CDDI: Process efficiency and experience is the killer app
Grahaem Brown
More than 80 percent of trials run over time and over budget. After badly designed project strategies, this is perhaps the greatest single source of wasted resources in the biopharmaceutical industry. Delayed trials also delay exit strategies, where these are the primary objective, or product introductions, diminishing or even destroying the return on investment.
Michael Tansey and Grahaem Brown have combined their considerable experience and expertise in avoiding these pitfalls in a start-up company as straightforward in its approach as it is in its name: Competitive Drug Development International (CDDI), which makes its debut at BIO-Europe in Vienna.
“Drug development is subject to many constraints that make it very inefficient, all of which is compounded by the inefficiencies which drug developers themselves perpetuate,” said Tansey in an interview with partneringNEWS™. “Granted, there are events and actions that no one can control in this complex process,” he admitted. “But a majority of delays result from elements that can very well be controlled, and getting this process right is mission-critical considering the pressures of the cost of drug development or the time-to-market that must be met.”
Michael Tansey
The pitfalls in drug development are legendary, according to CDDI co-founder Grahaem Brown—protocols that do not deliver on business objectives, poor protocol design that leads to multiple amendments, slow patient recruitment, delayed completion, additional costs, equivocal results, delayed exit, funding problems, or delayed regulatory approval, to name but a few of the problems.
“Pharma and biotechs stuck in this labyrinth do not need to be told about these problems”, Brown said, adding “They need people to deliver results, not just more advice.” In this environment, process efficiency becomes the killer application to cut through complexity. “This needs experience and meticulous attention to operational details. We plan for the best, expect the worst and prepare to be surprised,” he said.
Investors may be all too familiar with Lasagna’s Law, which states that the number of patients available to join a trial drops by about 90 percent the day a trial begins, only to re-appear as soon as the study is over. According to Nicholas Benedict, CEO of Lumavita AG, “Biotechs are cost-constrained and under pressure to start clinical trials quickly, so often ignore the important step of thoroughly checking the operational feasibility of a protocol before starting.”
“I have discovered that comparing the draft protocol with actual patient records in a sample of clinics, then adapting the protocol to real life, is fundamental to meeting recruitment targets. The small increase in up-front costs is dwarfed by the additional cost and delays caused by protocol amendments, including additional CRO costs and the company’s monthly burn rate if study completion is late,” Benedict explained.
Despite the well known pitfalls, investors are increasingly favoring companies that employ virtual and semi-virtual models to maximize cash efficiency. “CDDI is ready to take full responsibility to deliver a successful outcome,” said Tansey, “that is what this company is all about.” According to Brown, “We are not disinterested outside advisors, we like to be hands-on in an operational position with the development project and accountable for achieving the outcomes.”
Tansey and Brown have served as senior level managers for both big pharma and biotech companies with practical experience in bringing many drugs all the way from discovery to the market. “That’s something few people get to do even once,” said Tansey, adding, “and several of these drugs were blockbusters.”
“Our approach to process efficiency ensures that investment goes further, and that timelines are significantly shorter, saving big money” said Tansey. “In a competitive situation, the consequences can be more significant,” he said. “We have experience where two companies were simultaneously developing a drug and one of the companies arrived on the market five months before the competitor. That 5-month advantage was worth more than USD 500 million in profit. But there was also a first-to-market advantage that the competitor was never able to catch, such that the first-to-market continued to benefit for many years.”
So, how does cddi differ from many other consulting groups? Brown replied “CDDI is led by very experienced industry professionals, with a solid track record of working on over 20 projects from discovery to market, in a wide range of therapeutic expertise, we can operate at strategic and deep operational levels, with all the functional skills needed to run whole programs, or specific components.”
At CDDI, Tansey and Brown have formed a team of more than 20 US, EU and Asian partners, “people who are familiar with our specific approach,” said Tansey. “These are people ready to go at short notice, obviating the need to put in place a costly and time consuming infrastructure where this does not exist, whatever the size of the company, from start-up to big pharma,” he said. “We are, all of us at CDDI, people who get things done,” said Tansey. “Yes, we look at the high level issues. And yes, we make sure our objectives gel with the client’s. Then we focus on what specifically needs to be done. What is unique to CDDI is that we then actually do it, we get it done,” he said.
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