In this informative podcast, Ken Getz, CISCRP’s founder and Board Chair, discusses crucial information on what to expect, where to find, and questions to ask about clinical trials. Hosted by Dr. Michael Roizen, MD on his show “YOU The Owners Manual Podcast”. Access the podcast here.
Ken Getz is the founder of CISCRP and chairs the board of directors. He is also a professor and the Deputy Director at the Center for the Study of Drug Development, Tufts University School of Medicine where he directs sponsored research programs on clinical development design optimization and operating models; CRO and investigative site management practices; and study volunteer trends and policies. Ken is also the founder of CenterWatch, a leading publisher in the clinical trials industry and one of several companies that he has sold. A well-known speaker at conferences, symposia, universities and corporations, Ken has published numerous articles and chapters in peer-review journals, books, and in the trade press. He is the author of two nationally recognized books for patients and their advocates including The Gift of Participation, and the recipient of several awards for innovation and scholarship. Ken has held a number of board appointments in the private and public sectors, including serving on the Institute of Medicine’s Clinical Research Roundtable, the DIA Foundation, the Consortium to Examine Clinical Research Ethics, and the Clinical Trials Transformation Initiative.
Jessica Blaustein is the Director, Marketing and Development for Clarion Healthcare, a boutique life sciences consulting firm based in Boston. In this role, Jessica establishes new business relationships and leads a range of marketing and corporate outreach efforts. Prior to Clarion, Jessica was a Principal with JAMB Associates, where she conducted market assessments and primary market research for biopharmaceutical clients. Earlier, she was Manager of Communications with the Partnership for Organ Donation, a nonprofit organization dedicated to increasing organ donation for transplantation.
In addition, Jessica is the Director of Executive Women’s Programming on the board of the Boston chapter of the Healthcare Businesswomen’s Association, a nonprofit organization dedicated to furthering the advancement and impact of women in the business of healthcare. She received her BA from Harvard College and her MBA from the Harvard Business School.
I’m the Chief Financial Officer and director of Operations at CISCRP. I’m very happy to be a part of this wonderful organization where I work with my team to manage CISCRP’s financial and operating areas. I have more than 25 years of experience as a controller, director and senior executive in a variety of organizations in the health care industry including community health providers; clinical research education and publishing; and medical device and technology services.
I’m passionate about helping patients and their families learn about and find the best treatment options available. I’m also passionate about working with a highly professional group of people who work hard and want to make a difference.
I received a Bachelor’s degree in Accounting from the University of Massachusetts. I reside in the North Shore area of Boston with my husband and two children.
I am the Senior Director, Health Communication at CISCRP. In this role, I’m proud to oversee a team dedicated to helping sponsor companies provide clinical trial results to study volunteers in plain language. I am passionate about providing education to the public so they can make an informed decision as to whether clinical research is right for them. Working at CISCRP affords me the opportunity to engage patients in the continuum of the clinical research process; whether it’s providing education when they are in a physician’s office or receiving a lay summary after they have given the gift of participation by participating in a study.
I received my MBA from Temple University’s Fox School of Business. I reside in Bucks County, PA with my husband, three children, and two dogs.
At CISCRP, I manage the design, implementation, analysis and reporting of a variety of CISCRP research studies. I have more than 15 years of experience conducting primary and secondary research studies in the healthcare, life sciences and consumer goods industries. Prior to CISCRP, I worked at Colgate-Palmolive as a research manager. I hold an MBA from the Graduate School of Management at Boston University and a Bachelor of Science degree from Bryant University. I am passionate about helping others, and CISCRP offers ample opportunities in that regard. People often comment that I am a nice and genuine person. And I think those characteristics help me connect to the patients I interact with regularly through my work. I especially enjoy being involved in bringing patients and clinical operation teams together through the CISCRP Patient Advisory Boards; speaking with each other about ways to make clinical trials a better experience overall is very rewarding for me.
I am responsible for directing CISCRP’s educational and outreach initiatives, including AWARE for All: Clinical Research Education Days, MT Pharmacy and Journey to Better Health mobile experiential pop-ups, Amplifying the Patient Voice and Perceptions & Insights roundtable discussions, Patient Advisory Panels, and the Medical Heroes Appreciation 5K events.
My role offers me the opportunity to connect individuals with resources and empower them to make informed decisions about their health. I am fortunate to collaborate with and develop meaningful educational programs with passionate researchers and advocates from around the world.
I graduated from Brandeis University summa cum laude with a BA in Business, Theater Arts, and Latin American Studies, and I am pursuing my MPH at the Harvard T. H. Chan School of Public Health.
There’s a fundamental gap between researchers and the public. The goal of research is to produce information which fills knowledge gaps. But, often the information research produces is written for an audience who is already well versed in the subject. This results in complex data that is inaccessible to much of the public, even if the information is publicly available. Bridging that gap and translating complex information into something the public can understand is essential as we strive to be a more educated society.
Now, if you read that and understand it- keep in mind that it was written like a scientific abstract, that you can at least read at an 11th grade level, and you’re able to read something that scores incredibly low for general ease of reading. To make that paragraph more accessible, we can simply say this: information is not useful if you cannot understand it.
In my work as a Psychometrist, I recognized the desire of my patients to be more informed about their conditions and treatment plans, but also recognized the frustration at the lack of useful information. As a Sociologist, I recognized that despite our best efforts to produce information, it still wasn’t accessible to the public. My goal is to take these experiences, work as a bridge, and produce useful, understandable information. If we bridge the gap, we can create a more informed, more aware population who is equipped to be a more active part of their own medical journey.
After eleven years in the publishing industry, I joined CISCRP in June 2016.
It’s exciting to work with the Health Communication team to deliver lay language summaries into the hands of those most deserving – the actual clinical trial participants. CISCRP provides an important bridge between volunteers and researchers, facilitating transparency and awareness. I believe empowerment through knowledge benefits everyone.
I hold a BA in Communications from Clark University and live in the suburbs of Boston with my wife and two sons.
Prior to joining CISCRP, I spent ten years working as a contracts manager at various oncology research companies in the Boston area, most recently at BeiGene. I landed in the industry by chance, after studying English and Law at UMass. Clinical contract management provided an opportunity to meld those two interests, and to be part of several different teams working toward a common goal: to help patients. For the past decade, I’ve concentrated primarily on the legal documentation and processes essential to get clinical trials up and running. I’m excited now to transition to the Health Communication group, where my focus will be on a different aspect: delivering lay language summaries to patients once the trial is complete. I’m delighted to be part of an organization committed to patient communication and engagement. I believe in the efforts CISCRP is making to ensure that all stakeholders in the clinical research process have a voice.”
I hold a master’s degree from Teachers College, Columbia University, and bring over 12 years of project and program management experience in several industries including consumer electronics and educational publishing to CISCRP. Having participated in 3 clinical trials myself has provided a firsthand experience in what patients go through throughout the process – from hard to understand informed consent forms, to lack of engagement with the study team post participation. CISCRP’s mission to change this dynamic resonated with me and I am excited to be a part of the team.
When not in the office I volunteer most of my free time as an advocate in the diabetes community and running educational programs for adults with type 1 diabetes.
I am a graduate of the University of Massachusetts, Amherst with a BA in Psychology and Economics. As an undergrad, I was involved with multiple non-profits including interning at CISCRP. After graduating, I have been fortunate enough to be brought back on to work with the Health Communication program, which allows me to help ensure that patients get the results of trials they participated in. As a Project Manager, I get to learn a lot about the industry and provide an important service for patients!
During six years of clinical trial management for a contract research organization, I gained experience in the research process but struggled to find an area where I felt impactful. I wondered how I could contribute to the industry’s effort to engage patients in their health care. Joining CISCRP has provided me the opportunity to link my project management skill set with my passion for healthcare. I am proud to be a part of the Health Communication team, building a bridge between the scientific language of a researcher and non-specialist audience.
I am a graduate of Muhlenberg College with a BA in Economics and Business Administration with a concentration in management. At school I spent time interning with the Allentown Economic Development Corporation and as a peer tutor for economics, business, and statistics courses. After graduation I spent time working as an adviser for my youth group and as a Webmaster at Dart Sales. After a few months I was hired at CISCRP as a part of the Health Communication Program. Being a part of this team allows me to ensure that anyone who participates in a clinical trial receives the results of their clinical trial. As an assistant project manager I am looking forward to creating a positive experience for those who participate in clinical trials.
I started working at CISCRP as the Communicating Trial Results Intern in my final semester of the Masters in Public Health program at Boston University, where I focused on Epidemiology and Maternal and Child Health. Before this, I studied Neuroscience and Hispanic Studies at Dartmouth College, where I earned my BA.
After earning my MPH at BU in December 2017, I started working at CISCRP full-time and I have been thrilled to be a part of the team! I love getting to work here because I truly believe in the importance of the work we do to increase transparency and encourage participation in clinical trials.
I joined CISCRP In March of 2019 as the Editorial Panel and Quality Associate. I received my BS in Public Health from the University of Rhode Island. Prior to joining CISCRP, I most recently worked as a Surgical Inventory Specialist developing and complying to Operating Room processes. In addition to this, I spent the last 5 years working in infectious disease counseling and crisis intervention treatment and development.
I am thrilled to be a part of the CISCRP team! Day after day in a hospital setting, I would witness the conversational jargon between Patients and Healthcare Professionals. This gap in communication and understanding is too frequently overlooked in healthcare settings. With CISCRP I can apply my knowledge and experience to fulfill my passion, which is simply making a difference in healthcare.
Before coming to CISCRP, I worked in public health with maternal and child populations for over five years. I have always been passionate about helping others which is why I feel the Research Services Project Manager position is such a great fit for me.
My job allows me the opportunity to interact with patients regularly and convey their experiences to the organizations conducting clinical trials. I believe that seeking out the patient experience and perspective is critical as it helps ensure that the future of clinical research continually evolves and improves.
I’m thrilled to be a part of a fantastic team of people who all have the same goal of engaging patients as partners in the clinical research process. I hold a Bachelor’s of Science in Nutrition from Framingham State University and reside in Boston.
I hold a Bachelor of Arts in Business Marketing from the Isenberg School of Management at UMASS Amherst. Just prior to joining the CISCRP team, I spent three years working as the Assistant Director of Marketing and Outreach at the North American Thrombosis Forum – a healthcare non-profit founded by cardiologists at Brigham and Women’s Hospital to spread awareness and preventative education about blood clots. At the organization, I utilized my marketing knowledge to promote educational events, expand patient programs, manage online communications, and strengthen the overall brand strategy. I also discovered my passion for healthcare and patient advocacy. I am thrilled at the opportunity to come aboard such a wonderful and collaborative team of individuals at CISCRP and contribute my marketing expertise to further CISCRP’s mission.
Joan develops and executes strategic marketing, promotional and outreach campaigns to support CISCRPs mission of raising awareness and understanding about clinical research and the important role it plays in public health. Additionally, directs, plans, launches new initiatives for new growth opportunities.
A well-known speaker at industry conferences, Joan has presented on a wide variety of topics specific to the clinical trials enterprise. Joan is on the Board of Directors for Greater Gift, the US PharmaTimes Steering Committee for CROY, Steering Committee for Pharma Intelligence/ Informa Clinical & Research Excellence Awards (CARE), Steering Committee for PopUp Star and is an active member of the Association of Clinical Research Professionals (ACRP) and the Drug Information Association (DIA). Joan was on the Advisory Board for The Center for Information and Study on Clinical Research Participation (CISCRP) for over 10 years. In the course of her career, she has published in clinical trade journals and was an instructor for Barnett International’s CRA/CRC programs on the site identification/qualification process.
Accomplished and performance-driven marketing and operations executive with 20+ years of experience in the health life sciences with a successful track record in marketing and strategic planning, implementation, guidance and direction to companies and professionals. Ability to lead, motivate, mentor and establish strong relationships at all levels internally and externally. Strong professional networking and presentation skills among a wide range of industry business professionals.
Joan was formerly COO at CenterWatch. Her career included roles at ClinX, SCORR Marketing, CHI, Tufts CSDD and PAREXEL. Joan holds a B.S. in Marketing.
Scott has more than 20 years of marketing experience in the life sciences and technology sectors. At AES, Scott is responsible for company strategy, market intelligence, product management, creative services delivery, and the development and execution of all corporate marketing initiatives.
Prior to AES, Scott was director of marketing at Liquent (now a Parexel subsidiary), the leading provider of regulatory submission software and services for the biopharmaceutical industry. Before Liquent, Scott held a variety of marketing and web-based technology positions with SCT (now Ellucian), a developer of administrative software and outsourcing services to the higher education, local government, public utility, and process manufacturing industries.
Scott graduated summa cum laude from the S.I. Newhouse School of Public Communications at Syracuse University with a B.S. in Advertising and English.
With over 20 years of clinical research experience, Almenia Garvey, Director of Health Care Alliances at ICON, is a strong leader and proven relationship builder. Almenia is a site relations expert who specializes in minority recruitment, site selection strategy, investigator identification and investigator relationship management. ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries.
Mark Lacy is founder and CEO of Benchmark Research – a growing and dynamic firm with a network of quality investigative research sites throughout the United States. Mr. Lacy’s active participation with the Association of Clinical Research Professionals (ACRP) has encompassed serving as Chair of the Site Manager’s Forum, Chair of the Finance Committee, being elected to the Board of Trustees; and in 2005 being honored as a recipient of the Meritorious Service Award. Mr. Lacy also serves on the Board of Advisors for The Center for Information & Study on Clinical Research Participation (CISCRP), and as a member of the Executive Committee for the PharmaTimes U.S. Clinical Researcher of the Year competition.
In 2010, Mr. Lacy was selected by Entrepreneur Magazine as one of the top four “Established Entrepreneurs” for his success in growing Benchmark Research, and was recognized in 2011 by PharmaVoice as one of the 100 most Inspiring People. This entrepreneurial approach has extended into his formation of VaxCorps, a nationally prominent research network focusing on vaccines, of which he is the CEO. He is also emerging as a leader in real estate development in Texas with office buildings in Austin and ocean front resort properties on the Texas coast.
Prior to founding Benchmark Research, Mr. Lacy earned a B.A. degree from The University of Texas at Austin (Plan II Program, Summa Cum Laude); and held several prominent positions in state and national politics, including service under a Presidential Administration.
Brian has extensive experience in the pharmaceutical, biotechnology, chemical, research, education, and medical device markets. His over 25 years of experience has taken compounds and devices from pre-clinical to market. Prior to joining MedEvoke he spent his early career with Baxter Lifesciences, ThermoFisher Scientific, Atcor Medical, and the Artcraft Health organizations. His knowledge base and experience is extensive and has supported hundreds of global and domestic clients.
Brian graduated from the University of Maryland, College Park, with a Bachelor of Arts in economics and a minor in finance. He is certified in the principles of Good Clinical Practice developed by the International Conference on Harmonization. Brian has also completed numerous business courses and is a Lean Six Sigma Black Belt Champion.
Outside of work, Brian believes strongly in community service. He belongs to and holds leadership positions in local planning, and school boards. He and his wife of 26 years share a common belief that it’s important to be an active member and give back to their community.
Bonnie Segal is the Vice President and Co-Founder of Segal Trials, a consortium of research sites specializing in Psychiatry, Neurology, Addiction, Women’s Health and General Medicine.
Bonnie has been in medical research for 21 years and has been involved in every area of Segal Trials’ expansion and diversification. She leads the business development, operations and recruitment teams, as well as the company’s community advocacy initiatives, staff engagement and staff leadership programs. Bonnie has been a crucial part of the success of over 1,100 clinical trials conducted at seven research sites throughout South Florida and South Carolina, including the most recent development of a newly opened and privately owned 8,200 square foot inpatient and outpatient facility.
Bonnie began her healthcare career in 1993 founding Positive Aging, a company specializing in psychiatric services for individuals residing in long term care facilities. After the sale of Positive Aging, she started and sold another healthcare company, Essentials in Psychology before co-founding Segal Trials in 1998. Bonnie has a Bachelor of Science in Advertising from the University of Florida. Currently, Bonnie is on the CISCRP (The Center for Information and Study on Clinical Research Participation) Advisory Board, CNS Summit Leadership Council, and the Bracket Site Advisory Board, and is on the Board of Directors for NAMI Broward County.
Jeffrey (Jeff) W. Sherman, MD, FACP, is Chief Medical Officer and Executive Vice President at Horizon Pharma based in Lake Forest, Illinois. Jeff has more than 25 years of experience in the pharmaceutical industry at IDM Pharma, Takeda Global Research and Development, NeoPharm, Searle/Pharmacia, and Squibb/Bristol-Myers Squibb. He also serves on the Board of Directors of Strongbridge Biopharma and Xeris Pharmaceuticals.
Jeff received his bachelor degree in biology from Lake Forest College and medical degree from the Rosalind Franklin University of Medicine and Science/The Chicago Medical School. He completed an internship and residency in internal medicine at Northwestern University, where he also served as a chief medical resident. Additionally, he completed fellowship training in infectious diseases at the University of California-San Francisco (UCSF) and was a research associate at the Howard Hughes Medical Institute at UCSF in allergy and immunology. Jeff is an Adjunct Assistant Professor of Medicine at the Northwestern University Feinberg School of Medicine and a member of a number of professional societies as well as a Diplomat of the National Board of Medical Examiners and the American Board of Internal Medicine. Jeff also serves on the Rosalind Franklin University of Medicine and Science College of Pharmacy Advisory Board.
Jeff is a past president of the Drug Information Association (DIA) and a former member of the Board of Directors. He also was chairperson of the DIA Annual Meeting, received an Outstanding Service Award, is an inaugural fellow, and serves as the DIA liaison to the FDA Clinical Trial Transformation Initiative (CTTI) Steering Committee. Jeff in addition serves on the Board of Advisors of the Center for Information and Study on Clinical Research Participation (CISCRP). He is also a member of the Global Genes Medical and Scientific Advisory Board and involved through Horizon Pharma with the National Organization for Rare Diseases (NORD) and the European Organization for Rare Diseases (EURORDIS).
Michael Stadler is a Co-Founder and President of CLARINESS, providing executive leadership and strategic direction to the company and its subsidiaries. He brings more than 20 years of experience in launching and strategic management of organizations across consumer and business-to-business industries.
Prior to co-founding CLARINESS in 2005, Michael was Managing Director for Deltavista in Germany, a provider of risk management software and services, where he developed the business plan and market entry strategy. Michael and his team successfully implemented the strategy, grew and established the company as a key presence in the risk management services industry.
Before joining Deltavista, Michael assisted in the launch of the German affiliate of one of Europe’s largest online supermarkets, and served as the Chief Financial Officer. There, he oversaw finance, human resource and purchasing functions.
Earlier roles included positions of increasing responsibility, from Business Controller to Chief Financial Officer at Tele2, an international telecommunications company. He began his career in the controlling department of Procter & Gamble, holding various financial analysis positions.
Mr. Stadler earned a degree in finance & accounting from the University of St. Gallen in Switzerland.
Manfred is the head of the LG Chem Life Sciences Innovation Center in Cambridge, leading and managing the scientific team, overseeing the projects, driving open innovation and the transition of programs to the clinic and beyond.
Manfred is a physician and brings over 30 years of experience in clinical medicine and all aspects of drug development, e.g. in clinical development, quality management, medical and regulatory affairs, clinical and observational studies.
Prior to joining LG Chem Life Sciences, he held several leadership positions in global R&D with pharmaceutical companies including Merck & Co, Forest Laboratories (now Allergan) and he was Chief Medical Officer at TriNetX. Some innovative milestones in Manfred’s career were the introduction of electronic data capture, operational trial simulation, and most recently the substitution of clinical trials by the use of electronic medical records. He started his medical career as a practicing physician in the Institute of Air and Space Medicine of the German Airforce and in the Policlinic for Internal Medicine of the University of Munich.
Manfred received his MD and PhD from Ludwig Maximilian University of Munich, Germany, and a Clinical Pharmacology license from the Bavarian Physicians Chamber. His publication list includes abstracts, papers, and books in cardiovascular medicine, drug development, project management and observational studies.
Before joining CISCRP, I worked as a seasonal, part-time employee for 2 consecutive summers at The Transportation’s Children Center in Boston. I started as a volunteer at TCC in 2014, helping in toddler and pre-school classrooms because of my love for children. After receiving my Bachelor’s of Social Work degree from Elms College in May 2018, I continued working as a full-time teacher’s assistant in the toddler classroom. In November 2018, I transitioned to the newly opened infant room as an EEC certified infant/toddler teacher where I enjoyed spending time with infants in my care and connecting with team members and families.
In the past, I’ve enjoyed my role as a residential counselor for Behavioral Health Network in the Crisis Behavioral Acute Treatment program helping adolescents with behavioral and mental health issues transition back into the community. I also enjoyed interning at the Court Service Center in Springfield, MA, assisting litigants who could not afford lawyers. I am passionate about serving and creating positive change in underrepresented communities. I believe in dignity, respect, fair and equal access to resources and necessities as basic human rights.
I am so excited to learn from a variety of patient experiences, and to help educate communities about the importance of clinical research trials through my career at CISCRP!
I graduated with my master’s in medical anthropology from Boston University School of Medicine in 2016. Prior to starting at CISCRP, I worked on research studies focused on patient experiences with health care. Most recently, I worked on several projects related to substance use and people living with HIV. I am incredibly passionate about working with vulnerable populations and increasing access to care for patients through research. As Project Manager in Research Services, I am excited to connect with new patient groups and make research more approachable for vulnerable populations.
I joined the CISCRP team in September of 2019 as an associate project manager. I received my BS in Public Health at the University of Rhode Island. After receiving my degree and prior to working at CISCRP I was the co-founder of a non-profit called FastTrek.org that aims to quickly connect patients to clinical trials. I was also a public health peace corps volunteer serving in Guinea, West Africa, where I worked on malaria and maternal health care initiatives.
I’m excited to work at CISCRP because my position allows me to help bridge the gap between patients and clinical trial research. Working in the health communications department has allowed me to make sure patients whom have participated in clinical research are recognized as the true medical heroes they are. Currently I reside in Rhode Island and plan to continue my education in pursuit of my MPH.
I’m a current MPH student and graduate of Penn State University. My background has a heavy emphasis on research, especially in the field of neuroscience. I graduated from Penn State with an honors degree in neuroscience, with minors in psychology and German. After graduation, I traveled to England and later explored career options in the field of neuro-law, looking for a career that would allow me to combine my dual passions for science and advocacy. Ultimately, I returned to my research roots, accepting a place at Tufts University’s MPH program and taking on a research assistant role at the Tufts Center for the Study of Drug Development. My career path has now led me here, to CISCRP. I’m very excited to be joining an organization with such strong integrity and sense of purpose, and I’m looking forward to bringing my research skills to this setting and using them to make a difference.
