Winter 2015-16
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GET TO KNOW DR. PADMAJA SAI » OFFICE SPOTLIGHT: NEW SMYRNA BEACH »
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EGFR M+ – epidermal growth factor mutation positive;
NSCLC – non-small cell lung cancer.
Copyright © 2015 Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved. (9/15) PC-OC-0049-PROF
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FCS The Magazine
Winter 2015-16
contents
Dr. Vikas Malhotra
in this issue
DEPARTMENTS
6 FCS News
23 Get to Know Dr. Sai
24 FCS Events
31 Patient Letters
42 Radar Screen
SPOTLIGHTS
16 Office Spotlight: NEW SMYRNA BEACH
FEATURES
10 Foundation and FCS Events Have
18
21
32
38
40
Riding the Wave
urse Spotlight: CHRISTINA CARUSO
N
Expanding FCS’s clinical trial
enrollment
dministrative Spotlight: TOM CLARK
A
Leading FCS’s legal team
29
Patients at Heart
S teve Noga Industry-Sponsored Feature
Senior Medical Director, Medical
Affairs, Takeda Pharmaceuticals
Clinical Summit Recap
esearch Spotlight: KATIE GOODMAN
R
Finding a better way for patients
octor Spotlight: DR. VIKAS MALHOTRA
D
Helping mankind
Winter 2015-16
3
editor's
letter
Message from
Shelly Glenn
Dear Colleagues,
Although launched less than a year ago, it’s apparent
that the FCS CARE Core Values—Continuously
Support the Patient, Always Do the Right Thing,
Respectfully Engage and Exceed Expectations—are
more than just words on a page, a poster or a website.
The CARE Core Values reflect how our FCS physicians
and clinicians care for our patients, treat colleagues
and team members, deliver the best outcomes and
constantly strive for excellence.
With many of us making resolutions in our
personal and professional lives for 2016, it will be helpful to be mindful that these
values are central to how FCS has continued to grow and prosper due to the lifeblood
of our company—our physicians, clinicians and team members.
As we reflect on 2015 and look forward to an even better 2016, we are appreciative
of our dedicated team members who:
§§ Demonstrate the ability to deliver results by providing compassionate oncology
and hematology services with continual focus on the patient. This has been shown
through the dedicated efforts of clinicians and staff, the research and clinical trials
program, as well as throughout FCS, including the Financial Counselors who tirelessly
identify sources of fiscal support for our patients such as the FCS Foundation.
§§ Display commitment to personal excellence, accountability and integrity by
abiding by the highest regulatory standards, performing in the most ethical manner
and taking responsibility for our actions through the launch of Care Management,
additional standard operating procedures and implementation of enhanced
measurement programs (surveys, audits, etc.).
§§ Foster positive relationships, encourage diversity of thought, promote trust among
our teams and customers, encourage healthy debate and respect the thoughts
and opinions of others. Through attendance at ASCO, FLASCO, COA, ASH,
ASTRO, etc. and the exchange of information at the FCS annual Clinical Summit,
Operations Meeting, Radiology/Radiation Oncology Meeting and bi-annual
Nursing Conference, FCS continues to demonstrate that the talent, skills and
expertise of our people are our most important assets.
§§ Strive to provide excellence in all that we do. We create a standard of caring
that goes above and beyond, while embracing change in support of continuous
improvement for our patients. In 2015, many FCS physicians were named “Top
Docs” by US News & World Report and Castle Connelly, as well as receiving
community recognition such as being selected as Leukemia & Lymphoma Society’s
Man/Woman of the Year. Internally, Dr. Ralph Gousse was named the 2015 FCS
Humanitarian of the Year for his ongoing efforts in Haiti over the past 12 years.
As a result of your commitment to excellence, potential and prospective employees
and physicians increasingly seek opportunities to join FCS. Thank you for your
continued dedication to FCS patients, physicians, clinicians and fellow staff members
throughout Florida.
Wishing you the best for a joyful, healthy and productive New Year!
Shelly Glenn
Chief Marketing & Sales Officer
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FCS The Magazine
FCS
THE MAGAZINE
PHYSICIAN LEADERSHIP
PRESIDENT
WILLIAM N. HARWIN, M.D.
ASSISTANT MANAGING PARTNER,
DIRECTOR, EXECUTIVE BOARD
STEPHEN V. ORMAN, M.D.
MEDICAL DIRECTOR
MARK S. RUBIN, M.D.
SCIENTIFIC DIRECTOR OF CLINICAL RESEARCH,
DIRECTOR, DRUG DEVELOPMENT PROGRAM
LOWELL L. HART, M.D.
DIRECTOR OF RESEARCH OPERATIONS
ROBERT C. WHORF, M.D.
EXECUTIVE MANAGEMENT
CHIEF EXECUTIVE OFFICER
BRAD PRECHTL
CHIEF OPERATING OFFICER
TODD SCHONHERZ
GENERAL COUNSEL
TOM CLARK
CHIEF MARKETING & SALES OFFICER
SHELLY GLENN
CHIEF REVENUE CYCLE OFFICER
SARAH CEVALLOS
SENIOR MANAGEMENT
RAY BAILEY
CHRISTY BANACH
JEREMY BEHLING
LOIS BROWN
MELISA CHANDLER
MELODY CHANG
DAVID CURRY
RICH DYSON
JEFF ESHAM
MICHAEL ESSIK
INGA GONZALEZ
KATIE GOODMAN
ERIC GRINDSTAFF
CHRISTOPHER HOUSER
LEVESTER JONES
SUE KEARNEY
NICOLE PICAZIO
LOIS POEL
JEFFREY RUBIN
TARA RUSKA
LYNN SAWYER
DENICE VEATCH
SAMANTHA WATKINS
IN PARTNERSHIP WITH
PUBLISHED BY
He
n
d
ti n
g
He
o
Pro m
a li n g
r As a Te
ethe
am
g
To
a lt h, H o p e a
Florida Cancer Specialists would like to give a big thank you to our
valued sponsors of the 2015 FCS Nursing/Pharm-Tech Conference
held on August 26, 2015 at the MOSI Museum in Tampa, FL.
PLATINUM SPONSORS
SPEAKER SPONSORS
GOLD SPONSORS
Winter 2015-16
5
FCS
news
Physician Recruiting 2.0
N
ot long ago, word of mouth was the most reliable
method for building a staff of physicians. Finding a
new practice partner or physician generally meant
asking friends of friends for colleagues, medical school
peers or other qualified doctors who might be interested in joining
the team.
For years, this worked amazingly well for Florida
Cancer Specialists.
As FCS grew, however, the system became
more complex. “From a process perspective, the
strategy was all over the place,” explained Shelly
Glenn, FCS chief marketing and sales officer.
“Some physicians were recruiting colleagues.
Executive and senior management would also
work on the transition in various ways— and it
happened differently for many hires,” she said.
CEO Brad Prechtl wanted to focus on
realigning the system and the process to not only
Marathoners Honor Their
Patients One Step at a Time
get the best candidates, but to ensure that everyone involved knew
the pertinent information and no detail fell through the cracks.
In August 2015, FCS launched a new recruitment page on
the website. From there, prospective physicians can view current
openings and confidentially submit a CV and cover letter. This
streamlined system centralizes the initial point of contact for
recruitment, and on the back end, it tracks the entire hiring process.
After creating this system, Glenn and Lynn Clemens, marketing
coordinator, began working on driving more traffic
to the recruitment page. Today, FCS advertises with
the American Society of Clinical Oncology, Doximity
online MD network, various professional journals,
professional conferences and association events, and
academic/medical fellowship organizations.
All through the process, the system helps staff
continue to present FCS in a professional manner.
“We want to ensure that even if they are not a
chosen candidate, everyone has a positive experience
with FCS,” Clemens said.
She uses running as her meditation and has overcome personal
injury and challenges to press on toward her running goals.
Determined though she is, Cultrera is competing only with herself.
“My goal is to finish and my only competitor is myself,” she maintains.
BY TISHA KELLER
“I am happy to join those at the back of the pack, who incorporate
orking in cancer care, it
running into their busy lives and cross the finish
can be hard to witness the
line in their own time.”
struggle between life and
Delgado is training with a former patient
death day after day. One
and cancer survivor, Stephanie Carroll, for
way to fight back is to do something in your
the marathon. She is also running solo in
off-time that helps create the possibility of a
The Dopey, a combination of races over the
better future for these patients.
four-day weekend.
Dr. Jennifer Cultrera in Orlando and Kim
“I like this event because the money
Delgado, the Wellington office manager,
raised in this county stays in this county,”
decided to do just that. In early 2016, wearing
Delgado said. She raised over $5,000 in
eggplant-colored tees, they ran through four
pledges for the 2016 event.
Disney properties to raise money for leukemia
The LLC uses fundraisers such as this to
and lymphoma cancer research and care.
direct-pay insurance premiums, co-pays and
Kim Delgado and Daughter
The Leukemia & Lymphoma Society’s (LLS)
treatments, and to fund research for a cure.
“Team in Training” program is the only program for endurance
Delgado says the she hates the first two or three miles of any
athletes that enables people to do what they love and raise money for
run, but it’s her devotion to those in need that keeps her going.
blood cancer research.
“I keep going because I’m running for those who can’t,” she explained.
RunDisney manages the Walt Disney World Marathon
“And this time, I just want to get Stephanie across that finish line.”
Weekend presented by Cigna®, a four-day festival of long-distance
“Waking up early and taking each step towards that finish line
running. The event is already sold out for several of its 2016 races
is nothing compared to helping just one person survive their
scheduled for Jan. 16-20, 2016.
journey,” Cultrera agreed. “My motivation is to honor my patients
Cultrera is a seasoned endurance athlete who hasn’t missed a Disney
and expand resources for those I have yet to meet!”
Marathon Weekend since 2012. Delgado took up running a short two
2016 marks the 20th year of collaboration between the LLS and
years ago with her daughter, but this year she tackles her first marathon.
RunDisney. To participate in the Team in Training program, you
The two don’t train together, but they are both highly devoted to the cause.
don’t have to be athlete or even in shape. There are marathons,
“My connection to LLS through patients and other endurance
half marathons, cycling, triathlons and hiking adventures for every
athletes is very dear to me,” explains Cultrera, a hematologist and
athletic ability. Learn more at www.TeamInTraining.org.
medical oncologist at FCS in Orlando.
W
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FCS The Magazine
FCS
news
FCS patient Reina Campbell celebrated a surprise reunion with her son, U.S. Air Force Capt. Josh Gunderson, in a suite at a Bucs game. Joining her were several family
members, her oncologist, Dr. David Wright, FCS CEO Bradley Prechtl, and several other breast cancer patients and survivors.
FCS patient enjoys
surprise visit from her
son in Tampa
✚ FCS patient Reina Campbell,
whose son, Joshua Gunderson, is
a U.S. Air Force captain, was full
of tearful smiles at the Tampa Bay
Bucs Breast Cancer Awareness
game when her son surprised her
in front of a packed stadium of
fans who celebrated the motherson reunion with a long standing
ovation. Reina thought Joshua
was watching the game at the
Anchorage, Alaska, base where
he is stationed. She hugged and
kissed Joshua and cupped his face
while the reunion was broadcast
live from the Pirate Ship on the U.S. Air Force Captain Josh
stadium’s BucsVision screens. In Gunderson, who is stationed in
the stands, Gunderson’s younger Anchorage, Alaska, surprised his
mom, Reina Campbell of Tampa,
brother was just as surprised. during the Tampa Bay Bucs Breast
Those who’d been keeping the Cancer Awareness game on Oct. 11.
secret for months felt relieved. FCS
oncologists Dr. Waide Weaver and Dr. David Wright played significant
roles in planning the surprise, telling only a few family members that
Gunderson was coming to town. “Everyone knew but me!” Reina
said. Gunderson told his mom that he was proud of her for fighting.
“Honey,” she said. “I do it for you and your brother. Everything I do
is for you.”
Rx to Go Celebrates Expansion with Ribbon
Cutting and Open House
✚ Florida Cancer Specialists recently held a ribbon cutting
and open house to officially open a new expansion of its corporate
offices in Fort Myers. The extension will primarily house Rx To Go,
an in-house specialty pharmacy for oral oncolytics that serves the entire
state, and support expansion of the new Care Management Program.
Attending the Rx To Go ribbon cutting and open house were (left to right): Todd
Schonherz, chief operating officer; Johnny Streets Jr., Fort Myers City Councilman
Ward 2; Ray Bailey, pharmacy director; Dave Miller, Chamber of SW Florida
executive director; and Shelly Glenn, FCS chief marketing and sales officer.
Winter 2015-16
7
FCS
news
FCS Brings Cutting-Edge Radiation Oncology
to The Villages
✚ FCS has been pleased to announce that radiation oncology
was added Oct. 16, 2015, to the services available at FCS cancer centers
in The Villages. Sachin Kamath, MD, will lead the radiation oncology
team in providing greater access and convenience for cancer patients in
Sumter County. Radiation oncology treatment will be available at the
FCS Villages Cancer Center located at 1400 N. U.S. Highway 441,
Suite 540 (The Sharon Morse Building), in Lady Lake, Florida.
Annual Nurses Conference Promotes
Health, Hope, Healing
✚ Almost 300 nurses and pharmacy technicians from FCS
gathered at the Museum of Science and Industry (MOSI) in Tampa for
an annual conference on Sept. 26. Company leaders, including COO
Todd Schonherz and Director of Clinical Research Katie Goodman, RN,
BSN, CCRP, discussed topics including clinical research, team building
and best practices within the industry. Participants also raised money
for the FCS Foundation by selling specialty baskets at the conference.
Vendor Hall in the Museum of Science and Industry (MOSI) in Tampa
Dr. Sachin Kamath, who joined FCS on Oct. 16, will provide Radiation Oncology
services in The Villages.
Martha Polovich, PhD, RN, AOCN, during her presentation about Chemotherapy
Safe Handling.
James and Patricia Penny talk with Dr. Sachin Kamath about the Villages Cancer
Center and the convenience of having radiation oncology in the same location as
medical oncology.
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FCS The Magazine
Conference leader Verna Valentine, RN, BSN, OCN, recognizes Leslie Weiland,
RN, BS.
FCS
news
FCS Receives Top Award for Innovation in
Healthcare Delivery
✚ AmerisourceBergen, one of the largest global pharmaceutical
sourcing and distribution services companies, recognized FCS with its
most prestigious award for “Shaping Healthcare Delivery.” The award
celebrates a company that is making a positive impact on the industry
through innovative strategies. Brad Prechtl, CEO of Florida Cancer
Specialists, and founder and president Dr. William Harwin accepted the
award at AmerisourceBergen’s annual manufacturer summit in Orlando.
Hematology and Oncology Consultants join FCS
✚ FCS has announced that Hematology and Oncology
Consultants, PA (HOC), joined the practice, effective Sept.
1. The alliance with HOC adds two clinical sites to the FCS network,
extending services in the downtown Orlando area and to the Winter
Park community.
Medical oncologists joining FCS (left to right): Lee M. Zehngebot, MD; William B.
Grow, MD; Philip H. Dunn, MD; Stefani L. Capone, MD; David C. Molthrop, Jr.,
MD; Sonalee K. Shroff, MD.
The executive leadership team from AmerisourceBergen presents Florida Cancer
Specialists the 2015 Shaping Healthcare Delivery Award at their ThinkLive
Conference, held in Orlando on Oct. 8.
FCS welcomes new physician in North Florida
✚ FCS has been pleased to announce that Vijay Patel, MD,
has joined the Florida Cancer Specialists team and will be
seeing patients at FCS centers in Gainesville.
Vijay Patel, MD
AmerisourceBergen Provider Solutions President Dave Leverette (right) presents
the Shaping Healthcare Delivery Award to Florida Cancer Specialists Founder and
President Dr. William Harwin (center) and CEO Brad Prechtl (left).
Steven B. Newman, MD
FCS welcomes new physician in Collier County
✚ FCS has been pleased to announce that Steven B. Newman,
MD, has joined the Florida Cancer Specialists team and will
be seeing patients at the FCS cancer center at Napa Ridge.
Winter 2015-16
9
COVER STORY
Foundation
and FCS Events
Have Patients
at Heart
BY CHAY D. BAXLEY
F
lorida Cancer Specialists Foundation operates under a
simple, singular purpose – helping others. At the heart of
the FCS family, the Foundation is dedicated to assisting
patients and their loved ones struggling to cover essential
living expenses while undergoing lifesaving treatments. The
mission is a lofty one, requiring generous community support and
engagement throughout the state.
During October, a number of events are in place to promote
awareness, goodwill and the much needed funds that make FCS
patients’ dreams a reality. Throughout the month, our events hosted
both internally and externally continue to bring our mission to life. By
partnering with members of the local and national community, Florida
Cancer Specialists Foundation keeps the lights bright and hopes high
for approximately 1,000 patients each year.
Making Strides of Pinellas
Pam Venneri and Jessica Muh - DCC bake sale for Making Strides Breast
Cancer Walk Daytona Beach
Physician Liaisons Jolynn Wright and Julie Anning
Making Strides Hernando and Pasco County
Making Strides – Recap: Oct. 10, 2015
In support of the American Cancer
Society, over 20 team members from
Florida Cancer Specialists participated
in the national Making Strides initiative
throughout the state. For the Making
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FCS The Magazine
Strides of Lee County event, FCS surpassed
their goal to raise $3K by nearly $300.
The money will enable investment in
groundbreaking breast cancer research as
well as provide free information and services
for those diagnosed with the disease.
Making Strides means that more than 3.1
million breast cancer survivors nationwide
will celebrate another birthday this year.
PINK DAY IN PORT CHARLOTTE
PSS Charlie Moss
Carol Long, RN OCN, Tammy Bennett, Office
Manager/Head Nurse
Holly Bjerkness, RN, Nancy Snow, RN OCN, Mandy
Capsuto RN OCN
PINK DAY IN FORT MYERS AT RX TO GO
Photos featured: Rx To Go staff and t-shirt design
Pink Day – Recap: October 2015
An employee-driven event at FCS, “Pink
Day” occurred on Friday, Oct. 16, 2015. The
2015 Pink Day fundraising event brought
several offices together to bring their personal
brand of fun to the festive celebration to
raise money for the FCS Foundation. The
fifth annual home grown fundraiser included
lively raffles, bake sales and auctions at FCS’s
Corporate, Metro and Gateway sites where
the teams raised approximately $5K for the
Foundation.
Winter 2015-16
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COVER STORY
Tampa Bay Bucs Breast Cancer Awareness Game Recap: Oct. 11, 2015
Emotions ran high at Raymond James
Stadium in Tampa, Florida on Oct. 11. Fans
of the Jacksonville Jaguars, who lost to the
Tampa Bay Buccaneers, weren’t the only ones
who got teary eyed.
Before the Tampa Bay Bucs Breast
Cancer Awareness game commenced,
thousands joined together to participate in
the third annual 5K Run/Walk to support
breast cancer research and patient services.
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FCS The Magazine
The race benefitted the Florida Cancer
Specialists Foundation, as well as many other
distinguished organizations.
The highlight of the day, though, was
Florida Cancer Specialists patient Reina
Campbell. The mother of U.S. Air Force
Captain Joshua Gunderson, Campbell was
full of tearful smiles when her son – who she
thought was watching the game from his
base in Anchorage, Alaska – surprised her in
front of a packed stadium of fans that rose to
their feet in a well-deserved standing ovation.
Florida Cancer Specialists oncologists Dr.
Waide Weaver and Dr. David Wright played
significant roles in planning the surprise,
telling only a few family members that
Gunderson was coming to town.
“Everyone knew but me,” laughed
Campbell after embracing her family.
Shelly Glenn, Danielle Spears, Monica Clark, Maria Ramos-Person, Irene Nathanson
Dr. Syed Ahmed and Irene Nathanson
Laila Chatoor and Dr. Hafeez Chatoor
Dr. Y. K. Peter Park and Dr. Christina Park
Barbara Long
Terri Prechtl, CEO Brad Prechtl, Valerie Vance
50 Shades of Pink Recap: Oct. 3, 2015
On the evening of Oct. 3, visitors to the
Tampa Marriott Waterside Hotel and Marina
reported being teleported to France, for a
night brimming with Parisian charm. With
Dr. Julia Cogburn and Dr. Shalin Shah as
Honorary Chairs, the second annual “50
Shades of Pink” gala saw mimes, French bistro
setups, artisanal wine, delicious food and
incredible giveaways – et oui, a trip to Paris
was one of them.
Francophiles and philanthropists alike were
so delighted that the event quickly caught
the attention of local media. The Tampa
Bay Business Journal dubbed it “Top Five,”
an extraordinarily honorable distinction
considering the city’s many high-profile
events. 50 Shades of Pink garnered $60K in
proceeds to benefit the Foundation.
Winter 2015-16
13
COVER STORY
Profiles in Courage
While themselves dealing
that the experience helps
Brandi Riber, RN
Staff Nurse, Fort Myers Summerlin
W
hen Brandi Riber moved to the Sunshine State in 2004, she and her
husband purchased a home blocks away from Florida Cancer Specialist’s
Fort Myers Summerlin office.
“There’s a reason I’m here,” said Nurse Riber, who received her RN in
2009. She’s worked in oncology since 1993 as a phlebotomist. “From 2004, to know that this is
where I should be – that’s just amazing to me. I’ve been put here for some very obvious reasons.”
Six months after graduating nursing school and beginning her new career, Dr. William
Harwin diagnosed Riber with Stage II breast cancer.
“We sat in a room with my mom and my husband, and we figured out a game plan,” said
Riber. The couple’s 3-year-old daughter waited at home.
Thankfully, Riber recovered completely from her double-mastectomy and aggressive
chemotherapy treatment. In 2014, Riber was diagnosed with Stage IV cancer. Currently
undergoing experimental treatment, her prognosis is good. Her attitude is, too: “My mess is my
message,” she’ll say with a smile.
“This is my dream job. It really is.”
Sandy Secondo, BSN
Head Nurse, Bradenton East
“I’ve been in and out of oncology for 35 years,” said Nurse Sandy Secondo. Despite her
proximity to the field, Secondo’s 2012 breast cancer diagnosis still floored her. Years later and
breast cancer free, her outlook has been markedly changed.
“It altered my view of life as far as how precious life is and how unexpectedly it can change,”
said Secondo. “You can lose control and something else controls your life. That affects not only
the individual, but also the family – spouses and elderly parents – but also finances. You’re whole
lifestyle is changed.
“I’m still grappling with it, the whole way you look at life.”
For her patients dealing with a similar diagnosis, Secondo’s first-hand compassion can mean a
lot. For starters, there are no small requests – only reassurances that Secondo happily gives.
“When a patient has a complaint, you’re able to look at their complaint in more than just a
purely clinical aspect, because you were there too.”
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FCS The Magazine
with the symptoms and challenges of breast cancer, four FCS nurses find
them relate more closely to their patients.
Debbie Vogel, RN, OCN
Team Leader Integrated Clinical Services,
Fort Myers
Nurse Debbie Vogel jokes that she was a latecomer to the healthcare field. Before her 30th
birthday, tragedy brushed Vogel’s family circle. She enrolled in nursing school soon after, hoping
to one day work in oncology.
“Our best friend passed away from colon cancer when I was 28 years old,” said Vogel. “That
experience never left me.”
Today, Vogel, team leader for integrated clinical services, has been with FCS for 18 years. In
2014 she became a patient, too.
“I thought I knew what to expect,” admitted Vogel. “You know, you get a little cocky. Even
though I had done patient teaching for so many years and I’d done the education – you don’t
know until it happens to you. You really don’t.”
“FCS was so wonderful during that time,” recalled Vogel. “Truly, they were just so wonderful.
I was able to work when I could and rest when I couldn’t.”
Nancy Solak, RN, BSM, MPA
Research Coordinator, Fort Myers
“I don’t tell every patient,” started Nurse Nancy Solak. Solak is a breast cancer survivor twice
over – beating the diagnosis in 1993 and again a decade later 2013. “You sort of have to feel
your way around the situation. But for those who are very, very anxious, I’ll tell them how much
I understand. I’ve had chemotherapy.”
At 60, Solak has been a registered nurse for the majority of her life. When it came time to
undergo cancer treatment, she says she knew exactly where to turn. In FCS, Solak says she
found a safe haven – not to mention a rewarding place of employment.
“You know that you’re in good hands,” said Solak. “As a nurse I knew where I was going
to pick. You’re going to get as good of care here as you can in any major cancer center in this
country.”
Winter 2015-16
15
OFFICE SPOTLIGHT
Regional Director Rides
Wave of FCS Growth
BY ZANDRA WOLFGRAM
S
urfing, like many things in life, is all about practice and
timing. Once prepared, you need to be patient, wait for
the right moment and then while keeping your balance,
hold on and ride the wave to the end.
Though she was born and raised in Brooklyn, N.Y., you could say
that with the management of Central Florida facilities and the opening
of the Florida Cancer Specialists & Research Institute (FCS) New
Smyrna Beach location in January 2015, Senior Regional Director Inga
Gonzalez has proven to be a champion surfer.
When this senior manager first started with FCS, there were
seven office locations in Central Florida. Today, Gonzalez quickly
calculates, there are about two dozen. Or, she second guesses that
number, “It could be more…” The rapid swell of this region and
all of FCS demands that senior leaders like Gonzalez move quickly
and often to stay ahead of the growth wave.
And that’s precisely what she did nearly a year ago in opening
the New Smyrna Beach location on the state’s central Atlantic
coast. The second floor of a handsome, modern building located
in the heart of the New Smyrna Health Park already existed,
so Gonzalez focused on equipping it with computers, medical
supplies and a well-trained administrative and nursing staff.
A team of four physicians—Karin Bigman, M.D.; Kathleen
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FCS The Magazine
Doughney, M.D.; Eric Harris, D.O. and Mudussara Khan,
M.D.—rotate four half days a week seeing patients.
Office manager Pamela Venneri , who is a 30-year veteran
of the healthcare field, describes the location as “beautiful
and soothing”—and with three exam rooms and eight chemo
chairs in the infusion center facing generous windows that offer
patients views of the land and sky—it is also designed to be fully
functional.
Venneri joined the team of 12 in December just before the
grand opening. “It was a good move,” she says. “The staff here is
outgoing and friendly and they always put the patient first, but at
the same time our office has an easy, laid back feel to it.”
Though this is not the largest FCS office location by far,
Gonzalez says the potential impact to the surrounding area is
significant. “Both the local medical community and patients
are excited to have us here,” she says, adding, “FCS has grown
tremendously and the fact that we are here, standing strong and
offering services in underserved communities such as New Smyrna
Beach is amazing in itself. This is what it’s all about—providing
local care so patients do not have to travel. That’s huge!”
Though FCS is headquartered in Fort Myers, Gonzalez lives
175 miles north in Lake Mary with her husband, Peter, and two
sons, Kevin, 15, and Matthew, 8. She stays on the go and is most
often found traversing the state to attend in-person meetings
and interviews with staff and to give in-person hugs and hellos
to patients. “I like to engage in person; I like to be there and be
hands on,” she says.
“Though she has had a hand in opening nearly 20 offices during
her six years with FCS, she approaches each one with a mix of
enthusiasm and proactive planning. “It really depends on the size
and the volume, each location is different and
each one gets what it needs,” she says.
Gonzalez first dipped her toe in the industry
in 1998 when she founded a medical billing
and collections firm. After moving to Orlando
in 2005, Gonzalez jumped in deeper, overseeing
a pain management clinic. Subsequent to that,
she became the manager of patient services for
the Florida Heart Group, where she developed
physician protocols and optimized patient flow
for a medical team of 18.
She joined FCS in 2011 and grew into her
role of Senior Regional Director for FCS’s
central region, which currently comprises 24
locations. Over the span of her 17-year career
in healthcare management, this tenacious
taskmaster has developed the confidence,
agility and focus required to “hang 10” in the
fast-paced field of operations.
But this earnest 35-year-old executive is probably the most
surprised by her ascent to upper management. “Working with
FCS has helped me realize that my limits are larger than I ever
thought they would be,” Gonzalez confides. “When I began, I never
expected I would be supervising 200 employees in 20 locations. This
experience has helped me understand I could do so much more.”
And with more mergers on the horizon, Gonzalez is on board,
Winter 2015-16
17
18
FCS The Magazine
NURSE SPOTLIGHT
High (En)Roller
Christina Caruso’s crusade to expand FCS’s
clinical trial enrollment BY ZANDRA WOLFGRAM
T
hough she’s not quite a regular on the Vegas strip, you
could say Christina Caruso is a “high roller”—well make
that enroller.
The moniker given to this 46-year-old RN is one she’s
earned as a clinical research coordinator—one patient at a time…
every week.
At least that’s the goal. In 2014, she met it by enrolling 52 clinical
trial patients. She wears the badge of a “high enroller” with pride. Still,
she doesn’t match the production of William N. Harwin, M.D., Florida
Cancer Specialists & Research Institute’s innovative founding physician.
“He’s one of the highest enrollers every year!” she says reverently.
He’s also the inspirational thrust behind the company’s deep
commitment to growing its clinical research and trials. The FCS
medical team leader’s passionate commitment has sparked a top down
culture of compassion that Caruso feels is a natural fit.
Originally from the country’s heartland, Caruso, who moved to
Florida when she was six years old, saw both of her grandparents
succumb to lung cancer. She was there in the final days when Hospice
did what they could to make their final days in Columbus, Ohio,
comfortable. Though she would later work on the oncology floor at
Lee Memorial Health System for two years out of Edison College
(now known as Florida Southwestern State College) in Fort Myers, it
was not where she felt she could do the most good.
“It’s not easy to see the most sick take their last breath,” she
confided. “I didn’t want to do that on a daily basis, but I wanted to
help. I wanted to help treat them and help them fight cancer verses
just holding their hand.”
Overall, Caruso has worked with FCS for nearly 20 years. First in
1992 for five years in the front office at the Broadway location and
again after she completed her RN and OCN, she returned in 2000.
Today she has a CCRP and serves as the research coordinator working
out of the Summerlin office in Fort Meyers.
In 2006, she began working full time on clinical research trials. It’s
her responsibility to screen patients and utilize all possible tools to
explore whether a patient qualifies to enroll. Most patients are from
physician referrals and occasionally patients call in themselves, but
Caruso is pro-active in her search, continually reviewing schedules,
visit lists and reports in hopes of giving hope and a chance at a better
quality of life to still one more.
“We get to participate, to watch patients respond to these new drug
therapies. It’s awesome,” she says. “Without patient participation, we
wouldn’t have the drugs we have today, so they thank us, but we are
grateful for them.”
Caruso is proud of the exponential growth she has helped bring
about in FCS’s research program. “These are exciting times in
medicine,” she says.
“I’ve seen these trials more than double from less than 20 to more
than 48 Phase II and III trials.”
Caruso is quick to note that any success is a true team effort. “I’ve
learned from all of the doctors, they take time to talk and explain
things,” she says. “And I could not get through the day without my
assistant, Christa Killduff, she is amazing.”
Driven, compassionate and conscientious, Caruso is well suited for her
research role. “I am proactive. I do not want any hiccups, so I plan ahead.”
She is also tenacious.
“I’m going to fight for my patient. If a scan or test is close or if an
extra lab is required. I’m going to do whatever it takes to get them the
best care possible,” she says.
Despite the fast-paced demands of the job, Caruso understands that
to be focused at work, it’s important to have a healthy home life, too.
She lives in Three Oaks with her husband, Anthony, of 14 years, and
their two daughters, Catarina, 11, and Gianna, 9.
When she “checks out,” Caruso likes to recharge by reading,
working out and spending quality time with her family.
“My children are my life,” she says. At work, my patients come first
but my children come first when I am at home.”
For the past five years, she has been setting the example as an active
Girl Scout leader.
“I tell the girls they always have to try as part of our journey, but
I try to make it fun,” she says. “Just like the research at work, I enjoy
watching their growth and progress.”
If FCS feels it has taken any sort of gamble on Caruso, this high
(en)roller is certainly giving FCS patients the biggest kind of payoff.
Winter 2015-16
19
20
FCS The Magazine
INDUSTRY INSIGHT
Industry-Sponsored Content
Meet Steve Noga
Senior Medical Director, Medical Affairs,
Takeda Pharmaceuticals
A
fter spending the past four decades living in
Maryland and Florida, Steve Noga has certainly
acclimated well to the cooler climate of his new
work home in Cambridge, Mass. He began his new
position as Senior Medical Director, Medical Affairs at Takeda
Pharmaceuticals in June, as the last vestiges of snow were finally
melting from the region’s historic winter snowfall. Thankfully,
that meant his daily four-mile morning bike ride to the office was
snow-free.
Of course, the change in venue was certainly not motivated by the
anticipation of nice weather. Nobody moves to the Boston area for
those few days every year of sunshine. No, like thousands who came
before him, Steve moved to Cambridge to be a part of the world’s
most exciting biotechnology sector, and to rub elbows at the local
coffee shops and science labs with Nobel Prize winners, serial biotech
entrepreneurs and the “Who’s Who” of life science nobility. He was
thrilled at the prospect of joining Takeda – a company with a rich
legacy within the biotech industry, starting in 1993 by Millennium
Pharmaceuticals, which Takeda acquired in 2008. He was also eager
to participate in a thriving biotech hub of more than 200 companies,
15,000 employees and two preeminent educational institutions –
MIT and Harvard University.
“My first introduction to the Cambridge biotech market was
through a professional relationship I held during my tenure at Johns
Hopkins,” recalls Steve. “One of my counterparts at Dana-Farber
Cancer Institute, with whom we were collaborating at the time, was
a scientist named Iain Webb, with whom I worked closely. Years later,
Iain joined Millennium Pharmaceuticals (now Takeda) and remains
there today as a Senior Medical Director.”
Takeda has recently launched NINLARO (ixazomib), which was
recently approved by the U.S. FDA in combination with lenalidomide
and dexamethasone for the treatment of patients with multiple
myeloma who have received at least one prior therapy. As ixazomib
remains in clinical development in various multiple myeloma settings,
systemic light chain amyloidosis, and other malignancies, Steve’s role
is complex and demanding. As Senior Medical Director for ixazomib,
Steve is responsible for providing medical and scientific data for
relevant clinical documents, study protocols and reports, as well as
submission/registration documents. He also reviews and approves all
clinical documents related to the clinical studies, oversees all medical
scientific aspects of the indication and provides respective guidance to
the program team. The role necessitates that Steve call on the entire
body of his expertise and experience to ensure that the strategy behind
the clinical development of this cancer compound is rooted in sound
medical thinking and data. Additionally, he is a highly visible member
of the team driving this compound to approval and launch, and he
collaborates with Clinical Trial Management members in the selection
of principal investigators and recruitment of clinical study sites.
Bit by the science bug
His new role is a long way from his start in Florida, where he began
his medical studies. Steve’s affinity for Florida began in his college
years as an undergraduate student at the University of Florida, where
he was bit by the science bug. After completing his undergraduate
studies and receiving a BS degree in Medical Technology, he went
on to earn his PhD in Experimental Pathology. Using his early
academic experience as a springboard, Steve‘s thirst for learning led
him to the Johns Hopkins University School of Medicine, where
he received his medical degree (MD) in 1987. In subsequent years,
at the iconic Baltimore medical and research center, Steve served as
a Resident of the Osler House Staff, which provides three years of
comprehensive training in general internal medicine. In addition, the
Osler House offered Steve the opportunity to gain experience in acute
and ambulatory medicine, as well as research, teaching and patient
care. Following that three-year training, Steve spent a year as a clinical
fellow in oncology while finishing up his studies and work at Johns
Hopkins.
“My time at Johns Hopkins introduced me to the many
opportunities within oncology research, and I was especially interested
in the prospect of pursuing both an MD and PhD,” stated Steve.
For his initial foray into the professional field of medicine and
research, Steve remained at Johns Hopkins Medicine, first as Director,
Winter 2015-16
21
Industry Insight
Meet Steve Noga
Graft Engineering Laboratory
and then subsequently as
Director, Hemapheresis
Treatment Center, and CoDirector Hematopoietic and
Therapeutic Support. In
these positions, Steve made
his mark within the evolving
Johns Hopkins infrastructure
by establishing the Graft
Engineering Laboratory, which
handled all cellular products for the hospital, ultimately serving as a
model for global labs involved in the same processing. Additionally,
he established the Hemapoietic and Therapeutic Support Service,
which was a combined effort between the Oncology and Pathology
departments to process therapeutic apheresis, bone marrow harvesting,
and stem cells. Following this initial success, he left behind the many
years within the Johns Hopkins Health System for a new opportunity
with Baltimore’s LifeBridge Health, a healthcare organization
encompassing three hospitals and associated healthcare facilities. In his
nine years as Director and Chief, Hematology and Medical Oncology
as well as Director, Clinical Trials Research Unit/Platelet and
Thrombosis Laboratory at LifeBridge, Steve put together an impressive
list of professional accomplishments. He established a thriving
Medical Oncology Division that at its height included six staff
oncologists and six oncology nurse practitioners who accommodated
25,000 outpatient visits per year. Additionally, Steve helped institute
a 30-bed inpatient Medical-Oncology service and open the Lapidus
Cancer Institute that housed a 12-chair infusion center, a 16-bed
oncology unit, a breast health center and a six-bed hospice program.
Treating cancer patients was at the heart of the LifeBridge’s mission
and Steve certainly enhanced the hospital’s reputation as a leading
cancer center through these efforts.
It was clear that during the first twenty years of his career, Steve had
developed a keen and evolving expertise within cancer research and
treatment. Like many medical professionals in this challenging field,
Steve was drawn to the unmet medical need of cancer patients, the
plethora of cancers that people might develop, and the homogeneity
of the illness. Every patient’s cancer develops and grows in a singular
fashion and is distinctive in its sensitivities to particular cancer
therapies. At Johns Hopkins and at LifeBridge, Steve’s therapeutic
focus was an attempt to characterize the molecular variations between
tumors and offer individualized treatments to more patients. The
oncology community was moving towards precision medicine and
Steve’s work at these venerable Baltimore institutions, in addition to
his most recent involvement at Takeda, echoed this track.
“What drew me to oncology was my early involvement and
experience with bone marrow transplant programs, and the
complexities of the science that drove these initiatives,” mentions
Steve. “The severity of the illness that impacted the patients and our
potential to make positive changes in their lives by addressing severe
unmet medical needs made my position extremely compelling.”
22
FCS The Magazine
Like many medical
professionals in this
challenging field,
Steve was drawn to
the unmet medical
need of cancer
patients, the plethora
of cancers that people
might develop, and
the homogeneity of
the illness.”
Passionate about life
That desire to positively affect patients’ health and quality of
life continues to drive Steve and his team and they are excited by
the potential to introduce a new therapy into the lives of myeloma
patients. As a Senior Medical Director, the demands on Steve’s
position are as demanding as they are far-reaching. But, he manages
to keep this part of his life in perspective, creating balance with an
active life outside of work to maintain his focus. Besides being a bike
enthusiast, Steve has also devoted much of his adult life to growing
orchids, a passion he shares with his wife. Attached to their home is a
greenhouse that showcases their work and displays more than 200 of
those delicate flowers.
“As an oncologist, you can never entirely be ‘off the clock.’ The
importance of treating cancer patients and possibly improving their
lives stays with me at all times,” Steve avows. “But, working with my
wife around these flowers offers me a time to reflect in a serene venue
that actually can recharge me for my work.”
Q&A Profile
get to know your doctor
World traveler would
love to visit Egypt
Dr. Padmaja Sai answers some of our questions
Betty or Veronica?
What destination, as yet unvisited by
you, would you most like to experience?
Best of both. Like Betty,
I was always friendly and
was always very academic
in school and won many
academic awards and strived
to be at the top of the
class and used to be called
a walking encyclopedia.
Like Veronica, I, too, love
shopping and fashion.
Egypt, as it is one of the countries with
the oldest culture. I would love to visit,
especially the Egyptian Pyramids, and Giza
Necropolis. But, I will have to wait and see!
If you could bring back a historical figure
and spend a weekend with him or her,
who would that be?
Mahatma
Gandhi. He
was one of
a kind. His
principles of
practicing
non-violence
and truth in
all situations
made him a unique individual.
FOX News or MSNBC?
MSNBC
True or False: You’ve got
to be crazy to run for
president of the United
States.
True! Trump, for
example!
What specialty would you be in
if not for oncology?
What book do you
currently have on your
bedside table?
Travel and Leisure. I
love traveling to historic
Dr. Sai practices in
or exotic destinations
Palm Coast.
with family. My goal is to
travel most of the world
What’s for dinner when you really want
before I reach age 50 (nine more years).
to treat yourself right?
What is your most prized possession?
A gift (pendant) that was given to me by
my late grandfather. It is priceless as he chose
to give it to me out of 21 grandchildren.
Traditional, authentic South Indian food.
What is your greatest fear?
I am a Leo! I don’t have a fear of anything.
Surgery. I went to medical school
to become a surgeon, but while in my
third year, my grandmother’s cancer
diagnosis changed everything for me! I
used to accompany her to treatments and
experienced being on the other side. Also,
the doctors who took care of her amazed
me with their compassion and care. We
lost her to cancer, but I see her in every
patient, and I try to make a difference in
each one of their lives as much as possible.
Winter 2015-16
23
FCS
events
1.
2.
3.
5.
4.
1. OPERATIONS MEETING
4. PHYSICIAN LIAISON TEAM MEETING
More than 170 managers from FCS gathered at Raymond James Stadium
for the annual operations meeting. Teams assembled 60 Thanksgiving
baskets, which were presented to patients and their families who may not
have been able to afford Thanksgiving meals.
The FCS Physician Liaison (PL) team, under the leadership of Chief
Marketing & Sales Officer Shelly Glenn, take time out from their
meeting at One Buc Place for a “photo opp.” The PLs – whose primary
responsibility is executing referral base management initiatives – travel
from throughout the state for a planning retreat in Tampa each month to
exchange best practices and continue to elevate their knowledge base.
2. A SPECIAL CEREMONY FOR DR. LUIS CHU
Pictured (L-R): Patty Wacha, Linda Holmes ARNP, Dr. Luis Chu, Julius
Halas, J. Nilson of Sarasota Downtown and Physician Liaison Irene
Nathanson, RN
3. 20 YEARS WITH FCS!
Aileen Osterhout, Practice Applications Manager, recently celebrated 20
years with FCS. Congratulations, Aileen, on this significant achievement
and thank you for all of your outstanding work over the years! Aileen
shared that when she first started, FCS’ email platform was AOL, and the
company was only 5 offices large! Pictured (L-R): COO Todd Schonherz
and Aileen Osterhout
24
FCS The Magazine
5. AMERICAN CANCER SOCIETY’S “CEOS AGAINST
CANCER” IN WASHINGTON, DC
Pictured (L-R): Pat Geraghty, Florida Blue CEO, Ralph DeVitto,
American Cancer Society–Florida Division EVP, Shelly Glenn, Florida
Cancer Specialists Chief Marketing & Sales Officer and Tamer Youssef,
Wealth Plan Advantage CEO
FCS
events
6a.
6b.
6c.
7.
8.
6. “BOWLING FOR BOOBS”
8. 5K DASH FOR DAWN CENTER IN HERNANDO COUNTY
Dr. Gail Wright sponsored a special “Bowling 4 Boobs” event in New Port
Richey
The dash event is held to raise awareness on domestic and sexual
violence. Pictured (L-R): Sherri LaLande ARNP and Amy Jagger FC with
FCS Brooksville, Fl.
6a. P ictured (L-R): Roberta Baker, Dawne Vetzel, Physician
Liaison JoLynn Wright
6b. Pictured (L-R): Office Manager Peggy Dinsmore, Jane Nemetz
6c P
ictured (L-R): Dr. Arthur Matzkowitz, Patricia Rogers, Skyshane
Mustian
7. 2015 FCS EXCELLENCE IN RESEARCH AWARD
Cara M. O’Keefe, RHIA, CTR, CCRP, FCS Study Activation Coordinator
was awarded the 2015 FCS Excellence in Research Award. This is an annual
award is given to a staff-nominated member of the research team who had
demonstrated outstanding achievement and performance on the job.
CORRECTION – Featured in the Fall 2015 issue of FCS The Magazine,
please note that the money raised from the Knights of Columbus Charity
Ball event in Inverness, FL will be used to help local patients undergoing
cancer treatment, especially veterans.
Winter 2015-16
25
FCS
events
9a.
9b.
10a.
10b.
11.
12.
9. “WE CAN” WEEKEND
11. SOLIDER MARATHON
FCS physicians of Citrus County, Drs. Gus Fonseca, Sunil Gandhi,
Upender. Rao, Patrick Acevedo, Bill Harrer and Servillano Dela Cruz,
donated $1600 for this special lunch event for cancer patients and
their families. There were a total of 150 in attendance. Various speakers
educated on breast cancer, colon cancer and CT and PET scans.
Pictured: Office Manager Kim Delgado and patient Stephanie Carroll
with members of the armed forces. Stephanie was training for the race
originally in 2013, when she was diagnosed with Stage 4 breast cancer.
Running in this race was a ‘bucket list’ goal for her, and her first halfmarathon ever.
9a. Pictured (L-R): Chris Hightower–Office Manager Crystal River and
Inverness South, Dr. Bill Harrer–FCS Physician Crystal River and
Inverness South, Julie Anning RN Physician Liaison
12.BRADENTON EAST TEAM CELEBRATE
9b. Dr. Bill Harrer FCS Physician Crystal River and Inverness South
Staff at the Bradenton East office celebrate receiving the highest audit
score for the first audit implementation.
10.LADIES NIGHT OUT IN BROOKSVILLE
Front row: Alison Prasad, Wendy McGrath, Dr. Nadiminti, Linda Dunzik,
PA-C, Chris Sims; Missing from photo: Flor Uscanga and Dr. Telukuntla
Women in the Brooksville area had an opportunity to get pampered, enjoy
dinner and take part in a Q&A with physician panelists from FCS, Florida
Cancer Affiliates and Oak Hill Hospital.
Back row: Leah Blanding, Sue Labarr, Nadene Sawyer, Ruth Razin, Lisa
Hatcher, Sandy Secondo, Office Manager Amy Morrow, Paula Bauer,
Melissa Kreider
10a. Dr. Vikas Malhotra speaking
10b. Julie Anning RN Physician Liaison at the FCS booth
26
FCS The Magazine
13a.
13b.
14a.
14c.
13.GIRLS NIGHT OUT AT MEDICAL CENTER OF TRINITY
The 4th Girls Night Out community event hosted 650 women who were
introduced to Medical Center of Trinity, participated in education stations
and had a great evening.
13a. Pictured (L-R): Office Manager Patty Ortiz, Dr. K.S. Kumar, Physician
Liaison JoLynn Wright
13b. Pictured (L-R): Patient & Dr. K.S. Kumar
13c. Pictured (L-R): Patients sister, Dr. J. Ayub, Patient
13c.
14b.
14d.
14c.Bradenton West Office pictured (L-R front row): Tulia Gonzalez,
ARNP, Amy Morrow, JoAnn Padgett, Wendy White, (L-R 2nd row):
Pam Andress, Camila Delgado, Colleen Hamm, Loretta Mallari,
ARNP, (L-R 3rd row): Lorraine Wright, Andrea Gaskin, Jackie Diaz, Dr.
Whorf, Jade Valencia, Dr. Van Der Wall, Don Beardsley
14d. W
ellington Office pictured (L-R): Community Liaison for “FIVE
STAR HOME CARE”, Nicole Di Giovanni Naum and The Rapper,
“Johnny D’ Snake”aka–John Shwiner, FCS Foundation Volunteer
program Patient Support Volunteer
14.HALLOWEEN AROUND FCS
14a. Region 3 Highland Office pictured (L-R): Nancy Nolan, Barri
Rowland, Lucy Ponce, Bre Waiters
14b. Bradenton West Office pictured (L-R): Mary Ellen Hewitt, Arlene
Burns, Diane Perrault, Tulia Gonzalez, ARNP, Loretta Mallari, ARNP,
Jade Valencia, Pam Andress
Submit your recent event photos to FCS Marketing at
[email protected].
Winter 2015-16
27
Invites You To A
Saturday, April 16, 2016
6:00 pm - 11:00 pm
The Ritz-Carlton Hotel, Naples
Join us for an evening of cocktails and conversation,
LIVE performance by
dinner, dancing and an
unforgettable
Rock & Roll Music Hall of Fame Legend and First Lady of Motown
Martha
Reeves
& The Vandellas
“Fund-A-Family” live auction to directly support families of cancer patients.
Live auction of unique items and experiences.
Benefiting FCSF to provide non-medical living expense assistance to qualified cancer patients.
Patty Baker, Chair
Jackie Bearse, Founding Chair
Kirsten Ferrara, Jean Hertzog: Co-chairs
For ticket and sponsorship/underwriting information
please call 941-677-7181 or visit Foundation.FLCancer.com/Time
FCS
clinical summit recap
Clinical Summit Recap
The 2015 FCS Clinical Summit was a resounding success.
H
BY TISHA CREWS KELLER
eld Oct. 23-25, 2015, at the JW Marriott Grande
Lakes in Orlando, the back-to-back events featured
the latest in medical updates through Research to
Practice’s Year End Review CME Program and the
joint Clinical Trials & Research Seminar with Sarah Cannon
Research Institute for physicians, clinical staff and senior
leadership, and also provided opportunities for family (both work
and home) to relax and unwind.
The weekend began with a vendor fair, cocktail reception and
networking event for FCS physicians, physician assistants, nurse
practitioners, senior management and their guests.
Research to Practice
Early on Oct. 24, the annual FCS Clinical Summit commenced
with a FCS partner meeting with company update and financial and
operational updates by senior staff.
Clinician and physician-only “Year-End Review Research to Practice”
CME sessions followed for the rest of the day, and provided continuing
education credits for qualified attendees. Over 110 FCS doctors and
clinical staff took part in the full schedule coordinated by Dr. Bill
Harwin, which included acclaimed medical researchers from across the
nation. Speakers covered in-depth topics such as research and drug trials
involving breast cancer, genitourinary cancers, lymphoma/leukemia,
multiple myeloma, digestive tract cancers, dermatologic and non-small
cell lung cancers.
One highlight of the weekend was the Saturday evening cocktail
reception and FCS reception, where Dr. Ralph Gousse, an FCS Central
Florida partner physician and medical oncologist/hematologist, received
the 2015 FCS Humanitarian of the Year award.
Since 2003, Dr. Gousse has made over 45 mission trips to his native
country of Haiti, helping needy people with medical care, housing and
educational needs. In his honor, FCS donated $5,000 to Haiti Help Med
Plus, Inc., Gousse’s chosen charity.
Annual Research Meeting
The Annual Research Meeting on Oct. 25 was conducted by FCS
and Sarah Cannon Research Institute (SCRI), the exclusive provider of
clinical trials at FCS.
Winter 2015-16
29
FCS
clinical summit recap
This half-day format focused on the clinical trials and research of
FCS staff. The program was coordinated by Manish Patel, M.D., FCS
Director of Drug Development; Judy Wang, M.D., FCS Associate
Director of Drug Development; and Katie Goodman, R.N., FCS
Director of Clinical Research.
More than 85 FCS physicians attended the program, which gave
updates on the LUNG, HEME, GI and GU, and Phase 1 programs.
30
FCS The Magazine
Dr. Howard Burris of SCRI spoke about personalizing medicine and
immunotherapy and also facilitated group discussions on clinical trials at
FCS. Goodman outlined research program goals for 2016.
In every aspect, the weekend highlighted the accomplishments of the
FCS team and celebrated advances in medical treatment.
Visit https://youtu.be/WlQ1BZhAjeA to watch the video of Dr. Ralph
Gousse’s award, or find it from the FCS homepage at www.FLCancer.com.
FCS
patient letters
It is gratifying always to receive letters
from appreciative patients. Their
kind words remind us why we chose
our careers in medicine and inspire
us to do our best work. If you have a
letter from a patient that you would
like to see published, please submit
it via e-mail to FCS Marketing at
[email protected].
My wife has recently
completed her chemotherapy
treatment under the care of
Dr. Vipul Patel with FCS in
Ocala, FL. As this portion of
her breast cancer abatement
treatment comes to an end,
I must inform you of the
outstanding treatment she (and
we) have been accorded. Dr.
Patel is a phenomenal doctor
and more importantly a fine
and honorable human being.
Dr. Patel was not our original
medical oncologist. Another
doctor had been selected by the surgeon who performed the breast
surgery. During the first visit to the original doctor, we knew there
were issues that were unacceptable and asked for a second opinion.
That is when Dr. Patel was recommended. During the first 15
minutes of the initial visit, we knew Dr. Patel was the right choice. His
knowledge, professionalism, and most of all, his compassion, is superb.
Max Gibbons is a valuable credit to FCS in many ways. Max has
demonstrated his profound knowledge of day-to-day operations
of the facility with skill and determination. I have observed his
interaction with patients on numerous occasions and Max has been
nothing less than perfect.
The dear and devoted ladies in the chemotherapy room have all
been amazing. Their devotion, knowledge and compassion for their
patients are unquestionably the best.
FCS, the Ocala facility and Dr. Patel have made this facility the
best of the best. My wife and I thank you and all the fine professionals
at this facility for their care and compassion. Dr. Patel has made
an otherwise undesirable event pleasant because of the care and
compassion of these fine people.
Please feel free to share this letter with Dr. Patel, Max and the
wonderful nurses and medical technicians.
Thank you.
A patient’s husband of Dr. Vipul Patel, Ocala, Fla.
We faced an unexpected detour on Christmas
2014 that was life threatening – Large B-cell
Lymphoma NH. However, you took us in and
carefully diagnosed and brought me back to full
health again. We will NEVER forget you and
your determination to get me well and help us
in our uninsured state.
I am back on the road traveling and speaking.
I spoke nine times last week in London ONT
Canada, and speak this Sunday three times in
Maine. We have a full book of meetings from
now until January 2017. My strength and hair
are coming back very well.
We hope to see you again in December 2016.
Until then, please accept the enclosed gift of our
diary during my cancer, The Cancer Earthquake.
We are praying it can help many folks who will
face similar crises in their lives. Please notice that
we have dedicated it to you and others who stood
with us in this difficult time.
Thank you ever so much once again.
A former patient of Dr. Mary Li, Spring Hill, Fla.
Winter 2015-16
31
ADMINISTRATIVE SPOTLIGHT
Passionate About
His Profession
Attorney Tom Clark leads FCS legal team BY TISHA KELLER
T
om Clark is a highly decorated lawyer with an
immense resume of experience, and he loves his job.
On the phone, he can be as steady and unflappable as
Cool Hand Luke. But once he starts talking about his
passions—work and scuba diving—you start to understand that this
guy goes at everything he does full force and for the win.
As general counsel for FCS, Clark is responsible for managing the
complex ins and outs of nearly every aspect of FCS’s legal matters
from his office at the corporate headquarters in Fort Myers. With his
hand-picked team of three, he advises and represents FCS in various
business transactions and regulatory matters.
“There is never a dull moment,” Clark explains. “But our obligation
and goal is to provide the best service we can to our company.”
Clark is serious about the commitment to FCS, and he’s proud
to work for what he believes is an innovative and forward-thinking
company. In his eyes, the fact that FCS wanted to create its own
legal department is newsworthy in its own right. Typically, physician
groups don’t grow to the size of FCS, and they certainly don’t invest in
building an in-house legal team.
Back in August 2012, Clark was tapped to join FCS and create a
legal department to help the company grow and manage its daunting
legal matter project load including regulatory compliance and various
negotiations at the business level.
At that time, it was just Clark and his paralegal, Jennifer Barrett,
handling all of the legal issues for a growing FCS. In just three
short years, though, the department has grown by one full-time
legal assistant and another attorney, assistant general counsel Roger
Hochman. Day to day, the team is continually challenged by a volume
of issues that keeps them busy—and craving more.
“What’s notable about FCS, aside from the sheer size of the
practice and our in-house team, is its recognition that it is engaged
in a highly complex and highly regulated business,” Clark says. “FCS
is not only committed to providing the highest quality care possible
to its patients, but it is also committed to operating its business
in compliance with applicable state and federal laws, rules, and
regulations.”
32
FCS The Magazine
To that end, Clark’s team is involved in all business transactions
such as mergers and acquisitions and various other matters that might
involve health care fraud and abuse laws, self-referral laws, HIPAA,
billing issues, licensure issues, and a multitude of other state or federal
health care laws, rules, or regulations.
A devoted learner, Clark earned his bachelor’s degree in business
administration with honors from the University of Florida, a law
degree (JD) from Cumberland School of Law at Samford University,
and an advanced LL.M. degree in taxation from New York University
School of Law.
Prior to joining FCS, Clark was a shareholder with Henderson,
Franklin, Starnes & Holt, one of the largest full-service law firms
in Southwest Florida. His practice at that law firm was focused
on healthcare law, acquisitions and mergers, personal service
organizations, corporate and partnership structures, taxation, and
business planning—which are some of the reasons why one of his
clients from those days, FCS, brought him on board.
So, how does a work enthusiast like Clark relax and unwind? He
scuba dives in one of the world’s most renowned areas for schooling
sharks.
Cocos Island, a mostly uninhabited island in the Pacific Ocean off
the shore of Costa Rica, is sometimes referred to as “Shark Island.” It
is also a favorite destination for Clark.
Clark and his wife of 32 years are avid scuba divers, and they’ve
been enjoying the sport since the early 1990s. His three adult children
also dive, although much less often than their parents.
The pair has enthusiastically explored waters off West Palm Beach
and other locations worldwide, but Cocos Island is one of their
favorite experiences. Groups of hammerhead sharks, rays, dolphins
and other large marine animals are no match for Clark’s nerves.
Travel is the best part about diving, and getting to see the world
from a new point of view also has its appeal. About four years ago,
Clark came upon a pod of dolphins while diving. Without much ado,
he says, “They were kind of interesting.”
Of course, they didn’t involve solving complex legal matters, but on
vacation, Clark makes do.
Winter 2015-16
33
HOLD BACK
PROGRESSION
In patients with unresectable, well- or moderately differentiated, locally advanced or metastatic
gastrointestinal and pancreatic neuroendocrine tumors (NETs)
SIGNIFICANTLY IMPROVED PROGRESSION-FREE SURVIVAL (PFS)1
100
Median PFS for Somatuline Depot
not yet reached at 22 months
Progression-Free Survival Probability (%)
90
80
70
Somatuline Depot
vs placebo
reduced risk of
progression or
death by
60
50
Median PFS for
placebo: 16.6 months
95% CI: 11.2-22.1
40
30
53%
Hazard ratio=0.47
95% CI: 0.30-0.73
20
Somatuline Depot (n=101)
Placebo (n=103)
10
0
0
3
6
9
12
15
18
21
24
Time (Months)
Study design: Randomized, double-blind, placebo-controlled, multicenter, 96-week study of Somatuline Depot 120 mg
vs placebo administered every 28 days. Patients had unresectable, well- or moderately differentiated, nonfunctioning,
locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Primary endpoint was time
to disease progression or death.
INDICATION
Somatuline® Depot (lanreotide) Injection 120 mg is indicated for the treatment of adult patients with
unresectable, well- or moderately differentiated, locally advanced or metastatic gastroenteropancreatic
neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
IMPORTANT SAFETY INFORMATION
Contraindications:
Somatuline Depot is contraindicated in patients with hypersensitivity to lanreotide. Allergic reactions
(including angioedema and anaphylaxis) have been reported following administration of lanreotide.
Warnings and Precautions:
■ Cholelithiasis and Gallbladder Sludge: Somatuline Depot may reduce gallbladder motility and lead
to gallstone formation. Periodic monitoring may be needed.
■ Hypoglycemia or Hyperglycemia: Pharmacological studies show that Somatuline Depot, like
somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon.
Blood glucose levels should be monitored when Somatuline Depot treatment is initiated, or when
the dose is altered, and antidiabetic treatment should be adjusted accordingly.
Somatuline Depot is a registered trademark of Ipsen Pharma S.A.S. IPSEN CARES is a trademark
of Ipsen S.A.S. ©2015 Ipsen Biopharmaceuticals, Inc. April 2015. NET00124
SOMATULINE DEPOT
SIGNIFICANTLY
EXTENDED PFS IN
LOCALLY ADVANCED OR
METASTATIC GEP-NETs1
A 53% REDUCTION IN THE RISK OF DISEASE PROGRESSION OR DEATH VS PLACEBO1
IMPORTANT SAFETY INFORMATION (Continued)
Warnings and Precautions (Continued):
■ Cardiac Abnormalities: Somatuline Depot may decrease heart rate. In 81 patients with baseline heart rates of
≥60 beats per minute (bpm) treated with Somatuline Depot in the GEP-NETs clinical trial, the incidence of heart
rate <60 bpm was 23% (19/81) with Somatuline Depot vs 16% (15/94) with placebo; 10 patients (12%) had
documented heart rates <60 bpm on more than one visit. The incidence of documented episodes of heart rate
<50 bpm or bradycardia reported as an adverse event was 1% in each treatment group. Initiate appropriate
medical management in patients who develop symptomatic bradycardia. In patients without underlying cardiac
disease, Somatuline Depot may lead to a decrease in heart rate without necessarily reaching the threshold of
bradycardia. In patients suffering from cardiac disorders prior to treatment, sinus bradycardia may occur. Care
should be taken when initiating treatment in patients with bradycardia.
■ Drug Interactions: The pharmacological gastrointestinal effects of Somatuline Depot may reduce the intestinal
absorption of concomitant drugs. Concomitant administration of Somatuline Depot may decrease the relative
bioavailability of cyclosporine and may necessitate the adjustment of cyclosporine dose to maintain
therapeutic levels.
Adverse Reactions:
In the GEP-NET pivotal trial, the most common adverse reactions (incidence >10% and more common
than placebo) in patients treated with Somatuline Depot vs placebo were abdominal pain (34% vs 24%),
musculoskeletal pain (19% vs 13%), vomiting (19% vs 9%), headache (16% vs 11%), injection site reaction
(15% vs 7%), hyperglycemia (14% vs 5%), hypertension (14% vs 5%), and cholelithiasis (14% vs 7%).
You may report suspected adverse reactions to FDA at 1-800-FDA-1088 or to Ipsen Biopharmaceuticals, Inc.
at 1-888-980-2889.
Patient support is available through IPSEN CARES™:
(866) 435-5677 (8 AM to 8 PM ET)
Reference: 1. Somatuline Depot (lanreotide) Injection [Prescribing Information].
Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc; December 2014.
Please see Brief Summary of full Prescribing
Information on the following page.
To learn more, visit SomatulineDepot.com
SOMATULINE DEPOT® (lanreotide) Injection 120 mg
Brief Summary of Prescribing Information
1 INDICATION
SOMATULINE DEPOT Injection 120 mg is indicated for the treatment of
patients with unresectable, well- or moderately differentiated, locally
advanced or metastatic gastroenteropancreatic neuroendocrine tumors
(GEP-NETs) to improve progression-free survival.
4 CONTRAINDICATIONS
SOMATULINE DEPOT is contraindicated in patients with history of a
hypersensitivity to lanreotide. Allergic reactions (including angioedema and
anaphylaxis) have been reported following administration of lanreotide.
5 WARNINGS AND PRECAUTIONS
5.1 Cholelithiasis and Gallbladder Sludge
Lanreotide may reduce gallbladder motility and lead to gallstone formation;
therefore, patients may need to be monitored periodically [see Adverse
Reactions (6.1)].
5.2 Hyperglycemia and Hypoglycemia
Pharmacological studies in animals and humans show that lanreotide,
like somatostatin and other somatostatin analogs, inhibits the secretion of
insulin and glucagon. Hence, patients treated with SOMATULINE DEPOT
may experience hypoglycemia or hyperglycemia. Blood glucose levels
should be monitored when lanreotide treatment is initiated, or when the
dose is altered, and antidiabetic treatment should be adjusted accordingly
[see Adverse Reactions (6.1)].
5.3 Thyroid Function Abnormalities
Slight decreases in thyroid function have been seen during treatment with
lanreotide in acromegalic patients, though clinical hypothyroidism is rare
(<1%). Thyroid function tests are recommended where clinically indicated.
5.4 Cardiovascular Abnormalities
In patients without underlying cardiac disease, SOMATULINE DEPOT may
lead to a decrease in heart rate without necessarily reaching the threshold
of bradycardia. In patients suffering from cardiac disorders prior to
SOMATULINE DEPOT treatment, sinus bradycardia may occur. Care should
be taken when initiating treatment with SOMATULINE DEPOT in patients
with bradycardia.
In patients with baseline heart rates of ≥ 60 beats per minute (bpm)
treated with SOMATULINE DEPOT in the GEP-NETs clinical trial, the
incidence of heart rate < 60 bpm was 23% as compared to 16 % of
placebo-treated patients; 12% of patients had documented heart rates
< 60 bpm on more than one visit. The incidence of documented episodes
of heart rate < 50 bpm as well as the incidence of bradycardia reported
as an adverse event was 1% in each treatment group. Initiate appropriate
medical management in patients who develop symptomatic bradycardia.
5.5 Drug Interactions
The pharmacological gastrointestinal effects of SOMATULINE DEPOT may
reduce the intestinal absorption of concomitant drugs.
Lanreotide may decrease the relative bioavailability of cyclosporine.
Concomitant-administration of SOMATULINE DEPOT and cyclosporine may
necessitate the adjustment of cyclosporine dose to maintain therapeutic
levels [see Drug Interactions (7.2)].
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
The safety of SOMATULINE DEPOT 120mg for the treatment of patients
with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) was
evaluated in Study 3, a double-blind, placebo-controlled trial. Patients in
Study 3 were randomized to receive SOMATULINE DEPOT (N=101) or
placebo (N=103) administered by deep subcutaneous injection once every
4 weeks. Patients treated with SOMATULINE DEPOT had a median age of
64 years (range 30-83 years), 53% were men and 96% were Caucasian.
Eighty-one percent of patients (83/101) in the SOMATULINE DEPOT arm
and eighty-two percent of patients (82/103) in the placebo arm did not
have disease progression within 6 months of enrollment and had not
received prior therapy for GEP-NETs. The rates of discontinuation due to
treatment-emergent adverse reactions were 5% (5/101 patients) in the
SOMATULINE DEPOT arm and 3% (3/103 patients) in the placebo arm.
Table 1: Adverse Reactions Occurring in >5% in SOMATULINE DEPOTTreated Patients and Occurring More Commonly Than Placebo-Treated
Patients (>5% higher incidence) in Study 3
Adverse
Reaction
Any Adverse
Reactions
Abdominal
pain1
Musculoskeletal
pain2
Vomiting
Headache
Injection site
reaction3
Hyperglycemia4
Hypertension5
Cholelithiasis
Dizziness
Depression6
Dyspnea
SOMATULINE DEPOT
120 mg
(N=101)
Any
Severe
(%)
† (%)
Placebo
(N=103)
Any
Severe
(%)
† (%)
88
26
90
31
34*
6*
24*
4
19*
2*
13
2
19*
16
15
2*
0
0
9*
11
7
2*
1
0
14*
14*
14*
9
7
6
0
1*
1*
0
0
0
5
5
7
2*
1
1
0
0
0
0
0
0
Includes preferred terms of abdominal pain, abdominal pain upper/lower,
abdominal discomfort
2
Includes preferred terms of myalgia, musculoskeletal discomfort,
musculoskeletal pain, back pain
3
Includes preferred terms of infusion site extravasation, injection site
discomfort, injection site granuloma, injections site hematoma, injection
site hemorrhage, injection site induration, injection site mass, injections
site nodule, injection site pain, injection site pruritus, injection site rash,
injection site reaction, injection site swelling.
4
Includes preferred terms of diabetes mellitus, glucose tolerance impaired,
hyperglycemia, type 2 diabetes mellitus
5
Includes preferred terms of hypertension, hypertensive crisis
6
Includes preferred terms of depression, depressed mood
* Includes one or more serious adverse events (SAEs) defined as any
event that results in death, is life threatening, results in hospitalization
or prolongation of hospitalization, results in persistent or significant
disability, results in congenital anomaly/birth defect, or may jeopardize
the patient and may require medical or surgical intervention to prevent
one of the outcomes listed.
†
Defined as hazardous to well-being, significant impairment of function
or incapacitation
1
6.2 Immunogenicity
In Study 3, development of anti-lanreotide antibodies was assessed using
a radioimmunoprecipitation assay. In patients with GEP NETs receiving
SOMATULINE DEPOT, the incidence of anti-lanreotide antibodies was 3.7%
(3 of 82) at 24 weeks, 10.4% (7 of 67) at 48 weeks, 10.5% (6 of 57) at
72 weeks, and 9.5% (8 of 84) at 96 weeks. Assessment for neutralizing
antibodies was not conducted.
The detection of antibody formation is highly dependent on the sensitivity
and specificity of the assay. Additionally, the observed incidence of
antibody (including neutralizing antibody) positivity in an assay may
be influenced by several factors including assay methodology, sample
handling, timing of sample collection, concomitant medications, and
underlying disease. For these reasons, comparison of the incidence of
antibodies to SOMATULINE DEPOT with the incidence of antibodies to
other products may be misleading.
6.3 Postmarketing Experience
The profile of reported adverse reactions for SOMATULINE DEPOT was
consistent with that observed for treatment-related adverse reactions in
the clinical studies. Those reported most frequently being gastrointestinal
disorders (abdominal pain, diarrhea, and steatorrhea), hepatobiliary
disorders (cholecystitis), and general disorders and administration site
conditions (injection site reactions). Occasional cases of pancreatitis
have also been observed.
Allergic reactions associated with lanreotide (including angioedema and
anaphylaxis) have been reported.
7 DRUG INTERACTIONS
7.1 Insulin and Oral Hypoglycemic Drugs
Lanreotide, like somatostatin and other somatostatin analogs, inhibits the
secretion of insulin and glucagon. Therefore, blood glucose levels should
be monitored when lanreotide treatment is initiated or when the dose is
altered, and antidiabetic treatment should be adjusted accordingly.
7.2 Cyclosporine
Concomitant administration of cyclosporine with lanreotide may decrease
the relative bioavailability of cyclosporine and, therefore, may necessitate
adjustment of cyclosporine dose to maintain therapeutic levels.
7.3 Other Concomitant Drug Therapy
The pharmacological gastrointestinal effects of SOMATULINE DEPOT may
reduce the intestinal absorption of concomitant drugs. Limited published
data indicate that concomitant administration of a somatostatin analog
and bromocriptine may increase the availability of bromocriptine.
Concomitant administration of bradycardia-inducing drugs (e.g., betablockers) may have an additive effect on the reduction of heart rate
associated with lanreotide. Dose adjustments of concomitant medication
may be necessary. Vitamin K absorption was not affected when concomitantly
administered with lanreotide.
7.4 Drug Metabolism Interactions
The limited published data available indicate that somatostatin analogs may
decrease the metabolic clearance of compounds known to be metabolized
by cytochrome P450 enzymes, which may be due to the suppression of
growth hormone. Since it cannot be excluded that lanreotide may have this
effect, other drugs mainly metabolized by CYP3A4 and which have a low
therapeutic index (e.g. quinidine, terfenadine) should therefore be used with
caution. Drugs metabolized by the liver may be metabolized more slowly
during lanreotide treatment and dose reductions of the concomitantly
administered medications should be considered.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C
Lanreotide has been shown to have an embryocidal effect in rats and rabbits.
There are no adequate and well-controlled studies in pregnant women.
SOMATULINE DEPOT should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
Reproductive studies in pregnant rats given 30 mg/kg by subcutaneous
injection every 2 weeks (five times the human dose, based on body surface
area comparisons) resulted in decreased embryo/fetal survival. Studies
in pregnant rabbits given subcutaneous injections of 0.45 mg/kg/day (two
times the human therapeutic exposures at the maximum recommended
dose of 120 mg, based on comparisons of relative body surface area)
shows decreased fetal survival and increased fetal skeletal/soft tissue
abnormalities.
8.3 Nursing Mothers
It is not known whether lanreotide is excreted in human milk. Many drugs
are excreted in human milk. As a result of serious adverse reactions from
SOMATULINE DEPOT in animals and, potentially, in nursing infants, a
decision should be made whether to discontinue nursing or discontinue the
drug, after taking into account the importance of the drug to the mother.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use
The GEP-NETs clinical trial did not include sufficient numbers of patients
aged 65 and over to determine whether they respond differently from
younger patients. Other reported clinical experience has not identified
differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious,
usually starting at the low end of the dosing range, reflecting the
greater frequency of decreased hepatic, renal, or cardiac function,
and of concomitant disease or other drug therapy.
No dose adjustment required.
8.6 Renal Impairment
No effect was observed in total clearance of lanreotide in patients with mild
to moderate renal impairment receiving SOMATULINE DEPOT 120 mg.
Patients with severe renal impairment were not studied.
8.7 Hepatic Impairment
SOMATULINE DEPOT has not been studied in patients with hepatic
impairment.
10 Overdosage
If overdose occurs, symptomatic management is indicated.
Up-to-date information about the treatment of overdose can often be
obtained from the National Poison Control Center at phone number
1-800-222-1222.
17 Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling
(Patient Information).
Advise patients to inform their doctor or pharmacist if they develop any
unusual symptoms, or if any known symptom persists or worsens.
Advise patients experiencing dizziness not to drive or operate machinery.
Manufactured by: Ipsen Pharma Biotech
Signes, France
Distributed by: Ipsen Biopharmaceuticals, Inc.
Basking Ridge, NJ 07920
©2015 Ipsen Biopharmaceuticals, Inc.
RX ONLY
NET00107b
We Support the Health of your Practice
With the Same Dedication that You Support Your Patients
Your number one priority is the health of your patients. With the changing healthcare landscape, our number one
priority is the business health of your practice.
Dedicated exclusively to the viability of community oncology, ION Solutions provides contracting, technology, education
and advocacy support that ensures you have the tools to run your practice both efficiently and effectively. With the
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for your patients.
To learn how ION Solutions enables community oncology practices to improve operational efficiency,
financial performance and quality of care, contact your Strategic Account Manager or visit IONonline.com.
To experience ION Solutions advocacy support,
visit ourcommunitycounts.org.
38
FCS The Magazine
RESEARCH SPOTLIGHT
Savoring Success
Research director ensures FCS has key ingredients
for quality results BY ZANDRA WOLFGRAM
K
atie Goodman seems to know the recipe for success—
literally and figuratively.
A devoted mother, a nurturing gardener and aspiring
cookbook author, this 20-year RN holds a bachelor of
nursing science degree from Florida State University and is a certified
clinical research professional through the Society of Clinical Research
Associates. For the past 14 years, Goodman, based in Sarasota, has
served as the director of clinical research for Florida Cancer Specialists &
Research Institute (FCS).
While she has been overseeing the day-to-day operations and
managing a team of 73 nurses, research coordinators, data managers and
regulatory professionals, an estimated 5,000 patients have participated in
early phase and late phase trials offered throughout more than 30 FCS
locations across the state of Florida since 2001.
Having worked as both a critical care and pulmonary/thoracic surgery
nurse makes this calm and collected Tallahassee native uniquely suited to
her demanding executive role. “I’ll never forget what it’s like to be a nurse,
taking care of patients,” the detail-oriented director says. “But the reward
for me now is to make it easier for others to deliver quality patient care.”
Increased regulation and rapid scientific advances have made the
research division of FCS’s business one of the most dynamic. One of
Goodman’s constant challenges is keeping the team of more than 180
FCS physicians continually motivated to keep the company’s good
work moving forward.
“Research is hard work and it requires a lot of extra time on the part
of healthcare workers, but the end goal is to find new therapies—to
find a better way—for our patients,” she says. “Unless we are doing the
important work of clinical trials, we will never find the next best thing, so
we must continue to invest, commit and find the next treatment. We all
know it’s the right thing; we have to commit and pay attention to it. It’s
part of our mission.”
Through ongoing collaboration with FCS’s exclusive trials sponsor,
SCRI, Goodman is dedicated to bringing cutting-edge research to FCS
patients. In 2011, these efforts were recognized when the American
Society of Clinical Oncology awarded FCS the prestigious Clinical
Trials Participation Award.
The healthcare industry standard is 3 percent participation for oncology
clinical trials. Goodman is committed to ensuring that that number is
met, and hopefully, exceeded. “Some of our locations do better and some
less,” she says. “Every day I ask myself ‘What can I do to simplify the
process to make it easier to help our staff find and enroll patients?’”
On average, FCS enrolls 500 patients into clinical trials each year.
Once activated, a study can be underway from five to 15 years. Goodman
sees that as 500 opportunities for FCS to make a difference in the fight
against cancer. “Every medication we give was part of a clinical trial at one
point,” she says. “If FCS can’t get this done and play a large part, than no
one else can do it. We are perfectly aligned to advance the cause.”
As is the case with most researchers, Goodman is emboldened by
results. She need only look at fairly recent strides to know her 73-person
team is having an impact within the healthcare community. “We used to
follow chemo with more chemo for lung cancer. Now we have multiple
trials with multiple targets and multiple types and sub-types and not just
for lung cancer, but for every tumor type,” she says.
While recent advances are indeed “amazing” as Goodman says, she
is the first to admit that the more success is realized, the more work
needs to be done.
“The more targeted research becomes, the more challenging it is. It
asks us to find a needle in a haystack to find the one or two patients with
a particular mutation,” she says. “But FCS is a large practice and with so
many patients, we can find those needles.”
Though a miracle pill would be nice to discover, from what Goodman
has observed in FCS’s clinical trials, a “silver bullet” solution is not likely.
“Cancer will not be a cured with a blockbuster drug, but I do believe
we will be able to manage it like a chronic disease, much like diabetes,”
she says. “The future will continue to be in the work on very targeted
ways to control growth of cancer with less side effects.”
Goodman is optimistic about potential discoveries from every clinical
trial. “Even if it’s not a gigantic breakthrough, there is always something
to be learned. A trial with only 17 patients enrolled is still giving patients
access to something they wouldn’t or couldn’t have had,” she says.
Goodman says this about research as she might say about the Lemon
Chicken with Orzo recipe she’s testing for her yet-to-be-released
cookbook: “The most important thing we can deliver is high quality in
the safest way we can.”
Winter 2015-16
39
40
FCS The Magazine
DOCTOR SPOTLIGHT
Dr. Vikas Malhotra
The passionate teaching physician BY ZANDRA WOLFGRAM
A
t the tender age of 11, Vikas Malhotra looked up to his
30-year-old cousin. And why not? He was a talented artist
who could sketch replicas of all the major monuments in
their homeland of New Delhi, India; he had all the latest
LPs in his record collection, and was a fun guy to be around. So, when
the elder cousin was stricken with cancer, it was a big blow to the entire
family and one of the chief reasons Malhotra decided to pursue a career
in medicine.
The other motivation came from another family member he deeply
admired. “My mother had a deep desire for one of her kids to devote
himself to a field that would help mankind directly,” Malhotra says.
“If I wasn’t going to be a teacher, then I was going to be a physician.”
So at 17, just a few years after his cousin died, Malhotra enrolled
in a six-year program in pursuit of his dream to make a difference.
After graduating from medical school at the University of Delhi,
New Delhi, India, in 1991, he completed his Internal Medicine
Residency at Wright State University in Dayton, Ohio.
As Malhotra was studying his medical boards in oncology,
another cousin in her 30s died from metastatic breast cancer. “It just
strengthened my resolve to see what I could do to help,” he says.
He served as chief resident and received both the Best Resident
and Best Teaching Resident awards. He was a practicing internist
in Missouri for three years in an underserved community before
returning to do his fellowship in hematology and medical oncology
at the University of Missouri.
After his fellowship, he was appointed to the job of assistant
professor of medicine at the University of Missouri, where he was
given the Best Medical Student Teacher award as a faculty member.
He was active in clinical trials through Cancer and Leukemia Group
B (CALGB) and is the author of several publications on breast
cancer and esophageal cancer.
After meeting with Dr. William Harwin in 2006, Malhotra stayed
in touch and invited him back to visit his Brooksville practice for a
visit. In January 2012 when the timing was finally right, Malhotra’s
practice became affiliated with Florida Cancer Specialists & Research
Institute (FCS). Today, he serves patients at the Brooksville and
County Line Road offices—one of the busiest and most underserved
locations in the state—and is currently on the FCS Executive Board.
“Joining FCS was the best decision we’ve made. It really is
the most compelling choice right now. FCS has the best multidisciplinary approach to oncology, bar none,” he says.
Malhotra, 47, who is married to a pathologist, says though
cancer can be fatiguing, he and his wife, Meenakshi, remain “happy
physicians” and try not to miss their weekly movie date night to stay
connected. When he needs to rejuvenate his mind and body, he hits
scenic bike paths for a ride, the tennis courts with his two sons or
the sofa for some quiet time with his Kindle. “Reading is one of my
big passions that really destresses me,” he says. “I love to read about
physics and what’s happening in astronomy and astrophysics. It’s
fascinating and it helps me put things in perspective.”
After 15 years, Malhotra is still glad he chose the profession he
did. “I could never have predicted what the years have brought and I
would not go back and do anything different,” he says.
One of the things that clearly distinguishes this oncologist is his love
of teaching; a passion he’s convinced influences his approach to patients.
“It’s so important to me that the patient understand exactly what
I’m doing and why. If things are explained in a language they can
understand, they will be a partner and an ally. It makes a huge
impact. In fact, our compliance rates are higher and we find patient
satisfaction is higher, too,” he says.
Malhotra could not imagine a more exciting time to be practicing
medicine. He has witnessed first-hand the rapid growth of FCS and
the advances in pharmaceuticals that are changing the face of cancer.
“Almost half of cancer treatments are different than when I was in
training,” he marvels. He quickly rattles off several examples such as
multiple myeloma that once had an average survival rate of two years
and is now in many cases pushing 10 years. Herceptin, which was
a clinical trial drug when Malhotra was a second year fellow, is now
the drug of choice for HER2-positive breast cancer, and the “magic
drug,” Gleevec, is commonly called the “silver bullet” because of its
effectiveness in treating chronic myeloid leukemia.
“These are just a few advances that show just how far we’ve come,”
Malhotra says.” We have a long way to go and a big journey ahead,
but there is progress that is tangible that we see day in and day out.”
Winter 2015-16
41
what's on your radar?
the radar screen
Guideline Guide
I
BY DR. SCOTT TETREAULT
f you are like me, you check the
NCCN Guidelines® about two or
three times a day. Practicing modern
oncology without the guidelines
would be like driving in Manhattan
without a map. Let’s quickly cruise through
some recent guidelines changes.
Ovarian Cancer: The new category
1 recommendation for newly diagnosed
Stage II to IV patients is Carbo (AUC=2)
weekly plus Taxol weekly for 18 weeks.
Note: NOT every three weeks. Olaparib
(Lynparza) was added for third line in
patients with BRCA mutations.
Lung Cancer: Next-generation
sequencing (FoundationOne, Guardant
360, etc.) should be used in all patients. (Arguably, pure squamous
cell patients can skip these tests.) Nivolumab is added for all
patients after failure of first line treatment as an option. Proteomic
tests (like Veristrat) can be done if the patient was initially EGFR
negative AFTER failure of first line treatment (to judge whether
or not your second line treatment should be a TKI inhibitor). The
only thing that changed in small cell was a recommendation to
consider radiation to the primary in extensive stage small cell after
completing your six cycles of platinum VP-16.
42
FCS The Magazine
Breast Cancer: Negative margins at
lumpectomy are now confirmed as long as
you have “no ink on tumor.” Short course
radiation is endorsed over long course. For
ER Negative, HER 2 positive, LN negative
tumors 5mm or less, chemo plus Herceptin
can be considered. For Her 2 positive
tumors T2 or greater, or N1 or greater,
Perjeta can be added to your adjuvant
regimen for post-operative adjuvant therapy.
CLL: Ibrutinib was added as preferred
therapy for 17p deletion.
Colon Cancer: Avastin can be used
until progression and beyond progression,
so the doctor who wants to start Avastin
and never stop and never switch to Cyramza
or Zaltrap is within the guidelines. Erbitux and Vectibix are
interchangeable, at least according to NCCN.
Bladder/Kidney Cancer: Alimta was added as a
chemotherapy option in refractory bladder patients. In kidney
cancer, for surveillance in high risk, potentially cured patients, the
doctor can scan forever: It used to be up to five years, now there is
no stopping point.
Great work FCS team!
Thank you for your incredible hard work, passion
and dedication to our patients throughout 2015.
Warm wishes for a bright and prosperous new year!
Winter 2015-16
43
A cancer diagnosis changes everything.
Fighting cancer is a long journey. Florida Cancer Specialists
Foundation helps make the road a little easier.
W
e deeply care about our patients and their struggles.
Florida Cancer Specialists Foundation was created to help patients
who need financial assistance while undergoing treatment. The Foundation
allows those fighting their battle with cancer to concentrate on recovery
rather than their overdue rent, mortgage, electric or water bill.
Please call (941) 677.7181 or visit Foundation.FLCancer.com for more information
or to donate.