Biotech and life sciences companies frequently engage in partnerships to gain access to additional capital and research resources. For example, a large pharmaceutical or biopharmaceutical business may partner with a smaller biotech company to access new technology and therapies or to outsource testing of a drug that shows promise.
For the pharma company, a partnership with a biotech firm can reduce its carried risk and accelerate its product pipeline toward submission for FDA approval. For the biotech firm, a partnership with a larger, better capitalized pharma company provides capital and resources to move their technology through to final development. Partnerships with public institutions can provide grant funding and access to new technologies.
However, the dynamics of these partnerships have changed over time. Today’s biotech firms have more access to capital. Biotech management must now gauge whether their R&D and product development process really need a big pharma partner.
Potential Benefits of Partnerships for a Biotech Company
Private and public partnerships offer numerous advantages for biotech firms. These collaborations play a crucial role in advancing biotechnological innovations and their translation into real-world applications. Among the benefits of biotech partnerships:
Access to Resources: Partnering with private companies or public organizations allows biotech firms to access resources that can include funding, expertise, facilities, equipment, and data.
Research and Development (R&D) capabilities: Biotech firms may create partnerships with public companies to gain access to research findings, data, and scientific expertise that can accelerate the development of new products and therapies. Likewise, a biotech partnership with an academic institution, government agency, or nonprofit foundation can provide access to cutting-edge research that accelerates product development.
Funding: Public-private partnerships can provide biotech firms with financial support to fund the high costs of R&D and clinical trials.
Risk Sharing: Biotech research and development can be inherently risky and expensive. By forming partnerships, biotech firms can spread the risk with their partners, reducing the financial burden on each party.
Collaborative Knowledge Exchange: Partnering with private companies or with public universities and institutions facilitates knowledge exchange and fosters the cross-fertilization of ideas, innovative approaches, and new discoveries.
Intellectual Property and Licensing: Public-private partnerships can lead to joint intellectual property (IP) development and licensing, thus significantly reducing the costs of commercializing a technology or product.
Regulatory Support: Public partners, such as government agencies and nonprofit foundations, may assist biotech firms in navigating complex regulatory processes and compliance requirements. This support can streamline the approval process and ensure that products or therapies meet the necessary standards for market entry.
Market Access and Distribution: A partnership with a pharmaceutical or life science company can provide a ready-made pipeline for a biotech firm’s products. A partnership with a public institution may provide access to new markets, particularly for underserved populations or regions.
Name Recognition and Reputation: Collaborating with large pharmaceutical firms or with public entities allows biotech firms to work on projects that have a significant impact on public health. This alignment with public health objectives can enhance the firm's reputation and value in the business marketplace.
Notable Examples of Public and Private Biotech Partnerships
National Institutes of Health (NIH) and Biotech Companies
US government research agency the NIH often collaborates with biotech companies to advance medical research and innovation. These partnerships can range from co-funding research projects to licensing technologies developed by NIH scientists to private biotech firms for further development.
Pfizer and BioNTech
Global pharmaceutical company Pfizer collaborated with BioNTech, a German biotechnology company, to develop and produce the mRNA-based COVID-19 vaccine, which was one of the first vaccines to receive emergency use authorization during the COVID-19 pandemic.
Bill & Melinda Gates Foundation and PATH
The Bill & Melinda Gates Foundation, a private charitable organization, has partnered with PATH, a non-profit global health organization, on biotech initiatives to address global health challenges. These collaborations focus on developing vaccines, diagnostics, and treatments for diseases prevalent in low-income countries.
Sanofi and Regeneron
Multinational pharma company Sanofi has formed a long-standing partnership with Regeneron, a biotechnology company, to jointly develop and commercialize innovative therapies for various diseases, including cancer, immunology, and rare diseases.
Celgene and Agios Pharmaceuticals
Celgene, a biopharmaceutical company owned by pharma giant Bristol Myers Squibb, partnered with Agios Pharmaceuticals to discover, develop, and commercialize potential cancer treatments targeting metabolic pathways.
Novartis and Alcon
Swiss pharmaceutical company Novartis spun off its eye care division into Alcon, a separate publicly traded company. Novartis maintained a significant stake in Alcon, representing an example of a public-private partnership within the same parent company.
Government Grants to Biotech Startups
Many governments around the world provide grants and funding to support biotech startups. These partnerships help early-stage companies develop their technologies and bring innovative products to market.
How a Virtual Data Room Facilitates Biotech Partnerships
Biotech firms have a critical need to maintain the confidentiality of its data files and documents, and that need continues when engaged in a public or private partnership. The collaborative nature of life science research and product development creates vulnerabilities to hackers, cybercriminals, and the competition. When a biotech firm partners with another organization, public or private, the potential access points for hackers increases significantly.
The cost of a leak can be significant: a system frozen until ransom is paid; a market loss now that proprietary information is in the hands of the competition; a loss of reputation and market trust. A leak can also create legal exposure, since pharmaceutical and biotech companies must adhere to FDA and HIPAA regulations designed to protect clinical trial patient privacy, including electronic records submitted under the FDA’s 21 CFR Part 11 regulations.
A virtual data room (VDR) can mitigate security risks. A VDR is a secure online repository that allows organizations to store, share, and collaborate on sensitive documents and data within internal teams, with third-party subject matter experts, and with partner organizations.
Here's a step-by-step guide on how to use a VDR for biotech partnerships:
Select the Right VDR Provider: Choose a reputable and secure VDR provider that specializes in handling sensitive information related to biotech and healthcare industries. Look for features like data encryption, user permissions, activity tracking, and robust access controls.
- A ShareVault VDR provides a secure workplace for any authorized biotech team member, from any location or authorized device, at any time of the day. The biotech VDR administrator can set time and content limits on access and can deauthorize access at any time.
- ShareVault is the leading online platform for biotech and the Life Sciences. ShareVault has been selected by the Biotechnology Innovation Organization (BIO) and 40 other industry trade associations for their Business Solutions Program.
Setup and Organize the VDR: Set up the VDR with appropriate folders and subfolders to organize the data according to the needs of the partnership. Common categories may include preclinical data, clinical trial results, intellectual property, regulatory documents, financial information, and legal agreements.
- ShareVault streamlines the setup process with built-in software features like drag-and-drop tools to create folders and folder hierarchies, easy integration with file-sharing apps like DropBox, Google Drive, and Microsoft SharePoint and OneDrive, cross-referencing tools like inter-document hyperlinking, and a powerful full-text search engine.
- With its robust menu of organizational tools, ShareVault makes the process of building data file and document archives a fast and painless process for the biotech team and its partners.
Maintain Data Security: Data security is paramount for biotech companies and for its partners, not only for archived documents and data files but also when files are in transit during collaborations.
- ShareVault automatically encrypts every document with 256-bit encryption at the time when it is uploaded to the VDR. Files in transit are via HTTPS over Secure Sockets Layer (SSL), providing AES-256 encryption in transit.
- Additional ShareVault document protections include dynamic watermarking, secure printing, and the ability to remotely shred documents, even after they have been downloaded.
- In addition to its protections for archived documents, ShareVault offers Dynamic Native File Protection (DNFP), a Word-like document generation software that offers advanced security for work-in-progress documents.
Invite Participants and Assign Permissions: Invite the relevant stakeholders from public and private partner organizations to access the VDR. Ensure that each participant is assigned appropriate permissions based on their roles and the level of access required.
- With ShareVault’s permissioning protocols, a biotech firm can extend access to partners and, when the time is right, to regulators. All such collaborations are protected by ShareVault security protocols.
Control Document Versions: Biotech and life science development typically generates multiple iterations of documents. Version control ensures that all parties are working on the most recent iteration. The version control log is a useful tool for tracing the development of a product or software feature.
- ShareVault’s version control feature includes a detailed log of time, date, and document contributor – a good reference point when tracking how certain product features were developed, and a necessary element for review during a regulatory audit.
Track and Monitor Activity: Utilize the VDR's activity tracking and audit log features to monitor user activity within the platform. This allows you to see who accessed which documents and when, providing an additional layer of security and accountability.
- ShareVault’s monitoring tool is updated in real time. The VDR administrator can generate a detailed, comprehensive activity register with a single click.
Streamline Due Diligence: During the partnership negotiation and due diligence phase, the VDR can significantly speed up the process. By having all relevant information accessible in a centralized and secure location, both parties can efficiently review data and documentation.
- ShareVault further speeds the due diligence process with its Due Diligence Checklist, a software template that automatically generates the most commonly used folders and sub folders.
Facilitate Regulatory Compliance: Biotech partnerships often involve strict regulatory requirements. Using a VDR can help ensure that all parties comply with data security and privacy regulations, as well as maintain proper documentation for audits.
- When regulatory submissions are required, ShareVault is the preferred platform for sharing Electronic Trial Master Files (ETMF), Investigational New Drug (IND) applications, New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Biologics License Applications (BLA), Drug Master Files (DMF), Biologics Master Files (BMF), Emergency Use Authorizations (EUA), and other regulatory submissions.
Use a ShareVault VDR for your Biotech Partnerships
Biotech companies engaging in partnerships with commercial firms or with public sector organizations must always maintain a commitment to the security of data files and documents, to stave off hackers and to comply with regulatory agencies. ShareVault helps companies meet those needs with robust security features, permission management protocols, and detailed audit trails.
Biotech companies also need to manage their budgets effectively. ShareVault offers a cost-effective solution for managing confidential data with flexible pricing plans that allow companies to choose a plan that suits their needs and budget. ShareVault's pricing is transparent, with no hidden costs, so there are never any surprises.
To receive a customized ShareVault proposal, contact us today!