1.1 INCREASING BURDEN OF CHRONIC ILLNESS AND EVER-AGING GLOBAL POPULATION
With the ever-aging all-around citizenry and the growing accountability of abiding illness, there is an added assurance on the healthcare arrangement (particularly the biopharmaceutical industry) in adjustment or one to accomplish and sustain a top superior of life. According to the Apple Bloom Organization (WHO), the accountability of animal diseases accept been rapidly accretion for decades with this trend predominantly contributed by citizenry beforehand and ecology degradation.
1.2 DEFINITION OF MARINE BIOPROSPECTING
Marine bioprospecting is the seek for atypical compounds from accustomed sources in the abyssal environment. These activities accept added a abundant accord in the endure few years acceptable in allotment due to the connected abstruse advances enabling added amphibian exploration, accepting of the affluent all-encompassing assortment in the abyssal biome, as able-bodied as the burden from industry to aftermath accustomed assorted blockbuster drugs traveling off patent. Today, about 18,000 accustomed articles accept been appear from abyssal bacilli acceptance to about 4,800 alleged species. The bulk of accustomed articles from abyssal breed is growing at a bulk of 4% per year. The admission in the bulk of discoveries is abundantly the aftereffect of abstruse advances in exploring the ocean and the abiogenetic assortment it contains. Advances in technologies for celebratory and sampling the abysmal ocean, such as submersibles and accidentally operated cars (ROVs), accept opened up ahead adopted areas to accurate research. Back 1999, the bulk of patents of abiogenetic actual from abyssal breed has added at the bulk of 12% per year. Abyssal breed are about alert as acceptable to crop at atomic one gene in a apparent than their earthbound counterparts. Bioprospecting about requires the accumulating of a actual bound bulk of biomass for the antecedent discovery. Although added collections may be appropriate afterwards a able analysis has been made, bioprospecting about does not absorb threats to biodiversity commensurable to the ample biomass removals circuitous in agriculture assets for aliment or mineral exploitation.
1.3 THE SUCCESS OF NATURAL COMPOUNDS IN DRUG DISCOVERY AND BIOPHARMACEUTICAL BACK DROP
Biopharmaceuticals are one of the a lot of absorbing achievements of avant-garde science. Abounding biopharmaceuticals action top ability and few ancillary effects. And there is abundant added to come: radically new concepts are authoritative it to the market, and the advances accumulate advancing at a accelerated pace. The success of accustomed compounds in biologic analysis is unparalleled: for antimicrobial and anticancer therapies, for example, added than 70% of new actinic entities alien during the aeon 1981-2002 originated from accustomed products. It has been estimated by the US Civic Cancer Institute (NCI) that 1% of samples from abyssal animals activated in the class acknowledge anti-tumor abeyant (which compares agreeably with just 0.01% of samples of earthbound origin). In the endure few decades, advances in informatics, automation and imaging technology accept fabricated it accessible to awning 100,000s – 1,000,000s of baby molecules adjoin a specific biological ambition or cellular appraisal per day, compared with 10s-100s of compounds activated on animals over abounding months previously. Growing acquaintance of the limitations of historically admired approaches, and breakthroughs in robotics technologies, such as those acclimated in breach and anatomy determination, accept fabricated screening mixtures of structurally circuitous accustomed artefact molecules easier, and accept broadcast the abeyant role of accustomed actinic assortment in the biologic analysis process
2 THE OPPORTUNITY
2.1 AUSTRALIA CONTEXT
Australia is one of abandoned 17 mega-diverse countries in the apple and is acclaimed for the character of its biota. Australia has several appearance proving adorable to investors and advisers in the accustomed articles area. This includes, not least, admission to a assorted and different biota. Added generally, the appearance of Australia accessory to analysis and bartering action awning its able-bodied arrangement of law and abiding free arrangement of government, its abiding and airy economy, cellophane and able authoritative environment, absolute bookish acreage protections and top accurate and abstruse capacity. Australia has remained almost abandoned over time compared to a lot of countries. Consequently, Australia has a top admeasurement of ancient breed – that is, breed not occurring by itself elsewhere. For example, in the case of mammals, about 83% are ancient to Australia. Australia’s different abyssal ambiance contains the world’s bigger areas and accomplished assortment of close and abstemious seagrass breed and of mangrove species; some of the bigger areas of apricot reefs; aberrant levels of biodiversity for a advanced ambit of abyssal invertebrates; and it is estimated that about 80% of the southern abyssal breed action boilerplate abroad in the world. With abandoned 0.3% of the world’s population, Australia contributes 2.5% of the world’s medical analysis and 2.9% of all-around accurate publications (Invest Australia, 2007, p.6). In 2005, Australia ranked eighth in the OECD in acceding of the admeasurement of advisers in the absolute action force. This is aloft the OECD average. On a per capita basis, Australia has a analysis achievement alert the OECD average. In acceding of biotechnology research, Australia has several committed biotechnology analysis institutes. Australia’s biotechnology industry is steadily growing, with action above biotechnology fields including biomedicine, agronomical biotechnology, automated biotechnology and ecology biotechnology. The Australian Government is a allegiant apostle of the calm biologic industry and has been actual admiring in implementing initiatives to abound this sector. By any measure, Australian Government abutment for analysis and development in the biopharmaceutical industry has been and looks to abide to be strong.
2.2 MARINE BIOME REMAINS UNTAPPED/UNDER-INVESTIGATED-THUS PROSPECTS FOR NEW AND MEANINGFUL FINDINGS ARE SIGNIFICANT
Today, biopharmaceuticals accomplish all-around revenues of $163 billion, authoritative up about 20 percent of the pharma market. It’s by far the fastest-growing allotment of the industry: biopharma’s accepted anniversary beforehand bulk of added than 8 percent is bifold that of accepted pharma, and beforehand is accepted to abide at that bulk for the accountable future. Abyssal bioprospecting has the abeyant to added drive these trends. The abyssal biome charcoal beginning and beneath investigated, and thus, altogether assertive to drive both topline and basal band for assorted stakeholders in the biopharma amount chain. Investing in biotech R&D has yielded bigger allotment than the pharma-industry average. The accepted biologics-development activity supports an angle of connected advantageous growth. The bulk of biotech patents activated for every year has been growing at 25 percent annually back 1995. There are currently added than 1,500 biomolecules ability analytic trials, and the success bulk for biologics has so far been over alert that of small-molecule products, with 13 percent of biopharma articles that admission the Phase I balloon date traveling on to launch. To date, sampling of abyssal articles has primarily occurred in easy-to-reach littoral waters. As a result, 97% of accustomed articles of abyssal agent are from eukaryotic sources (organisms with circuitous cells), with sponges abandoned accounting for 38% of the products. However, the majority of the Earth’s metabolic assortment resides in prokaryotic bacilli (single-celled bacilli such as bacteria) and over 99% of the microbial association of the ocean charcoal to be explored, so it stands to acumen that abounding added abiogenetic sequences admired for articles are yet to be discovered. There is a accurate absorption in abyssal breed that reside in astute environments, such as hydrothermal vents and seamounts (‘extremophiles’). By the end of 2007, abandoned 10 compounds had been appear from Abysmal Ocean and ocean arroyo environments, with a added seven articular in 2010. Fewer than 10 abyssal accustomed articles accept so far been appear from hot aperture bacteria. Furthermore, if we breach down the assorted ecosystems of our seas and oceans and analyze the actinic dynamics, apricot reefs accept decidedly absorbing potential. The corals that we see are in actuality fabricated up of colonies that body up and beforehand in an ambiance breadth nutrients are low. Although apricot reefs abandoned absorb 0.1% of the world’s ocean surface, they are one of the a lot of assorted ecosystems on earth, hosting ~25% of all abyssal species. The focus on the apricot beach ecosystem as a ambition abode for alleviative purposes is not a new concept. As aboriginal as the 14th century, apricot reefs were a accepted antecedent for medicines. One convenance at that time is the use of angle acrimony float to amusement antagonistic stings from abyssal organisms. Today, apricot reefs accept already contributed its name in the biologic industry as one of the antecedent of biochemical compounds for new drugs and the possibilities are endless. The befalling affective advanced is substantial.
2.3 SPECIFIC EXAMPLES OF SUCCESSFUL MARINE BIOPROSPECTING
One of the aboriginal biochemical compounds acquired from the sea is Didemnin, a admixture abandoned for the analysis of assertive cancers. This admixture was acquired from the tunicate Trididemnum solidum. Unfortunately, Didemin did not survive in afterwards stages of its analytic trials. However, afterwards a alternation of added exploration, a about of the above breed was apparent to poses agnate traits. The tunicate Aplidium albicans possesses the admixture Aplidin® which has a agnate anatomy with Didemnin but far beneath toxic. Aplidin is an anti-tumor, anti-viral and immunosuppressive biologic that has been accustomed to be able in pancreatic, stomach, float and prostate cancers. Afterwards ability alternation of analytic test, Aplidin was accepted the allocation as an drop biologic that accurately treats assorted myeloma and astute lymphoblastic leukemia. In the United States alone, there are over 45,000 humans with assorted myeloma and an estimated 15,000 new cases in the U.S. anniversary year.
Yondelis® was developed by the PharmaMar Biologic Aggregation and was appear in the bazaar in 2003. This admixture is now awash by Zeltia and Johnson and Johnson. Yondelis contains the alive actuality Trabectedin. Trabectedin is acquired from apricot reefs. Accurately from the clarify agriculture sacs of the baby and anchored plant-like bearcat alleged sea squirts. Extracts of this beach associated breed has been begin to accommodate a analysis for soft-tissue bump and ovarian bump sarcoma. Yondelis was developed as a aftereffect of the Civic Cancer Institute Screening Program for abyssal plants and animals. Sea quirts were calm from reefs of West Indies and advised in the class at the University of Illinois. The anti-cancer biosynthetic admixture was again apparent to be anchored in the accommodating bacillus aural the sea squirts. Yondelis is produced in a semi-synthetic manner, afterwards the extracts from the sea squirts abide a patented actinic process. This action is beneath advancing and beneath ambitious to the accustomed abyssal biome. Moreover, even admitting the acceptance of Yondelis is abandoned for attenuate medical altitude such as sarcoma, there is still abeyant for this artefact to add a lot of amount to the lives of patients and added stakeholders. Added and added adopting Yondelis in their prescribing workflow for sarcomas and there are an accretion bulk of patients who are acute to medicines absolute platinum and Yondelis is one of the abandoned another anti-cancer medicines.
2.3.3 Pro Osteon
There are abounding break for a cartilage affix implant (e.g. admixture of the spine, joints in accoutrements and legs, fractures or gaps in basic acquired by agony or infection, articulate surgery). In a archetypal cartilage grafting procedure, a constructed actual is shaped by the surgeon to fit the afflicted breadth of the cartilage while pins or screws are acclimated to authority it in place. This actual builds a abutment anatomy breadth cartilage beef can interlace, change and heal. Pro Osteon Implant 500 has a absorptive microstructure breadth new tissues and claret beef can grow, thereby aesthetic beforehand and connects burst cartilage segments. Generically alleged “Bone Void Filler” and accustomed by the FDA in 1992, Pro Osteon Implant 500 is clinically accurate to be safe, able and amount effective. This actual is sterile, thereby aspersing adverse reactions from the patient’s allowed arrangement abnegation the implant. The capability of Pro Osteon Implant 500 lies in its source. It uses corals from the sea that has the aforementioned absorptive commutual anatomy of a archetypal cartilage affix thereby artful the centralized anatomy of a animal bone. Afterwards ability a patented actinic process, it converts the apricot into hydroxyapatite which is a mineral and the arch structural aspect of a animal bone. At this stage, the implant actual is now aswell osteoconductive which facilitates cartilage beef to braid into the absorptive structure. Afterwards the action and the healing action starts, the Pro Osteon Implant will eventually be covered and replaced by basic creating the mended allotment as able as it was before. Pro Osteon has abundant accustomed ability and a safe side-effect profile. The aggregation accomplishment this artefact is bulging at atomic $3 billion in sales by 2017. What’s more, the assembly of Pro Osteon is not absolutely abased on agriculture and extracting corals from their accustomed habitat. Special techniques accept been developed, which crave abandoned a baby allocation of apricot to be extracted, while the antithesis is developed artificially in the lab-thus announcement sustainability and adherence of the abyssal biome.
3 THE CHALLENGES
3.1 HOW TO CONSERVE AND SUSTAINABLY USE MARINE BIOLOGICAL DIVERSITY
Despite the actuality that abyssal bioprospecting is almost discreet and the convenance does not appoint the sustainability accident of assorted earthbound techniques, conservationists and the accessible still accept some concerns. For one, actual little is accepted about the attention cachet of abounding breed acclimated as sources of abyssal abiogenetic resources. Further, abounding breed action in accessible and brittle ecosystems. Abounding are aswell anxious with what we don’t apperceive in this almost beginning sub-industry at this point. For instance, the aftereffect on ecosystems of abatement of abyssal abiogenetic assets is ailing understood.
3.2 FEW NATIONS CAN SUCCESSFULLY DO BIOPROSPECTING ON THEIR OWN
Investment in abyssal biotechnology is not after risk. Sampling at sea costs a minimum of US$ 30,000 per day or US$ 1 actor for a month. It about takes 15 years overall, and an investment of up to US$ 1billion, to go from analysis to bartering product, due to the actuality that abounding articles abort to bear on aboriginal promises. As a aftereffect the acreage is bedeviled by almost few nations. Apparent claims associated with abyssal abiogenetic assets (MGR) arise from abandoned 31 countries. Ninety per cent of these patents arise from 10 countries (USA, Germany, Japan, France, UK, Denmark, Belgium, Netherlands, Switzerland and Norway), with 70% basic from the US, Germany and Japan. Despite the top levels of investment appropriate in R&D, biotechnology is a advantageous and important industry.
3.3 THE CURRENT UNCERTAIN AND UNPREDICTABLE LEGAL AND REGULATORY FRAMEWORK DISCOURAGES INDUSTRY (I.E. BIOPHARM COMPANIES) FROM INVESTING THEIR EFFORTS INTO BIOPROSPECTING
The abeyant of abyssal bioprospecting has become the accountable of all-embracing action agitation (particularly for areas above civic jurisdiction). One axial catechism is whether the abeyant allowances from abyssal bioprospecting care to be aggregate by the absolute all-embracing association or abandoned by the States or alone corporations with the accommodation to accomplishment them. Assorted groups are searching at this in adjustment to configure the a lot of alive set of behavior to antithesis the charge to beforehand addition and technological/biopharmaceutical advances, with the charge to accomplish abiding all stakeholders in the amount alternation are appropriately compensated, forth with the charge to ensure the constancy of these accustomed abyssal habitats. Increasingly, alone nation-states are establishing behavior that behest the way in which adequate abyssal habitats in their administration may be acclimated for bioprospecting and added accurate and bartering pursuits.
3.4 COSTS OF BIOPHARM/BIOTECH DISCOVERY
There are operational and abstruse challenges to bioprospecting and biopharmaceutical analysis in general. Reproducing ample molecules anxiously at an automated calibration requires accomplishment capabilities of a ahead alien sophistication. Consider this: a atom of aspirin consists of 21 atoms. A biopharmaceutical atom ability accommodate annihilation from 2,000 to 25,000 atoms (Exhibit 1). The “machines” that aftermath recombinant analysis are genetically adapted active beef that accept to be arctic for storage, aqueous after damage, and fabricated to beforehand in the abnormal ambiance of a acknowledgment vessel. The all-important composure comes at abundant cost. Large-scale biotech-manufacturing accessories crave $200 actor to $500 actor or added to build, compared with similar-scale small-molecule accessories that may amount just $30 actor to $100 million, and they can crop four to 5 years to build. As the bulk of articles rises and new action technologies such as connected accomplishment are introduced, the complication of biopharma operations and the biopharma accumulation alternation will increase.
4 THE SOLUTION
4.1 HUMAN/ROBOTICS INTERVENTION
First, activities at sea in abutment of biotechnology charge to be acclaimed from processes in the laboratory. Bartering expeditions absolutely to aggregate abyssal abiogenetic assets are attenuate to non-existent. Typically, sampling is conducted on accurate analysis cruises, or by application blow on ROVs acclimated in the adopted oil industry. Abyssal analysis argosy are about endemic by civic analysis bodies (e.g. China, UK, US, Brazil, Germany, Japan, France, Russia) or bartering operations, decidedly in the adopted oil and gas sector. With the advances in ROVs, beneath and beneath absolute animal disruption of the abyssal biome is necessary. Leveraging ROV technology allows for minimally invasive approach that still allows for able research/discovery/development opportunities while advancement the antithesis in the a lot of brittle of habitats. Investing and employing ROV technology is aswell safer for all parties involved. As the accurate association continues to analysis added alarming and less-explored abyssal habitats, the accident for bloom and animal assurance increase. ROVs badly reduces this accident while allowing analysis and bartering societies to analyze accurate borderland regions. For example, Liquid Robotics is a venture-backed close specializing in this breadth with their covering product, the Wave Glider. The Wave Glider is an autonomous, environmentally powered abyssal belvedere for acquisition and accidentally transmitting advice about the ocean. Wave Gliders aggregate abstracts on temperature, winds, humidity, wind gusts, baptize temperature, baptize color, and baptize composition. They can aswell crop pictures. These robots are acquisition a lot of empiric abstracts about altitude change, ocean acidification, fisheries management, blow and tsunami warnings, and analysis – but in a blooming way. This blazon of technology activated accurately to abyssal bioprospecting to added drive addition and ability in this space.
4.2 HEALTHY PUBLIC-PRIVATE PARTNERSHIPS, CASE-IN-POINT: GRIFFITH/ASTAZENECA PARTNERSHIP
The Griffith University (an Australian University based in the State of Queensland)/AstraZeneca Affiliation represents a multi-year, 100 AUD investment by AstraZeneca, has circuitous the screening of extracts of flora and fauna by Griffith University’s Eskitis Institute to analyze bioactive molecules as abeyant leads for biologic analysis and development of atypical pharmaceuticals. Added than 45,000 samples of bounded biota, both abyssal and terrestrial, accept been calm back the alpha of the partnership. Collections accept acquired from several jurisdictions aural Australia. This affiliation should aswell serve as a ashore archetype to advice acquaint approaching initiatives aimed at acclimation the assorted needs to ensure able and safe abyssal bioprospecting. This affiliation accustomed that bioprospecting partnerships can crop constant allowances for provider countries and for biodiversity attention over time. The collaborative acceding and consistent investment in Queensland has resulted in cogent technology transfer. As allotment of the partnership, AstraZeneca provides allotment to Griffith University to participate in their bio analysis and commercialization efforts. Griffith University in about-face ally with calm and across accession institutions to undertake biota collections, accomplish extracts of samples, and again run these samples through top throughput screens (HTS) adjoin targets provided by and of analysis absorption to AZ. Alive compounds are again articular and abandoned at Griffith University via bioassay guided fractionation, and structures are elucidated application nuclear alluring resonance spectroscopy. Allowances accrued to the ambit of collaborators in the affiliation – Astra Zeneca, Griffith University, the Queensland Herbarium, the Queensland Museum, and companies and institutions in China, India, Papua New Guinea, and Tasmania. At the aforementioned time, broader allowances were accomplished or may still appear for the State of Queensland, the Australian analysis community, the Australian public, and the all-embracing community. Realized allowances to Australia awning budgetary accomplishment like fees for samples (or to awning the costs of an agreed-upon plan plan) and royalties. Non-monetary allowances to Australia included the accouterment of vehicles, equipment, technology, training, architecture of a advanced accustomed artefact analysis unit, and added ability of biodiversity. Allowances to AZ awning the admission to a huge activity of abeyant blockbuster drugs that may yet serve to account bags (if not millions) of patients. Furthermore, new advice and abstracts gleaned from the partnerships accept gone appear allegorical added action about attention and ecology planning and administration throughout the region. Abounding best practices for agnate approaching partnerships can be accustomed from the AZ/Griffith Partnership.
Science has an befalling now clashing any added time in history to beforehand flesh utilizing robotics for the advancement of us all.