Developing A Gene Therapy Strategy that Navigates Economic Challenges & Regulatory Changes
Managing funding and resources in a capital-strapped industry
Major manufacturing and analytical pitfalls
Producing a gene therapy that is scalable and reproducible
Top regulatory hurdles you should look to avoid
Our panel of industry experts offers strategies and advice for gene therapy businesses amidst financial and regulatory changes. Watch and get insights into how to better manage strategic business decisions, technology and platform implementations, scaling your product at each stage, and more.
Our Panel of Industry Experts
Click on the speaker photos to read their bios
Scott has over 24 years’ experience working with viral vectors, vaccines and biologics in GMP environments. He has been responsible for cleanroom design, build out, and commissioning of vector facilities, as well as the oversight of cell therapy, fill finish and manufacturing support departments.
Scott started his career at Merck and Co. where he worked on the development of an Adenovirus-based HIV vaccine and later, the development, optimization, and validation of release assays for live virus vaccines. He then moved to Indiana University (IU) where he managed the IU Vector Production Facility (IUVPF), overseeing the GMP production and testing of Lentiviral and Retroviral vectors for the IUVPF and the National Gene Vector Laboratories (NGVL). While at the IUVPF he also managed the design, build, and commissioning of a new viral vector GMP production and testing facility.
After leaving the IUVPF, Scott joined Cincinnati Children’s Hospital Medical Center (CCHMC) managing the GMP Vector Production Facility, Viral Vector Core, and the Aseptic Processing Labs. Scott then moved to the University of Florida where he was the Director of Cell Therapy, Fill Finish and Manufacturing Support Operations for Florida Biologix and Brammer Bio. He was also responsible for the design of two new fill finish suites.
Most recently, Scott served as Vice President of Vector Operations at Orchard Therapeutics where he was one of the original ten members and responsible for viral vector development, GMP vector production, plasmid production, oversight of 10 CDMOs, due diligence, and facility design.
Scott is currently a Senior Principal and Head of Gene Therapy CMC at Dark Horse Consulting Group where he has been since February of 2020.
Paola is since 2018 a partner with the Sofinnova Telethon Fund, Italy’s first biotechnology fund focused on rare and genetic diseases. Prior to that, she was head of the Office of Biotechnology Transfer of Ospedale San Raffaele, an internationally renowned research hospital based in Milan, where she spent 14 years actively promoting and contributing to scouting, protecting and licensing intellectual property, including through the incorporation of start-ups.
Paola got a master's degree in intellectual property law before heading up the patent portfolio at St. Raffaele.
Prior to her time at San Raffaele, Paola spent more than 2 years working at The National Institutes of Health in Bethesda, Maryland, studying neurobiology using RNA interference.
She holds a degree in pharmaceutical biotechnology from the University of Milan and a master’s in Intellectual Property Law from the Just Legal Services, a legal training school in Milan.
Biotech executive, CEO and Co-Founder of Kiji Therapeutics and Entrepreneur in Residence (EiR) with AdBio Partners, Executive Chairman of the Board of StemBond and consulting through mC4Tx to several organizations, Professor at the Lisbon University and Board of Directors and Executive Committee member for Alliance for Regenerative Medicine (ARM).
President-Elect and Board of Directors member of the International Society of Cell and Gene Therapy (ISCT) from May 2022. Previously Chief Commercialization Officer and Chair of the ISCT Commercialization Committee (2014-2020) leading the expansion of the industrial community, strengthening the Committee to better represent the industrial translational objectives and needs of society membership.
Previously CEO of Bone Therapeutics (2019-2022) leading the listed company through strategic refocus, several raises and a successful M&A transaction. Before that, CEO of Zelluna Immunotherapy (2017-2019), where he established the corporate structure, raised successfully, built the team and launched the strategy for solid tumors allogeneic C>. From 2010-2017 was CMO/COO of TxCell, establishing and leading the professional C> product translation development for autoimmune diseases. Participated on the company IPO and several successful raises. From 2006-2010 was VP of Global Medical Affairs at UCB contributing to the development of the biologics portfolio, product approval and launch. In 2004, joined Nabi Pharmaceuticals as the VP of Medical/Regulatory Affairs for Europe, leading from inception the creation of the vaccine company in Europe.
After several public sector clinical, academic, and regulatory positions in Portugal and at the European Medicines Agency (EMA), namely as CHMP member, spent six years with BMS (1998-2003) as Country Medical Director, Executive Director, and VP of International Medical in Portugal and Belgium.
Holds an M.D. and Specialist in Infectious Diseases from the Faculty of Medicine, University of Lisbon, a Ph.D. in Immunology, University of Birmingham, and a certificate on Health Technologies Economics, Stockholm School of Economics. He is Fellow of the Faculty of Pharmaceutical Medicine of the RCP in the UK.
Experts from our Milan Cell & Gene Center of Excellence
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Luca Alberici, General Manager of the Milan, Italy facility is a value driven professional who came to AGC Biologics through the July 2020 acquisition of MolMed, a leading cell and gene therapy company. His rich educational background is complemented by more than 14 years of industry experience in roles of increasing responsibility for strategic business development and operations, licensing, project management and intellectual property for large molecule and specialty drug development and commercialization. Throughout his career, Luca has been fundamental in licensing and strategic supply agreements that drove top line results in his former position as Chief Business Officer at MolMed. In addition to practical proficiency with discovery and development for HIV and tumor therapies in his early career, Luca has extensive experience in negotiating go-to-market strategies and bringing new cell and gene therapies to market through partnerships with leading biopharmaceutical companies.
Luca earned a PhD and Masters in cellular and molecular biology from Libera Università Vita-Salute San Raffaele, in addition to a Master of Business Administration (MBA) from SDA Bocconi. He has a thorough understanding of European regulatory requirements and pricing policies, and is a published author and frequent industry speaker.
Giuliana holds a degree in Biology and a PhD in Gene Therapy from the University of Urbino. She is one of the brightest minds in the cell and gene therapy field and has strong experience in the development and industrialization of T- and hematopoietic cell transduction processes with lentiviral and retroviral vectors.
She has worked on the development of GMP processes for large-scale vector production and purification for lentivirus, retrovirus and adeno-associated viral vectors. As a leader at AGC's Cell and Gene Center of Excellence, she is designing processes that help scale and commercialize cell and gene therapies, making them available to the general population.