Investigators to Investors Workshop


 
Investigators to Investors (I to I)
Networking Workshop
At ISCT 2022 SAN FRANCISCO
Wednesday, May 4th 12:00-16:00 PT

Organized by the ISCT Business Development & Finance Committee the Investigators to Investors (I to I) in person Pre-Conference Workshop will bring together cell and gene therapy investors for a half-day educational event providing unparalleled access to cell and gene therapy key opinion leaders.

Location
ISCT 2022 San Francisco, Moscone West Convention Center, 800 Howard St, San Francisco, CA, 94103

Target Audience & Access
Access is reserved for Investors and Analysts interested in learning about the latest advancements in cell and gene therapy translation, and accessing leading experts from across the commercialization pipeline.


Session 1 – Ask the Experts

90-minutes

Rapid fire panel discussion on the latest advancements in CGT  – Ask your critical questions to leaders in cell and gene therapy clinical manufacturing, clinical trial design, therapeutic delivery and product commercialization. The track will commence with a state of the industry overview and panel discussion covering topics crucial to investor due diligence.

State of the Industry Address provided by: 
Asthika.jpg
Asthika Goonewardene
Managing Director, Senior Biotech Analyst
Truist Securities
United States

ASTHIKA GOONEWARDENE
Asthika Goonewardene is a Managing Director at Truist Securities covering biotechnology companies with a focus on cell therapy, immuno-oncology, and antibody technology. Prior to joining the STRH Biotech team in 2019, Mr Goonewardene was a senior analyst with Bloomberg Intelligence, leading coverage of the global biotech sector. Before joining Bloomberg in 2011, Mr Goonewardene worked as a senior management consultant at Datamonitor.  He started his career as an analyst at OSI Pharmaceuticals in 2005, and first joined the sell-side in 2007, with the biotech team at Piper Jaffray in London. Mr Goonewardene holds a BS in Biotechnology and an MBA in Technology Management from Rochester Institute of Technology.
Moderator 

Patrick Rivers, MBA
Co-Chair, ISCT Business Development & Finance Committee
Director of Research
Aquilo Capital Management
United States
PATRICK RIVERS, PhD
Patrick joined the investment team at Aquilo Capital in 2014. From 2005-2014 he worked as a research scientist in various drug development capacities for several public and private biotech firms, including Sutro Biopharma, Exelixis and Xoma. This experience includes research and development for preclinical and clinical stage products in oncology and inflammatory diseases. Patrick received his B.S. in Chemical Engineering at UCLA and his MBA from UC Berkeley's Haas School of Business.
Panelists
Curran__Kevin_circle.jpg
Kevin J. Curran, MD
Assistant Attending, Stem Cell Transplant and Cellular Therapy Program
Director, Immune Effector Cell (IEC) Program
Department of Pediatrics
MSK Kids, Memorial Sloan Kettering
United States
KEVIN J. CURRAN, MD
Bio TBC
S__Nikiforow.png
Sarah Nikiforow, MD, PhD
Asst. Prof, Stem Cell Transplantation
Medical Director, Cell Manipulation Core Facility
Technical Director, Immune Effector Cell Program
Dana-Farber Cancer Institute
United States
SARAH NIKIFOROW, MD, PHD
Sarah Nikiforow currently practices as Assistant Professor in Stem Cell Transplantation at Dana-Farber Cancer Institute, Assistant Medical Director of the DFCI Cell Manipulation Core Facility for the past 5 years, and Technical Director of DFCI's Immune Effector Cell Therapy Program. She also serves as Co-chair of the CIBMTR's Cellular Immunotherapy for Cancer Working Committee (CICWC), was a co-author of FACT's first Immune Effector Cell Standards and has served until now as ISCT's Regional Secretary for North America. Her expertise lies in spanning the clinical, regulatory and processing fields to bridge any gaps within Dana-Farber and in the field in general as cellular therapies explode in volume and number of applications.
schaffer_circle.jpg
Jon A. Rowley, PhD
Chief Product Officer & Founder
RoosterBio, Inc
United States
JON A ROWLEY, PhD
Jon A. Rowley, Ph.D., is the Founder and Chief Product Officer of RoosterBio Inc. Jon started RoosterBio in 2013 as part of his personal quest of having the biggest impact possible on the commercial translation of technologies that incorporate living cells, including cellular therapies, engineered tissues, and tomorrow’s medical devices. With a Ph.D. from the University of Michigan in Biomedical Engineering, Jon has authored over 35 peer-reviewed manuscripts and has 20 issued or pending patents related to biomaterials development, tissue engineering, and cellular therapy. He started his industry career at BD as a scientist and R&D manager in a Cell & Tissue Technologies group focused on applying high throughput screening technologies to cell therapy media development and tissue engineering. Jon then contributed to the clinical development of Aastrom Biosciences’ Tissue Repair Cell product, where he was Sr Manager of Process Development responsible for manufacturing process improvements and cell delivery to the patient. Jon also spent 5 years as Director of Innovation and Process Development in Lonza’s Cell Therapy CMO business. He currently resides in Walkersville, MD with his wonderful wife and their 3 awesome children.
schaffer_circle.jpg
David V. Schaffer, PhD
Professor; Director of QB3, Dept of Bioengineering
Helen Wills Neuroscience Institute
UC Berkeley
United States

DAVID SCHAFFER, PhD
David Schaffer is the Hubbard Howe Professor of Chemical and Biomolecular Engineering, Bioengineering, and Molecular and Cell Biology at the University of California, Berkeley, where he also serves as the Director of the Bakar Bioenginuity Hub and QB3-Berkeley. He received a B.S. from Stanford University in 1993 and a Ph.D. from MIT in 1998, both in chemical engineering. He then conducted a postdoctoral fellowship at the Salk Institute for Biological Studies before joining Berkeley in 1999. There, he applies engineering principles to optimize gene and stem cell therapies, work that includes developing the concept of applying directed evolution to engineer targeted and efficient viral gene therapy vectors as well as new technologies to investigate and control stem cell fate decisions. He has published >240 papers, has advised >90 graduate students and postdoctoral fellows, is an inventor on >50 patents, and developed technologies that are being used in 9 human clinical trials. In addition, he has co-founded eight companies, including 4D Molecular Therapeutics (NASDAQ FDMT), Ignite Immunotherapies (acquired by Pfizer) and Rewrite (acquired by Intellia). Finally, has received recognitions including the National Academy of Inventors, Andreas Acrivos Professional Progress Award, the American Institute of Chemical Engineers Pharmaceutical and Bioengineering Award, the American Chemical Society Marvin Johnson Award, and the Biomedical Engineering Society Rita Shaffer Young Investigator Award.

.


Session 2 – Meet the Experts

120-minutes

Opportunity to engage in four small group 30-minute roundtable breakouts with Cell and Gene Therapy experts. Breakouts will consists of 4-6 investors per KOL; appointments available on a first come first served basis.

Clinical Roundtable Experts
Curran__Kevin_circle.jpg
Kevin J. Curran, MD
Assistant Attending, Stem Cell Transplant and Cellular Therapy Program
Director, Immune Effector Cell (IEC) Program
Department of Pediatrics
MSK Kids, Memorial Sloan Kettering
United States

KEVIN J. CURRAN, MD
Bio TBC
S__Nikiforow.png
Sarah Nikiforow, MD, PhD
Asst. Prof, Stem Cell Transplantation
Medical Director, Cell Manipulation Core Facility
Technical Director, Immune Effector Cell Program
Dana-Farber Cancer Institute
United States

SARAH NIKIFOROW, MD, PhD
Sarah Nikiforow currently practices as Assistant Professor in Stem Cell Transplantation at Dana-Farber Cancer Institute, Assistant Medical Director of the DFCI Cell Manipulation Core Facility for the past 5 years, and Technical Director of DFCI's Immune Effector Cell Therapy Program. She also serves as Co-chair of the CIBMTR's Cellular Immunotherapy for Cancer Working Committee (CICWC), was a co-author of FACT's first Immune Effector Cell Standards and has served until now as ISCT's Regional Secretary for North America. Her expertise lies in spanning the clinical, regulatory and processing fields to bridge any gaps within Dana-Farber and in the field in general as cellular therapies explode in volume and number of applications.
Manufacturing Roundtable Experts
Jeff_Liter_circle.jpg
Jeff Liter, MBA
Chief Executive Officer & Founder 
Luminary Therapeutics
United States
JEFF LITER, MBA
Jeff is a seasoned CEO with a proven track record at profitably growing emerging companies and business divisions. He has raised over $10M in seed capital from angel investors to start four different companies which he then led to becoming profitable or acquired. At his time at PCT as their COO he supported over 20 clinical trials in the Cell and Gene Therapy field. These trials ranged from Phase I to Phase III pivotal trials.
phil_Vanek_circle.jpg
Phil Vanek, PhD
Chief Technology Officer
Gamma Biosciences
United States
PHIL VANEK, PHD
Phil is responsible for technical due diligence and evaluation of potential investments, as well as guiding operational, R&D and strategic initiatives carried out at portfolio companies. An entrepreneurial and strategic international business leader, Phil joins Gamma from GE Healthcare’s Cell and Gene Therapy business unit where he directed strategy and portfolio growth. Phil received his Ph.D. in Biochemistry and Molecular Biology at Georgetown University Medical Center followed by an IRTA fellowship at the National Cancer Institute in Maryland, and at the Hollings Cancer Center in Charleston, SC. Phil was an instructor for Johns Hopkins University Advanced Academic Programs teaching Biotechnology Marketing in the Masters of Biotechnology / MBA program, and has held leadership positions in a number of life sciences companies including Life Technologies, Becton Dickinson, and Lonza. Phil is a Board Member of CCRM in Toronto Canada and a Board Member of the ARM Foundation.
jon_rowley_circle.jpg
Jon A. Rowley, PhD
Founder & Chief Product Officer
RoosterBio, Inc
Aquilo Capital Management
United States

JON A. ROWLEY, PhD
Jon A. Rowley, Ph.D., is the Founder and Chief Product Officer of RoosterBio Inc. Jon started RoosterBio in 2013 as part of his personal quest of having the biggest impact possible on the commercial translation of technologies that incorporate living cells, including cellular therapies, engineered tissues, and tomorrow’s medical devices. With a Ph.D. from the University of Michigan in Biomedical Engineering, Jon has authored over 35 peer-reviewed manuscripts and has 20 issued or pending patents related to biomaterials development, tissue engineering, and cellular therapy. He started his industry career at BD as a scientist and R&D manager in a Cell & Tissue Technologies group focused on applying high throughput screening technologies to cell therapy media development and tissue engineering. Jon then contributed to the clinical development of Aastrom Biosciences’ Tissue Repair Cell product, where he was Sr Manager of Process Development responsible for manufacturing process improvements and cell delivery to the patient. Jon also spent 5 years as Director of Innovation and Process Development in Lonza’s Cell Therapy CMO business. He currently resides in Walkersville, MD with his wonderful wife and their 3 awesome children.
Commercialization Roundtable Experts 
Sven_2022.png
Sven Kili, MBChB, MRCS (Eng)
Co-Chair, Business Development & Finance Committee
Chief Executive Officer
Antion BioSciences
United Kingdom / Switzerland
SVEN KILI, MBShB, MRCS (Eng)
Dr Sven Kili, is Principal at Sven Kili Consulting Ltd. Where he provides specialist strategic consulting services to innovative Cell & Gene Therapy companies. His clients include small and medium sized companies from formation through to clinical development and commercialisation. He was previously the Head of Development for the Cell and Gene Therapy division of GSK Rare Diseases where he led teams developing and commercializing exvivo Gene Therapies for a variety of rare genetic disorders including Strimvelis®, the first ex-vivo gene therapy to be approved for children with ADA-SCID; Wiskott - Aldrich syndrome (WAS); Metachromatic Leukodystrophy (MLD) and Beta-Thalassemia. Prior to this, he was Senior Director, Cell Therapy and Regenerative Medicine for Sanofi (Genzyme) Biosurgery where he led the clinical development, approval and commercialisation activities of the first combined ATMP approval in the EU for MACI®. He and his team also prepared and submitted Advanced Therapy regulatory filings for Australia and the US, including health technology assessments and he was responsible for late stage developments for Carticel® and Epicel® in the US. Before joining Genzyme, Sven led the cell therapy activities and oversaw all UK & Irish regulatory functions and was the QPPV for pharmacovigilance for the Geistlich Pharma. Sven trained as an Orthopaedic surgeon in the UK and South Africa and since leaving full-time clinical practise has developed expertise Cell and Gene Therapy in clinical development, regulatory compliance, value creation, risk management and product safety, product launches and post-marketing activities. He is on the board of CCRM in Canada; Xintela - a Swedish Stem Cell company, the SAB for LGC Corporation and is the chair of the CGTAC as part of the UK BIA and a Board member of the Standards Co-ordinating Body for Regenerative Medicine. Most recently, Sven was appointed as Chair of the UCL course “Masters in Manufacture and Commercialisation of Stem Cell and Gene Therapies” steering committee. Additionally, he still maintains his clinical skills in the UK NHS and serves as an ATLS Instructor in his spare time..

Tay Salimullah
VP, Global Head Value & Access, Gene Therapies
Novartis
United States
TAY SALIMULLAH
Tay is Vice President, Global Head of Value & Access, currently building a 21st century integrated access function to transform rare diseases through gene therapies. Overseeing translational access; gene pricing & contracting, geneconomics; real-world data; and public policy.
He has diverse global market access, pricing, and commercial experience across biopharmaceuticals, consultancy, social sector and private equity. Since joining Novartis in 2013, Tay has led strategic and operations teams across various divisions in Pharma, Region Europe, Oncology, Cell & Gene Therapies (part of the original team that lead the first FDA approved cell therapy Kymriah® for children with acute lymphoblastic leukemia) and Group Global Health (launching the enterprise flagship sickle cell disease program). He was a founding member of Harmony®, the largest real-world data program in hematology in Europe. He is focused on inspiring associates to think early and differently about patient access and reimbursement.
Before Novartis Tay spent eleven years with Pfizer, where he held positions of increasing responsibility within commercial, market access and strategy development. In 2009 Tay completed his Global Health Fellowship: in-field healthcare systems experience in Malawi. He has also worked for a private investment group to incubate healthcare access across Asia. He has lived and worked in Europe, Asia, Africa and the USA and passionate about breakthrough thinking to transform global patient access.
Regulatory Roundtable Experts 
bambi
Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP
ISCT Deputy Chief Regulatory Officer
Director, Clinical Research & Early Product Development
Associate Professor, Pediatrics, Center for Cell and Gene Therapy
Baylor College of Medicine | Texas Children's Hospital
United States
BAMBI GRILLEY, RPh, RAC, CIP, CCRC, CCRP
For over 30 years, Bambi Grilley has worked primarily in the field of Clinical Research, focused predominately on oncology. She is an Associate Professor, Pediatrics at Baylor College of Medicine and the Director of Clinical Research and Early Product Development for the Center for Cell and Gene Therapy where she is responsible for coordinating the development, implementation, and conduct of clinical research protocols for use in four affiliated hospitals and institutions. Her expertise has helped to establish the Protocol Review Committees, the Data Review Committees, the Clinical Research Quality Control Program and the Clinical Research Quality Assurance Program. She has assisted investigators in conducting over 2000 clinical research studies and the submission of 213 Investigator Initiated INDs and currently, approximately 70 clinical research treatment studies are active with CAGT. She is the recipient of The Norton Rose Fulbright Faculty Excellence Award and the 2021 AACR Team Science Award for her work with the St. Baldrick’s Foundation - Stand Up To Cancer Pediatric Cancer Dream Team. She also serves as the Deputy Chief ISCT Regulatory Officer, Chair of NA LRA, Co-Chair of ISCT 2022 and member of multiple ISCT Committees. 
yong
Yong Fan, MD
Sr. VP, Global Regulatory Affairs
CARsgen Therapeutics
United States
YONG FAN, MD
Yong Fan has more than 30 years cellular and gene therapy development and regulatory experiences. Yong was primarily involved in Hematopoietic stem cell transplantation, cancer immunotherapies and other regeneration medicine product development at New York Blood Center, New York Presbyterian Medical Center, Memorial Sloan-Kettering Cancer Center and National Institute of Health prior to joining FDA/CBER/OTAT as a CMC reviewer where she reviewed quality (CMC) aspects of INDs, BLAs and 510(k)s participated policy and guidance development and pre-licensure inspection activities. Yong served as a regulatory consultant working with numerous regenerative medicine product developers to assist them with product development strategies, regulatory submissions, GMP compliance and resolving clinical hold issues for 3 years before joining CARsgen Therapeutics. Yong currently serves as senior vice president, global regulatory affairs and oversees CARsgen’s global regulatory strategies. Regulatory submissions and compliance, and interactions with global regulatory agencies.
j.barry
Jacqueline Barry, PhD
Chief Clinical Officer
CGT Catapult
United Kingdom
JACQUELINE BARRY, PHD
Jacqueline Barry is the Chief Clinical Officer, responsible for Clinical Translation and Delivery activities and an Executive Director of the Cell and Gene Therapy Catapult. She has extensive experience in the development of advanced therapy medicinal products and leads a multi-disciplinary team of Nonclinical, Regulatory, Clinical Operations and Programme Management specialists. She also leads the coordination of the UK Advanced Therapy Treatment Centre Network and is a Director of the Global Alliance for iPSC Therapies. She feels passionately about making advanced therapies available for patients and works closely with the MHRA and the NHS on the development of the ecosystems to support the adoption of these therapies. Prior her time at Cell and Gene Therapy Catapult, Jacqueline worked at the Scottish National Blood Transfusion Service where amongst other activities she designed the regulatory strategy for the Cellular Therapies for the Blood Transfusion Service and acted as Qualified Person for their release. She has a PhD from the University of Aberdeen and did post-doctoral research in neurophysiology at the University of Edinburgh


2022 I to I Workshop Organizing Committee:

ISCT Business Development & Finance Committee

Sven Kili, MD
Co-Chair, ISCT BDF Committee
Antion BioSciences
United Kingdom/ Switzerland

Patrick Rivers, MBA
Co-Chair, ISCT BDF Committee
Aquilo Capital
United States

Contact Us

SIMONE STICKLAND, ISCT (simone@isctglobal.org)