Archives: Speakers

Laura is the Director of Clinical Quality Assurance at Syros Pharmaceuticals. Strategic clinical research compliance business continuity leadership in COVID-19 environment. Expert knowledge of GCP Quality Operations and Compliance in the Pharmaceutical and Biopharmaceutical industries focusing on risk-based environments.

Amanda McEwen has over 14 years of experience in clinical research that spans work in academia, contract research organizations, and several Boston-area small-to-mid-size biotechnology companies. Throughout her career, Amanda has held roles of increasing responsibility within the Clinical/Regulatory Development space across a range of therapeutic areas including rare, neurodegenerative, respiratory, infectious, and metabolic diseases. Her experience includes a variety of therapeutic product types, including combination products, most notably a novel dry powder inhalation therapy to treat motor issues in Parkinson’s patients, Inbrija™, approved by the FDA and EMA. Amanda has a particular affinity for early phase work and has played pivotal roles in shepherding several programs from the bench to the clinic, most recently in her previous role as Vice President of Clinical Development of Nocion Therapeutics, where she successfully led the efforts to complete Nocion’s first Phase 1 study amidst the backdrop of the emerging SARS-CoV-2 pandemic. In addition to her work in industry, Amanda serves as an adjunct faculty member for Northeastern University’s Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices, specializing in courses on the strategic and technical considerations for IND and NDA/MAA submissions and Pharmacovigilance regulations and best practices. Amanda holds a BA in Psychology from the College of the Holy Cross and a Master of Research Methods in Psychology degree from the University of York.

Marissa Fayer is a 22-year medtech executive, innovator, entrepreneur, investor, and philanthropist. She is the CEO and founder of social enterprise / non-profit HERhealthEQ, President of DeepLook Medical, VP of Operations at Ultrasound AI, and US Partner at Goddess Gaia Ventures. Her mission is to move innovation and the health of women forward throughout the world. Marissa has previously served as an executive at Hologic, Olympus (formerly ACMI), Maquet-Getting (formerly Atrium Medical), Providien Medical, and Accumed Innovative Technologies. Her consulting clients include many of the Top 500 healthcare companies and innovative start-ups including Pfizer, Boehringer Ingelheim, Nuvasive, the National Institute of Health (NIH), Oerlikon Medical, Lonza Precision Medical, Emit Imaging, and others. Marissa sits on the board of medtech companies Welwaze Medical and DeepLook both focused on improving the diagnosis of breast cancer; Ultrasound AI focused on predicting Preterm birth, and PMD Medical focused on urinary incontinence; Marissa graduated from Boston University with a BS in Manufacturing Engineering and from University of Connecticut with an MBA. Marissa is a TEDx Speaker (2019 at TEDxLugano), a UCSC Miller Center Social Entrepreneur Fellow, and has been listed as one of the Top 100 Women in Medtech in 2018, a Top Woman Activist to Watch, awarded the 2018/9 Africa Development Award, a Wonder Women in Medtech, and has delivered keynote discussions at the World Alliance Forum, MedExec Women, Lithuanian Biotechnology Association, Leading Entrepreneurs of the World, Women’s Health Innovation Summit, DeviceTalks, HER.Talks, and others. Marissa has appeared in several online and print publications such as Medical Design & Outsourcing, BloombergLaw, FemTech Analytics, the Maven Collective, Med Device Online, and TheStreet.com. Marissa leads the #wealththroughhealth and #healthequityforwomen movements and is dedicated to innovative solutions for global operations and improving women’s health throughout the world. Marissa lives in New York City and can be found at www.marissafayer.com

An expert in clinical trial operations, Camila Matheny works closely with Pharma, Biotech and CRO customers to clearly articulate the value of adopting digital technologies to deliver decentralized and hybrid clinical trials. A member of the SCDM eSource Consortium and DTRA, Camila leads with data – the driving force behind bringing new therapies to market. With over 15 years of clinical trials experience, a background in data management and a passion for the latest cutting-edge technologies, Camila provides a unique combination of expertise to help guide the industry towards the future state of patient-first clinical trials.

Frederik Grell Nørgaard is Project Manager for decentralised trials at the Clinical Trial Unit, Danish Medicines Agency (DKMA). Frederik is working as a regulatory assessor and coordinator of clinical trials applications and runs several Danish initiatives such as the dialogue forum for decentralised trials (DCT). He is also the co-author and coordinator of the Danish DCT guidance. Frederik is a member of several workgroups within the Clinical Trials Facilitation and Coordination Group (CTFG) being involved in development of DCT guidance and a Q&A regarding the IVDR-CTR interface. Frederik has a background as Master in Pharmacy.

Alexis Davin is a clinical optimization specialist at N-SIDE and a volunteer at the GCSG. His experience in clinical supply expanded quickly by solving day-to-day supply challenges of biopharma companies. He is passionate about how digitalization can improve the clinical supply industry and, ultimately, impact patients’ health. Alexis is also supporting the development of new digital solutions to solve supply chain issues in clinical trials, which offers him a strategic view on industry trends and internal processes.

Jan Talts has extensive R&D and management experience from academia, the biotech industry, and the health care sector. He earned his PhD in Animal Physiology at Uppsala University working with extracellular matrix molecules in development and disease and has since then held positions as Associate Professor at Lund University Medical Faculty, Associate Professor and Section Leader for Anatomy and Cell Biology at the Royal Veterinary and Agricultural University, Copenhagen, Chief Medical Staff, Clinical Pathology, Lund University Hospital, and Senior Scientist, Project Manager and ECA certified QA Manager at the Swedish Regenerative Medicine Company Xintela AB. During the last years, he has been with Amniotics AB, first as Senior Scientist, then Chief Quality Officer and now Chief Operating Officer. He is the inventor on several patents and has published articles in international journals such as Cell, Molecular Cell, EMBO J, and PNAS. Jan Talts is well familiarized with most aspects of Advanced Therapy Medicinal Product (ATMP) development and have hands on experience within the preclinical, CMC, and regulatory fields.

I am an international business lawyer with an important corporate and transactional practice within the LifeSciences industry, mainly dealing with clinical R&D, finance, manufacture and logistics. I am from Spain but trained and with practice in the US, Latin America and, more recently, in the Nordics. I developed a deep expertise on: (i) Trading, infrastructure, public bidding processes; (ii) M&A, patent licensing, tax strategies; (iii) Foreign trade, customs, international business practices; (iv) Intellectual Property, IP monetization, technology transfer; and (v) implementation of strategies for small biotechs to become global. Currently I am the Head of Legal Affairs & Compliance at Pila Pharma AB in Sweden.

Arrash is an academic paediatrician at Imperial College, and is Huma’s Global Clinical Director. His previous national roles included working at the Department of Health and NHS England/Improvement. His healthcare experience includes some of the largest healthcare projects to date, including the 7-day hospital services programme and a range of other national initiatives.