PHARMACEUTICALS network expertise is crucial to successfully navigating quality control challenges and developing solutions in real-time .
From ‘ large-large ’ to ‘ small-small ’
Even before the COVID-19 pandemic , the pharmaceutical industry had been changing its focus on blockbuster drugs for common ailments that affect large populations to focusing on ' niche-busters ', orphan drugs for smaller populations of patients with unmet needs for rare diseases or other underserved medical conditions . 5 In 2021 orphan drugs accounted for 52 % of the 50 novel drugs approved by the FDA ’ s Center for Drug Evaluation & Research . 6 21 of the 26 orphan drugs received first-inclass approvals , an indication of the strong innovation ongoing in the rare disease sector . Several factors benefit developers of orphan drugs . The US government offers financial incentives . Drug candidates granted orphan designation often gain accelerated assessment and designated orphan drugs can receive market exclusivity for determined periods of time . The clinical trials are often smaller in size and have shorter clinical trial times , expediting regulatory approval and speeding time to market . A significant internal factor in orphan drug development also contributes to accelerating time to market . Orphan drug R & D and manufacturing require smaller volumes of material and production sizes . As such , they can benefit from choosing the same quality of materials in their early phases as they do in production . This helps compress timeto-market because they are using the same quality of material in the early phases before moving forward with production . An example of such raw material includes Biocertified * chemicals developed by Spectrum Chemical as part of a larger quality management programme . These raw materials undergo expanded laboratory testing , certifications and documentation to fulfill the unique requirements of each bioprocessing cycle from drug discovery to pilot and scaleup production . The high purity of materials assists in meeting regulatory and compliance requirements while reducing time to market for new drugs , vaccines and therapeutics . The pandemic placed a demand on pharma and biopharma companies to move quickly on making changes to their commercial operating models in improving agility , efficiency and resource allocation , a demand that is ongoing . Multiple sources of technology , including new analytical tools , will offer opportunities for new partnerships and more informed customer relationship . With the trending investment in digitalisation comes the need to integrate the new technologies into strategic planning , operating processes , as well as introducing
new methods of working . Senior management needs to bring their companies forward , providing leadership and resources to achieve competitive goals . Agility and forwardthinking will contribute to innovative solutions and accelerate success in a changing marketplace .
Conclusion
The COVID-19 pandemic has ushered in a new era in drug development cand in the ways that pharmaceutical and biopharmaceutical manufacturers will operate in the future . The industry ’ s contributions to medical discoveries and innovative medicines will mean tremendous growth and commercial success for market leaders and will bring great benefit to patients and customers on a global scale . •
* bioCERTIFIED is a registered trademark of Spectrum Chemical Mfg . Corp .
References :
1 : Research and Markets , 2021 Pharmaceuticals Research Review , March 2022 : https :// www . researchandmarkets . com / reports / 5555952 / 2021-pharmaceuticalspresearch [ review # src-pos-1
2 : Mordor Intelligence , Biopharmaceuticals Market – Growth , Trends , Covid-19 Impact , & Forecasts , January 2022 : https :// wwwmordorintelligence . com / industry-reports / global-biopharmaceuticals-market-industry
3 : J . Hinkel , A . Thakker & R . Tsang , Shock-Proof : How to Forge Resilient Supply Chains , Bain & Company , 18 November 2020 Bain & Company Brief . Used with permission : https :// bain . com / insights / shock-proof-how-to-forge-resilient-supply-chains
4 : A . Kumala , W . Miranda , T . Konersmann & A . Israel , Biopharma digital transformation : Gain an edge with leapfrog digital innovation . Deloitte Development LLC December 2021 : https :// www . deloitte . com / global / en / insights / industry / lifesciences / biopharma-digital-transformation . html
5 : T . Yang , Biopharma Business Models 2040 , Deloitte Consulting , 31 March 2020 : https :// www2 . deloitte . com / us / en / blog / health-care-blog / 2020 / biopharma-business-models . html
6 : Global Genes , 12 January 2022 : https :// globalgenes . org / 2022 / 01 / 12 / a-group-of-innovativeorphan-drugs-win-fda-approval-in-2021 /? gclid = Cj0KCQjwzqSWBhDPARIsAK38LY9-OfUXNy _ hbZhALGGP0MzvAoCj4QEAXNeVaP0j5CiHlhtWFgC3g8kaAt0qEALw _ wcB
Dr Vivek Kumar
BIOPHARMA MARKET DEVELOPMENT MANAGER
SPECTRUM CHEMICAL MFG . CORP . k + 1 732 214 1300 x 4655 J vkumar @ spectrumchemical . com j www . spectrumchemical . com
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