Winter 2015-16 A Fight Song Battles with breast cancer unite determined nurses INSIDE GET TO KNOW DR. PADMAJA SAI» OFFICE SPOTLIGHT: NEW SMYRNA BEACH»
In your patients with EGFR M+ metastatic NSCLC... How many have Del 19 mutations? Knowing your patients Del 19 status can help inform clinical decisions. Identify Del 19 a mutation with clinical significance in metastatic NSCLC. Please visit www.treatingnsclc.com for more information. 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 2 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 Riding the Wave 18 Nurse Spotlight: CHRISTINA CARUSO Expanding FCS s clinical trial enrollment 32 Administrative Spotlight: TOM CLARK Leading FCS s legal team 38 Research Spotlight: KATIE GOODMAN Finding a better way for patients 40 Doctor Spotlight: DR. VIKAS MALHOTRA Helping mankind FEATURES 10 Foundation and FCS Events Have Patients at Heart 21 Steve Noga Industry-Sponsored Feature Senior Medical Director, Medical Affairs, Takeda Pharmaceuticals 29 Clinical Summit Recap 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 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 4 FCS The Magazine
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 Not 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 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. Marathoners Honor Their Patients One Step at a Time BY TISHA KELLER Working in cancer care, it can be hard to witness the struggle between life and death day after day. One way to fight back is to do something in your off-time that helps create the possibility of a better future for these patients. Dr. Jennifer Cultrera in Orlando and Kim Delgado, the Wellington office manager, decided to do just that. In early 2016, wearing eggplant-colored tees, they ran through four Disney properties to raise money for leukemia and lymphoma cancer research and care. The Leukemia & Lymphoma Society s (LLS) Team in Training program is the only program for endurance athletes that enables people to do what they love and raise money for blood cancer research. RunDisney manages the Walt Disney World Marathon Weekend presented by Cigna, a four-day festival of long-distance running. The event is already sold out for several of its 2016 races scheduled for Jan. 16-20, 2016. Cultrera is a seasoned endurance athlete who hasn t missed a Disney Marathon Weekend since 2012. Delgado took up running a short two years ago with her daughter, but this year she tackles her first marathon. The two don t train together, but they are both highly devoted to the cause. My connection to LLS through patients and other endurance athletes is very dear to me, explains Cultrera, a hematologist and medical oncologist at FCS in Orlando. 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. I am happy to join those at the back of the pack, who incorporate running into their busy lives and cross the finish line in their own time. Delgado is training with a former patient and cancer survivor, Stephanie Carroll, for the marathon. She is also running solo in The Dopey, a combination of races over the four-day weekend. I like this event because the money raised in this county stays in this county, Delgado said. She raised over $5,000 in pledges for the 2016 event. The LLC uses fundraisers such as this to direct-pay insurance premiums, co-pays and Kim Delgado and Daughter treatments, and to fund research for a cure. Delgado says the she hates the first two or three miles of any run, but it s her devotion to those in need that keeps her going. I keep going because I m running for those who can t, she explained. And this time, I just want to get Stephanie across that finish line. Waking up early and taking each step towards that finish line is nothing compared to helping just one person survive their journey, Cultrera agreed. My motivation is to honor my patients and expand resources for those I have yet to meet! 2016 marks the 20th year of collaboration between the LLS and RunDisney. To participate in the Team in Training program, you don t have to be athlete or even in shape. There are marathons, half marathons, cycling, triathlons and hiking adventures for every athletic ability. Learn more at www.teamintraining.org. 6 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 stadium s BucsVision screens. In the stands, Gunderson s younger brother was just as surprised. Those who d been keeping the secret for months felt relieved. FCS U.S. Air Force Captain Josh Gunderson, who is stationed in Anchorage, Alaska, surprised his mom, Reina Campbell of Tampa, during the Tampa Bay Bucs Breast Cancer Awareness game on Oct. 11. 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. Conference leader Verna Valentine, RN, BSN, OCN, recognizes Leslie Weiland, RN, BS. 8 FCS The Magazine
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 Steven B. Newman, 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). 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 Florida 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 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. 10 FCS The Magazine
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 11
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. 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. 12 FCS The Magazine
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 When 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. 14 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 Surfing, 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 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 16 FCS The Magazine
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
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NURSE SPOTLIGHT High (En)Roller Christina Caruso s crusade to expand FCS s clinical trial enrollment BY ZANDRA WOLFGRAM Though 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
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INDUSTRY INSIGHT Industry-Sponsored Content Meet Steve Noga Senior Medical Director, Medical Affairs, Takeda Pharmaceuticals After 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 Co- Director 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. 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. 22 FCS The Magazine
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? 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. 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 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 before I reach age 50 (nine more years). 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. What s for dinner when you really want to treat yourself right? Traditional, authentic South Indian food. What is your greatest fear? I am a Leo! I don t have a fear of anything. What destination, as yet unvisited by you, would you most like to experience? 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. What specialty would you be in if not for oncology? 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 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. 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 4. PHYSICIAN LIAISON TEAM MEETING 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. 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 24 FCS The Magazine
FCS events 6a. 6b. 6c. 7. 8. 6. BOWLING FOR BOOBS Dr. Gail Wright sponsored a special Bowling 4 Boobs event in New Port Richey 6a. Pictured (L-R): Roberta Baker, Dawne Vetzel, Physician Liaison JoLynn Wright 6b. Pictured (L-R): Office Manager Peggy Dinsmore, Jane Nemetz 6c Pictured (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. 8. 5K DASH FOR DAWN CENTER IN HERNANDO COUNTY 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. 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 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. 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 9b. Dr. Bill Harrer FCS Physician Crystal River and Inverness South 10. LADIES NIGHT OUT IN BROOKSVILLE 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. 10a. Dr. Vikas Malhotra speaking 10b. Julie Anning RN Physician Liaison at the FCS booth 11. SOLIDER MARATHON 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. 12. BRADENTON EAST TEAM CELEBRATE Staff at the Bradenton East office celebrate receiving the highest audit score for the first audit implementation. Front row: Alison Prasad, Wendy McGrath, Dr. Nadiminti, Linda Dunzik, PA-C, Chris Sims; Missing from photo: Flor Uscanga and Dr. Telukuntla Back row: Leah Blanding, Sue Labarr, Nadene Sawyer, Ruth Razin, Lisa Hatcher, Sandy Secondo, Office Manager Amy Morrow, Paula Bauer, Melissa Kreider 26 FCS The Magazine
13a. 13b. 13c. 14a. 14b. 14c. 14d. 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 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 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. Wellington 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 Submit your recent event photos to FCS Marketing at marketing@flcancer.com. 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, dinner, dancing and an unforgettable LIVE performance by 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. BY TISHA CREWS KELLER Held 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. 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. 30 FCS The Magazine
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 marketing@flcancer.com. 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 Tom 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. 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. 32 FCS The Magazine
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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 90 Median PFS for Somatuline Depot not yet reached at 22 months Progression-Free Survival Probability (%) 80 70 60 50 40 30 20 10 Hazard ratio=0.47 95% CI: 0.30-0.73 Somatuline Depot (n=101) Placebo (n=103) Median PFS for placebo: 16.6 months 95% CI: 11.2-22.1 Somatuline Depot vs placebo reduced risk of progression or death by 53 % 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-NETs 1 A 53% REDUCTION IN THE RISK OF DISEASE PROGRESSION OR DEATH VS PLACEBO 1 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. To learn more, visit SomatulineDepot.com Please see Brief Summary of full Prescribing Information on the following page.
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 DEPOT- Treated Patients and Occurring More Commonly Than Placebo-Treated Patients (>5% higher incidence) in Study 3 SOMATULINE DEPOT Adverse 120 mg Placebo Reaction (N=101) (N=103) Any Severe Any Severe (%) (%) (%) (%) Any Adverse 88 26 90 31 Reactions Abdominal 34* 6* 24* 4 pain 1 Musculoskeletal 19* 2* 13 2 pain 2 Vomiting 19* 2* 9* 2* Headache 16 0 11 1 Injection site 15 0 7 0 reaction 3 Hyperglycemia 4 14* 0 5 0 Hypertension 5 14* 1* 5 0 Cholelithiasis 14* 1* 7 0 Dizziness 9 0 2* 0 Depression 6 7 0 1 0 Dyspnea 6 0 1 0 1 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 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
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RESEARCH SPOTLIGHT Savoring Success Research director ensures FCS has key ingredients for quality results BY ZANDRA WOLFGRAM Katie 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 At 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 BY DR. SCOTT TETREAULT If 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. 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. 42 FCS The Magazine
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. We 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.