2007 - Borderless Biotech & Mexico's Emerging Life Sciences Industry

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2007 - Borderless Biotech & Mexico's Emerging Life Sciences Industry

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Report developed by Crossborder Group for UCSD Extension and Merck on the growth of life sciences infrastructure -- both human and physical -- in four regions of Mexico: Guanajuato, Jalisco,......

Report developed by Crossborder Group for UCSD Extension and Merck on the growth of life sciences infrastructure -- both human and physical -- in four regions of Mexico: Guanajuato, Jalisco, Morelos and Nuevo León. The research for this project included site visits, interviews, and a range of data collection, looking at education, medical device manufacturing trends, pharmaceutical research, clinical trials, and advances that these regions in Mexico are making. Also touched on in this document is the potential for crossborder life sciences collaboration, particularly in the regions of San Diego and Baja California.

This report was a follow up to the more-comprehensive regional technology study, Borderless Innovation (2006) -- also developed for UCSD Extension.

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  • 1. Borderless Biotech & Mexico’s Emerging Life Sciences Industrya briefing paper by San Diego Dialogue a division of UCSD Extensionwith generous funding by Merck & Co. Inc.developed under contract by Crossborder Group Inc.June 2007 Borderless Biotech & Mexicos Emerging Life Sciences Industry -- []
  • 2. Executive SummaryThe San Diego Dialogue, a program of University Extension atthe University of California, San Diego, has spent the last threeyears focusing on issues of innovation and competitiveness inthe crossborder region. On the heels of the 2006 publication ofa major research report on the San Diego/Baja California Re-gion, Borderless Innovation, a relationship was establishedwith the global pharmaceutical company, Merck and its subsid-iary, Merck Sharpe & Dohme in Mexico City. Merck has had alongstanding commitment to innovation in the United Statesand, in recent years, its attention has turned to innovation inMexico and Latin America. With support from Merck, the SanDiego Dialogue launched a Life Sciences Gateway Initiative, withfour strategic life science regions identified by Merck in Mexico– Guanajuato, Jalisco, Morelos and Nuevo León. The focus ofthe partnership has been to build long term relationships be-tween the R&D, technology commercialization and life sciencebusiness communities in Mexico with their counterparts in California and across the United States.This briefing paper is an initial look at the multiplicity of opportunities that exist in Mexico. It providessome insight into what may be the barriers to harnessing necessary capabilities on the part of theMexicans, but also vis-à-vis perceptions of Mexico by the life science clusters in San Diego and OrangeCounties. The report highlights the contributions Mexican scientists and companies have made to thedevelopment of life sciences, and provides introductions to the regions identified by Merck. It is alsoa reminder of the capabilities of Baja California, and their connection to the greater San Diego region.What is significant to the U.S. is the extent to which Mexican regions are mobilizing national, state andlocal resources to coordinate their research with economic and workforce development. This docu-ment points out that there has been notable growth in research activity across Mexico measured byincreasing numbers of research centers and science graduates, growth in patent activity, expansion ofincubators and infrastructure of innovation, and growth in advanced manufacturing and clinical trialactivities across Mexico.These growing assets, and commitments from Mexico, represent a promising development for San Diegoand California. San Diego is one of the most vibrant life science research and development communi-ties in the world. The level of research funding, combined with the amount of venture capital cominginto San Diego companies, means that San Diego has become a global hub in the life sciences arena.The San Diego innovation community is linked to research, commercialization, investment and market-ing around the globe, and as such, is an appropriate gateway for a life sciences initiative across Mexico.This briefing paper is based on personal visits to the Mexican regions described in the report, as wellas a strategy for building relationships between the many partners in any effective innovation system.Seminars and roundtables over the next 12 months involving peer-to-peer interactions of leadershipfrom Mexico with leadership in California will focus on IP strategies, venture investing, strategicpartnering in manufacturing and clinical research, as well as basic research partnerships in areas ofbiomedicine and biotechnology. The data reported in this report will be amplified in subsequent whitepapers, which will go into much greater depth about each of the regions. For the purposes of this JuneForum Fronterizo, this briefing paper has been developed as a way of informing and inspiring potentialpartners, particularly in San Diego and across California, to investigate the opportunities to grow aborderless life sciences community by engaging our friends and potential partners in Mexico. Borderless Biotech & Mexicos Emerging Life Sciences Industry -- [1]
  • 3. A Vision of Borderless BiotechWhat do Genentech, the birth control pill, biomedical devices, and biotechnology have to do withMexico? More than most people think – and that creates a unique opportunity for not just the UnitedStates, but also for the California life sciences industry in particular. While much attention is focusedon Europe and Asia, several regions within Mexico are emerging as highly capable life sciences researchcenters, as well as sites for current – and future – industry growth.These regions, and the potential opportunity they present for collaboration with the San Diego andCalifornia life sciences industry, are the focus of this first briefing paper – and the focus of a 18-monthbinational project launched last December, 2006, between UCSD Extension’s San Diego Dialogue andMerck Sharp & Dohme (Merck) - the Life Sciences Gateway Initiative. Working with government andlife sciences leaders in some of Mexico’s most innovative regions (including the states of Guanajuato,Jalisco, Morelos, and Nuevo León), UCSD and Merck aim to “build sustainable binational relationshipsamong researchers, scientists and investors for the purposes of stimulating and nurturing the lifecycleof innovation….”1This collaborative effort joins together two separate ongoing efforts – Merck’s multi-year initiative topromote life sciences in Mexico through research, events, and education; and San Diego Dialogue’s2006 binational study, Borderless Innovation – a groundbreaking report that analyzed opportunities inthe San Diego-Baja California region to increase the competitiveness of science and technologyindustries. Combined with the efforts and activities within each region, the result is – so to speak – atriple helix of life sciences leadership.While not a focus of the current project, previous research done for the Borderless Innovation reportclearly demonstrated that Baja California is also one of Mexico’s emerging life sciences regions. Infact, each of the five states that will be discussed – Guanajuato, Jalisco, Morelos, Nuevo León and BajaCalifornia – have their own strengths and specialties. Most also share some of the same challenges thatcan potentially be best solved through unified efforts, as well as shared opportunities. Genentech and Mexican Innovators In California in the late-1970s, Genentech was not as well known as it is today. One of its co-founders, Dr. Herbert Boyer, was a professor of biochemistry and biophysics at UCSF, where several members of his research team, including Mexican-born Francisco Bolivar and Californian Ray Rodriguez, were diligently working to create a safe and effective biological mechanism to facilitate cloning of special bacteria. Their answer: a “plasmid vector” – a small, self-replicating genetic element with built-in coding of enzymes that allow its host – a bacteria, for instance – to thrive in environments in which many other bacteria cannot (for instance, in the presence of antibiotics). The resulting genetic package was the plasmid pBR322 (the “B” for “Bolivar”, the “R” for Rodriguez) – designed to be resistant to two antibiotics (ampicillin and tetracycline). When placed into a fast-growing bacterial host like E. coli, pBR322 allows the altered bacteria to be selected (screening negative bacteria). By subsequently modifying this plasmid to “carry” human genetic materials, they were able to stimulate the production of certain hormones by the bacterial host – such as insulin. Once a modified plasmid vector like pBR322 is coupled with a gene to promote insulin production and then inserted into an E. coli bacteria, the result is a self-replicating, genetically-modified cellular factory that can safely synthesize human insulin – a process that helped to launch Genentech as a multi- billion dollar company. Borderless Biotech & Mexicos Emerging Life Sciences Industry -- [2]
  • 4. Trends in Mexico’s Life Sciences Clusters "GoogleTM Metric" of In most discussions about the global life sciences industry, Mexico Selected Search Terms is not usually considered a prime location for innovations and high technology. This lack of general awareness, in fact, can bebiotechnology demonstrated with a simple metric comparing the number of 3,010,000 "san diego" “hits” certain phrases receive on the internet using the searchbiotechnology engine Google™. 2,010,000 indiabiotechnology 1,300,000 As seen at left, when combining the word “biotechnology” with mexico various phrases, such as “San Diego”, “Mexico”, “Guadalajara”,biotechnology monterrey 133,000 Measurement of the etc., relatively few English-language pages apparently exist that total number of reference some of Mexico’s biotech regions. While admittedly lifebiotechnology 74,200 returned results guadalajara using the Google TM sciences-related activities are still an emerging part of the econo-biotechnology 48,000 search engine my, and this Google™ metric is far from a perfect measurement of cuernavaca the actual situation, it does provide at least an indication of thebiotechnology 15,400 perceived degree of biotechnology activity (and perhaps perceived irapuato capability) in Mexico. That said, other indicators show more positive signs. US - Mexico Trade in Biotechnology & Life Science Goods (2003-2006, US$billions)Trade Trends 3.0According to the latest data from the US Department ofCommerce, trade between the US and Mexico in biotech- 2.5nology and life sciences goods is on the increase. In 2006, US$ billions 2.0trade in these goods had reached nearly $3 billion in totaltrade, and had an average annual growth of 15% between 1.52003 and 2006. 1.0What are these goods? The US Census Bureau defines these 0.5Advanced Technology Products as: 0.0 2003 2004 2005 2006 Biotechnology Products Focuses on medical and industrial applications of ad- US Exports Imports vanced scientific discoveries in genetics to the creation of new drugs, hormones and other therapeutic items for both agricul- tural and human use. What are Life Sciences? Life Sciences Products To use the definition outlined in the highly-acclaimed Concentrates on the application of scien- 2005 study by the Council on Competitiveness and Global Bioeconomy Consulting, “Catalyzing Cross-Bor- tific advances (other than biological) to der Innovation: The Mexican Life Sciences Initiative”, medical science. Recent advances, such as life sciences are: nuclear resonance imaging, echocardiogra- phy, and novel chemistry, coupled with “...broadly defined to include all biological technolo- new production techniques for the manu- gies and applications. This includes: biotechnology, facture of drugs have led to many new pharmaceuticals, plant and animal technologies, med- products for the control or eradication of ical devices, healthcare (e.g. translational research, disease. clinical trials), biological related information technol- ogy (e.g. bioinformatics, telemedicine), as well as biological-related production and manufacturing.” Borderless Biotech & Mexicos Emerging Life Sciences Industry -- [3]
  • 5. Birth Control and the “Dupont of Mexico” Mexico’s innovations in life sciences have not been limited to the last two decades. In fact, one of the pharmaceutical industry’s early success stories – the birth control pill – has roots in Mexico…literally. Early steroid research in the 1930’s showed that progesterone could inhibit ovulation in women, but commercial applications weren’t feasible since steroids at that time were isolated in very small amounts from animal glands – an expensive process. Dr. Russell Marker (a Chemistry professor from the University of Pennsylvania) developed an alternative process that converted toxic steroids (sapogenins) into the pregnancy hormone progesterone. Dr. Marker also discovered a viable source for this: the cabeza de negro – a wild yam in Mexico. In 1944, Dr. Marker and two entrepreneurs in Mexico City founded Laboratorios Syntex to develop and commercialize crystalline progesterone. While Dr. Marker left after one year following a dispute, Syntex’s co-founders soon hired Dr. George Rosenkranz, who envisioned building Syntex into “the Dupont of Mexico.” Dr. Rosenkranz’s team of researchers – including Dr. Alejandro Zaffaroni – not only were able to ultimately develop commercial quantities of progesterone, but ultimately won an international race in 1951 to synthetically develop cortisone (beating out a rival team from Merck, among others). Syntex’s researchers also included Luis Miramontes, a college student from UNAM in Mexico, who was instrumental in synthesizing norethindrone – the active ingredient to one of the two earliest oral birth control formulas. In 1964, Syntex expanded to Palo Alto, California, where the talents of Drs. Rosenkranz, Zaffaroni, and other Syntex alumni (including Dr. Carl Djerassi), helped contribute to the growth of California’s life sciences industry…Trends in Life Sciences Education & WorkforceRaw trade figures tell one story. Another story can be revealed by the notable annual increases indoctoral graduates specializing in key areas of science – including Agricultural Sciences, Natural &Exact Sciences, Health Sciences, and Engineering & Technology. While the number of those receivingdoctorates in these areas still is relatively small– an estimated 1,147 in all of 2005 – the numbersare nearly a five-fold increase over the last 500 Annual Doctoral Graduates in Mexico 450 By Area of Science (1987-2005, CONACYT)decade (with a 17% average annual increase). 400It’s also useful to consider that these numbers 350do not count the significant numbers of Mexican 300scientists that are graduating from doctoral pro- 250grams in the United States, Europe, and other 200countries. 150 100Master’s degree programs are also showing in- 50creases that bode well for Mexico’s biotech 0 1987 1989 1991 1993 1995 1997 1999 2001 2003 2005potential. According to CONACYT (Mexico’sNational Science and Technology Council), the Agricultural Sciences Natural & Exact Sciencesnumber of new students entering master’s de- Health Sciences Engineering & Technologygree programs in life sciences-related fields hasmore than doubled since 1995, from 674 stu-dents entering such programs to more than 1,500 in 2006. It should be noted, however, that thesepositive increases have also raised some concerns about the possible lack of high-skilled employmentopportunities in Mexico to absorb these graduates - a critique that underscores the opportunity forexpanding companies to investigate this potentially underutilized workforce. Borderless Biotech & Mexicos Emerging Life Sciences Industry -- [4]
  • 6. The SNI & Life Sciences Publications 2,000 SNI Registered Researchers By Area of ScienceIn addition to positive educational trends in life 1,750 (1995-2005p, CONACYT)sciences, Mexico’s National Researcher System 1,500also shows some interesting trends. The SNI (touse its Spanish acronym) is a voluntary but 1,250screened registry of accomplished researchers in 1,000Mexico. As seen at right, between 1995 and 7502005, the number of researchers registered inhealth, biotechnology, and agricultural science- 500related activities nearly doubled. Biology & Chemistry 250 Medicine & Health Sciences Biotechnology & Agricultural SciencesOver the last decade, the number of scientific 0 2005p/ 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004publications that Mexico is generating in lifesciences-related fields has also more than dou-bled in some notable areas, including chemistry,pharmacology, immunology, microbiology, and by 156% to over 2,600 companies. During thisplant and animal sciences. These last two areas, same time, China also surpassed Taiwan as havingin fact, appear to have relatively high global the largest number of foreign firms registered,strengths – according to Thomson Scientific’s Korea (with a 93% increase in number of firms)Essential Science Indicators, Mexico’s microbio- leaped over Canada and the UK, and the numberlogical publications are cited 39% higher than the of registered firms from Mexico fell behind theworld average, and plant & animal science publi- number of firms from India and Israel (the numbercations are cited 42% higher than average. While of FDA registered firms in these latter two countriesthis relative rating of citations isn’t necessarily as growing by 73% and 47% respectively, while Mexico’sstrong in other areas, it does provide an indepen- numbers increased by only 12%).dent and global indicator of Mexico’s increasingscientific capability. While FDA registered firms are not necessarily a perfect indicator (it doesn’t, for instance, neces- sarily reflect employment or actual amounts ofAn Update on Medical Devices and FDA goods traded), it does underscore the fast-movingRegistered Facilities shifts that can occur in an increasingly skilled global workforce. One state within Mexico that isSan Diego Dialogue’s 2006 publication, Borderless taking advantage of this opportunity is actuallyInnovation, described biomedical devices – one right next door: Baja California.component of the life sciences industry – as a“ready opportunity for regional economic devel- In 2003, Baja California biomedical device firmsopment efforts”, particularly in light of San employed just over 23,700 individuals. Based onDiego-Baja California’s “largely untapped oppor- 2006 data fromtunity to become one of the major hubs of Producen (an in- Baja Californiabiomedical device design, manufacturing, and dustry promotion Biomedical Device Employmentglobal marketing in the world.” While that still research center 34,088holds true from a regional perspective, such a sponsored in part 35,000vision might also hold true for a California-Mexico by the Government 30,000 26,419strategic relationship as well, particularly given of Baja California), 25,000the high concentration of biomedical device com- estimated employ- 20,000panies in Southern California. ment in this sector 15,000 had risen by 29% to 10,000Looking at the global expansion of medical device nearly 35,000. 5,000manufacturing, it’s also an opportunity that both Such growth is notcountries are at risk of losing: between 2003 and just the result of 0 2003 20062007, the number of China-based medical device State and localmanufacturers registered with the FDA increased economic develop- Borderless Biotech & Mexicos Emerging Life Sciences Industry -- [5]
  • 7. ment teams, but also by the industry itself, with ness, it also underscores the highly developedthe formation of the Cluster de Productos Médi- manufacturing expertise within Mexico, wherecos de Las Californias – the Medical Products production is done under high-quality, GMP stan-Cluster of the Californias. This group, made up dards, often in FDA-registered facilities. Forof many of Baja California’s largest medical prod- companies seeking options for lower-cost, high-ucts manufacturers, is actively encouraging quality, nearshore manufacturing of pharmaceu-suppliers to expand into Mexico – something that, ticals, Mexico can play a strategic role inif done correctly, can actually result in more outsourced manufacturing.competitive companies and more employment onboth sides of the US-Mexico border. The second- Two examples highlight this evolving opportunity:largest market for US medical equipment in Latin San Diego-based Diversa (covered previously inAmerica (after Brazil) could also become one of Borderless Innovation), continues to manufacturethe industry’s largest strategic partners, as well. enzymes and proteins through a strategic venture with FERMIC – one of Latin America’s largest pharmaceutical fermentation plants located nearPharmaceutical & Clinical Research Mexico City. FERMIC’s FDA-GMP approved facility has a production capacity of over 1.3 millionAs also reported in Borderless Innovation, Mexico liters, and an expansion underway that will in-is one of the largest pharmaceutical markets in crease that capacity to 1.9 million liters; inthe world and the largest in Latin America. With addition to having an on-site R&D department toindustry sales expected to reach nearly $14 bil- support their own efforts to become more in-lion in 2007, nearly all major multinational volved with custom manufacturing of newpharmaceutical companies are present, including biological and biotech products.Merck (operating as Merck, Sharp & Dhome de The second example demonstrates another typeMéxico), Abbot Laboratories, Astra Zeneca, Bay- of evolution: Boehringer Ingelheim – a globaler, Bristol Myers, Eli Lilly, Glaxo Smith Kline, pharmaceutical leader – announced in April 2007Roche Syntex, Novartis, Novo Nordisk, Pfizer, that one of their two Mexico facilities will nowSchering Plough, and Wyeth. While most of these offer contract manufacturing and packaging ser-pharmaceutical giants are involved with manu- vices for solid, semi-solid, soft-gel and liquidfacturing activities, many also have made pharmaceuticals. According to company state-significant investments in clinical research, as ments, not only will they be able to deliverwell. products at the same or lower cost compared to India or China, they will also be able to serve theThere are, in addition, several hundred other entire North American market from this locationpharmaceutical manufacturing companies pri- with existing safety certification in the US, Can-marily involved with generics. Nearly all ada and Mexico. Notably, a tri-country strategypharmaceutical companies are active in the na- might also facilitate (as well as potentially com-tional industry assocation, CANIFARMA (Cámara plicate) future measures to consider directNacional de la Industria Farmacéutica), which prescription drug importation from Mexico andrepresents the interests of two major categories throughout North America, as well.of firms: research-based pharmaceutical firms(which are represented by a sub-group within But pharmaceutical manufacturing is only oneCANIFARMA, called the Asociación Mexicana de part of the life sciences industry in Mexico.Industrias de Investigación Farmacéutica Pharmaceutical companies (largely members of[AMIIF]), and generics manufacturers (which are AMIIF) have also supported the development ofpart of CANIFARMA’s Asociación Nacional de Fab- strong clinical research clusters in key metropoli-ricantes de Medicamentos – ANAFAM). tan regions, including the DF (Mexico City), Cuernavaca (Morelos), Guadalajara (Jalisco), andAs mentioned, most of these firms are involved Monterrey (Nuevo León). According to AMIIF,with manufacturing (concentrated in Central clinical trials undertaken by their members haveMexico and the Distrito Federal [DF]), with very involved more than 1,250 institutions in Mexico,little activity in R&D. While at first glance, a more than 2,000 researchers, and over 51,000manufacturing focus might be considered a weak- patients (in 2005). Borderless Biotech & Mexicos Emerging Life Sciences Industry -- [6]
  • 8. These numbers are, in fact, increasing. While FDA-tracked clinical trials clearly are still concentratedprimarily in the United States, a recent study by Thomson CenterWatch notes that the Latin Americanclinical research market has “experienced significant growth over the past 10 years, especially duringthe last five.” FDA/NIH-Tracked Clinical TrialsWhy such growth? According to their 2005 survey of more than 300 (Active & Recent, May 2007)investigative sites in Latin America, some key elements are cited:large treatment-naïve populations, centralized health care systems, San Diego 1,729strong physician-patient relationships, high patient retention rates,Western-trained investigators, and disease patterns that reflect both Brazil 560developed and developing-world markets. In addition, participants inthis survey also noted that faster patient enrollment has typically led Mexico 501to a lower proportion of trials delayed longer than one month 435(compared to sites in the US and Europe). India China 423As seen in the graphs at right, Mexico, in fact, while still “emerging”as a global location for clinical studies, actually ranks slightly higher 0 500 1,000 1,500 2,000in current or recently-completed studies than either India or China.Mexico-based clinical researchers also have significant experience not source: ClinicalTrials.govjust in Phase III and IV trials, but also Phase II and an increasing numberof Phase I clinical trials. And, most speak English and are geographi- FDA-Tracked Clinical Trialscally closer to California companies. in Mexico - By PhaseMany studies are already also being conducted simultaneously in abinational (or multinational) context: a Phase III Merck study of HIV Phase IV 11%therapies that includes sites in San Diego and Mexico City (DF); a PhaseII study for asthma treatments by Hoffmann-La Roche in San Diego, Phase III 64%Monterrey, Guadalajara, and Mexico City; and a Phase III study byPfizer/Sanofi-Aventis for diabetes in San Diego, Mexico City and Mon- 23% Phase IIterrey are just three of many examples.Such binational protocols have the potential for not just speeding a life 1% Phase Isciences discovery to market faster, but also could be used to leveragea multi-regional clinical trials network that increases the skill base of 0% 25% 50% 75%researchers as well as fosters a value-based mechanism for creatingthe human and physical infrastructure necessary for supportingMexico’s emerging life sciences industry. Why Only Five Regions? While this initial briefing paper does not intend to be a comprehensive nor a definitive study of Mexico’s emerging life sciences industry, it is clear that the five states discussed in this document – Guanajuato, Jalisco, Morelos, Nuevo León, as well as Baja California – have some of the most-advanced life sciences facilities as well as some of the highest levels of human scientific capital in Mexico, as seen in this map showing the concentrations of SNI re- searchers by State. Other states, including Sonora, Tamaulipas, Colima, Yucatan and others, also have notable research capabilities in life sciences, but are not discussed here. Borderless Biotech & Mexicos Emerging Life Sciences Industry -- [7]
  • 9. Regions of Innovation in Life SciencesWhile over the coming months, more detailed briefings will be developed describing the life sciencesinfrastructure and activities within each State, a few highlights about these regions of innovation arepresented below. Notably, as is the case with other technology centers throughout the world, theseregions often are rooted around higher education centers – either public or private universities,Federal laboratories, and State technology institutes.As seen at right, all of them are substantially expanding 800 SNI-Registered Researchers 741 (2005 & 2007) 692their overall science base and SNI-registrations. In fact, 700increasing private sector interaction, new sources of fund- 600 575ing, as well as plans by State and local governments to 500 410 410 446 451foster the growth of life sciences in these regions, could 400 299play a large role in catalyzing their development and capa- 300 284 281bilities over the coming decade. Other factors may also 200play an unexpected role – such as Mexico’s lack of 100prohibitions in stem cell research, as well as its more 0flexible immigration rules (which have the potential to Baja Guanajuato Jalisco Morelos Nuevo California Leónfoster international interactions that may be less-commonor more difficult in the US). 2005 2007Guanajuato On arrival to the construction site of Mexico’s new National Genomics Laboratory for Biodiversity (LANGEBIO - Laborato- rio Nacional de Genomica para la Biodiversidad), one is struck by the contrast between the simplicity of the sur- rounding strawberry fields and the vision of creating one of the world’s foremost laboratories dedicated to sequencing plant, animal, and microbial genomes of potential use for agricultural, medical and industrial applications. While the CINVESTAV researcher discussing new 100,000 square foot facility is nearing completion adja- genetic structure of maiz cent to CINVESTAV – the Center for Research and Advanced Studies – LANGEBIO’s Director, Dr. Luis Herrera-Estrella (amember of the US National Academy of Sciences), has already led a team at the Laboratory to map outthe more than 52,500 genes of maiz palomero – one of the oldest species of maiz, and known to manyas pop corn.This accomplishment, coming only two years after the Some Biotech Projects in Guanajuato:launching of LANGEBIO, is part of CINVESTAV’s 25 yearhistory as a center for advanced biological and biotech Research into the production of naturalresearch. Located in Irapuato, Guanajuato, this Feder- insecticides using modified hairy-rootedally-funded center (part of the National Polytechnic plantsInstitute’s network of research facilities) is actually oneof Mexico’s centers of excellence in basic and applied Biocontrols of agricultural diseases usingresearch related to plant biology and agricultural bio- sporestech. Strong support from the State government and Development of a biological process thatCONACYT has allowed CINVESTAV to develop well-re- produces nanoparticulates of silverspected Masters and Doctorate programs in plantbiotechnology, with over 250 graduates from these Altering plants to act as bioreactors toprograms to-date. In addition, CINVESTAV is home to produce vaccines and other products Borderless Biotech & Mexicos Emerging Life Sciences Industry -- [8]
  • 10. the State government undertaking vigorous ef- forts to develop additional industrial and technology parks, as well as educational and transportation infrastructure, Guanajuato ap- pears to be positioning itself as a future leader in agricultural- and nutraceutical-related biotech- nology. CINVESTAV research labs host life Jalisco sciences visitors from US & Mexico What do wastewater from tequila production and antibiotics from frog skin have to do with lifeover 30 researchers specializing in biochemistry, sciences? Both are the focus of current biotech-biotechnology, microbiology and plant biology. nology research underway just West ofWhile CINVESTAV and LANGEBIO are perhaps the Guanajuato – in the neighboring State of Jalisco.best known of the State’s 35 research centers, Better known in the US by its capital, Guadalaja-just a short drive away is the Instituto Tec- ra, the State is one of Mexico’s largest with anológico de Celaya (TECELAYA) – one of 218 population of nearly 7 million. It also is one ofcenters that make up Mexico’s National System of Mexico’s leadingTechnological Higher Education. TECELAYA of- locations for clin-fers a doctorate program in chemical ical research, - 500 1,000 1,500 2,000engineering; as well as Masters and undergradu- health care, and Distrito Federalate degrees in chemical, mechanical, industrial technology manu- Morelosand biochemical engineering. This last program – facturing Estado de MexicoBiochemical Engineering – has a staff of more (including elec- Jaliscothan 30 professors, a current Master’s program tronics, Nuevo León Baja CA Surenrollment of nearly 40 students, and more than pharmaceuticals, Veracruz500 enrolled in the bachelor’s program. and software). Guanajuato Life Sciences Researchers Yucatan Registered in SNI - By StateWith an orientation toward bioengineering and As seen in the (Agricultural & Veterinary Queretaromolecular biotechnology, TECELAYA’s research- graph at right, Sciences, Life Sciences, Michoacan Medicine & Humaners also have developed an orientation toward Jalisco actually Puebla Pathology, Chemistry - 2005)commercial applications of their activities – par- ranks fourth in Coahuilaticularly in the food and agricultural industry. In the number of Baja CAfact, while few patents have sprung from TECE- SNI-registered re-LAYA (a situation not uncommon in Mexico), searchers thatseveral of their innovations have already been are focused on life sciences (after the DF, More-licensed by national and international companies los, and Estado de México). It is also home to– including a process using modified enzymes and well-respected educational institutions and re-bioreactors to allow higher extraction of natural search centers in health, genetics, food,pigment from marigolds - a process subsequently environmental and animal sciences – the largestlicenced to India-based AVT Natural Products and being the Universidad de Guadalajara (UdeG).Chrysantis of Chicago. UdeG’s CUCBA (Centro Universitario de CienciasAdditional life sciences-related institutions are Biológicas y Agropecuarias) alone has more thanalso part of the Guanajuato cluster – among them 50 life sciences-related researchers registeredthe University of Guanajuato’s Research Institute with the SNI, approximately 300 professors, andin Experimental Biology; and INIFAP (Instituto nearly 3,000 students enrolled in undergraduate,Nacional de Investigaciones Forestales y Agropec- graduate and doctoral programs – including neu-uarias), a National research institution with a robiology, molecular and cellular biology, seedlocal center housing 60 researchers focused on and forest science, genetic reproduction, plantforestry, agriculture, and animal sciences. With and animal biotechnology, and food science. This Borderless Biotech & Mexicos Emerging Life Sciences Industry -- [9]
  • 11. large cluster of students involved with biology has made UdeG thenatural state-level organizer for Jalisco’s annual Olimpíadas de Frog-Based Antibiotics?Biología – the Biology Olympics. Dr. Alfonso Islas and a small team from UdeG love frogs –While much smaller in size, the CONACYT-sponsored CIATEJ or, at least the antibiotic(Centro de Investigación y Asistencia en Tecnología y Diseño del properties in certain pro-Estado de Jalisco) and its over 80 researchers are also part of teins that they’ve isolatedJalisco’s life sciences research infrastructure – undertaking a vari- and have been researchingety of projects for agro-industrial and pharmaceutical companies, from the skin of the Ameri- can Bullfrog.while also acting as a training ground and educational center forpost-graduate students in biotechnology, food sciences, and envi- Working with both CONACYTronmental technology. Beyond education and projects, CIATEJ and Laboratorios Veterinar-researchers also generate scientific publications and patents (19 ios (LAVET), UdeG and Dr.publications and 5 patent applications in 2005 alone). Islas hope to turn this natu- ral antibiotic into potentialGuadalajara is also the home to another valuable resource: the animal and human applica-Biocluster del Occidente – a non-profit group formed in 2005 to tion following additionalenhance the competitiveness of existing pharmaceutical and bio- research…medical companies, as well as promote the development of newbiomedical and biotech firms. Headed by Dr. Gregorio Cuevas – ascientist and entrepreneur with a doctorate in Applied Biochemistry from MIT – the Biocluster hasbrought together five universities (including the UdeG, ITESO, and the Universidad Autónoma deGuadalajara), as well as CIATEJ, and some of Jalisco’s major veterinary and pharmaceutical compa-nies. The goal: to spur the growth of the life sciences industry in Jalisco and surrounding states, andto help protect and commercialize ideas developed by regional researchers. No discussion about life sciences in Jalisco can go with- out mentioning another research asset: the Hospital Civil de Guadalajara. The Hospital Civil is a teaching hospital affiliated with the UdeG, providing on a daily basis over 2,400 consultations, nearly 500 emergency room examinations, over 15,900 laboratory tests, and real-world learning experiences for 1,300 medical stu- dents. The Hospital Civil has the second-largest installed bed capacity in Latin America over its 12 floors, drawing patients from not just Jalisco, but from sur- rounding states as well. Hospital Civil de Guadalajara (photo courtesy of Hospital ) With a strong research focus, the Hospital has the only tissue bank in western Mexico. The Hospital currentlyhas 20 researchers involved with 15 separate lines of study (including stem cells), and in 2006, 43clinical trials were initiated (all were Phase II or Phase III trials with multinational sponsorship).Despite such achievements, Hospital Civil is only just beginning to consider clinical trials a strategicpart of its activities.MorelosSomewhat overshadowed by the concentration of life sciences resources in adjacent Mexico City(Distrito Federal), Morelos stands apart as the state with the second-largest number of SNI-registeredlife sciences researchers (more than 300) and the second-largest number of members in Mexico’sSociedad Mexicana de Bioquímica (Biochemistry Society - 58). Borderless Biotech & Mexicos Emerging Life Sciences Industry -- [10]
  • 12. This concentrated critical mass of human capital – largely in the city of Cuernavaca, Morelos – is madeup of a large number of research centers – fifteen in all – focused on biology, biotechnology, genomics,and health. While the Universidad Nacional Autónoma de México (UNAM) dominates Morelos’ lifesciences cluster, several other research centers are of note, including the Instituto Nacional de SaludPública (National Institute of Public Health, one of Mexico’s leading health research centers, withspecializations in diabetes, HIV, tuberculosis, and cancer, among others) and the Centro de Investi-gación en Biotecnología (Center for Biotechnology Research – CEIB) at the Universidad Autónoma delEstado de Morelos, focused on biological controls, natural products, and environmental remediation.However, it is UNAM’s Morelos campus that is the focal point for two major research centers. TheInstituto de Biotecnología (Biotechnology Institute - IBt) is the largest, with approximately 100researchers, nearly 250 students (graduate and post-graduate) and technicians, and over 80,000 squarefeet of laboratory space. Founded in 1982 by early biotechnology pioneer, Dr. Francisco Bolivar (ofpBR322 fame), IBt has become one of Mexico’s biotech centers of excellence, specializing in plantmolecular biology, biocatalysis, molecular medicine and microbiology.UNAM-Morelos is also home to the recently founded Centro CCG Laboratoryde Ciencias Genómicas (Center for Genomic Sciences – (photo courtesy of UNAM)CCG), a university research center co-founded by Dr. RafaelPalacios (a member of the US National Academy of Scienc-es), and the result of a larger effort to study nitrogen-fixingmicroorganisms. Notably, CCG’s research staff of 35 re-cently announced the complete gene sequence ofRhizobium etli – a bacterium that lives symbiotically withthe common bean.While many involved with Morelos’ life sciences industry aresome of the country’s leading scientists, to date relativelyfew examples exist of that knowledge resulting in patents or commercial products. Probiomed – oneof Mexico’s few domestic pharmaceutical and biotechnology companies – is one of the exceptions,establishing a strong research collaboration with the IBt that has resulted in the first domestically-created recombinant DNA-based pharmaceutical products in Mexico. Several other research collabora-tions with companies like Schering/Paion, Silanes, and Allied Domecq, are also underway at IBt. Patents and Culture Comparisons of global technology regions usually conclude that the low number of patents issued annually in Mexico must indicate a lack of ability or inventiveness. While patent applications in Mexico are certainly below what should be expected, the situation appears to be more complex than many conclude. In fact, while world-class research is often underway in these 300 Patents Granted to regions at university centers, there is little “cultural” emphasis at Mexico-Based Inventors the institutions for protecting ideas for possible future commercial- 250 ization – rather, peer prestige through publishing often trumps the 139 162 200 desire to protect innovative ideas, and legal rules for some re- 118 121 131 120 118 132 searchers create barriers for turning ideas into commercial products. 150 141 148 116 112 Proximity to the US also leads some Mexican inventors to file 100 applications there, avoiding Mexico’s patent system entirely. While 120 135 118 122 107 50 101 104 100 patent statistics typically only show the country of the “first listed 55 59 65 86 inventor”, a review of US patent data done for this briefing shows 0 1999 2001 2003 2005 1995 1996 1997 1998 2000 2002 2004 2006 nearly an equal number of US patents have a Mexico-residing inventor listed on the application, compared to the number of Mex Patents Granted to Mex Inventor (1st Inventor) patents granted each year in Mexico to Mexico-based inventors. US Patents Granted that Include Mex Inventor (any) With many of Mexico’s creative minds employed by multinational companies, there is also an increasing number of US corporate patent applications that have a Mexican inventor listed on US corporate patents… Borderless Biotech & Mexicos Emerging Life Sciences Industry -- [11]
  • 13. Nuevo LeónThey call it the “International City of Knowledge” – otherwise known as Monterrey, Nuevo León. Thismetropolitan area is the center of a major push by the State government (in collaboration with Federaland local officials, as well as key educational institutions) to grow beyond the traditional model of“manufactura” (manufacturing production) to what they call “mentefactura” (“mind”-production).To do this, the State is focusing its economic development and educational programs toward high-techindustries -- among the priorities, biotechnology and medical services.Much of their effort has been focused on schools. According to State officials, more than 32,000children are studying under updated educational programs that stress science and innovation. Inaddition, more than US$50 million in State and Federal funds has been invested in a variety oftechnology projects, including the construction of a new Parque de Investigación é InnovaciónTecnológica (PIIT - Research and Innovation Technology Park). The PIIT – built just minutes fromMonterrey’s airport – will have six research centers and from various universities (including theUniversidad Autónoma de Nuevo León [UANL], CINVESTAV, and ITESM-Monterrey Tec), as well asincubator space for IT firms, and a global business center affiliated with the University of Texas.While some evidence exists that biotech spin-offs are starting to form (particularly from long-timeindustry promoters, such as Dr. Hugo Barrera – a professor at UANL), universities continue to be thefocal point for life sciences activity. Largest in Nuevo León is the UANL – considered the strongestresearch university in Northeast Mexico, with over 145 life sciences-related researchers alone inMexico’s SNI registry (48 of which are in the School of Biological Sciences). While the UANL School ofMedicine offers a wide range of Doctoral and Masters degreesin medical and biomedical research, its Biological Sciencesprogram has 130 professors focused on biology, food sciences,and biotechnology. UANL also has a Centro de Incubación deEmpresas y Transferencia de Tecnología (Center for BusinessIncubation and Technology Transfer - CIETT) to support thefuture growth of those emerging spin-offs.Over at Monterrey Tec (ITESM), another biotech investmenthas also taken shape: a new, US$35 million BiotechnologyCenter that aims to integrate the school’s chemical engineer- Dr. Simon Goldbard visits withing, food, biology, and medical talent into new innovations Dr. Mario Alvarez, Director ofand new businesses. The Center is a four story facility with ITESM’s Biotechnology Centerfood safety testing labs, bioreactors, and research lab spacesurrounded by undergraduate and post-graduate science class-rooms. With a strong interest in connecting their capabilities to the international marketplace, theDirector of the Centro de Biotecnología made a point during a recent visit – the informational brochureused to promote the Center was printed in only one language: English. Monterrey’s life sciences industry continues to grow, sup- ported by its strong clinical trials capabilities. Many of these, in fact, occur at the UANL-affiliated teaching hospital (Hospital Universitario) and ITESM’s Hospital San José (the two largest centers for clinical research in Nuevo León). With the new Council of Specialized Medical Services (formed to pro- mote Monterrey as a “health tourism” destination), additional growth in medical services and clinical trials is likely, both at university sites, and at a small number of start-ups (such as Monterrey-based DeBBiOM) which will serve US firms seeking UANL’s Hospital Universitario clinical research options, as well as domestic firms facing Mexico’s new generics bioequivalency requirements. Borderless Biotech & Mexicos Emerging Life Sciences Industry -- [12]
  • 14. The Life Sciences Potential of Baja California Just south of San Diego, one can find not only the largest concentration of biomedical device companies in Mexico – but a small but growing number of biotech researchers and entrepreneurs, as well. Highlighted in Borderless Innovation, the Baja California biotechnology cluster is located primarily in Ensenada with its concentration of educational and research institutions, such as the Centro de Investigación Científica y de Educación Superior de Ensenada (CICESE), and the Universidad Autónoma de Baja California (UABC). In fact, Ensenada’s centers are themselves a reflection of historic crossborder leadership, as it was a contingent of representatives from UNAM, CONACYT, and UABC that visited the Scripps Institute of Oceanography in La Jolla as part of a feasibility study that led to the creation of what is now known as CICESE in 1973. Currently, CICESE’s Doctoral and Master’s degree programs in marine biology and biotechnology play a large role in Baja California’s future biotech potential (particularly in marine biotechnology), as does UABC’s Doctoral program in agricultural biotechnology and its Master’s programs in desert ecology, veterinary sciences, and health. The Instituto Tecnológico de Tijuana (Tijuana Technology Institute) also has Doctoral and Masters programs in chemistry, adding further life sciences potential to a region whose workforce is highly educated in global manufacturing and production. While Baja California does not have the largest number of SNI-registered life sciences researchers, it does have something few other regions in Mexico can claim – interaction with and proximity to one of the largest concentrations of biotech research and capital in the United States: San Diego.San Diego: A Portal for Borderless Biotech?This document is yet another part of a continuing effort to describe Mexico’s evolution in technologyand science. Clearly, certain intriguing crossborder opportunities appear to exist in the case of lifesciences – whether in ag-biotech, biocontrols, genomics research, pharmaceutical manufacturing,medical devices, or clinical trials. While all of Mexico cannot expect to immediately become aworld-leader in all areas of this sector, its history already shows examples of regional genius andconnections with California’s biotech and pharmaceutical industries. The question remains: can thishistory be expanded upon - and will it include San Diego?Given that San Diego has the largest concentration of US-based biotechnology firms along theUS-Mexico border and one of the largest in the United States, there is a strong case and a uniqueopportunity to work with the dynamic regions that make up Mexico’s emerging life sciences industry.Direct flights from both San Diego’s or Tijuana’s airports to these regions provides access that fewother locations in the United States can take advantage of. The broad use of English by many ofMexico’s technology leaders eliminates yet another barrier to increased interaction, scientific collab-oration, and possibly investment. Such an opportunity, first discussed in Borderless Innovation, canhelp act as a catalyst for both increasing multi-regional competitiveness in life science companies, aswell as accelerate Mexico’s growth in this sector.Just as the strength of a helix is based on the connections betweenits components, so too the potential for San Diego to become botha portal and a partner for Mexicos emerging life sciences regionscreates opportunities for each side of the crossborder region.Joining together the talent and capabilities of San Diego, Guana-juato, Jalisco, Morelos, Nuevo León, and Baja California in thedevelopment of a life sciences partnership may create a unique,international model that goes beyond borders. Ultimately, such apartnership might also extend to many other regions – in the US,Mexico, Canada, Europe and Asia – supporting new job growth, newdiscoveries, and a world of borderless biotech. Borderless Biotech & Mexicos Emerging Life Sciences Industry -- [13]
  • 15. Appendix - Websites for Additional Information Asociación Farmacéutica Mexicana www.afmac.org.mx Asociación Mexicana de Industrias de Investigación www.amiif.org.mx Farmacéutica Banco Nacional de Patentes (Mexico, searchable) www.impi.gob.mx/banapanet Cámara Nacional de la Industria Farmacéutica www.canifarma.org.mx Centro de Biotecnología - ITESM www.mty.itesm.mx/dia/ing_agricola/cbt.htm Centro de Investigación y Asistencia en Tecnología del www.ciatej.net.mx Estado de Jalisco Centro Universitario de Ciencias Biológicas y www.cucba.udg.mx Agropecuarias - UDG CICESE – Marine Biotechnology Department biotecnologia.cicese.mx CINVESTAV – Irapuato Campus www.ira.cinvestav.mx CONACYT - Consejo Nacional de Ciencia y Tecnología www.conacyt.mx Council on Competitiveness – Mexico Projects www.compete.org/gi/us_mexico.asp INMEGEN – Instituto Nacional de Medicina Genómica www.inmegen.gob.mx Instituto de Biotecnología - UANL www.fcb.uanl.mx/Mis_Webs/InicioIB.htm Instituto de Biotecnología - UNAM www.ibt.unam.mx Instituto de Investigaciones Oceanológicas - UABC iio.ens.uabc.mx Premios a la Innovación en Salud y Alimentación www.premiosinnovamex.com.mx Secretaría de Salud www.salud.gob.mx San Diego Dialogue www.sandiegodialogue.org Sociedad Mexicana de Biotechnología y Bioingeniería www.smbb.com.mxThis Forum Fronterizo briefing paper was developed by San Diego-based Crossborder Group Inc.(www.CrossborderBusiness.com) under contract with UCSD Extension and San Diego Dialogue, withthe generous support of Merck. The opinions expressed in this briefing paper do not necessarily reflectthose of San Diego Dialogue; the University of California, San Diego; Merck; or Merck Sharpe & Dohme.If you would like more information about Mexico’s emerging life sciences industry, please contact UCSDExtension-San Diego Dialogue at (858) 534-8638, or visit our website at www.SanDiegoDialogue.org; foradditional information about UCSD Extension’s Global Connect program, please visit our website atglobalconnect.ucsd.edu. Borderless Biotech & Mexicos Emerging Life Sciences Industry -- [14]