Case Studies

  • Thinking around a significant development road block

    The challenge

    A biotech client was unable to differentiate between doses in their Phase 2 clinical program. If FDA was to require two doses to be evaluated in Phase 3 clinical trials, then the development program would no longer be viable. The biotech client engaged d3 Medicine to establish if there was a path to keep the program viable.

    The solution

    The d3 Medicine team evaluated the overall data package, including the Phase 2 results, Phase 2a proof of concept results, existing PK/PD analyses and regulatory precedence data from relevant analogues in the therapeutic space. The team built PK models, performed contemporary PK/PD analyses across key clinical data sets, performed PK/PD simulations, constructed strategic argumentation to support a single phase 3 dose, wrote sections of the end of phase 2 briefing package and supported the client team at the end of phase 2 face to face meeting at FDA. 

    The conclusion

    The FDA accepted the analyses and agreed with a single dose arm to be evaluated in Phase 3 clinical trials.

  • Gaining acceptance of a new accelerated pediatric development pathway

    The challenge

    A biotech client was committed to developing a medicine for a pediatric indication as the first labelled indication.  There was no precedent for regulatory acceptance of an accelerated development pathway for this important disease affecting infants and specific adult subpopulations.

    The solution

    The d3 Medicine team evaluated the available information, and worked with the client team to construct a translational medicine strategy that leveraged preclinical models, disease and PK/PD modelling and simulation, modest PK and safety data from health adults to support switching from adults to infants at the end of Ph2a. d3 Medicine supported the client team at face to face scientific review meetings with European regulators.

    The conclusion

    European regulators accepted the accelerated development strategy proposed for a new treatment for an important pediatric disease. 

  • Identifying the root cause of a problem requires experience in execution as well as strategy

    The challenge

    A biotech client had progressed into Phase 2 with a intravenous (IV) compound that demonstrated variable PK and response. The biotech had exhaustively explored reasons for understanding the variability including potential association with biomarkers.

    The solution

    d3 Medicine was engaged to review the scientific data-package supporting the current development plan thinking, and provide insight on the clinical pharmacology and translational medicine strategy and regulatory strategy. d3 Medicine quickly established that there was non-standard practice at the clinical sites conducting trials regarding the intravenous administration of the new compound that was significantly contributing to variability

    The conclusion

    Identification of the IV administration issue lead to improvements in characterisation of the PK of the compound with existing data, improvements in ongoing studies and significantly impacted on the program strategy moving forward. 

  • Encouraging fresh thinking though collaborative peer review

    The challenge

    An NGO client wanted to pressure test their thinking around their development strategy for a novel antimalarial medicine.

    The solution

    d3 Medicine was engaged to peer review the translational medicine activities, clinical pharmacology and pharmacometrics strategy, pediatric plans and stimulate out of box thinking with the client’s development team. 

    The conclusion

    The NGO team were provided positive feedback and reassurance that they were indeed on track. The discussions also generated some fresh thinking that the clients development team was going to work up as additional strategies to accelerate development and mitigate risk.

     

  • Establishing novel quantitative approaches to connect pharmacology to the payer.

    The challenge

    A pharma client wanted to know if it was possible to quantify the societal impact of a new dose regimen or novel candidate against an emerging pandemic influenza strain.

    The solution

    The d3 Medicine team provided thought leaders in influenza, clinical pharmacology, PK/PD modelling, epidemiological modelling and health economics to tackle the ambitious goal. d3 Medicine facilitated the construction of an integrated road-map, lead and managed execution of the overarching project as well as its technical components including PK/PD analyses, epidemiological and health economic modelling.

    The conclusion

    An integrated modelling approach that linked pharmacology to the payer was established, along with a practical decision framework. This enables early and quantitative exploration of the health economic impact of a new dose regimen or novel candidate against an emerging pandemic influenza strain, under various scenarios. Such outcomes provide opportunity for earlier meaningful discussions between developers, regulators and payers.

     

  • Leading a complex technical due diligence for a major pharma

    The challenge

    A pharma client needed to perform a technical and commercial due diligence (DD) of a strategically sensitive technology platform opportunity. 

    The solution

    d3 Medicine was engaged to lead the client’s DD process to provide recommendations to executive management. d3 Medicine lead the client’s DD team to assess the technology platform, identify potential show-stoppers, risks and de-risking activities, construct development plans with associated timelines, costs and operational impact, and support a commercial assessment.

    The conclusion

    The outcomes of the due diligence were used to make important strategic decisions by the pharma client’s executive management.

  • Influencing policy and medical countermeasures preparedness

    The challenge

    Australia’s Defence Science and Technology Organization wanted to understand Australia’s potential to contribute to an international initiative with USA, UK and Canada on medical countermeasures preparedness against threats including emerging infectious diseases.

    The solution

    d3 Medicine was engaged to lead a national review of capability across areas of antimicrobial resistance, point-of-care diagnostics and advanced/innovative development expertise and manufacturing. National surveys addressing capability and technology were rolled out, medical countermeasures war-games were conducted, meetings with FDA and recommendations provided to Australian government.

    The conclusion

    A national task-force was established, Medical Countermeasures Products Australia (MCPA), to advance Australia’s interests in medical countermeasures preparedness.

  • d3 Medicine helped us look at the totality of our cenicriviroc clinical data through a different lens and develop a robust dose rationale that we presented to FDA in the context of our EOP2 meeting. FDA was in complete agreement with the scientific logic and dose selection from Phase 2b for further evaluation in Phase 3.
    Eric Lefebvre M.D. CMO, Martine Kraus, Ph.D. VP, Regulatory Affairs, Tobira Therapeutics
  • We engaged d3 Medicine to help us challenge conventional pediatric development paradigms for our RSV program.
    Dr. Sushmita Chanda, VP, Alios Biopharma
  • We engaged d3 Medicine to support the design and implementation of key components of an early development program.
    Richard Peck, MD – Global Head, Clinical Pharmacology, Roche
  • We engaged d3 to produce and execute a plan to optimally position a product company for a transaction.
    Mr. Richard Muruve, Chief Executive Officer and President of Arch Biopartners Inc.
  • We engaged d3 Medicine to pressure test our thinking around our translational medicines activities and confirmatory study planning, to be sure we are on an accelerated path to the delivery of life-saving medicines for malaria and stimulate some out of the box thinking.
    David Reddy, CEO MMV, Switzerland
  • d3 Medicine’s work has been essential in helping us develop an understanding of the potential value of a MedCM initiative in Australia.
    Dr Ralph Leslie, Research Leader and Dr. Felicia Pradera, Medical Countermeasures, Defence Science and Technology Organization (DSTO), Australia