, etc. The biotech market is further expected to accelerate in near future on the back of high demand for vaccines, CROs, biopesticides, biofertilizers, and biodiesel in India as well as at the global level. The Indian industry offers low cost, high quality FDA-approved products, diagnostics devices, contract manufacturing, and clinical trials services to the global markets.

Unfortunately, the supply of scientific knowledge coupled with managerial skills is not meeting the industry demand. The management talent is scarce and is often the weakest pillar in most biotechnology companies. The key to a successful career is to explore the many demanding untraditional career paths outside the routine R&D options, as many companies list the specific management positions. 

This is slowly changing with the availability of biotech-oriented management programs, where the students learn how to develop and manage new ventures along with product commercialization, patenting, business development, and regulatory affairs that influences the biotechnology industry. With the growing interest in the business applications of biotechnology, this is a critical time to understand this multi-disciplinary nature of such post graduate degree program, where the students get a solid grounding in the core business disciplines in emerging bioscience industries.

The Biotechnology Management programme at MITCON Institute of Management, Pune provides a strong and broad foundation to excel in wide range of career opportunities in the life sciences industry such as biotech business development, biotech marketing and sales, product management, intellectual property management, quality assurance and quality control management, regulatory affairs dossiers management, international business, and human resource management. Major biopharmaceutical companies hiring for such positions are Pfizer India, GlaxoSmithKline, Novartis, Abbott India, Panacea Biotec, Merck BioVentures, Sanofi-Aventis, Bayer Healthcare, Zydus Cadilla, Spinco Biotech, Emcure/Gennova biopharmaceuticals, and Lupin Biotech, etc.

For more information on the AICTE-approved Post Graduate Diploma (PGDM) in Biotechnology Management Program, Please visit http://www.mima.edu.in/biotechnology_management.asp

Admissions Open: Session 2012-14: Now Apply Online: http://mima.edu.in/mima_admission/

Contact: +91-8888844015/16

Biotechnology Management: New Opportunities and Possibilities

Biotechnology Management: New Opportunities and Possibilities

MITCON Institute of Management, Pune

Visit us: http://www.mima.edu.in

Biotechnology Management is an increasing need in today's biotechnology business world in which smart business decisions are often driven by a fundamental grasp of modern molecular biology, from pharmacogenomics to drug discovery.

The three pillars of biotech management are scientific and managerial talent, technology and money. Unfortunately, the supply of both scientific and managerial talent is not meeting the demand. In addition to scientific talent, management talent is scarce and is often the weakest pillar in most biotechnology companies. The skills required of a biotech executive are myriad and the path from an R & D-driven to a market-driven culture requires a complex repertoire of knowledge, skills and talents.

Biotechnology companies feel that people aren't coming out of school with the job-ready skills that the industry needs. This is slowly changing, thanks to the gradually growing number of management programs that are now offering biotech-focused courses. For instance, management students who choose to specialize in biotechnology management and entrepreneurship learn how to develop and manage new ventures at the same time they're learning about product commercialization, and ethical and regulatory issues that affect the biotechnology industry. 

With the growing interest in the business applications of biotechnology, this is a critical time to understand this multi-disciplinary post graduate degree program, where the students get a solid grounding in the core business disciplines to prepare them for leadership in emerging bioscience industries. The program also offers extensive entrepreneurial value addition skills through Entrepreneurship Development Cell at the institute.

However, since these programmes are so new, there is little standardization of curricula, educational resources are scattered, learning objectives are not standardized and the value propositions of such programmes are not clear. Like any new innovation, there needs to be a compelling value proposition addressing a clear market need if the programmes are to be sustainable and make a difference. 

We have identified knowledge gaps for students of Biotechnology. Grounded in the theoretical aspects of the field, students lack the knowledge about converting the processes into developed products, translation of concepts into business ideas, entrepreneurial aptitude, career navigation related issues and innovative outlook.

The programmes need to differentiate themselves from alternative offerings that do not satisfy students or potential employers. Life science commercialization has several unique characteristics that separate it from other technology development efforts. The uncertainty of clinical trials outcomes, long product development lead times, high regulatory hurdles and a difficult financing environment, particularly for easy stage ventures, are but a few of things that make bioentrepreneurship different from software, telecommunications or aerospace technologies. 

Case studies capture the complexity and context of the biotech industry, and effectively create a bridge between studying books and working in a business. This programme was created to fill the gap in biotechnology entrepreneurship and management education. The case method of teaching is a proven and engaging pedagogical approach that is part and parcel of medical, business and legal education. By simulating and analyzing problems, students have the opportunity to practice decision making in uncertainty with little business risk (although possibly substantial academic risk), create alternative solutions, and gain the benefit of seeing how their recommendations compare to the actual outcomes.

The main teaching methodology used during this program is the case method, a highly effective learning model which allows you to reach your full potential. The students can analyze each piece of new knowledge, concepts, techniques and ideas individually, in groups and in class, which will broaden your visions and will enable you to gain a global understanding and strategic perspective of business in the biotech industry.

For more information on the AICTE-approved Post Graduate Diploma (PGDM) in Biotechnology Management Program, see http://www.mima.edu.in.

TB diagnostic innovations: Can India take the lead?

TB diagnostic innovations: Can India take the lead?

Guest article by Madhukar Pai

No country has more cases of tuberculosis (TB) than India. Research from India played a critical role in the development of the global strategy to stop TB.Yet, Indian industry and academics have not developed any new tools (diagnostics, drugs or vaccines) for TB. Why has India has failed to innovate in TB R&D? To understand this better, we recently organized a conferenceat St. John´s Research Institute (SJRI)in Bangalore, India. For the first time, this meeting brought togetherover 200 representatives from industry, government, donors, academia, civil society and the media to discuss what it takes to innovate in TB diagnostics in India and to move from importation and imitation to innovation.The goal was to stimulate industry interest and investments in TB innovations.

Why focus on India? India has already made a big contribution in the area of generic drugs and vaccines, and successes in areas such as information technology and mobile telephony have greatly inspired a burgeoning biotechnology industry. With a strong, growing economy, and a large talent pool, there is great potential for India to contribute to what is called as the “More (value) for less (cost) for more (people) or MLM innovation,” especially in the area of healthcare technologies and delivery innovations.

It is often said that industry interest in TB is low, in part because the disease mostly affects the poor in developing countries. While this is true, should9.4 million TB cases/year not translate into a large global market for companies? What exactly is the size and nature of the TB diagnostics market in India and elsewhere?A preliminary analysis by McKinsey and Company suggested that the TB diagnostics market in India might be in the ballpark of about $100 million, although there was uncertainty surrounding the estimates from the private sector which does not report TB. The Indian TB control program (RNTCP) screens over 7.5 million people with suspected active TB every year, and a similar number is likely to seek care in the private sector. Thus, 15 million persons with suspected TB should translate into a fairly sizeable Indian market. In addition, diagnostics will be needed to diagnose extrapulmonary TB, MDR-TB, childhood TB, and latent TB infection. If a good, point-of-care testwere to be developed, it might open the option of intensive and active case finding. Furthermore, if a new test were to be developed on a platform that can be used for other diseases, then this opens new markets beyond TB. Lastly, there is a large potential market outside of India. Clearly, we need a more detailed TB market size analysis to engage both industry and funders.

The TB community has done a poor job of articulating its needs. ‘What products should we develop, and if we did develop products who purchase them?’ is a key question that industry representatives asked. A presentation by a senior RNTCP official provided some clues: What the RNTCP needs most is a new point-of-care test for active TB that is simple, easy, cheap and can be performed with minimal training at primary healthcare level; in addition, the program needs an indigenous, economical, simple, automated  (battery operated) or manual molecular test to detect drug resistance that can be done in a peripheral lab with minimal training. This wish list is a great place to start, but will need to be converted into clearly defined target product profiles (TPPs) that test developers and funders can aim for.

Other concerns raised by the industry included: lack of access to Indian sample repositoriesfor test development and validation, and limited funding andR&D facilities for TB;poor regulatory mechanisms to evaluate new tests and assure quality; unclear prequalification processfor TB tests by the World Health Organization; lack of venture capital funding for R&D and lack of celebrity/philanthropic support from within India; lack of awareness about funding opportunities, weak or non-existent collaboration between RNTCP and industry, between industry and clinicians, industry and academia. In addition, there are the usual barriers to innovation in India.

Companies, especially those not working in TB, want “mentorship” or technical advice on TB, and it is not clear who they can approach for issues specific to TB. When and how should companies engage with agencies such as WHO (globally) and RNTCP (within India) for advice, possible endorsement or evaluation? What is the procedure for companies to access the government market for TB tests? How will the RNTCP decide on which tests to scale-up, and how much is the RNTCP willing to spend?

As more TB products get developed, it is not clear which agency or organization can conduct head-to-head validation studies to identify the best products for scale-up. More importantly, which agency or organization should take on a “honest broker” role to bring together key stakeholders that make up the complete value chain for TB innovations in India?

Increased industry involvement and investment in TB R&D is an important goal. While the Bangalore conference was clearly a first step to begin a dialogue among the various stakeholders,it became clear that a lot more work is needed to address the needs articulated by the industry.Innovations in TB will also require the support of civil society, media, and patient groups which can bring attention to the need for new TB tools, advocating for scale-up of new products that are already available, and advocacy for increased investment in TB R&D. Lastly, if new tools have to be adopted and scaled-up to achieve impact, health system design and delivery innovations are equally important.

 

Dr Madhukar Pai is a professor and TB researcher based at McGill University, Montreal, Canada. He serves as co-chair of the Stop TB Partnership's New Diagnostics Working Group (NDWG), and as a consultant to the Bill & Melinda Gates Foundation (BMGF). The views expressed in this article are the author's ownanddo notnecessarilyreflect those of NDWG or BMGF. Initially posted on Speaking of Medicine