Speaker Biographies

Budgeting & Outsourcing

Data & Technology

Engagement & Enrollment

Feasibility & Site Selection

Risk-Based Monitoring

Interactive Roundtable Breakout Discussions


Budgeting & Outsourcing

Debora Araujo, Founder & CEO, ClinBiz
Débora S. Araujo has over a decade of experience in the pharmaceutical industry working and consulting for Fortune 500 companies. During her time in this industry her special focus has been on the business aspects of clinical trials including: clinical contracting and financial management, clinical outsourcing and CRO/vendor management, global clinical trial budgeting and forecasting, clinical financial analytics and metrics/KPIs, site budget development and negotiations, Fair Market Value (FMV) and global investigator site payments. She has also utilized her expertise and knowledge to drive practical change in this industry via thought leadership material, conference presentations and consulting engagements. Débora’s passion for driving practical change in the industry led her to launch ClinBiz (www.clinbiz.com), an online platform with a dedicated YouTube channel, podcast, blog and much more where clinical research professionals can stay connected and updated on the latest topics, trends and technologies related to the business aspects of clinical trials. Débora has also recently published a book on clinical trial agreement negotiations named ‘The Four Villains of Clinical Trial Agreement Delays and How To Defeat Them’ which quickly became an Amazon’s #1 New Release in the pharmaceutical and biotechnology category.

Chuck Bradley, Vice President, Clinical Development, FibroGen, Inc.
Charles Bradley is VP Clinical Development and Head of Clinical Operations at FibroGen Inc. located in San Francisco, CA. Dr. Bradley is an experienced clinical research professional with an in-depth background in all phases of drug development. He is a seasoned senior manager with knowledge of resource allocation, portfolio management, budgetary processes, outsourcing strategies, and regulatory requirements associated with drug development. He has expertise in driving clinical programs forward in entrepreneurial environments, smaller biotech companies, and large traditional pharmaceutical companies. Chuck received his Ph.D. in bioanalytical chemistry from the University of Delaware, received post-doctoral training in Clinical Pharmacology at Uniformed Services University, and is Board Certified in Applied Pharmacology.

Marina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine
Marina Malikova, PhD, MSci, MA, CCRA, RAC Executive Director, Surgical Translational Research: Operations and Compliance. Dr. Malikova has over 14 years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology. Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She has a strong background in biomedical sciences and has completed her postdoctoral fellowship in the field of cell signaling and cell migration. She also holds a Master’s Degree in Clinical Investigation, Certification in Project Management from Boston University and board certified in Regulatory Affairs (RAC). In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, strategic planning, and macro-management of research programs. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance. Dr. Malikova has 12 years of teaching experience as an Instructor for Clinical and Biomedical Sciences Program, Metropolitan College. She has developed and taught several courses such as: Design and Conduct of Clinical Trials, Drug Development, Introductory Pharmacology, Clinical Trials Management at Boston University, School of Medicine. She also serves as an Instructor of the Good Clinical Practices (GCPs) course for the Master of Science Program in Clinical Investigation, Division of Graduate Medical Sciences, Boston University, School of Medicine. Dr. Malikova is a member of Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Affairs Professionals Society (RAPS) and European Society of Radiology (ESR).

Cameron McClure, PMP, PMI-ACP, CSM, CCRP, Senior Manager, Clinical Business Operations, BeiGene
Cameron McClure is a California native and Senior Manager of Clinical Business Operations at BeiGene, Ltd. He is a certified Project Management Professional with a demonstrated history of working in the pharmaceutical and higher education industry. He finished his Bachelor’s Degree in Communication from California State University, Fresno and is currently pursuing his Master of Science Degree in Clinical Research Management (Regulatory Affairs) from Arizona State University. Outside of work, he enjoys music, fitness, fatherhood, and spending time with family and friends.

Scott Sawicki, R&D Sourcing Consultant, Adare Pharmaceuticals
Scott Sawicki is an R&D Sourcing Consultant at Adare Pharmaceuticals. He has over 25 year’s career experience having predominantly worked in senior positions for large multi-national corporations, mostly as a R&D Sourcing professional. His varied industry experience with both sponsors and CROs includes R&D Sourcing, Supplier Relationship Management and Business Development, with sponsor companies Adare Pharmaceuticals, Novartis Pharmaceuticals, Aventis, and CROs Syneos Health and Covance. In 2018, Scott joined Adare Pharmaceuticals as an R&D Sourcing consultant, leading Adare’s R&D team in selecting, negotiating, contracting and providing business oversight and strategic insights of CROs and other suppliers in support of Adare R&D efforts, including Medical Affairs.

Mai Nguyen, MPH, Senior Consultant, The Avoca Group
No Bio Available

Data & Technology

Jay Bergeron, Director, Pfizer Digital, Pfizer
Jay Bergeron is Director, Digital Client Partner for Early Clinic Development and Integrative Biology at Pfizer. He served as the Scientific Coordinator of IMI-eTRIKS, a $30M Public Private Partnership for building open source translation research information management systems.

DonBerry, PhD, Professor, Biostatistics, University of Texas M.D. Anderson Cancer Center
Donald Berry is Founder of Berry Consultants, LLC, and a professor in the Department of Biostatistics of the University of Texas M.D. Anderson Cancer Center. He was founding Chair of this department in 1999. Dr. Berry received his PhD in statistics from Yale University, and previously served on the faculty at the University of Minnesota and at Duke University. He has held endowed faculty positions at Duke University and M.D. Anderson. Dr. Berry is a well-known developer of statistical theory and methodology. He has designed and supervised the conduct of hundreds of innovative clinical trials, including Bayesian adaptive trials in cancer and other diseases. He is a Fellow of the American Statistical Association, the Institute of Mathematical Statistics, and the International Society of Bayesian Analysis.

MattDe Silva, Founder and CEO, Notable
Matt De Silva’s connection to Notable is an especially personal one. He founded the company in 2014 to give his father a fighting chance against brain cancer. Adopting precision medicine from the beginning, Notable went on to develop a clinically-validated platform to rapidly identify and advance cancer therapeutics at a fraction of the traditional time and cost. Previously Matt served as a portfolio manager and trader at Clarium Capital, a global macro hedge fund. Matt started his career on a foreign exchange and interest rate sales and trading desk at Bank of America Merrill Lynch. Matt received his BA magna cum laude in Applied Economics and Management from Cornell University.

Eric Gildenhuys, Vice President, Business Development, Deep 6 AI
Eric is responsible for developing and executing on the sales strategy for Life Sciences, Pharma, CROs, and Partnerships for Deep 6 AI. Eric has 25 years’ experience helping companies improve their revenue streams. He began his career by co-founding and selling a software company to Optio Software, helping guide Optio to a successful IPO by expanding into the healthcare market and launching its European headquarters. For the last 14 years, Eric has been helping software and professional services firms such as PwC all over the world in shifting the paradigm of their business development culture, resulting in new contracts worth $100+ million.

JudithKornfeld, Chief Business and Operations Officer, ORCATECH, Oregon Health and Sciences University
Judith Kornfeld, MBA, is the Chief Business and Operations Officer of ORCATECH. Through building worldwide strategic collaborations and alliances while positioning Intellectual Property assets and leveraging products in development, Ms. Kornfeld specializes in bringing innovative medical technologies to prosper in the medical industry. Prior to joining ORCATECH she assumed executive business development positions of emerging medical technological companies in the specialty pharmaceuticals and medical device industries. Recently, Ms. Kornfeld held the position VP of Business Development of TransPharma Medical, a company focused on developing pharmaceutical products based on breakthrough proprietary transdermal drug-delivery technology. Ms. Kornfeld holds a bachelor's degree in life sciences and an MBA, as well as an academic background in electrical engineering.

Jake LaPorte, Co-Founder & Global Head of the Novartis Biome, Novartis
Jake LaPorte, PhD, is Global Head of Digital Development at Novartis and responsible for leading the company’s digital efforts within their Global Drug Development organization. Jake began his career at McKinsey & Company, where he was a leader in their Pharmaceutical R&D practice, during his six-year tenure, developing an expertise in large, complex transformations and innovation. It was on a fateful, extended journey in Asia-Pacific, however, where Jake read Ray Kurzweil’s The Singulatiry is Near and became captivated by the possibility of digitalizing the Pharmaceutical R&D engine – he has focused his career to the realization of this concept ever since. He co-founded Snapdragon Chemistry, with the Head of the Chemistry Department at MIT, which seeks to enable companies to implement continuous flow chemistry in discovery, development and manufacturing, with the ultimate goal of fully digitalizing chemical synthesis. Most recently, Jake has held various leadership positions at PPD, Inc., where he collaborated with executives to develop and implement C-level, strategic initiatives, including a long-term transformation to create industry-leading approaches to clinical development in key therapeutic areas. Jake completed his Ph.D. in Organic Chemistry from Harvard University, where he was an HHMI doctoral fellow, and received his B.Sc. in Biochemistry and Mathematics, summa cum laude, from the University of Delaware.

Ijah Mondesire-Crump, MD, Research Director, nQ Medical Inc
Physician scientist conducting and supporting cutting-edge research (basic and clinical) in the fields of oncology, immunology and neurology. Established record leading translational research at a world-renown oncologic clinical research organization. Significant experience conducting clinical trial recruitment and consenting. Dedicated to exceeding performance benchmarks. Passionate and knowledgeable about health policy and design, and dedicated to driving more effective, system-wide healthcare management, research, pharmacologic therapeutics and biotechnologies.

Engagement & Enrollment

Jonathan Andrus, Chief Business Officer, Clinical Ink
"As Chief Business Officer, Jonathan Andrus leads Clinical Ink’s solution management and compliance teams to help sponsors and CROs better leverage eSource, eCOA and ePRO data. With more than twenty years of experience, Mr. Andrus brings extensive expertise developing eClinical services that integrate data and technology to help life science companies optimize study execution. At Clinical Ink, Mr. Andrus is responsible for P&L across Clinical Ink’s products and services, and he is also focused on building relationships and forging strategic partnerships with sponsors, CROs, regulatory bodies and clinical research professionals. Mr. Andrus joined Clinical Ink from BioClinica where he led the eClinical Solutions Group to develop their current service offerings, including data management, quality management, implementation services and IWRS. Prior to BioClinica, Mr. Andrus worked in pharmaceutical consulting and with CROs focused on quality, data management and validation. An active thought leader, blogger and presenter, Jonathan served as chair of the Society for Clinical Data Management (SCDM) in 2008 and 2013 and currently serves as the society’s Treasurer. He is also an active member of DIA (North American Advisory Council and Annual Conference Data/Data Standards Track Chair) and ASQ. He earned his bachelor’s and master’s degrees from Temple University’s College of Liberal Arts and Graduate School of Pharmacy and is a Certified Quality Auditor (CQA) and Certified Clinical Data Manager (CCDM®).

Bonnie Brescia, Founding Principal, BBK Worldwide
Bonnie A. Brescia is a founding principal of BBK Worldwide, and a leader in patient recruitment and engagement for more than 35 years. Widely recognized for helping to shape the recruitment discipline and a preeminent voice for patient centricity, her insights regarding the global clinical research community inform the industry and help fuel BBK’s leadership, innovation and global expansion. She leads the company’s involvement in its efforts dedicated to global excellence in clinical research, and was recently honored by the Boston Globe Magazine with a Top 100 Women-led Business award. Bonnie speaks at several industry events and conferences each year, and has conducted many forums on strategies for clinical trial marketing to diverse audiences. She is frequently quoted in the media on a broad range of industry topics including patient centricity and mHealth and was named to the PharmaVOICE 100 for her leadership. A mother of two daughters and mentor to many young professionals, Bonnie is committed to equal opportunities for diverse perspectives in business and community life.

Richard Brescia, Clinical Trial Participant
Richard spent his career in broadcasting. In June 2016, he was diagnosed with an advanced and aggressive head and neck cancer. After interviewing several specialists working in research hospitals in New York and Connecticut, he and his family began their treatment journey with a team of physicians and surgeons at the Smilow Cancer Center of Yale University Hospital. Nearly three years later, Richard has participated in three clinical trials — including interventional and pharmacokinetic studies.

Joan Chambers, Senior Director, Marketing & Outreach, CISCRP
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.

Cathy Critchlow, PhD, Vice President, Center for Observational Research, Amgen, Inc.
As Head of the Center for Observational Research (CfOR), Dr. Critchlow provides operational and strategic leadership for the design and conduct of observational research within Amgen. The CfOR Real World Data (RWD) Platform provides widespread access to patient health data and visualization and analytic tools based on innovative technologies to aid teams in the generation of rea- world evidence in support of Amgen products. Prior to joining Amgen in 2004, Dr. Critchlow was a faculty member in Epidemiology at the University of Washington. Dr. Critchlow earned her bachelor’s degree from Stanford University, and both her master’s degree in biomathematics and her doctorate degree in epidemiology from the University of Washington.

Emma D’Agostino, CF Patient, Patient Advocate, Member of FDA Review Committee, Patient Advocate
Ms. D'Agostino was diagnosed with cystic fibrosis at birth. She graduated from the University of North Carolina at Chapel Hill with degrees in biology and chemistry (Go Heels!) and is pursuing her doctorate in biochemistry at Emory University in her hometown of Atlanta. Ms. D'Agostino is a member of the Data Safety Monitoring Board and co-chair of the Research Summary Review Committee at the Cystic Fibrosis Foundation, as well as the consumer representative for the Pulmonary-Allergy Drugs Advisory Committee at the FDA.

Annick de Bruin, MBA, Director, Research Services, Center for Information & Study on Clinical Research Participation (CISCRP)
Annick de Bruin is the Director of Research Services at CISCRP. She is responsible for the design, implementation, analysis and reporting of a variety of CISCRP research studies including the Perceptions & Insights studies and numerous Patient Advisory Boards. She has more than 20 years of experience conducting primary and secondary research studies in the healthcare, life sciences and consumer goods industries. She holds an MBA from the Graduate School of Management at Boston University and a Bachelor of Science degree from Bryant University.

Rose Gerber, Director, Patient Advocacy and Education & 3x clinical trial participant, Community Oncology Alliance (COA)
Rose Gerber is a nationally recognized cancer advocate and cancer survivor. Her experience includes appearing on national television (MSNBC) to speak about cancer care, meeting with legislators in Washington, DC on cancer policy issues, and developing cancer programs. Rose was brought to the COA team to develop its patient advocacy program. One of her first accomplishments was to add an advocacy track to the annual conference, making the meeting one of the few that brings together physicians, administrators, and advocates. She serves as an invited member on national patient advocate panels, steering committees, and cancer coalitions. Rose has also served as a consumer reviewer on the Congressionally Directed Medical Research Programs – Department of Defense Breast Cancer research panels.

Phyllis Kaplan, Trial Volunteer and Patient Advocate; Senior Project Manager, Health Communication Services, Center for Information & Study on Clinical Research Participation (CISCRP)
Phyllis Kaplan is a Senior Project Manager on the Health Communication Services team at CISCRP, focusing on plain language summaries of clinical trial results. When not in the office, she volunteers most of her time as an advocate in the diabetes community and running educational programs for adults with type 1 diabetes. She holds a Master’s degree from Teachers College, Columbia University, and a Bachelor of Science degree from Long Island University.

Michael Keens, Chief Operating Officer, Firma Clinical
Michael Keens serves as the Chief Operating Officer for Firma Clinical Research, a niche service provider specializing in data analytics and clinical home care for clinical trials. In his role as COO, Mike specifically oversees Firma’s Clinical Home Care services, working with Sponsors to implement home nursing services in clinical trials to reduce patient burden in clinical trials and facilitate “bringing the trial to the patient.” Additionally, Mike leads Firma’s partnership efforts with Patient Advocacy organizations of all size (e.g., Alzheimer’s Association, National MS Society, Scleroderma Foundation, etc.), facilitating the introduction of these organizations to Pharmaceutical companies, and increasing their involvement within clinical trials to enhance patient benefit. Mike earned his B.S.in Biology/Psychology (double-major) from James Madison University, and his M.S. in Health Evaluation Sciences from The University of Virginia. An accomplished clinical trials professional with over 20 years of experience across multiple healthcare and drug development organizations, Mike has proven success in clinical operations, project management, business development and executive leadership.

Mary Jo Lamberti, PhD, Associate Director and Research Assistant Professor, Tufts Center for the Study of Drug Development (CSDD)
Dr. Mary Jo Lamberti manages multi-sponsored and grant funded research projects at Tufts CSDD. She has extensive experience conducting market research on pharmaceutical industry practices and trends affecting contract research organizations and investigative sites. She has been a speaker at conferences and has published articles in trade and peer-reviewed journals. Prior to joining Tufts CSDD, Dr. Lamberti was director of market research at CenterWatch. She has also worked on federally funded research studies in science education reform. Dr. Lamberti holds a BA from Wellesley College and a PhD in psychology from Boston University.

Angela Lee, Associate Director, Data Management, Otsuka
Ms. Lee has been working in clinical data management for 19 years. She is currently the Associate Director of Data Management at OTSUKA Pharmaceuticals. She earned her BS in Biology from Yale University and continued her studies at Yale School of Epidemiology and Public Health, where she earned her MPH. She spent over a decade working at CROs where she managed and streamlined processes and systems, including a global harmonization of SOPs. At Otsuka, Ms. Lee has been integral at managing and scaling up the ePlatform model for clinical data operations, working on processes integrating eConsent, IRT and eSource.

Christina Roman, MPH, Senior Manager of Community Engagement, Community Partnerships, Cystic Fibrosis Foundation
Christina Román is the Sr. Manager of Community Engagement at the Cystic Fibrosis Foundation in Bethesda, MD. In this role, she works on a range of projects at CFF which include managing patient engagement activities across the Foundation. Her work includes overseeing the community groups who contribute to CF research and care initiatives, insights research in the CF Community and overseeing the development of tools to help improve patient engagement. Christina earned her Masters in Public Health in 2013 from the University of Colorado, Denver.

Hollie Schmidt, Vice President, Scientific Operations, Accelerated Cure Project for MS
Hollie Schmidt is the Vice President of Scientific Operations at Accelerated Cure Project for Multiple Sclerosis. She co-chairs the Research Committee of iConquerMS, a participatory research network for MS established to perform and support patient-centered research in MS. In this role she works to promote patient engagement throughout the research process and to develop research collaborations on topics of interest to people with MS. She founded and leads the MS Minority Research Engagement Partnership Network, a multi-stakeholder initiative aimed at promoting racial and ethnic diversity in MS research studies. Before joining Accelerated Cure Project, Ms. Schmidt's endeavors included co-founding a management consulting firm and two software companies. Ms. Schmidt has an MS in Management, as well as a BS and MS in Materials Science and Engineering, all from the Massachusetts Institute of Technology. She also serves on the Institutional Review Board of Beth Israel Deaconess Medical Center and is Secretary for the Multiple Sclerosis Coalition.

Leah Szumita, MSN, Associate Director, Nursing, Clinical Trial Support Center, The Leukemia & Lymphoma Society, Beat AML/LLS
In her role as Associate Director of Nursing in the Clinical Trial Support Center, Leah Szumita supports The Leukemia & Lymphoma Society’s (LLS) efforts to educate and support patients and caregivers affected by blood cancers. Through education, advocacy, coaching and decision-support services, Szumita and the team of nurses help patients and their caregivers navigate the process of identifying and participating in clinical trials, and provide support through the continuum of their treatment and care. Prior to joining LLS, Szumita was staff nurse in the Medical Intensive Care Unit at Brigham and Women’s Hospital in Boston, MA where she later became a Clinical Nurse Specialist and Clinical Nurse Educator. Szumita is certified as an Adult Health Critical Care Clinical Nurse Specialist, Critical Care RN and gerontology RN. She graduated from Saint Anselm College with a Bachelor of Science in Nursing and obtained her Master of Science in Nursing at the University of Massachusetts Boston.

Feasibility & Site Selection

Rick Arlow, CEO, Complion, Inc.
Drawing on his engineering background, and inspired by his work in clinical research, Rick Arlow built the first version of the Complion software platform. In close collaboration with leading medical centers, Complion’s industry-leading workflow and document management software was born. Since then, Rick has built a world-class team experienced in clinical research. He is a frequent lecturer for several professional research organizations including ACRP, MAGI and SCRS.

Christina Brennan, MD, MBA, Vice President, Clinical Research, Northwell Health
Christina Brennan, MD has devoted her career to clinical research and currently serves as Northwell Health’s vice president of clinical research.
Committed to the advancement of science and medicine, Dr. Brennan has more than 19 years of extensive clinical research experience, including over 14 years in clinical research management roles. She is the immediate past president of the NY Metropolitan Chapter of the Association of Clinical Research Professionals. She also is on the advisory board of the Weschester Biotech project. She is an active member of the Clinical Trial Transformation Initiative (CCTI), with Duke University and the FDA, where she actively sits on some of their committees. She also sits on the oncology advisory board and technology site advocacy group with the Society for Clinical Research Sites (SCRS). She is also an active member of the Drug Information Agency, the Regulatory Affairs Professional Society, Women in Bio and the American College of Healthcare Executives. "

Marie Elena Cordisco, MA, APRN, NP-C, Nuvance Health; Director Clinical Trials, Western Connecticut Health Network; Interim Director, Division of Research, Health Quest

Cayce Drobek, Director, Clinical Operations, Teckro
Cayce brings more than a decade of clinical research experience, working at sponsor companies, CROs, and investigative clinical trial sites. Cayce has worked on numerous Phase I-IV trials across therapeutic areas. She has undergraduate degrees in Biology and Mental Health and holds two Master’s Degrees in Microbiology and Clinical Research.

Gabriela Feldberg, Practice Leader, Applied Analytics & Artificial Intelligence, AstraZeneca
Gabriela has spent 20 years in various roles across both pharma and CROs with much of her recent focus spent on building and leading highly effective global feasibility, site selection and patient engagement organizations. Gabriela’s current role as Practice Leader within the Data Science and Artificial Intelligence organization has continued to refine this mission with an additional emphasis on extracting maximum value for our patients by leveraging data science to provide valuable insights to better select investigators for clinical studies. Previously she has led global Feasibility, Site Selection and Patient Engagement groups at Covance and UCB. Prior to UCB, Gabi spent over ten years at Quintiles where she held positions of increasing responsibility. Gabi also held positions at Kimberly-Clark and Cordis earlier in her career. Gabi received her B.S. Degree in Chemistry from the University of Florida.

Kaitlin Folweiler, PhD, Data Scientist, R&D Data Science, Analytics and Insights, Janssen
Kaitlin Folweiler is Data Scientist in Data Science Analytics and Insights at Janssen Research & Development. Kait received her PhD degree in Neuroscience from the University of Pennsylvania in Philadelphia where she developed her skills in machine learning. In her current role, Kait utilizes her interdisciplinary skills in neuroscience and data science to bring insights and impact projects across the R&D organization, such as predictive analytics for complex biological problems and transforming clinical trials.

Jane Hart, Vice President, Global Clinical Affairs, 3M Health Care
Jane Hart has worked in the Clinical Research Industry for over 22 years. In her current position with 3M she leads the Global Clinical Development organization. Her team is focused on generating evidence to support the safe and effective use of KCI products primarily through company sponsored and investigator sponsored research. Jane started her career in Australia working in breast cancer research and relocated to the US 17 years ago. She is experienced in executing pre and post market studies globally for both drug and devices. Highlights of studies she has managed include FDA approval of a nanocoated cardiac stent, hormonal therapy for breast cancer and chemotherapy for hematological malignancies.

Amanda Hayden, Clinical Trial Manager, Global Clinical Services, Alkermes
Amanda Hayden is a Senior Director of Global Clinical Services at Alkermes, Inc, and has worked for 20 years in the clinical operations field. Amanda started her career as a CRA with a small CRO, progressing to Project Management roles at Antigenics (now Agenus), Millennium Pharmaceuticals (now Takeda), and Lantheus Medical Imaging. In her role at Alkermes, Amanda oversees the Study Start Up, Clinical Compliance and Clinical Systems and Disclosure teams. She has extensive prior monitoring and project management experience, with more than 10 years focused on Oncology trials. In the last 5 years, Amanda has spent significant time dedicated to large scale CNS trial start-up, including global trial submissions and launches in approximately 20 countries, as well as in overseeing ICH E6 R2 implementation and Inspection Readiness initiatives.

Justin Hensperger, MS, Site Intelligence Lead – Associate Director Internal Medicine, Pfizer
Justin Hensperger is an Associate Director, Site Intelligence Lead for internal medicine for Pfizer Inc. Justin studied medical laboratory science at University of Delaware, and a Master’s in clinical trial science from Rutgers. He began his career in pharma working at a CRO as a feasibility analyst before moving to the sponsor side. As a Site Intelligence Lead he is working on improving the way we utilize data to drive site selection, and ensuring that we select the right sites the first time for our studies.

Marcy Kravet, BS, MBA, Head, Operational Design Center, EMD Serono
Marcy Kravet is an Operations leader with a history of creating and implementing functions that drive efficiency and innovation in planning and execution. In 2018 Marcy joined EMD Serono to create the Operational Design Center (ODC) within Global Clinical Operations. Prior to joining EMD Serono, Marcy spent 12 years at Bristol-Myers Squibb in patient recruitment, late stage development, medical affairs scientific publications, and early development. Marcy also has experience working at a primary care research network and a patient recruitment vendor.

Hugh Levaux, Founder and CEO, Protocol First
Dr. Hugh Levaux is Founder CEO of Protocol First. The company offers innovative software solutions for clinical research.  Leading products are P1 EDC, a full eClinical research platform and Clinical Pipe, the industry’s first system-agnostic EHR-to-EDC connector application. Dr. Levaux has over 2 decades of clinical research experience.

Brandon Maggio, Associate Director, Global Clinical Operations, Boehringer Ingelheim
Brandon has worked in the industry for 15+ years and joined Boehringer Ingelheim in 2011. During his tenure at BI, he managed multiple pivotal Phase 3 trials within the Metabolic, CNS, Cardiovascular, and Respiratory therapeutic areas. In 2018, he took on the role of Global Clinical Operations Integration Lead for Decentralized Clinical Trials. This position coordinates all other supporting trial enabling functions, as well as, facilitation of educational and change management activities for BI’s clinical research ecosystem.

Beth Mahon, Global Feasibility Therapeutic Area (TA) Head, Feasibility Center of Excellence (FCoE), Clinical Insights and Experience, Oncology, Janssen
Beth Mahon, Global Feasibility Therapeutic Area Head for Solid Tumor Oncology, is part of the Global Feasibility Center of Excellence at Janssen R&D. She works to enhance program and protocol strategies for better and more cost effective scientific and regulatory outcomes while balancing customer-focused insights and data analytics in early planning and execution of clinical trials. Beth has over 19 years of clinical operations experience joined Janssen in 2007.

Sylvia Marecki, PhD, Design Analyst, EMD Serono
Sylvia Marecki joined the Operational Design Center within Global Clinical Operations at EMD Serono in 2019. Prior to joining EMD Serono, Sylvia led development and commercialization of products and services at Citeline/Informa, Decision Resources Group, and TriNetX, empowering data-driven decisions across clinical and commercial functions. She received her Doctorate in Pathology and Immunology from Boston University School of Medicine.

Len Rosenberg, PhD, RPh, Head, Clinical Operations, The Leukemia & Lymphoma Society, Beat AML/LLS
Dr. Rosenberg is a 30 plus year executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, eclinical and contract research organization sectors. With his diverse background which includes executive management, clinical and regulatory operations, business development, eclinical technology solutions and new product/licensing evaluations, he brings tremendous hands on insights to optimizing the drug development cycle, from the early start-up stage to global product registration. Dr. Rosenberg is Head, Clinical Operations at Beat AML, LLC, a division of The Leukemia & Lymphoma Society and also Managing Partner of eP2Consulting, Inc. since 2001.

Risk-Based Monitoring

Muhammad Ali, Central Monitoring, Pfizer
Muhamad Ali started his career as a Business/Quality Assurance Analyst. One of the key contributors on Pfizer’s RBM implementation team, managed formalization of Pfizer’s business process for RBM implementation. Currently working as a Sr. Central Monitor for Pfizer and responsible for coordinating with study teams to align on FDA ICH ICHE6 R2 guidelines

Linda Sullivan, Co-Founder & Executive Director, WCG - Metrics Champion Consortium
Linda B. Sullivan is Co-Founder & President of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has been a featured speaker at Performance Metrics, Risk-Based Monitoring, Quality Management & Clinical Trial Oversight industry meetings. Ms. Sullivan received a BS in Biology from Trinity College and a MBA from Dartmouth College where she was named a Tuck Scholar.

Lucien Agnant, Technology Integration Specialist, Clinical Management, Otsuka Pharmaceutical Development & Commercialization, Inc.
Lucien Agnant has spent the last two decades impacting the health of patients through direct patient care and research and development. While working at Otsuka, Lucien has held positions in Clinical Safety and Pharmacovigilance, Program Management, and most recently Clinical Management. Lucien has worked on multiple medicines across a variety of therapeutic areas including cardiovascular, neuroscience, nephrology, ophthalmology, dermatology, respiratory and oncology. In his current role, Lucien leads the technology integration group which focuses primarily on the integration of paperless systems (eSource, eConsent, eScanning).

Kevin Douglass, Associate Director, Process Excellence & Risk Management, Daiichi Sankyo, Inc.
Kevin is an Associate Director in Process Excellence & Risk Management at Daiichi-Sankyo. The Process Excellence & Risk Management (PERM) Team partners within Clinical Operations and with other functional areas to optimize clinical trial processes and tools, with a specific focus on risk-based quality management (including risk assessment, risk-based/centralized monitoring, and metrics oversight). PERM members are assigned to study teams and lead process improvement projects, usually in collaboration with CRO partners. Kevin has more than 30 years industry experience working for numerous companies (Wyeth, Rhone-Poulenc Rorer, Pfizer, and Shire) in various positions (Data Management, Database Programming, Quality & Compliance, and Operational Excellence). During that time, he was certified in Lean Six Sigma/Change Management and led multiple cross-functional continuous improvement projects. He received his BS in Biology from Ursinus College and MS in Biology from Villanova University. Kevin currently resides in New Jersey with his wife and spends most of his free time with their three daughters and 2 grandchildren. He can be contacted at kdouglass@dsi.com.

Laura Galuchie, TransCelerate Program Lead, Oversight Committee, Merck & Co., Inc.; TransCelerate Biopharma Inc.
Laura has a unique role which blends internal and external components. Laura is Merck & Co., Inc.’s assigned leadership to the Oversight Committee of TransCelerate BioPharma Inc. The Oversight Committee is the primary governing body for decisions related to the operational direction of TransCelerate, including project direction and expected outcomes. Laura draws on her experience as Director of Clinical Operations for a busy therapeutic area and Head of Clinical Performance, Analytics and Innovation to provide this perspective. Within Merck, she has responsibility for driving internal engagement with key stakeholders. She facilitates adoption and internalization of TransCelerate solutions in alignment with Merck’s objectives. Finally, she watches for opportunities to match innovative approaches to potential process improvement initiatives or other areas of focus.

Laurie Halloran, CEO, Halloran Consulting Group, Inc.
Laurie Halloran founded Halloran Consulting Group in 1998, originally operating out of an unfinished bathroom. Her time as a pediatric ICU nurse had inspired her to start a company that helps move new therapies through FDA processes to get them into the hands of patients desperately in need. By providing a strategic development team, innovative start-up companies could have access to world-class expertise at a fraction of the cost. Since its humble beginnings, Halloran has grown into a leading consultancy of like-minded experts who are dedicated to improving human health by making life science companies better at what they do. Laurie has been named 2018 Women’s Business Enterprise Star by the Women's Business Enterprise National Council (WBENC) and has won a 2017 Enterprising Women of the Year Award from Enterprising Women Magazine. Halloran Consulting Group was also named an Inc. 5000 Fastest Growing Company for the past five years in a row. In 2015, Laurie was honored by the Boston Business Journal as a Woman of Influence, in 2010 was selected as one of the 100 Most Inspiring People in Life Science by PharmaVoice, and in 2009, she was awarded Clinical Researcher of the Year by the New England Chapter of the Associate of Clinical Research Professionals. Laurie lectures at Boston University Medical School and the Tufts Center for Drug Development Post-Graduate program. She has previously taught at George Washington University and Harvard University. Laurie earned a Bachelor of Science in Nursing from Russell Sage College and a Master of Science in Management from Lesley University. She is also a Prosci Certified Change Practitioner.

Amy Klawitter, Senior Manager, Clinical management, Otsuka Pharmaceutical Development & Commercialization
I have worked in clinical research for 23 years and specifically with the pharmaceutical industry for 14 years within clinical management. I currently assist clinical teams to implement RBM (ICH E6 R2) guidance, technology integration for the Otsuka ePlatform and eSurveillance visual analytics. My passion is clinical research and trying to find new and innovative ways to make it easier for patients, sites and researchers.

Sheri Kuss, Clinical Quality Lead, Clinical Development Quality, Global Product Development, Pfizer, Inc.
No bio available.

Amy Neubauer, Director, Data Quality Oversight, Alkermes
Amy Neubauer serves as Director, Data Quality Oversight at Alkermes, a company developing innovative medicines that address the unmet needs and challenges of people living with debilitating diseases, such as schizophrenia, depression, addiction, multiple sclerosis, and cancer. She has 15 years of experience in clinical research with expertise in data management, project management, and vendor management, and is an experienced auditor of clinical trial systems, technologies, services and software. In her current role, Amy is responsible for the development of a clinical data sciences team to lead risk-based approaches and strategic data quality efforts for the organization through development and interpretation of algorithms, code, reports, and visualizations in support of clinical trial operations activities with a focus on impactful data insights and clinical data review.

Jonathan Rowe, Executive Director & Head, Quality Performance and Risk Management, Pfizer 

Jonathan Rowe has more than 20 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Executive Director, Head of Clinical Development Quality Performance and Risk Management at Pfizer, where his responsibilities include monitoring, modeling and predicting the Pfizer GCP Quality Management System, leading the analysis of Pfizer’s Clinical Trial Quality Performance and ensuring clinical trial quality risk management is built into all trials. At Pfizer he has held a number of roles including Clinical Director, with responsibility for the Phase IIIb and IV Lipitor program; Director, Intellectual Property Strategy Management; and Senior Director of Process and Performance. Jonathan spent a number of years in “small pharma” as the Head of Intellectual Property and Portfolio Strategy for Amarin and Dignity Sciences. Jonathan earned his Ph.D. and M.S. at the Albert Einstein College of Medicine and his M.A. from Binghamton University.

Diane Thornton Chandler RBM/Centralized Monitoring Lead, Medtronic
Diane’s background and experience includes 20 plus years in various clinical research positions, always with an eye toward process improvement. For the last 4 years, her focus has been on building the Centralized Monitoring strategy at Medtronic. Speaking on the topic of RBM and Centralized Monitoring, her emphasis is around cross-functional collaboration and change management as key drivers for program development success.

Marissa Volpe, Vice President, Global Clinical Development Operations

With support from her colleagues, peer’s, and manager; Marissa has built a high-performing, multi-function operations team at Sarepta Therapeutics focused on delivering high quality studies to advance medicine, particularly in the Rare Disease space.  She also recently completed teaching her first master’s course at Boston University focusing on clinical trials as part of the clinical research program.  Her background includes work in multiple therapeutic areas, but mainly focusing on Multiple Sclerosis before transitioning to oncology in 2015.  Marissa learned early on that the patient is the number one priority and continues to work daily to ensure we design and implement more patient centric clinical trials.

Andy Lawton, Director & Consultant, Risk Based Approach, Ltd.
Andy Lawton has extensive experience in computing, statistics, data management, RDE/RDC, system design, Risk Based Approach in both CSV and clinical trials. He is currently consultant and director of Risk Based Approach Ltd and has worked with a variety of companies and institutions on the implementation of ICH E6 R2, ICH E8, QMS/QbD and Risk Based Monitoring. Previously, Andy held the position of Global Head of Clinical Data Management at Boehringer Ingelheim were he also held positions of increasing responsibility during his 32 years with BI. Andy was a Founding Committee Member of ACDM, Member of TransCelerate RBM work stream and a Member of EFPIA WG on Data Transparency. His most notable publications is the paper with Dr. Alistair Ross on GP Audit - throughout 80's and 90's this was the most quoted paper in the BMJ, and he won “best author of the year 2015 and 2016” from the DIA, for the TransCelerate papers on SDV and Central Monitoring in the TIRS Journal.

Interactive Roundtable Breakout Discussions

Mike Wenger, Vice President, Patient Engagement, TrialScope
In October 2019, TrialScope acquired Clinical Trial Connect and hired its founder, Michael Wenger, as Vice President of Patient Engagement. A brain tumor patient and software developer, Mike is passionate about patient access to clinical trials. Previously, Mike worked at the Michael J. Fox Foundation where he helped develop the Fox Trial Finder, a clinical trial matching platform for Parkinson's disease patients. He also served as an adjunct professor at Rutgers University, teaching a full-stack curriculum. "


Rob Long, Executive Director, Uplifting Athletes
A suburban Philadelphia native, Rob is a former All-American punter at Syracuse and has lived the rare disease journey. In December of 2010, late in his senior season, Rob was diagnosed with anaplastic astrocytoma, a rare and aggressive form of brain cancer. His prognosis at the time was less than encouraging, and his surgery, recovery and treatment took 16 months. Prior to his diagnosis, Rob was on a path to the NFL as a punter, but that opportunity was lost by the time he was healthy enough to train again. A graduate of Syracuse University, Rob pursued a Masters in New Media Management from the S.I. Newhouse School of Public Communications. He also received a B.S. from the Martin J. Whitman School of Management. Rob played football all four years for the Orange and was voted by his teammates as a team captain his final two seasons. He became the second Executive Director of Uplifting Athletes at the end of 2018. Prior to taking over as the Executive Director, Rob served as Uplifting Athletes' Director of Rare Disease Engagement for nearly two years. Rob has a steadfast commitment and connection to the Rare Disease Community as a rare brain cancer patient. As a former star college football student-athlete, his passion and drive to advance the mission of Uplifting Athletes is inspirational. Rob and his wife, Irie, reside in South Philadelphia.

Charles Makin, Global Head, Real World Evidence Strategy, Biogen
Charles Makin leads Biogen’s Real World Evidence Strategy team, overseeing RWE projects across all therapeutic areas for marketed and pipeline products. Before joining Biogen, Mr. Makin served as the General manager/VP for ICON’s RWE-Late Phase Research unit, the world’s second-largest research group dedicated to prospective data collection; and led the team – comprised of several hundred biostatisticians, medical affairs personnel, project/program managers and data management professionals based in >40 countries – to the 2018 Late-Phase CRO Leadership Award. Prior to that, he held leadership positions in major drug commercialization research companies such as IMS, Mapi and Optum, including the roles of VP/Americas Head, Real-World Strategy and Analytics, Head of Observational Outcomes Research (Americas) and Global Head of Research Design and Proposal Development. He has also worked on the payer side (Anthem and Humana), where he led RWE initiatives, economic evaluations and health outcomes research studies. In nearly two decades in RWE, HEOR and drug commercialization, Mr. Makin has developed and implemented drug value, safety and effectiveness roadmaps for most of the top 20 pharmaceutical companies to influence payers, clinicians and HTA bodies and positively impact market access. He has served as Principal Investigator on over a 100 retrospective database analyses (EMR, linked, claims), global registries, medical chart reviews, economic models, PRO studies, physician surveys, ITC/NMAs, SLRs and GVDs across every major therapeutic area. He has also developed >25 value development plans and product market profiles and published on health policy. He has authored over 70 peer-reviewed manuscripts and scientific presentations, serves on the editorial board for multiple journals, and is an invited speaker at several conferences in the US and EU. Mr. Makin holds a BS in Pharmacy from the University of Pune, an MS in Pharmacy Administration (major in outcomes research) from Purdue University, as well as an MBA (Marketing), summa cum laude, and a Master of Management, summa cum laude, both from Goldey-Beacom College. He has also completed a Pharmacoeconomics and Outcomes research Fellowship from Humana.

Rangaprasad Sarangarajan, PhD, Chief Scientific Officer & SVP, Clinical and Translational Sciences, Research & Development, BERG
Rangaprasad (Ranga) Sarangarajan, PhD, is the Senior Vice President and Chief Scientific Officer at BERG who oversees all Research and Development activities including pharmaceutical development & translational sciences strategy development and planning. Dr. Sarangarajan is the co-inventor and co-architect of the BERG Interrogative Biology® technology. This ground-breaking technology is currently focused on next generation R&D innovation in the integration of artificial intelligence-based analytics, bioinformatics and Real-World Data (RWD), and Real-World Evidence (RWE) for speeding up identification/validation of targets, tractability, drug discovery and pharmaceutical development. He is also actively involved in the development of clinical programs in the late stage progress towards registration. Dr. Sarangarajan has numerous U.S. and international patents (granted and pending), covering areas of the discovery platform, cancer, neurology, metabolic diseases, diabetes, obesity and diagnostics. He has published extensively and has presented his research at national and international medical and scientific meetings. He co-authored and co-edited Cellular Respiration and Carcinogenesis, a first of its kind treatise on the role of mitochondrial function and metabolic network regulation in the etiology of cancer as it pertains to the seminal observations made by Otto Warburg.

Maura Snyder, MBA, Director, Patient Engagement Strategy & Portfolio, Janssen
Maura is the Director, Patient Engagement Strategy & Portfolio within the Investigator & Patient Engagement organization at Janssen. In this role, Maura oversees the IPE Portfolio team, Janssen's dedicated trial recruitment and retention experts, responsible for turning insight into action to design and implement impactful solutions that will enhance the clinical trial experience for the patient, their caregivers and clinical research sites. Prior to joining the Investigator & Patient engagement team, Maura served as Strategic Lead for Value Excellence team within Janssen’s commercial organization, launching a strategic marketing framework based on delivering customized value to stakeholders, based on stakeholders’ needs. Maura has held various positions within the clinical and commercial sides of the business. Through these roles, she has contributed to key decisions across the all product stages, pre-clinical through in-line. Maura holds a Bachelor of Arts degree from Villanova University and her Masters of Business Administration from Seton Hall University.

Alik Farber, MD, Chief, Division of Vascular and Endovascular Surgery, Associate Chair for Clinical Operations, Department of Surgery, Boston Medical Center
Alik Farber, MD is Chief of the Division of Vascular and Endovascular Surgery at Boston Medical Center and Professor of Surgery and Radiology at Boston University School of Medicine. Dr. Farber is a graduate of Brown University and obtained his medical degree from Harvard Medical School. He completed a residency in general surgery at Massachusetts General Hospital, a vascular surgery fellowship at Dartmouth-Hitchcock Medical Center and an endovascular surgery fellowship at the Southern Illinois School of Medicine. Dr. Farber’s administrative responsibilities include being Associate Chair for Clinical Operations in the Department of Surgery, Chair of Value Analysis Committee and Co-Director of Non-Invasive Vascular Laboratories. Dr. Farber is currently a National Co-Chair of the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial, a randomized, controlled trial enrolling patients at 135 sites across North America, Europe and New Zealand. BEST-CLI is funded by a $25 million grant awarded by the National Institutes of Health.

Peter Bergethon, MD, Vice President, Head of Digital and Quantitative Medicine, Biogen
Peter R. Bergethon, MD is Vice President and Head of Quantitative Medicine and Clinical Technologies (QMCT) at Biogen. He leads the identification of technologies and methodologies that transform drug development. QMCT creates value by leading the transition of clinical practice in Biogen’s core and emerging growth areas from a qualitative to a quantitative discipline, and connecting the Clinical with the Research enterprise, to advance therapeutics and personalized medicine. Peter came to Biogen in 2017 from Pfizer Worldwide Research and Development where he was Vice President and Head of the Pfizer Innovation Research Lab within the Early Clinical Development group. At Pfizer, Peter led both the Quantitative Medicine group and the Innovation Research Labs where he pioneered mobile and digital clinical assessment technology, human neurophenotyping, and multi-modal data analytics to accelerate clinical development in neuroscience, immunology, rare diseases, and cardiometabolic disease. He is an accomplished clinical neurologist and neuroscientist who, prior to joining Pfizer, was a Professor at Boston University and Tufts University in the Departments of Biochemistry, Neurology, Neurobiology & Anatomy, and Biomedical Engineering.

Alan Louie, PhD, Research Director, Life Sciences, IDC Health Insights
Dr. Louie leads IDC Health Insights' Life Science R&D Strategy and Technology Research with a focus on ongoing innovation and best practices in life science R&D. He brings more than 35 years of technology, product and strategy development from across the life science industry. In his time at IDC, Dr. Louie has authored more than 250 reports on innovation in the life sciences. Over his career, he was responsible for the development and commercialization of more than 30 products for a variety of industries, including many first-in-class product offerings. Dr. Louie has a PhD in Biochemistry from the University of California at Riverside.

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