Revolutionizing Drug Development—d3 Medicine Joins the Certara Family

Revolutionizing Drug Development—d3 Medicine Joins the Certara Family

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.

Specifically, we bring to Certara and its clients expanded capabilities and expertise, most notably in the areas of oncology, orphan diseases, infectious diseases and inflammation, including:

  • 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
drug label with clinical pharmacology sections highlighted
Clinical Pharmacology Comprises up to 50% of a Drug Label

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.

A programmatric approach todrug development

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.

Craig Rayner

About the Author

Dr. Rayner has more than 15 years of drug development experience. His past appointments include leadership roles in Clinical Pharmacology and Early development (Roche), Clinical development (CSL-Behring), in Business Development/Licensing as Global Due Diligence Director (Roche) and as an academic researcher in clinical pharmacology and infectious disease research (Monash University). Dr. Rayner has extensive experience in early and late development of therapeutics, regulatory interaction experience with all major global health authorities, multiple filings and accountability for numerous due diligences, active support of negotiations, deal making and integration activities. He holds an Adjunct Associate Professorship in Pharmaceutical Science (Monash University), and is broadly published in clinical pharmacology and also infectious diseases.