Bio-India

BioIndia™

India has been providing the developing world comprise of 2/3 of the world’s population with the necessary medicines from common cold to HIV, from antibiotics to anti-diabetics for the past several decades. Over these periods India has developed a well-developed drug manufacturing industry that now poised to compete with multinational pharmaceuticals companies such as, Pfizer, Roche, Merck and GSK globally. Initial model of the Bio-industry was to provide medicine to the bottom of the pyramids emerging as the model to provide cost saving options to the top of the pyramid (CK Prahalad).

Indian pharma and biotech corporations have obtained clearance from FDA to launch several generics drug in USA and many are in the pipelines. More and more biotech and pharma companies in India are partnering with their counter parts in USA for pre-clinical and clinical studies – an emerging bio-outsourcing economy.

India has developed a solid infrastructure for pre-clinical and clinical studies that is approved and recognized by FDA. Recently FDA expressed its intend to house inspectors and agents in India to assist Indian and USA bio-companies in their drug development, manufacturing and regulatory processes and compliance protocols – A step forward for BioIndia.

v Clinical trials in India is growing at a 60% AAGR
v Crossed USD 100 million in 2004.
v By 2010, the industry will spend USD 300M+ on clinical trials in India.
v 240 international studies recruiting subjects = 1.2% of the total studies worldwide
v 66% of international clinical trials are Phase III
v 207 sites FDA registered
v 40,000 subjects participated in clinical trials to date (<0.02%>

India companies have approximate share of 35% in DMFs and 25% in ANDAs filing globally
Second and third tier companies have aggressively scaled up ANDA/DMF filing in the US market over the last 2-3 years
www.biopreneur.org

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Ryan Baidya
California Takshila University

Bioventure

Prologue:
We know that every business is related to either inventive or innovative products or services and it must face some ups and downs throughout the phases of its development. Ultimately, and quite fortunately, a stage usually appears in typical development that can offer some comfort and satisfaction to participants of most business ventures. But purists in any field will advocate neither satisfaction, nor comfort alone, for its own sake. It is dedication, business zeal, will power to prove proficiency, and the unforgettable love of a product that entices most people involved to continue serving business goals. Our focus and our prime concern in this book is to explore bioventure and the journey of a bioventurer.

Bioventure represents a microcosm of the world at large concentrated into the small word of biological venture capital. As far as biopreneurs are concerned we have to define a scenario with a different kind of light—a light of a different color and temperature. It is an interesting and exciting a time for people wanting to appreciate the world of bioventure. And this is plainly because biotechnology, with emergent educational, governmental, and industrial support, is moving toward its wave crest.

We can think of bioventure being a sleek aerodynamic car racing on three wheels—technology, management, and capital. Each wheel is extremely sophisticated, and must be taken care of appropriately to drive the car to an ultimate and optimal destination. After spending many years learning and teaching, when I joined the practiced field of authentic business, I realized the need for the proper understanding of those three driving wheels. As people from the field of research work, and management, we may be aware of the greater issues related to our own unique areas of interest, but to be a truly successful biopreneur we must have a commanding grasp on all three driving wheels in our bio-business.

When we look at the world of bioventure we find several cases where people intended to invest heavily, but due to a lack of suitable knowledge they decided to shy away. There are instances where companies having a potential to expand their horizons by meeting a mere few necessities—such as patenting their ideas, and technology. Simply having enough information and facts regarding selling intellectual property or research-based material to pharmaceutical establishments may help some budding bioventures to succeed. But insufficient information also causes comparable ventures to lag behind other more aggressive competitors.

When these realizations struck me, I felt there was a lack of one extraordinary item in our immediate area which could solve our collective problems. That extraordinary item was a quality study curriculum that might be of assistance to all people in the field of bioventure. My intent is that this study material must contain substantial information for all—upcoming entrepreneurs, people from the field of management, and suited investors. This would not only to serve getting people from various fields under the one roof—bioventure—but it would also create a feeling of unanimity within bioventure.

Working together has always been a fun for people like us. Now we have the means to create that same fun—multiplied—by networking our talents, invented drugs, and various other biotechnological products. At the same time there could be an additional benefit waiting for each of us involved, in the form of earned capital. In all honesty, that is simply one future that I dream of for bioventure. The best possible future relies on greater understanding among the people associated with this business. This will be possible only if we can integrate our knowledge and experience, and operate within each other’s respective fields of expertise. If we can appreciate the views that those among us want to share, and vice versa, then a treasure trove in bioventure is not far off.

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Ryan Baidya
California Takshila University