In drug development, it’s clear that emerging biopharma (EBP) and biotech companies are spearheading innovation in clinical research. This industry segment has a broad development focus from bench to market, from novel agents to generics and biosimilars, and small molecules to cutting edge cell and gene therapies. This now accounts for approximately 80 percent of the total research and development (R&D) activity. Over the next five to ten years, the industry will continue to see a steady growth of R&D coming out of this segment. This makes it critical for both EBP and biotech sponsors and industry stakeholders to consider some of the distinct challenges these trial sponsors face in product development stages and commercialization. Having greater understanding of the inner workings of their expertise, technologies, and capabilities, that are needed for successful R&D, will be key to ensuring that a diverse range of treatment options across multiple indications are ultimately available for patients.
 
Like everything else in R&D, it is vital to consider the COVID-19 factor on maintaining the surge of development as well. Prior to the pandemic, EBP and biotech sponsors were increasingly turning to contract research organizations (CROs) to contain costs and secure therapeutic and clinical trial expertise to help meet their development objectives. The pandemic, whilst a painful time, has accelerated innovative delivery, timelines, patient centricity as well as trial design and execution.
 
Inner workings of EBPs
In 2020, EBP companies developed and launched 40 percent of all new drugs, illustrating a new paradigm in innovative drug development. With growing sector investments creating market competition, it can be a “make it or break it” time for these companies.
 
The stakes are high for EBP and biotech sponsors, with one or two breakthrough assets contingent on ambitious research and development goals, a trusted partner is crucial.  Sponsors’ leadership teams have exceptional scientific, business and financial acumen and seek complementary expertise from development partners for end-to-end thought leadership and services including strategic drug development planning, clinical conduct, and regulatory and commercial support.
 
Agility to follow the science with adaptive trial designs or accommodate alternative development pathways through the introduction of co-development sponsors, out-licensing, or mergers is pivotal. As development goals evolve and business priorities change, directional intent for each asset and regular communication with CROs and other partners is critical. 
 
The necessity of early planning
Well prior to launching the clinical phase of a trial, EBP sponsors need to construct a comprehensive clinical development plan to guide strategic direction, optimal trial design, and avoid pitfalls of early clinical development. Sponsors often turn to CRO partners to help them articulate the product vision, choose the right development path, and help convince stakeholders they are on the right path—optimizing cost, time, risk and return. 

In the clinical stage of a trial, established CROs lend support with extensive therapeutic expertise, technology and analytics capabilities, and greater global reach to overcome operational barriers to completion. For example, EBP sponsors, at the forefront of cell and gene therapy innovation, can utilize a partner for logistics, in-vitro laboratory requirements and to navigate a complex and evolving regulatory environment.  
 
Understanding subtleties and nuances in therapeutic areas can have a significant impact on expediting timelines of a clinical trial. A competent partner with domain expertise and real world data can navigate the indication, maximizing opportunity and mitigating risk.   
 
Understanding all development needs early into the process can be crucial.
 
Keeping patients in mind
The clinical development landscape has evolved, necessitated by the COVID-19 global pandemic. This is changing the way we conduct clinical trials. Assuring patient safety, maintaining development continuity, acceleration, and patient centricity have all become paramount.    
 
EBP sponsors are seeking scalable, decentralized trial (DCT) solutions including telemedicine, e-Diaries, virtual study teams, and mobile research healthcare professionals. Patients can now participate in trials from the comfort of home, and remote monitoring solutions permit clinical research associates to readily monitor data away from the investigational site. DCT solutions can help reduce burdens of the trial for both the patient and site.
 
The industry has been entrusted to deliver clinical trials, enhancing access and participation for historically underserved populations. Achieving diverse representation in clinical trials commences well prior to recruitment planning through a proactive, concerted approach. To secure inclusion of clinically relevant populations, the following actions are important to consider:
 
·       Characterizing the population
·       Validating against diversity and inclusion goals
·       Calibrating site selection against real-world data
·       Evolving to direct-to-patient strategies for recruitment, engagement, and retention
·       Increasing community-driven programs and partnerships
 
The broader impact
Break through innovation stemming from EBP and biotech sponsors is closely observed and changing the industry. But, it is a complex journey in an evolving landscape. To have greater insight into their key requirements, it behooves industry stakeholders to partner, lending thought leadership, development planning, and expertise in trial execution to improve the probability of success.