Catalyst - Fall 2011 - Strategy for Success - Planning for Clinical Development and Submission

Companies operating in the life sciences space in the United States are well aware of the “buyer beware” mentality of dealing with the U.S. Food and Drug Administration (FDA). When a company chooses to go through what many term “the regulatory hoops” necessary to obtain FDA approvals, they do so at their own time and expense.

Same can be said, in varying degrees, to submissions around the world and a variety of other tasks necessary to commercialize a drug or medical device.

So it would seem that companies, eager to get to market and, therefore, willing to assume those risks, would plan ahead properly. They would make sure they have in place what’s needed to not only start the race but to make it successfully to the finish line.

However, Diane L. Mauriello, Ph.D., president of Dante Resources, Inc., a New Jersey-based clinical/regulatory submission advisory firm, said, in her many years of experience, companies tend to call in the cavalry when things go wrong.

“But it doesn’t have to be this way. Upfront planning can make the entire process run smoothly. With a strategy in place, unforeseen problems can be solved early. Dante is able to help guide the process along, acting as gate keeper of information and the overall project planner who provides the strategy, handles daily management and progress. And, yes, we solve problems, should they arise.”

All companies looking to commercialize a device or drug have experts in place to manage the critical components of the business. Many companies, however, do not recognize that they lack the resources, manpower, or expertise to oversee the project.

That’s where Dante Resources, a specialized clinical research organization that offers filing plan, CTD and clinical submission services to the pharmaceutical industry and life science sectors, comes in. In business since 1993, all Dante professionals have advanced degrees and over 20 years of experience.

Dante Resources specializes in all areas of planning for clinical development and submission to regulatory agencies in the U.S. and around the world. From creating realistic timelines, overseeing due diligence, managing data, medical writing to quality control and assurance, their team provides project leadership throughout the entire process.

With a gate keeper on hand who is focused on managing all parts of the project, challenges can be overcome quickly. Global communications and problem management is quickly put in place. Dr. Mauriello described a typical example of how and why having a gatekeeper to oversee the submission process makes sense.

Consider that Company A is involved in a clinical development program and is ready to begin the submission process. Oftentimes, there are two people in charge: one managing the clinical trials and the other handling the actual submission. There is a communication breakdown and time is now running out.

“The same person cannot be on top of both areas,” Dr. Mauriello said. “Of course, they must work together but someone needs to be the go-to person in the process. In this example, Dante is able to manage issues daily pertaining to the submission, and the client is able to continue activities related to ongoing clinical trials.”

In this scenario, Dante is accountable and responsible for a clearly defined submission Scope of Work. “As we review, assess and fine tune the process, it’s our job to find omissions or problems such as incomplete reports or erroneous source data. It is also important to review and challenge the assumptions made and the conclusions reached with a critical eye. Those issues must be corrected, and that’s where having one gate-keeper is important.”

Additionally, it is critical to manage FDA communications to ensure that all areas of importance are addressed in a timely manner, so the company appears responsive at all levels of the process.

“Working this way allows us to understand and manage issues and lead people out of the hole,” she added. “We monitor, monitor, manage, manage. We never want surprises. Appropriate communication and follow up on daily progress gives us perspective and the ability to see problems and solve them before they can escalate. It’s a team approach that works -- every time.”

In a perfect world where a company recognizes, at the outset, that a captain is required to steer the ship into port, Dante comes in for a few weeks to assess, analyze, evaluate and determine what’s going on and what needs to be done, said Dr. Mauriello. “We put a strategy in place, set a timeline and look at absolutely every part of the equation, from every angle. We then move forward with a strategy in hand for success.”

For more information about Dante Resources’ expertise, visit 

EisnerAmper's Catalyst: Fall 2011 

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