Author: Danielle Ashley

AusBiotech 2018: Insight Gained as a Caregiver

Danielle Ashley

For nearly 15 years I’ve been working in the clinical research space, working for various Contract Research Organizations (CROs) and Functional Service Providers (FSPs) as well as a biotechnology firm that had a promising oncologic drug candidate to fight prostate cancer. Two weeks ago, I attended my first industry conference while unemployed and living in Australia to support my husband during his enrollment in a phase I clinical trial for a cancer vaccine (Visit here to read more about how that journey began).

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Lucky for me, the AusBiotech conference was taking place in Brisbane, starting only days after we arrived.  While I always knew patients and finding cures for the incurable gave me purpose and were at the core of why I do what I do, this trip has given it a whole new meaning. It really hit home.

As you could imagine, with such topics as cancer vaccines and immunotherapy being at the forefront in cancer research today, my interest in such has taken on a whole new meaning. When Tom decided he wanted to enroll in a trial half way around the world, to hopefully prevent his HPV related head and neck cancer from returning, it shed new light on the clinical research process. Here I was at this biotechnology conference in the presence of the very individuals that have been trying to find these answers. These individuals were among the pioneers that are trying to save my husband’s life. I hung on their every word.

I attended such talks as ‘Immunology/Oncology- Recent Advances’ chaired by Prof. Rajiv Khanna, Senior Scientist, QIMR Berghofer. Panelists for the discussion included Dr. Michael Rosenzweig, Executive Director Tumor Immunotherapy, Merck; Dr. Goslik Schepers, Investment Manager, Brandon Capital Partners; Dr. Anand Gautum, Senior Director and Head, External Science and Innovation, Australia, New Zealand and South East Asia, Pfizer and Dr. Daniel Baker, VP Janssen R&D.

One such highlight of the talk, which has me reflecting on the future of Tom’s care, was understanding the importance of how the integration of immunotherapy or immune based therapy in combination with other treatments will impact clinical outcomes. What I learned is that clinical outcomes need to be clearly determined for drugs like PD-1, because they are hugely reliant on the biomarker discovery program. As certain biomarkers need to be present in order for the drug to provide a larger probability of success. What they were referring to was combination treatment, such as cancer vaccine paired with immune checkpoint therapy.

What I now know from further research is that vaccines “rev up” the immune system but the tumor has a “immunosupressive microenvironment” that may prevent the vaccine from working. That’s why combination therapy and the biomarker discovery program are so important. Vaccination alone, may not be the answer.

Let me also point out that on October 1, 2018 , merely weeks before our trip to Australia, the Nobel Assembly decided to jointly award the Nobel Prize in medicine to two scientists for the discovery of PD-1 and CTLA-4 immune checkpoint therapy, James P. Allison and Tasuku Honjo.

I’ve also learned that there has been success in clinical trials in Texas For this combination therapy as they’ve seen a 33% response rate in tumors. (https://medicalxpress.com/news/2018-09-vaccine-anti-pd1-drug-incurable-hpv-related.html).

All of this is very promising in the world of cancer research. While scientists have been trying for nearly a century to determine how vaccines can be used to fight cancer, I am energized by the progress being made in clinical research today and have put a great deal of faith in those that are pioneers in this effort, such as Ian Frazer, the Principal Investigator for Tom’s trial.

For people who are fighting this disease now, time matters. What this translates to for companies and scientists trying to find these answers are how do they do this in the fastest and most cost-effective way possible.

I believe the answer to this is having access to data in the most efficient way possible, clinical trials rely on data being aggregated from many different sources. The answers are out there and it is only our ability to rely on technology and access to this data that will ultimately expedite this process and save the lives of those that are fighting so hard to live or have better quality of life. We need to harness the use of technology to reduce the life-cycle of clinical development without compromising patient care.

We also need to focus on how options are made available to patients seeking treatment, even if that means experimental treatment. I know, first-hand, what sacrifices are willing to be made. We have to empower patients and ensure they have all the information they need to make better informed decisions. One that not only benefits the researchers and the future of clinical development but one that increases patient’s overall odds of survival.

 

 

An American in Australia

An American in Australia

Danielle Ashley

It’s officially been just over 10 days since our arrival in the land of OZ.

While our reason for being here is for a clinical trial (read more about that here)  there was time before Tom’s first appointment and there will be plenty of time in between each visit. So, what do we do with this time? We explore!

It’s not quite like home in many senses.

It feels very familiar, very much like the U.S. or what Tom has dubbed Floridafornia, since it feels a bit like Florida and California. It feels like home…but not quite.

There have certainly been a few things that reminded us we weren’t in familiar territory. The first thing I noticed were the birds, their music was so different from what I’m used to. I love it! There are lizards! They are not the lizards I’m used to from Florida or Puerto Rico but they really don’t look to bother anyone.

Aside from that, we are getting used to the flip-flopped seasons with temperatures anywhere from 75-92 degrees Fahrenheit. Another thing we’ve had to get used to is the conversion since temperature is measured in Celsius here. We’ve figured out a trick to measure it quickly. Multiply the temperature by 2, then add 25. You’ll always be within a few degrees. You’ll be a bit more off in cooler temperatures.

EXAMPLE: 30 Celsius would be ~85 Fahrenheit. (30 x 2 = 60 + 25 = 85)

I’ve also made some other observations that make daily living feel a bit different:

  • Driving on the other side of the road, something I’m used to from my travels to Europe and Bermuda.
  • Table service isn’t always available, order at the counter and grab a table.
  • Many of the establishments we have frequented, thus far, do not have restrooms. You have to find a public restroom.
  • Shopping bags are not provided for free. You either have to bring reuseable or purchase plastic from 15-30 cents per bag. It’s great for the environment!
  • Ordering coffee is a whole different experience. There is no such thing as just ordering a “coffee”, you have to order either a “short black”= shot of espresso, a “long black”= shot of  espresso and water, or a “flat white”=  shot of espresso and steamed milk (Tom’s favorite).
  • Cars do not typically yield to people, neither do bicycles. Crosswalks don’t usually guarantee they will stop either.

 

There is much to see in and around Brisbane.

We have seen some beautiful places in such a short time. The city of Brisbane is outstanding, it really has a great mix of metropolis, art and nature. The South Bank is a favorite spot. They have literally brought the beach to the city with Streets Beach, a man-made beach and pool on the river side. It’s free and you can take in a great view of the city skyline. The promenade along the river is full of life and vibrancy and is sure to impress and amaze as there are parks, water activities, restaurants & cafes, arbours, fruit & vegetable gardens, museums, a ferris wheel, a peace pagoda and much more.

The Gold Coast is within an hour drive south and home to Surfer’s Paradise. It felt a lot like Miami. In fact, they have a Miami Beach at the Gold Coast. We’ve been told to avoid the Gold Coast from mid-November to beginning of December since this is when school lets out and it tends to get over-crowded and over rowdy. We’d compare it to Spring Break in the U.S.

The Sunshine Coast is a bit further away and to the north of Brisbane. Much more laid back than the Gold Coast and home to some beautiful beaches and neighborhoods. I enjoyed my favorite meal at the Black Pepper Cafe at Noosa. We had little time to explore so we decided to turn to the web for a bit more information on each beach. https://www.visitnoosa.com.au/regions/Beaches was a great website as it provided a pretty concise summary of the various beaches. We chose Noosa North Shore for our first peek at the ocean. It was quiet and you can drive on the beach but you needed a permit so we weren’t able to. However, on an adventure walk along the shore, I spotted my first jellies, which again reminded me that I was far from home.

We decided to take the +1 hour drive to the Glass House Mountains after Tom’s first on-study visit. We had a great view from Glass House Mountain Lookout. It was a great way to end the day and experience the sunset.

We also visited the Lone Pine Koala Sanctuary where we both were able to hold a koala and feed the kangaroos. This was new to both of us and we just loved it! The sanctuary is beautiful with so much to see other than kangaroos and koalas. We were able to enjoy and learn about other indigenous animals to the region. It was here that we heard our very first song of the pied butcherbird, which was mesmerizing and held us captive. We fed the wild Lorikeets whom were very brazen, even landing on our heads.

We hiked a portion of the rainforest at Tambourine Mountain, where we took in Curtis Falls and watched bats flying among the palm trees. They weren’t the only animals living among the trees. Note to self: always wear a hat in the rainforest. We paid a fee to walk along the SkyWalk, which is private. It was free, however, to walk the trail to Curtis Falls, which we ended up enjoying much more.

There is so much to do within an hour of the city and it has been a great way for us to get acquainted and take in what it must be like to be an Aussie.

Our trip has not been without doses of reality, as we are missing our son. We do get plenty of quality Skype time but it’s still challenging to be so far away. I’m often reminded about how we are missing the changing of the leaves and the approaching holiday season, a time to be with family and friends. Tom is still working, which has taken some getting used to with the time zone difference; he works with people from both the east and west coast of the U.S.

Despite all of that, there is no reason to hold back and miss what Australia has to offer. After all, as our lives get shorter, our memories get longer. I want those memories to be full of experiences, remind me what a full life I’ve lived and to be appreciative of the knowledge gained and shared through those experiences.

 

 

Preparing for Three Months Abroad for a Clinical Trial

Preparing for Three Months Abroad for a Clinical Trial

Danielle Ashley

For anyone who has prepared for a long term trip away from home, no matter the reason, you know that it can be daunting. There are so many things to consider; anything from “who will take care of the dogs?” to “how do I handle health insurance?”. This becomes even more challenging when you have less than two weeks to prepare and the destination is on a different continent, almost 10,000 miles away from home.

Just under a year ago, my husband received a cancer diagnosis, one he had hoped he’d never hear again after his battle five years prior. This was my first time experiencing anything like this, as we had only met and married two and a half years after his last treatment had ended. As you can imagine after receiving this news, our world came crashing down. The fear that it had returned, what that meant from a treatment perspective and how this would impact our family, his son (our) son, was just so overwhelming.

Getting through the first six months of 2018 was no easy feat, as I watched my loving husband endure pain, anxiety and sickness of a caliber I had hoped he would never have to endure. The year started off with surgery then lead into radiation and chemotherapy. He was tired, weak and depressed… so was I. Everything we had hoped and planned for, came to a screeching hault and our focus became about getting him through this and on the other side of cancer…We did!

It has now been over five months since his treatment ended and a follow-up scan, showed promise with no signs of cancer. While standard of care prescribes that he should have follow-up scans every three months, he has made it clear he is not waiting to take action. He is going to do everything in his power to ensure he has left no stone unturned to mitigate the chance of a repeat diagnosis. While he has a team of the best doctors, oncologists and radiation oncologists in the world, he has decided that he also has the power to impact his future.

With that, after a great deal of research and much deliberation, he had decided to enroll in a clinical trial in Australia. This was a very personal decision, one that I could do nothing more than support, no matter what he decided. Everything had moved very fast in terms of confirming his eligibility and then timing of his first visit. All this time, I had assumed I would be taking care of our “life” at home while he was going through this tremendous experience, solo.

In a very cosmic turn of events, I had subsequently and recently lost my job due to corporate restructure. There was now no question, “I am going with him”. This is what went through my mind along with a rush of emotion over how the universe has a unique way of providing for you, even when it isn’t always apparent or easy.

We are now only days away from leaving for our long trip. There have been so many important things to account for and consider over these past two weeks.

For anyone in this same situation, I recommend creating a checklist. As simple as that sounds, it really does make a difference. This is such an emotional time, filled with excitement so it’s easy to miss the little things. We are very fortunate that our son’s mother is going to keep him while we are overseas. While it is very difficult for us to be away from him, there is no better place for him to be.

CHECKLIST:

  • Ask questions and review all informed consents for the trial- Be sure you have a general schedule and are clear on how you will be cared for during the trial. What costs will and will not be covered?
  • Finding a place to stay-  There are various services and websites available that make it easy for you to find the right place within your budget.
  • Enlisting friends and family to house-sit while you are away- Taking care of plants, collecting mail, ensuring the pipes don’t freeze, during winter months and various other things to ensure your home is covered.
  • Planning for pet care- If you are as lucky as I am, loved ones can really help with this. If you are not as fortunate for any number of reasons, there are so many pet sitting services available as well as long term boarding.
  • Ensuring that you have the proper documentation for international travel and that you are aware of any restrictions on the length of your visit.
  • Be sure to have all doctor check-ups, vaccinations and shots and be sure to bring medications for the length of your trip.
  • Health Insurance- Check on your health plan. There are options to get trip insurance that will cover medical expenses and trip interruption or loss.
  • Enable international plan on your mobile phone. Another option is to purchase a SIM card locally.
  • Notify your credit card company and bank of your wearabouts. Many banks include fraud alerts and will freeze your card in the event of suspicious activity.
  • Freeze or hold any gym memberships or other club memberships while you are away.
  • Research any items that might be hard to find at your destination and try to pack them ahead of time. You may also have the option of relying on your family to send care packages.

Last but not least, lean on your family and friends. They want to help. I can speak from experience, that this matters. Preparing for this trip has really shown me how fortunate I am to have such loving and caring people in my life.

Now I am able to focus on my husband, his health and well being and maybe experience something spectacular along the way. Life surely is a journey and I am grateful to be able to take the journey with him.