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AlphaBioCom

LINK

WWW.ALPHABIOCOM.COM JULY 2018

SUMMER EDITION

Striking the right balance across our multifaceted lives is no easy task. The founders of AlphaBioCom recognize the importance of encouraging work-life boundaries. Whether it’s sweating it out at the gym, taking a long bike ride down the Schuylkill River Trail, slurping an ice cream cone at Zwahlen’s, catching up on the latest movies, or enjoying a sunny day in your favorite vacation spot, we all try to make time to rest, recharge, and renew our work-life balance. In this issue of AlphaBioCom LINK, we’re bringing you stories about how individuals across healthcare continue to improve the balance in their work and own lives. In the medical field, agencies are increasingly using patients’ self-described health status with traditional tools to inform approval and coverage decisions. Account manager Carolina Pombo juggles her client duties with a volunteer position as Program Coordinator with children at the Science Education Academy. Finally, our feature article provides an insightful look into the life of Ashley Juavinett, a neuroscientist who expresses herself outside the lab by writing and performing original music. Feeling the heat of the summer street? Check out a few of our ideas on how to manage the strain and maintain a cool head during the busiest summer days. Make sure you keep up-to-date with us on our Facebook and Twitter sites, and connect with us on LinkedIn. We’re always posting the latest in science news and developments in healthcare. From all of us at AlphaBioCom, we hope you take time to cultivate what balance means in your life. Have a relaxing summer! –Kate Sydnes, Scientific Editor

PATIENT-REPORTED OUTCOMES

IN MEDICAL PRODUCT APPROVAL AND COVERAGE

Patient-reported outcomes (PROs)—health status measures reported directly by patients—have historically been used to assess pain and quality of life. However, interest by medical product developers, regulatory agencies, and payers in disease state-specific PROs has increased in recent years, particularly in the oncology field. In 2009, the US Food and Drug Administration (FDA) released Guidance for Industry on using PROs in medical product development to support labeling claims. The oncology drug ruxolitinib (used to treat myelofibrosis) was the first product to employ this FDA guidance to develop a new PRO—the Myelofibrosis Symptom Assessment Form version 2.0 (MFSAF v2.0)—to support a labeling claim. When the first patients in a phase 1/2 trial experienced marked symptom improvement after taking ruxolitinib, the FDA advised that clinically relevant symptom improvement could be used with objective measures to support ruxolitinib registration, and the MFSAF v2.0 was developed accordingly to measure change in myelofibrosis symptoms. In 2015, ruxolitinib became the first drug approved for myelofibrosis, based in part on superiority relative to placebo in MFSAF v2.0 score improvement as a key secondary endpoint in a pivotal phase 3 trial. Other developers are increasingly following the ruxolitinib example. As of March 22, 2018, clinicaltrials.gov lists 1670 studies with the term “patient-reported outcome,” including 555, 233, 554, and 130 trials that are complete, active, recruiting, and not yet recruiting, respectively. Approximately equal numbers of phase 2 and phase 3 trials include PROs, likely because creating and validating disease-specific PROs early in the product development process and including them as endpoints in early-phase trials can facilitate interpretation of phase 3 trial results. Payers are also taking more notice of PROs; although a 2012 survey found that most payers place relatively little value on PRO data for coverage decision making, 47% and 78% of payers within and outside the US, respectively, reported using PRO data in a 2014 to 2015 survey, and the majority expect PRO data to become more important in the next 5 years. The number of disease statespecific PROs can thus be expected to continue to grow. –Judy Phillips, Scientific Communications Manager

Precision Integrity Passion


STRESS –

WHAT IS IT GOOD FOR?

Everyone feels stressed at some point. We are all busier than ever, with a multitude of things to do and places to be. We know many of the common causes of stress—jobs, traffic, money, family, and life in general. Stress, however, is not always bad. In short, small amounts, stress can actually increase motivation and preparation. There are three different kinds of stress: 1. Acute Stress. The most common type of stress that is caused by day-to-day triggers. For example, if you are being chased by a bear, that same stress helps you run faster by activating your flight-or-fight response. 2. Episodic Acute Stress. Frequent acute stress. The “glass half-empty” people; they accept stress as a permanent part of life instead of it being temporary. 3. Chronic Stress. When acute stress is not resolved and never seems to go away. Chronic stress is often detrimental to our bodies; it can increase the heart rate and blood pressure, and decrease the immune response. Triggers of chronic stress can stem from a variety of life events such as an unhappy marriage or family, a bad job or work environment, or having financial issues. The symptoms of chronic stress may include insomnia, stomach pain, or anxiety. Chronic stress may also lead to overeating (or undereating), social withdrawal, or use of coping devices such as drugs and alcohol. Chronic stress can also have a negative effect on mental health. Stress triggers the release of cortisol, which causes the physical symptoms of stress. Cortisol can also work along various neural pathways and change the concentration of neurotransmitters throughout the brain. These increased cortisol levels are often seen in patients with depression, leading to speculation that over time, chronic stress can lead to depression. People with chronic stress may begin to catastrophize, or constantly think negative thoughts about everything. When stress causes catastrophizing, this begins a vicious cycle, which may lead to increased stress. Stress will never be absent from our lives. The goal is to minimize stress and recognize how to cope with it. This can lead to improved mental health and overall well-being. Some techniques for dealing with stress can be practiced at any time. These include maintaining a stable sleep cycle (go to bed and wake up at the same time every day), form positive and healthy interpersonal relationships, be physically active at least 3 days a week, and eat well-balanced meals throughout the day. Pay attention to your body and be attuned for signs and symptoms of increased stress, which could include headache, increased or decreased appetite, altered sleep schedule, and irritability. When you notice these symptoms, begin techniques to help decrease and cope with your stress. The Centers for Disease Control and Prevention recommend the following techniques to help cope with stress: • Take care of yourself by eating healthy, exercising, and getting plenty of sleep • Find support by talking to other people about your struggles • Connect socially, as it’s easy to isolate yourself after a stressful event • Take a break from whatever is causing the stress • Avoid drugs and alcohol, which may seem to help with stress in the short term, but can actually cause more problems in the long term Other techniques to cope with stress include: • Set goals and priorities to help increase your sense of accomplishment and help prevent the cycle of catastrophizing from the beginning • Be realistic in what you can take on and don’t be afraid to tell people “no” • Take more time for yourself to participate in activities you enjoy Taking the time and steps to decrease your chronic stress will not only be beneficial for your body, but also for your mental health.

–Jennifer Meyering, Senior Scientific Communications Manager

Precision Integrity Passion


TESTING, TESTING –

FROM THE SCIENCE LAB TO THE MUSICAL STAGE

It may be difficult to picture a scientist leaving the lab and picking up a guitar to head out to an open mic night at a local coffeehouse. Conversely, it may be odd to consider a performing singer/ songwriter coming home from a weekend of music and putting on her lab coat to head out to her “day job.” Turns out, some colleagues have trouble picturing it as well. But those are two of the sides to Ashley Juavinett. A PhD neuroscientist serving her postdoctoral fellowship at Cold Spring Harbor Laboratory, Juavinett is also a singer/songwriter who has performed at music venues, coffeehouses, and festivals around the country, and has even released a few independent albums. “It’s funny, but at work, it usually takes time for me to come out to people as a musician,” Juavinett said during a recent phone conversation. “There’ll be some sort of an event, ‘Hey, I can play. I dabble.’ It’s just kind of happening now that people are starting to find out. A few months ago I started playing a few more gigs, and it was like, ‘You have this whole other side of you?’ ‘Yeah, kind of.’” To her colleagues, Juavinett is a dedicated scientist studying the effects of multisensory stimuli on mice and how the brain processes that information. “The question I’m studying is, ‘How does the brain combine visual and auditory information in order to guide behavior?’” she said. “The basic idea being that every moment you have to deal with a lot of sensory information, but somehow your brain has to combine it and help you navigate the world. To do this, we’re using a mouse model. We have these recording devices that are kind of amazing that allow you to record from hundreds of neurons in the brain simultaneously, so we implant these in the mouse brain and the mouse is freely moving and running around while we expose it to different types of visual or auditory stimuli, with the basic question being, ‘What is the brain doing when we present that stimuli?’” Of course, Juavinett knows plenty about auditory stimuli. She’s been playing guitar and writing original music for many years. She released an EP, 20 Miles to Freedom, as an undergrad at Lafayette College, and followed it up two years later with her first full-length album, Skies Apart. Though she mainly performs solo, she spent time as a member of The Dark Matter Turtles, a quartet of University of California San Diego medical students who, according to their Facebook page, enjoyed “moonlighting as a soulcoustapoppafunk band.” “I never really took that leap with music,” Juavinett said. “Science is what I know and what I love. But what’s nice is that I still get to stretch my creative muscles a little bit in music and writing. As long as I have an outlet, I’m a happy person. “My music has definitely gotten more

personal in the past few years. There’s always a time in people’s lives where it’s very vulnerable to be sharing your own personal story, and there would always be certain topics I would leave out. For me, the past few years, my music and my lyrics have gotten more personal, deeper, which is great for me as an individual, because writing music is therapy.” Juavinett has seen her musical styles evolve and grow as she herself has. “I’ve been trying different styles, I tried to move into jazz a bit, more raw folk-type things,” she said. “I’m moving away from the pure acoustic pop thing.” While Juavinett admits she hasn’t spent too much time in the local music scene – something she’d like to remedy moving forward – she has performed at various open mics, played an acoustic set at a Fall Festival in Huntington, and plays at a monthly live music yoga class. “That’s a super-fun and challenging new project,” she said. “It’s mostly instrumental and what I do usually includes a lot of vocals. I try to match the mood of the class, play more instrumental pieces, build up interesting textures. It’s a very different direction.” While it might seem that her work in neuroscience and passion for music live in very separate worlds, there’s no denying that the confidence Juavinett has gained by baring her soul in front of live crowds have helped color her love of promoting science. She has written for Massive Science as well as other science websites, and has worked with Guerilla Science, which is dedicated to creating entertaining and inspiring events and scientific installations for cultural events in an effort to connect people with science.

For a more in-depth version of this interview with Ashley Juavinett, click here

“I feel like I always need to be doing some type of outreach or engagement, that’s ultimately what gives me meaning,” she said. “I love research but I think the public engagement side of things is becoming more important to me. I enjoy teaching, too. I really enjoy public engagement. If I have some ability to do a mix of those things moving forward, that would be really great.” –Craig Ostroff, Managing Editor

Precision Integrity Passion


COORDINATING FUN FOR

FUTURE SCIENTISTS Science Education Academy (SEA) is a science, technology, engineering, and mathematics (STEM) nonprofit organization that aims to teach hands-on science to elementary school-aged children. SEA splits the year into three academic units: fall (Earth Sciences), winter (Physical Sciences), and spring (Biological Sciences). So as not to interfere with the kids’ schoolings, the program runs on Saturday mornings throughout the year. In addition to the Saturday morning programs, SEA provides supplementary events and programs such as the Science Carnival, Women in Science, Philly to Lesotho Exchange, and summer field trips. AlphaBioCom account manager Carolina Pombo has been a part of SEA for almost 10 years. She holds the position of Program Coordinator but also helps run experiments and orientations for new volunteers, attends meetings with different societies, and recruits volunteers. Carolina originally started volunteering with SEA to help kids with science. “Due to budget cuts, science classes do not do hands-on experiments anymore. I wanted to teach kids hands-on science,” she says. “One of my favorite things to teach is comparative anatomy by dissecting worms, crayfish, and a frog. However, one of the more fun experiments we do is teach the kids about phase changes by making slime and oobleck. “The thing I love most about science is discovery. I am driven by the need to know how things work, especially in biology. A scientific

Jeremy Gerrard, Project Manager

discovery can have an incredible impact on our future, whether it is in medicine or technology, but one of the most amazing things about science is that it is constantly changing, there is always something new to learn.”

On April 27, SEA ran the WEST PHILLY STEM-A-THON, a collaborative event with the annual Philadelphia Science Festival. The STEM-A-THON was run by volunteers from universities in Philadelphia, where kids aged 4 to 18 participated in experiments such as extracting DNA from bananas; making bouncy balls, slime, and a water filter; creating liquid nitrogen ice cream; and exploring chromatography. “I think learning science is very important for everyone,” Carolina says. “It is more about…learning how to think for yourself, how to find reliable sources of information, and how drawing conclusions from facts and observations will make a big difference in their lives and any future career/job they have. I also believe it is important to have a basic understanding of biology, to have conversations with your doctors about new therapies, like gene therapy, or emerging infections. Looking at trends, the majority of the available jobs in the next 15 to 20 years will require some knowledge of technology; how to navigate the internet, including social media; and being able to learn new computer programs, statistics, data mining, etc. We need to start preparing kids for that future now.”

“Learning science from books is just not fun.”

-Katie Ashman, Medical Editor

MEET THE STAFF

As a project manager, Jeremy is responsible for constructing and analyzing social media landscapes for clients, identifying and researching key opinion leaders, and updating the AlphaBioCom social media accounts. Jeremy also manages project timelines and status reports; provides logistical support for advisory boards, meetings, and congresses; and helps build publication plans for clients. Jeremy graduated from Auburn University with a BA in Journalism. Jeremy’s previous work experience includes years spent as the Digital/Online Editor, and later Senior Editor, for Food Engineering Magazine. Prior to the magazine, Jeremy tailored his skills as a journalist working for the Daily Local News out of Chester County, PA, where he gained experience cultivating and maintaining business relationships while juggling multiple projects under tight deadlines. During his free time, Jeremy enjoys cooking, listening to Patti Smith, playing guitar, and training for long-distance races.

Jeremy joined AlphaBioCom in October 2016.

As a Senior Scientific Communications Manager, Nicole works with the scientific lead and assists with development of individual publication outputs including abstracts, posters, slide decks, and both primary data and review manuscripts.

Nicole Seneca, PhD,

Senior Scientific

After graduating from Communications Manager the University of Central Florida with a bachelor’s degree in Molecular Biology and Microbiology, Nicole earned a PhD in Molecular Virology and Microbiology from the University of Pittsburgh, School of Medicine, for her research on molecular pathways used by human and virus proteins to create cancerous cells. Nicole was awarded the NIH Predoctoral Trainee Award in Molecular and Microbial Pathogenesis and Persistence while studying at the University of Pittsburgh, School of Medicine. Nicole has worked in several therapeutic areas, including infectious diseases, ADHD, and gene therapy for rare disorders. When she’s not writing for AlphaBioCom, you can find her hiking in the parks around Philadelphia or creating incredible meals at home.

Nicole joined AlphaBioCom in September 2016.

Precision Integrity Passion

AlphaBioCom LINK July 2018 newsletter  

Check out the July 2018 edition of AlphaBioCom LINK, with articles on finding a work-life balance, dealing with stress, and how patient-repo...

AlphaBioCom LINK July 2018 newsletter  

Check out the July 2018 edition of AlphaBioCom LINK, with articles on finding a work-life balance, dealing with stress, and how patient-repo...

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