• Director of Data Management Center Reflects on Nearly Two Decades of Research

    December 16, 2015 pendari Leadership

    Meet Marlene Cooper

    Marlene Cooper, M.S., has been involved in clinical trials data management and related research for 19 years.  She started her work in the field of HIV/AIDS in 1996 as a Project Coordinator for the Ryan White Care Act HIV Needs Assessment for Northeast Ohio while working on her Masters degree in Epidemiology at Case Western Reserve University in Cleveland, OH.  Working in the community, she became interested in the relationship between perceived susceptibility and risk behaviors as well as the need for programs to target underserved populations. Her initial introduction to clinical trials was as a Research Assistant at the Tuberculosis Research Unit at Case Western. However, it was when she relocated back to New York State, where she is originally from, that Marlene began her career at Frontier Science and Technology Research Foundation (FSTRF) focusing exclusively on clinical trials data.  Fast forward nearly twenty years to last December when Marlene was promoted to the position of Director of the ACTG Network Data Management Center at FSTRF.

    In addition to her duties as the Director of the ACTG Data Management Center, Marlene is also the Director of Data Management for the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network Data Management Center at FSTRF. She is responsible for all data management activities for both networks and ensures that dedicated clinical and laboratory data management, information technology, database operations and programming resources are available for research.  Marlene notes one of the most rewarding aspects of the work she and her colleagues perform is that it often directly impacts treatment guidelines and advances the understanding of how and when to treat individuals living with HIV/AIDS.

    “The results from ACTG clinical trials provide valuable information for clinicians regarding how to effectively manage HIV/AIDS, including co-infections, and gives insight into additional treatment options for hard to treat individuals,” said Marlene. “It’s humbling to think that I’ve played a small role in advancing the research by my work in support of these trials.”

    Marlene considers the ACTG Network a second family to her in many ways and although she has worked in different roles and in different capacities over the years, her relationships with colleagues remains a constant. She has worked with Robert Coombs MD, PhD, ACTG Network Laboratory Principal Investigator, University of Washington, Seattle, since first starting at FSTRF and considers him not only a colleague, but a good friend.

    “I enjoy all the relationships I have made with investigators, laboratory staff, protocol teams and other members of the HIV/AIDS research community,” said Marlene. “My relationship with Dr. Coombs in particular has allowed me to continue to foster my interest in the science of infectious diseases and specifically HIV infection, and how the virus hides in the body, mutates and avoids eradication.”

    Over the years, Marlene has seen a significant shift in technology at FSTRF.  With the move to the internet and cloud-based technology, she has seen the introduction of more commercial software solutions for data management.  At FSTRF, they are constantly looking to improve efficiency and make data more easily and readily available to ACTG Network investigators and statisticians.  In fact, they are currently in the process of transitioning to a commercial Clinical Trials Data Management System for clinical sites, so this is an exciting time for FSTRF and the ACTG Network.

     “Marlene brought to this effort an in-depth understanding of our work garnered through her background in epidemiology, and the knowledge and experience she gained over her 20 years in this field,” said Gregory Pavlov, President and Chief Executive Officer, Frontier Science and Technology Research Foundation. “Coupled with her innate understanding of computing and database concepts and technologies, and her outstanding organizational and communications skills, Marlene has proved to be the ideal person to lead this project that is critical to the long term success of our company.”

    In the future, Marlene plans to continue her work advancing clinical trials data management with new technology and providing high quality data to answer the research questions posed by ACTG Network researchers. She notes that she has learned patience, persistence and hard work pays off and it is exciting to see how far the field has come in the past twenty years; nevertheless, there is still much work to do to expand treatment access and identify a cure.  

    Marlene also has a closing message to others who work in the field of data management:

    “Keep up the exceptional work!  Accurate and quality data collection is critical to the success of our clinical trials and the valuable research conducted across the ACTG Network. The work you perform on a daily basis provides critical information that will help bring us one step closer to a cure for HIV.”

     

  • ACTG Leadership and Operations Center

    July 2, 2012 pendari Leadership

    On June 1, the ACTG Leadership and Operations Center (the LOC), at the Brigham and Women’s Hospital (BWH) in Boston, Massachusetts, will assume responsibility for management of the Network Leadership Group grant. BWH is home to the ACTG Network Principal Investigator (PI), Dr. Daniel Kuritzkes, and to clinical research site 107, one of the longest established in the network. In a month, the hospital will also host the ACTG’s fiscal, grant management, and contracting functions, giving the Network PI more control over the group’s financial operations. The move will help the ACTG keep its place at the forefront of HIV therapeutics research in a rapidly developing and competitive environment; and an enthusiastic and committed team of six has been working closely with staff at Social & Scientific Systems, Inc., and is ready to take charge.

    [The LOC team pictured top, from left to right:
    Sarah Maloney, Project Coordinator
    Angela Rhodes, Financial Analyst
    Haley Salinas, Finance Manager
    Benjamin Raynak, Contracts Specialist
    Stephen Fetters, Grants Administrator
    Lauren Robertson, ACTG Executive Director]

    [Lauren Robertson is pictured above]

    The new ACTG Executive Director, Lauren Robertson, is at its head and is a network veteran. She is a former grants administrator with the Harvard/Partners ACTG Clinical Trials Unit and returned to the network in December with an 8-year track record in research, operations, and grants management. Her capable managers, analysts, and specialists are similarly accomplished with over 20 years of experience in finance and grants management for the network. Some of the staff is transferring to the LOC from other positions at BWH, while others are new hires from the public and private sectors.

    The team will be taking on the management of finances and operations for a research network of 73 research sites and 21 specialty laboratories, spread across four continents, and currently enrolling participants to 25 separate clinical trials. It is an immense task and time-sensitive work that does not forgive errors, but the LOC is ready for it. The LOC team has the enthusiastic support of BWH, believes in the network’s mission, and is happy to be part of one of the world’s largest HIV/AIDS clinical trials networks. In Lauren Robertson’s words: “I’m extremely excited to be back with the ACTG.”

  • Co- Infections Explored

    January 1, 1970 pendari Leadership

    Marion Peters, MD, is an internationally renowned hepatologist. She is the John V. Carbone Professor of Medicine at University of California San Francisco and is Chief of Hepatology Research in Gastroenterology. 

    Peters trained in internal medicine, specializing in gastroenterology, hepatology and immunology in Australia, at the University of Southern California and at the National Institutes of Health (NIH). Her research focuses on viral hepatitis; immunology of the liver, including the role of host responses on viral hepatitis; and the effect of alcohol and HIV on liver disease progression.

    She has been a major scientific leader in the AIDS Clinical Trials Group. She has held numerous positions in the ACTG since 1999, including chairing the Liver Diseases Subcommittee and Hepatitis Research Agenda Committee. Peters currently chairs the Hepatitis Transformative Science Group (HEP TSG).  

    “The HEP TSG is comprised of clinicians and scientists from U.S. and international sites with diverse interests and patients,” Peters says. “Our vision is to provide HCV (hepatitis C virus) therapy to all patients living with HCV and HIV co-infection and patients with HCV mono-infection.”  

    She says the group’s goals include:

    1. Devising novel trial designs to accelerate evaluation and approval of new drugs and drug regimens in viral hepatitis.
    2. Expanding and strengthening clinical site capacity to carry out hepatitis trials.
    3. Strengthening capacity to diagnose; monitor; and evaluate clinical, virological and immunological outcomes.
    4. Strengthening hepatitis virologic and pharmacology research capacity for studies of drug-drug interactions between DAAs (direct-acting antivirals), ART (antiretroviral therapy) and other medications.
    5. Mentoring and supporting new investigators to pursue this agenda.

    She was a team member of a major therapeutic study of HIV and HCV co-infection (A5071; New England Journal of Medicine, 2004) and co-chaired the first study comparing adefovir and tenofovir for HIV and hepatitis B virus (HBV) co-infection (A5127; Hepatology 2006; 44: 1110-1116). She was an active contributing protocol team member to A5220 and many sub-analyses of A5071 and A5127. She has continued to contribute to the ACTG through patient referrals and management of HIV and hepatitis co-infected patients. Most recently she is co-chair of study A5269: The Activity of Nitazoxanide in Addition to Pegylated interferon and Ribavirin in Chronic HCV-HIV Co-infected Patients.

  • Meet Michael Lederman, MD

    January 1, 1970 pendari Leadership

    Michael Lederman is the Scott R. Inkley Professor of Medicine at Case Western Reserve University School of Medicine and University Hospitals of Cleveland where he is also Professor of Biomedical Ethics, Pathology, Microbiology and Molecular Biology.

    He received his bachelor’s degree in biology from Brandeis University and his medical degree from the Mt. Sinai School of Medicine. He trained in internal medicine at Case Western Reserve University, University Hospitals of Cleveland and the VA Medical Center where he served as chief resident in medicine and completed fellowship training in infectious diseases. Lederman received post-doctoral training in cellular immunology in the laboratory of Jerrold Ellner, MD, and he joined the faculty at Case in 1980.

    Lederman has been engaged in HIV/AIDS research since he and Oscar Ratnoff, MD, first described and characterized the occurrence of AIDS-related immune deficiency in otherwise healthy men with hemophilia in 1983. He has authored more than 290 peer-reviewed scientific publications largely focused on the mechanisms whereby HIV infection induces immune deficiency and on strategies to correct and prevent it. In 1985, Lederman established the Special Immunology Unit at University Hospitals of Cleveland, which was the first dedicated HIV clinic in Northeast Ohio and is now one of the largest providers of comprehensive HIV care in the Midwestern United States.

    “When the Unit was founded, our doctors felt strongly that the way to assure excellence in HIV care was to link the clinical care program to a strong HIV research program,” Lederman says.

    In 1987, he established the AIDS Clinical Trials Unit at Case/University Hospitals. Within the national network of the AIDS Clinical Trials Group (ACTG), he directs the Immunology Specialty Laboratories that provide immunologic monitoring of national HIV treatment trials. He also leads two program project teams: one that is developing novel topical strategies to prevent HIV acquisition (Basic and Clinical Studies of CCR5 Inhibition to Prevent HIV Transmission) and the other to explore the pathogenesis of immune activation and inflammation in HIV infection (Defining the Pathogenesis of Immune Deficiency in Chronic HIV Infection). He is the chairman of the ACTG’s End-Organ Disease/Inflammation Transformative Science Group.

    “In the HAART (Highly Active Antiretroviral Treatment) era, immune activation and inflammation persist despite virologic control and an increasing body of information links these processes to morbid outcomes,” Lederman says. “Interventional trials provide an important opportunity to preserve the health of our patients and to define the mechanisms that drive activation and inflammation in treated HIV infection.”

    Lederman is a member of the Association of American Physicians, the American Association of Immunologists, the Infectious Diseases Society of America, the HIV Medicine Association and is a Fellow of the American Academy of Microbiology and the American Association for the Advancement of Science. He serves on the editorial boards of several research journals and is a member of the Scientific Advisory Boards for the Forum for Collaborative Research and the Agence Nationale de Recherche sur le SIDA (ANRS).

    Lederman lives with his first wife and two dogs. He owns two daughters and two grandchildren. He swims (slowly) and plays the piano (badly).

  • Meet Savita Kanade of Pune, India

    January 1, 1970 pendari Leadership

    Once a person has participated in a clinical trial at the BJ Medical College AIDS Clinical Trials Group Network’s site in Pune, India, they transition from patient to friend.

    “If we find ourselves in their neighborhood, we will stop in for a visit,” says Savita Kanade, MSc.

    The communication between the clinical trial unit in Pune, about three hours southeast of Mumbai, and its participants is a two way street Kanade has cultivated over the years. Site staff are on the guest list for housewarming parties and weddings. Participants from studies dating as far back as 2007 are among those invited to events held at BJ Medical College, says Kanade, who supervises the Clinical Trial Unit’s outreach program.

    “My goal is to strengthen our CAB (Community Advisory Board) in terms of outreach, recruitment and retention and use social media to achieve this,” she says. “I would also like to develop a website for our CAB.”

    Kanade hails from a strong community health background. Before working at the ACTG site in Pune, she spent 15 years working as a social scientist on projects relating to women’s health including decision-making around abortion, domestic violence, formation of sexual partnership among adolescents and conversations between parents and teens about sex and sexuality.

    In addition to supervising outreach efforts at the Pune site, Kanade serves as CAB liaison and as Co-Vice Chair for the ACTG’s Outreach, Recruitment and Retention (OO&R) Subcommittee.

    “Savita always impresses me with the way she moves through this world,” says Michael Louella, Chair of the OR&R Subcommittee. “Whether it’s embracing new technologies or picking up the check after dinner, she does everything with a quiet grace that to me is sign of true strength and power.”

    She is a familiar face having presented twice at the ACTG Network meeting in Washington, DC, in July 2012. She spoke at the third community session about her CAB and during the OR&R Subcommittee Business Session about a survey she conducted of the Network’s sites and access to communications tools such as the Internet, phones and Fax machines.

    “I want our sites to know how to use social media,” Kanade says. “I post events to the ACTG Facebook page and I want this to be a tool that aids us in recruitment.”

    People living in and around Pune speak mainly Marathi (the local dialect) and Hindi (the national language) or English, and Kanade admits the biggest barrier to informing local people of clinical trial enrollment is translating science into comprehendible terms in the local language. But she is making progress, having translated informed consent materials and protocol schema into Marathi.

     

  • Cindy Firnhaber, MD, Discusses Her Work

    January 1, 1970 pendari Leadership

    Spend 30 minutes talking with Cindy Firnhaber, MD, and one word keeps coming to mind – driven. It’s an adjective quite fitting for a woman who has moved across the world to treat women at the highest risk for developing cervical cancer.

    “Women with HIV have increased rates of cervical dysplasia due to HPV and tend to show signs of these lesions 10 to 15 years earlier than women who do not have HIV,” Firnhaber says. “So we are seeing young patients in their mid-20s. It’s an incredible injustice and not how we were intended to live.”

    Firnhaber is the Technical Director of the ACTG’s Clinical HIV Research Unit (CHRU) in Johannesburg, South Africa. The CHRU is a non-profit research unit, providing treatment and prevention services for patients with HIV and associated conditions and is affiliated with the University of Witwatersrand Department of Medicine. Firnhaber has been involved since the CHRU’s inception in 1997. And she has also been the Manager of Right to Care’s Cervical Cancer program since 2008. Right to Care is a South African non-profit involved in the implementation and strengthening of care for HIV infected people.

    In the United States, young men and women are encouraged to take Gardasil, a three-dose injection proven to guard against the four strains of the human papillomavirus that lead to 80 percent of cervical cancer and genital warts cases. But this method of prevention is not available to the public sector yet in South Africa. Firnhaber relies on regular screenings to catch cases of HPV among her female patients in South Africa.

    “They haven’t had good access to screenings in the past, so we are changing that,” she says. “Often, where they were going to get their HIV care was not equipped to perform pap smears. So they would have to travel to another location for that test and they wouldn’t always go. We started providing paps in HIV clinics and now there are 25 other clinics in South Africa providing these dual services that we began at Right to Care.”

    In addition to the goal of increasing the number of women screened for HPV, Firnhaber says the question she is hoping to answer with her research concerns treatment of women with HIV and HPV.

    “Cervical dysplasia is a pre-cancerous lesion and the treatment of these is not as effective in women with HIV because the disease burden is higher and the lesions are in more areas of the cervix,” Firnhaber says. “I am looking for more effective ways of treatment.”

     

    Firnhaber earned her medical degree from the University of Colorado and then spent six months volunteering at Musami Mission in Zimbabwe as a medical officer. Her time in Zimbabwe inspired an interest in treating patients with infectious diseases and instilled a love of the continent in her. In 1996, she began treating patients with HIV in South Africa and met Ian Sanne, MBBCH, FCP, the Founder and Managing Director of the CHRU and Right to Care.

    In 2000, she returned to Colorado for four years, but continued treating patients with HIV. By 2004, she headed back to Johannesburg excited for the President’s Emergency Plan for AIDS Relief or PEPFAR, a funding source available to organizations like Right to Care.

    “I knew anti-retroviral therapy was allowing women with HIV to live longer and that was why getting a regular pap was going to be so important for early detection and prevention of HPV,” she says. “Both of these diseases are preventable and my driving force is keeping these women alive for their children.”

    At the 2012 ACTG Network Meeting, Firnhaber received the Constance B. Wofsy Women’s Health Investigator Award. The award recognizes investigators who have made significant contributions to research in HIV-infected women and who embody qualities exemplified by Dr. Wofsy, the late Co-Director of the AIDS Program and Associate Chief of Infectious Diseases at San Francisco General Hospital. Awardees mentor junior investigators, provide on-going clinical care for HIV-positive women and conduct research.

  • ACTG Applies for Competitive Grant

    January 1, 1970 pendari Leadership

    Several members of the AIDS Clinical Trials Group’s Executive Committee joined the Network’s Leadership and Operations Center staff for an intense week-long working session to complete the competitive renewal application.

    The ACTG Network applied for continued funding as a NIAID Clinical Research Network on Therapeutics for HIV/AIDS and HIV-associated Infections in Adults. NIAID is the National Institute for Allergy and Infectious Diseases and it established the ACTG in 1987.

    ACTG Chair Daniel Kuritzkes, MD, Chief of Infectious Diseases at Brigham and Women’s Hospital, worked on the grant at the LOC in Boston along with Network researchers Judith Currier, MD, ACTG Vice Chair and Chief of Infectious Diseases at the University of California Los Angeles; Robert Coombs, MD, PhD, University of Washington and ACTG Director of Laboratory Medicine; and Ian Sanne, MBBCH, FCP (SA), DTM&H, ACTG International Vice Chair and Founder of Right to Care in South Africa. LOC staff including Lauren Robertson, Executive Director; Haley Salinas, Finance Manger; Angela Rhodes, Financial Analyst; Melanie King, Financial Analyst; and Stephen Fetters, Grants Administrator, worked with the ACTG leadership on the application. The competitive grant would secure funding until 2020.

    While in town, Dr. Kuritzkes introduced the group to Barbara Bierer, MD, Senior Vice President for Research at Brigham and Women’s Hospital. Dr. Bierer is responsible for managing the hospital’s research program totaling more than half a billion dollars, as well as overseeing the hospital’s Biomedical Research Institute. The ACTG leadership praised the work being done at the LOC.

    “Lauren’s group is amazing,” Dr. Currier said. “The budget piece of a grant application is usually a fire drill at the end, but her staff are on top of it.”

    The ACTG leadership updated Dr. Bierer on the ACTG’s research priorities, including a specialty tuberculosis site in South Africa, and explained the Network’s laboratory infrastructure.

    “The domestic and international sites’ laboratories are functioning at the same level,” said Dr. Coombs. “The footprint for success is there. Once you have the people and the infrastructure in place, it keeps growing and keeps all of our sites self-sustaining.”

    Overall, Dr. Bierer said she was impressed by how smoothly the Network was running.

    “Usually when a group arrives in my office, it’s not a love fest,” Dr. Bierer joked. “Keep up the great work and stay in touch.”

  • Morag MacLachlan

    January 1, 1970 pendari Leadership

    Morag MacLachlan—the ACTG’s first official communications specialist—wants to make the natural response to the mention of the network “they do good work and I want to be part of it.” This means raising the Network’s profile, communicating its objectives clearly, and associating its name powerfully with its achievements.

    Raising the network’s profile will involve the sustained integration and development of social media, websites, grassroots meetings, private email groups, and personal and professional relationships to gather and distribute articles and videos that show the ACTG’s range, successes and potential. It’s a process that will help the Network’s stakeholders become better connected and better informed about how the group works, how to develop ideas into clinical trials, and why they should consider taking part in clinical trials. It’s a job that will need contributions and support from the ACTG’s members who will provide the stories to tell. And it is a job for someone with media savvy, broad communication and technical skills, and a personal commitment to the mission.

    Morag has all that: she’s a generalist—as comfortable with voice work as with the written word, just as happy editing text as shooting videos— and specializes in health communications. She started out at a TV station in Maine, then worked in print journalism (winning awards in each area, including one for health reporting) before entering health communications at Beth Israel Deaconess Medical Center. Along the way, a story on the problems of treating HIV infection and epilepsy in the same patient in Zambia struck a chord, then a chance conversation pointed her towards the ACTG, and she joined the Brigham and Women’s Hospital and the Network in July.

    Morag is now designing her strategy with very few preconceptions, but a great deal of help. She has met her new colleagues at the recent ACTG Annual Network Meeting. She has received phone numbers that she can call anytime, meaning that ACTG members are adding her to, rather than checking her off, their to-do lists; and heard many new ideas and suggestions that can be incorporated into network communications (advice ranging from how local activists empower the community, to the relative merits of avatars and real name accounts for online communication). So Morag is coming to know some of the talented, dedicated people who will be part of the ACTG’s message; she’d like to meet more of them, since Network communications will be about the entire ACTG—investigators, technicians, staff, analysts, participants, activists—because, as Morag says, “you can’t go wrong if you highlight the whole team.”

  • Dr. Susan L. Koletar

    January 1, 1970 pendari Leadership

    Susan L. Koletar, MD, FACP, FIDSA

    Dr. Koletar is Principal Investigator of the Ohio State University Clinical Trials Unit and Chair of the ACTG Performance Evaluation Committee. She serves on the ACTG Executive Committee and as investigator on several ACTG protocol teams.

    Dr. Koletar is Professor of Internal Medicine and Director of the Division of Infectious Diseases in the Department of Internal Medicine at The Ohio State University. Her clinical interests are infections in immune-compromised hosts, especially HIV-infected patients and transplant recipients. Her research interests are the diagnosis, treatment, and prevention of opportunistic and metabolic complications associated with HIV infection and its related therapies.

  • Tina Brenneman

    January 1, 1970 pendari Leadership

    [Spotlight originally posted August, 2011]

    Tina Brenneman joined SSS as the ACTG Operations Center Director on June 20, 2011.

    Tina has over 20 years of experience in management of federally funded clinical trials and epidemiologic studies.  She played key roles at the George Washington University Biostatistics Center Coordinating Centers for the Diabetes Complications and Control Trial (DCCT) and as a Research Scientist for the Diabetes Prevention Program (DPP), as the National Project Coordinator and Coordinating Center Manager. These programs were both funded by the National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK). The DCCT developed standards of care for insulin-dependent diabetes, and the DPP successfully prevented diabetes in high-risk persons using both lifestyle and drug treatment approaches.

    At Westat in Rockville, Maryland, Tina was a Senior Project Director and Manager of Development for the National Children’s Study Coordinating Center, and she worked with several large development teams.  She also served as the Project Director for private industry clinical trials in infectious disease.

    Tina grew up in Montgomery County, Maryland and returned there after college.  She attended Webster College/University in St. Louis where she obtained a Bachelor’s degree in Anthropology/Sociology and pursued graduate studies at George Washington University.

    Tina happily pursues volunteer work at Great and Small (http://www.greatandsmallride.org), a non-profit community-based program that provides therapeutic horseback riding lessons to persons with a wide range of physical, emotional, and cognitive disabilities. She also assists with rescued horses, where she applies her expertise in training to recondition and retrain rescue horses, including thoroughbreds retired from the track and school horses.

    Tina is excited about her new position and looks forward to meeting and working with everyone throughout the DAIDS-sponsored HIV/AIDS clinical trials networks.