CHINA-BIO
China Sky One Medical, Inc. Received Chinese Regulatory Approval for Four New Drugs
In June -- China Sky One Medical, Inc., a China-based life-sciences company for pharmaceutical, medicinal and diagnostic kit products, announced that it obtained approval from the State Food and Drug Administration (SFDA) in the People's Republic of China for four new drugs: Tobramycin Eye Drops, Compound Zinc Sulfate Eye Drops, Ofloxacin Suppositories and Ofloxacin Gels.
Tobramycin Eye Drops have been approved for the treatment of acute infection on eyelids. Compound Zinc Sulfate Eye Drops have been approved for the treatment of acute and chronic conjunctivitis and trachoma. Ofloxacin Suppositories have been approved for the treatment for bactericidal colpitis, and Ofloxacin Gels have been approved for the treatment for bactericidal injection. The Company estimates the size of the each market at approximately $ 2 million USD to $2.4 million USD
The new approvals bring the total number of China Sky One's externally used products to 53 and its total marketed products to 102, giving the Company one of the most comprehensive pharmaceutical product portfolios in China.
Improved Milk Production in Cows From Cactus Cattle Feed
In June, China Kangtai Cactus Biotech Inc.,a vertically integrated grower, developer, manufacturer and marketer of a variety of cactus-based consumer products in China, announced today test results from studies conducted of cows that received the Company's Cactus Cattle Feed. The studies, which included 30 cows, were conducted in conjunction with the Company's application for a Certificate of National Invention Patent and showed cows that received the Company's Cactus Cattle Feed increased milk production by approximately 15.2% during the twenty-day trial period.
The Company also conducted a second test, evaluating the ability of cattle to produce milk under adverse environmental conditions, including cold temperatures and strong wind conditions. The study selected 100 milk cows between the age of 2.5 to 3 years, and divided them into two groups. The cows in the control group were fed with the normal feed which was made by the ranch. The cows in the experimental group received the same feed, but also added 1kg cactus cattle feed to each ton of the normal feed. The milk production of the experimental group increased to 1,372kg from 1,350kg despite the adverse conditions. The milk production of the control group decreased to 1,286kg from 1,380kg. The results suggest that the use of cactus cattle feed additives could increase milk production by 8.44%.
Genesis Pharmaceuticals Closes $30 Million Private Note Placement
In June, Genesis Pharmaceuticals Enterprises, Inc., a leading pharmaceutical company in the People's Republic of China, stated that it successfully completed a private placement of $30,000,000 of its three year convertible notes.
The Notes carry an annual interest rate of 6.0% and are convertible into shares of the Company's Common Stock at a conversion price of $0.20 per share. In connection with the private placement of the Notes, the Company issued to purchasers of the Notes an aggregate of 75,000,000 five-year warrants to purchase shares of its Common Stock at an exercise price of $0.25 per share. The lead investor in the private placement was Pope Investments, LLC.
Ryan Baidya
California Takshila University
Friday, October 3, 2008
Bio-business in JAPAN -Q3 2008
BIO-JAPAN
Carna Biosciences Signs Reagent Supply Agreement with Caliper Life Sciences
In August, Carna Biosciences, Inc. announced the signing of a collaborative agreement with Caliper Life Sciences, Inc. USA. Carna will supply a set of discrete protein kinases aiding the expansion of Caliper's kinase profiling and assay development services, and ProfilerPro Kinase Selectivity Assay Kits. Caliper's products and services are widely used and highly regarded by leading pharmaceutical and biotech companies. The selection of Carna as a Preferred Provider enhances the visibility and use of Carna's products in the area of kinase inhibitor drug discovery -- a major focus of targeted therapy in the areas of cancer, neurological, and autoimmune diseases.
Kowa Company, Ltd. Acquires ProEthic Pharmaceuticals, Inc.
In August Kowa Company, Ltd., a privately-held company headquartered in Nagoya, Japan, announced the acquisition of ProEthic Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company based in Montgomery, Alabama.
ProEthic will change name to Kowa Pharmaceuticals America and will assume responsibility for all sales and marketing functions currently operating in Montgomery, Alabama. ProEthic's clinical development group will transfer to Kowa Research Institute, which is located in Morrisville, North Carolina.
The first pharmaceutical product to be launched by the new company will be pitavastatin, a novel HMG CoA reductase inhibitor for the treatment of hyperlipidemia. Pitavastatin is sold in Japan, Korea and Thailand under the brand Livalo(R). Pitavastatin has recently completed Phase 3 clinical development in Europe and the United Sates.
Sosei Completed Phase III Trial for NorLevo(R)
In July Sosei Group Corporation announced the completion of a Japanese Phase III clinical trial for the emergency contraceptive pill (ECP) SOH-075 (NorLevo(R)). Sosei acquired the exclusive distribution rights to the product in Japan from HRA Pharma.
The clinical study was designed to evaluate the safety and prevented pregnancy rate of SOH-075 in Japanese adult female subjects who require emergency contraception. No serious adverse events were reported during the study.
Galderma Announced Approval for Differin(R) Gel 0.1% in Japan
In July, Galderma Pharma S.A., a global specialty pharmaceutical company focused on dermatology, announced that Japan's Ministry of Health, Labor and Welfare has approved Differin(R) Gel 0.1% (adapalene), a novel topical treatment for acne vulgaris in Japan. The drug will be marketed in Japan by Galderma KK, the fully-owned Japanese arm of Galderma, and strategic alliance partner Shionogi.
Differin(R) has been available for over 15 years and is currently marketed in more than 80 countries, where it has become an important therapy for more than 22 million patients. Approval in Japan will reinforce Galderma's presence in the world's second-largest pharmaceutical market. Approval was based on non-clinical and clinical studies, which supported the efficacy and safety of the product for the registration outside Japan and on an extensive local clinical development program, including two phase 3 studies enrolling more than 600 Japanese patients.
Rare Indo-Japan Pharma Alliance:
Ranbaxy to Bring in Daiichi Sankyo as Majority Partner; Strategic partnership Creates Innovator and Generic Pharma Powerhouse in Asia
In June - Daiichi Sankyo Company, Limited, one of the largest pharmaceutical companies in Japan, and Ranbaxy Laboratories Limited, among the top 10 generic companies in the world and India's largest pharmaceutical company, announced that a binding Share Purchase and Share Subscription Agreement (the "SPSSA") was entered into between Daiichi Sankyo, Ranbaxy and the Singh family, the largest and controlling shareholders of Ranbaxy (the "Sellers").
Pursuant to the Agreement, Daiichi Sankyo will acquire the entire shareholding of the Sellers in Ranbaxy and further seek to acquire the majority of the voting capital of Ranbaxy at a price of Rs737 per share with the total transaction value expected to be between US$3.4 to US$4.6 billion.
If completed, the deal will:
Help Daiichi Sankyo diversify its business within a different segment of the pharmaceutical industry as; following years of divestments in unrelated businesses, Daiichi Sankyo will now participate in a full range of drug product offerings through branded, generic and over-the-counter product lines.
Allow Daiichi Sankyo to benefit from an upcoming wave of patent expirations in the U.S. and European markets, while also promoting generic products in the under-penetrated Japanese region.
Support Daiichi Sankyo's geographic expansion plans, particularly in fast-growing emerging markets such as India.
Leverage Ranbaxy's research resources and manufacturing capabilities, particularly within the Indian market.
Maintain Ranbaxy's independence as a subsidiary of Daiichi Sankyo by retaining, as is currently proposed, Ranbaxy Chief Executive Officer Malvinder Singh.
Enable Ranbaxy, through the support of a large globally-established pharmaceutical company, to further implement their own drug development ambitions
Provide the controlling family of Ranbaxy with an attractive opportunity to monetize their stake in the company
Japan’s MHLW Approves CyberKnife System for Extracranial Use
Robotic Radiosurgery System Offers Non-Invasive Treatment Alternative for Tumors Anywhere in the Body
In Juse - Accuray Incorporated, announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted Shonin approval of the CyberKnife(R) Robotic Radiosurgery System for use in treatment of extracranial tumors, including tumors that move with respiration. This regulatory approval dramatically expands the types of patients that can be treated with radiosurgery. As a result of this approval, the CyberKnife System may be used in Japan to treat tumors anywhere in the body, including those in the spine, lung, liver, pancreas and prostate.
In 1996 the CyberKnife System was first approved in Japan to treat tumors in the head and neck. Currently, there are 20 CyberKnife Systems installed throughout Japan, making it the second largest installed base of CyberKnife Systems after the United States. The CyberKnife System offers cancer patients worldwide a pain-free, non- invasive alternative to surgery.
Additionally, according to a 2006 report from global research firm, Research and Markets, Japan remains the world's second largest medical device market after the United States. Japan is currently facing a rapidly aging population and the incidence of lung cancer is on the rise. Lung cancer is the leading cause of cancer death among men and women in Japan. In 2003, the number of lung cancer deaths reached 41,615 (22 percent of all cancer-related deaths) in men and 15,086 deaths (12 percent of all cancer-related deaths) in women.
Santen and MacuSight Announce Partnership and License Agreement for Sirolimus in Ocular Diseases.
In June - Santen Pharmaceutical Co., Ltd. and MacuSight, Inc. announced that the two companies entered into a research and development partnership and license agreement for the Japanese and Asian development and commercialization of sirolimus for the treatment of ocular diseases including wet age related macular degeneration (wet AMD) and diabetic macular edema (DME). Sirolimus, originally known as rapamycin, is a highly-potent, broad-acting compound that has demonstrated the ability to combat a broad range of diseases and conditions. MacuSight is presently initiating a Phase 2 clinical trial of sirolimus in DME and preparing to initiate a Phase II study in wet AMD in the third quarter of 2008.
Under terms of the agreement, Santen receives rights to develop and commercialize sirolimus for ocular diseases and conditions in Japan and Asia. MacuSight retains development and commercialization rights to sirolimus in all other markets.
Santen has agreed to provide MacuSight with an initial upfront payment of $50 million dollars for funding MacuSight's continuing research and development efforts, as well as clinical development of sirolimus. Additionally, Santen will provide MacuSight with milestone payments and a royalty on future sirolimus sales in the Japanese and Asian markets.
Sirolimus is a highly-potent, broad-acting compound that has demonstrated the ability to combat disease through multiple mechanisms of action including immunosuppressive, anti-angiogenic, anti-migratory, anti-proliferative, anti-fibrotic and anti-permeability activity. Based on the versatility associated with these multiple mechanisms of action, MacuSight believes that its sirolimus product may serve as a potentially highly-efficacious therapeutic for a wide range of ocular diseases and conditions, including the treatment and prevention of wet AMD and DME.
Ryan Baidya
California Takshila University
Carna Biosciences Signs Reagent Supply Agreement with Caliper Life Sciences
In August, Carna Biosciences, Inc. announced the signing of a collaborative agreement with Caliper Life Sciences, Inc. USA. Carna will supply a set of discrete protein kinases aiding the expansion of Caliper's kinase profiling and assay development services, and ProfilerPro Kinase Selectivity Assay Kits. Caliper's products and services are widely used and highly regarded by leading pharmaceutical and biotech companies. The selection of Carna as a Preferred Provider enhances the visibility and use of Carna's products in the area of kinase inhibitor drug discovery -- a major focus of targeted therapy in the areas of cancer, neurological, and autoimmune diseases.
Kowa Company, Ltd. Acquires ProEthic Pharmaceuticals, Inc.
In August Kowa Company, Ltd., a privately-held company headquartered in Nagoya, Japan, announced the acquisition of ProEthic Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company based in Montgomery, Alabama.
ProEthic will change name to Kowa Pharmaceuticals America and will assume responsibility for all sales and marketing functions currently operating in Montgomery, Alabama. ProEthic's clinical development group will transfer to Kowa Research Institute, which is located in Morrisville, North Carolina.
The first pharmaceutical product to be launched by the new company will be pitavastatin, a novel HMG CoA reductase inhibitor for the treatment of hyperlipidemia. Pitavastatin is sold in Japan, Korea and Thailand under the brand Livalo(R). Pitavastatin has recently completed Phase 3 clinical development in Europe and the United Sates.
Sosei Completed Phase III Trial for NorLevo(R)
In July Sosei Group Corporation announced the completion of a Japanese Phase III clinical trial for the emergency contraceptive pill (ECP) SOH-075 (NorLevo(R)). Sosei acquired the exclusive distribution rights to the product in Japan from HRA Pharma.
The clinical study was designed to evaluate the safety and prevented pregnancy rate of SOH-075 in Japanese adult female subjects who require emergency contraception. No serious adverse events were reported during the study.
Galderma Announced Approval for Differin(R) Gel 0.1% in Japan
In July, Galderma Pharma S.A., a global specialty pharmaceutical company focused on dermatology, announced that Japan's Ministry of Health, Labor and Welfare has approved Differin(R) Gel 0.1% (adapalene), a novel topical treatment for acne vulgaris in Japan. The drug will be marketed in Japan by Galderma KK, the fully-owned Japanese arm of Galderma, and strategic alliance partner Shionogi.
Differin(R) has been available for over 15 years and is currently marketed in more than 80 countries, where it has become an important therapy for more than 22 million patients. Approval in Japan will reinforce Galderma's presence in the world's second-largest pharmaceutical market. Approval was based on non-clinical and clinical studies, which supported the efficacy and safety of the product for the registration outside Japan and on an extensive local clinical development program, including two phase 3 studies enrolling more than 600 Japanese patients.
Rare Indo-Japan Pharma Alliance:
Ranbaxy to Bring in Daiichi Sankyo as Majority Partner; Strategic partnership Creates Innovator and Generic Pharma Powerhouse in Asia
In June - Daiichi Sankyo Company, Limited, one of the largest pharmaceutical companies in Japan, and Ranbaxy Laboratories Limited, among the top 10 generic companies in the world and India's largest pharmaceutical company, announced that a binding Share Purchase and Share Subscription Agreement (the "SPSSA") was entered into between Daiichi Sankyo, Ranbaxy and the Singh family, the largest and controlling shareholders of Ranbaxy (the "Sellers").
Pursuant to the Agreement, Daiichi Sankyo will acquire the entire shareholding of the Sellers in Ranbaxy and further seek to acquire the majority of the voting capital of Ranbaxy at a price of Rs737 per share with the total transaction value expected to be between US$3.4 to US$4.6 billion.
If completed, the deal will:
Help Daiichi Sankyo diversify its business within a different segment of the pharmaceutical industry as; following years of divestments in unrelated businesses, Daiichi Sankyo will now participate in a full range of drug product offerings through branded, generic and over-the-counter product lines.
Allow Daiichi Sankyo to benefit from an upcoming wave of patent expirations in the U.S. and European markets, while also promoting generic products in the under-penetrated Japanese region.
Support Daiichi Sankyo's geographic expansion plans, particularly in fast-growing emerging markets such as India.
Leverage Ranbaxy's research resources and manufacturing capabilities, particularly within the Indian market.
Maintain Ranbaxy's independence as a subsidiary of Daiichi Sankyo by retaining, as is currently proposed, Ranbaxy Chief Executive Officer Malvinder Singh.
Enable Ranbaxy, through the support of a large globally-established pharmaceutical company, to further implement their own drug development ambitions
Provide the controlling family of Ranbaxy with an attractive opportunity to monetize their stake in the company
Japan’s MHLW Approves CyberKnife System for Extracranial Use
Robotic Radiosurgery System Offers Non-Invasive Treatment Alternative for Tumors Anywhere in the Body
In Juse - Accuray Incorporated, announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted Shonin approval of the CyberKnife(R) Robotic Radiosurgery System for use in treatment of extracranial tumors, including tumors that move with respiration. This regulatory approval dramatically expands the types of patients that can be treated with radiosurgery. As a result of this approval, the CyberKnife System may be used in Japan to treat tumors anywhere in the body, including those in the spine, lung, liver, pancreas and prostate.
In 1996 the CyberKnife System was first approved in Japan to treat tumors in the head and neck. Currently, there are 20 CyberKnife Systems installed throughout Japan, making it the second largest installed base of CyberKnife Systems after the United States. The CyberKnife System offers cancer patients worldwide a pain-free, non- invasive alternative to surgery.
Additionally, according to a 2006 report from global research firm, Research and Markets, Japan remains the world's second largest medical device market after the United States. Japan is currently facing a rapidly aging population and the incidence of lung cancer is on the rise. Lung cancer is the leading cause of cancer death among men and women in Japan. In 2003, the number of lung cancer deaths reached 41,615 (22 percent of all cancer-related deaths) in men and 15,086 deaths (12 percent of all cancer-related deaths) in women.
Santen and MacuSight Announce Partnership and License Agreement for Sirolimus in Ocular Diseases.
In June - Santen Pharmaceutical Co., Ltd. and MacuSight, Inc. announced that the two companies entered into a research and development partnership and license agreement for the Japanese and Asian development and commercialization of sirolimus for the treatment of ocular diseases including wet age related macular degeneration (wet AMD) and diabetic macular edema (DME). Sirolimus, originally known as rapamycin, is a highly-potent, broad-acting compound that has demonstrated the ability to combat a broad range of diseases and conditions. MacuSight is presently initiating a Phase 2 clinical trial of sirolimus in DME and preparing to initiate a Phase II study in wet AMD in the third quarter of 2008.
Under terms of the agreement, Santen receives rights to develop and commercialize sirolimus for ocular diseases and conditions in Japan and Asia. MacuSight retains development and commercialization rights to sirolimus in all other markets.
Santen has agreed to provide MacuSight with an initial upfront payment of $50 million dollars for funding MacuSight's continuing research and development efforts, as well as clinical development of sirolimus. Additionally, Santen will provide MacuSight with milestone payments and a royalty on future sirolimus sales in the Japanese and Asian markets.
Sirolimus is a highly-potent, broad-acting compound that has demonstrated the ability to combat disease through multiple mechanisms of action including immunosuppressive, anti-angiogenic, anti-migratory, anti-proliferative, anti-fibrotic and anti-permeability activity. Based on the versatility associated with these multiple mechanisms of action, MacuSight believes that its sirolimus product may serve as a potentially highly-efficacious therapeutic for a wide range of ocular diseases and conditions, including the treatment and prevention of wet AMD and DME.
Ryan Baidya
California Takshila University
Biobusiness in INDIA -Q3 2008
BIO-BUSINESSES IN INDIA
Sun Pharma Received FDA Approval for Generic Fosamax (R) Tablets
In September, Sun Pharmaceutical Industries Ltd. announced that the company received approval from FDA to market Alendronate sodium tablets (generic Fosamax). Alendronate sodium tablets are indicated for the treatment and prevention of osteoporosis in post menopausal women, to increase bone mass in men with osteoporosis, in the treatment of glucocorticoid induced osteoporosis, and Paget's disease of the bone in men and women.
Fosamax (R) tablets have annual sales of approximately US$ 560 million in the US alone.
Diakron and Orchid Pharma to Develop Anti-coagulant Drug
In August, Diakron Pharmaceuticals, Inc. announced the signing of an exclusive license agreement for a novel investigational oral anticoagulant drug candidate discovered and developed through Phase I clinical trials by Merck & Co. Inc. Under the terms of the agreement, Diakron has the exclusive rights to develop, and, if approved, market and distribute the compound worldwide.
In a simultaneous transaction, Orchid Chemicals & Pharmaceuticals Ltd., the Chennai (India) based pharmaceutical major ("Orchid Pharma"), has signed an agreement to partner with Diakron as a significant shareholder and developer for the anticoagulant drug candidate. Orchid will be undertaking the next stages of development.
Codexis and Arch Pharmalabs in Strategic partnership
In August, Codexis, Inc., a leader in biocatalysis technology, and Arch Pharmalabs Limited, a leading Indian active pharmaceutical ingredients (APIs) and intermediates manufacturer, announced a major new strategic collaboration, expanding their three-year partnership in pharmaceuticals manufacturing.
Codexis, based in Redwood City, CA, will offer multiple pharmaceutical intermediates and active pharmaceutical ingredients (APIs) made with its proprietary biocatalytic processes to both innovator and generic drug manufacturers. Sales in India will be through its subsidiary, Codexis Laboratories India Private Limited. Arch, which is based in Mumbai, India and has ten facilities throughout the country, will be Codexis' exclusive manufacturer for these products. The two companies will also co-market products.
Satyam Computer Service Ltd partners with Sciformix, Inc to Provide Comprehensive Drug Safety Management Services.
In June – Satyam Computer Services Ltd, a leading global consulting and information technology services provider, announced that it formed an strategic partnership with Sciformix, Inc., a Westborough, Massachusetts-based, Life Science Knowledge Process Outsourcing (KPO) company, to data management services in "Pharmacovigilance." Several high-profile withdrawals of popular drugs from the marketplace made this partnership more important. Pharmaceutical companies presently are looking for ways to manage risk and taking a more proactive approach toward collection and assessment of drug safety information.
This partnership addresses the worldwide increase in focus on drug safety, which is leading to increased volumes of adverse events being reported to the regulatory authorities. Satyam and Sciformix will collaborate to enable pharmaceutical and biotechnology companies to better monitor safety of the products they market by offering services across the safety management spectrum, ranging from case intake to international regulatory reporting.
Ranbaxy Received a Tentative Approval to Manufacture and Market Valganciclovir Hydrochloride Tablets
In June - Ranbaxy Laboratories Limited announced that it received a tentative approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Valganciclovir Hydrochloride Tablets, 450 mg. It will be launched by Ranbaxy upon receiving final approval and resolution of litigation currently pending in Federal District Court, as an affordably priced alternative to the branded product, Valcyte.
Valganciclovir HCl I used for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir HCl is also indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart and kidney-pancreas transplant patients at high risk.
Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, thereby providing a potential of 180-days of marketing exclusivity, offering a significant opportunity in the future. Total annual market sales for Valganciclovir HCl Tablets were $239 million (IMS - MAT: March 2008).
Ranbaxy Laboratories Limited, one of the largest pharmaceutical companies in India, manufactures and markets a wide range of generic drugs. The Company is doing businesses in over 125 countries and has extenssive international affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.
FDA Approved Escitalopram Oxalate Tablets (generic)
In June - Lupin Pharmaceuticals, Inc. (LPI) announced that received a tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Escitalopram Oxalate Tablets 10 mg and 20 mg from the U.S. Food and Drug Administration (FDA).
Lupin's Escitalopram tablets are the AB-rated generic equivalent of Forest Laboratories' Lexapro(R) tablets, used for the treatment of major depressive disorder. According to the IMS-Health Sales data the brand product had annual sales of approximately $2.6 billion for the twelve months ended March 2008,
Commenting on the approval, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. said, "We are pleased to receive this tentative approval and look forward to bringing Escitalopram tablets to the US market as an affordable generic alternative post patent expiry."
Lupin intends to introduce the products in the market through its network of national wholesalers and drug stores post patent expiry in March 2012. This will strengthen Lupin's presence in the Selective Serotonin Reuptake Inhibitor (SSRI) segment.
Ryan Baidya
California Takshila University
Sun Pharma Received FDA Approval for Generic Fosamax (R) Tablets
In September, Sun Pharmaceutical Industries Ltd. announced that the company received approval from FDA to market Alendronate sodium tablets (generic Fosamax). Alendronate sodium tablets are indicated for the treatment and prevention of osteoporosis in post menopausal women, to increase bone mass in men with osteoporosis, in the treatment of glucocorticoid induced osteoporosis, and Paget's disease of the bone in men and women.
Fosamax (R) tablets have annual sales of approximately US$ 560 million in the US alone.
Diakron and Orchid Pharma to Develop Anti-coagulant Drug
In August, Diakron Pharmaceuticals, Inc. announced the signing of an exclusive license agreement for a novel investigational oral anticoagulant drug candidate discovered and developed through Phase I clinical trials by Merck & Co. Inc. Under the terms of the agreement, Diakron has the exclusive rights to develop, and, if approved, market and distribute the compound worldwide.
In a simultaneous transaction, Orchid Chemicals & Pharmaceuticals Ltd., the Chennai (India) based pharmaceutical major ("Orchid Pharma"), has signed an agreement to partner with Diakron as a significant shareholder and developer for the anticoagulant drug candidate. Orchid will be undertaking the next stages of development.
Codexis and Arch Pharmalabs in Strategic partnership
In August, Codexis, Inc., a leader in biocatalysis technology, and Arch Pharmalabs Limited, a leading Indian active pharmaceutical ingredients (APIs) and intermediates manufacturer, announced a major new strategic collaboration, expanding their three-year partnership in pharmaceuticals manufacturing.
Codexis, based in Redwood City, CA, will offer multiple pharmaceutical intermediates and active pharmaceutical ingredients (APIs) made with its proprietary biocatalytic processes to both innovator and generic drug manufacturers. Sales in India will be through its subsidiary, Codexis Laboratories India Private Limited. Arch, which is based in Mumbai, India and has ten facilities throughout the country, will be Codexis' exclusive manufacturer for these products. The two companies will also co-market products.
Satyam Computer Service Ltd partners with Sciformix, Inc to Provide Comprehensive Drug Safety Management Services.
In June – Satyam Computer Services Ltd, a leading global consulting and information technology services provider, announced that it formed an strategic partnership with Sciformix, Inc., a Westborough, Massachusetts-based, Life Science Knowledge Process Outsourcing (KPO) company, to data management services in "Pharmacovigilance." Several high-profile withdrawals of popular drugs from the marketplace made this partnership more important. Pharmaceutical companies presently are looking for ways to manage risk and taking a more proactive approach toward collection and assessment of drug safety information.
This partnership addresses the worldwide increase in focus on drug safety, which is leading to increased volumes of adverse events being reported to the regulatory authorities. Satyam and Sciformix will collaborate to enable pharmaceutical and biotechnology companies to better monitor safety of the products they market by offering services across the safety management spectrum, ranging from case intake to international regulatory reporting.
Ranbaxy Received a Tentative Approval to Manufacture and Market Valganciclovir Hydrochloride Tablets
In June - Ranbaxy Laboratories Limited announced that it received a tentative approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Valganciclovir Hydrochloride Tablets, 450 mg. It will be launched by Ranbaxy upon receiving final approval and resolution of litigation currently pending in Federal District Court, as an affordably priced alternative to the branded product, Valcyte.
Valganciclovir HCl I used for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir HCl is also indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart and kidney-pancreas transplant patients at high risk.
Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, thereby providing a potential of 180-days of marketing exclusivity, offering a significant opportunity in the future. Total annual market sales for Valganciclovir HCl Tablets were $239 million (IMS - MAT: March 2008).
Ranbaxy Laboratories Limited, one of the largest pharmaceutical companies in India, manufactures and markets a wide range of generic drugs. The Company is doing businesses in over 125 countries and has extenssive international affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.
FDA Approved Escitalopram Oxalate Tablets (generic)
In June - Lupin Pharmaceuticals, Inc. (LPI) announced that received a tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Escitalopram Oxalate Tablets 10 mg and 20 mg from the U.S. Food and Drug Administration (FDA).
Lupin's Escitalopram tablets are the AB-rated generic equivalent of Forest Laboratories' Lexapro(R) tablets, used for the treatment of major depressive disorder. According to the IMS-Health Sales data the brand product had annual sales of approximately $2.6 billion for the twelve months ended March 2008,
Commenting on the approval, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. said, "We are pleased to receive this tentative approval and look forward to bringing Escitalopram tablets to the US market as an affordable generic alternative post patent expiry."
Lupin intends to introduce the products in the market through its network of national wholesalers and drug stores post patent expiry in March 2012. This will strengthen Lupin's presence in the Selective Serotonin Reuptake Inhibitor (SSRI) segment.
Ryan Baidya
California Takshila University
Biopreneur -
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.
Ryan Baidya
California Takshila University
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.
Ryan Baidya
California Takshila University
Info around
Tits bits ………
California Takshla University
Biopreneur immerges into a formal educational Institution beginning June 2008. Biopreneur become a part of California Takshila University, Silicon Valley. Biopreneur now will have the resources and capabilities to offer more entrepreneurial trainings, workshops and boot-camps.
LARTA Conference
Recently Biopreneur attended LARTA-NIH organized one day conference of biopreneurs. It was a wonderful opportunity to learn potential ground-breaking technologies are in development by fresh and seasoned entrepreneurs.
Do No Harm: Dr. Anil Bansal, IMA, India
Biopreneur-of California Takshila University launched its bio-business-public health seminar series in June. On June 24, Dr. Anil Bansal, Executive member of Indian Medical Association presented a seminar/colloquium on “Do No Harm: mild, medium, hot” – practice of medicine at the dawn of the 21st century.
AAPIO-25th annual convention -
Biopreneur attended 25th anniversary convention of American Association of Physician of Indian Origin. Convention’s prime message was on metabolic problems on health; and medical practice in California in near future. CEO of California Medical Association, Joe Dunn highlighted the later part in detail
California Takshla University
Biopreneur immerges into a formal educational Institution beginning June 2008. Biopreneur become a part of California Takshila University, Silicon Valley. Biopreneur now will have the resources and capabilities to offer more entrepreneurial trainings, workshops and boot-camps.
LARTA Conference
Recently Biopreneur attended LARTA-NIH organized one day conference of biopreneurs. It was a wonderful opportunity to learn potential ground-breaking technologies are in development by fresh and seasoned entrepreneurs.
Do No Harm: Dr. Anil Bansal, IMA, India
Biopreneur-of California Takshila University launched its bio-business-public health seminar series in June. On June 24, Dr. Anil Bansal, Executive member of Indian Medical Association presented a seminar/colloquium on “Do No Harm: mild, medium, hot” – practice of medicine at the dawn of the 21st century.
AAPIO-25th annual convention -
Biopreneur attended 25th anniversary convention of American Association of Physician of Indian Origin. Convention’s prime message was on metabolic problems on health; and medical practice in California in near future. CEO of California Medical Association, Joe Dunn highlighted the later part in detail
Saturday, August 30, 2008
Venture Forum 2008 -
VENTURE FORUM 2008
Larta Institute organized its yearly venture forum on May 30, 2008 at Santa Clara Convention Center, Silicon Valley, CA. Biopreneur of the California Takshila University is being one of the affiliates of the program promoter had the privileged to witnessed the excitement of the entrepreneurs at the event.
This year the Venture Forum was dedicated to the life sciences primarily because of a large numbers of early stage innovators in the life sciences through the exclusive partnership of LARTA with the National Institutes of Health (NIH). Furthermore this year Venture forum attracted entrepreneurs from several other countries. There were 80 companies exhibited their inventions at the conference – from USA NIH-funded forty eight (48), from affiliates program twenty-four (24), and International – eight (8). It was a highly coordinated and dedicated effort of the Larta team (as show above).
Keynote speaker Steve Burrill of Burrill and Company shared his vision of the life-sciences in the coming decades. Mr. Burrill pointed out the opportunities and challenges for the sector. According to him memory and metabolic-diseases related area will receive the highest attention from the market. He also indicated that more and more people were gravitating toward staying well concept – thus the market opportunities for the wellness industry are undisputable. Just to give a quantitative feeling of his statement – Current drug market is about US$240 billion while size of the wellness product market is US$300 billion and growing.
On the financial market stocks of nutraceuticals product companies consistently did better than the both the indexes for past five years.
One of his encouraging statements for the entrepreneur was “big company is not an innovator, small company is”. Taking string of that statement we discussed with Mr. Burrill and his associate. regarding possible working association with Biopreneur of the California Takshila University. He had one advice for our forum members – “when seeking investment entrepreneur must realize that the use of investment capital comes with the change in strategy.”
Attendees enjoyed an wonderful lunch session with the President of ResearchAmerica , Ms. Mary Woolley. She asked state to take much larger role in advancing research and lack of coordination and attention in the U.S.
We all anticipate and work for science fiction-like breakthroughs.
What we need now more than ever is an advocacy breakthrough, particularly advocacy by innovators and entrepreneurs. She explained the need of public investments in both the fundamental research as well as in technology commercialization. These investment in-turn created jobs and stimulated the nation’s economy.
She further emphasized the need for regenerative research in order to stay ahead of the global competition. Countries like Singapore, South Korea, India and EU nations are implementing more of the current knowledge of the regenerative technologies than that of USA.
Clearly we need more public awareness and governmental support in this area.
We ended the forum with an extraordinary speech on human health crisis in developing countries by Mr. Boris Nikolic, Senior Program Officer, at Global Health Discovery, Bill and Melinda Gates Foundation. Dr. Nikolic challenged every entrepreneur in the audience with the current inequality of health that exist in the world. Guiding principles of the Bill and Melinda Gates foundation is –All lives – no matter where they are – have equal value. It is foundation’s goal to reduce inequality of lives.
Where does the inequity lie?
With the 2/3 of the world’s 6 billion people that live in the developing world. The greatest need is among the 1 in 6 that lives on less than $1 per day.
Millions die unnecessarily each year from diseases that are currently treatable or preventable
» AIDS, TB and malaria alone kill 6 million people annually
» Vaccine-preventable diseases kill more than 2 million children annually
Access to existing, effective health interventions is severely limited for most of those in need
» Systems for delivery of vaccines don’t regularly reach all of those in need
» Vaccines available for many years in wealthy countries, but are not used widely in the developing world
The Result: a global health problem that undermines economic development, social and political stability
He concluded his callings with the vision of the Gates foundation –"There is no bigger test for humanity than the crisis of global health. Solving it will require the full commitment of our hearts and minds. We need both. Without compassion, we won’t do anything. Without science, we can’t do anything. So far, we have not applied all we have of either." Bill Gates, World Health Assembly, May 2005
I had the opportunities to meet some of the entrepreneurs who have made exceptional technological advancement in their field. I also met a Professor-preneur, like myself from Brazil, who not only teaches entrepreneurship to his life sciences students but also a founder of a positive cash-flow bio-business in Brazil. Above you see Prof. was explaining to me his peptide technology for metabolic syndrome.
More information on Larta and Venture forum can be found at www.Larta.com. Also stay tune for the up-coming events by Larta and its affiliates including TIP, Biopreneur/ California Takshila University.
Ryan Baidya
California Takshila University
Larta Institute organized its yearly venture forum on May 30, 2008 at Santa Clara Convention Center, Silicon Valley, CA. Biopreneur of the California Takshila University is being one of the affiliates of the program promoter had the privileged to witnessed the excitement of the entrepreneurs at the event.
This year the Venture Forum was dedicated to the life sciences primarily because of a large numbers of early stage innovators in the life sciences through the exclusive partnership of LARTA with the National Institutes of Health (NIH). Furthermore this year Venture forum attracted entrepreneurs from several other countries. There were 80 companies exhibited their inventions at the conference – from USA NIH-funded forty eight (48), from affiliates program twenty-four (24), and International – eight (8). It was a highly coordinated and dedicated effort of the Larta team (as show above).
Keynote speaker Steve Burrill of Burrill and Company shared his vision of the life-sciences in the coming decades. Mr. Burrill pointed out the opportunities and challenges for the sector. According to him memory and metabolic-diseases related area will receive the highest attention from the market. He also indicated that more and more people were gravitating toward staying well concept – thus the market opportunities for the wellness industry are undisputable. Just to give a quantitative feeling of his statement – Current drug market is about US$240 billion while size of the wellness product market is US$300 billion and growing.
On the financial market stocks of nutraceuticals product companies consistently did better than the both the indexes for past five years.
One of his encouraging statements for the entrepreneur was “big company is not an innovator, small company is”. Taking string of that statement we discussed with Mr. Burrill and his associate. regarding possible working association with Biopreneur of the California Takshila University. He had one advice for our forum members – “when seeking investment entrepreneur must realize that the use of investment capital comes with the change in strategy.”
Attendees enjoyed an wonderful lunch session with the President of ResearchAmerica , Ms. Mary Woolley. She asked state to take much larger role in advancing research and lack of coordination and attention in the U.S.
We all anticipate and work for science fiction-like breakthroughs.
What we need now more than ever is an advocacy breakthrough, particularly advocacy by innovators and entrepreneurs. She explained the need of public investments in both the fundamental research as well as in technology commercialization. These investment in-turn created jobs and stimulated the nation’s economy.
She further emphasized the need for regenerative research in order to stay ahead of the global competition. Countries like Singapore, South Korea, India and EU nations are implementing more of the current knowledge of the regenerative technologies than that of USA.
Clearly we need more public awareness and governmental support in this area.
We ended the forum with an extraordinary speech on human health crisis in developing countries by Mr. Boris Nikolic, Senior Program Officer, at Global Health Discovery, Bill and Melinda Gates Foundation. Dr. Nikolic challenged every entrepreneur in the audience with the current inequality of health that exist in the world. Guiding principles of the Bill and Melinda Gates foundation is –All lives – no matter where they are – have equal value. It is foundation’s goal to reduce inequality of lives.
Where does the inequity lie?
With the 2/3 of the world’s 6 billion people that live in the developing world. The greatest need is among the 1 in 6 that lives on less than $1 per day.
Millions die unnecessarily each year from diseases that are currently treatable or preventable
» AIDS, TB and malaria alone kill 6 million people annually
» Vaccine-preventable diseases kill more than 2 million children annually
Access to existing, effective health interventions is severely limited for most of those in need
» Systems for delivery of vaccines don’t regularly reach all of those in need
» Vaccines available for many years in wealthy countries, but are not used widely in the developing world
The Result: a global health problem that undermines economic development, social and political stability
He concluded his callings with the vision of the Gates foundation –"There is no bigger test for humanity than the crisis of global health. Solving it will require the full commitment of our hearts and minds. We need both. Without compassion, we won’t do anything. Without science, we can’t do anything. So far, we have not applied all we have of either." Bill Gates, World Health Assembly, May 2005
I had the opportunities to meet some of the entrepreneurs who have made exceptional technological advancement in their field. I also met a Professor-preneur, like myself from Brazil, who not only teaches entrepreneurship to his life sciences students but also a founder of a positive cash-flow bio-business in Brazil. Above you see Prof. was explaining to me his peptide technology for metabolic syndrome.
More information on Larta and Venture forum can be found at www.Larta.com. Also stay tune for the up-coming events by Larta and its affiliates including TIP, Biopreneur/ California Takshila University.
Ryan Baidya
California Takshila University
Sunday, August 3, 2008
WHO ARE BIOPRENEURS? - California Takshila University
WHO ARE BIOPRENEURS?
Miyuki Shiratani and Ryan Baidya
Cupertino, California
Biopreneurs or bioentrepreneurs are normally adventurous, innovative, analytical, problem solvers. PhD training in any given field gives the primary skills and core knowledge of that field. However, there is another whole set of skills and understanding that is not covered in normal PhD training. That aspect is the understanding of entrepreneurship itself, which makes it easier to manage and administer the aspects of a specific business. With bioventure comes extreme complexity that requires business knowledge and understanding. To become an established and successful bioentrepreneur no one can avoid the business aspects of such a venture. A successful biopreneur must acquire and command the necessary basic knowledge of general business practices. Planning a business and the execution of that plan to achieve real success are two completely different aspects of bionventure, or of any business. A person may have to go through an intermediary phase, or phases—becoming a technical manager—and might also have to be a lead scientist or researcher as well.
The transition from technical contributor to technical manager is not easy. Globally, in biotechnology, scientists are often given the responsibility for projects and people without much thought or additional management training. This is especially true in the case of biopreneurs who want to establish a business without outside administrative help. If they transition perfectly—i.e. they understand the proper place and roles of administrative people and mold themselves in accord with that—they’ll gain the same outcome as having outside managers brought into the team. The fact is that some biopreneurs make the transition rather well, though many experts agree that the industry has had a rough time in such transitional phases; it needs improvement. So, to reach the peak in your business, you cannot underestimate the need for efficient management styles.
Try to understand what happens within the minds of many biopreneurs. Failure in the transitional stage to manager occurs because most people with a PhD in biotechnology, while chalking out a business plan, focus on the scientific and technological aspects of the whole matter. As they consider their potential product and related incidentals, they see it only from a scientist’s point of view. Thus when it comes to the administrative aspects of the venture, they believe that implementing supervisory skills is simply a matter of time and gaining experience. They expect it to be a basic learning situation while they operate their new business.
Stan Sewitch, a human resources (HR) consultant in San Diego, contradicts that all too common belief saying, "Management is not an additional set of responsibilities requiring new skills to be added to one's professional repertoire," he continues, "Management is an entirely different career from that of the individual contributor in science." Sewitch, former director of human resources for Mycogen, San Diego, CA, USA, adds that technical professionals too often believe that managing people is a skill-set to be acquired. In most cases, they find out too late that this isn't the case. It’s best to take Sewitch’s advice seriously from the very outset of a project.
A researcher willing to set up a business based on his or her concept in biotechnology, known as a biopreneur in the industry, must achieve several useful qualities to reach the goal of becoming a successful businessman. Along with gaining managerial awareness it is also advantageous to know how they themselves are different from other businessmen. It surely helps them to smooth out any pertinent difficulties while adding indispensable qualities. It is essential to prospective biopreneurs to prepare for the future by learning and planning for their bio-venture. They must understand, along with other things, prior to commencing their business, their own drawbacks and weaknesses and how they may overcome them or at least be prepared to face them.
TRAITS OF A RESEARCHER AND A BUSINESSPERSON
RESEARCHER BIOPRENEUR (Science+ Business)
Determinant & Stubborn Determinant
Ambitious Ambitious with realism
Problem solver Problem solver & delegator
Unbound Explorer Disciplined Exploration
Risk taker Risk taker & hedger
Leadership (some cases) Leadership & Team Player
Cheer leader (some cases) Cheer leader
Sales person (some cases) Sales person
Hard worker Hard worker
From the above chart it is quite clear that researchers and biopreneurs are different in fundamental ways. You can recognize one thing clearly; if you are willing to become solely a researcher you may follow one path, inventing new things day in and day out. But if your goal is to become a successful businessman you will have a somewhat different pathway to take. If fortune is inviting you to become a biopreneur you must choose a special lifestyle— one where you must play both roles—researcher and businessman. Along with the characteristics that a researcher exhibits a biopreneur carries additional attributes which demand particular attention. For example, a researcher’s character-set insists on being ambitious. In contrast the character of a biopreneur requires ambition based on reality. That “reality” makes an ideal situation because in bioventure you must work to promote yourself along with your company’s brand. There is no place for airy ambition as you are required to make a profit for your investors. In the case of bioventure, you will be forced into certain obligations such as: competitive intelligence, task-management, finding investors and funding, tax concerns and monetary returns for your investors, marketing strategies, concrete branding—the future of your brand, reworking corporate structure etc. These things will prevent you from exploring new product-lines without ample concern for profit in the venture. Thus, still retaining characteristics of a researcher, which you truly are, you will also think and execute things like a businessman. That means not to embellish, so that you will become an ideal biopreneur.
Valuable opinions
Co-founder and Chairman of Responsys, Inc., Anand Jagannathan talked about the characteristics required to be an entrepreneur. Entrepreneurs need to have determination and drive, the ability to face rejection, and they need to be risk takers. They must know their “value proposition” with respect to customer “pain points.” Most successful entrepreneurs, Jagannathan suggests, have a clear definition of their personal success that goes beyond reaching the IPO stage, an ability to listen and adapt to customer’s requirements, and the ability to recognize and seize opportunity. Though it may be easy to read or listen to this, it’s really very difficult to follow through. And, to materialize the whole concept is even harder.
Mr. Bipin Shah, a successful entrepreneur, now a V.C. in the Silicon Valley, once presented advice to the new entrepreneurs:
• Start only if you are committed for the long haul and prepared to go through the ups and downs.
• Start only if you have the deepest passion for what you are going to do.
• Start only if you are prepared to “fail” if things go “wrong” and they “do…”
• Start only if you are absolutely convinced that you are killing a real pain that exists in the market today.
Though an old familiar story but probably novel to new entrepreneurs—starting anything new always has risk factors, which could lead to failure. If you are inclined to stop at this point, or move on to other tangential visions, you may never return to your dream of establishing a real bio-venture and it will remain merely a fantasy. Whether it’s a new, or an established venture, risk is always an innate part of the game. But you have to stick to your original choice of acquiring success. Gururaj “Desh” Deshpande rejected thoughts of returning to his life as a professor and software engineer—Re: book titled From Financial Flop to Billionaire. After his first failure, Desphande stayed the course, always true to his original vision. Now a very successful entrepreneur, he relates: “A manager means doing things (the) ‘right way’ and a leader means doing the ‘right things.’” If it's something you really believe in, he asserts, "…you're going to make it happen."
Here, before you decide which role fits you best, you have to know exactly what right thing and exactly which right way… Reading theories and building a business plan, based on theory alone, is not very hard, maybe even a little too easy. Your planning must be based first on reality. After that you have to be prepared to pursue essential intermediate goals in order to achieve success. First and foremost, you must consider possible risk factors that you or your company may need to face. Risks have to be faced; not succumbing to your fears will make you an ultimate winner.
Leadership—It’s Expected
Outstanding leaders in business have the ability to convince others. You must have the ability to inspire your peers and to execute things at the right time. You have to motivate investors and partners to have faith in your abilities and concepts, so that they do not waver to invest or support your decisions.
It is particularly true that gaining something is frequently easier than retaining it. Leadership is that same sort of thing. As a leader you may have to make decisions without having all the information at hand, but your decisions will have to be a strong enough so that no one will want to oppose you afterward. Though only real experience helps true leaders to make decisions effectively, nonetheless, many times intuition, based on personal and concrete understanding, is also a great and positive assist.
You have to stick to your decisions until a time when you find significant flaws in them. Here you will have to mindful that as a leader you must not play the part of a dictator. Good and generous leaders have their goals focused on their team’s goals. You have to be always ready to listen to your people because they may, in fact, have better ideas in mind than you. You must build a good team to execute what you think. Thus capable minds should surround you—their suggestions, comments and interpretations will always be helpful. You should try to remain the center-point of the team, and so your communicating skills will keep them in concert. You have to be strongly connected to your team-members, ready to listen to and talk to them as needed.
It may appear to be the job of managers but you also must learn how to separate your inner being—compartmentalizing yourself as required for a group venture. You must know how to gain the qualities needed to accomplish the duties of full leadership. You have to sanction yourself with powers like ego-power, self-power and agency-power. And it is your soul-power—the power of your spirit—that will keep you totally responsive to all appropriate feedback. That power will never lead you to feel-on-top of anyone, nor beneath anyone either. Also ego, if used positively, can make you self-aware; it can increase positive values in your life. But remember, your ego-power must not become tactless egotism—self-centered selfishness—optimally it should lightly touch egoism, i.e. self-interest. That difference subtlety prevents you from losing your humanity.
As Deepak Chopra has shared, you as a leader have to have the ability to look and listen—not normal looking, and listening—you must not be blinded to observing reality. For the best possible future of your business, you must not be deaf to free-flowing ideas and advice from your partners and your subordinates.
Interestingly, this vision is not only for you, but also for the sake of social justice and environmental responsibility. After all you must be responsible for any harm caused to ambient surroundings if it’s caused by your bioventure. So you ought to cultivate a sense of consciousness, and social-environmental awareness. Consciousness differentiates tangled hierarchies. Consciousness is necessary to virtually connect with reality. And so, it is a sense of consciousness, and awareness, that every human being, whether in business or any field or job, must possess, for the betterment of society and the environment in general.
A Simple Philosophy
Business is a service for the society and money is the by-product of that service. Every time, as you think of building a new venture, you ought to remind yourself of that statement. The by-product of the business is your profit and it is the living blood of your company, but the service you provide to society must not be any less than oxygen. That might be considered yet another responsibility, but as a leader you have to be prepared for such concepts.
Leadership is dependent on time and circumstances. You must be prepared to prove your abilities every time you are faced with requisite circumstances. You have to create a wholly positive environment for ongoing projects. As a leader you have to have understand synchronicity—a sense of co-ordination, and a sense of harmony within several jobs. A leader feels, visualizes, takes a risk, and accomplishes a commitment to pick up broken pieces, as he or she moves along to meet various goals. A leader never loses the winning spirit.
Nearing the end of this section, I would like to recap and philosophize. It’s not wrong to say that leaders, and followers, co-create each other. Leaders, followers and environments co-arise within the same space and time. It is rule itself that differentiates the ruler from others. Although there are several points or characteristics that may help an entrepreneur to manage the role of the ruler, there is nothing that is fixed in any business. Rules work for business, but business is never for the sake of rules. Rules or basic guidelines to prepare your business are conceived from previous business experiences.
As a leader you will have to make your own rules. Time will allow such opportunities. Then why talk about not-making-rules or avoiding it? Why listen to other people? It is for a breakthrough or to invent new or better rules, when you will reach new vantage points of understanding—newer positions of understanding, thus modifying older rules.
Knowledge is only a stairway that leads you to a level of success—you have to become successful first, by devising your own strategy. When your strategy is proven, you will establish your own rules in which to rule your business, as you see fit. This tipping point will be perceived as the birth of a real industry leader. …Hats off!
Inside the Minds of Biopreneurs
Now you know or at least have a vague notion of what a biopreneur is, a hint of the managerial aspects of the job, as well as the role and the ways of a leader. Now let’s take a brief journey through the mind of a biopreneur. What they hold in their minds makes them different from other researchers, as it also makes them known to the world! What is the inspiring source of such strong will-power! According to Mr. Olaf Isachson, the author of Joining the Entrepreneurial Elite, the ten most traits of entrepreneurs, including biopreneurs possess, are:
• They are in charge of their own destiny. Contradicting this, anyone can say that every man is the master of his own destiny, it is true! But the winning drive is this: Like other people, entrepreneurs, when problems arise, do not leave their destiny in hands of an unforeseen circumstance.
• They are non-conformists, able to be stand-alone or be with people. It is their iron mettle that helps them to face any situation. They know how to mold themselves in accordance with a given situation.
• They move beyond the local, the provincial, the familiar and the tried and true. In short they are true risk-takers.
• They avoid time-consuming trifles and are swift to make decisions. True leadership is always a part of their character. Always, even in the roughest and hardest situations, they remain cool and calm—to make the right and best decisions.
• There are no obstacles, only challenges and temporary setbacks. The word obstacle does not exist in the vernacular of biopreneurs. It is a merely a challenge, as they love to call it, and obviously it is a challenge that makes them so excited and charged.
• The harder they work the more energy they generate. They generally possess nonstop energy to go on, and on, and on…
• They love what they do, and their devotion and passion allows them to move beyond the confines of themselves. The passion and love for what you are about to do will make its outcome much better, and of course generally positive.
• They are visionaries and their biggest competitors are themselves. It is ultimately their unique vision and decisions that make up responsibilities for the future of their ventures. Certainly, if they are wrong, they will reverse an imminent catastrophe.
• They seldom give up. Failure is not in their vocabulary. Just like the word obstacle they are not ready to think of failure. A small piece of advice here: it is better to have confidence, not thinking of failure or obstacles, but you have to keep your eyes open for anything of that sort too, so that you find yourself and your people ready to face it, if it appears in the future.
• They firmly believe there are no sins of commission—only those of omission. That may differ depending on the individuals. However, it is also a particular trait that biopreneurs possess quite proudly.
Paths to success
We always like to know and teach, especially when we know a lot about business, leadership, etc., or about a formula that may bring success. I do not think there is any generalized formula or equation that can be used to define success. However, this does not prevent us from exploring and finding a cluster of formulas, or sets of characteristics, that may give us a foreseeable indication of a pathway to success. In bioventure this information is quite valuable. It is actually based on experience as well as the experiments of others who might inform us about possible, though not 100% flawless, paths to success. One thing might be applicable to X, though it may not equally be applicable to Z, and so on. A group of scholars at MIT’s Sloan School of Management did research on this subject for five years. According to their studies here is their model for success:
• Success takes a balance of forces. Technology is not always necessary and is almost never sufficient.
• Due to the power of open communication by the virtue of the Internet revolution, the business model of future company might be a huge corporation or it might be a very small enterprise.
• Decentralization is key phrase of the future. In order to be successful one must make decisions based on ones proximity to the knowledge of his or her customers.
• True activities, not the corporate organization charts, will become the primary building blocks in a business. Out-sourcing and alliances will eliminate the need for huge personnel, and becomes the enabler of the small businessperson intent on staying lean but growing into a big business.
• Companies large and small will be both global and local. They will need the local touch and all will face global competition.
• The most impacting discovery of this research is regarding the coming golden era of microenterprises—a vision that is saturated in the power of Internet. Given the low cost of communications, everyone can be well informed and thus will make good decisions. The highly motivated, the creative and innovative, the biopreneur, will convert imparted data and knowledge into business wisdom, and build successful companies to compete with gorilla-corporations.
As I already have mentioned these are possible ways; it depends upon you, as you are the sole responsible agent for the future of your company. It is useful and a wise decision for the time being to read these ideas to comprehend the right way before you make any hasty decisions. No one and nothing in particular will bring success unless you understand and decide what is good for you. It is well said that success is the progressive realization of a worthy goal. Success comes from the ability to feel compassion.
Success Redefined
Inderjit Singh, founder and CEO of Infiniti Solutions and also TIE Singapore, a member of parliament in Singapore, he has shared the story of his entrepreneurship. Acquiring a seat in government or joining a multinational company formerly defined success in Singapore. This might resonate with many of us who have known success in Japan, or have equated it to signing-up with a multinational organization, or gaining a government position. Singh climbed the ladder of success in Singapore through the same means. But then he attempted something a bit different; he was able to acquire venture funding from inside of Singapore, and from abroad. In doing this he ultimately realized his entrepreneurial dream by changing previously construed, or tacitly defined, limits.
He said, as a member of parliament he championed the cause of transforming Singapore from a corporate based economy into an entrepreneurial one by addressing all concerns, impediments, and challenges to entrepreneurship—his mission leaving: “no stone left unturned.” According to him the key characteristics required to be a successful entrepreneur are as follows:
1) Determination
2) Risk-taking
3) Leadership
4) Number one sales person and number one cheerleader
5) Problem solver
So you see the basic traits required to be a successful entrepreneur stay same. It is only the method of utilizing these traits that change. Over the course, methods change with things such as the mind, time, and circumstances.
Though not directly connected to bioventure let us share another important success story. A well circulated story, if not well known, is one in which Ireland was looking to become a major center for Microsoft and wanted a major server hub. Unfortunately, Microsoft’s investigation revealed that Ireland’s electronic infrastructure could not support it because it did not have enough resident bandwidth. So everything stopped. What to do now! There was no looking back and no crying tears of woe. Ireland took on the enterprise, implementing the required bandwidth building it to the latest specifications in a very short span of time. The rest is history, thus establishing Ireland as a global center of excellence in Internet activity. And that is how one should be prepared for any forthcoming or unforeseen, unexpected, problem. Now then two questions arise:
How would another country have dealt with such a challenge?
How are other countries prepared to participate in similar dynamic and global marketplaces?
The problem and its solution will remain at their places we just have to find them out. Now that we have enjoyed a little bit of success kind a thing, let us explore some new ways to attend success:
Some Critical Success Factors In Biopreneurs
Strong Will Power That Can Motivate Others.
Early Contact With Successful Entrepreneurs.
Exposure To Success Stories And Case Studies.
Gain Practical, Real World Experience Before, During And After PhDs.
Be Willing To Be Unusual/Unconventional.
Agree To Embrace Risk, And Possibly Failure.
Ready To Leave A Large Company.
Great Idea To Start With.
Excellent And Passionate Team - Near And Long Term Vision.
Ability To Change Course Mid Stream.
Execution, Execution And Execution!!
Strategic And Marketing Brilliance.
Frugality & Excellent Cash Management.
Support Network - VCs, Board, Advisory Board And Other Value Add People.
Though it may look like bringing the same old line in front again, I should like to remind you again that things are not to be followed strictly. Those are important yet very flexible rules. Those tools are for the sake of your business and your business is not there to prove their practicality. Every ruler creates his/her own rule but it’s only after you be sure of calling yourself a ruler in business.
Sum up
As someone once said, the best of us is not what we do but what we inspire in others. Thus when we share our experience and knowledge it increases. Whatever the way we choose or wherever we move to work the basic knowledge and way will remain the same. We may face failure and obstacles only to remember, “Failure is one of the major milestones of an entrepreneur and each obstacle is an opportunity”. It’s not a theory, as a theory is also based on what we learn out of our failure and experiment, but our own flaw and failure will teach us the right way to success. It will make us winner one day. Everything is dependant on our mind as Silicon Valley is not a geographical location it is just a “state of mind”. Think as a winner and you will find yourself as a winner. If you loose the vigour of your mind you will be nowhere in near future.
If experiment is the only thing that you have in hand, do it sincerely, genuinely and with an inimitable passion for them. With the human life span longer and the business cycle shorter, the opportunities are immense for those with the motivation, the temperament, and the guts to do it their way. There was no one-way, there is no one-way and there will be no one-way. It was the biopreneur’s way, it is the biopreneur’s way and it will be the biopreneur’s way.
(This artilce is taken from a book titled – Biopreneurs: the Molecular Millionaires)
Miyuki Shiratani currently is in charge of international logistic for Devicenet, USA, Inc. She has over 10 years’ international and multicultural experience (Japan, US, India) in both IT and biotech industries. She also held responsibilities of international marketing communications at Sharp Electronic Corp., Osaka, Japan; and sale/customer relations at JUSCO, Japan. She received her BA at Kansai Gaidai University, Osaka, Japan, and MBA at the San Jose state University, CA.
Ryan Baidya is an entrepreneur a business strategist and who has 12+ years of experience in biotech. He launched several biotech and high-tech businesses in Silicon Valley/USA, and Tokyo/Japan. He founded BioZak and BioZak-Infobase, and served as one of the founding management. Prior to that he was with Genprobe, , HyseQ; and GeneAsia. He serves as an advisor to Golden-Embryo, Pune/India; and KZAISoft corp., Durgapur/India. He gave numerous lectures on life sciences and bio-business topics at conferences, primarily in USA, and Japan. He authored articles, patents, and commentaries. Dr. Baidya received his MS from IIT Kanpur, PhD from the University of California, Santa Cruz and MBA from the San Jose State University, CA..
Miyuki Shiratani and Ryan Baidya
Cupertino, California
Biopreneurs or bioentrepreneurs are normally adventurous, innovative, analytical, problem solvers. PhD training in any given field gives the primary skills and core knowledge of that field. However, there is another whole set of skills and understanding that is not covered in normal PhD training. That aspect is the understanding of entrepreneurship itself, which makes it easier to manage and administer the aspects of a specific business. With bioventure comes extreme complexity that requires business knowledge and understanding. To become an established and successful bioentrepreneur no one can avoid the business aspects of such a venture. A successful biopreneur must acquire and command the necessary basic knowledge of general business practices. Planning a business and the execution of that plan to achieve real success are two completely different aspects of bionventure, or of any business. A person may have to go through an intermediary phase, or phases—becoming a technical manager—and might also have to be a lead scientist or researcher as well.
The transition from technical contributor to technical manager is not easy. Globally, in biotechnology, scientists are often given the responsibility for projects and people without much thought or additional management training. This is especially true in the case of biopreneurs who want to establish a business without outside administrative help. If they transition perfectly—i.e. they understand the proper place and roles of administrative people and mold themselves in accord with that—they’ll gain the same outcome as having outside managers brought into the team. The fact is that some biopreneurs make the transition rather well, though many experts agree that the industry has had a rough time in such transitional phases; it needs improvement. So, to reach the peak in your business, you cannot underestimate the need for efficient management styles.
Try to understand what happens within the minds of many biopreneurs. Failure in the transitional stage to manager occurs because most people with a PhD in biotechnology, while chalking out a business plan, focus on the scientific and technological aspects of the whole matter. As they consider their potential product and related incidentals, they see it only from a scientist’s point of view. Thus when it comes to the administrative aspects of the venture, they believe that implementing supervisory skills is simply a matter of time and gaining experience. They expect it to be a basic learning situation while they operate their new business.
Stan Sewitch, a human resources (HR) consultant in San Diego, contradicts that all too common belief saying, "Management is not an additional set of responsibilities requiring new skills to be added to one's professional repertoire," he continues, "Management is an entirely different career from that of the individual contributor in science." Sewitch, former director of human resources for Mycogen, San Diego, CA, USA, adds that technical professionals too often believe that managing people is a skill-set to be acquired. In most cases, they find out too late that this isn't the case. It’s best to take Sewitch’s advice seriously from the very outset of a project.
A researcher willing to set up a business based on his or her concept in biotechnology, known as a biopreneur in the industry, must achieve several useful qualities to reach the goal of becoming a successful businessman. Along with gaining managerial awareness it is also advantageous to know how they themselves are different from other businessmen. It surely helps them to smooth out any pertinent difficulties while adding indispensable qualities. It is essential to prospective biopreneurs to prepare for the future by learning and planning for their bio-venture. They must understand, along with other things, prior to commencing their business, their own drawbacks and weaknesses and how they may overcome them or at least be prepared to face them.
TRAITS OF A RESEARCHER AND A BUSINESSPERSON
RESEARCHER BIOPRENEUR (Science+ Business)
Determinant & Stubborn Determinant
Ambitious Ambitious with realism
Problem solver Problem solver & delegator
Unbound Explorer Disciplined Exploration
Risk taker Risk taker & hedger
Leadership (some cases) Leadership & Team Player
Cheer leader (some cases) Cheer leader
Sales person (some cases) Sales person
Hard worker Hard worker
From the above chart it is quite clear that researchers and biopreneurs are different in fundamental ways. You can recognize one thing clearly; if you are willing to become solely a researcher you may follow one path, inventing new things day in and day out. But if your goal is to become a successful businessman you will have a somewhat different pathway to take. If fortune is inviting you to become a biopreneur you must choose a special lifestyle— one where you must play both roles—researcher and businessman. Along with the characteristics that a researcher exhibits a biopreneur carries additional attributes which demand particular attention. For example, a researcher’s character-set insists on being ambitious. In contrast the character of a biopreneur requires ambition based on reality. That “reality” makes an ideal situation because in bioventure you must work to promote yourself along with your company’s brand. There is no place for airy ambition as you are required to make a profit for your investors. In the case of bioventure, you will be forced into certain obligations such as: competitive intelligence, task-management, finding investors and funding, tax concerns and monetary returns for your investors, marketing strategies, concrete branding—the future of your brand, reworking corporate structure etc. These things will prevent you from exploring new product-lines without ample concern for profit in the venture. Thus, still retaining characteristics of a researcher, which you truly are, you will also think and execute things like a businessman. That means not to embellish, so that you will become an ideal biopreneur.
Valuable opinions
Co-founder and Chairman of Responsys, Inc., Anand Jagannathan talked about the characteristics required to be an entrepreneur. Entrepreneurs need to have determination and drive, the ability to face rejection, and they need to be risk takers. They must know their “value proposition” with respect to customer “pain points.” Most successful entrepreneurs, Jagannathan suggests, have a clear definition of their personal success that goes beyond reaching the IPO stage, an ability to listen and adapt to customer’s requirements, and the ability to recognize and seize opportunity. Though it may be easy to read or listen to this, it’s really very difficult to follow through. And, to materialize the whole concept is even harder.
Mr. Bipin Shah, a successful entrepreneur, now a V.C. in the Silicon Valley, once presented advice to the new entrepreneurs:
• Start only if you are committed for the long haul and prepared to go through the ups and downs.
• Start only if you have the deepest passion for what you are going to do.
• Start only if you are prepared to “fail” if things go “wrong” and they “do…”
• Start only if you are absolutely convinced that you are killing a real pain that exists in the market today.
Though an old familiar story but probably novel to new entrepreneurs—starting anything new always has risk factors, which could lead to failure. If you are inclined to stop at this point, or move on to other tangential visions, you may never return to your dream of establishing a real bio-venture and it will remain merely a fantasy. Whether it’s a new, or an established venture, risk is always an innate part of the game. But you have to stick to your original choice of acquiring success. Gururaj “Desh” Deshpande rejected thoughts of returning to his life as a professor and software engineer—Re: book titled From Financial Flop to Billionaire. After his first failure, Desphande stayed the course, always true to his original vision. Now a very successful entrepreneur, he relates: “A manager means doing things (the) ‘right way’ and a leader means doing the ‘right things.’” If it's something you really believe in, he asserts, "…you're going to make it happen."
Here, before you decide which role fits you best, you have to know exactly what right thing and exactly which right way… Reading theories and building a business plan, based on theory alone, is not very hard, maybe even a little too easy. Your planning must be based first on reality. After that you have to be prepared to pursue essential intermediate goals in order to achieve success. First and foremost, you must consider possible risk factors that you or your company may need to face. Risks have to be faced; not succumbing to your fears will make you an ultimate winner.
Leadership—It’s Expected
Outstanding leaders in business have the ability to convince others. You must have the ability to inspire your peers and to execute things at the right time. You have to motivate investors and partners to have faith in your abilities and concepts, so that they do not waver to invest or support your decisions.
It is particularly true that gaining something is frequently easier than retaining it. Leadership is that same sort of thing. As a leader you may have to make decisions without having all the information at hand, but your decisions will have to be a strong enough so that no one will want to oppose you afterward. Though only real experience helps true leaders to make decisions effectively, nonetheless, many times intuition, based on personal and concrete understanding, is also a great and positive assist.
You have to stick to your decisions until a time when you find significant flaws in them. Here you will have to mindful that as a leader you must not play the part of a dictator. Good and generous leaders have their goals focused on their team’s goals. You have to be always ready to listen to your people because they may, in fact, have better ideas in mind than you. You must build a good team to execute what you think. Thus capable minds should surround you—their suggestions, comments and interpretations will always be helpful. You should try to remain the center-point of the team, and so your communicating skills will keep them in concert. You have to be strongly connected to your team-members, ready to listen to and talk to them as needed.
It may appear to be the job of managers but you also must learn how to separate your inner being—compartmentalizing yourself as required for a group venture. You must know how to gain the qualities needed to accomplish the duties of full leadership. You have to sanction yourself with powers like ego-power, self-power and agency-power. And it is your soul-power—the power of your spirit—that will keep you totally responsive to all appropriate feedback. That power will never lead you to feel-on-top of anyone, nor beneath anyone either. Also ego, if used positively, can make you self-aware; it can increase positive values in your life. But remember, your ego-power must not become tactless egotism—self-centered selfishness—optimally it should lightly touch egoism, i.e. self-interest. That difference subtlety prevents you from losing your humanity.
As Deepak Chopra has shared, you as a leader have to have the ability to look and listen—not normal looking, and listening—you must not be blinded to observing reality. For the best possible future of your business, you must not be deaf to free-flowing ideas and advice from your partners and your subordinates.
Interestingly, this vision is not only for you, but also for the sake of social justice and environmental responsibility. After all you must be responsible for any harm caused to ambient surroundings if it’s caused by your bioventure. So you ought to cultivate a sense of consciousness, and social-environmental awareness. Consciousness differentiates tangled hierarchies. Consciousness is necessary to virtually connect with reality. And so, it is a sense of consciousness, and awareness, that every human being, whether in business or any field or job, must possess, for the betterment of society and the environment in general.
A Simple Philosophy
Business is a service for the society and money is the by-product of that service. Every time, as you think of building a new venture, you ought to remind yourself of that statement. The by-product of the business is your profit and it is the living blood of your company, but the service you provide to society must not be any less than oxygen. That might be considered yet another responsibility, but as a leader you have to be prepared for such concepts.
Leadership is dependent on time and circumstances. You must be prepared to prove your abilities every time you are faced with requisite circumstances. You have to create a wholly positive environment for ongoing projects. As a leader you have to have understand synchronicity—a sense of co-ordination, and a sense of harmony within several jobs. A leader feels, visualizes, takes a risk, and accomplishes a commitment to pick up broken pieces, as he or she moves along to meet various goals. A leader never loses the winning spirit.
Nearing the end of this section, I would like to recap and philosophize. It’s not wrong to say that leaders, and followers, co-create each other. Leaders, followers and environments co-arise within the same space and time. It is rule itself that differentiates the ruler from others. Although there are several points or characteristics that may help an entrepreneur to manage the role of the ruler, there is nothing that is fixed in any business. Rules work for business, but business is never for the sake of rules. Rules or basic guidelines to prepare your business are conceived from previous business experiences.
As a leader you will have to make your own rules. Time will allow such opportunities. Then why talk about not-making-rules or avoiding it? Why listen to other people? It is for a breakthrough or to invent new or better rules, when you will reach new vantage points of understanding—newer positions of understanding, thus modifying older rules.
Knowledge is only a stairway that leads you to a level of success—you have to become successful first, by devising your own strategy. When your strategy is proven, you will establish your own rules in which to rule your business, as you see fit. This tipping point will be perceived as the birth of a real industry leader. …Hats off!
Inside the Minds of Biopreneurs
Now you know or at least have a vague notion of what a biopreneur is, a hint of the managerial aspects of the job, as well as the role and the ways of a leader. Now let’s take a brief journey through the mind of a biopreneur. What they hold in their minds makes them different from other researchers, as it also makes them known to the world! What is the inspiring source of such strong will-power! According to Mr. Olaf Isachson, the author of Joining the Entrepreneurial Elite, the ten most traits of entrepreneurs, including biopreneurs possess, are:
• They are in charge of their own destiny. Contradicting this, anyone can say that every man is the master of his own destiny, it is true! But the winning drive is this: Like other people, entrepreneurs, when problems arise, do not leave their destiny in hands of an unforeseen circumstance.
• They are non-conformists, able to be stand-alone or be with people. It is their iron mettle that helps them to face any situation. They know how to mold themselves in accordance with a given situation.
• They move beyond the local, the provincial, the familiar and the tried and true. In short they are true risk-takers.
• They avoid time-consuming trifles and are swift to make decisions. True leadership is always a part of their character. Always, even in the roughest and hardest situations, they remain cool and calm—to make the right and best decisions.
• There are no obstacles, only challenges and temporary setbacks. The word obstacle does not exist in the vernacular of biopreneurs. It is a merely a challenge, as they love to call it, and obviously it is a challenge that makes them so excited and charged.
• The harder they work the more energy they generate. They generally possess nonstop energy to go on, and on, and on…
• They love what they do, and their devotion and passion allows them to move beyond the confines of themselves. The passion and love for what you are about to do will make its outcome much better, and of course generally positive.
• They are visionaries and their biggest competitors are themselves. It is ultimately their unique vision and decisions that make up responsibilities for the future of their ventures. Certainly, if they are wrong, they will reverse an imminent catastrophe.
• They seldom give up. Failure is not in their vocabulary. Just like the word obstacle they are not ready to think of failure. A small piece of advice here: it is better to have confidence, not thinking of failure or obstacles, but you have to keep your eyes open for anything of that sort too, so that you find yourself and your people ready to face it, if it appears in the future.
• They firmly believe there are no sins of commission—only those of omission. That may differ depending on the individuals. However, it is also a particular trait that biopreneurs possess quite proudly.
Paths to success
We always like to know and teach, especially when we know a lot about business, leadership, etc., or about a formula that may bring success. I do not think there is any generalized formula or equation that can be used to define success. However, this does not prevent us from exploring and finding a cluster of formulas, or sets of characteristics, that may give us a foreseeable indication of a pathway to success. In bioventure this information is quite valuable. It is actually based on experience as well as the experiments of others who might inform us about possible, though not 100% flawless, paths to success. One thing might be applicable to X, though it may not equally be applicable to Z, and so on. A group of scholars at MIT’s Sloan School of Management did research on this subject for five years. According to their studies here is their model for success:
• Success takes a balance of forces. Technology is not always necessary and is almost never sufficient.
• Due to the power of open communication by the virtue of the Internet revolution, the business model of future company might be a huge corporation or it might be a very small enterprise.
• Decentralization is key phrase of the future. In order to be successful one must make decisions based on ones proximity to the knowledge of his or her customers.
• True activities, not the corporate organization charts, will become the primary building blocks in a business. Out-sourcing and alliances will eliminate the need for huge personnel, and becomes the enabler of the small businessperson intent on staying lean but growing into a big business.
• Companies large and small will be both global and local. They will need the local touch and all will face global competition.
• The most impacting discovery of this research is regarding the coming golden era of microenterprises—a vision that is saturated in the power of Internet. Given the low cost of communications, everyone can be well informed and thus will make good decisions. The highly motivated, the creative and innovative, the biopreneur, will convert imparted data and knowledge into business wisdom, and build successful companies to compete with gorilla-corporations.
As I already have mentioned these are possible ways; it depends upon you, as you are the sole responsible agent for the future of your company. It is useful and a wise decision for the time being to read these ideas to comprehend the right way before you make any hasty decisions. No one and nothing in particular will bring success unless you understand and decide what is good for you. It is well said that success is the progressive realization of a worthy goal. Success comes from the ability to feel compassion.
Success Redefined
Inderjit Singh, founder and CEO of Infiniti Solutions and also TIE Singapore, a member of parliament in Singapore, he has shared the story of his entrepreneurship. Acquiring a seat in government or joining a multinational company formerly defined success in Singapore. This might resonate with many of us who have known success in Japan, or have equated it to signing-up with a multinational organization, or gaining a government position. Singh climbed the ladder of success in Singapore through the same means. But then he attempted something a bit different; he was able to acquire venture funding from inside of Singapore, and from abroad. In doing this he ultimately realized his entrepreneurial dream by changing previously construed, or tacitly defined, limits.
He said, as a member of parliament he championed the cause of transforming Singapore from a corporate based economy into an entrepreneurial one by addressing all concerns, impediments, and challenges to entrepreneurship—his mission leaving: “no stone left unturned.” According to him the key characteristics required to be a successful entrepreneur are as follows:
1) Determination
2) Risk-taking
3) Leadership
4) Number one sales person and number one cheerleader
5) Problem solver
So you see the basic traits required to be a successful entrepreneur stay same. It is only the method of utilizing these traits that change. Over the course, methods change with things such as the mind, time, and circumstances.
Though not directly connected to bioventure let us share another important success story. A well circulated story, if not well known, is one in which Ireland was looking to become a major center for Microsoft and wanted a major server hub. Unfortunately, Microsoft’s investigation revealed that Ireland’s electronic infrastructure could not support it because it did not have enough resident bandwidth. So everything stopped. What to do now! There was no looking back and no crying tears of woe. Ireland took on the enterprise, implementing the required bandwidth building it to the latest specifications in a very short span of time. The rest is history, thus establishing Ireland as a global center of excellence in Internet activity. And that is how one should be prepared for any forthcoming or unforeseen, unexpected, problem. Now then two questions arise:
How would another country have dealt with such a challenge?
How are other countries prepared to participate in similar dynamic and global marketplaces?
The problem and its solution will remain at their places we just have to find them out. Now that we have enjoyed a little bit of success kind a thing, let us explore some new ways to attend success:
Some Critical Success Factors In Biopreneurs
Strong Will Power That Can Motivate Others.
Early Contact With Successful Entrepreneurs.
Exposure To Success Stories And Case Studies.
Gain Practical, Real World Experience Before, During And After PhDs.
Be Willing To Be Unusual/Unconventional.
Agree To Embrace Risk, And Possibly Failure.
Ready To Leave A Large Company.
Great Idea To Start With.
Excellent And Passionate Team - Near And Long Term Vision.
Ability To Change Course Mid Stream.
Execution, Execution And Execution!!
Strategic And Marketing Brilliance.
Frugality & Excellent Cash Management.
Support Network - VCs, Board, Advisory Board And Other Value Add People.
Though it may look like bringing the same old line in front again, I should like to remind you again that things are not to be followed strictly. Those are important yet very flexible rules. Those tools are for the sake of your business and your business is not there to prove their practicality. Every ruler creates his/her own rule but it’s only after you be sure of calling yourself a ruler in business.
Sum up
As someone once said, the best of us is not what we do but what we inspire in others. Thus when we share our experience and knowledge it increases. Whatever the way we choose or wherever we move to work the basic knowledge and way will remain the same. We may face failure and obstacles only to remember, “Failure is one of the major milestones of an entrepreneur and each obstacle is an opportunity”. It’s not a theory, as a theory is also based on what we learn out of our failure and experiment, but our own flaw and failure will teach us the right way to success. It will make us winner one day. Everything is dependant on our mind as Silicon Valley is not a geographical location it is just a “state of mind”. Think as a winner and you will find yourself as a winner. If you loose the vigour of your mind you will be nowhere in near future.
If experiment is the only thing that you have in hand, do it sincerely, genuinely and with an inimitable passion for them. With the human life span longer and the business cycle shorter, the opportunities are immense for those with the motivation, the temperament, and the guts to do it their way. There was no one-way, there is no one-way and there will be no one-way. It was the biopreneur’s way, it is the biopreneur’s way and it will be the biopreneur’s way.
(This artilce is taken from a book titled – Biopreneurs: the Molecular Millionaires)
Miyuki Shiratani currently is in charge of international logistic for Devicenet, USA, Inc. She has over 10 years’ international and multicultural experience (Japan, US, India) in both IT and biotech industries. She also held responsibilities of international marketing communications at Sharp Electronic Corp., Osaka, Japan; and sale/customer relations at JUSCO, Japan. She received her BA at Kansai Gaidai University, Osaka, Japan, and MBA at the San Jose state University, CA.
Ryan Baidya is an entrepreneur a business strategist and who has 12+ years of experience in biotech. He launched several biotech and high-tech businesses in Silicon Valley/USA, and Tokyo/Japan. He founded BioZak and BioZak-Infobase, and served as one of the founding management. Prior to that he was with Genprobe, , HyseQ; and GeneAsia. He serves as an advisor to Golden-Embryo, Pune/India; and KZAISoft corp., Durgapur/India. He gave numerous lectures on life sciences and bio-business topics at conferences, primarily in USA, and Japan. He authored articles, patents, and commentaries. Dr. Baidya received his MS from IIT Kanpur, PhD from the University of California, Santa Cruz and MBA from the San Jose State University, CA..
Sunday, July 13, 2008
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%>
-----------------------------
Ryan Baidya
California Takshila University
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
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
-----------------------------
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
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.
--------------------------
Ryan Baidya
California Takshila University
Monday, April 21, 2008
Biopreneur - Magazine available
We are please to bring our first issue of Biopreneur-eMagazine to you. I would like tothank all the members who directly and indirectly participated in this initiative andprovided encouragements to other in doing so. Below is a link of the magazine -"BIOPRENEUR"http://www.biopreneur.org/images/E_mag_Biopreneur.pdf
Magazine is also available for download on Invent India, Federation of European Biotechnology, Silicon India, LInkedIn -Biopreneur-forum,USA-Indian Chamber of Commerce-group, PharmaConnection, www.Biopreneur.org (site) and a few other bio-business related sites.
for our next issue - we are accepting recommendation for:(1) Corporation Profile - for an early stage emerging company(2) Die-hard entrepreneur profile - (3) Regional articles related to -Finances, economics, market that aredirectly and/or inderectly effect bio-businesses.
Thank you,
Ryan Baidya
California Takshila University
Magazine is also available for download on Invent India, Federation of European Biotechnology, Silicon India, LInkedIn -Biopreneur-forum,USA-Indian Chamber of Commerce-group, PharmaConnection, www.Biopreneur.org (site) and a few other bio-business related sites.
for our next issue - we are accepting recommendation for:(1) Corporation Profile - for an early stage emerging company(2) Die-hard entrepreneur profile - (3) Regional articles related to -Finances, economics, market that aredirectly and/or inderectly effect bio-businesses.
Thank you,
Ryan Baidya
California Takshila University
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