2019 has been a year full of surprises and breakthroughs for the pharmaceutical industry. Be it new medical innovations, technological advances, mega acquisitions, or the changing regulatory landscapes, pharma world couldn’t stop creating waves of excitement throughout the year. As we usher in the year 2020, let’s have a look at the top 6 things that created a major impact on the pharma industry.
- The advent of AI in drug discovery
As expected by the pharma industry experts, Artificial Intelligence (AI) continues to expand its web of applications throughout the pharma industry. Its enhanced data capture tools along with Optical Character Recognition (OCR) applications, are helping data analysis and interpretation faster and speeding up more informed and timely decisions. AI tools are being used increasingly in drug discovery which is the most cost and time-consuming area of pharma. Several pharma companies are using AI-based software to fast track drug screening processes and expedite the crucial clinical decision making for drugs in trials.[i] Further, AI is also proving to be a valuable tool for diagnosis, precision medicine, creation of hyper-targeted drugs, predicting pharmacological behavior of drugs, genetic research and interpretation and many more.[ii] In the present scenario, where the pipeline of new molecules is drying rapidly and patents are getting expired steadily, AI is definitely here to stay for a long time giving a boost to the drug discovery process.
- The influence of IoT on pharma manufacturing
The Internet of things (IoT) is taking the industry by storm and there is no way the pharma industry will remain oblivious to it. For pharma, IoT is bringing radical changes in drug manufacturing, equipment maintenance, and supply chain management. IoT enabled ‘smart factory’ that includes intelligent communication and interaction with other objects and systems through sensors has taken the routine pharma manufacturing to the new heights increasing the overall production efficiency. By collecting data of each equipment and its status and processing this vast information using big data analytics and AI, pharma manufacturers can predict impending equipment failures, optimize maintenance tasks in real-time and cut down the unplanned downtime. Different IoT solutions such as real-time tracking of men and material, smart packaging, and cold chain monitoring are making the pharma supply chain more transparent, efficient, and cost-effective.[iii]
- Capitalizing on the benefits of legal cannabis
Since the legalization of marijuana by Canada, other countries are reconsidering the current position of cannabis and its derivatives as controlled substances. In the USA, cannabis is legalized for medical or recreational use in 33 states whereas countries such as Mexico, Luxembourg and New Zealand are in the process of regulating the use of marijuana. Further, FDA has approved the first cannabidiol (CBD) drug—Epidiolex for epilepsy treatmentꟷin June 2018 which can be considered as a hallmark for the beginning of the development of more cannabis-based drugs for medical uses.[iv] As a result, there has been a resurgence in research for new marijuana-based therapies which is just going to expand more in the future.
- FDA’s new initiative for fast track of generics
FDA issued a guidance document titled “Competitive Generic Therapies (CGT)” on February 15, 2019, that discusses a new regulatory pathway that is aimed at promoting development, expedited review and timely market entry of generic drugs.[v] Designation of a drug as a CGT can be granted if at the time of ANDA (abbreviated new drug application) filing, there are no unexpired patents, unexpired exclusivities, and there is no more than one approved drug in the active section of the Orange Book. The biggest advantage of drugs designated as CGT by the FDA is that these drugs are eligible for 180-day marketing exclusivity. This new step of FDA is expected to increase competition for drugs that have less generic competition and also to decrease the potential for drug shortages.
- Megadeal of the year – Bristol Myers Squibb Acquires Celgene
In 2019, the pharma industry witnessed one of the biggest acquisitions when Bristol Myers Squibb (BMS) announced its $74 billion takeover of Celgene on November 20, 2019.[vi] As per the terms of the merger agreement, Celgene became a wholly-owned subsidiary of BMS. With this deal, the new joint company has expanded its product portfolio in therapeutic areas including oncology, immunology and inflammation, and cardiovascular diseases. With this deal, BMS is also expected to get a position in cell therapies as in 2018, Celgene had acquired Juno Therapeuticsꟷa company which is working on various cell receptor therapies aimed towards the treatment of cancer, relapsed and/or refractory diffuse large B-cell lymphoma, and other multiple targets.
- Green signal from FDA for new drugs
The year 2019 saw the approval of 48 novel drugs from the US FDA. Some of the key approvals of this year include[vii]:
1) Skyrizi, which received FDA approval for treating plaque psoriasis and is estimated to generate annual sales of $3.2 billion by 2024.
2) Mayzent won FDA approval becoming the first oral drug to treat secondary progressive multiple sclerosis (SPMS) patients with active disease.
3) Zulresso, a drug designed to treat postpartum depression, became the first treatment for the depressive disorder to be approved by the FDA.
Sources:
[i] https://www.digitalauthority.me/resources/artificial-intelligence-pharma/
[ii] https://www.mastercontrol.com/gxp-lifeline/3-trends-shaping-the-pharma-industry-in-2019/
[iii]https://www.pharma-iq.com/manufacturing/articles/the-role-of-iot-in-pharma-manufacturing-and-distribution
[iv] https://apnews.com/ae6205b0a71443afb61b9486adeeef8a
[v]https://www.fda.gov/regulatory-information/search-fda-guidance-documents/competitive-generic-therapies
[vi]https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-completes-acquisition-celgene-creating-le
[vii] https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019
