Each month, PharPoint Research hand-selects a non-profit to support through fund-raising and awareness building to aid in research and/or resource development. Also known as our Working Together for Change campaign, this company-wide initiative is dedicated to serving communities in need. Therefore, we are excited to announce The Conservation Fund as January’s selected non-profit for the Working Together for Change campaign.
About The Conservation Fund
The Conservation Fund is a non-profit that pursues environmental preservation and economic development in the United States. Since its
inception in 1985, the organization has protected more than 7 million acres of land and water in all 50 states. Most relevant areas include parks, historic battlefields, and wild areas. In addition, The Conservation Fund works with community and governmental leaders, businesses, landowners, conservation non-profits, and other partners.
In addition, The Conservation Fund operates nine programs to support its mission.
Conservation Leadership Network: Developing networks of shared knowledge and technical skills for on-the-ground conservation solutions. Most relevant initiatives include collaborative solutions between communities and corporations.
Freshwater Institute: Conducting research, development, and training in water resource management. This includes developing technology and providing engineering services for aquaculture systems.
Mitigation Solutions: Achieving important conservation results by protecting high-priority wildlife habitat, clean water, and recreation areas.
Natural Capital Investment Fund: Helping innovative entrepreneurs build locally-owned enterprises. Most noteworthy, this creates lasting jobs and community wealth, while using natural resources responsibly.
Strategic Conservation Planning: Offering solutions that government leaders, conservationists, and others need to create systemic and lasting change in major cities, watersheds, and multi-state regions.
Working Forest Fund: Acquiring and permanently protecting ecologically significant forestland. Rather, this supports forests’ role in providing clean air and water, wildlife habitat, and economic benefits for communities across America.
Interested in contributing to The Conservation Fund to help support their programs? There are many opportunities to suit your time and resources:
PharPoint Research Expands Collaboration with Medrio amid Recent Growth
SAN FRANCISCO, CA–(Marketwired – December 14, 2016) – PharPoint Research, a North Carolina-based Contract Research Organization (CRO), has committed to a contractual expansion in the number of clinical trials they will conduct with Medrio, a Software as a Service (SaaS) company providing electronic data capture (EDC) services to clinical trials. This agreement is a direct result of the growth of PharPoint Research, as evidenced by their recent Fast 50 award by the Triangle Business Journal.
The commitment between the two companies strengthens their partnership and reflects the value that PharPoint Research has placed in Medrio’s services during this period of rapid growth. PharPoint Research views Medrio as one of the top EDCs for quick study build and high data quality, and therefore as conducive to the efficiency that PharPoint Research will require as it continues to emerge as an industry leader and one of the busiest CROs in the region. “With our growth, we continue to utilize Medrio as our primary tool for data capture,” said Moya Hawkins, Director of Data Management at PharPoint Research. “Medrio helps us to facilitate a streamlined and rapid approach to study start-up while maintaining clean data throughout a study’s lifecycle.”
PharPoint Research and Medrio have enjoyed a mutually productive relationship for many years, beginning in 2010 when PharPoint put their first project in Medrio’s EDC system. In 2013, PharPoint Research joined Medrio’s Partner Program, through which Medrio provides extensive sales and marketing support, offers previews of upcoming product developments, facilitates new business opportunities for participating CROs, and more. PharPoint Research has found the Partner Program to be a valuable resource throughout the journey toward its current growth, and continues to take advantage of the program’s benefits.
Of the increased use of Medrio by PharPoint Research in the coming year, Mike Novotny, founder and CEO of Medrio, said, “Nothing could be more rewarding than knowing that PharPoint Research has found the capabilities of our software, and the benefits of our partner program, to be so helpful during their explosive growth. We’re honored that they’ve chosen to expand their business with us over the next year.”
About PharPoint Research
PharPoint Research is a full-service contract research organization (CRO) that specializes in Project Management, Clinical Monitoring, Data Management and Biostatistics. The company is uniquely poised to serve the needs of pharmaceutical, biotechnology, and medical device development organizations. PharPoint Research is experienced in strategic consulting engagements and Phase 1 through Phase 4 clinical research projects across a variety of therapeutic areas, including infectious disease, oncology, CNS, cardiovascular, and rare disease indications. PharPoint Research is headquartered in North Carolina, with strategic operations service provider partners around the world, including North and South America, Europe, and Asia-Pacific. For more information, please visit pharpoint.com.
About the Fast 50 Award
The Triangle Business Journal, a weekly business newspaper, is the leading provider of local business news for the Raleigh-Durham–Chapel Hill area of North Carolina. Each year the Triangle Business Journal honors the fastest growing companies in the Research Triangle area of North Carolina with the Fast 50 Awards. PharPoint Research received the award in recognition of the significant growth that the company has experienced over the last 12 months. This growth is the direct result of providing excellent client service, expertise and uncompromised quality to the pharmaceutical and biotechnology industry. This is the fourth time since 2011 that PharPoint Research has won this annual award.
Medrio offers an integrated eClinical software platform with a fully hosted EDC system. Our technology features an easy-to-use drag-and-drop interface, allowing study managers to build their studies in days instead of months without requiring any programming. Medrio’s new mobile suite, mSource, supports both event-based and subject-based workflows, offline data entry, and Patient Reported Outcomes (PRO). Although Medrio has extensive experience in all study phases, our m1 application leads the way in early-phase and Phase 1 trials, with over 500 Phase 1 trials to date. Medrio costs up to 75% less than traditional EDC solutions. For more information, please visit our website. To schedule a demo and learn more about Medrio’s Partner Program, please submit your information here and a member of our team will be in touch shortly.
PharPoint Research Tim LaCroix firstname.lastname@example.org
An orphan drug is a product intended for the treatment, diagnosis, or prevention of a rare disease. A rare disease also affects fewer than 200,000 people in the United States.
Although orphan drugs treat only a small number of patients, orphan drug development shows a large return on investment for potential Sponsors. For instance, companies researching solutions for rare diseases have little competition from branded and generic alternatives. Companies also have the opportunity to carve out a specialized orphan market that no other company is actively pursuing. In addition, the FDA offers a fast-tracked regulatory review process and lower-cost late-stage development to aid in the development of orphan drugs because they treat serious or life-threatening conditions.
To reduce challenges associated with orphan drug development and improve the patient experience, Sponsors should take a patient centric approach to clinical trials. Shifting a trial design to a patient centric approach for rare disease trials does not require an overhaul of current trial standards. However, it does mean that researchers must change their focus to see the trial through the eyes of patients and caregivers. Sponsors can reduce risk and increase effectiveness of orphan drug clinical trials as a result of making these changes in the study design.
History – The U.S. Orphan Drug Act
From 1967 to 1983, only 34 drugs were approved by the FDA to qualify as orphan drugs. The FDA recognized the lack of incentive for pharmaceutical companies to develop cures for rare diseases. As a result, the FDA established the Office of Orphan Product Development (OOPD) in 1982. In addition, Congress passed the Orphan Drug Act with financial incentives for companies developing products for rare diseases in 1983. The three primary incentives that the Orphan Drug Act gives manufacturers are:
Federal funding of grants and contracts to perform clinical trials of orphan products
A tax credit of 50% of clinical testing costs
An exclusive right to market the orphan drug for seven years from the date of marketing approval. This allows for greater discretion in pricing.
Other benefits for Sponsors for orphan-designated products include:
Close coordination with the FDA throughout the drug’s development
Priority FDA review
A waiver of drug application fees
As a result, the OOPD assigned a total of 2,112 orphan drug designations and the FDA approved 347 between 1983 and 2009. The Orphan Drug Act has played a major role in the development of certain rare disease products that may have never made it to market without the OOPD. For example, an effective treatment for infant botulism (a rare neurological disease affecting approximately 100 children in the United States annually), was developed because of the California Department of Health Services and OOPD grants, and was also in close coordination with the FDA.
Today, as a result of the implementation of the OOPD, more than 575 orphan drugs have been successfully developed and marketed. Worldwide sales of these drugs are predicted to reach $176 billion by the end of 2020.
Logistical Challenges of Orphan Drug Development
As orphan drug development expands, clinical trials are becoming more complex and expensive. For instance, the average cost of moving one orphan drug to market can cost $350 million. Clinical trials account for a large percentage of the overall price. In addition, a drug typically takes 10 to 15 years to make it to market.
When designing an orphan drug trial, Sponsors may have difficulty finding historical disease information such as disease prevalence and examples of treatment patterns. Developing a study protocol without this information can be challenging. In addition, for many rare diseases no standard clinical trial designs or study outcomes exist. This makes it difficult to select endpoints, outcome measures, tools, and biomarkers. The lifelong nature of a rare disease also makes it difficult to determine appropriate study durations.
The potential patient population of a study is limited since rare diseases affect a small number of individuals. This is because small patient populations decrease study variation. In addition, the genetic basis or associated comorbidities of many rare diseases can be confounding factors in study predictability. Also, potential clinical trial patients, investigators, and clinical centers are rare and located around the world. So, finding individuals to participate in a study can be time consuming and require high travel costs.
In addition, rare diseases are frequently discovered at birth or during childhood. For ethical reasons it is considered appropriate for drugs to be tested in adults before in children. Therefore, pediatric studies require Sponsors to carefully balance the ethical considerations of conducting studies in a vulnerable population with concerns about site selection, recruitment, compliance, and statistical powering.
Patient Centricity as a Solution for Orphan Drug Trials
Since historical research on rare diseases is typically sparse, investigators can look to patients, patient advocacy groups, and families as the thought leaders on their disease. These individuals and groups can identify the clinical outcomes that are most meaningful to a small subset of individuals with highly specialized needs. 
Research and Development – Patients can provide input on identifying health research priorities and participate in the design and undertaking of research projects. For instance, one study on patient involvement in orphan drug trials found that patients prefer equal collaboration with researchers. This is because researchers are guided towards designing more relevant trials with useful outcome measures. Patient experience and input can be especially beneficial when:
Setting the research agenda
Promoting collaborative research networks
Providing financial support for research infrastructures
Research and development organizations or departments should engage with patient associations and families that have a special interest in, and experience with, rare diseases. As a result, researchers gain a greater understanding of the natural history of the disease and the potential therapeutic impacts that would be most meaningful for patients to find relevant trial patients and produce accurate outcomes. Researchers can also conduct qualitative research studies on the internet habits of these groups provide insights into what a patient population will need from a clinical trial. Additionally, advocacy groups can provide feedback on the appropriateness of a trial’s protocol and help drug developers reach patient populations. Sponsors must use these varieties of communication methods to embrace patient centricity and focus on the quality of life for potential patients.
Clinical Development – Patient involvement in clinical development may contribute to the successful delivery of trials because of the increased likelihood of recruitment and retention. Some companies investigating orphan drugs involve patients at all stages of clinical development, from providing input into study protocol, the selection of endpoints, to the dissemination and implementation of findings. Since they often have advanced networks, patients can help to enhance communication about research participation opportunities. In addition, patients can disseminate trial-related findings in a manner that is most meaningful to other patients.
Also, consideration of acceptable physical burden, treatment durations, and travel requirements is necessary when looking towards optimal recruitment and retention. Rare diseases affect individuals on a global level and many patients are children so caregivers and parents must be accounted for when evaluating travel time and costs. In addition, implementing trial centers across several countries may enable higher levels of participation. An alternative to traditional trial design is the idea of in-home clinical services, where the majority of simple clinical procedures (treatment administration, blood draws, and health monitoring) are administered by trial professionals at home. Therefore, travel to designated trial sites is reduced as is the disruption to the life of the patient and their family.
Approval and Market Access – The FDA has introduced a Patient Engagement Advisory Committee to facilitate patient involvement in the regulatory process. Companies also collaborate with patient advocates to demonstrate the burden of the disease, add it to the policy agenda, and help to incorporate the benefit-risk preferences into a structured evaluation process.
Educating a small but dispersed market is essential for market success. As a result, disseminating knowledge and awareness amongst physicians, patients, and payers is necessary for orphan drug advocacy. One way to approach drug education is by leveraging clinical programs to establish an active and engaged treatment community. Consequently, this aids in rapid product uptake because the clinical program may have already identified a high proportion of available patients. Sponsoring patient registries can also enhance disease understanding during development and enable tracking of patient progress post product launch. Since education is critical for successful market access for orphan drugs, targeted communications are also more effective than traditional, large-scale sales forces. Target audience assessments are less complex for orphan drugs than non-orphan drugs because the patient population is less diverse. With fewer disease experts, micro-targeting and micro-messaging personalized to individual needs is feasible and therefore yields favorable results.
While orphan drug clinical trials may require customized patient centric design, these trials have the potential to produce effective outcomes for patients and Sponsors alike. Furthermore, with regulatory support, financial incentives, and effective study design and management, orphan drug trials can be a valuable to any Sponsor’s clinical trial landscape.
Each month, PharPoint hand-selects a charity to support through fund-raising and awareness building to aid in research and/or resource development. Known as our Working Together for Change campaign, this company-wide initiative is dedicated to aiding those in need and serving the community. PharPoint has decided to feature Living Beyond Breast Cancer as October’s selected charity for the Working Together for Change campaign.
About Living Beyond Breast Cancer
Living Beyond Breast Cancer (LBBC) is a non-profit organization designed to provide programs and services to help people whose lives have been impacted by breast cancer. LBBC was founded in 1991 by Marisa C. Weiss, MD, a radiation oncologist, as a way to offer resources and support for patients who had completed treatment for early-stage breast cancer. To address this, Weiss held a conference with the goal of providing a safe space where women could gain accurate and easy to understand breast cancer information from medical experts, while finding and connecting with each other. The organization began to hold two annual conferences in the years to follow, and initiated a quarterly educational newsletter. The breast cancer helpline was later established to provide peer support services from volunteers with a personal history of breast cancer. These services were designed to empower those affected by breast cancer, to make sense of their “new normal,” and provide a place to interact with others sharing in their experience. Today, LBBC’s annual budget has grown to more than $5 million with a dedicated staff and engaged board of directors to allow LBBC to reach people around the country.
LBBC calls on volunteers, including some of the foremost healthcare professionals in the United States, to provide wisdom and experience to help those affected by breast cancer with medical, emotional and practical concerns. A variety of programs and services are offered for people with all stages of breast cancer, such as:
Breast cancer helpline
Interested in contributing to LBBC to help support their programs? There are a variety of opportunities to best suit your time and resources:
Share your story: There is power in sharing your experience especially for those facing a new experience or who may feel alone and LBBC features many different voices of breast cancer on their blog. You may write your own story or work with an LBBC staff member to develop your narrative.
Volunteer: LBBC has many different volunteer opportunities available, from office assistance and distributing materials in your community, to serving as peer support on the Breast Cancer helpline.
Give Back: LBBC fulfills its mission through the generous support of individuals, corporations, and foundations. Every donation makes a difference and helps to continue support, education, and advocacy efforts.
Have you or someone you know found support through LBBC? Please share your experience in the comments below.
Each month, PharPoint hand-selects a charity to support through fund-raising and awareness building to aid in research and/or resource development. Known as our Working Together for Change campaign, this company-wide initiative is dedicated to aiding those in need and serving the community to the best of our ability. PharPoint has decided to feature the American Cancer Society for July’s Working Together for Change campaign.
About the American Cancer Society
The American Cancer Society (ACS) is a nationwide, community-based voluntary health organization dedicated to eliminating cancer as a major health problem by preventing cancer, saving lives, and diminishing suffering from cancer, through research, education, advocacy, and service. Originally founded in 1913, the ACS is one of the oldest and largest volunteer health organizations. Headquartered in Atlanta, Georgia, the ACS has regional and local offices throughout the country that support 11 geographical divisions and ensure we have a presence in every community.
The ACS relies on the strength of approximately 2.5 million dedicated volunteers throughout the United States and has a presence in most communities. They raise funds to support crucial research, provide cancer patients rides to and from treatments, and give one-on-one support to those facing a cancer diagnosis.
The ACS saves lives by helping people stay well and get well by finding cures, and fighting back.
Helping people take steps to prevent cancer or find it at its earliest, most treatable stage
Develop guidelines for recommended screening tests, so people know what tests they need to help prevent cancer or find it at its earliest, most treatable stage.
Develop nutrition and physical activity guidelines to help people eat healthy and get active.
On cancer.org, individuals can create a personalized health action plan to use to talk with their doctor about what cancer screening tests and healthy lifestyle choices are right for them.
The ACS is available around the clock to help people through every step of their cancer experience
Whether people have questions about cancer, need practical solutions to daily problems, like finding a ride to treatment, or want to talk to someone who has been there, the ACS offers 24/7 support at 1-800-227-2345.
In 2014, the ACS fulfilled nearly 800,000 requests for cancer information via phone, email and online chats.
Through the ACS Clinical Trials Matching Service, patients are connected with more than 6,000 ongoing studies.
Through the ACS Hope Lodge® network, cancer patients and families are provided with free overnight lodging when they have to travel away from home for treatment. In 2014, about 276,000 nights of free lodging to nearly 44,000 patients and caregivers, saving more than $36 million in lodging expenses.
With more than 120 sites at hospitals and treatment centers across the country, the ACS Patient Navigator Program provides one-on-one guidance to people facing cancer. In 2014, 56,000 patients received help understanding their cancer diagnosis and were connected to the resources they needed.
The ACS funds and conducts research that helps to better understand, prevent, and find cures for cancer.
The ACS has spent more than $4 billion on cancer research since 1946, playing a role in nearly every cancer breakthrough in recent history.
ACS research and funded researchers have helped:
Confirm the link between cigarette smoke and lung cancer
Establish the link between obesity and multiple cancers
Develop drugs to treat leukemia and advanced breast cancer
Show that mammography is the most effective way to detect breast cancer
The ACS funds beginning researchers with cutting-edge ideas early in their careers – 47 of whom have gone on to win the Nobel Prize.
The ACS works with lawmakers to pass laws to defeat cancer and rally communities worldwide to join the fight
Along with nonprofit, nonpartisan advocacy affiliate, the American Cancer Society Cancer Action Network℠ (ACS CAN), the ASC has helped:
Enact polices that prevent cancer, such as smoke-free laws to prevent and curb cigarette smoking
Educate lawmakers on policies that provide access to quality and affordable health care, including cancer screening tests and treatments
Encourage increased federal investment in cancer research
Outreach for awareness and support continues to provide the assistance necessary for the American Cancer Society. As the world’s largest movement to end cancer, 4 million people around the world participate in the 6,000+ American Cancer Society Relay for Life® events held each year. Not only this, but the ACS is the leader in the fight to end breast cancer. The Making Strides Against Breast Cancer® events unite nearly 300 communities across the US to help save lives from breast cancer – and together, finish the fight against the disease.
How You Can Help
Interested in contributing to help the ACS to continue their live-saving work? Donate here to help fund research, provide 24/7 patient support, and develop programs for early detection and prevention. Or, find volunteer opportunities and join the annual 2.5 million volunteers in the US to provide help and hope to cancer patients and to work toward a future free from the pain and suffering of cancer. If you are interested in participating in an event, there are an array of opportunities to suit your interests. From black-tie galas to full-length marathons, there is an event to let you join in the spirit of camaraderie and compassion to work together and save lives from cancer.
If you or someone you know is suffering from cancer, the American Cancer Society can help. Visit their website for information and resources on cancer and learn about how the ACS is changing lives within our communities.
Patient enrollment for clinical trials is a complex process that involves not only patients, but physicians and trial professionals. Clinical trials strive to execute drug treatments on a sample group that is large enough to be statistically significant while also being representative of the population that the drug intends to serve. Differences in age, gender, race, and ethnicity all play a part in how effective a drug will be on an individual patient, which is why pharma companies must be diligent to include a diverse group of patients in their sample population. But this hasn’t always been easy to do. Join PharPoint Research as we explore who participates in clinical trials, why patient diversity is important, and what we can do to increase patient enrollment.
The History of Clinical Trial Participation
Companies performing clinical research trials are required to follow stringent guidelines set forth by the National Institute of Health (NIH), which is the primary agency of the U.S. government responsible for biomedical and health-related research. The NIH is part of the U.S. Department of Health and Human Services and is the largest biomedical research agency in the world.
Over the years the NIH has enhanced their clinical trial policies to increase safety and patient representation in clinical research that better accounts for variations of a drug’s effects across gender, ethnic, and racial bounds. But these policies have evolved over time and have not always been in place.
For example, as late as the 1990s some researchers were hesitant to include women in clinical trials who had likelihood of becoming pregnant. The researchers feared the drugs being evaluated could lead to birth defects, so certain experimental drugs were mainly tested in men. Makes sense, but when a subset of these drugs finally made it to market there were select instances where female patients experienced unforeseen adverse events. While not the only factor, the lack of an all-encompassing sample population was a major component that allowed these adverse events to occur.
In 2001 the NIH updated its policy on the inclusion of women and minorities as subjects in clinical research, so that “all NIH-funded clinical research will be carried out in a manner sufficient to elicit information about individuals of both sexes/genders and diverse racial and ethnic groups and, particularly in NIH-defined Phase 3 clinical trials, to examine differential effects on such groups.” These updates help to ensure that clinical trials include a more robust sample population, but this doesn’t mean it is always easy for clinical trials to recruit minorities and patients from certain backgrounds.
Obstacles for Patient Recruitment
So the question becomes “Why can it be difficult to recruit certain patients for some clinical trials?” Unfortunately, there is no one single answer, but rather a group of factors that when brought together can create a burden for patient recruitment.
One problem stems from a clinical site’s geographical location and a prospective patient’s inability to make feasible travel arrangements. Another problem is the lack of translation resources due to budget restrictions. This leads to information only being provided in English which is a significant deterrent for non-native speakers. However, one of the most significant indicators of participation for a clinical trial is a prospective patient’s socioeconomic status. Patients with annual household incomes below $50,000 are 32% less likely to participate in clinical trials than higher income patients. This is due to factors such as the inability to schedule time off work, travel costs, insurance co-pays, and insufficient information about clinical trials as a treatment option.
The good news is that trends are changing. Between 2010 and 2014 the proportion of African American participants in Phase 3 clinical trials increased from 10% to 23% and as of 2016 the average participant population in all NIH clinical trials more or less matches the racial and ethnic makeup of the U.S. To better serve the needs of our diverse population, the industry is also adopting new ways to include underrepresented communities for clinical trials through patient-centric trials, where patients play an active role in the development of the trial they participate in.
The Growth of Patient-centric Trials
The vast wealth of information available through online resources has led to modern patients who are better informed about the medicines they use. The pharma industry has reacted by experimenting with patient-centric clinical trials that include greater patient involvement in the research, development, and planning stages. Pharma’s goal in using this technique is to boost recruitment, reduce costs and ultimately, speed up a drug’s timeline to market.
So, what does “patient-centric” really mean and how can this approach be used for clinical trials? Patient-centric trials are designed to focus on society, technology, patient lifestyles and the realization that trials can be better designed and executed if the needs of patients are more adequately addressed.
Some of the ways pharma companies are finding ways to integrate patient voices into clinical trials are through social media and engaging patients early on in the trial process.
Social Media and Wearable Sensors
The capabilities of online communication and technological monitors have made the connection between physicians and patients stronger than ever. Social media and advocacy groups such as the Michael J. Fox Foundation and the ALS Association provide online forums for participants to share health information, and a similar approach can help clinical trial professionals collect health data from patients and increase communication with physicians. Likewise, wearable sensors provide physicians with up-to-date health information from trial participants when geographic or time constraints may be a factor in clinical trial participation. (For more information on how doctors are communicating with patients through technology, check out PharPoint’s wearable sensor blog post).
Getting patients involved in the clinical trial enrollment early on is key. This goes beyond just enrolling patients, but also encouraging engagement throughout the process. Inviting patients to review draft protocols and procedural schedules gives patients better insight into the maintenance of a clinical trial and how their own health will be managed. Additionally, asking patients how and when they prefer to be involved can have a big impact on how a development team designs a trial. Educating patients on the drug development process and how the clinical trial will affect their lives gives patients a more active role in the trial and can increase enthusiasm for playing a part in extending medical research.
Innovative drug development continues to work towards more effective patient processes. Through the means of patient-centric trials, enrolled patients are more involved in the clinical process, enabling faster drug development and a more accurate sample population. This process is only in the beginning stages, but is a step in the right direction and our team at PharPoint is excited to see where it goes.
If you are interested in participating in a clinical trial or would like to find clinical trials near and relevant to you, visit The Center for Information and Study on Clinical Research Participation. Have you or someone you know participated in a clinical trial? Have you experienced first-hand a patient-centric trial? Tell us about it in the comments below!
Wearable sensors are ubiquitous these days. From step trackers to smart watches, these handy devices have gained wide-spread attention over the past several years. It is probably safe to assume that many of the people reading this article are a part of the one in five American’s who wears a fitness tracker, like the FitBit, to calculate distance walked, calories burned, floors climbed and activity duration and intensity.
While fitness trackers are well-known and continue to grow in the mobile industry, wearable sensors have quickly infiltrated the world of healthcare. With the help of wearables, doctors are readily connecting to patients in real-time and users are monitoring specific ailments through innovative technological development.
Want to learn more about how these wearables work? Join PharPoint as we explore the history behind wearable sensors, how the healthcare industry has adapted to this trend, and what the future of the technology may hold.
What are Wearable Sensors?
First, let’s get down to the basics of these tiny computers. Wearable sensors are made using micro-electromechanical systems (MEMS), or miniature devices made of mechanical and electrical components designed to work together to sense and report the physical properties of their local environment. MEMS were first developed in the 1970s and gained popularity in the automotive (airbag deployment) and medical (blood pressure measurement in IV lines) fields throughout the 1980s and 1990s.
Today, wearables are a new domain for MEMS sensors, especially in activity monitors. These devices collect data about the physical and chemical properties of a user’s body to feed algorithms and create insightful information for the user. Take the Apple Watch for instance, where downloads can help users:
Remember to stay hydrated
Engage in short meditation sessions
Navigate sleep patterns
The examples below outline a variety of the tracking capabilities captured by the Apple Watch.
These charts are interactive and better inform the user about their lifestyle, but let’s go a step further to see how these metrics are also beneficial to the healthcare industry.
How Healthcare is Getting Involved
As of early 2016, healthcare is amongst the top three global industries for wearable sensors. There is a rising demand from physicians to incorporate wearable health tracking technology for monitoring a patient’s health. Why this increased demand? Let’s explore some of the reasons:
Rising Healthcare Costs
Patients who use wearables and are connected to the cloud could provide doctors with greater information at the beginning of a visit. This shift in patient involvement can offset healthcare costs by leading to fewer and shorter doctor visits, fewer unnecessary medical tests and higher rates of treatment success.
Simplicity and Ease of Use
Wearable sensors are designed with clear, user-friendly interfaces to increase interaction for the wearer and device. Information about the user’s activity is clearly generated to provide general feedback about performance. This is useful for both patients and physicians to better understand a patient’s condition over time. Doctors can use this information to monitor a patient’s vital signs as a baseline to interpret progress and relapse after surgery. Doctors can also use these devices to monitor patient conditions in between appointments to make more accurate health recommendations based on the long-term data provided by the wearable.
Alternative to Implantable Sensors
Another technology that has been used to monitor medical conditions is sensors inserted into the body, known as implantable sensors. Implantable sensors require invasive procedures and must meet stringent size, safety and performance requirements. Wearables have become a viable alternative to implantable sensors since they’re non-intrusive, inconspicuous and available at lower costs. In addition, regulatory processes for wearables are more time efficient and less costly than for implantables.
Let’s go over some examples of wearable sensors that are currently used in the healthcare sector:
These thin adhesives send alerts when a user experiences an asthma situation. The stickers also provide journaling options, treatment plans, displays and the tracking and information on symptoms.
Much like their predecessors, new sensored back braces monitor lower back pain, provide users with stability and suggest helpful exercises to increase strength and decrease pain.
Some slip-on knee braces are now embedded with sensors to store movement information while the brace itself provides stability to the joint and leg.
These thick adhesives are padded with electrodes to keep track of heart rate, breathing, temperature, steps and body position (in case of a fall) to send information to healthcare providers.
Google has patented sensing contact lenses which measure glucose levels in the user’s tears and sends the readings through a user display on a mobile device.
The Future of Wearable Technology
It’s estimated that there will be 3 billion wearable sensors by 2025 but even so, the staying power of the technology is debatable, as many reason researchers question the long-term impact of these devices due to the high rate of abandonment. It’s estimated that about half of those who buy fitness trackers stop using them after six months.
Why the high rate of abandonment? One theory suggests that while wearables are good at telling us what we’re doing wrong (not enough steps, not enough restful sleep, too much sugar), they don’t provide enough positive feedback for users or give incentives to increase healthy behavior. Another issue is the data overload that can plague physicians. A constant stream of information about patients can be difficult for doctors to decipher and find time to analyze, therefore making the data provided by patients obsolete.
So, how do we overcome these barriers? One solution is to combine wearable devices with biometrics to provide actionable insights (like suggestions for how to lower blood pressure or easy exercises to incorporate into daily routines). This makes wearable devices less boring and users are incentivized to keep using them. Another way to increase usability is to ensure physicians are confident in the technology, how to read it, and the assurance the data they are receiving is reliable and accurate.
As these technologies progress, more and more wearable sensors are gaining FDA approval and other medical clearances from all over the world. With the consistent development of wearable sensors and their integration into the healthcare system we are sure to see more advancements in the patient-doctor interaction in the future.
Do you have experience using wearable sensors? Share your experience in the comments below!
You may have heard the term “biosimilars” discussed in the news or the office and wondered what it means. Don’t worry, you’re not the only one. Biosimilars recently became a popular topic after 2 biosimilar drugs were approved for use in the United States. So, what are biosimliars and why should we care? Let’s learn a little bit more about this innovative medical treatment and how these drugs could have a big impact on drug costs and our healthcare system.
A Breakdown of Biologics
Before we get into the details of biosimilars, let’s discuss biologics, or drugs that biosimilars intend to mimic. Biologics is a drug classification that describes variations of living proteins specifically made or programmed to counteract disease. Biologics have been around for 33 years and differ from many traditional treatments by targeting the cause of a disease rather than treating just the symptoms. Biologics are effective against diabetes, cancer, autoimmune conditions like rheumatoid arthritis, multiple sclerosis, Crohn’s disease and a variety of other conditions.
What are Biosimilars?
A biosimilar is a pharmaceutical drug that is almost an identical copy of a biologic manufactured by a different company. Biosimilars are officially approved versions of original “innovator” products and can be manufactured when the original product’s patent expires. It’s important to understand that biosimilars are exactly that – similar to the original biologic. Why aren’t they identical? Because biologics are complex, living cells and that means they can’t be exactly replicated like generic drugs.
So Biosimilars and Generic Drugs aren’t the Same Thing?
Nope, these are two separate drug forms. Generic drugs are approved after the brand-name drug’s patent has expired, and have the same active ingredient, strength, dosage form, route of administration, and bioequivalencey as the brand-name drug. These are known as small molecule drugs because their chemical make-up isn’t as complex as biologics. Since biologics are complex mixtures of molecules, they are harder to clone than a small molecule drug.
Confused? No problem, here’s more information about the differences between generic drugs and biosimilars:
Simple and well-defined
Complex with potential structural variations
Predictable chemical process to make identical copy
Specialized biological process to make similar copy
So, you’ve heard about biosimilars and wondered why the term has attained buzzworthy status. We’re here to break down the reasons for this rise in popularity:
1. Biosimilars recently became available in the U.S.
The FDA recently demonstrated its willingness to approve biosimilars as long as there are “no clinically meaningful differences in terms of safety and effectiveness from the reference product [the biologic].” The first biosimilar approved for use in the U.S. was Zarxio (a medication that helps patients receiving chemotherapy make white blood cells, preventing infections common among cancer patients) in the spring of 2015. Zarxio has the same active ingredient as a biologic called Neupogen, and was shown to be just as safe and effective.
2. Biosimilars are available at lower costs
Once the patent on a biologic has expired, its formula is no longer protected. So other companies can release a drug with the same chemical recipe which drives the cost down. Some estimate that they could save U.S. consumers $250 billion over the next decade.
That being said, the steep price differences that we are accustomed to seeing with generic vs. brand-name small molecule drugs won’t be replicated with biosimilars. This is because it takes more energy, time and money to make a biosimilar than it does to make a generic drug.
It’s likely that we’ll see many more biosimilars hitting the market in the U.S. over the coming years. Some worry about the safety and effectiveness of biosimilars, however, rest assured that since biosimilars are a complex and emerging drug classification, regulations on biosimilars will be complex and robust as biosimilars continue to develop.
Do you have experience with biosimilars? Tell us about it in the comments below!
PharPoint’s Pharma 101: An article series to teach you all about how drugs make it to market. This week: Phase I Clinical Trials.
You might not always think about it when you are buying prescription at your pharmacy, but all drugs and treatments being sold on today’s market have undergone rigorous testing and various trials to make it to your doorstep. In our previous post, Pharma 101: What is a Clinical Trial? we provided an overview of the clinical trial process, covering the clinical trial basics, from who is involved in a trial to why clinical trials are so important. For lesson 2 of PharPoint’s Pharma 101 Series we’ll explore the steps and elements that occur in Phase I the clinical trial process.
Many people have heard of clinical trials and know about the FDA, but what would your response be if someone asked you “What takes place in Phase I of the clinical process? What are researchers attempting to achieve at this early stage of development?”
Would you choose that researchers are testing a drug’s:
C. Movement through the body
D. Biochemical and physiological effects
E. All of the above
If you chose “E” then you would be correct. The purpose of a Phase I clinical trial is to assess the pharmacovigilance (PV), tolerability, pharmacokinetics, and pharmacodynamics of a drug or treatment, with the ultimate goal of learning how to administer the right drug at the right dose to the right patient at the right time.
Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
The degree to which overt adverse effects of a drug can be tolerated in the body.
The movement of the drug into, through, and out of the body. The study of pharmacokinetics evaluates the time course of a drug’s absorption, distribution, metabolism, and excretion.
The study of the biochemical and physiological effects of drugs on the body and the mechanisms of drug action and the relationship between drug concentration and effect.
General information about Phase I clinical trials
Now that we know what researchers are testing a drug or treatment for, the question becomes how are researchers accomplishing this? The answer, by collecting data on the dosage, timing, treatment safety and side effects from human subjects.
By Phase I of the clinical process, researchers have already proven that a drug or treatment is safe for animals, so people who join Phase I trials are the first human subjects to test a new therapy or combination of therapies. Usually, Phase I trials last from several months up to a year with 20 – 100 participants. Researchers recruit such a small number of participants to minimize the risks of experimental therapy. Healthy volunteers are typically included in Phase I, though there are some instances where subjects with serious diseases are enrolled into a trial. Examples of this would be those subjects with terminal cancer or HIV where the experimental treatment is one of the last viable options they have. Participants are closely monitored throughout the duration of the trial and must often agree to routine visits or checkups.
How is the therapy administered?
The quick answer? Slowly. Doctors incrementally increase the dose of the drug being studied to trial participants. Their goal is to determine the dose that is most appropriate without causing severe side effects. It is assumed at the onset of a Phase I clinical trial that an increased dose of a drug is associated with increased efficacy, or the ability to produce a desired or intended result. For this reason, Phase I trials are known as dose-escalation trials that are designed to determine the maximum tolerable dosage (MTD) associated with an acceptable level of dose-limiting toxicity (DLT).
In addition, doctors must also determine the best way to administer a drug. This could be either orally or intravenously depending on the therapy. It’s also worth noting that placebos are never used in Phase I clinical trials.
Are there different kinds of Phase I clinical trials?
Yes, there are 3 kinds of Phase I clinical trials that study different components of a drug’s effect on the human body.
In these trials, small groups of participants are given one dose of the drug and are observed and tested for a period of time to confirm whether or not the drug is safe. If the participants react well to the drug, a new group of participants are given a higher dose. This process is continued until intolerable side effects begin or pharmacokinetic safety levels are reached.
These trials investigate the pharmacokinetics and pharmacodynamics of multiple doses of the drug, looking specifically at safety and tolerability. Low doses of the drug are administered, and fluid samples are taken from the participants at different points throughout the trial to learn how the drug is processed in the body.
These are short trials designed to investigate differences in absorption of the drug in the body which is caused by eating before the drug is taken.
What happens next?
A Phase I clinical trial is complete once a dose or a range of doses is determined that is safe and effective in trial participants. While about 70% of experimental drugs move on to Phase II trials, the work isn’t over yet. The drug or treatment must pass through 3 more phases of development before it is approved for market use and less than 12% of medicines that make it into Phase I clinical trials will go on to be approved by the FDA.
One of the foremost limitations to conducting clinical research is finding suitable trial participants. Volunteers for clinical trials are always needed and participating is one of the best ways to help advance scientific research to aid in healthcare development.
Interested in learning about what happens after a drug successfully passes through Phase I? Stay tuned for our next chapter of PharPoint’s Pharma 101 Series as we discuss the ins and outs of Phase II trials.
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