The fight against COVID 19 has highlighted the importance of renewing outdated processes and updating this sector’s technology. Over 233 treatments are currently under consideration, and 161 vaccines are in development as of June 2020.2 While the pandemic has created opportunities for the biopharma industry to demonstrate the industry’s value, it also has led to potential short- and long-term challenges.3. Applications also get used for same-day deliveries of drugs and other essential supplies. In this year’s survey, we asked respondents to grade themselves based on our definition of digitally mature: an organization that uses digital technologies and capabilities to improve processes, engage talent across the organization, and drive new value generating business models. We need to grow our reachability to a larger extent.”, “Need to adapt to market changes with respect to customer needs.”, “Our major concerns would include security issues because of intervention of technologies like IoT, managing the epidemic going on right now and finding a cure, and working on customized treatments based on previous data available.”, “Our top strategic priority would be to start more and more R&D initiatives globally so we have a good hold in each market for research.”, “Overall productivity by digital partnering and advancements in technology is key. Taking action against systemic bias, racism, and unequal treatment, Key opportunities, trends, and challenges, Go straight to smart with daily updates on your mobile device, See what's happening this week and the impact on your business. As Stephen M. Hahn, FDA commissioner, stated, “We want to help patients by expediting promising treatments and are committed to maximizing our regulatory flexibility and proactively bringing the best innovators together to ensure we are getting the right treatments to the right patients at the right time.”10. The algorithm was able to suggest two drugs to reduce the Ebola activity within a day. Leaders can incentivize the organization to take informed risks, learn quickly from failures, and rapidly scale successes. Alok Ranjan and Shruti Panda led the text analysis efforts and Madhushree Wagh interpreted the findings. Companies could be well served to take advantage of this momentum to incorporate digital technologies into the patient experience, either in clinical trials or via digital medicines and therapeutics. Atomwise used AI  technology to develop a treatment for Ebola and with excellent results. Regulatory Trends and Developments in the Pharmaceutical Industry in 2018 In the 2017 fiscal year, the FDA issued 114 warning letters to pharmaceutical manufacturers contravening Current Good Manufacturing practices (cGMPs). That means. View in article, US Food and Drug Administration, “FDA continues to accelerate development of novel therapies for COVID-19,” news release, March 31, 2020. Additionally, globally, social unrest around racism issues is increasingly calling on leaders to develop, implement, and sustain new initiatives. It is comprised of businesses producing and developing new drugs and generic drugs, and also over the counter pharmaceuticals. Now, through real-world evidence, health systems and health plans may know even more about how well drugs work in patients than pharma companies do. History. DTTL (also referred to as "Deloitte Global") does not provide services to clients. Both the survey and the second round of investor statements were sourced during March and April 2020, at the peak of the COVID-19 pandemic. The words “China” and “rare” shrunk from their relatively prominent position in Q4 2019. Despite this urgency, bets should be selective and strategic; companies should prepare for risk but not let it hold them back. Jessica Overman, Deloitte Services LP, is a senior research analyst with the Deloitte Center for Health Solutions. Additionally, here’s what our analysis found: The data comes from two different sources. From a talent perspective, conquering the next frontier will likely require new talent and organizational structures to effectively play in the world of today and tomorrow simultaneously. But while this work on therapeutics and a vaccine is on companies’ to-do list, some of them said that the pandemic has compelled them to focus on immediate and existing priorities (e.g., R&D, digital transformation, cyber) across therapeutic areas and functions. There has also been a focus on changing how pharmaceutical companies view patients’ role in the drug design and manufacturing process. While these challenges continue to disrupt the industry, the pandemic has also propelled multiple partnerships to develop a COVID-19 vaccine. He works with corporate leadership to identify market opportunities, build sustainable capabilities, and transform business and organizational models for growth. The Canada Pharmaceutical market studied was anticipated to show a slow growth with a CAGR of 2.4%. View in article, David Voreacos, Katherine Chiglinsky, and Riley Griffin, “Merck cyberattack’s $1.3 billion question: Was it an act of war?,” Bloomberg, December 3, 2019. According to the 2018 RAPS report, more than 99 percent of regulatory professionals hold a university-level degree, and 44 percent of regulatory professionals hold a master’s degree. That being said, pharmaceutical manufacturing procedures must incorporate sterility protocols, such as end product microbial contaminant testing and filtration procedures, to fully ensure product sterility. Bushra holds a postgraduate business management diploma in international business from the Symbiosis Institute of Management Studies, Pune, and a bachelor’s degree in science from Ambedkar University, Agra. Solid Dose Pharmaceuticals Remain Strong. Due to social distance measures, fewer people are going to pharmacies. Companies are using AI to identify suitable drugs for medical conditions while cutting down costs and time. The FDA  has introduced Track and Trace serialization procedure. Amazon’s new online pharmacy company Amazon Pharmacy is fully operational and set to dominate the market. When asked about the top issues that will have the greatest impact on their company in the next year, pharma company leaders ranked the following challenges as their biggest concerns: Changes in consumer attitudes and behavior: Consumers are changing their attitudes and behaviors in numerous ways—from increased use of technology and willingness to share data, to their interest in using tools to make decisions about prescriptions and care.5 Survey responses aligned with Deloitte’s vision of the future of health centered on the consumer—80% of respondents chose changes in consumer attitudes and behavior as an issue that will have the greatest impact on their company (figure 1). Findings from a new survey and analysis of investor calls in the first half of 2020, Change in consumer behavior prompting a change in strategic thinking, Strategic priorities include R&D, establishing presence in global markets, and transformation of functions using digital and information technologies, Digital maturity: Investments rise, but many aren’t there yet, The future of health for biopharma companies in the decade ahead, “Considering the pandemic, the world is witnessing, strategies for drug development is our focus. Biopharma companies will likely keep an eye on these developments and revisit their strategies accordingly. 2020 will also see big data and AI technology continue to take center stage in the pharmaceutical industry. See Terms of Use for more information. Even though it seems like a lot has changed around us in the last few months, our analysis of investor call transcripts and a survey conducted during the pandemic suggest that many of these statements are still true. View in article, Edwin Elmhirst and Lisa Urquhart, “Big pharma sports smallest late-stage pipeline for a decade,” Evaluate Vantage, June 17, 2020. Biopharma companies have been racing to discover effective treatments and vaccines for COVID-19. The pharmaceutical industry is one of Canada's key creative sectors. There will be a focus on making the drug manufacturing and distributing procedures efficient by integrating technology. Patients will be intimately involved in making critical decisions about the sale, distribution, and production of drugs. December 30, 2020. It will make patient care more efficient. “A year spent in artificial intelligence is enough to make one believe in God.” — … Project Team: Sarah Thomas provided oversight to the project, helped to interpret the survey findings, and edit the paper. In the past, pharma companies knew the most about their products. Frank Montgomery, PhD. Other new services introduced this year include GoApotik, which has partnered with an eCommerce retailer for distribution. This article reviews current drug development trends and their impact on pharmaceutical manufacturing. Comprehensive audit, advisory, consulting, and tax capabilities can deliver value at every step, from insight to strategy to action. Pharma companies face a range of policy and regulatory issues—activity that affects the pace at which drugs come to market, supply chain and safety, tax, and pricing polices limiting payment rates. Get the Deloitte Insights app. Her recent research has focused on the future of health, drug pricing policies, and digital technology innovation. A 2016 survey of pharma executives found that of the six most serious issues related to a new product launch, four of them are related to talent. One is a survey of 60 biopharma company leaders —primarily middle-sized companies in terms of revenue. But for the pharmaceutical industry, 2020 has been something of a defining moment. The 2020 Bio/Pharma Virtual Congress will consist of four interactive, educational tracks: formulation, manufacturing, drug dosage form trends, and bio/pharma industry challenges. Innovation starts with insight and seeing challenges in a new way. A lot of falsified medicines have begun to enter the market. The European Union has followed a different approach to the issue. These are challenging times for pharma companies as economic, supply chain, and other forms of uncertainties abound. Our top priority right now would be to be more available on social platforms in order to reach our customers. Tops Health Info is Trying to Give the Best Information to the people. Digital Training. As we wrote in an article on patient-centricity earlier this year, “companies should not only embrace [a patient-centric] approach, but prepare to participate in an emerging ecosystem where philanthropies dedicated to particular diseases, patient advocacy groups, health plans, health systems and physicians, regulators, competitors, and technology and wellness companies are all better connected so that the patient is at the center.”6, —EVP/VP business/corporate development, biopharma company, Cyber and advances in technology: The next most common issues cited were cybersecurity threats (70%) and advances in technology (68%). View in article, Milken Institute, “COVID-19 treatment and vaccine tracker,” July 27, 2020. Text analysis of those responses found emphasis on words such as “business model,” “collaboration,” and “growth.” Consistent with other findings and the industry trend, leaders and analysts on the investor calls also spent a lot of time discussing “R&D.” Some of the other words that found a prominent mention were “competition,” “regulatory,” “counterfeit,” and of course, “coronavirus.”11. Some companies are beginning to use AI technology to automate workflow and production. To learn more about regulatory challenges and opportunities in other industries, visit the Regulatory Outlooks homepage. Business/Regulatory Trends for the Pharma/Biopharma Industry 1 ... Regulatory Trends • Enforcement pressure is increasing –During the fiscal year 2010 (FY 10= Oct. 2009 until Sept. 2010), 41 Warning Letters were issued, which is 60% more than during FY 09 (only 27 In our previous research, global executives, business leaders, and analysts of biopharma companies said they were somewhere along the half-way mark in terms of achieving digital maturity and adoption of flexible leadership and learning models.12. This article focuses only on the results for biopharma companies; insights on the results for medtech companies can be found here. Certain services may not be available to attest clients under the rules and regulations of public accounting. The prominent pharma industry trends include artificial intelligence (AI), additive manufacturing, blockchain, and other Industry 4.0 technologies. Pharma companies’ focus on the consumer may reflect gains in information symmetry between manufacturers and plans. Pharma companies are up against a fresh set of challenges even as the pandemic has spurred adoption of technologies and other innovations to support virtual work and other functions. DTTL and each of its member firms are legally separate and independent entities. See something interesting? In this blog let us understand the impact on the pharma industry. M&A, leveraging digital (including AI) for transforming business, refocusing on therapeutic area strategy, and balancing new opportunity with risk are also being considered important in the next five years. In the United Kingdom, click and collect options are becoming more popular. We will only see more use of AI in the pharmaceutical industry in the future. 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