CherryCircle Software, Inc.
March 26, 2018 Issue
Q&A with Dr. Yash Sabharwal, President and CEO of CherryCircle Software, Inc. providing an FDA Compliant Cloud-based Software Solution that Identifies and Controls Risk for Drug Development and Medical Device Companies integrating all of the Pharmaceutical Manufacturing Processes
Dr. Yash Sabharwal
President & Chief Executive Officer
CherryCircle Software, Inc.
Interview conducted by:
Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – March 26, 2018
CEOCFO: Dr. Sabharwal, what is the concept behind CherryCircle Software, Inc and your QbDVision?
Dr. Sabharwal: The concept behind CherryCircle Software is to develop novel software solutions for the life sciences industry with our first product, QbDVision™, focused on pharmaceutical manufacturing. It was an idea that I came across when I was Chief Operating Officer at Xeris Pharmaceuticals. At the time I was responsible for managing the development of our manufacturing process for our lead product. We wanted to use the Quality-by-Design framework, which is a scientific and risk-based approach that the FDA likes to see pharmaceutical companies utilize as they are managing their manufacturing process development. As I was trying to implement this framework, I found that there are no integrated software tools available for companies to manage this process. As I looked into this further, I found that people end up using multiple software packages to manage the process. They will generate risk tables using Excel spread sheets. Then they will use a statistics program like Minitab to design some experiments and process the data. All of the data then gets written up in a report that gets logged into another software package for electronic document management and finally they use a separate, project management software to coordinate all of these activities. There is no integration between any of these software packages they are using. Microsoft Excel is not something that the FDA considers to be a validated solution and so tracking changes you make in an Excel spreadsheet is not compliant with data integrity requirements. I found it strange that there were no software solutions out there to meet this need for companies in the process development stage. So, I parked this idea my head and when I left Xeris a few years later, I reached out to someone I know who is a very good enterprise level developer and we decided to start this project to build a compliant software solution which could be a central repository for all the information you need to manage your process development and do it in a way that will meet the regulatory requirements.
CEOCFO: How does QbDVision work?
Dr. Sabharwal: It is a SaaS based solution. The focus of the software is on data and requirements management and not so much on document management. The problem you have with document management solutions is that you write a lot of reports and you put these into an electronic library, but all the data is buried in the reports. Our intent was to bring the data up front. The first version of the software specifically allows you to manage the development of your pharmaceutical manufacturing process using Quality-by-Design principles. In our software you are following what the FDA and other regulatory agencies want you to do, which is to “start with the end in mind.” This means that you first lay out the requirements for the patient in terms of safety and efficacy of the drug product you are developing. Once you have defined the patient requirements, then you can think about the final attributes of the product than ensure the patient requirements will be met. These are the attributes of the product that are important at the end of the manufacturing process. Our software allows you to define all of these. Next, our software allows you to define your manufacturing process and, for each step in the manufacturing process, the critical material attributes and critical process parameters of each step. You can link all of these together to basically get a risk map with traceability from process parameters and material attributes of your manufacturing operation to the final product quality attributes to the patient user needs. That is really the kind of progression the FDA wants people to think about at the very beginning, so the process development is more holistic and keeps the patient in mind.
CEOCFO: Is it a big leap for people to look at it in the reverse order? Is it intuitive once it is pointed out to them?
Dr. Sabharwal: This process is actually defined in various regulatory guidance documents and QbDVision actually guides you through the process with this reverse thinking. If you look at the menu items in the main menu bar; you first create a project and you put some definition around it and then you define your patient requirements in a Target Product Profile (TPP). The elements of the standard TPP are defined in an FDA guidance and they tell you exactly what they want you to consider for the patient level requirements. So, these are pre-built into the software and we even provide the links to the FDA guidance so that people can get more information if they need it. Something that I always found interesting is that all this information is in the heads of quality professionals and regulatory professionals, but nobody ever makes it available directly in the software where you can get more information if you need it. Then the next step in the software is to lay out the final product quality attributes as part of your Quality Target Product Profile (QTPP). Then you lay out your manufacturing process. The software guides you through all of it so that it is intuitive you go through the process in a logical way. In the beginning, many of these requirements will be roughly defined. But, over time you will build and refine these requirements and QbDVision provides the capability to do this.
CEOCFO: Is QbDVision in use today or are you still development?
Dr. Sabharwal: We are just about to release the first beta version in about a week. We started development on this product in last July, so it has taken about nine months to get to this point which is pretty incredible. We are in the process of signing up some pilot customers to do the Beta testing for us. We are targeting the final release of the first version in late May or early June.
CEOCFO: What have you learned so far that may have changed your initial concept or way of getting to the end result?
Dr. Sabharwal: Our initial information around the gap in the marketplace was correct. However, it has been interesting to that even though the industry knows this is something that they need to do, they have not embraced this holistic approach as much as the FDA would like them to. I think that is because it is a bit overwhelming for companies that do not have a lot of experienced staff. There is a lot of literature out there discussing quality-by-design, but it quickly gets heavy on the statistics and engineering and I think people just get overwhelmed by that. Our intent is to make it much more approachable and to automate many of the activities that people currently have to accomplish with statisticians and other experts. Therefore, I think that while people understand the need for this, there is still some reticence because they do not quite understand how to go about doing it. Our goal is steer more people to risk-based development with QbDVision by providing a tool makes them much more comfortable with the process. What we are learning is that as we talk to more people, there is clearly a gap in the market and I think we are going to fill it with this software, especially given the ease of use that we have designed into the product. We see this as a sizable opportunity for the company, especially given the increased focus by regulatory agencies on the use of the approach for pharmaceutical and medical device development.
CEOCFO: What will be your plan to generate sales and generate interest once Beta testing is completed?
Dr. Sabharwal: We are bringing many key opinion leaders in the field around this project. I have an advisory board made up of people who have backgrounds in both small pharma and big pharma. They are consultants who clearly understand that not only is the greater adoption of Quality-by-Design processes necessary for good final product quality and for better profitability, but also that the regulatory agencies are now starting to mandate this approach more and more. These consultants have already been instrumental in helping refine our user interface and software functionality and their input will be valuable going forward as expand the functionality of the software. We would like to work with many of these pharmaceutical consultants to help identify initial customers, because many small or mid stage companies really rely on these consultants to guide them on what they should be doing and how they should be doing it from a regulatory and process development perspective.
CEOCFO: Would you tell us about the QbDVision iterative risk assessment for the future? How does that work? Where does it come into play?
Dr. Sabharwal: Iterative, risk-based approaches are critical to the cost-effective management of complex manufacturing processes. QbDVision is all about risk assessment, evaluation and control and these risk tools are peppered throughout the software. You may decide, for example, that for your injectable drug, the amount of drug in the final dose is often very important. You may have a tight range because if you are too low, it will not be enough to have the therapeutic effect and if you are too high, the patient could experience an adverse reaction. So, you will define the dose range as a critical quality attribute of your product and perform an initial risk assessment. That is, given my current process, what is the impact to the patient if I am out of specification, and how well do I have it controlled? In the beginning you are not going to have a lot of information about it. You are going to say, “Well, this is a high risk right now, because I have not fully gone through the process of making the drug product or testing it.” QbDVision allows you to go through this thought process for every quality attribute that you define. You can assign a risk level to it and you can link it to other variables that are downstream in the process. Once you have an initial assessment completed, you can start your development activities to evaluate the risk and look for opportunities to reduce risk. You make a pilot scale batch and you learn from that. As you learn from that you go back and enter that information in the system. As you learn, you may reduce your risks over time. That is really what the FDA wants you to do. They want you to show them that initially a lot is unknown and you have high risks around your process and as you manufacture and you scale up your manufacturing you learn more and reduce the risks. It is this very process of risk assessment, risk evaluation and risk control that is laid out in the guidelines that the FDA wants to see. Our software allows you to iteratively track the evolution and risks of your process to show the regulatory agencies how you reduce your risk over time and ultimately arrive at a well-controlled manufacturing process. That is the essence of the QbDVision solution.
CEOCFO: Would more than one person be collaborating on the software? Is it typically one person that is following through on the whole process?
Dr. Sabharwal: It will be a team of people. You will have team members from manufacturing that will be users. You will have quality and regulatory team members that will be users. Therefore, it is intended to be a collaborative environment where people can see all of the information and they can see how it is evolving over time. The software is intended to be compliant with all the data integrity requirements the FDA wants to see as well, meaning that you cannot delete data and you cannot fudge data. Once you put something in the system, other people need to see it and approve it before it becomes added or removed as a formal requirement. There is a whole set of regulations around data integrity and audit trails and QbDVision is built to meet these data integrity requirements so individual users cannot change or remove information in a way that is not appropriate.
CEOCFO: Security is critical. What are the steps you have taken to make QbDVision secure? Are people looking at security in this type of a product the way that they should?
Dr. Sabharwal: Absolutely; security is critical! Unfortunately, in the pharma world, they have been slower to migrate to some of the newer technologies, so you still have many legacy systems in the pharma space. We have built QbDVision on Amazon Web Services and we are utilizing some of the latest trends and technologies for security, reliability, and testing. We have built the entire software such that it follows best practices, which is that everything is encrypted and it is encrypted both at rest and in transit. Because it is always encrypted that certainly provides you with your highest level of security. We have other layers of security built into it at different levels of the application. Because it is all built on Amazon Web Services, hacking us effectively means that you are hacking Amazon.
CEOCFO: Are you seeking investments, partnerships or funding as you move forward?
Dr. Sabharwal: Yes, we are. We have been raising money on a small convertible note round right now. My expectation is that as we start to establish a small customer base over the next few months we will be reaching out to do a Series A round that we will use as growth capital to build the infrastructure and grow the company. This is the third company that I have started and I have a pretty good track record so far! I sold my first company and grew the second one to over $100M in value. So, I have a lot of experience with building and starting up technology companies and growing them. I am very excited about this opportunity. It is also nice that it takes very little capital to build software solutions. As a result, we have gone a long way with very little investment so far. However, we will definitely be seeking new investments later in the year.
CEOCFO: Why is QbDVision not just convenient, but important?
important because I think it makes the quality-by-design framework available
more broadly for companies without the need for the vast resources typically
found in big pharma companies. And using this approach has been shown to
produce higher quality products for less cost over time. Of course, there is
also the regulatory perspective, which is that the FDA is really starting to
require it and mandate it for generic drug manufacturing. They want to see
this framework implemented. However, even aside from that, the complexity of
drug development has increased drastically over the past ten to fifteen
years as the industry has moved more to the biologics realm and now we are
moving into biosimilars, which are generics for biologics. The complexity
around the manufacturing process is increasing significantly and everybody
understands that there is no way to test all of the variables that you have
in these processes. Therefore, you have to be very smart about understanding
and identifying what is critical and what is not critical and doing the
appropriate studies early on so that you truly reduce the risk as you go
forward. The worst thing you want to do is develop a formulation early on,
complete some clinical studies with this formulation and then have a failure
when you go to scale up manufacturing process. If the changes to resolve a
failure are significant, you may have to go back to the beginning and redo
your pre-clinical for the clinical studies. Unfortunately, that happens more
often than one would think and that affects the company and its prospects
going forward. It certainly affects investors who thought that whatever
money they were investing was going to be sufficient to get them to a
certain level and then they find they must invest a lot more to go back and
repeat work that could have been potentially avoided if the quality by
design approach had been taken early on. The stakeholders are numerous in
this process including the investors, the company itself, the regulatory
agencies and then finally the patients. If a company has a potentially
impactful drug for treatment of a condition that patients are struggling
with, the delay of two to three years to get that product on the market can
be devastating. Therefore, from all of these perspectives, trying to build a
product where you are designing quality to your process from the beginning
is very, very important.
“Our software allows you to iteratively track the evolution and risks of
your process to show the regulatory agencies how you reduce your risk over
time and ultimately arrive at a well-controlled manufacturing process. That
is the essence of the QbDVision solution.”
CherryCircle Software, Inc.
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