“Overall U.S. economic indicators continue to trend positively in the second quarter. Life sciences organizations are benefiting from those macroeconomic indicators, as well as overall industry confidence. The S&P Biotechnology Select Industry Index is up 25% year-over-year, M&A activity is strong, the pipeline of drug therapies is robust, investments are up, and beneficial regulatory changes are unfolding. We are here to empower businesses and talent to fully leverage the opportunities presented by this environment.“
– Bret Cerasoli, President, Black Diamond Networks
“With numerous drug therapies in development and ongoing regulatory changes, labor demand is surging, influencing businesses throughout the sector. Life sciences companies can succeed in this environment by understanding market dynamics, assessing internal skills deficiencies, and taking proactive measures to address them. BDN will continue to serve as a resource to biotech, pharmaceutical, and medtech companies, ensuring they have access to the right people in the right roles at the right time.“
– Ben Locwin, SME, Head of Project Solutions, Black Diamond Networks
As we step into the second quarter of 2024, the life sciences industry continues to enjoy the surge of confidence we detailed in our Q1 2024 Outlook. The S&P Biotechnology Select Industry Index is up more than 25% year-over-year and life sciences deal activity shows no sign of slowing. Along with a robust drug therapy pipeline and regulatory shifts, we anticipate the industry will continue on the upswing in Q2.
Industry Intel
Here are the top trends shaping the sector as we navigate the months ahead.
Cybersecurity and AI
With the industry embracing digital transformation, cybersecurity and AI play critical roles in safeguarding data and accelerating innovation, respectively. While cybersecurity measures aim to counter threats like ransomware attacks, AI continues to exceed expectations in diagnosis, drug development, and regulatory compliance. Many companies are trying to play catch-up with regulations such as new FDA guidance around cybersecurity as they try to keep pace with nefarious agents. While on the other side of the equation, regulatory agencies are trying to keep up with regulations for the rapid pace of AI growth and its use in the industry.
Meanwhile, Generative AI is surpassing expert estimates of how fast the technology can evolve. Mt. Sinai researchers, for example, showed that GPT-4 can match, and even outperform, ophthalmologists in managing glaucoma or retina disease. This is something some thought may never happen, let alone this early in AI’s evolution. AI has the potential to accelerate clinical development, transform application development and testing, and improve quality management. Experts estimate AI could generate $60 -$110 billion annually for the pharma and medical product industries. Several key issues the industry is struggling with are how to monetize the technology and prove its value, and how to credit AI with breakthroughs.
Oncology Drives the Market
Oncology remains a top segment for new therapies, treatment modalities, and investments. Growth in the global oncological drug market is still on track to approach $500 billion by 2030. Regulatory efforts, such as the FDA’s Project Optimus, aim to optimize chemotherapy dosages, promising more accurate and precise targeting of cancer cells while sparing the patient’s healthy cells and overall health.
Cell & Gene Therapies (CGT) Give Hope Where There Was None
Cell and gene therapies are revolutionizing healthcare, offering potential cures for diseases once deemed untreatable. From blood cancers and lymphomas to rare diseases and inherited disorders, CGT holds promise for transforming patient outcomes and quality of life. Hundreds of CGT drugs in the pipeline are giving hope to those living with Type 1 Diabetes (T1D), sickle cell disease, inherited spinal muscular atrophy, hemophilia, and inherited retinal diseases, among many others.
GLP-1 Drugs Hold Promise Beyond Weight Loss and Blood Sugar Control
GLP-1 drugs such as Ozempic, Wegovy, Rybelsus, and Mounjaro have emerged as remarkable success stories, demonstrating significant efficacy beyond blood sugar control and weight loss. Their potential to address conditions such as Metabolic dysfunction-Associated Steatohepatitis (MASH) and other liver and kidney diseases opens new avenues for treatment exploration. Clinical trials also are being run to determine if GLP-1 drugs curb alcohol and drug cravings. We will continue learning about the vast potential of these drugs in the coming months and years.
The real challenge is ensuring there is enough supply to meet consumer demand. Novo Holdings’ recent $16.5 billion acquisition of Catalent, a key manufacturing subcontractor of Wegovy, is a remarkable example of pharma’s attempts to meet demand.
Clinical Trial Advancements Usher in a New Era of Inclusivity, Accuracy, and Speed
The FDA’s endorsement of decentralized clinical trials (DCTs) promotes inclusivity and efficiency in clinical research, paving the way for enhanced data quality and faster trials. With DCTs, there is more diversity in the patients who can participate, leading to a more accurate assessment of drug efficacy. With a streamlined enrollment and tracking process, DCTs will hasten the clinical trial process, enable a faster FDA review of data, and ensure any safety issues are discovered promptly.
Likewise, the International Council for Harmonization (ICH) draft guidance E6 (R3) includes profound changes in the structure and conduct of clinical trials, from planning to reporting. The focus on principles, digital technology, ethics, and quality increases the responsibilities of clinical trial ethics committees, investigators, and sponsors.
Election Year Dynamics
The upcoming election injects uncertainty into the industry’s outlook, with potential shifts in regulatory priorities and investment landscapes, no matter which way the results swing. We’ll be keeping a close eye on this as the year progresses.
FDA Update
The FDA is amidst the largest reorganization in its history. The administration-wide overhaul will impact organizations across industries, including life sciences. The FDA is proposing significant revisions to oversight programs for drugs and medical products, and initial signs indicate its inspection process could become stricter in the process.
In addition to the aforementioned Project Optimus, here are other regulatory initiatives we’re monitoring.
- FDA Data Modernization Action Plan (DMAP)
- The DMAP seeks to leverage advancements in data science, analytics, and technology to improve the FDA’s ability to analyze, share, and act upon data effectively. DMAP progress is slow, however, largely due to leadership changes at the FDA. The roadmap is in place, but DMAP execution will require the reinvigoration of the FDA and sponsor companies.
- FDA Drug Supply Chain Security Act (DSCSA)
- The DSCSA ensures prescription drugs are identifiable, trackable, and traceable. Late last year, the FDA released new guidance about verification systems for certain prescription drugs, including quarantining and investigating suspect or illegitimate products.
- FDA Project Orbis
- Project ORBIS is a new way for oncology products to be submitted and reviewed simultaneously around the world, thereby streamlining the process and safely getting vital drug therapies into patients more quickly. Partners include the U.S. FDA, the Australian Therapeutics Goods Administration, Brazil’s National Health Surveillance Agency, Health Canada, Israel Ministry of Health Pharmaceutical Administration, Singapore Health Sciences Authority, Switzerland Swissmedic, and United Kingdom Medicines and Healthcare Products Regulatory Agency. The impact on companies will be significant, as they’ll receive more official observations from inspections that need to be remediated following the inspection itself.
- Our internal analysis of FDA inspection trends indicates that the administration is conducting more and more inspections of facilities that are resulting in findings (observations). This is putting more pressure on companies to proactively close internal gaps. Increasingly, they’re incurring more remediation activities and corrective actions after the inspections than in the past many years.
Talent Talk
Reflecting the industry’s focus on quality and innovation, we anticipate growth in demand for numerous roles, including:
- Clinical Trial Managers and Support (CRAs, ClinOps)
- Quality Engineers
- Validation Engineers
- CGT Experts
- Project Managers
- AI Experts
- Data Scientists
- Regulatory/Compliance Experts
- Therapeutic Oncologists
- Quality Assurance and Quality Control Analysts
What clients need to know
- Innovation and regulatory changes are driving talent demand. Prepare for change by ensuring you have the people, resources, and knowledge you’ll need now to avoid being crunched later.
- Many organizations are managing build-outs, expansions, tech upgrades, and a shift in priorities. This requires forward thinking and planning to ensure you will have talent with the right skills to help you succeed now and in the future.
- Pay rates are stabilizing, with outliers tending to be less extreme than they were several years ago.
- Talent wants to be a part of something that matters, so designing and framing opportunities with a solid “Why?” behind them helps build currency with top talent.
- Finding the right talent in the right role at the right time will be more crucial than ever in Q2 and beyond. Ensure you have a strong talent pipeline or a partner like BDN with access to life sciences industry experts in all kinds of roles.
What consultants need to know
- Continuous skill development and awareness of industry trends and initiatives are essential for staying competitive and meeting evolving client needs.
- Hybrid work options will continue to be very popular, as they are a good balance between what consultants want (flexibility, option to work remotely) and what companies want (more time on-site).
- Staying abreast of evolving regulatory landscapes will help you effectively support clients to navigate compliance requirements.
BDN Happenings
Don’t miss us May 2-3 at Pharmacovigilance USA 2024 in Waltham, Mass. BDN Head of Product Solutions Ben Locwin is a featured speaker and Chairman at the event, which offers valuable insights into best practices and emerging trends in drug safety and regulatory compliance. (Learn more about pharmacovigilance on our blog.)
BDN’s expansion into Basel, Switzerland, enhances our global reach and strengthens our ability to serve clients across Europe and beyond.
Are you looking for top life sciences talent? Or, are you hoping to apply your skills to exciting career opportunities in life sciences? Connect with us to learn more.
