|Derycz Scientific’s leadership aggressively focused on helping pharma companies|
|Thursday, 20 October 2011 06:06|
Why would a pharmaceutical company need to work with Derycz Scientific?
Peter Derycz, Founder and CEO of Derycz Scientific: During the testing phase for a company’s new drug, its researchers will be searching through the millions of journal articles and other content that exist in support of the scientific process. After this phase, clinical trials are carried out and the publication planning process accelerates, culminating in scholarly articles that will be submitted to peer-reviewed scholarly journals. Once published, they become a significant component of a company’s investigatory new drug application (IND) submitted to the FDA and other agencies outside of the United States. If the product achieves regulatory approval, the articles take on a new role as the promotional and educational efforts get underway. Each step in this process presents its own challenges, which a dedicated content specialist like Derycz Scientific can help with.
Can you outline specifically what some of those challenges are?
Peter Derycz, Founder and CEO of Derycz Scientific: There is the cost of locating, verifying, procuring, formatting, updating, and translating/localizing drug-related published content in the clinical and regulatory arenas. It is well known that a submission to the FDA can easily run to a considerable length, as it consists of reviews and copies of published studies of the drug in question. Assembling, sending and managing this mass of materials is a significant undertaking for any pharma company. It is crucial for a company’s bottom line that this task be completed in as economical a fashion as possible and in a manner that avoids unnecessary duplication of materials or preparation errors that could lead to submission delays or rejections that ultimately affect shareholder value. A separate challenge involves managing the published content that is used by marketing, sales and medical affairs teams to help support the product following regulatory approval.
Is it really a challenge to prepare an FDA submission?
Peter Derycz, Founder and CEO of Derycz Scientific: Since 2008, the FDA has mandated that all electronic submissions adhere to the electronic Common Technical Document (eCTD) format. The eCTD format is also increasingly being adopted in countries outside of the U.S. As with all electronic submissions, delays will arise when last-minute requests for eCTD-quality documents are made. The eCTD format requires enhanced and specific digital document formatting and the inclusion of key navigation aids, making last-minute requests even more challenging. This is due to the fact that when regulatory authorities encounter non-compliant files, they can stop the review until the pharmaceutical company supplies them with corrected versions—a situation that can cost the company huge sums in lost revenue and sink a stock overnight.
Would a pharma company require your services after its drug is approved for market?
Peter Derycz, Founder and CEO of Derycz Scientific: Yes, because that’s when its promotional and educational efforts kick into high gear. As with the R&D phase, facilitating the flow and management of copyrighted content poses a challenge, this time among the company’s legion of sales representatives. As made manifest by the rising importance of evidence-based promotions, there is no better weapon in a sales representative’s arsenal than research studies that can be effectively spotlighted for the healthcare professionals (HCPs) with whom they meet. Being able to bolster one’s claims for a new drug with science—in addition to the promotional materials prepared by a company’s marketing firm—is not only a bright idea; it has become the principal method by which the company can distinguish itself from competing products. It has also become one of the few ethical methods remaining to communicate with HCPs in light of the highly restricted code of interactions adopted within recent years.
Many larger pharmaceutical companies already have an in-house staff of specialists overseeing content management. So are you targeting mostly smaller and mid-sized companies?
Peter Derycz, Founder and CEO of Derycz Scientific: Actually, we serve both large and small to mid-sized companies. Large companies need help to make business processes more efficient and lower the total cost of ownership. Smaller and mid-sized companies, with relatively fewer resources at their fingertips, face greater challenges in establishing a standardized and scalable infrastructure for acquiring and distributing previously published content to employees. A larger company is considerably more likely than a start-up to have a librarian on staff who has experience dealing with these issues, but a larger and diverse pool of knowledge workers to serve. These functions are often decentralized within small and mid-sized companies. For smaller research-driven companies, nearly all expenses are research-related. This makes it especially important to maximize research spending and eliminate unnecessary costs related to the acquisition and distribution of paid content. This includes the decision to purchase journal subscriptions and implementing automated cost controls to rein in costs. In the ideal scenario, a pharma company of any size would only need to depend on a very small number of third parties to facilitate all of its scientific literature requirements.
In order to provide your clients with access to such a wide range of published content, you must have deals with numerous publishers. How does that work?
Peter Derycz, Founder and CEO of Derycz Scientific: We write a check to scholarly publishers every month from the fees we collect from our clients. Over the past few years, we’ve forged relationships with a wide range of publishers worldwide, from the New England Journal of Medicine to the British Medical Journal Group and the American Academy of Family Physicians.
Derycz Scientific intends to release an iPad app in the coming months. What will it do?
Peter Derycz, Founder and CEO of Derycz Scientific: With the iPad in hand, pharma sales representatives have a valuable, powerful new tool for on-demand information sharing with healthcare professionals. According to a recent survey of 100 physicians conducted by The Harrison Group, more than one-third had received product information via iPad from a pharma sales rep. Of this subgroup, 68% reported being extremely satisfied or very satisfied with the format. In addition, 8 in 10 physicians rated the digital format as the same or better than previous methods of learning about new medications, such as paper-based visual aids. By making it easier for pharma reps to access these articles, Derycz is making a powerful tool for reps to add value to HCP interactions—and potentially helping to educate more doctors about the benefits and risks of new medications that can ultimately help patients.
How is the business looking today, and what’s in store for Derycz Scientific in the years to come?
Peter Derycz, Founder and CEO of Derycz Scientific: The past fiscal year was one of tremendous growth for us. We raised revenues by while significantly expanding our customer base and publisher agreements, expanded into new markets like Japan, and continued to innovate by enhancing and developing new technology solutions. Among our notable recent accomplishments, we completed our acquisition of Techniques Appliquées aux Arts Graphiques, S.p.A. (TAAG), which provides us with a physical presence in Europe, and provides global customers with a truly global information logistics solution. We now have over 500 clients, many of whom are Fortune 100 global pharmaceutical and life science companies, and we have distributed over 6.2 million articles to over 100 countries in fiscal 2011. With many contracted accounts and stable market demand, we expect this number to increase in fiscal 2012.