Top 10 Pharma Industry Trends & Innovations in 2021

                                 

Top 10 Pharma Industry Trends & Innovations in 2021

The COVID pandemic has forced all companies to rethink many aspects of their business, including manufacturing and the same holds true for pharma companies. The pandemic also highlights the need for improving the speed and accuracy of finding and mass-producing novel drugs, treatment methods, and vaccines to respond to such large-scale and high-pressure demand. Below are most relevant solution 

1. Artificial Intelligence and Machine Learning

The use of artificial intelligence and machine learning is accelerating the drug discovery and development processes. Pharma industries are exploring the use of these technologies to address the various challenges, such as automation and optimization of the manufacturing processes, as well as designing effective marketing and post-launch strategies.

Patient identification is a crucial step in the drug discovery and development process, especially for conducting clinical trials. Artificial intelligence simplifies the identification of eligibility criteria and the inclusion of patients and also makes the cohort identification process faster and cheaper. AI algorithms can be used to identify patient cohorts for drug discovery, clinical trials, and real-world evidence (RWE) studies.

The machine learning-based software can scan through electronic health records (EHR) and unstructured doctors’ notes to find the right patients based on phenotypes.

 

Drug Discovery: Different machine learning approaches, such as few-shot learning, reinforcement learning, active learning, and representation learning, can be utilized to aid the drug discovery process. The deep learning solution uses small and noisy datasets to predict and optimize potential drug candidates, further eliminating the need for large datasets.

2. Automation to Autonomous

Year 2020 helped the world unleash the true potential of digitisation at a pace never seen before. As the world moved from offline to online, businesses adopted cloud and AI to automate operations and accelerated their digital transformation at record speed.

Many pharma organizations are in the process of updating their process from manual/semi-automatic to automatic. Those are being in the automatic level, are on a journey from automation to autonomy. In the first wave of automation, pharma organization had automated what they thought was automatable, but cloud and AI have opened new possibilities, and changed the definition of what is automatable

To become the state of autonomous, need to automate more of the complex decisioning and edge-use cases—and this requires more AI, cloud, data, and intelligent automation. Cloud is giving us the ability to deal with lots of data and computing power - which opens use cases for AI that we didn’t think existed before. As a result, a lot of processes will move to no-touch, low-touch or fully autonomous processing.

The current challenge for Cloud system is to meet the GMP requirement. However, with collaboration of Pharma and IT expert, it will be resolved soon and Autonomous will be the future of Pharma manufacturing system.

 

3. Big Data & Analytics

Clinical data management became a crucial area of focus. The large volumes of data available throughout the drug discovery and development process require high-performance systems to properly analyze data and derive value from it. The advancement in analytical techniques is also turning historical and real-time data available with pharmaceutical companies into valuable assets for predictive, diagnostic, prescriptive, and descriptive analytics. Moreover, these analytics techniques are used on almost all types of medical data from patient records, medical imaging, and hospital data etc.

In-silico modeling can be utilized to build customized drug development roadmaps by augmenting the available data, analysis.

 

4. Flexible Production

The pharma industry is exploring new ways of manufacturing due to the changing market dynamics, such as small batches for precision medicine. Single-use technology is gaining popularity as it reduces downtime and increases productivity by eliminating complex steps like cleaning and validation between separate production stages. New types of bioreactor systems and continuous manufacturing processes address the increasing focus on biopharmaceuticals. In addition to eliminating downtime, continuous manufacturing has low energy needs, achieves high productivity, and minimizes the amount of waste.

Arlift technology (single-use airlift bioreactor systems) uses bubbles instead of mechanical mixing to move cells and nutrients. The reactor comes with disposable bioreactor bags, an integrated heater, and offers precise regulation of biochemical parameters such as pH, dissolved oxygen, and temperature. The single-use system can be used for a variety of cell cultures and fermentation and the startups have achieved growth of bacteria, yeast, microalgae, and bacteriophage amplification.

For continuous manufacturing process refer https://pharmatutor21.blogspot.com/2021/02/continuous-manufacturing-improve.html

5. Precision Medicine

Gene expression, metabolomics and Genome data analysis tools helps pharma organization to enter in the field of precision medicine. Precision medicine comes from the idea of treating each patient as a unique individual. Advancements in data analysis are providing new insights into how the human body responds to drugs (Pharmacokinetics - absorption, bioavailability, distribution, metabolism, and excretion). This knowledge, along with advanced manufacturing methods such as additive manufacturing, is making personalized medicine a reality. Drug exposure models determine the pharmacokinetic and pharmacodynamic properties of drugs for arriving at the right dosage for drugs based on age, sex, comorbidities, and other clinical parameters.

 

Additive manufacturing (AM) or additive layer manufacturing (ALM) is the industrial production name for 3D printing, a computer-controlled process that creates three dimensional objects by depositing materials, usually in layers.

 

6. Additive Manufacturing -3D printer

The need for precision medicine is also making pharmaceutical companies rethink the manufacturing process. A lot of research is underway for making advanced 3D printers that print tissues or cells. 3D printing of human tissues has great applications in drug development, organ engineering, and regenerative medicine. This allows the development of age or physiology-dependent medical formulations, as well as precision pills. Bioprinters also help in pushing innovation in bioinks, tissue engineering, and microfluidics.

FabRx is a British startup that manufactures M3DIMAKER, a 3D printer for making personalized pills. M3DIMAKER uses proprietary technology for direct powder extrusion. The single-step printing process uses a single screw extruder for the extrusion of powdered material. It manufactures pills with properties such as sustained or delayed dose, and multidrug combination pills (polypills). The printer also enables small batch production for clinical trials and precise personalized dosage forms for individuals.

7. Extended Reality (XR)

Mixed reality (MR), virtual reality (VR), and augmented reality (AR) is enabling visualizations like never before. Pharma organizations are exploring the possibilities of these technologies in pharmaceutical research and manufacturing spheres. Extended reality tools enable data-rich and meaningful real-time location-agonistic interaction among research teams.

The VR-based molecular visualization tool imports molecular data from public databases or custom inputs and helps researchers to design proteins, iterate 3D structures, and also work in a virtual workspace with global team members.

AR can be utilized in pharma and biopharma manufacturing system. The solution enables technicians and line operators to increase their productivity and efficiency by prompting various tasks in real-time, in an AR environment. This suite supports all shop floor processes like manufacturing, filling, primary packaging, and secondary packaging.

 

8. Real-World Data

Real-world data (RWD) and real-world evidence (RWE) are transforming innovations in the pharmaceutical industry. RWD includes patient health status, treatment data, and health reports collected routinely. The pharmaceutical industry, owing to its research-intensive nature, has to make sure that the data they use is reliable and of real value. The availability of real-world data enabled by the Internet of Things (IoT), sensors, and wearables is restructuring the way the pharma industry is functioning.

 

9. Digital Therapeutics

Digital therapeutics deliver evidence-based therapeutic interventions using software to prevent, manage, or treat physical, mental, and behavioral conditions. These non-pharmacological, tech-driven solutions are either stand-alone or used along with medications, devices, or therapies. Digital therapeutics let each individual have greater control over their health and outcomes.

Cognivive, a US-based startup, offers evidence-based digital therapeutics for the treatment of neurocognitive and neuromotor impairments. The neurorehabilitation treatment uses a medical device to help patients recover from a stroke.

10. Curative Therapies

There is a paradigm shift happening in the area of treating illnesses from managing diseases to curing diseases altogether. Curative therapies such as cell and gene therapies are changing the way we deal with chronic diseases or difficult to treat conditions by eliminating the need for long-term treatments. In gene therapy, genetic material is introduced into the cells to compensate for abnormal genes or to make a beneficial protein. Genetically engineered viruses are the most common vectors used for gene therapy.

Mogrify is a British startup that develops a proprietary direct cellular conversion platform to transmogrify any mature human cells. The platform technology identifies the transcription factors or small molecules required to convert any mature cell into any other mature cell type by analyzing sequencing data and regulatory networks. Mogrify develops novel cell therapies for musculoskeletal, auto-immune, and cancer immunotherapy, as well as ocular and respiratory diseases.

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