The attempt to combat rare diseases is a challenging task that exemplifies how the pharmaceutical industry addresses unmet medical needs. This Award will recognize the efforts of an individual, team, or company that demonstrated excellence while developing a drug intended to treat rare diseases. The judges will be looking for a drug development program or trial with the largest potential impact in the rare disease space. Outstanding patient centric processes and innovation in study conduct to overcome the various obstacles of rare disease drug development will also earn high marks.

FINALISTS

• Alexion, AstraZeneca Rare Disease
• BridgeBio and ML BioSolutions
• Inozyme Pharma
• KalVista Pharmaceuticals
• Marinus Pharmaceuticals
• SpringWorks Therapeutics
• Travere Therapeutics

WHO COULD ENTER

To be eligible, drug development activities must have taken place between January 2023 – February 2024.  Entrants must have played a role in drug development and/or trial conduct, and all joint parties must be disclosed in the application.

Artificial intelligence (AI) is revolutionizing healthcare and its application in Pharma is gaining momentum. AI technology provides new opportunities to improve drug discovery, clinical development, and commercial adoption of new medicines. This Award will recognize the efforts of an individual, team, or company in leveraging artificial intelligence to improve a clinical trial process, or to support the successful operations of a clinical trial.

FINALISTS

• ICON
• Medidata
• Moderna
• TrialWire
• Yseop

WHO COULD ENTER

The judges will be looking for innovative uses of AI that provide a meaningful impact on protocol design, trial execution, or other related activities.  To be eligible, activities must have taken place between January 2023 – February 2024.  Entrants must have played a role in the design, implementation or application of the AI tool, and all joint parties must be disclosed in the application.

Sponsors and drug development teams are increasingly adopting novel recruitment strategies and technologies to actively engage patients in the clinical trial journey.  To support successful enrolment and to better understand the perspective of the patient, fundamentals of consumer and behavioural science are being applied in the clinical research arena.  This Award will recognize the efforts of an individual, team, or company in bringing innovative approaches to support patient-consumer engagement in clinical trial recruitment.  The judges will be looking for creative initiatives that fostered connection with the patient community and delivered a positive and meaningful impact on trial enrolment.              

FINALISTS

• CTI Clinical Trial & Consulting in collaboration with Bexion Pharmaceuticals
• Kura Oncology
• Moderna
• OcuTerra Therapeutics
• PepGen
• PPD, Part of Thermo Fisher Scientific

WHO COULD ENTER

To be eligible, clinical trial recruitment activities must have taken place between January 2023 – February 2024.   Entrants must have played a role in the design or implementation of the study recruitment strategy, and all joint parties must be disclosed in the application.

This Award recognizes the promising and disruptive role that digital health technology is currently playing in clinical trials.  Technological innovators are discovering novel ways to gather high quality patient data using an array of digital tools.   Advances in development of smartphone apps, mobile health devices, and a host of other products are revolutionizing the way patients participate in clinical trials. The judges will be looking for the product that represents the best advance in improving patient data collection and/or the patient experience in clinical trials. Those considered may include electronic patient diaries, mobile health devices or any other digital tools that support, encourage, or aid the patient’s participation in the clinical trial. 

FINALISTS

• IQVIA 
• Medidata's eCOA - Medidata, a Dassault Systèmes Company
• Moderna and ProofPilot
• TrialWire

WHO COULD ENTER

All recently launched or significantly updated technologies are eligible to enter if they were used in at least one clinical trial between January 2023 – February 2024. Companies wishing to enter must have played a role in the development/use of the nominated technology, and all parties to any joint development agreements must be disclosed in the application.  Both technology companies and trial sponsors utilizing the technology are eligible to enter, individually or jointly.

This Award recognizes the vital importance of using the most sophisticated platforms to catalyse and optimize data gathered during clinical trials. Advances in software and applications have a pivotal role to play at all stages of the trial process, assisting Sponsors in effective management of study logistics, monitoring, risk mitigation and timely data collection and analysis.  The judges will be looking for the product or suite of products that help study teams better manage and oversee clinical trial activities.

FINALISTS

• Bioforum, The Data Masters
• Certara
• CluePoints
• Cytel
• Medidata: The Medidata Clinical Data Studio Team
• Phastar
• TrialWire

WHO COULD ENTER

All recently launched or significantly updated technologies are eligible to enter if they were used in at least one clinical trial between January 2023 – February 2024. Companies wishing to enter must have played a role in the development of the nominated technology, and all parties to any joint development agreements must be disclosed in the application.

This Award will recognize an early phase research project that met or surpassed its objectives on a range of key performance indicators. The entrant should show that the successful completion of the program was material in enabling the sponsor to advance its drug to the next development phase either on or ahead of schedule and/or keeping within its development budget.

FINALISTS

• Delix Therapeutics
• Flare Therapeutics
• Immunic Therapeutics
• Verve Therapeutics

WHO COULD ENTER

To be eligible, results for the study or program under nomination must have been released between January 2023 – February 2024. Entrants must have played a role in the early phase research, and all joint parties must be disclosed in the application.

Enhancing the diversity of clinical trial populations is critical to achieving equity in healthcare and improving health outcomes in our most vulnerable populations.  Historically, clinical trial populations have been rather homogenous, and treatment effect and patient outcomes observed in a trial setting may have limited applicability to the larger ‘real world’ population. 

This Award will recognize a company, team or individual who has demonstrated exceptional initiative in promoting diversity and inclusion of underrepresented populations within a clinical trial or drug development program. The entrant should describe the activities/strategies implemented and the impact they had on patient enrolment. Activities ranging from patient-focused study design, use of technology, awareness and recruitment campaigns, or other creative and innovative approaches will be considered.  Evidence of the impact these activities/strategies had on recruitment should also be included.   

FINALISTS

• Johnson & Johnson/Janssen Research & Development
• Medidata, a Dassault Systèmes Company
• Merck, Diversity & Inclusion in Clinical Trials (DICT) Team
• The Association of Diversity in Clinical Trials

WHO COULD ENTER

To be eligible, the initiatives undertaken must have been activated between January 2023 – February 2024. Entrants must have played a role in the design, launch or execution of the plans, and all joint parties must be disclosed in the application.

This Award will be presented to two or more organizations who have set a new benchmark in partnering through collaborative clinical trial activity that took place in 2023/24.  Partnerships could take place between multiple pharmaceutical and/or biotech companies or between a pharmaceutical and/or biotech company and a contract research organization, research institute, non-profit, or cooperative group. 

FINALISTS

• Biomed Valley Discoveries and xCures
• Medidata and Society for Clinical Research Sites
• Moderna and ProofPilot
• Tarsus Pharmaceuticals and Tufts University School of Medicine

WHO COULD ENTER

To be eligible, the collaborative clinical trial activity in question must be ongoing or completed between January 2023 – February 2024. Entrants must have played a role in the collaborative clinical trial activity, and all joint parties must be disclosed in the application.

Clinical trials are high risk, expensive, resource-intense undertakings that present significant challenges to early-stage companies with limited financial and human capital.   This award will recognize a start-up pharma/biotech company that has developed creative and innovative approaches to the formidable challenges that clinical trials present to small organizations.  Solutions may include innovations in designing team structures, resourcing solutions, technology, or process/workflow efficiencies around any clinical trial related activity.  Solutions must be those developed or applied between January 2023 – February 2024.

FINALISTS

• Crescendo Health
• Lindus Health
• Mural Health

WHO COULD ENTER

Start-up pharma/biotech companies wishing to enter must have designed, delivered, and launched the innovation (alone or with a partner), and all parties to any joint development activities must be disclosed in the application.

This Award will recognize the clinical research team who has made significant contributions in advancing a new therapy through one or more clinical phases.  The judges will be looking to reward the high performing team that has been most successful in reaching its goals, adopted effective working practices, achieved major milestones within expected timelines, and contributed to the advancement of new therapies.

FINALISTS

• Agios Pharmaceuticals, Agios 017 ENERGIZE Team
• George Clinical, Phase II IgAN Study Research Team
• Merck, Diversity & Inclusion in Clinical Trials (DICT) Team
• PPD, Part of Thermo Fisher Scientific, Government and Public Health Services Team

WHO COULD ENTER

To be eligible, the core project for the nominated team must be ongoing or completed between January 2023 – February 2024.  Entrants must have played a role in the core project for the product.

Fuelled by the digital revolution in healthcare data, clinical research teams are increasingly advancing drug development through use of real-world data (RWD) and real-world evidence (RWE). Both can have many tactical applications throughout the clinical development lifecycle.  From study design to site selection and patient recruitment, to safety monitoring and post-market surveillance, RWD represents an efficient and powerful tool to drive insights and optimize clinical research. And RWE, when fit for purpose, can play a pivotal role in drug approvals, as acknowledged in recent regulatory guidance documents.

This Award will recognize the efforts of an individual, team, or company that demonstrates excellence in applying RWD/RWE to support drug development. The use of RWD/RWE could occur as early as development of the protocol concept, through trial completion and/or regulatory application submission.   The judges will be looking for creative and innovative uses of RWD/RWE to support a drug’s clinical development journey.

FINALISTS

• ICON
• ICON and the International Paroxysmal Nocturnal Hemoglobinuria Interest Group
• Medidata, a Dassault Systèmes Company
• UBC

WHO COULD ENTER

To be eligible, clinical research activities must have initiated, progressed, or completed between January 2023 – February 2024.  Entrants must have played a role in the design, implementation or application of RWD/RWE, and all joint parties must be disclosed in the application.

This Award will recognize the clinical trial which reported results that had the greatest impact and is expected to lead to an advance in healthcare. The judges will be looking to reward the clinical trial with the largest commercial impact, highest impact on patient population, the greatest disruption in a market, or the advancement of clinical trial design. This might include the first demonstration of a clear clinical effect for a new drug in an area of unmet medical need, a pivotal study of a new drug with a breakthrough mechanism of action, or a major study of a potential new or expanded indication for an already marketed product.

FINALISTS

• Agios Pharmaceuticals
• KalVista Pharmaceuticals
• Karuna Therapeutics – A Bristol Myers Squibb Company
• Novo Nordisk
• Servier Pharmaceuticals

WHO COULD ENTER

To be eligible, results for the study under nomination must have been presented in the public domain between January 2023 – February 2024. Entrants must have played a role in the clinical study, and all joint parties must be disclosed in the application.