Written by: Gerald L. Klein, MD; Roger E. Morgan, MD; Shabnam Vaezzadeh, MD; Pavle Vukojevic, MD; Burak Pakkal, MD; Michael Fath, PhD; Renu Jain, PhD; Larry Florin, MBA; Victoria Manax, MD
Drug, Device, and Diagnostic Development
3D printing technology is revolutionizing the field by significantly advancing pharmaceutical and medical device manufacturing, as well as playing a pivotal role in the innovation of clinical study methodologies. It can produce complicated shapes and geometric internal structures that can improve drug release.[1] For example, advanced techniques such as extrusion methods and photopolymerization are used to produce transdermal drug delivery through microneedle systems.[2] 3D printing may help accelerate drug formulation via formulation by design, in large-scale manufacturing, and personalized dosing, to name a few of these benefits. An FDA-approved example is Spritam® tables for treating epilepsy, which are designed to disintegrate within seconds after taking a sip of water, showcasing the potential for creating dosage forms with instantaneous drug release. Tailoring the size, drug release profile, and shape of dosage forms can be particularly useful for special populations, such as children who might need smaller or special doses and older adults with various physiological conditions. These will all require a close working relationship with the FDA’s Emerging Technology Team to help facilitate new guidance for this developing technology.[3]
It’s crucial for the safety team in a clinical trial to educate the principal investigators and their teams so they understand basic pharmaceutical and clinical safety reporting requirements. Common errors include:
Not reporting serious adverse events (SAEs) and adverse events (AEs) of special interest in a timely fashion
Not providing AE/SAE follow-up reports
Not following up on clinically significant laboratory abnormalities
The inappropriate assignment of causality
Inadequate narrative reports for SAEs
510Ks do not require a clinical trial. However, a robust clinical trial is often required for other important reasons including:
Clinical differentiation, e.g., data for generating publications and presentations (resulting in increased physician and patient adoption)
Increasing product licensing potential
Real-world evidence (RWE) and Health Economics and Outcomes Research (HEOR) data for improved market access and insurance reimbursement
Data for investment opportunities
Medical Affairs
The use of AI may improve the efficiency of enrolling patients in clinical trials. New products are being released that have the potential to quickly match patient charts with protocols and eligibility criteria. Patient enrollment and retention is a commonplace problem in clinical trials and one of the main reasons for slow enrollment or incomplete studies.
An often-overlooked opportunity in medical affairs (MA) is to promote recommended guidance documents for both diagnostic and therapeutic regimens.
It has been estimated that only 55% of the US population receives recommended healthcare services.[4] This varies from country to country but is still far below what it should be.
This is partially a combination of health care providers (HCPs) not prescribing recommended care and patients’ poor medication adherence.[5,6]
This presents an opportunity for MA teams to help improve care delivery by reminding HCPs of the current guidelines for optimum disease care and outcomes
A recent study of type 2 diabetic (T2D) patients found that the following would have improved their medical adherence:[7]
Medical information
Assistance with disease management
Increased and more informative doctor-patient interaction
Better information about the medication and its side effects
MA professionals can improve this situation by providing informative materials that can help improve patient care and increase the appropriate use of their products.
Many physicians are not aware of potential drug-drug interactions; MAs can augment patient safety/drug efficacy by informing HCPs of this vital information.
As an example, numerous medications have interactions with Cytochrome P450 enzymes, yet there is often a lack of communication from physicians regarding the risks these interactions pose. Utilizing artificial intelligence could enhance patient safety by screening all concurrent medications, ensuring that patients are not prescribed drugs that could lead to adverse interactions.
Nursing schools and hospital nursing departments can be overlooked by medical affairs teams in favor of medical and pharmacy schools. These nursing institutions can be great places to interact with HCPs who can help with the following:
Initiate and conduct investigator-initiated trials
Educate other HCPs on the significance of the products
Assist in providing inappropriate education to patients
Provide a deeper understanding of how patients accept products and determine what additional information is required
Provide lectures at conferences and continuing education meetings
Publish articles and white papers in nursing journals and other publications
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[1] Awad, A., Yao A. et al. Advances in powder bed fusion 3D printing in drug delivery and healthcare. Advanced Drug Delivery reviews 174, 406-421.
[2] Sophia N. Economidou, Dennis Douroumis, 3D printing as a transformative tool for microneedle systems: Recent advances, manufacturing considerations and market potential, Advanced Drug Delivery Reviews, Volume 173, 2021: 60-69.
[3] Timothy Tracy, Lei Wu, Xin Liu, Senping Cheng, Xiaoling Li, 3D printing: Innovative soklutions for patients and pharmaceutical industry, International Journal of Pharmaceutics, Volume 631, 2023.
[4] McGlynn EA, Asch SM, Adams J, Keesey J, Hicks J, De Cristafaro A, Kerr EA. The quality of health care delivered to adults in the United STates. N Engl J Med. 2003 Jun 26;348(26):2635-45.
[5] Woolf SH, Johnson RE. The breakpeven point: when medical advances are less important than improving the fidelity with shich they are delivered. Ann Fam Med. 2005 Nov-Dec;3(6):545-52.
[6] Marcum ZA, Hanlon JT, Murray MD. Improving Medication Adherence and Health Outcomes in Older Adults: An Evidence-Based Review of Randomized Controlled Trials. Drugs Aging. 2017 Mar:34(3):191-201.
[7] de climens A., Pain E. et al: Understanding reasons for treatment discontinuation, attitudes and education needs among people who discontinue type 2 diabetes treatment: results from an online patient survey in the USA and UK.