The life sciences are far from immune to the wide-ranging challenges seen across most sectors right now. From talent shortages, skills gaps, and the need to reduce costs through flexibility to supply chain fragility and shifting consumer behavior, obstacles abound—as do opportunities. The very nature of clinical operations, however, adds layers upon layers of complexity to current challenges.
For starters, conducting clinical trials is expensive and time-consuming: 40% of sites in multi-center studies face under-enrollment, and 11% fail to enroll a single patient. 18% of patients who do enroll in a trial end up dropping out. What’s more, only one in ten drugs that reach clinical stage development make it to FDA approval and commercialization—and up to half of those failures are due to bureaucratic and procedural errors.
Add to that critical needs for safety, reliability, diversity in patient enrollment, decentralized clinical trials, and regulatory compliance, and it’s no wonder that clinical operations consulting is the #3 most in-demand skill for project-based work within the life sciences industry. Across all areas of life science consulting, BTG has seen growing demand within R&D and clinical development, specifically to address:
- Go/no-go decisions on early clinical assets
- Increasing efficiency to reduce the rising costs of running trials
- Optimizing protocol design to account for competitive factors
- Implementing new technologies—including artificial intelligence—to improve R&D strategy development processes, clinical operations, or clinical trial length
- Addressing the changing regulatory/access environment
- Developing sophisticated portfolio tools
- Creating a more sustainable pipeline
Most often, these needs are project-based and/or triggered by skills (or bandwidth) gaps. Increasingly, as life science companies are preparing for lower cost structures due to the labor reduction act, there is a need to flex resourcing up and down with demand—versus building a large cost base of labor. As such, many top executives are finding independent talent to be the ideal fit when it comes to sourcing strategic support.
Independent clinical solutions consultants are an excellent resource for these leaders, offering targeted expertise and more flexible engagement structures than other resourcing options can provide. With training from top consulting firms and niche boutiques, experience at leading pharmaceutical and biotech companies, and advanced degrees in areas such as chemistry, biology, and medicine, they can support clinical leaders by helping to:
- Optimize the R&D function
- Improve pre-clinical research and clinical development productivity
- Innovate and implement clinical development initiatives/strategies
- Provide capacity to help with trial execution
- Provide pharmacovigilance and regulatory consulting expertise and execution support
- Assist in optimizing resource allocation and balancing risk across the portfolio
- Incorporate D&I considerations into trial design and execution
- Identify and implement the latest technology and tools
Whether organizations seek interim leadership support during times of transformation or lack critical talent in emerging categories and day-to-day needs, the unique on-demand model BTG has developed offers access to curated and vetted top-notch independent talent, including 1,250+ clinical and R&D experts. In fact, 80% of the top 20 pharmaceutical companies turn to BTG for strategic and tactical support. Here’s why:
Robust research and development resources
The industry’s sharpened focus on precision medicine is both driving drug development innovation and being driven by it. Already, firms are exploring AI-generated simulations for drug discovery and using AI-derived imaging biomarkers to develop companion diagnostics and guide treatment decisions.
Meanwhile, digitalization is helping make supply chains more resilient by improving transparency and facilitating the reliable exchange of real-time information. Optimized supply chains, in turn, grant organizations greater agility, allowing them to respond more quickly to sudden demand or targeted needs.
Taking advantage of digitalization and optimization opportunities not only requires subject matter expertise in a variety of niche areas but also the ability to evaluate and prioritize technologies for implementation. BTG’s R&D clinical solutions consultants have the ability to support these initiatives in a number of ways:
- Early-stage TA and asset strategy and project management support
- Pre-clinical asset evaluation, acquisition, and divestiture
- Clinical supply chain optimization
- Transformation and innovation of R&D organization
- Biomarker plan and/or companion diagnostics strategy and execution
- Data management and operationalization
For example, when a global pharma company wanted to understand potential digital capabilities across the R&D and clinical value chain, BTG provided a two-person team: A former McKinsey consultant and a junior consultant.
The former McKinsey consultant was a digital health specialist with expertise in transformations, AI in product development and workflow optimization, and RWE acquisition and analytics. The junior consultant had experience supporting pharma R&D strategic growth initiatives, including market landscapes, operational improvement plans, new market entry, and M&A.
Within 5 months, the two-person clinical solutions consulting team had performed a complete assessment of the client’s current capabilities, goals, and market landscape. They also prioritized potential technologies and recommended several options, complete with cost/benefit analysis and a high-level implementation plan for each.
Improved clinical development management
As technology speeds innovation (and vice-versa), pharmaceutical companies often have a broad range of assets in the clinical development pipeline. Products must be brought to market safely, but lengthy cycles often bog down progress. When dealing with products across multiple therapeutic areas, timelines can also become tangled if there isn’t a PM keeping everything on track.
Though newly emerging, the digitization of trials offers the potential to improve clinical trial ROI by reducing costs, shortening cycles, and increasing participation across a more diverse patient population. The resulting data may be more robust, but trial design must include ways to ensure they’re also reliable—and secure.
For companies looking to build these sorts of next-gen capabilities into their processes or identify other digital tools to help improve cycle times, it’s essential to have the right resources in place. BTG’s 5,500 life sciences experts include clinical solutions consultants, SMEs, and PM/PMOs with deep experience managing clinical development, trials, and CROs. They can help with:
- Simplification and transformation of clinical trial processes and cycle time improvement
- Continuous improvement program design, analytics, and change management
- Protocol development and clinical trial design
- Digital tool identification and capability building for next-gen clinical trials and innovation
- Development and launch of platform technologies
In one case, a Fortune 500 pharma company sought to streamline the time and cost associated with clinical development. They wanted to redesign and improve clinical processes by eliminating waste and reducing complexity, as well as increase speed to market and access to patients. To put it simply: They were looking for transformation.
BTG created Flexhub, a Flexible Project Manager Resourcing Model where the client could deploy resources as needed. This meant, on average, five BTG consultants were providing fully remote support to help manage cross-functional task forces at the company, facilitate stakeholder engagement, drive business process mapping and redesign, and implement communication strategies.
Currently, Flexhub is supporting the client’s transformation, moving their global clinical trial apparatus to a next-gen, increasingly digital/virtual model.
Expertise in regulatory strategy and execution
Regulatory considerations are an inherent part of clinical product development, but changes in the regulatory/access environment can delay or disrupt cycles if a company is caught off-guard. What’s more, regulatory submissions require a coordinated approach, and without a comprehensive strategy or framework, there’s ample room for error.
It should come as no surprise that these, too, are areas where AI is becoming increasingly common. From pharmacovigilance to GxP compliance, automation is making it possible for companies to strengthen regulatory processes while accelerating product development. The primary speedbump for many organizations, however, is a gap in expertise with regard to regulatory strategy and process redesign—let alone AI implementation.
We are starting to see more AI-driven projects, but often a client’s resources are focused on product development, leaving little-to-no bandwidth elsewhere. In either case, BTG clinical solutions experts can provide regulatory consulting in a variety of areas:
- Regulatory strategy, management, and process redesign
- Regulatory and GxP compliance consulting recommendations
- Pharmacovigilance process improvement initiatives
- RWE and RWD
- EU regulations (IVDR) navigation
- AI tools for the regulatory submission process
When a large international pharmaceutical company was developing a new dosing device, its regulatory group needed a consultant to guide them on design control and regulatory approval. BTG brought in a former PA principal consultant with a 20+ year track record in R&D and extensive experience in bringing drug delivery devices to market.
The consultant worked onsite at the company for six months, following a design control pathway of establishing user needs, design input and output, and design validation. After identifying a qualified supplier, he performed full qualification testing and successfully submitted the regulatory filing.
Portfolio prioritization, management, and more
The life sciences industry is fortunate to have so many paths of opportunity, yet it’s in identifying the right paths, balancing risk, and optimizing resource allocation that life sciences companies are able to actually move forward.
The value of an outside perspective with deep industry expertise cannot be overstated when it comes to outside-in portfolio analysis, assessment, and review. BTG independent talent have helped many top companies perform data analytics for portfolio strategy and optimization, as well as tool selection and system implementation.
BTG clinical solutions consulting teams are built to support success by tailoring the team structure to the client’s needs. Depending on the project or initiative, our talent can complement existing internal resources, leverage prebuilt resourcing from consulting boutiques, and/or deliver teams with both consulting and operating experience.
As life sciences organizations invest in overcoming ever-changing challenges, they often find themselves with knowledge and resourcing gaps: business process expertise to support new technology implementations, operating model design to support organizational overhauls, and even project management support to keep transformations on track.
BTG’s unique on-demand model can help you:
- Access curated and vetted top-notch independent talent, including 1,250+ clinical & R&D experts
- Provide a seamless process to deliver customizable solutions to your team
- Define and projectize the opportunities
- Deliver strategic and tactical support that helps bridge the gap between scientific teams and senior stakeholders
What makes independents so well-suited to projects of this nature? As independent pharmacovigilance expert Kerry Coffee notes: “What I see from clients is that they appreciate having the ability to bring in one or two individuals as opposed to a large team. As an independent, I can also work a bit more closely with my clients, rather than going off into a room with other partners and deciding, ‘Okay, here’s what the solution is.’”
Aside from the flexibility and intimacy of the work, independents also frequently bring very targeted expertise, especially compared to what’s available through large consulting firms. Independent clinical solutions and forecasting expert Jeffrey Boschwitz pointed out, “The big firms often use people who haven’t done it a lot of times and don’t understand how to gather claims, audit, or prescription data and what the risks and limitations are.”
Amid increasing competitive pressures, speed is of the essence in life science clinical product development. Delays cost, and so do mistakes. With the support of experienced independent clinical solutions consultants, neither has to be an issue.
About the AuthorMore Content by Emily Slayton