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Drug discovery is complex and can take a long time.
Author Medi-Ops Team Categories Medical & Healthcare News

The Journey of a Drug: Idea to FDA Approval

Drug development is an essential process in the healthcare and medical industry. So much goes into creating safe and effective drugs to better treat different conditions and serve patients better. 

According to the FDA, here are the steps for drug development…

Step One: Discovery and Development

In this step, the need for a new drug has been identified, and research begins in a laboratory. Researchers typically find new drugs when insights into a disease are found, existing treatments produce unanticipated effects, or technological advances create new avenues for development. The trial and error process begins in research to find compounds that are viable options for further research. When compounds are found promising, researchers continue to conduct experiments and gather information on the compound itself as well as how to produce it most effectively in drug form. The effectiveness and interactions with other drugs and compounds are also studied and observed at this stage.

Step Two: Preclinical Research

Testing involving people is taken seriously and can not be conducted until researchers are sure that the drug is safe. That is why in preclinical research, good laboratory practices (GLP) are used. These consist of rules to ensure ethical safety and requirements for quality testing and procedures. The results from testing at this stage determine if the product is safe to move on to clinical studies and patient testing.

This step answers the majority of questions about the realities of the drug and how it interacts with the human body. Even so, before public production and distribution can even be discussed, the research team moves on to the next step of clinical research.

Step Three: Clinical Research

As one of the most lengthy aspects of the drug development process, clinical research goes on for years. This step involves the testing of the drug with people. Developers design the studies around Clinical Research Phases and the Investigational New Drug Process (IND). These processes must be completed before human testers are involved. The IND application must be submitted to the FDA before clinical trials can start. All of the preclinical research and data, as well as information about the investigator and developers, must be included. The FDA will respond to the application and either approve clinical trials or place a clinical hold if requirements aren’t met.

There is a specific protocol and plan developed by researchers and manufacturers for clinical trials. This includes confirming participant numbers, groupings, and qualifications, drug dosage and administration, and data collection and analysis.

Clinical Trial Phases

Phase 1: The first phase involves a small number of qualified participants with the condition being treated. This stage lasts several months, and if the results prove successful, the drug moves on to phase two. 70% of drugs move on to the next phase.

Phase 2: This phase utilizes a larger group of people (sometimes several hundred) and will be carried out anywhere from a few months to over 2 years. The timing of this stage is dependent on the drug and determines the efficacy and side effects of the drug. As this phase is more in-depth and informative on how the drug will perform commercially, only 33% of drugs continue.

Phase 3: Anywhere from 300 to 3,000 people with the condition participate in this phase over one to four years to monitor efficacy and reactions. 25-30% of drugs continue to phase 4.

Phase 4: Several thousand volunteers with the condition are involved in this final phase to ensure the safety and efficacy of the product.

Step Four: FDA Review

Once the drug developer determines from all research that the drug is safe and effective, they will file an application to market the drug, which will be reviewed by the FDA review team. The New Drug Application (NDA) will include all of the data gathered from each step of the process up until this point as well as directions for use, labeling, patent information, safety updates, data from other studies, and drug abuse information. The review team is made up of individuals from different fields of medicine who will review all of the data, conduct clinical study site inspections, and assemble all reviews and reports as a record for FDA review.

When determining a safe and effective drug, the FDA will work with the applicant on narrowing down prescribing information (the “labeling” process). If the FDA requires more information or additional studies, they will address that with the applicant.

Step Five: FDA Post-Market Safety Monitoring

Continued monitoring of the drug and its safety will be in effect once public availability is established. This is conducted through supplemental applications, INDs for marked drugs, manufacturer inspections, drug advertising, active surveillance, generic drug manufacturing, and reporting.

As you can see, this process is extensive and lengthy. Between 30 and 50 drugs get approved each year on average. While this process takes a long time, it is important to ensure the safety of drugs and have total knowledge of side effects and how the drug interacts with the human body, environment, and other substances. All in all, drug design, testing, and implementation are essential in the healthcare industry as a whole and should be held with high respect and importance.

Time is important and is shown in this picture by an hourglass.
Author Medi-Ops Team Categories Medical & Healthcare News

Timing is Everything

In the healthcare community and industry, timing is crucial for day-to-day operations and successful patient care. Without proper preparation and time budgeting, patient’s lives are in danger, and the efficiency of the industry is at risk. The importance of time not only goes into patient transport and care but also in blood and organ transport. Medi-Ops prides itself on fast and efficient transportation in any scenario – whether that be patients or medical product. Taking a look at each aspect of timing and its importance, we can begin to see that time may be the most vital aspect of the healthcare industry.

Timing In Blood Transport

Blood has a strict shelf and requirements for transportation in order to maintain the integrity of the product for medical use. Temperature-controlled transportation is essential in blood transport as blood and plasma have different temperature requirements. While blood can have a shelf life of up to 35 days if stored well, products should never have a transportation time of over 24 hours. 

Transportation requirements go further than just timing in blood transport, however, the time aspect, along with the container requirements, go hand in hand to bring the best transportation situation for patients, clinical trials, and other medical needs. A note with blood transportation is also that while the blood product itself has the capability of being in transport for a few hours, sometimes the patient requiring the blood doesn’t have that kind of time. In these cases, emergent transportation is a necessity and the importance of timing increases greatly.

Timing In Organ Transport

Similar to blood and its timing and transportation requirements, organ transportation has its fair share of rules and regulations to ensure proper maintenance and transport of all products. From organ removal to transplant, the process is complex and time-sensitive. Temperature and containers are still a huge aspect of this process. The timing of transporting organs between facilities can’t be overlooked. Depending on the organ, different timing constraints are in place. For example, kidneys can maintain integrity up to 24 hours, while organs like the heart and lungs only have 3-6 hours of viability. 

With the high demand of organ donors and recipients waiting for organs to become available for transplant, ensuring organs don’t go to waste on account of a timing mistake is of utmost importance! These are patients’ lives on the line and not a process or situation that can be taken lightly.

Not to mention, other medical products such as vaccines, pharmaceuticals, and other products have their own sets of time and transportation requirements.

Timing With Patient Transport

Patient transportation – whether in the form of emergency or non-emergency transportation, relies on schedules and timing to cater to patient needs. Emergency transportation obviously has a huge emphasis on timing as getting patients from the place of emergency to a medical care facility when in distress is vital. This is definitely a moving-as-fast-as-possible situation while maintaining the safety of the patient.

Emergent situations require the utilization and coordination of different services to cater to the specific situation and patient needs. Ambulatory transport, as well as air medical services, are considered and booked in these cases depending on the patient. Emergencies, unfortunately, come up quickly and unexpectedly, creating a great need for impeccable logistics and transport services that are on the ready to help any patient that should need it. 

Even in NEMT cases, patients need to get to medical appointments and facilities on time, creating an emphasis on communication and coordination in the transportation industry so that patients utilizing these services have the best experiences possible.

Medi-Ops and Timing

A wealth of services are vital in order to be able to cater to any situation that should arise. That’s why Medi-Ops offers patient transport in forms of both ground (lights and sirens, STAT, scheduled, and four transport) and air (next flight out, onboard courier, and aircraft charter) transport as well as emergent and NEMT transportation (stretchers, wheelchairs, or rideshares). In addition, ground and air courier transportation services are available to approach medical product transport needs from any angle necessary. When lives are on the line, a mistake by just a few minutes can be detrimental. That’s why the ability to stick to strict time constraints and requirements shouldn’t be just anyone’s responsibility. Medi-Ops continues to provide the highest quality transportation services in which timing is one of the highest priorities.

Medi-Ops works hard on implementing high-quality and innovative medical logistics for any situation. With our innovative and future-thinking mindset, we are constantly looking ahead on how to continuously tweak and change logistics in order to provide the most efficient transportation (for patients and medical products alike) possible. Another service offered is that of medical consulting so that we can meet everyone where they are at and improve the medical transportation industry one step at a time!

Medical logistics are already benefiting from the use of electric vehicles.
Author Medi-Ops Team Categories Courier Services

Electric Vehicles and Sustainability

As the topics of sustainability and climate change sweep the world and continue to grow exceedingly important, all areas of medical logistics need to be evaluated in order to promote better environmental practices for all parties involved. This includes looking for solutions in vehicles – both ground and air – as well as evaluating other aspects of transportation. Autonomous vehicles are one way to promote sustainability, but electric and green vehicles can’t be overlooked when it comes to transportation and sustainability.

Climate Change and Its Importance

The importance of climate change can’t be underestimated, and the impact of vehicles is no joke. Highway vehicles release around 1.5 billion tons of greenhouse gases into the atmosphere each year. In addition, the carbon pollution from gasoline and emissions is paramount. Burning fossil fuels releases carbon dioxide, methane, nitrous oxide, and hydrofluorocarbons which contribute to the Earth’s atmosphere warming and changes to the climate that we see daily. Greenhouse gas (GHG) emissions from transportation amount to 29 percent of the total emissions in the US. While 29 percent might not seem like that large of a number, transportation emissions are the leading contributor to GHG emissions. 

Taking care of the environment and looking after our planet is extraordinarily important. The field of transportation is one that everyone – individuals, companies, and organizations alike – can look towards to find solutions and promote more sustainable practices. While making these choices on a personal level can be easier than on a worldwide level, every choice counts and is paramount for the future of our planet.

What are Environmentally Friendly Vehicle Options?

Electric Vehicles are a great option here due to the fact that they use an electric motor that emits no exhaust and doesn’t require liquid fuel. There are hybrid electric or plug-in hybrid options here that can also contribute to a more environmentally friendly future.

Eco-friendly vehicles are pretty broad in that they run more efficiently and are said to be environmentally friendly, however as with any sustainability initiatives and products, these terms can mean a lot of different things.

Hydrogen fuel-cell cars are powered by hydrogen as opposed to batteries and are another green option in terms of vehicles and transportation. Hydrogen cars can typically offer a longer driving range than electric, making them a more reliable option for long-distance travel. The only downside here is that electric cars can offer a more responsive driving experience through better acceleration and torque.

Vehicular Solutions to Climate Change

Medical transportation and logistics rely heavily on vehicles and their operators. Both emergency and non-emergency transportation require reliable, efficient vehicles to transport patients, medical equipment, and products alike. Medical transportation needs to retain its reliability and efficiency while looking for ways to take strides toward a more sustainable future. 

As environmentally-friendly, green vehicles become more reliable and continue their technological development, medical transportation companies such as Medi-Ops can begin to invest in green solutions and vehicles without compromising their reliability. 

The vehicles above are great options for ground transportation, but what about air transportation? The aviation industry is a large contributor to GHG emissions. Electric planes and aircraft may point towards a sustainable future. Producing zero direct emissions and operating quietly means electric planes are reducing their carbon footprint and reducing noise pollution. The difficulty here is that there is limited energy storage capacity of batteries, which significantly restricts aircraft range and payload capability. 

The challenges that appear in creating electric and green vehicles with the same capability as traditional vehicles are apparent. However, the future of these developments is incredibly promising. This industry is rapidly growing and many new prototypes and developments present as viable options for overcoming some of these challenges and hurdles in the future. 

What This Means for Medi-Ops

Good medical logistics means less error and unnecessary trips as well as more efficiency. Medi-Ops is able to expand on efficiency of logistics for this reason. Looking ahead, as technology develops and electric vehicles in both ground and air transportation become more viable, medical transportation can begin to switch out gas vehicles for electric options. As the primary concern in transportation surrounding healthcare is patient safety, these changes can only be made when there are guarantees that green vehicles can do their jobs to the level of efficiency and speed as current transportation options.

An exciting future lies ahead when it comes to sustainable transportation in terms of the healthcare and medical fields. At Medi-Ops, the use and implementation of green vehicles is an exciting prospect and component of the future of medical transportation. Since we work in both ground and air transportation, a keen eye on the advancements in green vehicles and air technology is a top priority. The technological advances in this field are thrilling and hold much promise for a future of fighting climate change and pursuing environmentally friendly practices.

Cell and gene therapy will revolutionize healthcare!
Author Medi-Ops Team Categories Medical & Healthcare News

Revolutionizing Medicine: The Potential of Cell and Gene Therapies

Cell and gene therapies are groundbreaking approaches in the field of medicine and revolutionize disease treatment. With the use of cells and genetic material, treatments for a wide range of conditions are created. These therapies are truly incredible and have so much potential for the future.

What are Cell and Gene Therapies?

Cell therapy utilizes the transplantation, manipulation, and modification of cells (from the patient or a donor) to treat or cure a disease. This can involve multiple types of cells. Stem cell therapy can be used to replace damaged tissues, T-cell therapy can target and destroy cancer cells, and regenerative medicine uses cells to stimulate tissue repair in areas such as heart disease or orthopedic treatments.

Gene therapy alters or corrects genetic material (DNA or RNA) within a patient’s cells to treat or prevent a disease. This can involve several different therapy routes – gene replacement to replace a defective or missing gene with a functional one, gene editing to correct mutations or introduce therapeutic changes, gene addition to introduce new genes into cells, or RNA therapies to regulate gene expression or correct defects.

There are even some treatments that involve the use of both gene and cell therapies! Clearly, these are precise and important therapies that have shown success in the development of treatments for cancer, genetic disorders, neurodegenerative diseases, cardiovascular diseases, and rare diseases.

Cell and gene therapies represent a paradigm shift in healthcare, offering the potential for more targeted and personalized treatments. However, their development and implementation involve significant challenges, including safety concerns, regulatory approval, manufacturing scalability, and cost-effectiveness. Ongoing research and advancements in technology continue to expand the potential applications of these therapies and improve their accessibility to patients.

The Importance

Cell and gene therapies represent groundbreaking approaches in the field of medicine and have the potential to revolutionize the treatment of various diseases. Patients with previously incurable diseases now can have hope of new treatments or significant improvement in their quality of life. Precision medicine also owes a lot to cell and gene therapies. These therapies are easily personalized to the patient which increases treatment efficacy and minimizes adverse effects. Since chemotherapy and radiation come with so many severe side effects, cell and gene therapies are beginning to become viable alternatives in order to target the root cause of treatments and reduce collateral damage to healthy tissues. Cancer treatments especially are being transformed and have seen a lot of success in this area.

Not to mention, successful therapies can reduce the economic footprint for patients with chronic diseases since they lower the need for lifelong medication, hospitalizations, and other expensive treatments. These developments have promoted scientific knowledge drastically and there is so much potential and uses still to be discovered in this field.

The Process

The journey from the initial idea of a cell or gene therapy to its widespread use on a commercial scale involves several complex steps and can take many years, often more than a decade. Many pharmaceutical companies and therapy developers don’t even see any money for decades until FDA approval and widespread use. Here’s a simplified overview of the key stages involved:

  1. Research: An idea is formed, emerging from basic research and collected scientific data in a field related to molecular biology or genetics. Researchers will begin to conduct extensive laboratory studies to validate the idea and feasibility/safety/logistics of the therapy. 
  2. Development: The scientists then will demonstrate how the therapy works in preclinical models. They will begin to develop the methods for producing this therapy on a large scale.
  3. Clinical Trials: Researchers will submit an Investigational New Drug Application (IND) to the FDA to start clinical trials. This application requires extensive information, data, preclinical studies, and plans for human testing. Upon approval, clinical trials begin in phases. Phase one is small-scale trials with a limited number of volunteers (safety and dosage are tested and found in this stage). Phase 2 expands trials involving patients to confirm efficacy and side effects. Phase 3 is a large-scale trial with a diverse patient population to continue confirmation of safety and efficacy.
  4. Regulatory Approval: If clinical trials all prove successful, the sponsor will submit an application for regulatory approval. Agencies will review all the data to ensure the therapy’s safety and integrity.
  5. Manufacturing: The process used in clinical trials is performed on a large scale to produce the therapy commercially. Quality control and consistency are vital here.
  6. Market entry: After regulatory approval, the therapy is marketed and sold to healthcare providers. Negotiations with payers and systems occur here to ensure patient accessibility. There is continuous monitoring of the therapy’s safety and efficacy in the real-world patient population here and adjustments are made if necessary.
  7. Expansion: The therapy will expand to other countries as more regulatory approvals and market access negotiations come through. Ongoing research and improvements will continue throughout this phase as well as assessment of long-term effects on patients over time.
  8. Patient Access and Education: This entails ensuring healthcare providers are trained to administer the therapy and that patients and professionals alike know the benefits and risks of the therapy.

Quite the process! The development of these therapies is innovative, relatively new, and changing and saving lives already. As gene and cell therapies continue to grow and develop, there is no doubt that this new frontier of medicine will deliver genius, ground-breaking treatments in the world of medicine and healthcare.

Healthcare hands holding the globe.
Author Medi-Ops Team Categories Hospitals, Medical & Healthcare News

The Power of Sustainability for Enhanced Patient Care and Environment Conservation

Healthcare operations, including hospitals, clinics, and pharmaceutical companies, are increasingly recognizing their role in addressing environmental challenges such as energy consumption, waste generation, and carbon emissions. By adopting sustainable practices, these organizations aim to minimize their ecological footprint as well as enhance patient care, reduce healthcare costs, and promote social well-being. These initiatives encompass areas like efficient resource utilization, green healthcare building designs, and community engagement. Ultimately, sustainability in the healthcare industry not only mitigates environmental impact but also ensures that healthcare institutions are better positioned to provide high-quality care while contributing positively to the communities they serve. Sustainability is an important aspect to look at within healthcare in order to continue improvement and innovation throughout the industry.

The Environmental Impact of Healthcare Operations

Healthcare facilities, while vital for providing medical care, often leave a substantial environmental footprint. They are among the most energy-intensive buildings, with high energy consumption due to constant lighting, heating, cooling, and the operation of specialized medical equipment. Additionally, healthcare facilities generate significant amounts of waste, including hazardous medical waste, contributing to landfill congestion and environmental risks. Water usage is another concern, as hospitals consume large volumes for sanitation, patient care, and other operational needs. Given these factors, healthcare organizations must recognize the urgency of addressing their environmental impact. Not only does this serve to reduce their carbon emissions and energy costs, but it also demonstrates a commitment to public health by minimizing pollution, conserving resources, and promoting sustainable practices in an era where environmental responsibility is paramount.

Everything has an environmental impact, and in the case of healthcare, the impact is a necessary cost in order to save and improve lives. This impact can always be reflected on and reduced as much as possible while also maintaining the integrity and functionality of these facilities.

Sustainability Initiatives in Healthcare

Green hospitals, also known as eco-friendly or sustainable healthcare facilities, represent a progressive and conscientious approach to healthcare design and operations. These hospitals prioritize environmental responsibility by integrating eco-conscious practices through energy-efficient building materials and systems (such as solar panels and advanced insulation, to reduce energy consumption and greenhouse gas emissions). Green hospitals also implement sustainable waste management protocols, recycling, and waste reduction initiatives, which not only minimize their ecological impact but also set an example for responsible waste disposal in their communities. 

Sustainability doesn’t stop there. LEED (Leadership in Energy and Environmental Design) certified hospitals are healthcare facilities that have undergone an intense evaluation process resulting in the recognition that the facility has sustainable and environmental design and operation practices. The U.S. Green Building Council (USGBC) awards these internationally recognized certifications. As stated with green hospitals, these buildings prioritize reduced energy consumption and advanced waste management as well as incorporating enhanced patient wellbeing with natural healing environments.

Healthcare expands beyond hospitals, encompassing a wide range of strategies and actions aimed at minimizing the industry’s environmental impact while improving patient care and operational efficiency. These initiatives involve adopting energy-efficient technologies, reducing waste, and implementing sustainable procurement practices. In addition to environmentally-focused buildings, reducing single-use plastics, properly managing hazardous waste, and implementing recycling programs are all taken into consideration. 

Healthcare Sustainability and Patient Care

Sustainability efforts extend to patient care, with initiatives promoting telemedicine to reduce patient travel, optimizing resource utilization, and incorporating eco-friendly medical equipment and practices. Overall, sustainability initiatives in healthcare represent a holistic approach that enhances patient outcomes, reduces costs, and supports the long-term viability of healthcare systems. Patient and staff well-being in green hospitals and facilities is promoted through improved indoor air quality, natural lighting, and healing gardens. Natural elements such as gardens in hospitals have been shown to improve patient well-being and recovery. By embracing sustainable practices, green hospitals not only contribute to a healthier planet but also demonstrate a commitment to patient care, employee well-being, and community health.

Medical Transportation and Sustainability

Sustainability in medical transportation is a growing imperative within the healthcare industry. This concept revolves around reducing the environmental impact of healthcare-related travel while improving efficiency and patient outcomes. Sustainable medical transportation initiatives encompass a range of practices, including the use of fuel-efficient vehicles, adopting eco-friendly transportation technologies, and supporting green hospitals and facilities that offer sustainable practices and initiatives. By incorporating these practices, healthcare organizations not only contribute to reduced carbon emissions but also enhance access to care for patients, especially those in remote or underserved areas. Sustainability in medical transportation aligns with broader healthcare sustainability efforts, demonstrating a commitment to eco-conscious practices prioritizing the well-being of patients and the planet.

The Future Of Sustainable Healthcare

The term “sustainability” is often thrown around and not taken seriously in today’s world. In addition, it is a growing term and value for many individuals and companies alike. As the value of sustainability becomes stronger and increasingly important, the healthcare industry, known for its innovation, will hopefully continue to provide cutting-edge solutions to promote eco-friendly practices within its systems. Organizations continue to claim and recognize their role in sustainability and these practices will continue to see advances through technology, data analytics, awareness, and integrated initiatives. In this version of the future, healthcare will become a model of environmental responsibility and will continue to improve lives and communities alike through sustainable practices.

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