1.1 INCREASING BURDEN OF CHRONIC ILLNESS AND EVER-AGING GLOBAL POPULATION
With the ever-aging international inhabitants and the rising burden of continual sickness, there’s an elevated reliance on the healthcare system (notably the biopharmaceutical {industry}) so as or one to realize and maintain a top quality of life. According to the World Health Organization (WHO), the burden of human illnesses have been quickly growing for many years with this pattern predominantly contributed by inhabitants development and environmental degradation.
1.2 DEFINITION OF MARINE BIOPROSPECTING
Marine bioprospecting is the seek for novel compounds from pure sources within the marine setting. These actions have elevated an amazing deal in the previous few years seemingly partially because of the continued technological advances enabling additional oceanic exploration, acknowledgement of the wealthy generic variety within the marine biome, in addition to the stress from {industry} to provide given varied blockbuster medicine going off patent. Today, about 18,000 pure merchandise have been reported from marine organisms belonging to about 4,800 named species. The variety of pure merchandise from marine species is rising at a price of 4% per 12 months. The enhance within the price of discoveries is essentially the results of technological advances in exploring the ocean and the genetic variety it comprises. Advances in applied sciences for observing and sampling the deep ocean, comparable to submersibles and remotely operated automobiles (ROVs), have opened up beforehand unexplored areas to scientific analysis. Since 1999, the variety of patents of genetic materials from marine species has elevated on the price of 12% per 12 months. Marine species are about twice as more likely to yield no less than one gene in a patent than their terrestrial counterparts. Bioprospecting sometimes requires the gathering of a really restricted quantity of biomass for the preliminary discovery. Although additional collections could also be required after a promising discovery has been made, bioprospecting typically doesn’t contain threats to biodiversity akin to the big biomass removals concerned in harvesting sources for meals or mineral exploitation.
1.Three THE SUCCESS OF NATURAL COMPOUNDS IN DRUG DISCOVERY AND BIOPHARMACEUTICAL BACK DROP
Biopharmaceuticals are one of the crucial spectacular achievements of recent science. Many biopharmaceuticals supply excessive efficacy and few unintended effects. And there’s far more to return: radically new ideas are making it to the market, and the advances preserve coming at a speedy tempo. The success of pure compounds in drug discovery is unparalleled: for antimicrobial and anticancer therapies, for instance, greater than 70% of latest chemical entities launched in the course of the interval 1981-2002 originated from pure merchandise. It has been estimated by the US National Cancer Institute (NCI) that 1% of samples from marine animals examined within the laboratory reveal anti-tumor potential (which compares favorably with simply 0.01% of samples of terrestrial origin). In the previous few a long time, advances in informatics, automation and imaging expertise have made it attainable to display 100,000s – 1,000,000s of small molecules towards a selected organic goal or mobile assay per day, in contrast with 10s-100s of compounds examined on animals over many months beforehand. Growing consciousness of the restrictions of traditionally invaluable approaches, and breakthroughs in robotics applied sciences, comparable to these utilized in separation and construction dedication, have made screening mixtures of structurally complicated pure product molecules simpler, and have expanded the potential function of pure chemical variety within the drug discovery course of
2 THE OPPORTUNITY
2.1 AUSTRALIA CONTEXT
Australia is one in all solely 17 mega-diverse international locations on the earth and is famend for the distinctiveness of its biota. Australia has a number of options proving engaging to traders and researchers within the pure merchandise space. This consists of, not least, entry to a various and distinctive biota. More typically, the options of Australia conducive to analysis and industrial exercise embrace its sturdy system of regulation and secure democratic system of presidency, its secure and resilient financial system, clear and environment friendly regulatory setting, complete mental property protections and excessive scientific and technological capability. Australia has remained comparatively remoted over time in comparison with most international locations. Consequently, Australia has a excessive proportion of endemic species – that’s, species not occurring naturally elsewhere. For instance, within the case of mammals, roughly 83% are endemic to Australia. Australia’s distinctive marine setting comprises the world’s largest areas and highest variety of tropical and temperate seagrass species and of mangrove species; among the largest areas of coral reefs; distinctive ranges of biodiversity for a variety of marine invertebrates; and it’s estimated that round 80% of the southern marine species happen nowhere else on the earth. With solely 0.3% of the world’s inhabitants, Australia contributes 2.5% of the world’s medical analysis and a couple of.9% of worldwide scientific publications (Invest Australia, 2007, p.6). In 2005, Australia ranked eighth within the OECD by way of the proportion of researchers within the complete labor power. This is above the OECD common. On a per capita foundation, Australia has a analysis output twice the OECD common. In phrases of biotechnology analysis, Australia has a number of devoted biotechnology analysis institutes. Australia’s biotechnology {industry} is steadily rising, with exercise throughout biotechnology fields together with biomedicine, agricultural biotechnology, industrial biotechnology and environmental biotechnology. The Australian Government is a staunch advocate of the home pharmaceutical {industry} and has been very supportive in implementing initiatives to develop this sector. By any measure, Australian Government help for analysis and improvement within the biopharmaceutical {industry} has been and appears to proceed to be robust.
2.2 MARINE BIOME REMAINS UNTAPPED/UNDER-INVESTIGATED-THUS PROSPECTS FOR NEW AND MEANINGFUL FINDINGS ARE SIGNIFICANT
Today, biopharmaceuticals generate international revenues of $163 billion, making up about 20 p.c of the pharma market. It’s by far the fastest-growing a part of the {industry}: biopharma’s present annual development price of greater than eight p.c is double that of standard pharma, and development is anticipated to proceed at that price for the foreseeable future. Marine bioprospecting has the potential to additional drive these developments. The marine biome stays untapped and below investigated, and thus, completely poised to drive each topline and backside line for a number of stakeholders within the biopharma worth chain. Investing in biotech R&D has yielded higher returns than the pharma-industry common. The present biologics-development pipeline helps an outlook of continued wholesome development. The variety of biotech patents utilized for yearly has been rising at 25 p.c yearly since 1995. There are at the moment greater than 1,500 biomolecules present process medical trials, and the success price for biologics has to this point been over twice that of small-molecule merchandise, with 13 p.c of biopharma merchandise that enter the Phase I trial stage occurring to launch. To date, sampling of marine merchandise has primarily occurred in easy-to-reach coastal waters. As a outcome, 97% of pure merchandise of marine origin are from eukaryotic sources (organisms with complicated cells), with sponges alone accounting for 38% of the merchandise. However, nearly all of the Earth’s metabolic variety resides in prokaryotic organisms (single-celled organisms comparable to micro organism) and over 99% of the microbial group of the ocean stays to be explored, so it stands to purpose that many extra genetic sequences invaluable for merchandise are but to be found. There is a selected curiosity in marine species that stay in excessive environments, comparable to hydrothermal vents and seamounts (‘extremophiles’). By the tip of 2007, solely 10 compounds had been reported from Deep Ocean and ocean trench environments, with an extra seven recognized in 2010. Fewer than 10 marine pure merchandise have to this point been reported from scorching vent micro organism. Furthermore, if we break down the varied ecosystems of our seas and oceans and evaluate the chemical dynamics, coral reefs have notably spectacular potential. The corals that we see are literally made up of colonies that construct up and thrive in an setting the place vitamins are low. Although coral reefs solely occupy 0.1% of the world’s ocean floor, they’re one of the crucial various ecosystems on earth, internet hosting ~25% of all marine species. The deal with the coral reef ecosystem as a goal place for medicinal functions isn’t a brand new idea. As early because the 14th century, coral reefs have been a recognized supply for medicines. One apply at the moment is the usage of fish gall bladder to deal with venomous stings from marine organisms. Today, coral reefs have already contributed its title within the pharmaceutical {industry} as one of many supply of biochemical compounds for brand new medicine and the chances are infinite. The alternative shifting ahead is substantial.
2.Three SPECIFIC EXAMPLES OF SUCCESSFUL MARINE BIOPROSPECTING
2.3.1 Aplidin
One of the early biochemical compounds derived from the ocean is Didemnin, a compound remoted for the therapy of sure cancers. This compound was obtained from the tunicate Trididemnum solidum. Unfortunately, Didemin didn’t survive in later phases of its medical trials. However, after a collection of additional exploration, a relative of the previous species was found to poses comparable traits. The tunicate Aplidium albicans possesses the compound Aplidin® which has an analogous construction with Didemnin however far much less poisonous. Aplidin is an anti-tumor, anti-viral and immunosuppressive drug that has been demonstrated to be efficient in pancreatic, abdomen, bladder and prostate cancers. After present process collection of medical take a look at, Aplidin was granted the classification as an orphan drug that particularly treats a number of myeloma and acute lymphoblastic leukemia. In the United States alone, there are over 45,000 folks with a number of myeloma and an estimated 15,000 new instances within the U.S. every year.
2.3.2 Yondelis
Yondelis® was developed by the PharmaMar Pharmaceutical Company and was launched available in the market in 2003. This compound is now bought by Zeltia and Johnson and Johnson. Yondelis comprises the lively substance Trabectedin. Trabectedin is derived from coral reefs. Specifically from the filter feeding sacs of the small and motionless plant-like invertebrate referred to as sea squirts. Extracts of this reef related species has been discovered to include a therapy for soft-tissue sarcoma and ovarian neoplasm sarcoma. Yondelis was developed on account of the National Cancer Institute Screening Program for marine vegetation and animals. Sea quirts have been collected from reefs of West Indies and studied within the laboratory on the University of Illinois. The anti-cancer biosynthetic compound was then found to be embedded within the symbiotic microorganism inside the sea squirts. Yondelis is produced in a semi-synthetic method, after the extracts from the ocean squirts endure a patented chemical course of. This course of is much less intrusive and fewer demanding to the pure marine biome. Moreover, regardless that the utilization of Yondelis is just for uncommon medical circumstances comparable to sarcoma, there’s nonetheless potential for this product so as to add plenty of worth to the lives of sufferers and different stakeholders. More and extra adopting Yondelis of their prescribing workflow for sarcomas and there are an growing variety of sufferers who’re delicate to medicines containing platinum and Yondelis is likely one of the solely various anti-cancer medicines.
2.3.3 Pro Osteon
There are many indications for a bone graft implant (e.g. fusion of the backbone, joints in legs and arms, fractures or gaps in bones attributable to trauma or an infection, Hillsboro oral surgical procedure). In a typical bone grafting process, an artificial materials is formed by the surgeon to suit the affected space of the bone whereas pins or screws are used to carry it in place. This materials builds a help construction the place bone cells can interlace, regenerate and heal. Pro Osteon Implant 500 has a porous microstructure the place new tissues and blood cells can develop, thereby stimulating development and connects fractured bone segments. Generically referred to as “Bone Void Filler” and permitted by the FDA in 1992, Pro Osteon Implant 500 is clinically confirmed to be protected, robust and value efficient. This materials is sterile, thereby minimizing adversarial reactions from the affected person’s immune system rejecting the implant. The effectiveness of Pro Osteon Implant 500 lies in its supply. It makes use of corals from the ocean that has the identical porous interconnected construction of a typical bone graft thereby mimicking the interior construction of a human bone. After present process a patented chemical course of, it converts the coral into hydroxyapatite which is a mineral and the chief structural aspect of a human bone. At this stage, the implant materials is now additionally osteoconductive which facilitates bone cells to weave into the porous construction. After the process and the therapeutic course of begins, the Pro Osteon Implant will ultimately be coated and changed by bones creating the mended half as robust because it was earlier than. Pro Osteon has nice demonstrated efficacy and a protected side-effect profile. The firm manufacturing this product is projecting no less than $Three billion in gross sales by 2017. What’s extra, the manufacturing of Pro Osteon isn’t fully depending on farming and extracting corals from their pure habitat. Special methods have been developed, which require solely a small portion of coral to be extracted, whereas the stability is grown artificially within the lab-thus selling sustainability and stability of the marine biome.
Three THE CHALLENGES
3.1 HOW TO CONSERVE AND SUSTAINABLY USE MARINE BIOLOGICAL DIVERSITY
Despite the truth that marine bioprospecting is comparatively unimposing and the apply doesn’t impose the sustainability danger of assorted terrestrial methods, conservationists and the general public nonetheless have some considerations. For one, little or no is understood in regards to the conservation standing of many species used as sources of marine genetic sources. Further, many species happen in weak and fragile ecosystems. Many are additionally involved with what we do not know on this comparatively nascent sub-industry at this level. For occasion, the impact on ecosystems of elimination of marine genetic sources is poorly understood.
3.2 FEW NATIONS CAN SUCCESSFULLY DO BIOPROSPECTING ON THEIR OWN
Investment in marine biotechnology isn’t with out danger. Sampling at sea prices a minimal of US$ 30,000 per day or US$ 1 million for a month. It sometimes takes 15 years general, and an funding of as much as US$ 1billion, to go from analysis to industrial product, on account of the truth that many merchandise fail to ship on early guarantees. As a outcome the sector is dominated by comparatively few nations. Patent claims related to marine genetic sources (MGR) originate from solely 31 international locations. Ninety per cent of those patents originate from 10 international locations (USA, Germany, Japan, France, UK, Denmark, Belgium, Netherlands, Switzerland and Norway), with 70% originating from the US, Germany and Japan. Despite the excessive ranges of funding required in R&D, biotechnology is a profitable and vital {industry}.
3.Three THE CURRENT UNCERTAIN AND UNPREDICTABLE LEGAL AND REGULATORY FRAMEWORK DISCOURAGES INDUSTRY (I.E. BIOPHARM COMPANIES) FROM INVESTING THEIR EFFORTS INTO BIOPROSPECTING
The potential of marine bioprospecting has develop into the topic of worldwide coverage debate (notably for areas past nationwide jurisdiction). One central query is whether or not the potential advantages from marine bioprospecting should be shared by your complete worldwide group or solely by the States or particular person companies with the capability to take advantage of them. Various teams are this with the intention to configure essentially the most wise set of insurance policies to stability the necessity to promote innovation and technological/biopharmaceutical advances, with the necessity to verify all stakeholders within the worth chain are appropriately compensated, together with the necessity to make sure the longevity of those pure marine habitats. Increasingly, particular person nation-states are establishing insurance policies that dictate the way in which during which protected marine habitats of their jurisdiction could also be used for bioprospecting and different scientific and industrial pursuits.
3.Four COSTS OF BIOPHARM/BIOTECH DISCOVERY
There are operational and technological challenges to bioprospecting and biopharmaceutical discovery typically. Reproducing giant molecules reliably at an industrial scale requires manufacturing capabilities of a beforehand unknown sophistication. Consider this: a molecule of aspirin consists of 21 atoms. A biopharmaceutical molecule would possibly include something from 2,000 to 25,000 atoms (Exhibit 1). The “machines” that produce recombinant therapeutics are genetically modified residing cells that should be frozen for storage, thawed with out harm, and made to thrive within the uncommon setting of a response vessel. The vital sophistication comes at nice price. Large-scale biotech-manufacturing amenities require $200 million to $500 million or extra to construct, in contrast with similar-scale small-molecule amenities that will price simply $30 million to $100 million, and so they can take 4 to 5 years to construct. As the variety of merchandise rises and new course of applied sciences comparable to steady manufacturing are launched, the complexity of biopharma operations and the biopharma provide chain will enhance.
Four THE SOLUTION
4.1 HUMAN/ROBOTICS INTERVENTION
First, actions at sea in help of biotechnology have to be distinguished from processes within the laboratory. Commercial expeditions purely to gather marine genetic sources are uncommon to non-existent. Typically, sampling is performed on scientific analysis cruises, or through the use of downtime on ROVs used within the offshore oil {industry}. Ocean-going analysis vessels are sometimes owned by nationwide analysis our bodies (e.g. China, UK, US, Brazil, Germany, Japan, France, Russia) or industrial operations, notably within the offshore oil and gasoline sector. With the advances in ROVs, much less and fewer direct human disruption of the marine biome is critical. Leveraging ROV expertise permits for minimally invasive ways that also permits for efficient analysis/discovery/improvement alternatives whereas sustaining the stability in essentially the most fragile of habitats. Investing and using ROV expertise can also be safer for all events concerned. As the scientific group continues to analysis extra harmful and less-explored marine habitats, the chance for well being and human security enhance. ROVs dramatically reduces this danger whereas allowing analysis and industrial societies to discover true frontier areas. For instance, Liquid Robotics is a venture-backed agency specializing on this space with their marquee product, the Wave Glider. The Wave Glider is an autonomous, environmentally powered ocean-going platform for gathering and remotely transmitting details about the ocean. Wave Gliders gather information on temperature, winds, humidity, wind gusts, water temperature, water coloration, and water composition. They can even take footage. These robots are gathering plenty of observational information about local weather change, ocean acidification, fisheries administration, hurricane and tsunami warnings, and exploration – however in a inexperienced approach. This kind of expertise utilized particularly to marine bioprospecting to additional drive innovation and effectivity on this house.
4.2 HEALTHY PUBLIC-PRIVATE PARTNERSHIPS, CASE-IN-POINT: GRIFFITH/ASTAZENECA PARTNERSHIP
The Griffith University (an Australian University primarily based within the State of Queensland)/AstraZeneca Partnership represents a multi-year, 100 AUD funding by AstraZeneca, has concerned the screening of extracts of natural world by Griffith University’s Eskitis Institute to determine bioactive molecules as potential leads for pharmaceutical discovery and improvement of novel prescription drugs. More than 45,000 samples of regional biota, each marine and terrestrial, have been collected for the reason that begin of the partnership. Collections have derived from a number of jurisdictions inside Australia. This partnership must also function a grounded instance to assist inform future initiatives aimed toward balancing the varied wants to make sure efficient and protected marine bioprospecting. This partnership demonstrated that bioprospecting partnerships can yield constant advantages for supplier international locations and for biodiversity conservation over time. The collaborative settlement and consequent funding in Queensland has resulted in important expertise switch. As a part of the partnership, AstraZeneca supplies funding to Griffith University to take part of their bio discovery and commercialization efforts. Griffith University in flip companions with home and abroad gathering establishments to undertake biota collections, make extracts of samples, after which run these samples by excessive throughput screens (HTS) towards targets offered by and of therapeutics curiosity to AZ. Active compounds are then recognized and remoted at Griffith University by way of bioassay guided fractionation, and constructions are elucidated utilizing nuclear magnetic resonance spectroscopy. Benefits accrued to the vary of collaborators within the partnership – Astra Zeneca, Griffith University, the Queensland Herbarium, the Queensland Museum, and corporations and establishments in China, India, Papua New Guinea, and Tasmania. At the identical time, broader advantages have been achieved or should still emerge for the State of Queensland, the Australian analysis group, the Australian public, and the worldwide group. Realized advantages to Australia embrace financial remuneration like charges for samples (or to cowl the prices of an agreed-upon work plan) and royalties. Non-monetary advantages to Australia included the supply of automobiles, gear, expertise, coaching, constructing of a state-of-the-art pure product discovery unit, and elevated data of biodiversity. Benefits to AZ embrace the entry to an enormous pipeline of potential blockbuster medicine that will but serve to profit 1000’s (if not tens of millions) of sufferers. Furthermore, new data and information gleaned from the partnerships have gone in the direction of informing extra coverage round conservation and environmental planning and administration all through the area. Many greatest practices for comparable future partnerships will be established from the AZ/Griffith Partnership.
End Note:
Science has a chance now in contrast to another time in historical past to advance mankind using robotics for the betterment of us all.
Protecting Ocean Regions With Robotics
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