Faith Holmes, MD, brings more than 30 years of experience in direct patient care, and 11 years of medical practice management to her role as Elligo’s Chief Medical Officer. Her unique perspective plays an important part in building the company’s network of Research Ready physician practices and preparing them to conduct research. Dr Holmes’ rich perspective — including experience in family medicine, hospice, and palliative medicine that spans solo practice and single specialty and multispecialty group practices — allows her to build rapport with study managers, site staff, and investigators, and provide medical and scientific knowledge to support future growth. Dr Holmes has served as the Principal Investigator for interventional, diagnostic device, and observational trials in several therapeutic indications in Elligo’s eSolutions model and at the Elligo Clinical Research Center. She earned her BS in chemistry and biology from Trevecca University, her MD from ORU School of Medicine, and is board certified in family medicine and hospice and palliative medicine.

Aly Jackson is a Business Development Project Leader within the Pharma Partnering organization at Genentech/Roche. In this role, Aly leads diligence efforts and deal discussions with potential partners to enable collaborations on drug discovery and development. Her primary focus is on platform partnerships, such as those that enable target discovery, lead identification, and drug delivery. Prior to this role, Aly served as a Human Factors Engineer in Device Development at Genentech, supporting the development of combination products such as large on-body injectors, autoinjectors, and pre-filled syringes. She’s also held various roles within Pharma Technical, including manufacturing, regulatory, and MSAT. Aly received her Bachelor’s and Master’s degrees in Bioengineering from UCLA, and her MBA from UC Berkeley. In her free time, she enjoys playing soccer, mountain biking, and traveling the country to explore national parks. 

Dr. Holly Robertson is the Head of Advisory Services at Medidata Solutions where she leads a team of subject matter experts, providing guidance to clients and partners in adopting decentralized clinical trial (DCT) strategies and technologies. She obtained her PhD in Pharmacology from the University of Colorado Health Sciences Center in Denver, CO. Dr.Robertson has over 20 years of experience in pre-clinical, translational, and clinical research at leading academic institutions including the McGovern Institute for Brain Research at Massachusetts Institute of Technology (MIT), Duke University, and Duke Clinical Research Institute (DCRI). She also held appointments at the Broad Institute and the Stanley Center for Psychiatric Research. Since 2015, she has led multi-disciplinary teams in developing operational strategies for DCTs including the ADAPTABLE Study, the Industry’s first and largest fully decentralized clinical megatrial with over 15,000 patients enrolled. She is an active member of Clinical Trials Transformation Initiative (CTTI) participating in the Embedding Clinical Trials into Clinical Practice working group, and the European Forum for Good Clinical Practice (EFGCP) eConsent Initiative resulting in several publications and resources for the clinical trial community. Throughout her career, Dr. Robertson has worked collaboratively with sponsors, sites, patients, ethics committees, and technology companies to pioneer successful strategies in changing the clinical trial landscape. She is passionate about developing patient-centered technologies that improve the design and execution of clinical studies, ease patient participation, and accelerate commercial outcomes to improve patient health.

Zdenek Zencak is the Global Clinical Operations Development Unit Head for Cardiovascular, Renal and Metabolism and currently acting as Head of Program Strategy and Planning in Novartis Global Clinical Operations. In this role, he leads a team that oversees the planning and execution of Novartis global clinical trials across various therapeutic areas. Dr Zencak has more than 20 years of experience in the pharmaceutical industry, with a strong background in Development. He joined Novartis in 2006 and has held various roles in the Novartis Development organization since then. Dr Zencak has a PhD in Chemistry from the University of Basel. He lives and works in Switzerland.

Noble Shore has been leading efforts to develop and integrate innovative technologies in clinical research for nearly 20 years. Noble has led groundbreaking projects including (a) one of the first RBM/EDC integrations on the market which was used in the H1N1 pandemic response in 2009, (b) an automation engine for CDISC SDTM transformations used on over 200 studies since 2012, and (c) launch of the unified Advantage eClinical technology platform for clinical research which was used to qualify Remdesivir as the first available treatment for COVID-19 in 2020 and which has been used on over 1,100 studies to date. Noble holds an MS in Software Engineering from the University of Maryland and a BS in Computer Science from Carnegie Mellon University.

Shira Orr is a pioneering force in the domain of drug delivery systems. She has been developing biopolymers for 25 years starting in the Israeli Technology Intelligence unit at the age of 18. Following her military service Shira completed her BSc and MSc - cum laude at Tel Aviv University. Throughout her PhD studies she received the distinguished Kraitman excellence scholarship, followed by a postdoc at Harvard Medical School. Following her postdoctoral work, Dr Orr has gained experience in the pharma industry. Dr Orr believes that the non-lipid bio-polymer based nanoparticles delivery system is the answer to gene therapy and will reshape the boundaries of gene therapy and patient care.

Charlie Paterson is a clinical development expert and associate partner at PA Consulting. He has a background in physics and extensive knowledge of lab technology, clinical trials design and execution, and provider operations. Mr Paterson drives the development and adoption of breakthrough technologies with leading organizations across the clinical trials continuum using data-driven approaches.

https://www.linkedin.com/in/charliepatersoninnovates/

Kelsey Jakee, managing consultant with PA Consulting, has an established track record of leading and managing transformation in pharmaceutical R&D. Over the past 14 years, she has advised Top 20 BioPharma and industry consortia on clinical innovation, new service and business model development, R&D technology strategy, digital transformation, improving the patient experience, and leveraging novel data sources across preclinical, clinical, and drug safety. Her mission is to drive high-impact and lasting change in clinical research to help us all live our best lives.

https://www.linkedin.com/in/kelseyjakee/

Sam Whitaker is the CEO and Co-Founder of Mural Health, a Philadelphia-based technology company dedicated to making it easier to participate in clinical trials. Sam founded Mural Health not long after his friend, Harley, tragically passed away from ALS. After witnessing the barriers his friend faced to participate in a clinical trial - coupled with his 15 years of experience in clinical trial technology - Sam set out to create a modern, participant-centric solution that was missing in the industry. With kindness and compassion at its core, Sam and the Mural Health team created Mural Link, the industry’s first holistic participant management platform that makes clinical trial participation easier–for patients and caregivers alike–while delivering smoother operations for sites, strategic value for sponsors, and better recruitment and retention.

Previously, Sam founded Greenphire, a clinical trial participant payments company. Building on that experience, he launched Mural Health with the vision of removing barriers to trial participation, fostering more diverse research populations, and ultimately improving clinical research outcomes.

Mandana Borna is the head of oligonucleotide drug product development at Biogen overseeing all aspects of drug product development from formulation design and container closure selection to process development, scale up and tech transfer to support Biogen’s expanding oligonucleotide portfolio. Her responsibilities encompass every phase of product development from preclinical, and clinical stages through to commercialization and life cycle management. Additionally, Mandana continues to lead the non-viral drug delivery activities at Biogen to advance new technologies and overcome challenges of delivery of oligonucleotide and other large molecule therapeutics. She plays a key role in shaping short-term and long-term drug delivery strategies to support Biogen’s pipeline. In addition to internal drug delivery formulation development, Mandana’s team identifies cutting-edge non-viral delivery technologies, design feasibility studies, performs technical assessment and leads project partnership. Mandana holds PhD degree in Materials Science & Biomedical Engineering from McGill University, and her research is focused on formulation development and drug delivery. She has been invited speaker in multiple drug delivery conferences and serves as a reviewer for several journals.

Wout Brusselaers is the founder and CEO of Deep 6 AI, a precision research company that empowers healthcare organizations and life sciences companies to de-risk and accelerate clinical research. Wout founded Deep 6 AI in 2016 to improve clinical trial outcomes through AI-driven software that mines electronic medical record (EMR) data to precision match patients to trials. Wout leverages his entrepreneurial experience and deep operational expertise to help address the industry’s patient recruitment and retention challenges. Wout holds a Masters in International Economics from the University College Dublin and a Licentiate degree in Economics from Vrije Universiteit Brussel.

Alessandro Cavecchi is the Head of the Pharmaceutical Technology Section within Chiesi Farmaceutici’s R&D department, holding a Magister degree in Industrial Chemistry from the University of Parma (IT). With over 20 years of experience in developing inhalation dosage forms, Alessandro has specialized expertise in Dry Powder Inhalers (DPIs) and pressurized Metered Dose Inhalers (pMDIs). In his current role, he ensures the scientific integrity and robustness of formulation and process development for the dosage forms in Chiesi Farmaceutici's R&D pipeline.

Before joining Chiesi, Alessandro served as Senior Formulation Manager at Zentiva (Sanofi Generics), where he was responsible for the formulation and manufacturing development of generic inhalation products. He also worked at Novartis as a Formulation Fellow, supporting the establishment of the Breezhaler® portfolio.