GHP Executive Awards 2017

10 | ghp Executive Awards 2017 Contact Details Company: ICPD Address: 242 Broadway, Schenectady, NY 12305 Phone: (518) 631-8100 Fax: (518) 631-8199 Email: [email protected] Website: resistance, not only in terms of mechanism but just as importantly in frequency and magnitude. On the other hand, helping clinicians identify the right drug and dosing regimen for a patient is complex. This requires a true understanding of both clinical care and antibiotic stewardship. These complex problems require sophisticated solutions. Sophisticated solutions begin with people. Our scientists are experienced and world recognized: as evidenced by over 2500 presentations, 1200 scientific publications in peer-reviewed journals, numerous book chapters and over 20 years serving as Editors of prominent scientific journals. Our experience spans the continuum from bench-top to the patient’s bedside, integrating diverse information to make better drug development, regulatory and clinical decisions possible. It is because of our collective experience that ICPD scientists often see opportunities others do not. For instance, for a quarter century multiple drug companies saw the potential value of the antibiotic, oritavancin. Elli Lilly discovered oritavancin in the late 1980s and in the 1990s tried to develop it as a once-a-day antibiotic, but without success. Why? Because that’s what pharmaceutical companies always do with long-half-life drugs like oritavancin. Two other companies, InterMune and then Targanta in the 2000s saw the potential value and acquired it and tried to develop it as a once-a-day antibiotic, again without success. Lilly failed. InterMune failed. Targanta failed. Despite this, we were determined to succeed and through our work with Targanta scientists, we realized that given the unique pharmacokinetic and pharmacokinetic-pharmacodynamic profiles of oritavancin, everyone had it wrong. The drug needed to be administered as one big dose rather than a series of small doses. The Medicines Company stepped in and believed us and bought Targanta. In 2014, oritavancin was approved by the FDA as a single-dose therapy.” As Paul outlines, all of the firm’s vital services would be impossible without the vast industry knowledge of the firm’s founders, and their ongoing commitment to supporting the industry and working to support its members. Right from the beginning ICPD, has been committed to ensuring that it works collaboratively with supporting government regulators and industry to ensure that it succeeds, as Paul outlines. “ICPD was founded by Drs. Sujata M. Bhavnani, Christopher M. Rubino and myself in 2004 with a simply audacious goal: to change the way that antimicrobial agents were developed and used to treat patients. This would in turn allow us to de-risk development for the benefit of patients. By focusing on this objective, we now advise our clients on what studies and analyses are best to support their development program. This can include making tough calls when a program is facing failure. Unlike many others, we realize that the goal of drug development is not regulatory approval, but rather to bring a safe, efficacious, well-differentiated and durable therapy to market. This perspective benefits patients, drug regulators and drug developers alike. As such, since inception, rather than focusing on wining contracts from pharmaceutical and biotechnology companies or showing off to our peers at trade shows, our strategy was to gain the confidence of drug regulators and influence their thinking about the importance of pharmacokinetics-pharmacodynamics for rational antimicrobial drug development. Tactically, since 2004 we have participated in nearly every open public workshop focused on the development of antimicrobial agents sponsored or co-sponsored by the Food and Drug Administration and other organizations, like the Infectious Disease Society of America and the National Institutes for Health. We consistently offer new ways to look at the complex problems that vex drug regulators and developers. The contracts from pharmaceutical and biotechnology companies naturally follow. Today, many early and nearly every antimicrobial agent in mid- to late-stage development have been touched by ICPD. We have invested in building our own in vitro and in vivo laboratories. We generate our own state-of-the-art pre- clinical data. To do this, we have invested in computational infrastructure and people. By housing all of this under one roof, ICPD scientists are able to operate in cross-functional teams and become intimately familiar with the drugs they work on. All the while, we train young scientists, thus shaping the future of antimicrobial drug development and ensuring our continued success.” These young scientists, and the firm’s existing staff, are crucial to its success, and as such the firm works hard to ensure a supportive culture not dissimilar to its approach with the industry as a whole. Leadership style and corporate culture are strongly linked, and therefore ICPD’s culture and work ethic comes right from the top of the organisation, as Paul is keen to highlight. “Core to our success is the collaborative environment we have built. Scientists and support staff are set on a level field, allowing any employee to reach out to the highest tiers of ICPD’s organizational structure. This culture promotes frequent and open communication throughout all levels of ICPD, further strengthening the benefits yielded through our strategy of vertical integration. Moreover, the office doors of myself and Drs. Bhavnani and Rubino are always open to any employee with a concern, be it professional or personal in nature.” Ultimately, ICPD’s achievements so far have depended upon its strong leadership and dedication to their mission. The firm’s leaders, Drs. Ambrose, Bhavnani and Rubino are bold and unafraid of criticism, which has allowed them to set goals and accomplish what others dream about. Overall, it is these factors that have allowed them to build buildings and laboratories from the ground up without a penny from investors and essentially no debt, and they will continue to build upon this success going forward, as Paul concludes. “Many have questioned ICPD’s success in a field which up until recently received fairly little funding and interest from drug developers. Our answer to these individuals is that it all boils down to one’s outlook. Too many ask and answer questions of why not. ICPD’s outlook is best captured by an ode by Arthur O’Shaughnessy in which he stated, “We are the music makers, and we are the dreamers of dreams. This guiding philosophy is what allows us to continue to innovate and lead the field of antimicrobial translational medicine; and perhaps one day, develop drugs of our own, and this will remain the firm’s ongoing focus as we look towards a bright and exciting future.”