Biotechnology and Medicine: Global Perspective Gundu H R Rao, PhD Emeritus Professor, Laboratory Medicine and Pathology, Anesthesiology, Lillehei Heart Institute, and Biomedical Engineering Institute, University of Minnesota, Minneapolis, Minnesota, USA 55455. Gundurao9@gmail.com There are more than 3000 biotech companies in the world. However, reliable sources indicate that only about 100 out of these 3000 companies, are offering commercial products. Majority of them depend on public or private funding for sustaining their operations. Of the 100 top biotech companies listed in Wikipedia, 70% of them are US companies. Only one from India and one from China are listed in this list of top 100 companies. The revenue generated ranges from a high of 15,000 million dollars to less than a few million dollars. Advance in biotechnology and biomedicine has contributed significantly, to the increased revenues in animal and agricultural products worldwide. Similarly, there is significant contribution in tissue engineering, drug discovery and development, development of biomarker assays for diagnostics, management of therapies, cellular and molecular therapies. China, one of the fastest developing economies, has initiated exchange program with 152 countries and signed memorandum of understanding with 96 countries, to become one of the major players in this field. One of the earliest and most significant biotechnology revolutions is the development of dairy industry in India. In the area of agriculture, India is the world’s largest producer of sugar and sugarcane (285 million tones). India is the second largest producer of Potatoes in the world, after China. In the area of biomedicine, India produces 60% of the global health vaccines (USD 665Million) using the World Health Organization protocols. The growth of Biotechnology and biomedicine in India is sporadic. Department of Biotechnology, Government of India, feels that it is time now, to develop a well thought-out, robust, state-of-the-art biotechnology and biomedicine program in India. In this overview, I will share my concept of how these technologies should be developed in India, to meet the needs of the country as well as to be globally competitive. It gives me great pleasure to share some of my thoughts with you all, on these two very important topics: biotechnology and biomedicine. Biotechnology as we know today contributes significantly, to the growth and progress of research, in all of the areas selected for discussion, under various “sub-themes” for this international conference. The priority areas include, basic biology, biomedicine, bio-agriculture, bioenvironmental technology, biodiversity and bio-safety. Government of India has established a biotech park in Lucknow (UP), which houses 16 entrepreneurs, a Genome valley in Hyderabad, which is well supported by the State Government. Government of India also has approved the establishment of biotech parks in the States of Karn

1. Biotechnology and Medicine: Global Perspective
Gundu H R Rao, PhD
Emeritus Professor, Laboratory Medicine and Pathology, Anesthesiology, Lillehei
Heart Institute, and Biomedical Engineering Institute, University of Minnesota,
Minneapolis, Minnesota, USA 55455.
Gundurao9@gmail.com
There are more than 3000 biotech companies in the world. However, reliable
sources indicate that only about 100 out of these 3000 companies, are offering
commercial products. Majority of them depend on public or private funding for
sustaining their operations. Of the 100 top biotech companies listed in Wikipedia,
70% of them are US companies. Only one from India and one from China are listed
in this list of top 100 companies. The revenue generated ranges from a high of
15,000 million dollars to less than a few million dollars. Advance in biotechnology
and biomedicine has contributed significantly, to the increased revenues in animal
and agricultural products worldwide. Similarly, there is significant contribution in
tissue engineering, drug discovery and development, development of biomarker
assays for diagnostics, management of therapies, cellular and molecular therapies.
China, one of the fastest developing economies, has initiated exchange program with
152 countries and signed memorandum of understanding with 96 countries, to
become one of the major players in this field. One of the earliest and most
significant biotechnology revolutions is the development of dairy industry in India.
In the area of agriculture, India is the world’s largest producer of sugar and
sugarcane (285 million tones). India is the second largest producer of Potatoes in the
world, after China. In the area of biomedicine, India produces 60% of the global
health vaccines (USD 665Million) using the World Health Organization protocols.
The growth of Biotechnology and biomedicine in India is sporadic. Department of
Biotechnology, Government of India, feels that it is time now, to develop a well
thought-out, robust, state-of-the-art biotechnology and biomedicine program in
India. In this overview, I will share my concept of how these technologies should be
developed in India, to meet the needs of the country as well as to be globally
competitive.
It gives me great pleasure to share some of my thoughts with you all, on these two
very important topics: biotechnology and biomedicine. Biotechnology as we know today
contributes significantly, to the growth and progress of research, in all of the areas
selected for discussion, under various “sub-themes” for this international conference. The
priority areas include, basic biology, biomedicine, bio-agriculture, bioenvironmental
technology, biodiversity and bio-safety. Government of India has established a biotech
park in Lucknow (UP), which houses 16 entrepreneurs, a Genome valley in Hyderabad,
which is well supported by the State Government. Government of India also has
approved the establishment of biotech parks in the States of Karnataka, Himachal
Pradesh, Gujarat, and Kerala. Uttar Pradesh is the second largest economy in India. It is

2. home to 78% of the livestock population. One of the earliest and most significant
biotechnology revolutions is the development of dairy industry in India. India continues
to be the largest milk-producing nation in the world. Currently it produces 121 million
tones of milk, which is close to 17% of the world’s milk production. Institute of Human
Genetics in Electronic City, Bangalore is working on the Buffalo genome for quite some
time under the leadership of Prof Sharath Chandra. In the area of agriculture, India is the
world’s largest producer of sugar and sugarcane (285 million tones). Area under
sugarcane cultivation is highest in Uttar Pradesh. India is the second largest producer of
Potatoes in the world, after China. In the area of biomedicine, India produces 60% of the
global health vaccines (USD 665Million) using the World Health Organization protocols.
Various National Laboratories and Research Institutes contributed significantly to
the success of biotechnology revolution in India, for the development of animal and
agricultural products. Some of the Institutes that contributed to this phenomenal success
include; National Dairy Research Institute (www.ndri.res.in) Karnal, Haryana. The work
related to livestock’s was first started at the Imperial Institute of Animal Husbandry and
Dairying at Bangalore in 1923. The name was changed to National Dairy Research
Institute in 1947 after the independence of the country and it was shifted to Karnal in
1955. The Indian sugarcane committee originally established the Indian Institute of
Sugarcane Research (www.iisr.nic.in) in Lucknow, UP in 1952. Later in 1954
Government of India took it over. Similar to NDRI, Central Potato Research Institute
(www.cpri.net.in) was first started in Patna by Sir Herbert Stewart in 1949 and then
shifted to Simla (HP) in 1956. Serum Institute www.seruminstitue.com, of India Ltd,
Pune (1966), a privately owned company has developed into one of the largest
manufacturer of measles and DTP group of vaccines.
Where do we stand in biotechnology research and development in India today
compared, to what is happening in this field in the rest of the world? In the list of top
hundred biotechnology companies documented in Wikipedia, more than 70% are US
companies. The annual revenue generated by these companies range from a high of
15,000 million US dollars to a low of 50 million. Australia, Belgium, Canada, Denmark,
Germany, The Netherlands and Switzerland make the bulk of the other 30% of the top
100 companies. India ranks 23rd (Biocon, Bangalore) and China 96th (Sinovac Biotech) in
the global rankings. Currently, the United States of America offers the largest platform
for the biotechnology companies and is the leading consumer of biotechnology products.
There are over 2000 biotechnology companies in the US and offer employment to over
60% of the worldwide workforce. Bioscience research and development in the US is
valued at 50 billion. There are more than 5.5 million scientists, engineers and technicians
in the US. One of the major success stories of the biotech revolution is the genetically
engineered crop. Genetically modified (GM) crops continue to see extensive global
adaptation. In the US, 50% of the cropland is now planted with GM seeds. Implementing
this technology has resulted in the generation of 110 billion dollars revenue for the year
2010. The total estimated revenue for all sources of biosciences would exceed 300 billion
dollars this year in the USA.

3. Well established pharmaceutical, chemical and agro industries, universities and
research institutions, trained human resources, state-of-the-art infrastructure, active
government, private and public support and enhanced investment are the key for the
growth and sustenance of biotech parks. Directory of biotechnology parks and incubators
developed by Argos Biotech (www.argosbiotech.de) has less then 50 parks listed
worldwide. The only park mentioned from India in this list is the Lucknow Biotech Park.
Professor William Hoffman of University of Minnesota has developed a map
(www.mbbnet.umn.edu/scmap/biotechmap.html) of the biotech park clusters in which,
only three sites in India show up: Biocon, Bangalore, Shanthi Biotech of Hyderabad and
an unknown site in New Delhi, although these do not fit the real criterion of a cluster.
Conceptually, industrial clusters are “geographic concentrations of competing,
complementary, or interdependent firms and industries that do business with each other
and/or have common needs for talent, technology, funds and infrastructure”
(BIOTECHNOLOGY CLUSTER ANALYSIS– CINCINNATICMSA: EXECUTIVE SUMMARY; Prepared by Ke Chen and Dr.
Howard Stafford University of Cincinnati, Department of Geography October 2005)
Critical factors for cluster development include: strong science base,
entrepreneurial culture, growing company base, ability to attract key staff, availability of
finance, premises and infrastructure, business support services and large companies in
related industries, skilled workforce, effective networks, supportive policy environment.
Successful clusters develop social networks linking managers, scientists, engineers and
financiers. Individuals and organization with a diverse range of skills and experiences
populate them. They become “hubs” of activity, with fairly rapid entry and exit of
organization and individuals. According to a study by Milken Institute of USA,
“America’s Life Science Clusters”, San Diego metropolitan area takes the lead, following
closely behind, Boston, Raleigh-Durham NC; San Jose, CA; and Seattle-Bellvue-Everett,
Washington. The study concludes that having a combination of elements for success
including top R & D institutions, local venture capital firms, a base of well trained
scientists and engineers, a pool of managers capable of turning good science into good
business, -- are the key to developing a thriving biotech hub or a cluster.
What is the fastest growing economy doing to compete in this area? China, which
remained isolated from the rest of the word for centuries, has realized that with the
globalization of the economy, scientific collaboration has become the main stream of
development. China has initiated exchange program with 152 countries and signed
memorandum of understanding with 96 countries. China has 200 major biotech
laboratories. Main achievements include the development of: two-line hybrid rice,
disease resistant wheat, insect resistant rice, transgenic animals; cow, lamb, pig, and
rabbit, biological pesticides, BT-insecticide, bio-fertilizers, recombinant nitrogen fixing
bacteria, biological forage additives, mammary gland bioreactor. China has 150 new
drugs in clinical trials. They have developed 20 bio-parks 500 bio-enterprises and 300
biomedicine facilities. Whereas in India, which is also considered one of the fastest
growing economies of the world, there are 340 biotech companies, of which more than
180 are located in Bangalore. Information about the Indian biotech facilities and their
contribution could be obtained by contacting following organizations: Department of
Biotechnology (DBT), Ministry of Environment and Forestry, Indian Bio-safety Clearing

4. House, Indian Genetically Modified Organism Research Information System
(IGMORIS), Indian Bio-safety Rules and Regulations, Capacity Building and Bio-safety,
Institute of Bioinformatics and Applied Biotechnology, Bangalore, Genome Valley
Hyderabad, DNA-bank, Lucknow, Department of Science and Technology, Indian
Council of Medical Research, Defense Research and Development Organization (DRDO)
and Indo-US Science and Technology Forum (IUSTF).
In spite of the fact that China and India are trying to get into the global market in
biotechnology, why are they not listed in the list of Global Biotech Parks? If we take a
look at the size of some of the global biotech parks, it becomes very clear as to how
competitive is this field. Here is some information of the Global Biotech Parks and how
much of investment they have made in their venture. East River Science Park, New York
(USD700 Million); Beijing Bioengineering and Pharma Park (USD250 Million).
Medipark, Czech Republic (USD200 Million), Thailand Park, Klonghuang (USD175
Million), International Biotech Park at Hinjewadi (http://www.ibpl.net) Pune, India,
(USD140Million), Life Science and Biotech Park, Astana, Kazakhstan (USD 50 Million).
There are over 3000 biotechnology companies in the world. However, according to
reliable sources, only 100 of them offer approved products. The rest rely on private and
public equity capital market for their survival. Therefore, it is important to develop
sustainable biotech companies, parks or clusters in order to be competitive in the present
global market. Direct material cost of goods in many pharmaceutical companies (small
molecules) seems to be between 3 to 8%, compared to greater than 50% direct material
cost of biotech products. Biotech industry has recognized this problem and is making
every attempt to develop enabling technologies to improve yields though cell line
engineering, media optimization, cell culture methods, fermentation technology,
improvement in purification processes, use of less expensive bacterial and transgenic
expressions.
In spite of the fact that China and India have hundreds of biotech companies, a
Google search hardly reveals few names worthy of mention. The reasons are many and it
is hard to rectify the inadequacy of modern search engines to do a better job of literature
search. For instance, Hirudin extracts from the medicinal leech were first used for
parenteral anticoagulation in the clinic in 1909. Although this is a biologic for all
purposes, a search on biotech products hardly picks up this drug. Similarly Heparins,
Coumarins, were developed as biologics in the early 30s and have been used successfully
as anti-coagulants for over 60 years. Yet they all escape the notice. Gland Pharma of
Hyderabad (www.glandpharma.com) has been in existence for over quarter of a century
developing indigenously Heparin, as a biologic for medical use, yet you hardly find its
name, in literature searches as a biotech firm. Whereas, if you look at the website of the
Department of Biotechnology ( http://dbtindia.nic.in/uniquepage.asp?id_pk=18), you will
see a list of biotech parks in India at various stages of development. Information on even
the best-known parks like the Rajiv Gandhi InfoTech park at Hinjewadi, Pune, Genome
valley at Hyderabad, DNA Park at Lucknow, UP, the proposed parks at Karnataka,
Himachal Pradesh, Gujarat, Andhra Pradesh and Kerala, lack details as to what they are
developing and how much revenue they are generating.

5. Department of Biotechnology, Government of India, describes the growth of
biotechnology in India as follows: “The India biotechnology sector has, over the past two
decades, taken shape through a number of scattered and sporadic academic and industrial
initiatives”. (Ec.europa.eu/research/biosociety/pdf/nbds_india.pdf), If we look at the
successful biotech industries that have generated significant revenues in India, such as
Serum Institute of India, Pune; Biocon, Bangalore; Shantha Biotech, Hyderabad; Dr
Reddy’s Laboratory, Hyderabad; Eli Lilly-Ranbaxy, New Delhi, they all are privately
owned companies developed by entrepreneurs. Department of Biotechnology also admits
that the time is now ripe, to integrate these efforts though a pragmatic National
Biotechnology Development Strategy (biotechnews.gov.in). If we look at the revenue
generating regional institutions, Western region seems to have contributed the most
(USD720 million). Prominent contributors are Serum Institute of India, Venkateshwara
Hatcheries and Mahyco-Monsanto. Southern Cluster (Bangalore, Hyderabad and
Chennai) has contributed USD525 millions to the revenue. Prominent contributors are
Biocon and Rasi Seeds. Northern region has generated a total of 200 million dollars.
Prominent contributors are Panacea biotech and ELi Lilly-Ranbaxy. All of these revenues
came from companies that existed long before the Government of India conceived the
National Biotechnology Development. Department of Biotechnology and the decision
making bodies of Government of India should think out of the box and develop
prioritized schemes for the development of biotechnology on a need basis and should not
leave it to sporadic development. On the other hand, the private sector in the area of drug
development, has done superbly by developing largest number of US-FDA approved
cGMP facilities outside of USA, for the drug discovery and development in India. May
be the private sector will develop biotech sector also the same way as they did for the
development of generic drugs.
Researchers have realized the role of rDNA research in Animal and Agricultural
Sciences. The Chicken Genome Sequencing Consortium is working on sequencing
Chicken genome. A team of researchers headed by the University of Illinois received a
$10 million federal grant, to complete the sequence of the swine genome. Studies are in
progress in the Institute of Human Genetics, Bangalore, on the water buffalo genome,
under the leadership of Professor Sharathchandra. Researchers have developed biotech
pigs that produce high levels of omega-3 fatty acids by inserting the "fat-1" gene that
comes from the roundworm Caenorhabditis elegans. Six of the 10 clones produced
increased levels of omega-3 fatty acids, which are believed to ward off heart disease.
Omega-3 fatty acid rich eggs are already available in the market. A joint venture of
Monsanto and Cargill, received approval from USDA to begin selling the 1st crop
improved through biotechnology with added nutritional benefits for use in animal feed.
The product, Mavera™ High Value Corn with Lysine, has been improved to grow with
increased levels of lysine, an amino acid that is essential for animal diets
(www.monsanto.com), especially those of swine and poultry. There is considerable work
going on for the improvement of nutritional value of commercial crops. There is renewed
interest in developing specialty foods that are rich in complex carbohydrates. India with
the highest number of type-2 diabetics needs to concentrate on, how to reduce the
glycemic load in the diet. Improving the quality of food as well as designing or
engineering the composition of the food will be of great importance. For instance, the

6. American Diabetic Association (ADA) published a reaffirmed statement of support on
agricultural and food biotechnology as they too have recognized the role of healthy food
in the better management of diabetes. On a separate note, Dow Agro-Sciences announced
that it has received the first regulatory approval for a plant-made vaccine from USDA's
Center for Veterinary Biologics. The vaccine protects poultry from Newcastle disease,
and is the first plant-made vaccine to be approved.
Medical Biotechnology is the largest component of the biotechnology industry.
Key products in this sector include biological drugs; vaccines and in-vitro diagnostics,
Major areas of research and development are treatments for cancers, infectious diseases,
autoimmune conditions, HIV/AIDS, and other diseases for which no effective treatments
exist. Biotechnology-derived medicines are valued currently at over 70 billion and are
one of the fastest growing components of the pharmaceutical industry. Just a list of drugs
developed by one company, Genentech, indicates the significance of this sector in the
Biomedicine area. Genentech drug products produced by recombinant mammalian cells
include: BioOncology; Avastin® for metastatic colorectal cancer, Herceptin® for
HER2-positive metastatic breast cancer, Rituxan® for non-Hodgkin's lymphoma.
Immunology; Raptiva® for moderate-to-severe plaque psoriasis, Rituxan® for
moderately-to-severely active rheumatoid arthritis, Xolair® for moderate-to-severe
persistent asthma. Tissue Growth and Repair; Activase® for heart attack and stroke
and TNKase® for heart attack. Cathflo® Activase®, for the restoration of function to
central venous access devices. Pulmozyme® for cystic fibrosis. (www.gene.com).
Examples of Marketed Recombinant Protein Drugs include: hormones, enzymes,
immunological & anticancer agents: Alteplase (protease Activase® ~59,000
(glycoprotein) CHO enzyme, t-PA), erythropoietin EPOGEN® ~30,000 (glycoprotein)
CHO (hormone), Infliximab REMICADE® ~149,000 (monoclonal antibody),
Bevacizumab Avastin® ~149,000 CHO (monoclonal antibody), Entanercept, Enbrel®
~150,000 CHO (monoclonal antibody), Rituximab, Rituxan® ~145,000 CHO
(monoclonal antibody) somatotropin, Nutropin® ~22,000 E. coli, and insulin (hormone).
In the area of biomedical engineering, cellular and molecular therapies are gaining
importance. One of the fascinating areas of research is reprogramming cells, to cure
diseases or repair disease organs. Kyoto University researchers have discovered a way to
turn skin cells into induced pluripotent stem cells (iPS cells). These reprogrammed cells
behave like embryonic stem cells. When these engineered cells are transfused to mouse
with blood disorders, the transfused cells behave like bone marrow cells and produce
normal healthy blood cells. Induced pluripotent cells can yield a wealth of information on
the fate and function of healthy individual heart cells. Cellular Dynamics International
(CDI) in Madison, Wisconsin has been manufacturing cardiomyocytes and mailing them
on dry ice, to various academic centers for in vitro studies. When these iPS cells are
cultured they form blobs of cells and behave like a piece of heart tissue in terms of their
response to pharmacological stimuli. The iPS generated heart cells offer great potential
for drug evaluation, toxicity testing of chemotherapeutics etc. Apart from the use of
engineered cells for therapy, there is considerable interest in gene-editing application for
therapeutic purposes. Researchers have used a novel method of “editing” the genome to
treat mice with hemophilia by replacing the defective gene with the one that promotes

7. blood clotting. By engineering different zinc fingers and attaching them to a gene-cutting
enzyme, researchers have created tools that can snip the genome at a specific place and
repair the defective target gene. After such treatment the mice produced enough protein
to speed clotting process (M.Holmen, K. High et al. Nature 475:217-221).
In the area of cellular and molecular therapies, tissue engineering is gaining great
importance. At the Center for cardiovascular repair, University of Minnesota, researchers
(Prof Doris Taylor and associates) have created bio-artificial hearts using a novel
approach, in which the animal hearts act as biological scaffold for tissue engineering
(Technology Rev. Oct 2011PP84-90). Pig or rat hearts are chemically stripped of all the
cells and the extracellular matrix is used as scaffold for growing cardio-myocytes in a
bioreactor. Researchers add freshly harvested heart cells to these animal heart
preparations and incubate them in a bioreactor and provide cues like pressure and
electrical stimulus. The main objectives of these studies are, to use cellular matrix of
cadaver or pig’s organ to populate with patients’ cardiac progenitor cells. If this approach
works, this technology could transform the field of organ transplantation. Considering the
importance of this approach, a large grant was provided to two of the largest institutions
in the area of applied medical sciences, Medtronic Inc of Minneapolis and Genzyme of
Cambridge, MA. They have announced a Joint Venture project, which includes:
development of an ongoing Phase 2 clinical trial investigating the use of cell therapy to
repair damaged heart tissue and to bring this therapy to market. Development of a
portfolio of advanced delivery devices, that will locally deliver therapeutic cells, to the
heart in a less invasive manner. Conducting long-term cell therapy research into repairing
damaged heart tissue.
Another approach to address the problems associated with organ transplantation is
to develop bio-artificial organs. Researchers at the University of Minnesota have been
working with such ideas for over two decades, to develop bio-artificial liver, pancreas
etc. A bioengineering company from Minnesota, Excorp Medical Inc (www.excorp.com)
has developed a bio-artificial liver using genetically engineered pig liver cells. The
device has obtained FDA approval as an “orphan” device. Minnesota Company has sold
the technology to an Indian company based in Hyderabad, for further development and
marketing. Basically the technology involves obtaining liver cells from genetically bred
swine and using them in disposable cylinders similar to that used for kidney dialysis. Pig
liver cells cultured on biomaterial matrix, serves as temporary liver for the defective liver
till it recovers. Application of this device is similar to extracorporeal circulation used in
the dialysis. Polymer technology and engineering skills have been in use for the
development of tissue valves, vascular grafts, and surgical sutures as well as for other
surgical applications. Researchers have developed intelligent polymers, which behave
differently and help address the medical problems. For instance they have developed
altered chemistry of the medically approved biopolymers for use as biological glue. They
have altered the chemistry of these polymers in such away that these will be in liquid sate
at body temperature but solidify at a few degrees higher. This technology has been
successfully used in the repair of vascular anastamosis (G.C.Gunter et al: Nat Med.
17:1147-11520). Using similar technologies, biodegradable semiconductors for
electronics in temporary medical implants have been developed. Researchers have even

8. used bio-molecules such as glucose in the blood, to power the microcircuits or
implantable devices.
By and large all vascular diseases including the heart disease are triggered by
inflammation of the vessel wall. When fat build up on the arteries they produce
inflammation that leads to atherosclerosis and hardening of the arteries. MIT researchers
have developed technique for curbing inflammation using interference mRNA
technology, which disrupts the flow of genetic information from the cells nucleus to
protein-building machinery (gene expression). In an animal model researchers delivered
short strands of mRNA that turns down the inflammatory response by blocking activity
of a specific gene in white blood cells called monocytes. Packaged in nanoparticles made
from a layer of fat-like molecules called lipoids, the micro-RNA successfully reduced
inflammation in a mice model. The RNA snippets targeted CCR2 receptor, a protein on
the surface of monocytes. Mice treated with this type of micro-RNA showed much lower
levels of inflammation in atherosclerosis, cancer and faster recovery from heat attack.
We discussed earlier, the need to develop a teamwork approach for the success of
biotechnology clusters. We have similar needs, to develop teamwork or network, as well
as multidisciplinary research for the growth of biomedicine and biomedical technology.
Biomedicine as we know today is a multidisciplinary specialty and I will provide few
examples to illustrate this fact. Eric J Topol and associates at Scripps Research Institute,
California, have developed a method for predicting acute vascular events by monitoring
the circulating levels of endothelial cells in the blood. According to them, the number of
circulating endothelial cells are four times higher in patients who had heart attacks than
the normal healthy subjects. They used flow cytometer to study the number of cells in the
blood sample, as well as for following the changes in the shape and structure of these
cells. Pharmacology on a chip was a dream subject of investigational pharmacologists for
many years. MIT scientists have developed MicroCHIPS that are under clinical trial for
the treatment of osteoporosis. The chip senses the need for the drug and delivers a
controlled level of the drug, terparatide. The MiniMed Paradigm® REAL-Time Revel
System (Medtronic Inc, Minneapolis) combines continuous glucose monitoring with an
insulin pump. The MiniMed Paradigm REAL-Time Revel System allows people with
diabetes, the ability to monitor their glucose patterns and gives them the tools to react
quickly. A wireless transmitter sends information from a glucose sensor to the glucose
monitor for readings every 5 minutes, 24 hours a day. Users specify the amount of insulin
they want the pump to deliver based on the readings and their meals. Brain-computer
Interface team (www.technologyreview.com/SINGAPORE), has developed a brain-
computer interface, that offers hope for stroke rehabilitation by nearly rewiring their
damaged nerves in the brains
The introduction of the “pill camera”, a tiny capsule containing a video-recording
device that can be used to image the gastrointestinal tract—ushered in a new era in
medical diagnostic procedures. Now, an MIT trained assistant professor of mechanical
engineering, Mark Rentschler, is taking the concept to the next level by trying to give the
capsule greater mobility and open the door to advanced, robotic surgical procedures. His
approach begins with adding treads and remote control capabilities, so that the device can

9. maneuver around the various tissues and organs within the abdominal cavity and tract,
video tape and send the images to a database. These types of ideas are the dream of
biomedical engineers. For instance, developing “nanosensors” patrolling the blood stream
for detecting the first sign of an imminent acute vascular event like heart attack or stroke,
capable of releasing anti-clotting or anti-inflammatory drugs to stop it, would be a great
idea. We already know there are many biomarkers that predict the development of acute
vascular events. What we do not know is when would such an event take place, what
triggers the acute phase and how to prevent it from happening. We are developing a non-
invasive Gluco meter, if we use software embedded program for the use of a diabetic
management program, it will improve the preventive strategy by many fold. There is a
great need for the development of simple cost-effective diagnostic devices that would
change the way we deliver health care in India. One prime example is the way Forus
Heath Inc and i2i-telesolutions of Bangalore have put together a tele-ophthalmology
program for detection of premature retinopathy in newborn children. The indigenously
developed camera takes images of the eye both in white light and color and the data is
transferred to the clinic by smart phones and the clinicians give virtual consultation to the
patient’s family. We are developing a similar program with them for the detection of
early precancerous oral lesions using tele-oral pathology. Similar technology can be used
for a variety of diagnostic situations. Researchers at USA have developed a Melanoma
monitor, which uses a multispectral camera to peer below the skin surface. Using a
database of lesions for comparison, the system can recommend that mole be biopsied. Its
accuracy is higher than that of a standard examination www.mealsciences.com.
Researchers have developed a wristband that measures skin response throughout the day
to gauge the stress response. The data can be downloaded to a computer for further
analysis and management of stress (wwe.affectiva.com). We are trying to develop a
similar devise for monitoring blood pressure throughout the day so that one can calculate
the pulse pressure and provide an optimal customized therapy for the management of
hypertension.
We market a product called V-Patch, which monitors the vital signs of a critical
care patient and sends the data to a call center. The technologists monitor the data and if
they find any abnormal readings, intimate the attending doctor. This type of systems can
be further improved, so that the doctor can access this data directly instead of the need for
a call center. My associate in Bangalore, Mr. Madangopal, is developing a hand-held
device, which can monitor the vital signs and send the data to a web-server or cloud and
this data can be accessed by the doctor live or as saved images. Further improvements
have been made in the data transfer and reading capabilities. Software applications are
available for reading CT, MRI, PET scans on an iPhone, iPad. A built in technology asks
the users to distinguish between slightly different shades on the screen, ensures that
lighting conditions are suitable. Doctors can zoom, annotate, use false colors to enhance
details, measure precise distances between features www.mimsoftware.com. A
disposable EEG array has been developed that fits into the scalp in about five minutes. It
is US-FDA approved and simple enough to operate www.hydrodot.net. A device that
analyzes the blood levels of Prostate Specific Antigen (PSA) has been developed. A drop
of blood is used on a cartridge that can be inserted into the device and accurate levels can
be detected in 15 minutes www.clarosdx.com. We are in the process of developing a

10. variety of mobile diagnostic devices that can do simple diagnostic tests on a tablet and
upload the data to a web or cloud. Then one can use some thing like a 2NET HUB that
provides a single collection point for the wireless data generated by a plethora of mobile
diagnostic devices, which use a variety of communication standards such as Bluetooth,
Wi-Fi and ANT+ www.qualcomlife.com. Main objective of our project is to take the
diagnostic platform to the level of the Taluk’s, make the diagnostic data available on web
or cloud, develop web-consulting and electronic prescription capabilities, pharmacies that
can supply drugs at low cost.
The purpose of my presentation is not to present you a list of Global Biotech and
Biomedical companies and talk about their achievements. But to provide a basis for a
lively discussion and some “out of the box” thinking on how to go about developing
world-class biotechnology clusters. If we look at the various modern biotech parks that
are under development in different states, it becomes evident that they do not fit the
description of classical biotech cluster. Majority are developed in far off places where no
complementary technology centers or educational and research institutions exist. On the
other hand, if we look at the top ten biotech companies in India: Serum Institute of India,
Pune, Biocon, Bangalore, Panacea Biotech, HP, Rasi Seeds, Attur, Salem, Nuziveedu
Seeds, Hyderabad, Novo Nordisk India, Bangalore, SIRO Clinpharm, Mumbai,
Novozymes, Bangalore, Shantha Biotech, Hyderabad, and Jubilant Orangosys, they are
products of sporadic development by the entrepreneurs. Now the question we need to ask
is how do we develop a world-class technology park? Do we need to develop one or more
of them or let the Biotech and Biomedicine industry develop on their own, on a need
basis, dictated by the market demands like the drug discovery and development industry.
India has become the premier platform for off shoring high-technology sector,
information technology. Therefore, there is considerable debate, optimism and
expectation to see an IT like revolution, in the areas of Biotechnology and Biomedicine
(BM). Asian countries have a great opportunity to play a critical role in this revolution.
Let us examine what is the difference between the IT revolutions that we have seen in
India VS expected BT & BM revolution. In the late 1990s thousands of Indian IT experts
went to USA, to work on the much-anticipated Y2 problem, which plagued the computer
industry. They established contact with the US companies. After the dot-COM crash,
there was a huge number of trained Indian IT persons who had to go back to India, who
could do the back office work for US companies in India, for a reasonable wages. On the
other hand, in order to compete in BT and BM areas, we need to build the infrastructure
needed, provide competitive edges for the trained Indian scientists and engineers,
establish not only primary biotech platforms, but also needed supporting net work of
resource centers, educational and research institutions. More importantly these centers
should have a mandate to develop products on a need basis, for the local consumption as
well as for global market.
According to the DBT brochure, the Biotech Park at Karnataka will be structured
into three components viz. Institutional & Research & Development Block; Biotech
Incubation Centre and Common Instrumentation Facility; and Biotechnology Industries
Cluster comprising of independent private industry units. The Karnataka Biotechnology

11. and Information Technology Services (KBITS) is the implementing agency and they
have identified a few Public Private Partners for the Biotech Park. Although the
description seems like an excellent way to go about developing a biotech cluster, there
seems to be lack of serious commitment on the part of the State Government to prioritize
the needs and follow through the development of such a biotech cluster. Several States in
India have allotted land and procured funds to develop these parks, but in many cases the
development is very slow and the response of public-private sector funding is lacking,
and there seems to be no rush in occupying the so-called incubator facilities. We should
have the political will, determination and a sense of commitment to develop such
centralized facility or else follow the lead of China and develop bilateral or multilateral
programs with international consortiums.
My travels within the country for the last several years have revealed that the
educational institutions have not done much to train the students, to meet the
requirements of global workforce. Individuals trained in high-end institutions are usually
grabbed by the US and European countries. Even at the research institutions very little is
done to create the competitive edge needed for success. Much of the research done at the
research institutions remains buried and never sees the market or a clinic. Translational
research facilities do not exist. Just recently I participated in an international conference
on Drug Discovery and Development in Mysore. The team of investigators had
developed over 300 new molecules, yet none of them had been tested for clinical
application or for commercialization. As the Department of Biotechnology has finally
recognized, it is time to act and develop a National Strategy for the Development of
Biotechnology and Biomedicine. It is also high time to start translational research
facilities along with the major Universities and National Laboratories, similar to the
CSIR model of regional research laboratories (RRL).
Before concluding my presentation, I would like to mention my ideas on this
subject and share with you some of my dreams. I have been working as an adviser to an
expert team at the prestigious Rajiv Gandhi University of Health Sciences (RGUHS),
Bangalore. In order to develop some of the ideas that I have expressed in this essay to
fruition, I am working on several pieces of this puzzle. One of which is organization of an
Indo-US workshop, in Bangalore, to discuss thoroughly the need for a State-of-the-art
Translational Science Facility, which is easily accessible to the medical community as
well as to the start-up companies. In addition, I am also working on the development of
indigenous drugs for cardiovascular applications. In view of the high diabetic population
in India, primary focus is on the development of a cost effective “polypill” for lowering
blood sugar. We are also working on the development of low-cost non-invasive
diagnostic devices for cardiovascular applications. Finally, I am working on a “dream
project”, which envisions development of a robust e-health platform, which is IT-
supported, web-enabled, providing easily accessible, acceptable and affordable healthcare
for all.

12. Some useful Links:
National Center for Biotechnology Information (NCBI)
www.ncbi.nlm.nih.gov/
CENTER FOR MARINEBIOTECHNOLOGY AND BIOMEDICINE
cmbb.ucsd.edu/
About.com Biotech andBiomedical Pages
biotech.about.com/
Archive of "Journal ofBiomedicineand Biotechnology".
www.ncbi.nlm.nih.gov › NCBI› Literature
http://www.biopharminternational.com/
http://www.bioprocessintl.com/
http://www.biosciencetechnology.com/
http://www.biotecniques.com/
http://www.genengnews.com/
http://www.the-scientist.com/