Some of the most exciting work in the life sciences today is taking place in small biopharma companies, although these biopharmaceutical startups do their work amidst a storm of challenges and complexities. Setbacks are common, and a company’s growth can easily be halted by just a few of those challenges occurring at the same time.
Choosing the right software can help a small biopharmaceutical company facing growing pains emerge with greater strength and resilience. With the right digital tools, a biopharma startup can meet data compliance demands, generate better insights for smoother decision-making, and build the connections needed to demonstrate the company’s capabilities and trustworthiness to investors.
Improve Data Management
Data management is a must for any biopharma company. Regulatory requirements and effective research both demand a clear, organized means of storing, analyzing, and generating data. Collaboration among clinical trial teams relies on an effective approach to data management.
One benefit of being a small biopharmaceutical company or start-up is that typically, no older system exists to pose challenges with data interoperability or security. “These companies with smaller product portfolios, often without the burden of legacy systems and silos frequently associated with larger pharmaceutical companies, have the opportunity to transition more rapidly to a data driven approach, doing it ‘right first time,’” writes Dr. Sara Fidalgo, Data Standards and Governance Manager for IDMP at GSK.
Creating effective data management approaches for small and growing biopharma companies includes:
- Choosing interoperable tools and platforms for clinical trial management, electronic Trial Master Files (eTMF), Medical Affairs efforts, publications, and related tasks.
- Incorporating robust security features, including role-based access control (RBAC) to protect collected data while organizing the efforts of those who use that data.
- Meeting regulatory requirements for data authentication, collection of metadata such as time and date stamps, and privacy and security tools.
Better data management can improve small biopharma companies’ efforts to raise necessary funding. Instead of relying on little more than an idea, start-ups must produce data backing up that vision.
“Today’s financing is contingent on clinical catalysts and platform differentiation,” writes Dr. Kaouthar Lbiati, a board member at Hepion Pharmaceuticals and Theralase Technologies. To demonstrate the differentiation financiers demand, effective data management is essential.
As data management improves, it is likely to become a key factor in small biopharma companies’ ability to grow and to enter into larger business deals, including mergers or acquisitions, write Jan Ascher and fellow authors at McKinsey.
Leverage Digital Tools for More Nimble Decision-Making
“From staying on top of emerging trends to conducting thorough market research, biotech startups must constantly adapt and innovate to meet customer needs and stay competitive,” writes Liam Hopkins at EFB Public. With the right digital tools, small and growing biopharma companies can collect data more effectively and leverage it for more insightful and flexible decision-making.
To balance security and flexibility in data management, Nicola Gardner at ThermoFisher Scientific recommends asking these five questions:
- Should data be stored on site or in the cloud? Both methods have benefits and drawbacks. The right digital tools will let teams coordinate data storage efforts, allowing for the best combination of local and remote data storage for the organization.
- Which data security tools are we using? A combination of encryption and RBAC can provide better protection than either method alone, notes Gardner. Choosing digital platforms with built-in tools that meet or exceed regulatory standards can help ensure the organization remains compliant as it grows.
- How are backups and recovery handled? Data loss and cyber attacks can be devastating for a biopharma company engaged in significant research. The right digital tools provide backup and recovery options and strategies to protect small and growing biopharma companies from data disasters.
- Are our tools purpose-built? It can be tempting to use general tools everyone on your team recognizes, but doing so can cost a small or growing biopharma company far more than it could possibly anticipate. Purpose-built digital tools provide the capabilities and protection specific to clinical trial work, research and development, publishing scientific findings, and bringing a product to market.
- How do our devices communicate with one another? Tools that allow smart devices to communicate effectively can help reduce the risks associated with hand-copying data from one source to another. They can streamline decentralized trials and make the process more efficient and enjoyable for patients and clinical trial team members. As the product moves toward launch, this intercommunication among tools and platforms streamlines the work of Medical Affairs teams and others as well.
Connect With the KOLs Who Can Boost Your Work
“Developing a great product is not enough to improve patients’ lives and maximize value potential; the product must also be commercialized,” write Delaney Burns and fellow researchers at McKinsey. Failure to make the necessary connections to communicate a product’s value is frequently connected to product launches that underperform or fail, say Burns et al.
Currently, 85 percent of the world’s small, research-focused biopharma companies are located in the United States, writes Trelysa Long, Policy Analyst at ITIF. Competition among these companies is fierce, and they operate within a community of life sciences experts and professionals with often limited attention.
The right digital tools make it easier for small biopharma companies to build essential relationships with key opinion leaders (KOLs) and other influential parties. By streamlining data management and communications, these tools can help Medical Affairs teams place publications in the right outlets, share information easily, and get the attention of KOLs at the right time with the right content.
Building connections is also essential to securing funding. As interest rates rise, investors prefer to fall back on success stories they’ve known in the past, bypassing biopharma start-ups that are newer on the scene. “What we’ve really seen lagging now is seed money for new founders who don’t have a track record for having started successful companies in the past and don’t have a very strong extensive network of people in funding and in company development,” says Dr. Craig Kenesky, a patents and innovations attorney at Wilson Sonsini.
To compete with more pedigreed start-ups, small biopharma companies need to build the professional networks required to demonstrate their credibility and integrity.
Starting a biopharmaceutical company is one of the most exciting business ventures out there today, although that excitement is punctuated by ongoing challenges. With the right software, a growing biopharma company can focus on its research, development, and product launches — building better professional connections and establishing a reputation for success.
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