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The Citeline Awards, now in its 7th year, will return to Boston in April 2023, bringing together hundreds of renowned leaders in biopharmaceuticals, CRO and diagnostics, to honor the greatest innovations in clinical R&D. The Awards will bring together leading names in the industry, for an evening of networking and celebration, to toast the inspirational work and tireless commitment, shown by the brightest minds in the industry.
Winners will be celebrated across 12 categories, celebrating a broad spectrum of R&D activities, from excellence in rare disease drug development, best artificial intelligence in clinical trials, to successes in early phase research (preclinical and phase I). Share your accomplishments with our highly esteemed judging panel and be in with a chance of winning.
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.
To enter this category, please answer the following:
Terms of the entry fee:
To be eligible, the initiatives undertaken must have been activated between August 2021 – January 2023. 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 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.
To enter this category, please provide the following:
Terms of the entry fee
To be eligible, results for the study or program under nomination must have been released between August 2021 – January 2023. Entrants must have played a role in the early phase research, and all joint parties must be disclosed in the application.
This Award will recognize the clinical research team who have 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.
To enter this category, please answer the following:
Terms of entry fee:
To be eligible, the core project for the nominated team must be ongoing or completed between August 2021 – January 2023. Entrants must have played a role in the core project for the product.
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.
To enter this category, please provide the following:
Terms of the entry fee:
To be eligible, results for the study under nomination must have been presented in the public domain between August 2021 – January 2023. Entrants must have played a role in the clinical study, and all joint parties must be disclosed in the application.
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 be rewarded.
To enter this category, please provide the following:
Terms of the entry fee:
To be eligible, drug development activities must have taken place between August 2021 – January 2023. Entrants must have played a role in drug development and/or trial conduct, 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.
To enter this category, please provide the following:
Terms of the entry fee:
All recently launched or significantly updated technologies are eligible to enter if they were used in at least one clinical trial between August 2021 – January 2023. 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 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.
To enter this category, please provide the following:
Terms of the entry fee:
All recently launched or significantly updated technologies are eligible to enter if they were used in at least one clinical trial between August 2021 – January 2023. 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 be presented to two or more organizations who have set a new benchmark in partnering through collaborative clinical trial activity that took place in 2021/22. 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.
To enter this category, please provide the following:
Terms of the entry fee:
To be eligible, the collaborative clinical trial activity in question must be ongoing or completed between August 2021 – January 2023. Entrants must have played a role in the collaborative clinical trial activity, 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 execution of a clinical trial.
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 enter this category, please answer the following:
Terms of the entry fee:
To be eligible, activities must have taken place between August 2021 – January 2023. 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.
Clinical trials are high risk, expensive, resource-intense undertakings that present significant challenges to small 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 August 2021 – January 2023.
To enter this category, please provide the following:
No entry fee for this category
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.
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.
To enter this category, please provide the following:
Terms of the entry fee:
To be eligible, clinical trial recruitment activities must have taken place between August 2021 and January 2023. 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.
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.
To enter this category, please provide the following:
Terms of the entry fee:
To be eligible, clinical research activities must have initiated, progressed, or completed between August 2021 – January 2023. 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.
Jeffrey Bockman
Laura Brown
Joan Chambers
George Gasparis
Laurie Halloran
Marion Howard
Cliff Kalb
Alison Messom
Michael Rice
Ken Suh
Dr Laura Brown is Course Director of the MSc in Clinical Research, University of Cardiff and a Training and QA Consultant.
Dr Brown has held a number of international and senior management positions in the pharmaceutical industry. She has worked for several international companies including GlaxoWellcome, Hoechst Marion Roussel and Phoenix International.
She was a member of the Editorial board of the Good Clinical Practice Journal for 10 years. She is author of several books including Project Management for the Pharmaceutical Industry, a Practical Guide to the Clinical Trial Directive and several articles on the new EU Clinical Trial Regulation.
Joan develops and executes strategic marketing, promotional and outreach campaigns to support CISCRPs mission of raising awareness and understanding about clinical research and the important role it plays in public health. Additionally, directs, plans, launches new initiatives for new growth opportunities.
A well-known speaker at industry conferences, Joan has presented on a wide variety of topics specific to the clinical trials enterprise. Joan is on the Board of Directors for Greater Gift, the US PharmaTimes Steering Committee for CROY, Steering Committee for Pharma Intelligence/ Informa Clinical & Research Excellence Awards (CARE), Steering Committee for PopUp Star and is an active member of the Association of Clinical Research Professionals (ACRP) and the Drug Information Association (DIA). Joan was on the Advisory Board for The Center for Information and Study on Clinical Research Participation (CISCRP) for over 10 years. In the course of her career, she has published in clinical trade journals and was an instructor for Barnett International’s CRA/CRC programs on the site identification/qualification process.
Accomplished and performance-driven marketing and operations executive with 20+ years of experience in the health life sciences with a successful track record in marketing and strategic planning, implementation, guidance and direction to companies and professionals. Ability to lead, motivate, mentor and establish strong relationships at all levels internally and externally. Strong professional networking and presentation skills among a wide range of industry business professionals.
George Gasparis has over 35 years of experience in the administration or conduct of human subjects research. Prior to founding “PEER”, he served as the Asst. VP and Sr. Asst. Dean for Research Ethics at Columbia University (CU), CU Medical Center (CUMC) from 2003-12, where he directed the IRB Office and compliance team. He worked at the Office for Human Research Protections (OHRP) for seven years and served as the Director, Division of Assurances and Quality Improvement from 2000-03, where he led the development of the OHRP QI Program and electronic submission of the Federalwide Assurance (FWA). He has also served as the Director, The George Washington University Medical Center (GWUMC) IRB and Research Pharmacy after serving as a Data Manager for over 40 clinical trials at GWUMC.
Laurie Halloran founded Halloran Consulting Group in 1998, originally operating out of an unfinished bathroom. Her time as a pediatric ICU nurse had inspired her to start a company that helps move new therapies through FDA processes to get them into the hands of patients desperately in need. By providing a strategic development team, innovative start-up companies could have access to world-class expertise at a fraction of the cost. Since its humble beginnings, Halloran has grown into a successful consultancy of like-minded experts who are dedicated to improving human health by making life science companies better at what they do.
Laurie has been named 2018 Women’s Business Enterprise Star by the Women's Business Enterprise National Council (WBENC) and has won a 2017 Enterprising Women of the Year Award from Enterprising Women Magazine. Halloran Consulting Group was also named an Inc. 5000 Fastest Growing Company for the past three years in a row. In 2015, Laurie was honored by the Boston Business Journal as a Woman of Influence, in 2010 was selected as one of the 100 Most Inspiring People in Life Science by PharmaVoice, and in 2009, she was awarded Clinical Researcher of the Year by the New England Chapter of the Associate of Clinical Research Professionals.
Dr. Howard is Principal and Founder of Cambridge BioStrategies, LLC, a corporate and business development practice supporting biomedical companies at the interface of science, strategy and valuation.
She has over 25 years of experience in medical research, technology assessment and appraisal, and provides an in-depth understanding of the treatment landscape - including the molecular & cellular mode of action of therapies and translational research insights. Combined with competitive, commercial, regulatory and pharmacoeconomic considerations, this informs her counsel on corporate strategy, product positioning, development and commercialization.
Dr. Howard advises on early and late stage clinical trial designs across a wide range of therapeutic categories. Her clients include North American and European private and public biotech and pharmaceutical companies as well as venture capital firms.
She has been a mentor and reviewer for emerging technologies and companies for the Massachusetts Biotechnology Council (MBC) and has served on the Board of the Hypersomnia Foundation and the NTSAD patient advocacy group as well as on advisory boards of GSK, Shire and others.
Cliff Kalb is President of C. Kalb& Associates, LLC, a pharma consultancy in intelligence and strategy.
He has served for over four decades in a broad variety of senior level functions the industry. Cliff was Senior Vice President with Wood Mackenzie, where he provided thought leadership on life science industry issues and directed their knowledge based research and consulting practice.
Previously, he served as Senior Director, Strategic Business Analysis at Merck, heading their global intelligence function. Earlier in his career he worked for Marion, Pfizer, and Roche in sales, market analysis, health economics, public policy, marketing, licensing, business intelligence and business development building experience across virtually all therapeutic categories.
He also headed commercial development for a biotechnology firm affiliated with J&J.A molecular geneticist by training, Dr. Alison Messom has nearly 20 years of industry experience, working both within Pharmaceutical Companies and Clinical Research Organisations and is the current Chairman of the Board of Directors of the ICR.
With detailed experience of directing global clinical trials, Dr.Messom has worn many different hats during her career. She has had the opportunity to travel far and wide on business; lived in the UK, France and Switzerland, and gained operational experience in over 50 countries and line management in over 30.
During the course of her career she has line managed at all levels from CTAs through to Directors and VPs. At both i3 Research and ICON she helped build a new department of dedicated line managers for CRAs and also Start Up teams. While within the Pharma environment she line managed teams within Study and Project Management, Clinical Supplies, Translational Medicine, Data Management, Statistics, Informatics and IT – showing that line management skills are transferrable across functional areas.
Mike leads Defined Health’s Gene and Cell Therapeutics and Rare Diseases practices. He also co-heads the oncology practice focusing on hematologic malignancies and genetically defined cancers. Prior to Defined Health, Mike gained over a decade of experience creating new biotech ventures from academic inventions pertaining to nucleic acids and cellular platforms applied across monogenetic diseases and oncology. Industry positions involved translational research, strategic planning, technology transfer, finance and business development.
Mike holds an MBA, with a concentration in Biotechnology from the Alfred Lerner School of Business and Economics, at the University of Delaware, an MS in Molecular Pharmacology from Thomas Jefferson University and a Bachelor of Science degree in Biology from the University of Delaware. Mike studied the molecular basis of cancer at the Kimmel Cancer Institute and is recognized for his extensive intellectual property and publication portfolio pertaining to cancer genetics, recombinational DNA repair, gene therapy, diagnostics, and agricultural trait improvement.
Mike is an inaugural member of the American Society of Gene and Cell Therapy (ASGCT), as well as a member of the Society for Immunotherapy of Cancer (SITC), the American Society of Clinical Oncology (ASCO), the American Society of Hematology (ASH), the Licensing Executives Society (LES), and the American Heart Association (AHA).
Kenneth Suh is a visionary and pragmatic pharmaceutical executive with over two decades of business, commercial and development leadership experience. He was most recently the President of VIVUS, Inc., a NASDAQ listed pharmaceutical organization from July 2018 to October 2019. Under his leadership the organization increased top line sales by 29% and EBITDA by 45% compared to a significant decline in performance prior to his appointment. He was the founder of Willow Biopharma Inc., a private specialty pharmaceutical company based in Toronto. He served as President and CEO and Board Director of Willow from September 2015 to July 2018. He successfully led the transaction between Willow and VIVUS whereby Willow became a subsidiary of Vivus, Inc. on April 2018 and the management team of Willow took on management positions at VIVUS. He was the architect of the $135 million Pancreaze acquisition. He served as President and Chief Executive Officer and Board Director from 2013 to 2015 for KRIM Biopharma Inc., successfully raising over $225 million for M&A purposes. He also held various key marketing and sales positions with increasing responsibilities at Novartis Pharma Canada from 2006 to 2013. He received an Honours Bachelor of Commerce Degree from the University of Guelph, Ontario in 1999.
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The Citeline Awards are now in their 7th year of recognizing the outstanding achievements across the whole spectrum of key R&D activities in the biopharmaceutical industry. Take a look back at our previous Awards and winners.
