Clarkston’s Erica Parks Murray and LaToya Lee Jones recently attended the 7th annual Women of Color in Pharma (WOCIP) Conference – Collaborate | Connect | Conquer. The annual conference brought together executives, physicians, scientists, researchers, clinical professionals, and technology experts to discuss the latest trends, challenges, and opportunities driving progress in pharma. In this recap, our experts share their key takeaways from the 2023 WOCIP Conference.
With so many mergers and acquisitions taking place in the industry, many leaders talked about the importance of finding the path forward when everything is changing around you. Conversations also revolved around the importance of diversity in clinical trials and dispelling the myth that this is a real challenge. And, as the industry continues to undergo digital transformation, speakers highlighted the importance of minimizing dissenters to drive alignment toward organizational and professional goals. We dive into these themes and more below:
Key Takeaways from the 2023 WOCIP Conference
1. Untapped Opportunity: Building on Key Trends from 2023
As we think about the past year and what’s to come in the pharma industry, leaders spoke of an “untapped opportunity.” What we’ve known pharma to be is changing – or has already changed – and the way we’ve operated in the past is becoming less applicable today. However, the industry isn’t quite ready. To be ready and prepared, industry leaders will need to prioritize digital transformation, focusing on incorporating good clinical practices and meeting patients where they are. In particular, speakers discussed:
- Commercialization is becoming critically important to deliver “the right message, to the right customers, at the right time that they want.” In today’s landscape, consumers increasingly have access to more and more information, and they want to receive it at the right time and in the right channel – this isn’t a new concept in the retail and CPG industries. However, life sciences firms will need to adopt this approach to meeting the patients where they are. One way we’re seeing firms do this is through post-launch partnering, with an emphasis on patient-centric approaches. These post-launch partnerships can help provide the insights and resources to better understand patient needs, which ultimately leads to improved patient engagement and outcomes.
- A lack of diversity in clinical trials impacts the bottom line – it’s not just a “nice to have.” Scientific examples of commercial products that didn’t have enough diverse clinical participants and were pulled off the market include Troglitazone (Rezulin) and Aducanumab (Aduhelm). As one strategy to improve DE+I in clinical trials, it’s believed that the Food and Drug Omnibus Reform Act (FDORA) will help diversify clinical trials, as the FDA will require most drug and device trials to submit Diversity Action Plans before proceeding. These plans will aim to promote the enrollment of participants from diverse racial backgrounds and will be required for 1) Phase III clinical trials, 2) important drug studies, and 3) premarket approvals.
- The Inflation Reduction Act (IRA) has had significant impact on the pharma industry, including for Contract Manufacturing Organizations (CMOs), manufacturing, and more. There will be millions – even billions – of dollars in financial impacts that businesses will absorb because of this. As a result, getting products to market faster will become even more critical for business economics. The pharma industry should lean on learning from other industries, like consumer products, on how to drive product innovation and increase automation during particularly lean times.
2. Diversity in Clinical Trials: Opportunities for Collaboration to Make Change
As mentioned above, diversity in clinical trials isn’t just the “right thing” to do – it can also have a significant impact to your business. Improving diversity in clinical trials represents an opportunity for meaningful, impactful, and necessary change in pharma. The adequate representation of patients with the disease or condition of interest from a diverse patient population is critical for many reasons, including:
- Identifying differences in safety and efficacy
- Building trust among patients
- Incorporating diverse “patient voices”
- Improving health equity in the access to clinical research and innovative treatments
We’ve seen some notable progress in the space when it comes to regulatory guidance. In May 2023, draft guidance on “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” was released. This guidance recognizes that decentralized trials will likely increase patient access, reduce associated costs, and ultimately provide patient convenience. Additionally, draft guidance released in 2021 on “Digital Health Technologies for Remote Data Acquisitions in Clinical Investigations” provides recommendations for decentralized trial design, digital health technologies, safety monitoring plans, and much more.
The Drug Trial Snapshot Program is also noteworthy. It was implemented in 2015 as part of the FDA’s action plan in response to Section 907 of the 2012 FDA Safety and Innovation Act (FDASIA 907), which was enacted to require the reporting on the diversity of participants in clinical trials and the extent to which safety and effectiveness data are based on demographic factors like sex, race, and age. The snapshot contains both patient information (what the drug is and how it’s used), as well as clinical trial information (who participated in trials, drug side effects, efficacy and safety subgroup analysis, and demographic data).
As we look toward more inclusive and diverse clinical trials, regulatory guidance can serve as key stepping stones for future growth and regulatory change.
3. What’s the Hype: The Evolution of Generative AI and What You Need to Know
Generative AI analyzes large volumes of data sets to make predictions based on the data. You can consider it a “smart reader that’s been told how to read something.” It develops content but doesn’t interpret the data; that’s where human intervention comes into play. For firms utilizing any type of generative AI, fact checking data will be paramount. This requires human interaction and understanding, debunking the myth that generative AI will take away the jobs of knowledge workers. Yes, generative AI is changing how we perform our jobs, but it’s not replacing them completely.
Companies should also keep in mind that as with any data project, it all starts with good, clean data. One way to think about this is GIGO – garbage in, garbage out. AI models rely heavily on the quality of the data that they’re using to learn from. If the data isn’t complete or is inaccurate or bias, the results will reflect those flaws. This is particularly impactful when we think about how AI models can perpetuate bias and systematic unfairness, which can lead to unfair outcomes, particularly for people of color. Cleaning data to remove biases and unfairness provide a more accurate and reliable picture of the data. One way to address biased data algorithms is to diversify digital talent.
Generative AI is here to stay. Leveraging generative AI has the potential to automate many repetitive and time-consuming tasks, thereby freeing up our time to focus on higher-level strategic and creative work. It can also help to increase productivity and improve our decision-making. However, as with any data project, strong data governance policies and practices will be paramount.
Driving Progress in Pharma: The Future of the Industry
The pharmaceutical industry is undergoing rapid change, driven by factors such as industry consolidation through mergers and acquisitions, the need for effective commercialization strategies, and the adoption of digital transformation technologies. These factors are creating new challenges and opportunities for businesses.
Interested in learning more about these challenges and opportunities facing pharma today or how to navigate them? Let’s connect.