Hybrid Concepts International (HCI) is a niche consulting and advisory firm (current team of ~ 20) serving the fields of cell therapy, gene and gene-modified cell therapies, regenerative medicines, tissue engineering, xeno, and cell-based drug discovery. HCI primarily serves innovative starts-ups and biotechs, also, established biotech, pharma, VCs, non-profits, and subcontracts for other consulting firms. HCI can fulfill both i) project-specific, hourly rate consulting contracts, and ii) longer-term, more largely scoped, part-time, titled advisory contracts. Examples of work over 145 clients served (U.S./Canada/Europe/Asia/AU/Global): • Ad hoc multi-disciplinary consulting for pluripotent stem cell-derived islets for therapy and discovery • Regulatory strategy/translational diligence for cell therapies• Regulatory, CMC, IP for cell therapy tools/platform technologies• CMC & regulatory for therapeutic MSC (and MSC-based combination products), NK cell, engineered T cell, and CAR (including CAR-T, CAR-NK and next gen) therapies• Translational R&D, CMC, and regulatory for gene-modified cell therapies for HIV and cancers (supported uplisting to NASDAQ)• CMC, Regulatory, R&D, and diligence for in vivo gene therapies (AAV and adenoviral), early or BLA stage• Gene edited xenotransplantation products • in vivo gene therapy or gene editing• 361 HCT/P strategies/compliance• NewCo multi-disciplinary consulting for clinicians, IP holding firms, and investment firms for rare diseases, cancer, infectious disease• CIRM CAP and TAP member• Regulatory for parent firm of numerous regen med cpys• Regulatory, CMC and/or diligence for numerous pluripotent cell-derived product/indication support for U.S. development/commercialization • CMC for HCT/Ps:i) exosomes;ii) reproductive;iii) tissue engineered/decellularized;iv) combination products;v) pluripotent-derived products;vi) adipose-derived;vii) medical device outputs.Please visit www.OurHybridConcepts.com

See https://www.roslinct.com/about-us/#leadership.Support USA and UK sites.

• Chair of the CMC Regulatory Task Force (TF) (2022-present).• Former Co-Chair of the Science & Technology (S&T) Committee (2016-2022).

• The Standards Coordinating Body (SCB) is a non-profit organization (501c3), and a consortium of national and international stakeholders in the fields of Gene, Cell & Regenerative Therapies, and Cell-based Drug Discovery.• Supported SCB establishment as a Public-Private Partnership (PPP) with the National Institutes of Standards & Technology (NIST); initiated first discussions with other Federal Agencies (including FDA) domestically and other relevant organizations worldwide. • SCB Co-founder, past President and Board Chairman, and currently member of the SCB Board of Directors• Previously first Co-Chair for the SCB Cell Therapy SectorPlease visit www.standardscoordinatingbody.org

Prior HCI Advisory role.Visit www.ManaTherapeutics.com

Prior HCI advisory Role.Please visit www.roosterbio.com

Prior HCI Advisory role. please visit www.maxcyte.com

• Developed and integrated product regulatory strategy within corporate and clinical strategies for cellular biologics over a wide range of clinical indications• Led or supported development of regulatory strategies and submissions (FDA IND & BLA; ex-U.S. includes Health Canada and EMA) during clinical phase development for Mesoblast’s stem cell therapy products; co-led for what is on track to being first ever allogeneic cell therapy BLA • Regulatory rep on global project teams (lead for Pharm/Tox), provided strategic regulatory leadership and guidance to the teams in defining regulatory requirements and relevant impact on project/product issues (includes preclinical, clinical, strategic input)• Led CMC regulatory rep on global project teams, and worked closely with manufacturing, QA, QC, and CMOs as CMC regulatory submission lead or support (U.S. Master File; ex-U.S. IMPD, Module 3 CTD format), with the end goal of licensure• Led Joint Process Development Committee with CMO covering proof-of-concept, CAPA remediation, GMP tech transfer and support of regulatory submissions • Consult/supported R&D, clinical, and safety teams as subject matter expert (e.g., preclinical studies, clinical trial designs, and potency assays), as well as enhancing internal staff knowledge base• Performed due diligence and competitive/regulatory intelligence on products and technologies as assigned• Supported the commercial team for U.S. and Canadian pricing and reimbursement strategies and documentation, including patient and payor journeys, branding and market access• Mesoblast rep for the ARM and the ISCT. At ARM, both the Regulatory Committee and Science & Technology Committee (I'm co-Chair of S&T), as well as the Cell Therapy Section; at ISCT, both the NA Legal and Regulatory Affairs (LRA) Committee, and the Commercialization Committee and PPD Subcommittees. • Board member on Standards Coordinating Body; Public-Private Partnership initiative

• Selected via highly competitive process as one of two Fellows placed in the Office of the Commissioner (OC) in 2011; Appointed to Office of the Chief Scientist, Office of Regulatory Science and Innovation; Initiated Fellowship in the Office of Strategic Partnerships and IP in OC. Worked on IP and Emerging Tech projects.• CBER Office of Cell, Tissue and Gene Therapies (OCTGT) work included:- Primary regulatory file review for biologics, devices, and biologic-device Combination Products, such as pre-INDs, INDs, and 510(k)s, and exposed to challenging technology and/or policy issues;- Major projects included the current state-of-the-field and identifying trends for MSC-based products (it was nominated by OC and CBER for FDA-wide presentation); also worked on preclinical cell-based Regenerative Medicine IND trend project to complement new FDA Guidance Document on Cell and Gene Therapy Pharm/Tox. Both published in 2014 in Cell Stem Cell and Nature Biotech. • Member of the MSC Consortium on the NIH campus, and acted on planning committee for Center of Excellence in Regulatory Science and Innovation (CERSI) UMD exchange program workshop.• Exposed to international regulatory affairs via the Advanced Technology Medical Product (ATMP) cluster (FDA, EMA, and Health Canada).• Exposed to product jurisdiction: i) via the Tissue Reference Group (i.e. is the product a '361' HCT/P?) and ii) did a rotation in Office of Combination Products, including drafting Request for Designation (RFD) reviews.• Co-founded OCTGT's Device Reviewers Forum; co-hosted OCTGT's Cell Therapy Working Group sessions; member of OCTGT's Pluripotent Stem Cell Working Group; participated in cross-Center initiatives in Regenerative Medicine and Wound Healing.• Did rotation in CVM Animal Biotechnology Interdisciplinary Group (ABIG), exposed to scientific, regulatory, policy, and political issues surrounding use of relevant technology in human use products, including Regenerative Medicine.

• Department manager responsible for developing market-driven international R & D to prioritize and manage multiple scientific projects in parallel in a fluid environment via contract lab or academic/industrial collaborations.• Resident expert in Regenerative Medicine, tissue engineering, stem cell therapy, and immunology, and was responsible to train executives about related concepts and mechanisms, including adult skin stem cells.• Strategized product development of ReCell® device for wound healing, initiated market and product requirements for ReCell Next Generation devices, and worked on implementation of translational research to expand Avita’s Regenerative Medicine pipeline via combination products with collaborators in new clinical indications.• Interacted with clinical, manufacturing, IP, regulatory and sales, in order to maximize value-added by R & D, with the intention of maximizing international sales, minimizing costs, and staying ahead of the competition.• Contributed to clinical trial documentation for regulatory (FDA) approval of the ReCell device.

• Resident expert in Immunology, specifically transplant immunology.• Was lead scientist for in-house immunology platform, including internal development of preclinical transplant and disease models.• Managed and coordinated self-initiated and ongoing academic preclinical collaborations involving transplant immunology via government grant or sponsored research agreement.• Had Advisory role and contributed to development of in vivo models for validation and improvement of proprietary adult stem cell products for use in clinical trials.• Gained expertise in manipulation of proprietary adult stem cell products, including labeling and tracking of proprietary adult stem cells in vivo.• R & D was prioritized for progressing clinical trials utilizing proprietary adult stem cells initiated through IND filings.

• Preclinical transplant modeling to support clinical development of adult Multipotent Adult Progenitor Cells (MAPCs) for tolerance induction.

• Consulted with the Company post-employment on various R & D issues.

• Innovative research leader, scientific project manager, and team coordinator for numerous R & D activities within the Company and outside collaborators. • Initiated, planned, executed, tracked, and completed tasks including assay development, generation of GE animals for transplantation or infectious disease/biodefense applications, development of preclinical cell and animal models, and controlled gene expression in vivo.• Resident expert in Regenerative Medicine, xenotransplantation, immunogenetics, spatially controlled in vitro & in vivo gene expression (constitutive, conditional and/or inducible expression), and immunobiology of transplant rejection.• Characterized the world’s first immunocompromised large animal model to study human infectious diseases and aid in vaccine development. This work has been submitted the USPTO and published. Project results were originally funded by DARPA and NIST's ATP program to generate fully human, high volume, polyclonal antibodies in GE pigs.• Co-authored 5 other trans-disciplinary publications.• Assisted executive management in IP, technological due diligence, innovation, FDA filings, and developing corporate financing methodologies (i.e. non-dilutive grant funding).• Initiated and worked on external national and international collaborations (involving CDAs, MTAs, research agreements, etc), utilizing strong oral and written communication, interpersonal, and negotiating skills, under strict ethical standards and confidentiality.• Prepared and presented formal presentations and summary/quarterly reports for executive management, and supported multi-million dollar grants.• Revivicor was acquired by United Therapeutics (NASDAQ:UTHR) in 2011.

• The Center provides entrepreneurs and small businesses an understanding of and a base for quantifying their business opportunities.• Performed market research, market opportunity assessment, and competitive analysis for a multi-state medical service opportunity.

• The purpose of this initiative is to encourage a trans-disciplinary, integrative approach to health research. • The overall mission of this program is to train a new generation of researchers capable of combining various approaches in devising innovative solutions for research, and treating complex medical problems with regenerative tools (stem cells, engineering and biotech). • This Canadian Institutes of Health Research funded initiative is considered to be the first of its kind, spanning multiple Universities and fields.

• Earned my Ph.D. at the University of Toronto, Faculty of Medicine, Graduate Department of Immunology. My specialties were transplantation, immunobiology of transplant rejection, and generation and characterization of complex GE mice. • Selected accomplishments include earning a cumulative G.P.A. of 3.83, and authoring 11 peer-reviewed scientific publications across many fields (first author of 2 in Circulation and the Journal of Immunology), with more in preparation.• Supported multi-million dollar projects by designing and proposing scientific approaches for institutional research grant applications, including over $100,000 in personal grant awards.• Trained and co-supervised 3 staff members as technicians and co-operative university students working toward multi-faceted projects, worked as a teaching assistant, and as a professional tutor.

• Gained hands-on experience and training on working with GE mice, conducting transplantation, understanding the immunobiology behind transplant rejection, and gene therapy.