Thinking Without BordersTM
Developing Medicines that MatterTM
These guiding principles fueled the creation of d3 Medicine. With a goal of revolutionizing the pharmaceutical paradigm to accelerate developing medicines that benefit society, combining d3 and Certara was a ‘no brainer.’
Delivering on our clients’ mission
The d3 Medicine staff join Certara’s Strategic Consulting (CSC) division, which was formed in July 2015 through the merger of Quantitative Solutions and Pharsight Consulting Services. We are now the largest and most transformational consultancy of its kind, with more than 100 scientists, most with PhDs or PharmDs.
d3 Medicine’s staff is comprised of experienced drug developers, clinical pharmacologists and regulatory specialists. Our team can advise on all aspects of drug development strategy. Partnering with our clients, we derive a more robust plan that has been pressure tested from multiple angles. We incorporate contemporary thinking in regulatory science, quantitative clinical pharmacology and value-focused decision-making.
Patient health is always at the forefront on our work.
By combining with Certara’s unique model-informed drug development and regulatory submittal and communications expertise, we can move forward more quickly on achieving our mission: we are revolutionizing drug development by applying quantitative science and smart regulatory strategy to inform the most crucial decisions.
- drug development optimization strategy, stewardship and implementation,
- regulatory consulting and liaison services with global health authorities, and
- evaluating, strategizing, and optimizing licensing and M&A plans.
Spotlight on the clinical pharmacology road map
As clinical pharmacology comprises more than 50 percent of a drug label, the need to optimize safety and efficacy in drug development is critical. We understand the impact of clinical pharmacology on a drug development program and devise strategies to harness that knowledge toward a more successful program in consideration of:
- the rigors and latest thinking on the part of the regulators;
- speed, efficiency, and optimization of the development process;
- the competitive landscape and a ‘pharmacology-to-payer’ perspective
We begin with a client assessment, diagnosis and gap analysis. Next, we develop and implement a road map that translates model informed drug development (MIDD) into the decision-making process and leverages all data to align with that optimized clinical strategy. Our expertise from having sat on both sides of the table at critical regulatory meetings provides confidence in our recommendations on how to best leverage MIDD throughout a program.
We can support specific products, programs or entire portfolios, participate in licensing and due diligence activities, work alongside a drug development team, or serve as that fully outsourced partner.
Tailoring a road map to optimize regulatory and commercial success
Our work provides ongoing stewardship for many clients, supporting them at pivotal times during their development programs, including interactions with health authorities, during due diligence or at the deal table with potential commercial partners. Many opportunities to develop medicines faster and better may be unlocked via embracing integrated leadership in clinical pharmacology and regulatory science coupled with advances in pharmacometrics and biosimulation.
Far too many cases treat drug development like a relay race, with the baton handed from one participant to the next. We see it as a team sport where clinical pharmacology helps bring the domains of expertise together in an integrated manner with a renewed focus on regulatory science innovation. We focus on cost, time and certainty, all oriented to the patient need.
Our team of drug development and regulatory science specialists guides the client’s program by testing and evolving the strategy to optimize the development program. Moreover, our growing modeling and simulation toolkit, for which Certara has the largest portfolio and client base, further differentiates us. Demand for all of these capabilities is growing exponentially.
Solving the toughest drug development problems
To learn more about our approach, I hope that you’ll watch this webinar on quantitative pharmacology strategies for pediatric drug development that I presented with my colleague, Dr. Patrick Smith.