With over two decades’ experience in the biotechnology and pharmaceutical industry, Birgit Schultes, PhD brings deep immunology and cell therapy expertise to Intellia. She manages a multidisciplinary team focused on ex vivo applications of CRISPR/Cas9 to generate novel cell therapies for oncology and autoimmune indications. Prior to joining Intellia, Dr Schultes served as senior director, In Vivo and Exploratory Immunology, at Unum Therapeutics (now Cogent Biosciences, Inc.), where she was responsible for its In Vivo team and leading its exploratory immunology efforts. Earlier in her career, Dr Schultes held a variety of translational research roles in biology and immunology at Momenta Pharmaceuticals, United Therapeutics and AltaRex Corp. Additionally, Dr Schultes co-founded and served as scientific advisor at Advanced Immune Therapeutics, a company working to develop novel cancer therapeutics.

Dr Schultes received her MS in Biology and PhD in Immunology from the University of Bonn, Germany, and a degree in Advanced Management Development from Boston University.

Nathan is a dedicated life sciences professional with nearly 25 years of experience across biopharmaceuticals, medical devices, and combination products in individual contributor and leadership roles. He has experience in small-scale and large-scale manufacturers as well as professional services/consulting. He is passionate about commercializing safe and effective products that will improve the quality of life for patients and their caregivers. He considers himself a builder of strategy, teams, systems, and best practices to ensure internal and external stakeholders are successful. His career foundation was established in engineering, product and process development, manufacturing, continuous improvement, and program management roles. Over time, Nathan made a transition to focus on quality and regulatory affairs to complement my technical experience. In his current role, he build strategic solutions internally and externally to enable clients to accelerate the development and commercialization of new therapies. Nathan focuses on providing solutions that are not only technically sound, but also compliant with evolving regulations and industry best practices. He acquired the Certified Quality Auditor (CQA) designation through the American Society for Quality (ASQ) and hold a Regulatory Affairs Certification (RAC-US) through the Regulatory Affairs Professionals Society (RAPS). Additionally, he is currently a Board Member for the Parenteral Drug Association (PDA), Southeast Chapter.

Pam Cusick is an experienced research professional with more than 30 years of expertise in study design, implementation, and analysis. Her background in public health communications and research, coupled with her passion for patient advocacy, dovetail with Rare Patient Voice’s mission and vision. She hopes to expand Rare Patient Voice’s panels to include all patients and family caregivers who want to share their opinions and impact their disease category. Pam earned a BA in Psychology from Sweet Briar College, and a MA in Psychology from the New School for Social Research. She is Past-President of the Board of Directors and Scientific Advisory Council Lead for the Horses and Humans Research Foundation. As Senior Vice President, Pam’s focus is on the continued growth and success of RPV, with an eye on client services, business development, and oversight of patient outreach, panel management, and marketing. 

Paul O’Donohoe is Senior Director, eCOA Product and Science at Medidata Solutions, a clinical software platform provider. He is responsible for providing strategic oversight of the development of Medidata's electronic clinical outcome assessment technologies, and supporting internal teams and partners around the implementation of industry, regulatory and scientific best practices in clinical trials using mobile health technologies. He is passionate about developing the field of eCOA and mobile health through research and active involvement in industry consortia, and was previously the Industry Vice-Director of the C-Path ePRO Consortium.

Previously, Paul worked as a research psychologist at a child and adolescent mental health clinic based in Dublin, Ireland. He moved into the health consulting field with United BioSource Corporation where he worked across the health outcomes, health economics and health data capture groups. Prior to Medidata, Paul was Director of Health Outcomes at CRF Health (now Signant Health), an eCOA provider, where he led their health outcomes team. He has a MSc in Cognitive and Clinical Neuroscience.

• • Svenja Wacker, PhD is a bilingual (German/English), licensed clinical neuropsychologist with expertise in global clinical trial management and consultation, as well as extensive experience in hospital-based rehabilitation neuropsychology, neuropsychological assessment and intervention, program development, and medical staff training.
• • Dr Wacker graduated from George Mason University with a PhD in clinical psychology and a fellowship in clinical neuropsychology at Yale University School of Medicine. She completed a postdoctoral residency at Harvard Medical School in neuropsychological assessment.
• • Dr Wacker has supported a diverse research portfolio in international clinical trials. As a cultural-linguistic expert consultant she contributed to the training, certification, and remediation of site raters and data validation protocols. As Associate Director of Clinician Network with Cogstate, she grew a global expert consultant pool of 150 neuropsychologists, and managed all aspects of recruitment, training, certification, performance monitoring, and operational logistics for their work on a broad portfolio of clinical trials.
• • In her 15 years of clinical practice, Dr. Wacker focused on the assessment of neuropsychological functioning in adult patients. She aimed to guide clients to a place of personal resilience and empowerment through an array of brain-based therapeutic techniques.

Dr Loudon is a Board certified General and Pediatric Neurosurgeon, with 20 years of clinical and biomedical research experience. Graduate training at NINCDS/NIH and MD Anderson Cancer Institute.

Harshal Shah is Head of Device Strategy & Innovation at Sanofi with the responsibilities of setting medium to long term device strategy for Sanofi’s global portfolio of R&D pipeline, driving innovation and IP generation, managing new device technology research and supporting technical due diligences. He has spent 17 years in medical device and drug delivery technology industry in strategic leadership roles. He has BS in Mechanical engineering from Nirma Institute of Technology, MBA in Supply Chain and Finance from Syracuse University, and Post-grad in Cancer Biology & Therapeutic Development from Harvard Medical School.

Andrew holds a First Class Combined Honours in Biochemistry and Chemistry and a PhD in Polymer Chemistry from Aston University along with over 34 years in R&D. His early work at ICI led to novel chlorine-resistant reverse osmosis membranes. At Johnson & Johnson, he patented a non-woven polymer fabric, contributing to the success of ob® ProComfort® tampons. From 1996, he developed advanced biomedical polymers at Biocompatibles UK Ltd, culminating in the award-winning Drug Eluting Bead (DEB) Technology, acquisition by BTG, and subsequent acquisition by Boston Scientific where Andrew became a VP of R&D. Andrew formerly was R&D Director at Owen Mumford, leading to the creation of a COVID-19 vaccine autoinjector. He has published 259 peer-reviewed articles, holds 57 patents, and is a Fellow of multiple prestigious scientific societies. As Principal Scientist at Calla Lily Clinical Care, Andrew leads the research and development efforts of the company's novel vaginal drug-device combination products.

Dr. Niya Bowers joined the Bill & Melinda Gates Foundation in 2015, as a Senior Program Officer in Chemistry, Manufacturing and Controls (Integrated Development). She works closely with foundation’s strategy teams and partners and provides technical expertise and strategic guidance for therapeutic drug development in Global Health. Dr. Bowers has over 30 years of experience in pharmaceutical product development, including the end-to-end development of drug substances, drug products, and analytical. She also has in-depth experience in Process Analytical Technology (PAT), regulatory, and project management. Prior to joining the Foundation, she was a managing partner of Garden State Pharmatech, LLC, a CMC consulting firm. From 2010 to 2014, she was an executive director in Merck’s Global Science Technology and Commercialization organization. She was responsible for late phase analytical development for both drug substance and drug product and the head of Merck’s Global Process Analytical Technology. Before Merck, she was a director of Oral and Specialty Product Development in Schering-Plough Research Institute. She led the development, filing and approval of over 15 commercial products at Schering-Plough and Merck.

Dr Ketaki Deshmukh is a pharmaceutical professional with over a decade of experience in academia and industry, her expertise encompasses the design and development of novel lipid-based, polymer and inorganic nanoparticles for drug and gene delivery. She currently serves as a Senior Scientist at Novo Nordisk, where her work focuses on advancing novel lipid nanoparticle formulations for therapeutic applications. Dr Deshmukh holds a PhD in nanomaterials from BITS Pilani, her academic foundation, combined with industry experience, provides her with a holistic perspective on the challenges and opportunities in lipid nanoparticle-based drug delivery.

Raffi Tonikian, PhD is the Director, Translational Biomarkers at AbCellera and is responsible for outlining the desired characteristics to guide antibody development. Dr Tonikian completed his PhD and postdoc at the University of Toronto’s Center for Cellular and Biological Research in protein and antibody engineering. Dr Tonikian joined AbCellera from Merck where he served as Oncology Medical Affairs Director in Canada. Dr Tonikian brings his broad expertise in autoimmunity and oncology to design and implement translational and biomarker strategies across several programs.

Will holds a Masters in Mechanical Engineering from the University of Bath, in the United Kingdom. As a Principal Engineer at Crux, he has over 16 years experience in mechanical engineering for extreme operating conditions and environments. As technical lead on multiple medical device due-diligence studies, Will is well-versed in identifying and understanding technical risk and the positive impact early stage due-diligence and risk management can have on a project. Being an advocate for Systems Engineering methodologies, Will adds a data-driven perspective across the full device lifecycle.