One of the keys to success is effective leadership. Managing the science and mentoring people is often referred to as an "art" and indeed after years of experience in these areas I have built effective business acumens that have help turn "art" into "practice". Knowing what constitutes an effective team, how to build a team, and how to ensure that the team is productive requires an understanding of the corporate and scientific vision, accountability, effective leadership, a sense of urgency, execution of directives and the ability to find solutions.  In addition, being a critical thinker, results-driven, and experienced in multiple therapeutic areas provides an insider's view of how to get the job done. As part of your team I can also help design a program to streamline annual reviews and how to focus on what are the critical contributions in your organization.

     All companies go through change. Small companies may have grown organically and hired talented individuals to grow the science however have not had the time or experience in managing the science, mentoring people, and organizing the teams. Small companies will also need a savvy consultant to deal with marketing new technologies, venture capital, mergers or IPO's. Larger companies need a consultant to find solutions to specific needs, restructure teams, to review in licensing opportunities, as a third party expert in competitive landscaping, to confidentially review companies they intend to collaborate or purchase,  to review new technologies as an independent third party, and other confidential purchases. As part of your team I can help as a change consultant.

     My experience has been that many drug-discovery teams can be unintentionally redirected by trying to provide presentation materials or examples for investor meetings which in turn makes them appear to miss critical milestones required for ensuring that programs become successful. The reality is that you need to "build in" selling points in every discovery & development project with clear transition "talking points". This helps to ensure that science is "in step" with the corporate vision and contributes to the therapeutic product profile of your intended therapeutic agent.

     For example, first-in-human clinical studies are significant corporate milestones; therefore preclinical teams need to be highly focused and efficient while clinical development teams need to be ready to orchestrate the clinic, review boards, budgets, and the FDA guidelines. The focus will be to maximize the possibility of success and minimize the risk of falling short of expectations.

     The road from idea to IND (Investigational New Drug) and IND to NDA (New Drug Application) is an exhilarating venture with real world timelines. Many early-stage drug-discovery teams, particularly at small startups and in academic programs, have not had the time to build internal experience on how to best travel this road, so as to get to a high quality IND-Ready agent and file an IND as fast as possible, with controlled expenditures, and with a compound that has the best chance of successful entry into the clinic and beyond. These teams can benefit tremendously from the advice and leadership of an experienced drug-discovery and drug-development consultant.

     From Idea to IND as part of your team I can help you in developing chemical biology, chemical proteomics, target selection, target validation, screening file enrichment, hit-to-lead teams, targeted and combinatorial library analysis and design, intellectual properties, utilizing contract research and contract manufacturing organizations, medicinal chemistry SAR/SXR, analytical teams, integration of biological data, integration of pharmacokinetic data (ADME), toxicology data, safety data, formulations, API, pharmacodynamic data, target product profiles, business acumens, and pre-IND materials.

     From IND to NDA I can help you in drug manufacturing organization contacts, drug product discussions, SOP's, 21CFR's, INN/USAN/ATC considerations, and my experiences pertaining to focusing on the clinical task at hand.

     My participation in your team is to streamline efforts, contribute to the intellectual property when needed, and help move ideas to IND's and IND's to an NDA; moving from concept to reality in moving "from principle to practice".