Practical Pointers for Product Development and Medical Affairs / May 2023

Written by: Gerald L. Klein, MD; Roger E. Morgan, MD; Shabnam Vaezzadeh, MD; Burak Pakkal, MD and Michael Fath, PhD

Product Development

  • Academic Innovation Centers can serve as pivotal hubs in the context of product development. These hubs can be a focal point in the development of entrepreneurial centers. The ideal center combines diverse university schools of science, nursing, engineering, dental, pharmacology, and dentistry medicine along with a business school. If they can break down the myriad of academic political walls and combine forces with regional governments, state governments, and industry, they can develop a scientific and economic powerhouse. Tremendous centers of innovation and entrepreneurship have been established in the Boston, San Francisco, San Diego, NJ/NY Corridor, and in Research Triangle Park, North Carolina. Academic leadership should proactively enhance the effectiveness of their innovation centers in order to be more effective.

  • Efficient clinical trial enrollment is a critical factor in successful product development. Poor patient enrollment into clinical trials is one of the main reasons for study failure. This is an expensive, time-consuming process. One way that may aid this process is to use Artificial Intelligence (AI) to help with enrollment. There are many AI systems available to achieve this critical goal. Some examples include:

    • IBM Watson Health: Uses machine learning and Natural Language Processing (NLP) to analyze medical records and identify eligible patients for clinical trials. Provides predictive analytics for patient recruitment and engagement.

    • Deep 6 AI: Leverages AI to match patients to clinical trials by analyzing structured and unstructured data from electronic health records. Focuses on speed and accuracy in patient identification.

    • TriNetX: A global health research network that uses real-time access to HER data to identify eligible patients for clinical trials. Offers analytics and patient recruitment solutions.

    • Antidote: Utilizes AI to connect patients with relevant clinical trials. Uses advanced search algorithms to match patient profiles with trial eligibility criteria.

    • CureMetrix: Employs AI to enhance patient identification and engagement through medical imaging analysis and predictive analytics. Helps improve the accuracy of patient matching and recruitment.

    • Clinical AI: Uses AI to streamline the clinical trial process, from patient recruitment to data analysis. Focuses on automating trial management and enhancing patient engagement through AI-driven insights.

  • Include clinical research training for students in health care related programs. Providing proper training for students in medical, nursing, PA, PharmD, and other health care related programs can contribute significantly to product development. We believe that it is important to teach the basic elements of clinical research to all health care students in order to instill the following virtues:

    • Increase their scientific curiosity

    • Enhance their ability to understand the scientific literature

      • Increase their capability to analyze pharmaceutical product effectiveness and adverse effects.

    • Improve their interpretation of clinical trials

    • Be able to apply scientific literature to clinical pracctice

    • Increase the likelihood that students will engage in conducting clinical research and publication

Medical Affairs

  • Webinars serve as a powerful way to get your message out. In order for this to be successful, the target audience must be persuaded to watch this event in either real time or at a later date. This can be enhanced by the following:

    • Selecting appropriate speakers

    • Timing of the event

    • Cutting edge or important subject matter

    • Promotional campaign to attract an audience

  • Strategy: One key strategy in product promotion is to identify a medical need. This could be:

    • Specific populations: consider unique patient groups (e.g., pediatric, geriatric or rare diseases) that require tailored solutions.

    • Intolerant patients: highlight cases where patients cannot tolerate existing therapies. Position your product as an alternative.

    • Niche Situations: Explore scenarios where your product fills a gap. Initiate communication with key opinion leaders (KOLs) and other healthcare providers.

  • Cost-effective data generation using surveys and small studies: The use of surveys and small studies are a cost-effective way to produce data for poster sessions at scientific conferences. This data can be published in a brief publication, and then followed up with subsequent studies and publications. It may be a way to initiate a marketing campaign when you are faced with a low budget.