Biotech/Pharma Breakthroughs Commenced in 2018 will Extend further in 2019
Scientists and entrepreneurs were not only looking for genomes but also proteomes , metabolomes, transcriptomes, and many other data modalities for quantifying the state of health and disease in 2018. Algorithms and data were supercharged but not replaced the human intelligence in this new era of biology and medicine.
The developments have been carried out in the following areas in 2018 as:
Blood transfusion through genome sequencing, with more than 99% accuracy, with the aim to modernize therapy for rare blood donors and at risk recipients.
Functional cure of HIV using CRISPR to stop virus replication, by disrupting the two regulatory genes, tat and rev, are essential for virus replication. Discoveries of new CRISPR enzyme Cpf1 creates sticky ends help removing the larger chunks of genetic code, creating value in diagnosing cancer. Lot of work has been done on personalized medicines to make a standard of care for some serious health problems as cancer e.g. CAR-T cell therapy. Roger Haenni explains the blockchain-based marketplace for health data has a great promise to keep patients in loop about the state of their health.
“Consumers wanted to do more with their genetic data. They anticipated interacting in new ways to help them improve their lives.”
Human Microbiome exploited which secretly controls everything about us.
Growing human body parts in Lab by achieving the advancement in stem cell technologies e.g. heart, eyes, bones, muscles, brains, liver etc. Kidney is regenerated using stem cells in Australia.
The recent advances in the field of biofabrication have been enormous. From 3D printers to recapitulating human organ’s geometry and functions. Fabricated liver system, microfluidic dialysis on a chip, and bioprinted pancreas are within reach but implementing these technologies is going to require critical thinking of immunocompatibility, cost effectiveness and fabrication reproducibility.
“At the MIT Media Lab created a wonderful collection of open-source fluidic hardware via Metafluidics. Similarly, do-it-yourself (DIY), do-it-together (DIT), and citizen science movements around biology and biotech are growing at a rapid pace.”
Advances made in synthetic biology, to make us healthier and make world a better place to live. Pamela Ronald developed a drought-resistant strain of rice. We focused on seed variety, enhanced local food security and provided safe, abundant &nutritious food to the consumer.
Chinese traditional medicine has become an unlikely breakout star of analytical chemistry, this is a new wealth of scientific support derived from natural products.
New drug developed to treat pancreatic cancer and a vaccine to protect football players from concussion.
Protection against pandemics is another big project by 2019 where the coalition for epidemics preparedness innovations is making sure that we are ready for further outbreaks, working to ensure that everyone has access to vaccines at times of risk.
Work has been carried out in bioenergy solutions. Bacteria exploited to power the biological solar cell works equally as efficiently under darker skies as under bright light.
Smarter bioelectronics and in-vivo biosensors on biophysical level, able to sort out what human brain interfaces with the distinctly trans human idea of higher-order cognitive brain-signal processing. Treating depression with the use of brain implants, based on deep brain stimulation.
Artificial intelligence diagnoses eye diseases. Ocular lasers have been tested out. Future uses could extend into displays, photovolaics and wearable sensors etc. AI based methods speed up the development of nanoparticles could be used for delivery of medicines.
The projects like conservation of land and water, enhancing farm diversity, soil fertility, reducing erosion and minimizing harmful inputs are also developed. Serious issues affecting the planet, environmental warning- biodiversity collapse. The survey done by Landcaster University from world’s most diverse ecosystem, the outcome of which doesn’t look good, unless urgent and joined-up action is taken. Robotic insects could pollinate plants may affect bees. However, this discovery still provided complexities of bee wing motion patterns and aerodynamics.
The project Earth Bio genome will be hoping to protect biodiversity by boosting it in 10 years by sequencing the DNA of all life forms on the earth.
Nicole Prause provided the understanding of how real sexual activity is likely different from visual representation.
Modern trends like Digitalization, automation, artificial intelligence (AI), enhanced data analysis and growing trends towards personalized products will be among the pharmaceutical developments in 2019, according to the industry experts. Traditionally pharma sector will slow to accept the change due to cost factor and regulatory requirements.
Major challenges will be mounting the pressures to reduce the cost of drugs, continuing the concern over counterfeit products entering the supply chain. Re-evaluation of expensive research programs aim at developing blockbuster drugs.
Two big unknowns are going on in 2019. One is the countries after U.K.s Brexit break up with European Union EU, as companies scramble to adjust operations to avoid disruption in pharmaceutical supplies. The scheduled breakup will be shown in March. The other one is track and trace serialization requirements in February by FMD EUs Falsified Medicine Directive and the US government’s Drug Supply Chain Security Act DSCSA moves ahead for implementation. Many companies especially in Europe are still not ready to meet the serialization directives in Europe.
Global pharmaceutical supply chain internal system will watch implementing new software solutions and modify the business process to meet the requirement of the EU FMD, the US DSCSA and global track and trace initiatives. Opportunities to transition of product data in to information assets by appropriate information technology (IT) will provide significant enterprise benefits. Companies that leverage serialization requirements will build bridges, a truly revolutionary benefit, between themselves and their network directly and indirectly and ultimately to the patients who consume their product.
Executives in US and Europe are consulted for pharmaceutical processing to have their opinions on major issues, challenges and developments they expect to see in 2019. Their responses are as follows:
There will be a focus towards developing smaller volume of biotech products and we can expect further breakthroughs for rarer conditions. So the industry is no longer focus on mass production i.e. “one size fits all” approach, meeting the demands for personalized medicine, says Daniel Tedham. Companies will try to differentiate their experiences with patients from their competitors and add value. We’ll see companies exploring the printable electronics more likely integrated in to pharmaceutical products in 2019. Sensors could potentially determine when the product is used, storage condition, ensure security, identify which market a product is being used, something very exciting.
Most of the organizations move towards starting the core competencies of digital transformation making changes from batch to continuous production for newer therapies, according to Bob Lenich. Digital twin technology will be used for simulations of equipments and unit operations. Helping to deliver operation improvements across the life cycle of plant and have capabilities in both augmented and virtual reality.
Pharmaceutical manufacturers have more options to speed up technology transfer and add tool sets to automation making it more efficient to perform technology transfer. CAR-T cell therapy will adhere to people based process.
Pharmaceutical industry is seeing a huge demand in oncological and immune-suppressant therapy, which is fueling increase in drug manufacturing using high potency active pharmaceutical ingradients(HPAPIs), Ben Wylie says.
Rather than looking for past 3-5 year plan cycle, the modern software companies look for change in automation, robotics, regulatory requirements, consumer demand for both information and transparency from the manufacturers of the products they purchase for marketing and continued improvement in processes, according to Julien Faury. Blockchain technology definitely impacted the business and society. The cloud advanced analytics, AI and IoT are amongst the innovations transform the pharma and healthcare industry the same way they already have transformed the media, retail, and banking industries.
According to John McCullough the hot new technology is AI today, where the world is anxiously awaiting for its further developments. It’ll take around more 10 years. New opportunities will arise to incorporate software/ technology streamlines regulated processes which are slow by today’s standards.
Ben Wylie described the disposable technology would be cost effective and flexible to make this solution especially as an alternative for process capability.
Data driven decision making will get deeper as our systems and tools become increasingly ubiquitous allowing decision makers to finitely quantify events rapidly, by Tu Tran. This trend is apparent in all fields from sports to pharma.
Bob Lenich says that data is a new currency, organizations must be able to collect data and put it in to context for production decision support, real- time product release and better handling the variability.
Anita Paz says as it’ll help make improvements to supply chain operations.
Serialization move in pharma sector is underway. The real struggle is both in US and EU, the situation in US is better than EU. 100% readiness seems not possible for EU in 2019, says Julian Faury and Evren Ozkaya. However the deadline for serialization compliance is approaching fast in case of EU.
Pharma industry has been extremely risk-averse. The focus has been usually on minimizing risk instead of maximizing performance and patient care said by John McCullogh.
According to analysis, the adherence programs at scale are estimated to have positive impact from 2020 to 2026, with highest degree of growth 29% in 2026. So this year 2019 will be the year where pharma addresses adherence at scale (by Tom Kottler).
The supply chain partners, in conjuction with patients they serve, participate in global digital supply network that enables the participants to share the information based on new business and value- exchange models. This‘ll be the fundamental driver of increased product safety, empowered patients, and a more effective and efficient global medicine supply chain.
The trends most likely to be hitting the news cycle as:
Failure of the Alzheimer’s drug development leads to a better understanding of disease in 2019.
STAT listed one of the top trend that how do they pay for innovation. With the success of CAR-T immuno-oncology therapies are for cancer, in addition to gene therapies more is expected in 2019 for SMA ( Spinal Muscular atrophy), if it is approved it could run as $5 million a dose.
Although criticism of the pharmaceutical industry is common, both publicly and in political circles, the reality is developing and successfully selling drugs is incredibly expensive and difficult. As the first step pointed out Alzhemer’s- which represents hundreds of millions of dollars spent on failed projects. But success comes with many challenges, not just getting to market, but also being profitable, once a drug gets to the market.
Opioids crisis is not over but the efforts by government and law enforcement don’t seem to be making a big change.
Biotech initial public offerings (IPOs). Some individuals were record breakers – Moderna, Allogene Therapeutics and Rubius Therapeutics. The total fund for the year is raised around $8.2 billion. Gossamer Bio filed for an IPO to raise $264.5 million to fund its immunology clinical programs. Hong Kong Stock exchange rules allow biotech companies without a product to file IPOs, numerous international biotechs are looking to that exchange as a potential option to raise funds.
He Jiankui, a researcher from the Southern University of Science and Technology of China announced that a set of twins had been born in which he had used CRISPR gene editing to modify the embryos. The story of He Jiankui and the sets of twins is likely to continue into 2019. We also expect more stories of CRISPR to float to the top.
https://crosstalk.cell.com/blog/five-biotech-trends-im-excited-about-in-2018
https://explorebiotech.com/biotechnology-breakthroughs-of-2018/
https://www.rdmag.com/article/2018/10/outlook-2019-tech-data-and-biotech-boom
https://www.biospace.com/article/7-biotech-trends-to-look-out-for-in-2019/
Waiting for your valuable comments
Thank You!!
Dreamer
6 年Precise information. However I would like to draw your attention towards both upstream and downstream process of biosimilar development for developing countries like us. Skilled human resources are nedded and Entrepreneurs need to step ahead on this matrer.
Accountant / GST and audit management
6 年I hope this information also will help you out , https://bit.ly/2GpyUPz?
Researcher
6 年Sure, I'll send you the link via email. Thanks
Senior Research Associate and Junior Professor- Dept of Biophysics, PTE // Ph.D. Biotechnology // CONNECTING THE DOTS TO BUILD TECHNOLOGIES // PHOTOGRAPHER
6 年Thanks for writing a nice piece of summary of all the key development in 2018. Precisely, from your writing AI and Cripr is taking the center stage. To me both have the potential to bring a new revolution both in terms of genome editing and controlling the humanity. On the other hand we are not thinking about the darker side of these technologies. Specially with Crispr, lot of things being said than done and lot of things being kept hidden than published. It is promising but at the same time a threat to us too. The example of the Chinese scientist you put in the end is the threat, Crispr cannot control everything that could happen from one mutation inside a genome. Same goes with the advent of AI. We are loosing our own privacy with each passing day. I would appreciate if you could also put the cons into your writing and finally end with some strategies to balance it. We now need a clear cut policy for future technologies that would be coming or it will be tool late.?