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 help you from rapid startup, through discovery, collaboration, and commercialization/exiting-all while providing the industry-leading security required to protect your priceless intellectual property.

Lifecycle Part 1: Setting Up Data Infrastructure for Success

A good beginning is essential to success in any biotech pursuit. With the exception, perhaps, of Big Pharma-those established companies with portfolios of products generating revenue-R&D efforts within pharma are driven by the need to succeed early and big. Whoever provides the funding, whether for a startup or an ongoing concern, will have a keen interest in seeing steady, and preferably rapid, progress toward the drug-hunting goal.CDD Vault is designed for smooth and rapid deployment. Our goal has always been to give researchers the informatics platform they need to shepherd an idea from concept to clinical trials and beyond. This is why our products are so easy to use, and so tightly integrated. We want to enhance-not hinder-research efforts.

What Our Customers Say

While we can say that we've designed CDD Vault to get you off to a roaring start, it may be more helpful to hear from our customers who have already experienced the enormous benefits of launching their efforts 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

Biotech startups, and similarly focused R&D operations, typically face the challenge of long setup times for deploying an informatics platform. Time-and financial resources-is lost on purchasing and setting up expensive infrastructure that is difficult to use, and that requires specially trained IT staff (or costly third-party service organizations) to manage.Security becomes another concern as protecting intellectual property is absolutely mission critical to any R&D organization. Yet many informatic solutions are disjointed and aren't built with security designed in at the root level. Data must be secured in storage-as well as in transit. Without unified security designed into the solution from inception, providing the security required can be costly, risky, and uncertain.Scalability is another challenge startups face. Startups need to be agile, adding resources-either with direct headcount, or through 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 was designed for easy deployment. This means you can be up and running within 90 minutes. It provides a unified "single version of the truth" for chemical data, biological data, or a combination of both. It is fully maintainable with no additional IT personnel or resources, which is a major budget saver. And it easily scales as your organization grows. It's ease of use makes it affordable, with no additional fees for support and training.Critically important: CDD Vault is designed with multiple layers of integrated security. We call it Vault for good reason. Your data is safe. When it comes time to collaborate with CROs, or in any other ways share data, 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.The good news is that if you aren't happy 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

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. Jeffrey Albert, Founder and Director of IntelliSyn 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," Dr. Albert says. "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," Dr. Albert says. "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 all-important single version of the truth-a centralized, easily used and searchable data store for molecules, reagents, assays, and whatever other data you want to store.Some systems make it difficult to load information, so too often data is held in noncentralized locations. This problem multiplies when chemists, biologists, and engineers respond to a difficult-to-use system by finding their own storage methods.The efficiency of having CDD Vault as a centralized repository is described well in real-life terms by Adam Kallel, Senior Director of Computational Chemistry, Plexium."We now have the ability to put all of the data in one place," Kallel says. "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 they're 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 know 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, from an operational point some organizations choose to work with multiple instances of CDD Vault. 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, which eliminates the inefficiency and roadblocks of having different types of systems for each discipline.CDD Vault supports the needs of each discipline because it makes it easy to define new protocols, add new data fields, register both molecules and biological entities, cross reference batch information and ELN entries to help their 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 big goal, of course, is to convert data into insights. CDD Vault helps you do 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. With a single click, you can search data, import data, and manage your collaborations. CDD's relational database automatically associates bio data with molecules. Related information such as batches, plates, experimental data, or files appear alongside the structure. With a single click, you can perform a chemical substructure or similarity search, giving you 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 SAR table. Have a collaborator not using CDD or want to do further analysis with a different tool? 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 the CDD Vault lets you use private and external data smarter. 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 pharma industry, which is why Collaborative is part of our name. CDD Vault was created with collaboration in mind. And, most importantly, it was created with secure collaboration in mind. Using CDD Vault, you can provide CROs, academic partners, other pharma 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.Along the way, all data movement is secure, as it is encrypted, and done directly with CDD Vault. This means no e-mailing 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," Johnston says. "CDD really allows me to control access to the database, where I can have my specific CROs enter their data directly into the database. So, 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 medchem consultants can go and log into the 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, you know, 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

In addition to helping humanity, one of the biggest reasons for starting a biotech company is to turn research into creation of IP that can not only help others, but can generate revenue to reward past efforts and fund future work. When a significant discovery is made, there are multiple paths our customers have taken, including:

• 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 the process through its central repository, the ability to access just the data requires, 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.
• Selling Compounds. Many of our customers discover interesting compounds which they sell to larger pharmaceuticals, while continuing the search for additional interesting entities.
• Selling the Company. Some of our customers have been acquired by larger pharmaceutical companies, including Bristol Myers Squibb and Pfizer.
• 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 described using CDD Vault for due diligence:"We use CDD Vault as a data room for our investors," says Jennifer Johnston, Ph.D., and Co-Founder, An2H Discovery. "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 and date and detail of each step in the discovery process. Many companies falter here because of disorganized, decentralized, and incomplete lab notebooks-paper and digital. CDD Vault solves the problem with seamless integration between its database and 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. Kallel notes that 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," Kallel says. "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," Kallel says. "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

CDD has several layers of security, including use of TLS encryption for data in transit, as well as dual firewalls-one in hardware, the other in software.  CDD Vault isn't hosted on the public cloud, but on our privately held and protected software-as-a-service servers. Our industry-leading, multi-layered security includes SSAE 18 attestation of security best practices as specified and audited by the American Institute of Certified Public Accountants (AICPA). We use an outside security firm to try to ethically perform penetration tests in order to identify and remediate any potential vulnerabilities before they could be exploited. Access to our data center includes retinal eye scans.Our security layers include:

• Pharma-audited, and meets FISMA and NIH Standards
• SSAE 16 Type II, SSAE 18 SOC 2 Type II compliant
• 2-Factor Authentication, Single Sign-On
• Separate user access and access levels
• Securely store and share documents
• CDD compliant with GDPR

In practical terms, this means your data is securely stored within the CDD        Vault-not sitting on a corporate server that might be hacked into, or in a spreadsheet in someone's desktop or laptop computer. It also means that when sharing data, you can simply provide granular access to specific data sets within the CDD Vault, rather than taking the risk of sending data as attachments in easily hacked e-mails.In adopting AICPA SSAE 18 standards, which requires annual audits by an AICPA security specialist, we are protecting your molecules in the same way banks protect your money.

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 are 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.