scholarly journals The new contraceptive revolution: developing innovative products outside of industry†,‡

2020 ◽  
Vol 103 (2) ◽  
pp. 157-166
Author(s):  
Rebecca L Callahan ◽  
Neha J Mehta ◽  
Kavita Nanda ◽  
Gregory S Kopf
Keyword(s):  
Unmet Need ◽  
Lessons Learned ◽  
Innovative Drug ◽  
Middle Income ◽  
Government Organizations ◽  
Drug Products ◽  
Technological Advances ◽  
Challenges And Opportunities ◽  
Innovative Products ◽  
Early Phase Clinical Trials

Abstract A significant global unmet need for new contraceptive options for both women and men remains due to side effect profiles, medical concerns, and inconvenience of many currently available products. The pharmaceutical industry has largely abandoned early research and development for contraception and will not likely engage to bring new products to the market unless they have been significantly de-risked by showing promise in early phase clinical trials. This lack of interest by big pharma comes at a time when scientific and technological advances in biology and medicine are creating more opportunities than ever for the development of new and innovative drug products. Novel partnerships between the academic sector, small biotechnology companies, foundations, non-government organizations (NGOs), and the federal government could accelerate the development of new contraceptive products. We discuss the challenges and opportunities that we have encountered as an NGO with a mission to develop novel contraceptive products for low- and middle-income countries and how it differs from developing products for higher-income markets. We hope that our experiences and “lessons learned” will be of value to others as they proceed down the product development path, be it for female or male or for hormonal or nonhormonal contraceptives.

scholarly journals Building Capacity and Training for Digital Health: Challenges and Opportunities in Latin America

10.2196/16513 ◽  
2019 ◽  
Vol 21 (12) ◽  
pp. e16513 ◽  
Author(s):  
Walter H Curioso
Keyword(s):  
Latin America ◽  
Rural Areas ◽  
Training Programs ◽  
Digital Health ◽  
Unmet Need ◽  
Developed Countries ◽  
Lessons Learned ◽  
Resource Constrained ◽  
Challenges And Opportunities ◽  
And Training

Tackling global health challenges demands the appropriate use of available technologies. Although digital health could significantly improve health care access, use, quality, and outcomes, realizing this possibility requires personnel trained in digital health. There is growing evidence of the benefits of digital health for improving the performance of health systems and outcomes in developed countries. However, significant gaps remain in resource-constrained settings. Technological and socio-cultural disparities between different regions or between provinces within the same country are prevalent. Rural areas, where the promise and need are highest, are particularly deprived. In Latin America, there is an unmet need for training and building the capacity of professionals in digital health. This viewpoint paper aims to present a selection of experiences in building digital health capacity in Latin America to illustrate a series of challenges and opportunities for strengthening digital health training programs in resource-constrained environments. These describe how a successful digital health ecosystem for Latin America requires culturally relevant and collaborative research and training programs in digital health. These programs should be responsive to the needs of all relevant regional stakeholders, including government agencies, non–governmental organizations, industry, academic or research entities, professional societies, and communities. This paper highlights the role that collaborative partnerships can play in sharing resources, experiences, and lessons learned between countries to optimize training and research opportunities in Latin America.

Lessons Learned From the COVID-19 Pandemic and the Implications for Pharmaceutical Graduate Education and Research

2022 ◽  
pp. 324-345
Author(s):  
Alok Bhushan ◽  
Kimberly B. Garza ◽  
Omathanu Perumal ◽  
Sudip K. Das ◽  
David J. Feola ◽  
...  
Keyword(s):  
Graduate Education ◽  
Unmet Need ◽  
Well Being ◽  
The United States ◽  
Lessons Learned ◽  
Pharmaceutical Sciences ◽  
Research Mentoring ◽  
Challenges And Opportunities ◽  
The Impact

The COVID-19 pandemic has resulted in changes in the way we teach at all levels of education globally. This chapter specifically focusses on the impact of COVID-19 pandemic on MS and PhD programs in pharmaceutical sciences in schools/colleges of pharmacy in the United States. Potential expectations to bring the pandemic in control by rolling out the vaccine gives us hope, but there is an unmet need of medicines to treat patients affected by the disease. The impact of the pandemic on pharmaceutical sciences education has been on the pedagogy of teaching, research, mentoring, writing, and enrollment. This has also affected the progression of students in their programs as well as their stress levels and well-being. The role of administrators and accreditation agencies is critical in supporting graduate education by providing leadership and directions for the successful outcomes of these programs. Challenges and opportunities for these graduate programs are discussed in this chapter.

scholarly journals Innovations in Pediatric Drug Formulations and Administration Technologies for Low Resource Settings

Pharmaceutics ◽  
2019 ◽  
Vol 11 (10) ◽  
pp. 518 ◽  
Author(s):  
Stephen E. Gerrard ◽  
Jennifer Walsh ◽  
Niya Bowers ◽  
Smita Salunke ◽  
Susan Hershenson
Keyword(s):  
Unmet Need ◽  
Oral Dosage ◽  
Pediatric Medicine ◽  
Middle Income ◽  
Low Resource Settings ◽  
Low Resource ◽  
Medicine Development ◽  
Increased Risk ◽  
Challenges And Opportunities ◽  
Medicines For Children

Despite advances in regulations and initiatives to increase pediatric medicine development, there is still an unmet need for age-appropriate medicines for children. The availability of pediatric formulations is particularly lacking in resource poor areas, due to, for example, area-specific disease burden and financial constraints, as well as disconnected supply chains and fragmented healthcare systems. The paucity of authorized pediatric medicines often results in the manipulation and administration of products intended for adults, with an increased risk of mis-dosing and adverse reactions. This article provides an overview of the some of the key difficulties associated with the development of pediatric medicines in both high and low resource areas, and highlights shared and location specific challenges and opportunities. The utilization of dispersible oral dosage forms and suppositories for low and middle-income countries (LMICs) are described in addition to other platform technologies that may in the future offer opportunities for future pediatric medicine development for low resource settings.

scholarly journals Novel Humanitarian Aid Program: The Glivec International Patient Assistance Program—Lessons Learned From Providing Access to Breakthrough Targeted Oncology Treatment in Low- and Middle-Income Countries

2015 ◽  
Vol 1 (1) ◽  
pp. 37-45 ◽  
Author(s):  
Pat Garcia-Gonzalez ◽  
Paula Boultbee ◽  
David Epstein
Keyword(s):  
Health Care ◽  
Insurance Coverage ◽  
Lessons Learned ◽  
Innovative Drug ◽  
Access To Treatment ◽  
Assistance Program ◽  
Middle Income ◽  
Middle Income Countries ◽  
Patient Assistance ◽  
Low And Middle Income

Imatinib was the first targeted therapy approved for the treatment of cancer. With its approval, it was immediately clear to Novartis that this breakthrough therapy would require an innovative approach to worldwide access, with special consideration of low- and middle-income countries. Lack of government reimbursement, universal health care, or health insurance coverage, few trained specialty physicians or diagnostic services, and poor health care infrastructure were, and continue to be, contributing barriers to access to treatment in low- and middle-income countries. The Glivec International Patient Assistance Program (GIPAP) is an international drug donation program established by Novartis Pharma AG and implemented in partnership with The Max Foundation, a nonprofit, nongovernmental organization. GIPAP was established in 2001, essentially in parallel with the first approval of imatinib for chronic myeloid leukemia. Since 2001, GIPAP has made imatinib accessible to all medically and financially eligible patients within 80 countries on an ongoing basis as long as their physicians prescribe it and no other means of access exists. To date, more than 49,000 patients have benefited from GIPAP, and 2.3 million monthly doses of imatinib have been approved through the program. GIPAP represents an innovative drug donation model that has set the standard for access programs for other targeted or innovative therapies. The purpose of this article is to describe the structure of GIPAP, as well as important lessons that have contributed to the success of the program. This article may assist other companies with the development of successful and far-reaching patient assistance programs in the future.

scholarly journals Lessons Learned from Twelve Years of Partnered Tobacco Cessation Research in the Dominican Republic

2016 ◽  
Vol 11 (2) ◽  
pp. 99-107 ◽  
Author(s):  
Deborah J. Ossip ◽  
Sergio Díaz ◽  
Zahira Quiñones ◽  
Scott McIntosh ◽  
Ann Dozier ◽  
...  
Keyword(s):  
Dominican Republic ◽  
Tobacco Control ◽  
Tobacco Cessation ◽  
Early Stage ◽  
Lessons Learned ◽  
Middle Income ◽  
Health Crisis ◽  
Challenges And Opportunities ◽  
Tobacco Epidemic ◽  
The One

Engaging partners for tobacco control within low and middle income countries (LMICs) at early stages of tobacco control presents both challenges and opportunities in the global effort to avert the one billion premature tobacco caused deaths projected for this century. The Dominican Republic (DR) is one such early stage country. The current paper reports on lessons learned from 12 years of partnered United States (US)-DR tobacco cessation research conducted through two NIH trials (Proyecto Doble T, PDT1 and 2). The projects began with a grassroots approach of working with interested communities to develop and test interventions for cessation and secondhand smoke reduction that could benefit the communities, while concurrently building local capacity and providing resources, data, and models of implementation that could be used to ripple upward to expand partnerships and tobacco intervention efforts nationally. Lessons learned are discussed in four key areas: partnering for research, logistical issues in setting up the research project, disseminating and national networking, and mentoring. Effectively addressing the global tobacco epidemic will require sustained focus on supporting LMIC infrastructures for tobacco control, drawing on lessons learned across partnered trials such as those reported here, to provide feasible and innovative approaches for addressing this modifiable public health crisis.

scholarly journals Building Capacity and Training for Digital Health: Challenges and Opportunities in Latin America (Preprint)

2019 ◽  
Author(s):  
Walter H Curioso
Keyword(s):  
Latin America ◽  
Rural Areas ◽  
Training Programs ◽  
Digital Health ◽  
Unmet Need ◽  
Developed Countries ◽  
Lessons Learned ◽  
Resource Constrained ◽  
Challenges And Opportunities ◽  
And Training

UNSTRUCTURED Tackling global health challenges demands the appropriate use of available technologies. Although digital health could significantly improve health care access, use, quality, and outcomes, realizing this possibility requires personnel trained in digital health. There is growing evidence of the benefits of digital health for improving the performance of health systems and outcomes in developed countries. However, significant gaps remain in resource-constrained settings. Technological and socio-cultural disparities between different regions or between provinces within the same country are prevalent. Rural areas, where the promise and need are highest, are particularly deprived. In Latin America, there is an unmet need for training and building the capacity of professionals in digital health. This viewpoint paper aims to present a selection of experiences in building digital health capacity in Latin America to illustrate a series of challenges and opportunities for strengthening digital health training programs in resource-constrained environments. These describe how a successful digital health ecosystem for Latin America requires culturally relevant and collaborative research and training programs in digital health. These programs should be responsive to the needs of all relevant regional stakeholders, including government agencies, non–governmental organizations, industry, academic or research entities, professional societies, and communities. This paper highlights the role that collaborative partnerships can play in sharing resources, experiences, and lessons learned between countries to optimize training and research opportunities in Latin America.

scholarly journals Over-the-counter sales of antibiotics for human use in India: The challenges and opportunities for regulation

2021 ◽  
Vol 21 (2) ◽  
pp. 147-173
Author(s):  
Gerard Porter ◽  
Anita Kotwani ◽  
Lovleen Bhullar ◽  
Jyoti Joshi
Keyword(s):  
Stakeholder Participation ◽  
Economic Incentives ◽  
Social Scientists ◽  
Over The Counter ◽  
Middle Income ◽  
Information Campaigns ◽  
Challenges And Opportunities ◽  
Regulatory Instruments ◽  
Human Use ◽  
And Control

This article assesses the regulatory framework relating to over-the-counter (OTC) sales of antibiotics for human use in India. The OTC sale of antibiotics is recognised as a pathway for the emergence of antimicrobial resistance (AMR); a serious public health challenge in need of urgent regulatory responses. Analytically, this article identifies opportunities within existing laws in India and highlights gaps that need to be filled by modifying existing laws or developing new ones. Conceptually, it suggests a need to reflect on the limits of traditional, top-down, ‘command-and control’ regulation and to think about alternative approaches. The article therefore advocates for an approach to regulation that incorporates two elements. First, it argues for a broader concept of regulation that encompasses binding as well as non-binding regulatory instruments and initiatives aimed at influencing stakeholder behaviour (including soft regulation, economic incentives, information campaigns and uses of technology). Second, it makes the case for enhanced stakeholder participation in regulatory design. The article will be relevant for health policy and drug regulators in India and other low- and middle-income countries, as well as legal scholars, social scientists and others interested in the regulation of OTC sales of antibiotics for AMR containment.

scholarly journals Barriers to training in laparoscopic surgery in low- and middle-income countries: A systematic review

2021 ◽  
pp. 004947552199818
Author(s):  
Ellen Wilkinson ◽  
Noel Aruparayil ◽  
J Gnanaraj ◽  
Julia Brown ◽  
David Jayne
Keyword(s):  
Laparoscopic Surgery ◽  
Low Cost ◽  
Surgical Care ◽  
Successful Implementation ◽  
Middle Income ◽  
Middle Income Countries ◽  
Technological Advances ◽  
Local Access ◽  
And Training ◽  
Low And Middle Income

Laparoscopic surgery has the potential to improve care in resource-deprived low- and-middle-income countries (LMICs). This study aims to analyse the barriers to training in laparoscopic surgery in LMICs. Medline, Embase, Global Health and Web of Science were searched using ‘LMIC’, ‘Laparoscopy’ and ‘Training’. Two researchers screened results with mutual agreement. Included papers were in English, focused on abdominal laparoscopy and training in LMICs. PRISMA guidelines were followed; 2992 records were screened, and 86 full-text articles reviewed to give 26 key papers. Thematic grouping identified seven key barriers: funding; availability and maintenance of equipment; local access to experienced laparoscopic trainers; stakeholder dynamics; lack of knowledge on effective training curricula; surgical departmental structure and practical opportunities for trainees. In low-resource settings, technological advances may offer low-cost solutions in the successful implementation of laparoscopic training and improve access to surgical care.

Foundations of Advanced Neuroanatomy: Technical Guidelines for Specimen Preparation, Dissection, and 3D-Photodocumentation in a Surgical Anatomy Laboratory

2019 ◽  
Author(s):  
Luciano César PC Leonel ◽  
Lucas P. Carlstrom ◽  
Christopher S. Graffeo ◽  
Avital Perry ◽  
Carlos Diogenes Pinheiro-Neto ◽  
...  
Keyword(s):  
Oral Tradition ◽  
Dynamic Range ◽  
Tap Water ◽  
Three Dimensional ◽  
High Dynamic Range ◽  
Surgical Anatomy ◽  
Lessons Learned ◽  
Specimen Preparation ◽  
Technological Advances ◽  
Key Steps

Abstract Objective This study was aimed to provide a key update to the seminal works of Prof. Albert L. Rhoton Jr., MD, with particular attention to previously unpublished insights from the oral tradition of his fellows, recent technological advances including endoscopy, and high-dynamic range (HDR) photodocumentation, and, local improvements in technique, we have developed to optimize efficient neuroanatomic study. Methods Two formaldehyde-fixed cadaveric heads were injected with colored latex to demonstrate step-by-step specimen preparation for microscopic or endoscopic dissection. One formaldehyde-fixed brain was utilized to demonstrate optimal three-dimensional (3D) photodocumentation techniques. Results Key steps of specimen preparation include vessel cannulation and securing, serial tap water flushing, specimen drainage, vessel injection with optimized and color-augmented latex material, and storage in 70% ethanol. Optimizations for photodocumentation included the incorporation of dry black drop cloth and covering materials, an imaging-oriented approach to specimen positioning and illumination, and single-camera stereoscopic capture techniques, emphasizing the three-exposure-times-per-eye approach to generating images for HDR postprocessing. Recommended tools, materials, and technical nuances were emphasized throughout. Relative advantages and limitations of major 3D projection systems were comparatively assessed, with sensitivity to audience size and purpose specific recommendations. Conclusion We describe the first consolidated step-by-step approach to advanced neuroanatomy, including specimen preparation, dissection, and 3D photodocumentation, supplemented by previously unpublished insights from the Rhoton fellowship experience and lessons learned in our laboratories in the past years such that Prof. Rhoton's model can be realized, reproduced, and expanded upon in surgical neuroanatomy laboratories worldwide.

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