< PreviousNUCLEAR MEDICINE 30 Pharma Business International www.pbiforum.net As a diagnostic tool, nuclear medicine offers physicians precision medical imaging that can be used to identify and diagnose certain conditions by using small amounts of radioactive material. It’s especially useful in pinpointing molecular activity, enabling doctors to judge the severity of a condition. In this way, it can also show how well a patient is responding to therapeutic interventions, cutting down extended periods where doctors previously had to wait and see how a patient was reacting. In this way, nuclear medicine can also provide an accurate assessment of Alzheimer’s disease and other types of dementia even in the presence of other pathologies that are masking these symptoms. This means a quicker diagnosis for patients, potentially preventing extended assessment periods in which their symptoms can worsen. It has opened up new possibilities for imaging diseases of the brain, but it has also changed the way in which some conditions are diagnosed altogether. Previously, diagnosing internal problems often needed surgery, but nuclear medicine makes this unnecessary, the better to safeguard vulnerable patients as any surgery carries with it a risk, especially in the rise of antimicrobial resistance (read more on page 18). It’s an important, now indispensable The nuclear option Nuclear medicine is unique in that it can be used both as a diagnostic imaging tool and therapeutically. We take a closer look at the possibilities offered by this approach and what the future holds. 32 Á 30-33.qxp_Layout 1 10/02/2020 13:08 Page 1© Shutterstock /VshivkovaNUCLEAR MEDICINE 32 Pharma Business International www.pbiforum.net diagnostic tool, but it has a lot of exciting scope in a therapeutic context where it can treat some cancers, problems with the thyroid, heart conditions and gall bladder disease. The same agents used in nuclear imaging can be used to deliver treatment with the radiopharmaceutical either swallowed, injected or inhaled. Also known as radiotracers, radiopharmaceuticals are the drugs used in nuclear medicine to highlight internal organs or veins. They’re a combination of a radioisotope bonded to an organic material with the latter conveying the former to the specific organ or region. Radioisotopes emit gamma rays that imaging machines can read and with specifically designed cameras, doctors can track the path of tracers. When it comes to treatment, there are several therapeutic possibilities. For example, radioimmunotherapy (RIT) is a personalised cancer treatment that combines radiation therapy with the targeting ability of immunotherapy, a treatment that mimics cellular activity in the body’s immune system. In the future, it may be possible to embed chemotherapy into medical imaging agents that will attach only to cancer cells. This means that chemotherapy would only kill the target cells and not the nearby healthy tissue, potentially reducing some of the adverse effects associated with this approach. At present, experts across a variety of fields – including nanotechnology and biomedical engineering – are investigating ways to deliver the drugs to the correct site without affecting surrounding tissue, making treatments safer and more effective. For patients, nuclear medicine can send off warning signs due to negative connotations and fears around radioactive materials. However, it’s purposefully designed to act naturally and in conjunction with the body, minimising the possibility of side effects. The total radiation dose either diagnostically or therapeutically is no more than what is received during routine X-rays or CT scans. In any case, more and more patients will be either treated, diagnosed or both with nuclear medicine as it becomes more prevalent as demand increases globally. Currently, researchers are developing new tracers and creating ever more innovative and precise scanners and imagers. Back in mid-2019, Karyopharm Therapeutics’ Xpovio became the first nuclear export inhibitor approved in the United States after the Food and Drug Administration awarded marketing authorisation in combination with dexamethasone for treating adult patients with relapsed or refractory multiple myeloma, a type of bone marrow cancer. Towards the end of the year, McMaster University’s Nuclear Reactor (MNR) in Canada partnered with the Netherlands- based Nuclear Research Consultancy group to provide the global market with a steady supply of isotopes used for cancer treatments. The partnership creates a single point of contact for the production and delivery of the radioiodine, I-125 – an isotope used in the treatment of prostate and other various types of cancer. The dual supply responds to the worldwide healthcare industry’s demand and ensures patients have reliable access to treatment. Demand will continue to grow as more patients are diagnosed and treated with nuclear medicines. As well as cutting down on long assessment periods, it allows doctors to see which medicines are working; make safer, swifter diagnoses, and target effective treatments to specific areas. With the scope offered by current research and with breakthroughs on the horizon, nuclear medicine will soon become industry standard, as commonplace in hospitals as CT scans are today. 30-33.qxp_Layout 1 10/02/2020 13:08 Page 3Pharma Business International 33 www.pbiforum.net NUCLEAR MEDICINE © Shutterstock /Petr SmaginDRUG DISCOVERY 34 Pharma Business International www.pbiforum.net Drug discovery 2.0. From dramatically reducing development times, dealing with big data, and cutting costs, artificial intelligence is upending the traditional model of drug discovery. 34-37.qxp_Layout 1 10/02/2020 13:09 Page 1Pharma Business International 35 www.pbiforum.net DRUG DISCOVERY © Shutterstock /Production Perig As if there was any doubt that artificial intelligence (AI) is transforming the industry, all ten of the world’s biggest pharmaceutical companies are all involved at one stage or another with AI, whether that’s via direct collaboration, or funding via a venture capital arm. While big data and machine learning can be utilised right across the pharmaceutical and healthcare sectors, it’s in drug discovery where some of the most important research is taking place. The best estimates put the time it takes for new drugs to make it from the lab to market between ten and fifteen years. Not only can AI be used to drastically shorten this process, but also reduce the £1.5 billion price tag that comes with it. The cost of discovering and developing new drugs has been increasing over the years, especially as greater regulatory scrutiny and ongoing healthcare pricing issues means that new treatments can be kept from reaching patients. Here AI can help by dealing with the massive amounts of data involved in new drug development. The overwhelming amount of health records, genetics profiles, preclinical studies and clinical trial data can all be correlated and examined en masse, and patterns found. During development stages, new data is coming in daily and with AI, all of this can be added to and compared with a huge pre-existing pool of data, providing a thorough foundation to build on. Issues and inconsistencies can be identified early and gaps in research 36 ÁDRUG DISCOVERY 36 Pharma Business International www.pbiforum.net © Shutterstock /GorodenkoffPharma Business International 37 www.pbiforum.net DRUG DISCOVERY found as well as conveying where research has been clustered and allowing researchers to see where better to focus their efforts. With machine learning, data isn’t only correlated, and patterns extrapolated, but outcomes can be generated, providing pathways for drug discovery. A research team simply couldn’t do this on their own but, guided by these same researchers, AI can use all the facts generated from this massive data pool to create hypotheses that can then be tested and speed up the development process. With a shorter development process, there’s less cost involved, meaning that potential new treatments can move to clinical study faster, offering a lifeline for patients. Last year, Hong Kong start-up Insilico Medicine developed a new AI system that dramatically accelerates the drug discovery process from years to days. In the industry’s first successful experimental validation of AI for drug discovery in cells and animals, the company successfully created a series of entirely new molecules capable of combatting disorders like fibrosis. Traditionally, drug discover begins with the testing of thousands of small molecules to get just a few lead- like molecules. Only one in ten of these pass clinical trials in human patients making it a protracted, costly and inefficient process. But with Insilico’s AI, it was able to ideate and generate novel molecules from start to finish in just twenty-one days. Powered by generative chemistry utilising modern AI techniques, the company’s GENTRL can rapidly generate molecular structures with specified properties in a technique similar to that used by DeepMind (the AI company acquired by Google in 2014) to outcompete human GO players. The start-up has made the source code open source to make it more broadly accessible to the public and allow other companies and research teams to leverage the technology. This year, just a few months after Insilico’s breakthrough, a clinical trial began in Japan exploring the first drug candidate discovered using AI. DSP-1181 is being progressed as a long-acting and potent serotonin 5-HT1A receptor agonist for obsessive- compulsive disorder as an initial indication. It was jointly created by combining Sumitomo Dainippon Pharma’s science and know-how in monoamine GPCR drug discovery, with University of Dundee spin-out Exscientia’s Centaur Chemist AI platform for drug discovery. With this AI- powered process, it required less than twelve months to complete the exploratory research phase, less than a quarter of the time of the typical average of 4.5 years using conventional research techniques. Although artificial intelligence is still in its infancy where drug discovery is concerned, the breakthroughs have already been profound. From dramatically shortening development times, to reducing costs, the technology is helping to change the way in which new drugs are discovered, developed and brought to market. 34-37.qxp_Layout 1 10/02/2020 13:09 Page 438 Pharma Business International www.pbiforum.net © Shutterstock /New AfricaPrevention before treatment Pharma Business International 39 www.pbiforum.net VACCINES T he anti-vaxxer movement is one of the biggest threats to disease prevention and is a growing problem, particularly in the US where vaccines have been linked (with little evidence) to autism. What once seemed a small and misinformed minority is now spreading into the mainstream, aided in no small part by social media and misinformation. Diseases that had otherwise been thought to be either wiped out or under control now threaten to reignite, and no one across the political divide seems prepared to risk the vote necessary to deal with the issue. Conspiracy theories have been abound for decades now, but society has recently been affected by them more than ever before – not just with anti- vaccination conspiracy theories, but chemtrails, political and even the flat-earth movement. While not directly related to the pharma industry, these trends are worrying Anti-vaxxers, super viruses and industry predictions. It’s a hectic timetable for the vaccination industry, but as one of our main lines of defence against infectious diseases, we can’t afford to take it easy. 41 Á 38-41.qxp_Layout 1 10/02/2020 13:12 Page 2Next >