Ken is the Director of Sponsored Research and Associate Professor at the Tufts Center for the Study of Drug Development, and Chairman of the Center for Information and Study on Clinical Research Participation, a non-profit organization that he founded to raise public and patient awareness of the clinical research enterprise. He is founder and owner of CenterWatch, and an owner and board member of the Metrics Champion Consortium. A well-known speaker at symposia, universities, and corporations, Ken has published extensively in peer-reviewed journals, books and in the trade press.  He has been an active DIA member for 25 years and has held board appointments in the private and public sectors.  Ken earned his MBA from Northwestern University.

Hollie Schmidt is the VP of Scientific Operations at Accelerated Cure Project for Multiple Sclerosis. She co-chairs the Research Committee of iConquerMS™, a research cohort established to perform and support patient-centered research in MS. She also founded and leads the MS Minority Research Engagement Partnership Network, a multi-stakeholder initiative aimed at increasing racial and ethnic diversity in MS research studies.

Mr. Adams has been a founder or co-founder of life science and technology based companies in Massachusetts for the past several years. Mr. Adams has been instrumental in developing new proprietary therapeutic and medical device technologies and bringing the technologies to commercialization. The companies he has founded include, Compellis Pharmaceuticals, a developer of therapeutics to treat obesity and its co-morbidities, diabetes and hypertension and Mosaic Technologies, a venture backed MIT spin-out genomics company that developed patented technologies for genetic analysis and detection. Chris is the holder of more than 20 issued US and international patents for medical devices and pharmaceuticals.

Marilyn is currently Director of Clinical Operations at Nuvation Bio. She has dedicated the past 12 years to clinical development and operations, with a sole focus in oncology drugs. She is passionate about executing clinical trials with agile and innovative teams and enjoys working with emerging biotech companies to establish flexible, best practice processes.

Molly James is the Associate Director of Strategic Sourcing at Beam Therapeutics. In this role she manages all vendors and leads strategic partnerships for the development organization within Beam. She has over 10 years of experience in strategic sourcing and vendor management within the pharmaceutical industry.

Jenn Curry is Head of Patient Engagement Capability at Biogen.  In this role, Jenn is accountable for driving the capabilities optimizes the execution of patient-focused drug development and maximizes the degree of impact on enrollment and the participant experience in Biogen’s clinical studies.  Jenn entered the field of clinical research as a Research Assistant at Massachusetts General Hospital in 2003 and shifted her focus to industry, specifically patient recruitment, in 2006.  Prior to joining Biogen in 2019, she spent 9 years at AES/Acurian Inc., advancing from Project Manager to Director of Operational and Strategic Solutions while honing her expertise in patient recruitment.

Cory Burke is the Executive Director Head of Biometrics and Data Management at Black Diamond Therapeutics. Cory has over 25 years of experience in the pharmaceutical industry in both CRO and Sponsor side. She has worked in many aspects of data management, database programming and SAS programming in the industry. She works collaboratively with Clinical Operations, Medical, Translational Medicine and many other cross functional teams. She has worked on a wide range of therapeutic areas (Oncology, Dermatology, Cardiology, Gastrologic,etc) from Phase I-IV.

Leticia has over 25 years of industry experience managing research projects and clinical studies in various roles. She spent many years working for big pharma giants such as Biogen and Merck. Currently Leticia is the Vice-President of Global Clinical Operations at Brainstorm Cell Therapeutics, a biotech company working on cell therapy for ALS. Leticia also serves as an IRB member at Yale University, and is the Chair and President of the New England Chapter of the Association of Clinical Research Professionals (ACRP)

Laura Taraboanta, MS is a clinical strategy and development professional with a demonstrated history in health care and clinical trials. She is currently the of Head Clinical Innovation at Click Therapeutics, with a focus on improving speed, efficiency, and cost of prescription digital therapeutics discovery, development and implementation. Prior to Click, Laura was leading clinical operations at Woebot Health, a mental health company focused on delivering evidence-based treatment through an AI chatbot. Laura has been part of two successful FDA Breakthrough Designations for software as medical devices and has overseen numerous research projects in CNS and oncology, tapping into the potential of virtual trials to empower patients. Laura is keen on tackling health disparities by accelerating digital therapeutic development so that clinically-proven, safe and effective solutions can be universally available to patients and their providers.

Nick is a globally experienced Clinical Operations, Program and Vendor Management professional with greater than 15 years of experience across the biotech/pharmaceutical industry. He is currently the Head of Clinical Operations and Program Management at Delix Therapeutics. Prior to Delix, Nick has spent time at CRO’s and both small and large Biotech, in roles of increasing responsibility across Research and Development. Nick holds both a Bachelor of Science degree and MBA from the University of Massachusetts Amherst.

Veronica Ludensky is the Director of Procurement, Clinical. She is responsible for establishing and growing the procurement function for clinical services to leverage the Flagship ecosystem to advance companies’ clinical development goals.

Veronica has almost two decades of experience in clinical sourcing functions for multiple compounds from Phase 1 through 4, in small biotech, large pharma and CROs. During her career, Veronica was responsible for supporting project teams across multiple therapeutic areas in selecting, negotiating costs, contracting and business oversight of CROs, laboratories and all other vendor types in support of clinical programs at AstraZeneca, Alexion Pharmaceuticals, Millenium Pharmaceuticals and Takeda.

Revati Tatake, PhD, is the Global Head of Pharma Research, Analysis and Competitive Intelligence at GlobalData Healthcare.  Revati has over 25 years of multidisciplinary experience in academic research and the healthcare industry, both on the client and agency sides of the business. Previously she worked as a VP of Databases and Analytics at GlobalData, where she made significant contributions to Pharma Intelligence Center. Before joining GlobalData, Revati worked at Citeline/Informa, where she was involved in competitive intelligence and analytics of clinical trials and drugs in the areas of Autoimmune/Inflammation, Central Nervous System, and Ophthalmology.  Earlier, Revati worked at Boehringer Ingelheim Pharmaceuticals for over 12 years as Senior Scientist to Senior Principal Scientist, where she led drug discovery projects involving traditional high-throughput screening, as well as innovative approaches for gene and cell therapies. She also worked at Boehringer Ingelheim as a Director of Competitive Intelligence for projects in cardiometabolic space and research beyond borders. She is a co-inventor on many issued US patents related cell and gene therapies and has several publications in peer reviewed scientific journals. Revati holds a PhD in Tumor Immunology from the Tata Cancer Research Institute in Mumbai, India. She did her postdoctoral fellowship at the University of Connecticut Health Center and Boehringer Ingelheim.

Ajay Sadhwani is an executive Life Science Professional with over 25 years of clinical research experience. Proven leader of cross functional teams and people management of large and small functional groups with a track record of successfully leading teams and motivating individuals to perform at their highest level.

Jay has over 17 years of clinical development experience.  He currently is the clinical lead for the PAH program at Keros Therapeutics.  He has been working at smaller biotech companies for the last 8 plus years.  In addition, he is an adjunct faculty member at Northeastern University teaching in the Masters of Regulatory Affairs program.

Harry Barnett Harry is the co-founder and Executive Chairman of Lubris BioPharma, a clinical-stage biotech company developing a proprietary version of the novel, ubiquitous human protein, PRG4, for use in multiple indications.  Novartis owns rights to Lubris’ technology for ophthalmology. Harry’s two-decade life science career includes: (i) co-founding and executive management roles at three life science companies and two CROs; (ii) incubating, partnering and licensing successfully a wide array of pharmaceutical products and technologies including Pepcid Complete®, the OTC hearburn remedy sold by J&J, and; (iii) innovating multi-center, clinical trial processes using techniques that have been adopted as industry standard.  Prior to his transition to life science and biotech, Harry was a transactional business lawyer in private practice at DLA Piper in San Diego, and later at Faneuil Advisors, Inc., an investment advisory firm based in Boston where he served as General Counsel and Executive Vice President.

Kevin P Killeen, PhD is the Chief Scientific Officer at Matrivax Research & Development Corp.  Dr. Killeen has extensive training in the fields of molecular biology, microbiology, protein chemistry, immunology, and vaccinology.  His undergraduate BS degree is from Stonehill College (biology and chemistry), Ph. D from University of Rhode Island (microbiology), and post-doctoral fellowship at Harvard Medical School (molecular genetics and protein toxin chemistry).  Dr Killeen has more than 30 years of experience in the field of biotechnology at IDEXX Corp., VRI/AVANT-Celldex Inc, and Matrivax Corp.  He has published more than 30 vaccine manuscripts, authored four chapters, written several science reviews, is an inventor on more than ten patent/applications, and served for 12 years as a member of the URI Dean’s Advisory Council.  Dr. Killeen was the principal investigator (PI) on vaccine related grants and contracts exceeding $11 MM and coordinated greater than $13 MM in funding from the Bill & Melinda Gates Foundation.  Career highlights include the commercialization of two diagnostic tests, directing nine (9) vaccine candidates (live-attenuated/oral and subunit/injectable) into Phase 1 and 2 clinical trials, and guiding the clinical development of CholeraGarde^®, an oral, single-dose cholera vaccine towards a Phase 3 clinical trial and out-licensing.  Moreover, while at VRI, Dr Killeen identified and performed scientific due diligence on rotavirus vaccine candidate 89-12, advanced through Phase 2b studies and ultimately out-licensed to GSK and commercialized as Rotarix^®, a >$1 billion ‘blockbuster’ vaccine.

Colleen Graham has over 20 years of extensive Clinical Research experience. She began her research career at a Clinical Site, and has held a variety of operational positions from an Ethical Review Board to CROs and Pharmaceutical companies, both large and small. Her experience includes Phases I-IV drugs, biologics and device studies across a variety of therapeutic areas working with companies such as Biogen, Pfizer, and Takeda Pharmaceuticals. Her operational experience includes resource management, process development and she has managed large-scale global studies. Colleen is currently Director of Clinical Development Operations at Momenta Pharmaceuticals, where she responsible for clinical development of M281 in rare immune-mediated diseases.

Eric Harvey is the Senior Director of Biometrics and Data Science at MMS. He has over 20 years of experience in pharmaceutical research, spanning pre-clinical through phase IV clinical trials, device and diagnostic studies. Prior to MMS, he led biostatistics, programming, data management, data science and information technology groups at various CROs. He also led a clinical research department at a large hospital system. Eric is a problem solver at heart whose focus is to identify data driven opportunities to increase efficiency and improve quality.

Helen Chalk is a Clinical Development leader who has worked in Clinical and Program Management roles across the pharmaceutical, biotechnology and CRO sectors for over 25 years.  She has a breadth of global industry experience including oversight of Phase 1-4 clinical trials, medical affairs and global managed access programs in indications including oncology, autoimmune disorders, respiratory disorders, cardiovascular and infectious diseases.  Fueled by opportunities to build effective, cohesive teams and processes, Helen enjoys the challenges and daily risk management required to develop drugs and bring them to market.

Beyond work, Helen loves to travel with her family and spend time with her two dogs.  Helen relishes any opportunity to ride horses and to volunteer in a therapeutic riding program in Norfolk, MA.

Yolanda is the Vice-President of Clinical Operations at Accutar Biotechnology. She brings along 17 years of experience in Clinical Development, with focus on both Clinical Operations and Clinical Project Management. Her areas of expertise include strategic operations planning at the compound-level; first-in-human study planning & adaptive execution in therapeutic areas of oncology and ophthalmology. Leadership with cross-functional teams has included the development and implementation of governance and operational strategy, optimizing processes and building dynamic teams to exceed business objectives. Prior to joining Accutar, she held various positions at Bayer in the US and a number of countries within Asia. This attributes to her extensive knowledge of bridging-strategy between the two continents.

Nan Doyle is a patient engagement catalyst with a passion to strengthen access to diagnosis and treatment for people living with rare genetic conditions. She has deep roots in medicines development, and is known for building durable relationships based on a foundation of active listening and inquiry.
Most recently, Nan established and built the Rare Disease Patient Engagement function for Takeda Pharmaceuticals. The role required strategy-driven partnerships with patient organizations; and tight, de-siloed collaboration with R&D, Clinical Development, Commercial, Regulatory, Access, and other colleagues around the world.
Nan is also a board-certified genetic counselor, where she developed front-line understanding of patient and care partner practical, emotional, financial and policy needs.

Robert Loll is the SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies with award-winning creative and superior execution.  Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 16+ years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare.  Robert is an Advisory Board member for The Center for Information and Study on Clinical Research Participation (CISCRP), an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.

Jenifer Ngo Waldrop joined the Black Women’s Health Imperative (BWHI) as Executive Director of the Rare Disease Diversity Coalition (RDDC) in October 2022. Before joining the leadership team of RDDC, she developed models and programs for diversity, equity, and inclusion initiatives to support multiple business units with Fortune 500 companies and organizations in Asia, Canada, and the US.

Jenifer has led initiatives at non-profit organizations where she recruited local community members to participate in numerous health-related fundraising events and developed programs to target disparities and underrepresented groups. In addition to facilitating development and fundraising, Jenifer developed a reputation for successful coalition building.

Jenifer received her undergraduate degree from Colby College and her Master of Human Resources Development from Villanova. As the Professional Development Director of the National Association of Asian-American Professionals (NAAAP) of Colorado, Jenifer continues her outreach in society. Through this organization, she mentors formally and informally.

John Seman is the CEO and Founder of REVITALE Pharma.  He began his career working in Big Pharma - Johnson & Johnson and Bristol Myers Squibb - in sales, marketing and business development.  The second half of his career was spent as a serial entrepreneur having Founded a half dozen companies that provided either products or services for the pharmaceutical industry.  John earned his bachelor's and master's degrees from the Massachusetts College of Pharmacy.

Rinaldo leads the Clinical Procurement team at Sarepta Therapeutics; which focuses on the clinical trial outsourcing for phases 1 through 3. His tenure as a Procurement professional includes roles at large and small organizations across both pharmaceuticals as well as biotech organizations. He has an MBA from Northeastern University and is a Certified Professional of Supply Management.

Derek is the Director of R&D Procurement in Servier Pharmaceuticals, located in Boston area. Before that Derek worked for Biogen for 5 years managing clinical strategic sourcing.

Dr. Sherris has over 30 years’ experience in translational medicine involving basic research, pharmaceutics and diagnostics.  Dr. Sherris has been a successful serial entrepreneur developing biotechnology companies from the ground up, devising corporate strategy, enacting programs and carrying companies through funding and acquisition with six exits working with venture capital, investment banks and angel investors.  Dr. Sherris has been employed by pharmaceutical and biotechnology companies to manage external (academic groups and contract research organizations) and internal (directly manage, augment and expand internal scientific programs) research and development. Dr. Sherris has been a frequently invited guest speaker at biopharmaceutical business and scientific conferences, a published author and holder of patents in a wide range of therapeutic areas including oncology, ophthalmology, dermatology, neurology, gene therapy and infectious disease.

Meredith Frank-Molnia is currently employed as Vice President of Clinical Affairs at Vericel Corporation. Previously, Meredith held the position of Senior Director Clinical Management, while working at Axiom Real-Time Metrics Inc., where she established and expanded their Clinical Management department. Meredith has been in Clinical Project Management/Operations for 26 years in numerous roles of increasing responsibilities. Meredith has worked managing device/biologic and drug studies.

Mary Jo Lamberti is a Research Associate Professor at Tufts University Medical School and Director of Sponsored Research at the Tufts Center for the Study of Drug Development. She has extensive experience on benchmarking drug development operating practices. Her research focuses on a variety of areas including outsourcing and partnerships, clinical research workforce issues, investigative site initiation and management, patient recruitment and retention, and the use of technologies and digital solutions in clinical trials. She has been a frequent speaker at global industry conferences and has published extensively. She holds a B.A. from Wellesley College and a Ph.D. from Boston University.

Abigail Dirks is a Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to industry drug development performance, including clinical research associate (CRA) performance, impact of decentralized clinical trials (DCT), and investigative site burden. She recently received her Master’s in Health Informatics and Analytics from Tufts University and has a BS in Data Science and Mathematics from St. Michael’s College. She also has experience in web development for North Shore Nurse Practitioner Associates, a psychopharmacology practice.

Maria Florez is involved in research looking at the impact of digital transformation in clinical research and organizational strategies and practices driving improvement in development operations and economics. Maria has been a researcher and strategist in the healthcare sector for 15 years. She has held positions at Cleveland Clinic and at New York-Presbyterian Hospital of Columbia and Cornell Universities and has published articles in trade and peer-reviewed journals. She holds a B.S. in economics and an M.A. in international economics from The Fletcher School of Law and Diplomacy at Tufts University.

Sean Smith is a Biological Threat Exclusion Coordinator (BTEC) for CBP in the Office of Field Operations/ Agriculture Programs and Trade Liaison/ Agro/Bio-Terrorism Countermeasures. As a BTEC, Mr. Smith is charged with supporting and developing U.S. Customs and Border Protection (CBP) operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S.

Mr. Smith joined CBP in 2005 as an Agriculture Specialist (CBPAS) and was promoted to Supervisory CBPAS in 2008. He has served CBP in the following ports of entry: San Diego, San Ysidro, Otay Mesa and Boston Logan Airport. From 2011- 2018, Mr. Smith served as the primary Public Affairs Liaison and Border Community Liaison, respectively, for CBP in New England. He has also volunteered to assist in past domestic and international CBP disaster recovery operations, including: Hurricane Ike (2008), 'Operation Safe Return' (Haitian Relief Effort- 2010), and Hurricane Harvey, DHS Surge Capacity Force (2017).

Prior to CBP, Mr. Smith contributed to wildlife conservation for nearly a decade, completing field work on rare endemic Hawaiian birds on the Big Island of Hawaii, and raising rare and endangered birds (in some cases, extinct in the wild) at the San Diego Zoo's Avian Propagation Center. Also, Mr. Smith is a former reserve firefighter and EMT for the City of Borrego Springs in California. He holds a Bachelor of Science degree in Ecology and Systematic Biology from Cal Poly San Luis Obispo, California.

Mr. Smith, his wife, two children, one dog, and one chicken live in an old farmhouse in Massachusetts.

Charity Roddy serves as the Director of Patient Engagement for Therapeutics and Oncology at Moderna. In this capacity, she leads patient engagement initiatives, education, and recruitment efforts across oncology and rare disease programs. With over 15 years of diverse experience in the pharmaceutical industry, Charity has held various roles spanning the entire drug development lifecycle. She is deeply committed to enhancing the patient experience in clinical trials and advancing innovative approaches to patient engagement.

Ashley Sullivan has more than 13 years’ experience in clinical research. As Director of Study Start-up at Allucent, Ashley is responsible for leading, developing and coordinating activities and staff within Study Start-up & Site Intelligence and developing and implementing business strategies to ensure quality and timely performance of all start-up activities. She guided the overhaul and implementation of a specialized SSU module within CTMS allowing for improved metric tracking and reporting. Ashley also focuses on collaborating across functional areas to ensure a smooth working relationship between Study Start-up and other departments for overall successful trial conduct and delivery for clients.

Dr Rappo is Senior Director of clinical development at BiomX, a biotech company developing phage cocktails designed to target and destroy harmful bacteria. Prior to joining BiomX in 2020, Dr Rappo worked on the clinical development of dalbavancin and other anti-infectives at Durata Therapeutics, Actavis and Allergan. As an adult infectious disease physician, she focuses on developing safer and more effective treatment options for difficult to treat infections.

Shalome Sine is a Senior Manager and Quantitative Insights Specialist at the Center for Information and Study on Clinical Research Participation (CISCRP).

Shalome believes that the patient's voice can be a powerful force toward building inclusive, efficient clinical trials. Through her work, she hopes to help clinical trial sponsors and teams bring actionable patient insights into practice to improve clinical trial operational processes. 

Shalome manages both quantitative and qualitative patient voice projects, specializing in quantitative, survey-based patient insights projects. She holds a Master of Public Health from Tufts University and a Bachelor of Science from Penn State University.

Brian Wehrle is the Vice President of Research and Development for Medical Imaging at Clario, where he spearheads efforts to push the boundaries of medical imaging technology. With over 25 years of dedicated experience in medical imaging, Brian is passionate about delivering innovative solutions that exceed client expectations. Under his leadership, Clario has seen the successful buildup of its Medical Imaging AI team, significantly enhancing its capabilities in this critical area. Additionally, Brian played a pivotal role in driving the creation of a Generative AI team, further solidifying Clario’s position at the forefront of AI in healthcare. His commitment to innovation and excellence in medical imaging makes him a respected leader and a visionary in the field.

Nina is an experienced executive director of clinical services with over 25 years in the pharmaceutical/biotechnology and clinical research organization industry. She oversees US and EU Project Services teams including project management, client partnerships, team and portfolio management. She has demonstrated success in managing first-in-human through large, international clinical programs with multiple protocols in Phase I-III drug development resulting in several NDAs/BLAs. Before joining ICON, Nina served as Project Director focusing on Neuroscience, Immunology & Infectious Disease at Covance and held several PM roles at Takeda, TAP Pharmaceuticals, Gilead and Genentech. Nina holds a BS in Cellular Molecular Biology and a Masters in Biomedical Laboratory Science.

Ana Natera is a highly accomplished Clinical Director with extensive experience in clinical research and cardiac monitoring. She has been instrumental in driving innovative solutions and expanding the integration of technology in clinical trials. Her dedication to patient-centered care is evident in her commitment to improving cardiac monitoring through technological advancements. In addition to her professional achievements, she is an advocate for fostering connection within the industry and contributes to advancing technology in clinical trials. She is also passionate about increasing diversity, equity, and inclusion in the clinical space.

Ana holds a Bachelor’s in Biomedical Electrical Engineering, a Master of Science in Forensic Science, and an MBA, bringing a unique blend of technical expertise and business acumen to her role.

Dr David Gibboni has been part of the clinical research community for 15 years, with experience on the vendor side of outsourcing selling services to pharma clients, and on the sponsor side as a senior manager for an oncology-focused global pharma company. His consulting business, DJGibboni Consulting LLC, offers sales. business development, and outsourcing consultation for vendors in the clinical research arena, tapping his vast network of industry connections.

Caitlin Hirschman has more than 20 years of clinical research experience across Phase 1-4 studies in a variety of therapeutic areas including pulmonology and has spent the last 12 years working with cystic fibrosis. She has successfully provided oversight and clinical trial management support for more than 14 cystic fibrosis studies, including multiple U.S. and global programs. Ms. Hirschman supports teams to ensure high-quality and timely program delivery, providing extensive knowledge of clinical operations, including trial implementation, monitoring and delivery. Ms. Hirschman has managed trials through the clinical development lifecycle from first-in-human to large 200+ center multinational phase 3 trials.

Baljeet Kaur is an Agriculture Operations Manager (AOM) for U.S. Customs and Border Protection (CBP) at the Boston Field Office (BFO) consisting of six New England States (MA, ME, VT, NH, CT, and RI).  As an AOM, Ms. Kaur is charged with providing guidance to personnel within the BFO on various agriculture matters including, but not limited to: regulated garbage compliance, regulation of biological material, and entry requirements for regulated agriculture commodities.  Ms. Kaur has more than 15 years of public service with CBP, and has worked in a variety of environments including, air passenger, air cargo, and maritime.

Dr. Haun is an experienced medical doctor, trained in internal medicine and emergency medicine, with 10+ years of clinical practice. He has a high-quality 10+ years’ work history in the drug development and research industry. Among his previous experiences, he was the head of a global medical affairs department for 4 years, acted as primary medical monitor in 30+ clinical trials, mainly in complex studies in a variety of therapeutic areas including oncology, rare diseases, and advanced therapies (gene, cell, chaperone therapies, etc.). He joined WEP Clinical bringing his expertise in applying knowledge and skills in epidemiology, internal medicine and different medical specialties in drug development, clinical trials, and drug safety. He has successfully implemented several techniques to improve site identification and selection and patient centric solutions to ensure timely enrolment and high retention in challenging patient populations with rare and ultra-rare diseases. He is also experienced in elaborating study plans (medical monitoring, clinical monitoring, safety management etc.) and tools (site reference manual, pharmacy manual, treatment manual etc.).

Juliane K. Mills is a seasoned explorer in the world of clinical research with over 20 years of experience. Juliane's mission is simple but powerful: to make a real difference for people battling rare diseases. At Worldwide, she's the go-to person for creating smart, streamlined plans that help bring new treatments to those in need, without forgetting the real people behind the diagnoses – the patients, their loved ones, and their caregivers. Juliane's work is all about connecting the dots between cutting-edge science and the everyday lives of those affected by rare conditions. She's not just a researcher; she's a champion for better health, working tirelessly to ensure that new, life-changing treatments move from the lab bench to the bedside as smoothly and swiftly as possible.

Carrie Lewis has over 20 years of varied Clinical Research experience.  Carrie is currently an Executive Director, Clinical Program Optimization at Endo USA, Inc. where she oversees Clinical as well Business Operations, eTMF/inspectional readiness, and Training/Oversight.  Prior to Endo, Carrie garnered extensive knowledge in many roles while in academia, at large sponsors, generic sponsor, as well as a global CRO.  She has a Master’s Degree in Clinical Research Administration and has experience in multiple therapeutic areas.

As a Solution Consultant, Jason works with Sponsor organizations to understand their challenges and come up with creative solutions leveraging the elluminate platform. Jason has lead design & development for several products ranging from a Data Management Workbench, Data Integrations, Clinical Operations Platform, Clinical Analytics, and Risk Based Quality Management.  Jason has been in the clinical trials industry for over 15 years and his prior experience includes, global central laboratory, eCOA design, process improvement, and building an automated workforce.

David Ng is Vice President, Global Biometrics at Novotech, a global CRO.   David has over 30 years of experience in global data management, statistics, and regulatory interactions; and has worked on numerous treatments for rare diseases, from proof of concept to submission and ultimate regulatory approval.   David has also collaborated with various organization and vendors to optimize data access and collection, from early EDC and ePRO systems to the use of EMR in clinical development.

Kelsey Buhler has been a Product Specialist at Viedoc Technologies since 2021, and specializes in providing technical demos, support, and project management for Viedoc study builds. Prior to her role at Viedoc, she has 7 years combined experience as a Data Manager/Project Manager at a Medical Device CRO, a Data Entry Specialist, and a Clinical Subjects Associate, where she would obtain consent from subjects in clinical trials. All these experiences drive her passion for user-friendly Electronic Data Capture (EDC) systems that increase efficiencies for the subjects, site, and all other study users.

Kris joined TFS in August 2024, bringing nearly 40 years of clinical research experience to the Oncology and Rare Diseases business unit. Within her role, Kris manages a global team of experts ranging from physicians to clinical specialists and is responsible for supporting the project delivery of all oncology and rare disease programs.

Kris's diverse experience spans working with CROs, pharmaceutical companies, and academic institutions, with more than half of her career focusing on oncology and rare diseases. Her extensive background includes leadership positions as Vice President of Operations, Executive Director of Strategy, and Head of Project Management, among other clinical roles across the industry.

She is deeply committed to improving the patient's journey, particularly for those seeking life-altering and life-saving therapies through clinical trials. Her expertise in patient recruitment, retention, and study visit design allows her to provide valuable guidance to her team and sponsors, ensuring the highest quality in operational execution and deliverables in these complex therapeutic areas.

Stephanie Hitchcock is an Director of Project Management at PCM Trials. Stephanie specializes in adapting trial designs for mobile visit services. She is passionate about expanding the use of high-quality, patient-centric models to drive clinical development. Stephanie is an expert in establishing logistics and procedures on a global scale for complex visit schedules and expanding the scope of what mobile visits can support globally.

Elaina Haeuber, M.S., Senior Vice President, Head of Oncology, has more than 20 years of leadership and project management experience in the biotechnology, pharmaceutical, and CRO industries. She is passionate about driving innovation and bringing new treatments to patients.

In this role Ms. Haeuber oversees a team of oncology/hematology experts in the delivery of tailored and strategic clinical development programs. Along with her team, Ms. Haeuber is dedicated to understanding the acute needs of both patients and sponsors to create impactful project plans, mindful of risk, budget, and time to market.

Ms. Haeuber gained her clinical research operations and project management experience in the biopharmaceutical industry through positions at large pharma, small biotech, and CROs. Programs she supported have led to marketing approval in both the US and EMA. Ms. Haeuber earned a B.A. from Boston University and an M.S. from the University of Illinois at Chicago.

Behtash Bahador is the Director of Health Literacy at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

Anthea has over 30 years of experience within operational and recruitment leadership for clinical sites, technical validation, analytical and manufacturing aspects of cGMP, and quality oversight spanning GxPs.  She advocates for risk-based, phase-appropriate approaches designed to enable compliance, and has a drive for process and attention to detail with a focus on using technology to ease the quality burden.

As Vice President of Commercial Strategy at IQVIA, Anthony Mikulaschek manages all operations, data management, quality management, training and eCOA project work associated with IQVIA eCOA. Anthony has extensive experience in validated system implementation, systems integration, business process reengineering, IT operations, and consulting. He has successfully led the development, delivery, and management of technology solutions for over 30 years including 26 years in the Pharmaceutical sector.

Ben Dudley is the Chief Commercial Officer at MMS. He is a seasoned executive with experience gained over a 27-year career in the industry, in both the biopharma and clinical development services sectors. Ben’s deep, broad expertise spans drug development, sales and customer relationship management, operational leadership, and process optimization. His impressive career includes leadership roles at Parexel, Covance and AstraZeneca, where he consistently demonstrated his ability to lead and innovate across various operational, functional, and commercial domains.

Amy Manley is the Vice President, Clinical and Medical Operations at Paratek Pharmaceuticals.  She has over 25 years of experience in the pharmaceutical industry in roles of increasing leadership.  Prior to joining Paratek, she worked at Wyeth, Pfizer, and Shire.  Amy has worked in numerous therapeutic areas including Neuroscience, GI, Ophthalmology, and Infectious Disease.  She’s been fortunate to have been part of the development and approval of 6 globally marketed products.  She is a solution focused, proven leader who loves working with high performing teams and has thrived in the small biotech environment.