IPI Autumn 2020

Page 66

Technology

Pharma’s Quantum Leap: Launching New Medicine in the Age of AI The importance of the pharmaceutical industry has been thrown into sharp relief by the COVID-19 pandemic, with governments, business, and everyday people pinning their hopes for the future on the industry’s development of a vaccine or treatment. The pandemic has also exposed pharma’s challenges to the public. Commentators and leaders have expressed shock at how long the discovery and testing processes will take to find a vaccine or treatment. The US President even met with top pharma executives early in the pandemic to push them to go faster – only to be rebuffed and told the discovery process and drug trials cannot be accelerated all that much. The truth is the pharmaceutical industry has long been squeezed by tight regulation, cost controls on medicines, and the necessarily extensive drug discovery and research process. There is some hope, however, we are on the cusp of a change across the sector. In February 2020, a team at MIT discovered a new antibiotic in record time using a machine learning algorithm. Will AI technology usher in a quantum leap in pharmaceuticals? Will this new technology solve some of pharma’s longstanding structural problems? Pharma: Between a Rock and a Hard Place The future may be rosy, however, the pharma sector faces significant challenges at the moment. The problem is the sheer cost of bringing a drug to market remains exceedingly high and many drugs fail before ever reaching the market. The average cost of drug development varies greatly across the pharma industry, which makes it difficult to pinpoint accurate data. The Tufts Center for the Study of Drug Development puts the cost of bringing a drug from research to the market at $2.7 billion, while a study by JAMA Network pins the cost between $314 million and $2.8 billion. The point is clear no matter which study you believe: it is monumentally expensive to develop new drug treatments. 64 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Drug costs soar because of the nature of research and the fact only about half of the chemical compounds identified in a study make it to the human drug trial or Phase III, with the others being discarded or at best set aside for future research. The costs are also driven up by the necessary regulatory research framework in which research operates and by the subsequent required reporting.

good use cases for AI technology and it can help the pharmaceutical industry in specific cases. We need to be careful, however, when we talk about AI. We need to stop thinking of it as magic and move to thinking of AI like any other technology: a tool with the potential to solve a problem. Identifying the right problems to solve is critical to leveraging the right solutions with tremendous impact.

Even when a medicine reaches Phase III, it’s not guaranteed to make it to market. Phase III is often the most expensive part of bringing a drug to market and can last up to several years, depending on the drug being evaluated. At the conclusion of the Phase III trial, medical writers must then manually go through the data and write the daunting CSR (clinical study report), a process which can take months or even a year.

Data: Why AI Makes Sense in Pharma AI is, at its core, computer software that analyses data, applies a reasoning process to the data, and then identifies patterns in the data to utilise — explaining and collating the data as output. Admittedly, this is a vague and highly technical definition so let’s look very briefly at an example. Many pharma companies are using natural language generation (NLG) to automate the writing of portions of the CSR report. NLG technology connects to structured clinical data, analyses it, and explains the results of the analysis in written language.

Some industry analysts were surprised by lacklustre growth numbers in 2019 from some of the biggest pharma companies in the industry. It makes sense, however, when you look at the structural challenges in the industry. Soaring research costs coupled with crowding in the market (e.g. competitive companies that sell the same drugs and research the same topics), and controls on the costs of medicines all lead to squeezed industry profits. Many in the pharmaceutical industry have hyped Artificial Intelligence (AI) as a panacea with the potential to cure pharma’s chronic problems. There are

Simply put, good quality structured data is the fuel on which AI technology runs. Anecdotally, the longest pharma projects we’ve seen occurred due to the work that is required to structure and organise the data. The better structured the data, the faster an AI project can be deployed and the lower the overall cost of the project. Challenges exist, but the pharmaceutical industry is well positioned to leverage AI. Autumn 2020 Volume 12 Issue 3


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Articles inside

End-to-end Visibility – The Foundation of Addressing Today’s Challenges in Pharmaceutical Distribution

15min
pages 100-288

Automated Quality Control of Pharmaceutical Packaging Materials

7min
pages 92-95

Advanced Capsule Development for Today’s Needs: HPMC

24min
pages 82-91

Using Phase-appropriate Delivery to Accelerate Inhaled Product Development

10min
pages 78-81

Creating a Fit-for-purpose Supply Chain for the COVID-19 Vaccine

10min
pages 96-99

Calcium Bioavailability is Key

5min
pages 74-77

Trapped Ion Mobility Mass Spectrometry (TIMS) Drives High-throughput Phosphoproteomics Research

9min
pages 70-73

Pharma’s Quantum Leap: Launching New Medicine in the Age of AI

11min
pages 66-69

Respiratory Drug Delivery – What has Happened and What Might the Future Hold?

11min
pages 48-53

Returning to Basics of siRNA Design to Fulfil Therapeutic Potential

11min
pages 58-61

The Role of Connected Inhalers in Improving Usability and Adherence in Respiratory Disease

18min
pages 42-47

Optimising HPAPI Value Chain to Achieve Maximised Product Value

14min
pages 36-41

Regeneron v Kymab: Transgenic Mice Claims Found Insufficient

14min
pages 54-57

Pre-filled Safety Syringes and the Self-administration Trend A Mutually Reinforcing Relationship

7min
pages 32-35

Barriers in Medical Device Innovation

12min
pages 14-19

Agile and Flexible – A Fitness Check for the Pandemic Era

5min
pages 26-27

Editor’s Letter

4min
pages 8-9

The Patent Landscape Behind COVID-19 Vaccines

9min
pages 22-25

Successful Marketing of Medicinal Cannabis and Cannabis-derived Products – Part II

10min
pages 28-31

Pharmacovigilance: Why are so Many Companies Failing their Regulated Audits?

6min
pages 10-11

Building Solid Foundations for Regulatory Data Automation

6min
pages 12-13

Ensuring the Pharmaceutical Industry is Prepared for a Future Pandemic

9min
pages 20-21
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