Pharma innovation and regulation: Must these two things forever be at odds?
An overview of navigating regulatory challenges to creating innovative pharmaceutical therapies (1,100 words, 5.5 minutes)
Developing innovative drugs and therapies involves steering through a complex web of regulatory challenges, requiring a comprehensive understanding of the regulatory landscape and practical strategies to overcome them. Yale News notes that while the U.S. FDA, European Medicines Agency (EMA) and Health Canada operate similarly, some nuances make the drug approval process move more quickly in certain regions.
According to a report following a workshop organized by the National Academies of Sciences, there are obstacles to innovation in pharmaceutical manufacturing related to regulation. One of these challenges is that regulatory bodies require thorough clinical trials to demonstrate a drug’s safety and effectiveness. While complying with these standards can be costly and time-consuming, they are mandatory and cannot be negotiated.
The pharmaceutical industry faces a significant challenge in keeping up with the continuous updates to regulatory guidelines. As noted in a recent article, these guidelines are in constant flux, making it difficult for industry professionals to remain current. Given the critical importance of adherence to these guidelines, it is essential to stay informed to avoid delays or other forms of non-compliance. This task is even more challenging because regulatory standards vary from region to region, presenting logistical hurdles for companies that operate on a global scale. Harmonizing these standards and dealing with multiple regulatory bodies requires a high level of expertise and attention to detail, both essential for success in this complex and rapidly evolving industry.
There are some strategies that pharma companies implement to navigate regulations successfully. The Journal of Cardiovascular Translational Research writes that it is essential for companies to start a dialogue with regulatory agencies early in the drug development process. Early engagement with regulators can help identify potential issues and streamline approval.
Another recommendation is to develop a global regulatory strategy that considers the specific requirements of different regions. The website Proventa International notes it is also essential that companies assemble cross-functional teams that include experts in regulatory affairs, compliance, and quality control.
Additional sources:
https://www.theindustryoutlook.com/manufacturing/editors-column/three-regulatory-strategies-for-pharma-companies-to-expedite-product-development-nwid-4001.htmlhttps://commetric.com/2022/12/23/sustainability-in-pharma-how-can-pharma-brands-get-greener/
THIS WEEK 10/03/23
Sun Pharma Canada announced clascoterone cream (Winlevi) is now available in Canada. Winlevi is an androgen receptor inhibitor for the topical treatment of acne vulgaris in patients 12 years of age and older.
Health Canada authorized Pfizer Canada and BioNTech SE’s Omicron XBB.1.5-adapted monovalent Covid-19 vaccine for patients six months and older. The updated vaccine will be available in Canada as a single dose for patients five years and older, regardless of prior Covid-19 vaccination history.
The U.S. FDA approved Biogen’s tocilizumab-bavi (Tofidence), a biosimilar of Actemra recommended for treating moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
Fabre-Kramer Pharmaceuticals announced the U.S. FDA approved the company’s gepirone hydrochloride extended-release tablets (Exxua) for treating major depressive disorder in adults.
LISTEN UP
In season 10 of the NPC Podcast, Shanil Ebrahim, Partner and National Life Sciences and Healthcare Consulting Leader at Deloitte Canada, discusses improving healthcare literacy, expanding the use and integration of healthcare data, and public-private collaborations promoting equity in healthcare. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea and Mark McElwain.
HEALTHBIZ REWIND
This feature of NPC Healthbiz Weekly looks back at some of the most insightful moments from previous NPC Podcast episodes. In Healthbiz Rewind, you’ll read bold life sci predictions made during the renowned “Prognostication Korner” segment of the NPC Podcast.
Ann Gomez
Speaker, Author & Founder
Clear Concept Inc.
Toronto
Season 10, episode 02
Listen to this episode here
What bold predictions will you make about the life sciences industry during the coming 12 to 24 months?
I think about where we’ve just come through with this pandemic. People’s employee bases became so much more empowered and willing to lobby for what they wanted. There was a lot of job switching and a talent shortage, so employers wished to ensure that people had what they wanted. The question becomes: is it going to last, or is it going to bounce back? During slower times, when there’s less shift, will there be less employee-driven autonomy and power? I don’t believe that. I think that the world has forever shifted and that the highest-performance teams will be those who understand the power of creating high-performance cultures, granting autonomy, helping people work with meaning, and helping people feel connected to a bigger purpose and connected to colleagues.
I believe that pharma and health sciences have the opportunity to lead the charge here. I’ve worked across several different industries and have certainly come across some examples of high-performance teams, but not as consistently as I see in this sector. I think we’re going to continue to see that the life sciences industry will continue to lead the charge about what a high-performance team will look like.
Coming up soon: It’s the 17th Annual National Pharmaceutical Congress on Wednesday, November 22, 2023
The 17th Annual National Pharmaceutical Congress will be held on November 22, 2023, at the Mississauga Convention Centre. As Canada’s most significant stage for leaders in the pharmaceutical industry, the Congress presents industry reflections, ideas, and innovations. The Congress is attended by more than 200 delegates annually and is an opportunity to learn, reflect, and network with the industry’s most prominent thought leaders and visionaries. Register now for 50% off the regular price.
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