Our latest training video is for tinea pedis. As with all of our training videos, this most recent one is led by a leading expert in the industry and contains extensive technical information specific to the study area / product. After watching our videos, trainees are tested on their retention of the topic.
To learn more about our training program or see some our videos, contact us!
We are pleased to announce the arrival of our latest training video! We have been hard at work developing and filming comprehensive, indication and product-specific training videos for the individual therapeutic areas we’re conducting trials in. Each video is extensive, with more than 30 minutes of technical information specific to that indication or product, as explained by a key opinion leader in the industry. Following the deep dive into the indication or product, trainees will get to take part in a brief test to aid in retention of the topic. Check out our latest on rosacea:
To learn more about our training program or see some our videos, contact us!
This Friday, Oct. 20, leaders from Catawba Research will be attending an FDA Public Workshop in Silver Spring, MD.
The Topic: "Overcoming Barriers to Product Development, Regulatory Approval and Commercialization of Affordable, High Quality, Generic Topical Dermatological Drug Products"
The event takes place at the FDA White Oak Campus: 10903 New Hampshire Avenue – building 31, room 1503. Silver Spring MD.
Catawba Research is a premier contract research organization (CRO) with decades of industry experience and know-how. Our unique process is designed to get products to market efficiently, reliably and on time. Catawba’s full-service team understands the intricacies of clinical management. We've worked with many pharmaceutical, device, formulation development and biotechnology companies the world over. We'd love to meet you in person at the workshop and explore ways to help your upcoming projects flow smoothly.
Over the last three years, Catawba Research has entered the pharmaceutical space to much industry attention. The North Carolina-based, multimillion dollar company has doubled its revenue and the number of studies initiated every six months.
Drawing on more than 25 years of experience in executing clinical trials for global pharmaceutical companies, founder and CEO Zaidoon A. Al-Zubaidy attributes Catawba's success to its unique efficiency model.
"Our process revolves around a core of highly-trained individuals to carry out trials," Al-Zubaidy said. "We call it guerilla-style clinical research."
Specifically, Catawba's guerilla-style model incorporates several key components. These include an intense program assessment to identify obstacles; a strategy to success outline; an expert network to staff up or down accordingly throughout the duration of the program; and the latest management technology designed to keep trials on pace.
"We also do a lot internally to ensure our team is at its best to deliver positive outcomes," Al-Zubaidy said. "The goal is always to move the study forward in a timely and fiscally-responsible manner. To do this, everyone involved has to be clear headed, energized and ready to act."
One way Catawba creates an agile unit is by limiting the number of projects the team takes on per year. Al-Zubaidy also taps into a vast network of regional clinical research associates and remote workers to reduce time lost on travel, while safeguarding against burnout.
"We want our people zoned-in on the task at hand and not feeling like they're being pulled in a thousand different directions," Al-Zubaidy said. "Frankly, there are many mechanisms in our method that help us create a better trial experience, but at its core are the basic principles to treat people as a priority, with fairness and honesty."
The most recent results from Catawba's contemporary process came by way of a completed rosacea clinical trial. Catawba enrolled 1,000 patients in 22 weeks from 33 sites. The timeline for the entire project – including investigational product at the site to the delivery of the final clinical study report – was nine months.
"We're proud to have 100 percent of our projects wrapped up on time and on budget," Al-Zubaidy said. "Much of our success today comes down to a modern, highly-focused approach that allows us to accelerate time of study completion, without sacrificing excellence. Our method is based more on future vision than old routines.
When it comes to clinical research, it goes without saying that the relationship between CRO and Sponsor is of utmost importance. Sponsors are footing the bill of the clinical trial and have specific timelines and deliverables that are imperative for success. The most fruitful CRO-Sponsor relationships are built on respect, communication, and collaboration to achieving this shared goal.
However, one of the most overlooked relationships in clinical research is the relationship between CRO and Investigator Site. This relationship is arguably just as important to the success of a trial as the relationship with the Sponsor. At Catawba Research, we are acutely aware that the same attention that is paid to our Sponsor needs to be paid to our Sites. After all, it is the investigator sites that are responsible for running the trial day in and day out. Without Sites, there are no patients and there is no trial. We believe that finding the right Investigator Sites and keeping them happy is the key to ensuring trials stay on track and the data is of the highest quality. We treat our Sites as our clients.
At Catawba Research, one of our key differentiators is our relationship with our Sites. We take pride in working with high-quality, high-enrolling Sites and maintaining excellent relationships. These Sites enjoy working with the Catawba Research team and want to keep working with us, study after study.
Just how do we go about making our Sites happy? The first key element is timely payments. We are seriously committed to living up to our financial obligations and making sure our Sites are paid promptly.Secondly, we don’t limit out Sites to a capped number of patients. Catawba rewards high-enrolling Sites to be competitive and to keep on enrolling. We start off with a high number of contracted patients, unlike other CROs, we encourage competitive enrollment.
Another cornerstone of our strong Site relationships is transparency, and being clear and open in communication with one another. Furthermore, we share a keen attention to quality and ensuring the data being presented is consistent with the protocol and GCP.
Additionally, we have found that respect gains respect back. When our CRAs go in to monitor, we are not there to attack or criticize our sites like private investigators. Picking faults and shaming their colleagues with a ‘Gotcha’ attitude. Instead we are there to support and collaborate, all the time making sure the data is of the highest quality. The result? Excellent relationships where everyone is happy to see one another and the Sites are happy to invite us back their doors.
Over the years we have found that mutual respect, transparency, a common focus on quality, competitive enrollment, and timely payments lay a solid foundation for a long-lasting relationship between Catawba Research and Site. Not only does it make working with one another more enjoyable, but in the long run, it benefits everyone including the Sponsor.
Happy sites equate to better enrollment, quality data, and project success. Therefore, making sure both our Sites and our Sponsors are happy is Catawba Research’s key for a successful business.
Over the past several years, we have witnessed our company, Catawba Research (Catawba), transform into a growing and prosperous CRO. We are very fortunate to experience such success, and as a part of our mission throughout this growth has been to establish a company culture unique to Catawba. An integral cornerstone to this company culture is our keen focus on corporate responsibility. We strive to be so much more than a successful CRO, but also leave a legacy as good stewards to the world in which we live.
Here at Catawba, corporate responsibly comes in many forms. One of the initiatives we are proud of is our focus on engaging employees in charity. We give our employees an extra paid time off (PTO) day if they use that day for a charitable cause. This charity is up to each employee, as we realize everyone has different causes they’re passionate about. Thus far, Catawba employees have used this time to help the fight against breast cancer, donate to the local homeless shelter and volunteer at local elementary schools.
Additionally, Catawba makes a generous donation to each charity that our employees volunteer at. We have much to be thankful for in life, Catawba is committed to sharing these blessings with the community around us.
Another important facet of Catawba’s focus on corporate responsibility is grooming the next generation of talented clinical research professionals. Catawba is proud to have recently formed an affiliation with the University of North Carolina Wilmington (UNCW). UNCW offers a strong clinical research program, and Catawba is excited to announce we will be taking on interns from that program to get them ‘hands-on’ industry experience.
Additionally, Catawba has developed a unique training program where we hire young, talented individuals and teach them the CRO industry through rotations in various departments. We realize it can be difficult to break into this industry, so we have developed a way to bring in intelligent, hard-working team members and give them all the training they need to start a successful career in clinical research.
The team at Catawba Research is dedicated to being a vanguard of corporate responsibility, and this mindset is a central part of the company’s culture. At the end of the day, there is so much more to business than the bottom line. Our goal is to give back to the community in which we live and leave a great legacy.
To learn more about Catawba’s services or career opportunities, get in touch!
Running a clinical trial can feel a lot like going into battle. Planning a clinical trial is fraught with complex series of obstacles and potential pitfalls that must be expertly maneuvered to achieve victory. Along the way there are key decisions that must be made and a heck of a lot of strategy involved. Being involved in the thick of a clinical trial can leave you battered and bruised; it can be a long and tiring process. So how do you make it through the battle unscathed? Much like modern day warfare, modern day clinical trials necessitate a whole new approach.
Historically, battles were fought with huge armies lined up in a field, attacking one another with weapons of varying accuracy, with the end result being lots of casualties along the way. Over the years, there has been a dramatic shift in this approach, with more battles relying on strategy and guerrilla warfare. Small, specialized teams now carry out stealth attacks, and advances in technology have paved the way for new means of achieving the desired end goal. The modern-day warrior is smart, savvy, and strategic. Long gone are the days of huge armies, cannons, and a conventional battlefield.
Just as there has been a shift in the way wars are won, there has been a shift in how clinical trials are run. The way huge CROs run clinical trials looks a lot like the old days of war. Large teams are assembled to run a clinical trial, and every study is treated with the same approach – “let’s throw more people at this mission.” This result is a cumbersome chain of command, lots of overhead cost, and varying levels of success. COSTLY!
At Catawba Research, we have developed a ‘guerrilla style’ of approach to clinical research. At our core is a small, specialized team of highly trained individuals to carry out your trial. We assess each program to identify potential obstacles, and outline a strategy for success. Then we staff up or down accordingly throughout the duration of the program with our network of expert contractors, that are familiar with the nuances of that particular indication. This allows for a much nimbler approach to clinical research, while keeping costs down and speeding up execution. We also deploy all the latest technology, such as our CTMS and video training to ensure your trial is operating efficiently and that high-quality data is being collected. This new approach to clinical research proves beneficial to all parties involved. In and out. Done!
Clinical trials don’t have to feel like you’ve endured a war. Say farewell to the days of big, bloated clinical research. We invite you to experience Catawba’s new ‘guerrilla style’ approach to clinical trials. Reach out to us today and discover the benefits for your upcoming program.
Catawba Research is pleased to announce another achievement for a recently completed rosacea clinical trial. In this trial, Catawba enrolled more than 1000 rosacea subjects in 22 weeks from 33 sites.
The time line for the entire project including investigational product at the site to delivery of final clinical study report was 9 months. Catawba Research continues its excellent 100% track record in successfully completing clinical trials on time without a single change order.
Catawba Research is proud of yet another rapid study completion and committed to achieving aggressive timelines for our clients.
See more about this program in the enclosed press release:
Learn more about our rosacea CRO services or get in touch with us for additional information.
The team at Catawba Research has recently completed a first-to-file submission for acne clinical trial . In this study, Catawba enrolled a staggering 1125 acne vulgaris subjects in 8 weeks from 12 sites.
The time line for the entire project from the delivery of investigational product at the site to submission of final clinical study report was 6 months. Catawba Research has a lot to be proud of: our sterling record of successful completions of Phase III clinical trials coupled with our innovative approach to clinical research, has further enhanced our reputation in the industry.
Catawba Research is proud of this first-to-file milestone and committed to delivering quality results within fast timelines for our clients.
See more about this program in the enclosed press release:
Learn more about our acne CRO services or get in touch with us for additional information.
Route 505(b)(2) vs. 505(j)
Your life is consumed by the single minded challenge of developing a generic drug product by navigating the FDA’s 505(j) regulatory pathway. Your journey has finally come to an end. The FDA has issued you an approval. Congratulations! You’ve endured this journey at a great financial risk; testing your business and scientific acumen. Not to mention the legal battles that could have taken you to the ‘poor house’ and ‘nut house’.
However, you have arrived at an already over-crowded souk with competitors from the 4 corners of the globe, selling their wares. Your approval is rapidly declining in worth due to the existence of other AB rated ANDAs (Abbreviated New Drug Application) and most likely, there are more to follow on the next caravan of approvals.
Upon reflection, investing your money in a Dunkin Donuts franchise or a nail salon may have a wiser decision, but pharma is all you know. May be another regulatory route with a quicker approval time and the potential for a greater reward may have been the more appropriate route to pursue. You’re too poor for a full on New Molecular Entity (NME) New Drug Application (NDA) and you’re still licking your wounds from your ANDA battles. Where do you go from here?
“Difficult situations inspire ingenious solutions”, Plato (maybe)
Won't you get hip to this kindly tip, and go take that regulatory trip, get your kicks on Route 505(b)(2). What is that?
Taking the 505(b)(2) route may have led to a quicker market approval of your new product and ensured that you are the only one at the finish line, likely to be alone free to sell your product unopposed for 3 to 7 years.
This paper will outline offer a historic overview of the regulatory landscape and will compare and contrast the 505(j) and 505(b)(2) regulatory pathways, with examples of successful ‘transformations’ of generic products into ‘branded generics’ and their impact on the consumer.
With a greater threat from the generic pharmaceutical industry, coupled with lengthy and costly development programs and a limited product pipeline, pharmaceutical companies of innovator drug products have looked to creative regulatory ways to maintain their competitive edge.
Section 505 of the Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments) describes three types of new drug applications:
The 505(b)(2) application was intended to motivate innovation without creating duplicate work on what is already known about a drug. Therefore, it is possible to submit a 505(b)(2) application that relies on literature and data not developed by the applicant i.e. the FDA’s finding of safety and effectiveness for a previously approved drug product (e.g., to support a new claim). As outlined in Figure 3 (below), there has been a steady increase in 505(b)(2) applications and subsequent approvals.
“Does this qualify for a 505(b)(2)?”
A 505(b)(2) application can be submitted for products that are either a New Chemical Entity (NCE)/New Molecular Entity (NME) or for those previously approved with new changes. In either case, an application may rely on the Agency's finding of safety and effectiveness of the previously approved product, coupled with the information needed to support the change from the approved product, i.e. bridging studies or published literature. In October 1999 by the FDA published the Guidance for Industry, Applications Covered by Section 505(b)(2), in which the agency identified the types of applications that are covered by section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (the Act). Below are examples of 505(b)(2) applications:
The 505(b)(2) regulatory pathway has been widely used by a variety of small, medium as well as large pharmaceutical companies for an array of examples as listed above.
Figure 3: Continued growth in 505(b)(2) approvals. The 505(b)(2) route continues to be a viable opportunity for many pharmaceutical companies.
*source: http://camargopharma.com/2016/02/2015-505b2-nda-approvals/
The Drug Efficacy Study Implementation (DESI). ‘Youthful old drug’
The Drug Efficacy Study Implementation (DESI) was the process used by FDA to evaluate for effectiveness for their labeled indications over 3,400 products that were approved only for safety between 1938 and 1962.
The FDA estimates that in the United States until recently perhaps as many as several thousand drug products are marketed illegally without required FDA approval. As a result, the agency has undertaken a vigorous exercise to enforce the Federal Food, Drug, and Cosmetic Act (1962) with regard to drugs marketed in the United States that do not have required FDA approval for marketing.
A DESI product can be ‘legitimized’ and brought to its youthful state by a company submitting and gaining approval via the 505(b)(2) pathway. Once approved, the FDA normally intends to allow a grace period of roughly 1 year from the date of approval of the product before it will initiate enforcement action (e.g., seizure or injunction) against marketed unapproved products (older products) of the same type, it is possible that a substantially shorter grace period would be provided, depending on the individual facts and circumstances.
Financial advantages of this ‘pharmaceutical plastic surgery?’
The advantage to companies pursuing the policy of gaining approval for their DESI product has resulted in extremely favorable market conditions for the sponsors, as best illustrated by colchicine. URL Pharma used publications and commissioned studies to show that colchicine was safe and effective, and received patents on its formulation. URL Pharma also sued five makers of manufacturers of colchicine, claiming they have been illegally marketing their colchicine products since Colcrys’s approval (URL Pharma’s brand name). URL Pharma has claimed that its approval helped make colchicine safer for everyone, noting there wasn’t even a standard dosage for the medicine until the company went through the FDA approval process. URL was sold for a substantial profit; Colchrys is now owned by AR Holding Company and Takeda Pharmaceuticals USA.
Let Catawba Research, LLC be your guide
Catawba Research, LLC is currently involved in a number of 505 (b)(2) clinical programs. Our clients have realized the cost and time advantages of pursuing this regulatory route and have chosen Catawba as their guide on their journey.
Successful ‘transformations’ of generic products into ‘branded generics’ via the versatile 505(b)(2) regulatory pathway has offered a time and cost effective solution to our clients to become ‘innovative’ and offer solutions to the consumer by providing improved and modified versions of previously approved products that benefit the patient.
We are looking forward to taking you on this exciting journey. For more information, explore our website.
