Critical Data Considerations for All Lifecycle Stages of a Biotech Startup

Biotech Startups Have a World of Opportunity … And We Are Here to Help You Succeed

In this article, we look at the key lifecycle stages of biotech startups, and demonstrate how the CDD Vault technology can support you from rapid startup through discovery, collaboration, and commercialization or exiting—all while providing industry-leading security to protect your valuable intellectual property.

Lifecycle Part 1: Setting Up Data Infrastructure for Success

A strong foundation is essential for success in any biotech endeavor. With the exception of Big Pharma, established companies with revenue-generating product portfolios Research and Development (R&D) efforts in the pharmaceutical industry are driven by the need to succeed quickly and significantly. Regardless of funding source, there is keen interest in seeing steady and rapid progress toward drug discovery goals.

CDD Vault is engineered for smooth and rapid deployment. Our mission will always be to provide researchers with an informatics platform that can guide an idea from concept to clinical trials and beyond. This is why we've designed our products to be user-friendly and tightly integrated. Our aim is to enhance—not hinder—research efforts.

What Our Customers Say

While we can attest to CDD Vault's ability to jumpstart your efforts, it may be more compelling to hear from our customers who have experienced the substantial benefits of launching their projects using CDD Vault. Here's what some of our customers have to say:

"Twenty of our biologists and chemists participated in a side-by-side test, and all twenty voted to go with CDD Vault." 
- Adam Kallel, Senior Director of Computational Chemistry, Plexium

"Redbrick selected CDD Vault because it fulfilled all our technical specifications, was user-friendly and inherently flexible."
- Andy Hogben, Managing Director, Redbrick Molecular

"We looked at many options for a chemistry database. CDD is an economical and effective solution: The flexible web-based interface without the need for internal IT support fits our small company requirements very well. And CDD is fun to work with."
- Scott Thacher, Ph.D., CEO, Orphagen Pharmaceuticals

"Our biologists and chemists can use CDD Vault comfortably after minimal training-just an hour or so. It's browser-based, with a very logical interface, which definitely helps in usability."
- Cen Gao, Ph.D., Computational Chemist & Drug Designer, Acerand Therapeutics

"We used CDD Vault at AstraZeneca, and it worked so well that we required some of our CROs to also use it. CDD Vault is popular because of its flexibility and ease of use. So, when starting our own company, it was natural to use CDD Vault, and we're really happy that we did."
- Jeffrey Albert, Ph.D., Founder and Director of IntelliSyn

Challenges Faced by Biotech Startups

Challenges Faced by Biotech Startups

Biotech startups and similar R&D operations typically face several challenges:

1. Long Setup Times: Deploying an informatics platform often results in significant time and financial resource expenditure.
2. Complex Infrastructure: Purchasing and setting up expensive infrastructure that is difficult to use and requires specially trained IT staff or costly third-party service organizations to manage.
3. Security Concerns: Protecting intellectual property is mission-critical for any R&D organization. Many informatics solutions are disjointed and lack security designed at the root level.
4. Data Protection: Data must be secured both in storage and in transit. Without unified security designed into the solution from inception, providing the required security can be costly, risky, and uncertain.
5. Scalability Issues: Startups need to be agile, adding resources—either through direct headcount or through the use of CROs or other partnerships—fluidly and securely. Scaling with other solutions can be difficult, time-consuming, and expensive.

How CDD Resolves the Challenges

CDD Vault addresses these challenges through:

1. Easy Deployment: CDD Vault can be up and running within 90 minutes.
2. Unified Data Management: It provides a unified "single version of the truth" for chemical data, biological data, or a combination of both.
3. Low Maintenance: Fully maintainable with no additional IT personnel or resources, which is a major budget saver.
4. Scalability: Easily scales as your organization grows.
5. User-Friendly Interface: Its ease of use makes it affordable, with no additional fees for support and training.
6. Integrated Security: CDD Vault is designed with multiple layers of integrated security. We call it Vault for a good reason. Your data is safe.
7. Controlled Data Sharing: When it's time to collaborate with CROs or share data in other ways, CDD Vault allows you to do so on a granular basis. Your partners and collaborators see only the data they need to perform their work. You control what is seen and what isn't.
8. Easy Migration: If you aren't satisfied with your existing system, it's easy to switch to CDD. Our support team can help you migrate your data.

Lifecycle Part 2: Supporting Discovery

In scientific research, discovery is paramount. CDD Vault is designed to simplify and accelerate the discovery process. Dr. Jeffrey Albert, Founder and Director of IntelliSyn, illustrates the everyday value of such efficiency:

"For example, if we want to set up a new model or even a new collaboration, we don't need to have dedicated IT infrastructure, which also means we don't have to wait a week or more to get things set up. We can do it ourselves in real-time, and the resulting output is pretty close—or identical—to the capabilities that we had when working inside major pharma."

This contrasts sharply with less flexible systems, where change requests had to be routed through layers of IT support groups. Dr. Albert adds,

"In cases like that, the lead time between identifying a problem and getting a solution could run anywhere from a week to never. This is frustrating when you know you could do the same thing with CDD Vault in a matter of minutes, or at longest a single day."

When it comes to science, discovery is everything. That's why CDD Vault is designed to simplify and speed up the discovery process. The everyday value of such efficiency is illustrated with something Dr. Albert said, in describing how much easier CDD Vault is compared to other tools he has worked with.

"For example, if we want to set up a new model or even a new collaboration, we don't need to have dedicated IT infrastructure, which also means we don't have to wait a week or more to get things set up. We can do it ourselves in real-time, and the resulting output is pretty close-or identical-to the capabilities that we had when working inside major pharma. This contrasts with having to work with less flexible systems, in which change requests had to be routed through layers of IT support groups. In cases like that the lead time between identifying a problem and getting a solution could run anywhere from a week to never. "This is frustrating when you know you could do the same thing with CDD Vault in a matter of minutes, or at longest a single day."

Centralized Repository for a Single Version of the Truth

CDD Vault integrates with your existing systems and provides the critical "single version of the truth"—a centralized, easily used, and searchable data store for molecules, reagents, assays, and any other data you wish to store.

Some systems make data loading difficult, leading to information being held in non-centralized locations. This problem multiplies when chemists, biologists, and engineers respond to a difficult-to-use system by finding their own storage methods.

Adam Kallel, Senior Director of Computational Chemistry at Plexium, describes the efficiency of having CDD Vault as a centralized repository:

"We now have the ability to put all of the data in one place. And it doesn't matter what kind of information we're storing. We can store PDF files, Excel spreadsheets, PowerPoints, assays, DNA bar codes—all of these things—and they all get indexed and are all searchable. The ability to store whatever we need and have it all searchable is hugely important, greatly enhancing efficiency."

Emphasizing the value of having a single version of the truth, Kallel adds:

"When people used to store data on Excel spreadsheets and on shared drives, the big concern was always: Is this the most current data set? Or is it sitting on somebody's hard drive? With CDD Vault, we know exactly where to find our data, and we can be certain it is the most recent version."

What Our Customers Say

Here's what some of our other customers have to say about the efficiency and ease of use of CDD Vault

"We had Excel sheets all over the place and data from different projects that were just separated in different folders and after a while, it got to the point that it was just hard to manage. We chose CDD, and we're really happy with the service and the cost and the way the database is evolving."
- Ruo Steensma, Ph.D., Director of Chemistry, Orphagen Pharmaceuticals

"I have evaluated different systems during my 25 years in the biotech industry. For us, the main factor in choosing CDD Vault was the ease of implementation-how intuitive and easy the system is to use. Sometimes you get systems that are very powerful, but only one person who is trained can use it. Most of us like systems where it's so easy to use that it doesn't require a big learning process to get value from it."
- Julio Medina, Ph.D., and CEO, R2M Pharma

"Five years ago, our lab tested 20 compounds a year with no way to handle 200. Today, with CDD's software, we can fully process 3,000 new compounds per year and advance the best compounds to late-stage development."
- James McKerrow, M.D., Ph.D., University of California San Diego, CDD Scientific Advisory Board

Multi-Vault Storage with Unified Search

CDD provides the option of deploying multiple vaults. This has proven popular with organizations that want to store molecules in one Vault, chemical reagents in a second Vault, and perhaps cell lines in a third, and DNA-encoded libraries in a fourth. While a single CDD Vault can be used to store all of the above and more, some organizations choose to work with multiple instances of CDD Vault for operational reasons. The cross-Vault searchability of CDD means that regardless of how many Vaults are used, they can all be searched as a single, efficient entity.

Unifying Data from Chemists and Biologists

Chemists and biologists have differing needs, yet both benefit when they can access the information they need from CDD Vault. This eliminates the inefficiency and roadblocks of having different types of systems for each discipline.

CDD Vault supports the needs of each discipline by making it easy to:

• Define new protocols
• Add new data fields
• Register both molecules and biological entities
• Cross-reference batch information and Electronic Lab Notebook (ELN) entries to aid research

The flexibility means they can make the changes they need on the fly, without requiring the intervention of technical expertise.

Data Visualization and Analysis

The ultimate goal is to convert data into insights. CDD Vault helps you achieve this with an intuitive and powerful set of visualization and analytic tools.

From the CDD Vault dashboard, you can:

• View molecule and experimental data while tracking updates up to the minute
• Search data, import data, and manage your collaborations with a single click
• Access automatically associated bio data with molecules in the relational database
• View related information such as batches, plates, experimental data, or files alongside the structure
• Perform chemical substructure or similarity searches with a single click, giving immediate access to data around additional related molecules

This view is customizable, with Boolean query capabilities for potency, selectivity, and other properties you define. You can easily add and remove data columns until you have your ideal Structure-Activity Relationship (SAR) table.

For collaboration or further analysis with different tools, two clicks export your data to an Excel or SD file. It's also easy to batch import data into CDD. Simply select the fields from the flat file you'd like to upload, and CDD imports the data.

Using CDD Vault allows you to use private and external data more intelligently. It's easier to selectively share data without sacrificing security. All data within a CDD Vault belongs to one or more secure projects. Scientists only have access to projects that are relevant to them, thereby only seeing data pertaining to their experiments. Put simply, projects allow you to mine aggregated data when you want to, with whom you want to, with just a few clicks.

What Our Customers Say

"With CDD Visualization, we can overlay multiple assay curves for a single compound into one graph. This allows us to see the assay variability of the same compound between different runs, or to compare behavior of multiple compounds in different runs. Using different colors for each run, we can easily see the difference, and identify patterns."
- Cen Gao, Ph.D., Computational Chemist & Drug Designer, Acerand Therapeutics

"The Vault's powerful and flexible system not only facilitates rapid compound registration from our external medicinal chemistry teams but also seamlessly integrates this information with a wide range of in vitro and in vivo testing results. This enables rapid assessment of the developing SAR across multiple dimensions; everyone appreciates how well the system works while requiring virtually no internal IT support."
- Jim Lanter, Ph.D., Senior Director of Medicinal Chemistry, Arkuda Therapeutics

"There have been several benefits in shifting to CDD Vault, from outsourcing the technical aspects of running the database to having a robust user interface with a competent technical support team. In addition, having access to a panel of in-built tools that allow the first analysis of data to occur directly within the CDD Vault database has been very useful in supporting our project."
- Dr. Andrej Trauner, Project Manager in Discovery Research, Bioversys AG

"CDD Vault is a great choice for a start-up and has scaled well as our Research enterprise has expanded rapidly. Our scientists find the protocol and GUI structure to be excellent. From my perspective as a data analyst, the API has enabled me to code and automate complex custom analyses and automate integration and sharing of chemical and biological data for presentations which has been an exceptional time-saver for the laboratory researchers."
- Scott Silveria, Principal Data Analyst, Arcus Biosciences

Lifecycle Part 3: Supporting Collaboration

Collaboration is an essential part of the pharmaceutical industry, which is why "Collaborative" is part of our name. CDD Vault was created with collaboration—and secure collaboration—in mind. Using CDD Vault, you can provide Contract Research Organizations (CROs), academic partners, other pharmaceutical companies, and others secure, granular access to your data.

The security of CDD Vault means that one of your chemistry CROs can register a compound to your Vault, while a biology CRO can upload assay data on the compound, with each party tightly restricted in what they can see and do. The Structure Masking feature of CDD Vault means a biology CRO, for example, only sees the compound ID but does not see the chemical structure.

CDD Vault is securely accessible from anywhere. Data from any source can be uploaded and managed easily in one CDD Vault, allowing groups to privately organize, track, and mine research data gracefully. You can designate precisely who has access when and to which data, enabling secure collaborations in ways not previously possible by better controlling who can or can't access data, all while maintaining a single scalable Collaborative Drug Discovery database.

All data movement is secure, as it is encrypted and done directly with CDD Vault. This means no emailing of spreadsheets, with all the potential for interception or compromise that comes with that. All data within the CDD Vault is protected by our industry-leading layers of security.

Jennifer Johnston, Ph.D., and Co-Founder of An2H Discovery, provides a great example of the powerful collaboration that can be achieved using CDD Vault:

"We have CROs all over the world. We have people in China, Ireland, France, Scotland, England. And then in the US, we have people in New Jersey, San Diego, New York City, Michigan, and Boston. CDD really allows me to control access to the database, where I can have my specific CROs enter their data directly into the database.

For example, let's say we have a new SAR compound that my chemist here in California has designed. People in China will make those compounds. Those people in China then can enter them, register them into the database. That then triggers shipment of compounds to our CRO in New Jersey to then run biochemical assays on the new compounds.

That biochemical data then gets entered into the database, and my medicinal chemistry consultants can log into CDD and see what's going on with the SAR they designed from both the compounds that have been made and registered, as well as what's the data that's coming out in our biochemical assays.

At the same time, the lab in Ireland can enter patient sample data, as well as cellular assay data that we're using for compounds that have already been through our biochemical assays. So we kind of have it rolling through with compounds, biochemical assays. Those compounds then get shipped to Ireland, we do those in our patient assays, and then that gets added in and we do our SAR cycles that way."

What Our Customers Say

Our customers value the ease and security with which they can use CDD Vault for collaboration. Here's what some of our other customers have to say:

"CDD easily allows us to securely collaborate, while keeping some data private, all in one system."
- Ellen Berg, Ph.D., Chief Scientific Officer, Eurofins DiscoverX

"CDD Vault is a lifesaver. We really needed a way to capture the data we were creating and be able to share and analyze it - before we were capturing data on spreadsheets."
- Malcolm Kendall, President & CEO, Indel Therapeutics, Inc.

"It's a great tool for mining and sharing data with collaborators. I've used a couple of other programs, but they don't put everything together so intuitively."
- Mary Lynn Baniecki, Ph.D., Harvard Medical School

Lifecycle Part 4: Securely Sharing Intellectual Property with Investors, Partners, and Buyers

One of the primary reasons for starting a biotech company is to turn research into intellectual property (IP) that can not only help others but also generate revenue to reward past efforts and fund future work. When a significant discovery is made, our customers have typically taken one of the following paths:

1. Filing Data with the FDA: When moving toward clinical trials, filing paperwork with the FDA or other regulatory agencies can be an arduous process. CDD Vault simplifies this process through its central repository, the ability to access just the required data, and the fact that the data has already been cleaned. Clean data is essential. We've seen spreadsheets where multiple different characteristics were contained within a single cell, and in which cell values and nomenclature differed between spreadsheets. CDD Vault ensures the capture of clean data.
2. Selling Compounds: Many of our customers discover interesting compounds which they sell to larger pharmaceutical companies while continuing the search for additional interesting entities.
3. Selling the Company: Some of our customers have been acquired by larger pharmaceutical companies, including Bristol Myers Squibb and Pfizer.
4. Going IPO: Others have taken the route of expansion through an initial public offering of stock to fund expansion of their research efforts.

Bringing Order to Due Diligence

Whether registering data with the FDA, marketing compounds, selling the entire company, or going public through an IPO, due diligence will be an integral part of the process. CDD Vault makes due diligence a breeze. Everything is already in one place. If selling just a subset of discoveries, the items offered for sale can be easily brought into a separate, securely isolated group for permissioned access by those performing due diligence. You can use CDD Vault to create your own digital deal room.

Here's how one of our customers, Jennifer Johnston, Ph.D., and Co-Founder, An2H Discovery, described using CDD Vault for due diligence:

"We use CDD Vault as a data room for our investors. Just as we do for CROs, we can create an isolated space for the investors and diligence teams to access only the data we want them to see, and we can organize it however we want. This one-stop shop for our data saves a lot of time and energy, as well as increasing our compliance. Moreover, it's completely searchable, and so we spend much less time trying to remember who, when, and where specific data was generated, and no longer have to figure out how to find it."

When selling your entire company, CDD Vault makes it easy to transfer your IP assets. Just assign full access upon completion of your company's purchase.

In contrast, we know of instances in which companies—without CDD Vault—had to spend significant time combing through nearly 100 different Excel spreadsheets, de-duplicating and cleaning data just to begin the due diligence phase. When you have someone interested in purchasing assets, you don't want to waste time with version control over disparate hard drives, thumb drives, and other distributed devices. Multiple spreadsheets can create a nightmare for version control, as multiple spreadsheets can have data on the same molecule—but with different results. CDD Vault keeps everything in a powerful, yet easy to work within, central repository.

Protecting Intellectual Property with CDD Vault Electronic Lab Notebook

A crucially important element of due diligence is the ability to document time, date, and details of each step in the discovery process. Many companies falter here because of disorganized, decentralized, and incomplete lab notebooks—both paper and digital. CDD Vault solves this problem with seamless integration between its database and Electronic Lab Notebook (ELN). Scientists can drag and drop data directly into an ELN entry, then import the data into the registration system, all the while maintaining a traceable link.

While it might not seem like something as simple as ease of use could make a difference in protecting your intellectual property—the crown jewels of any biotech organization—a real-life example from Adam Kallel, Senior Director of Computational Chemistry at Plexium, illustrates the point:

"ELN compliance is especially important for patent data and protection of intellectual property. 100% ELN compliance means that our intellectual property is protected, whereas before, it sometimes wasn't. You have to be able to show documentation for patent protection, and some of our scientists weren't keeping their notebooks up to date—just because the old ELN was so difficult to work with. Having everyone in 100% compliance is a great relief for all of us. I really appreciate the ease of use that CDD brings to ELNs because as part of my responsibilities I used to have to serve as the ELN police, running around making sure everyone was in compliance."

Kallel stresses how ease of use can make a big difference with ELNs:

"The CDD ELN system is so much easier for our people to use. Our previous ELN system was very formalized and required the chemists to use it in a specific manner, so everyone, including the biologists, appreciate that CDD Vault allows them to just drag and drop spectra as PDF files. It lets them put in the reaction scheme just by sketching it in with Marvin. And it's much easier for compliance. Our previous ELN system was so cumbersome and difficult to use, that not all of our ELNs were always up to date. With CDD Vault, our compliance has gone up to 100%."

Exceptional Security Meets SSAE 18 SOC 2 Type II Attestation Standards

What Our Customers Say

Here's what some of our customers say about the efficiency of CDD Vault and its ELN for bringing together data to share with partners, investors, and due diligence teams should you decide to license or sell a finding, or your entire company:

"CDD Vault provides a centralized system where the entire team can view and compare compounds side by side. We can focus on meaningful discussions and not worry about data being in different places. It's also easy to put together presentations for investors because all the data is already there."
- Gabriel Gracia, Ph.D., Senior Scientist, Kurome Therapeutics

"We were spun out of academia and didn't have any data tracking system. With CDD Vault we are now able to compile all results in one place and compare different compounds on the same page-really useful! The ELN is very beneficial as well. We can easily prepare a slide deck from the well-organized data to present to investors and partners."
- Joanne Babula, Ph.D., Research Scientist, Ridgeline Therapeutics

"Chemical and biological data are the most important internal asset for an R&D company. It is crucial for us to update our research operations and improve the collection and sharing of data. CDD Vault makes sure that our data is secure, searchable, and shareable."
- Dr. Reto Naef, Chairman of the Board of Directors and CEO, TOPADUR Pharma AG

"Using the CDD ELN as our official lab notebooks has had a great impact on all of us. We started out with another online lab notebook service, but it was a bit time-consuming and complicated, which meant no one was entering their data. Since we've switched to CDD, all of our employees and consultants are up to date on the lab notebook, and it's a resource that I routinely use when working with people in Ireland, or China, and I need to look at data outside their work hours. Using the CDD lab notebook function has provided us with a fantastic transformation."
- Jennifer Johnston, Ph.D., and Co-Founder, An2H Discovery

We're Here for Your Complete Journey

Collaborative Drug Discovery is here for your complete journey. Big Pharma loves startups because startups and other small research companies—are nimble, driven, and led by passionately brilliant scientists. Big Pharma wants you to succeed so they can purchase your molecules, IP, or your complete organization.

We're here to help you from day one through your first big sale, and then your next big sale. We have many repeat customers who have used CDD Vault to create—and sell—one company, and then come to us again as they prepare to launch their next.

CDD Vault, with its native ELN, tight security, and ease of collaboration, is the ideal informatics platform upon which you can work your way through the full lifecycle of a startup. We'll help you hit the ground running, capture your data, convert data to insight and product, and provide the documentation required for due diligence when the time comes to sell or file... a compound, or your company.

This blog is authored by members of the CDD Vault community. CDD Vault is a hosted drug discovery informatics platform that securely manages both private and external biological and chemical data. It provides core functionality including chemical registration, structure activity relationship, chemical inventory, and electronic lab notebook capabilities.