The 2023 PharmaVoice Crystal Ball: Peering into the future of life sciences

Creating an innovative path forward

“The biggest challenge that the life sciences industry needs to overcome is the threat of stalled innovation. Manufacturers have game-changing products in their pipelines that could save many lives or vastly improve patients’ quality of life, yet there are numerous hurdles that stall a drug’s clinical development or route to market and impede patient access. And unfortunately, pharma companies have become conditioned to believe that the path to market has to be long and arduous. Overcoming those hurdles — and making sure that innovative medicines get into the hands of patients quickly and easily — should be pharma’s No. 1 priority in 2023.”
Mike Gallup, CEO, Norstella

Women’s health movement

“The degree to which women’s health has been deprioritized can no longer be ignored, especially in light of a pandemic that has made health disparities even more evident. Around the world, we see more governments and other stakeholders beginning to take action. The industry is taking more action as well. I fully believe that 2023 will be the moment that we see both societal obligation and business opportunity in this space converge — with more research, more deals and more partnership — because when women’s health is a priority, we create a stronger and healthier society.”
Kevin Ali, CEO, Organon

New pay models

“As the gig economy expands and massive layoffs continue in the technology sector in 2023, we can expect to see a shift away from insurance-based high-deductible and high-copay options toward low-cost, cash-based models for basic primary care, prescription medication coverage and overall healthcare plans. Similarly, as collaboration between digital health companies increases, larger integrated platforms that offer seamless and affordable healthcare services will solidify as strong alternatives to ‘big-insurance’ and ‘big-healthcare’ offerings. A consequence of these shifts will also be a growing emphasis on additional subsidies of the healthcare landscape like preventive care, wellness programs and ‘food-as-medicine’ concepts.”
Satish Srinivasan, CEO, founder, DiRx

Goldilocks syndrome

“As a serial biotech entrepreneur, a major challenge emerging is fundraising during the early stages of biotech creation. The bar has been raised for the required inflection points along the runway of early fundraising rounds like Series A or B. Investors often seek both safety and efficacy signals from early clinical trial data before the next fundraising round. Early-stage biotechs will need to navigate the ‘goldilocks phenomenon’ of generating enough data around a lead series toward candidate nomination and phase 1 trials and expanding out the pipeline or platform to mitigate risk if clinical data is not as robust as expected.”
Dr. Ranjit Bindra, co-founder, Modifi Biosciences

FDA watch

“We’re watching the FDA’s receptiveness to new products and the sector’s ability to bring innovation to market. In 2021, more products were approved in the biopharma arena than in pharma, yet pharma continues to have more cash and capital market support. Rebalancing that phenomenon will be critical to the biopharma, medical technology and innovation sectors.”
Donna LaVoie, CEO, president, LaVoieHealthScience

Investor warm up

“In 2023, I predict the challenging market forces will continue to put pressure on biotech and medtech companies, with companies that can share positive human clinical data finding a warmer reception from investors and strategic partners than earlier stage companies. For a biotech company such as Novadip Biosciences, with a goal of pursuing an IPO in 2024, we will be carefully monitoring the capital markets and engaging with investors in the U.S., to determine the right time and strategy to pursue additional private and public financing.”
Dr. Denis Dufrane, CEO, co-founder, Novadip Biosciences

AI scrutiny

“There will be a lot of scrutiny on AI models. The FDA, EMEA and the White House have all published new regulations about AI. Life sciences organizations will have to prove how trustworthy their AI models are. To be trustworthy, AI models need to be transparent, explainable, reliable, secure, safe and preserve privacy.”
Nagaraja Srivatsan, independent life sciences consultant

Post-pandemic

Vaccine tracking

“As coronavirus joins influenza, RSV and adenovirus as an endemic respiratory disease, governments, private institutions and individuals will need a plan to react and answer critical questions. Do vaccination and testing rates for influenza and coronavirus run closer to 2021-2022 numbers, or do they revert to the annual rate of influenza vaccination and respiratory testing prior the SARS-CoV-2 pandemic? Will there be a sense of urgency to develop and approve improved vaccines, therapeutics, and diagnostics? The answers will determine the supplies we need for testing and vaccines, and how regulatory bodies approach approvals. Additionally, many diagnostic and vaccine companies that pivoted to SARS-CoV-2 and infectious diseases in general are pivoting back to their pre-pandemic business. Do respiratory disease products return to a commodity market? These are the questions we should be asking ourselves as we come into the new year.”
Jeffrey Fischer, president, co-founder, Longhorn Vaccines and Diagnostics

Regulatory advances

Dosing adjustments

“Project Optimus, an initiative by the FDA, is poised to have a huge impact on drug development. In the wake of evidence that many approved oncology drugs are inadequately characterized with approved doses that may be too high, Project Optimus attempts to reform the dose selection paradigm in oncology drug development. Project Optimus recommends a core change in how doses are selected and studied during oncology clinical trials and post-approval studies. We expect Project Optimus to motivate the drug industry to evolve its antiquated reliance on maximum tolerable dose-based research and push forward more innovative, adaptive study designs.”
Sirj Goswami, CEO, co-founder, InsightRx

Nitorsamine control

“One current topic which is expected to continue challenging the pharmaceutical industry is the control of nitrosamine levels present in drugs, as regulators are placing increasing focus on this. Excipients, as part of final drug products, are being assessed for nitrosamines and nitrites (as potential precursors toward nitrosamine formation). Helping customers further address this challenge and meet regulatory authorities’ requirements must be a future focus.”
Ulrich Deutschmann, chief commercial officer, DFE Pharma

In the workforce

Weaving in DE&I

“Executive leadership and board diversity and equity need to weave in equitable policies and practices throughout the life sciences ecosystem, this includes internal and external stakeholders. Diversity of thought should be met with subsequent action.”
Dr. Kemi Olugemo, director of communications, Women of Color in Pharma

Diversity training

“Diversity, equity and inclusion within workforces will be the biggest trend for 2023. There are companies and institutions offering training, and the dilemma begins when realizing that the teams need to include more diverse and passion-driven individuals regarding DE&I, which also brings about the term and topic ‘culture appropriation.’ A team of diverse Americans must be the overall consortium to create a diversity program geared toward equity and inclusion of all Americans in order to get the best results. There are language and cultural beliefs within different groups that must be shared with healthcare professionals. Some of these can cause discomfort speaking about, but with this education and understanding implemented, this would bring about major changes to how diversity training programs are presented through pharma and other companies.”
Barry Holmes Jr., vice president, strategy and business development, Genesis Medical Research Group