Biotech 2050 Podcast

Synopsis: Joel Schneider, Ph.D. and Robert Kotin, Ph.D. are the President & CEO and Founder & Chief Technology Advisor, respectively, of Carbon Biosciences, an emerging leader in the development of novel parvovirus-derived gene therapies. Joel and Robert sit down with host Rahul Chaturvedi to discuss the arc of their careers, how the AAV field has changed over the last decade, and how they approach building out their team at Carbon. They also talk about Carbon’s focus on cystic fibrosis and the implications of The Cystic Fibrosis Foundation investing in their Series A. Finally, they both weigh in on what excites them when thinking about the future of gene therapy. Biographies: Dr. Joel Schneider joined Carbon as CEO in 2022, after serving as Chief Operating Officer at Solid Biosciences. As Solid’s first employee, he played an instrumental role in building the company’s unique disease-focused business model. Dr. Schneider is an accomplished biosciences executive with a track record of achievement in identifying, developing, and financing high potential therapeutic modalities and has diverse leadership experiences across R&D, technical and corporate operations, and corporate development organizations. Dr. Schneider holds a Ph.D. from Rutgers University and an undergraduate degree from Brandeis University and is the author of numerous peer-reviewed articles related to Duchenne and stem cell biology. He completed a postdoctoral fellowship at Harvard University in the Department of Stem Cell and Regenerative Biology, where he characterized and developed the small molecules that enhance skeletal muscle regeneration. Dr. Robert Kotin has been a leader in adeno-associated virus (AAV) research for 35 years, focusing on the molecular biology of the virus’s non-structural proteins and then leveraging this understanding to develop novel AAV vectors for somatic cell gene therapy. Beginning as a postdoctoral fellow at Cornell University Medical Center, Dr. Kotin discovered a common integration site for AAV DNA in human chromosome 19, which he designated AAVS1 locus. He spent most of his career in the Intramural Research Program at the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH), first as a tenure-track investigator and then as a tenured senior investigator and Head of the Laboratory of Molecular Biology and Gene Therapy. While at the NIH, Dr. Kotin’s laboratory invented and developed a scalable recombinant adeno-associated virus (rAAV) production process in Sf9 cells which was licensed by UniQure, ThermoFisher, Voyager, Biomarin, and others and was used to produce Glybera™, the first rAAV product granted regulatory agency approval for sale. Additional research from the Kotin lab resulted in the discovery of an AAV replicative product that has been described as closed-ended linear duplex DNA (ceDNA) and became the basis of the non-viral gene therapy company Generation Bio (NASDAQ: GBIO). Dr. Kotin served as vice president of virology and gene therapy at Voyager Therapeutics from 2014 to 2016. Since 2016, he has served as an adjunct professor at UMass Medical School, where his research interests include vectorizing and characterizing ancestral parvoviruses based on inferred sequences from endogenous virus elements (EVEs) as novel gene therapy vectors. Dr. Kotin earned his B.A. in biology from the University of California, Santa Cruz, and his doctorate in microbiology from Rutgers University and the University of Medicine and Dentistry of New Jersey (now Robert Wood Johnson Medical School).

Synopsis: Matt Gline is the CEO of Roivant Sciences, a company that delivers innovative medicines and technologies to patients by building Vants – nimble, entrepreneurial biotech and healthcare technology companies. Matt discusses his transition from CFO to CEO at Roivant and how he prepared to step into the CEO role for the first time. He talks about Roivant’s model and how it’s different from other biotech companies, and how the current market conditions inform how Roivant operates across its portfolio. He also discusses some of the inefficiencies across biotech and where he sees room for improvement, how telemedicine emerged as a silver lining from the pandemic, and his thoughts on the current labor market. Biography: Matthew Gline serves as Chief Executive Officer of Roivant Sciences. Mr. Gline joined Roivant in March 2016 and previously served as Chief Financial Officer. From April 2014 to March 2016, he was a Vice President at Goldman Sachs, Fixed Income Digital Structuring, where he focused on technology and data strategy. Prior to Goldman Sachs, Mr. Gline was a co-founder of Fourthree, a risk analytics technology and consulting company. From 2008 to 2012, he served as Vice President at Barclays, Enterprise Risk Management Advisory, where he provided analysis for corporate clients related to capital markets access for financing and risk management. Mr. Gline earned his A.B. in Physics from Harvard College.

Synopsis: Jack Bailey is the CEO of G1 Therapeutics, a commercial-stage biopharmaceutical company focused on the discovery, development and delivery of next generation therapies that improve the lives of those affected by cancer. Jack worked at Eli Lilly for 19 years followed by GSK for 12 years, and served on the company board at G1 Therapeutics before stepping into the role of CEO. Jack provides his perspective on the state of the industry and how the current macro environment is affecting financing, the supply chain, and attracting and retaining talent. He talks about his team’s work at G1, the proactive approach they’re taking to combat cancer, and the unique commercial aspect of the company. He also discusses the current legislative and regulatory environment, concerns he has, and opportunities for the future. Biography: As Chief Executive Officer, Jack Bailey leads G1 in its mission to fundamentally change the chemotherapy experience for patients with cancer. Mr. Bailey has over thirty years of commercial pharmaceutical experience and has an in-depth understanding of the healthcare marketplace. He has extensive experience in commercialization, health systems, health policy, and government affairs. Previously, Mr. Bailey led the GlaxoSmithKline pharmaceuticals and vaccines business as President of the U.S., with responsibility for commercialization efforts across the company—oncology, immunology/rare disease, respiratory, and vaccines portfolios. He also was a member of the company’s Pharmaceutical Investment Board responsible for the clinical development investments by the company. Earlier in his career, he held various senior commercial leadership positions at Eli Lilly and Company, including Senior Vice President of the Account-Based Markets Division that included both the oncology and cardiovascular portfolios along with the managed markets groups. Mr. Bailey was appointed to the G1 Therapeutics Board of Directors in March 2020 and in September 2020, he was named CEO. He also serves on the board of the UNC Health System, Emergo Therapeutics, a privately-held biotechnology company, and is a past member of the board at Harvard T.H. Chan School of Public Health, the board of directors of PhRMA, the pharmaceutical industry trade association, and the North Carolina Biotechnology Center. He holds an MBA from the University of North Carolina and a B.S. in biology from Hobart College.

Synopsis: Nabiha Saklayen, PhD, is the Co-Founder and CEO of Cellino Biotech, a company working to democratize access to personalized stem cell-based therapies for patients at scale. Nabiha joins host Rahul Chaturvedi for a discussion about her entrepreneurial journey and her learning process in the early days of building a start-up. She talks about opportunities and challenges in the field of regenerative medicine and the exciting science her team is pursuing at Cellino to use stem cell-derived regenerative medicines to treat diseases such as Parkinson’s, diabetes, and heart disease. She also touches on changes and trends in biotech she’s observed over the years. Nabiha first appeared on the Biotech2050 podcast for its 100th episode - listen here: https://on.soundcloud.com/HkAxq Biography: Nabiha Saklayen is the Co-Founder and CEO of Cellino. Cellino’s proprietary technology makes personalized stem cell-derived therapies scalable for the first time. Nabiha was selected as a Pioneer in MIT Tech Review's 35 Innovators under 35 list for her patented inventions in cellular laser editing. She received her Ph.D. in Physics from Harvard University as a Howard Hughes Medical Institute (HHMI) International Fellow. She is also the inaugural Tory Burch Foundation Fellow in Genomics at the Innovative Genomics Institute led by Nobel Laureate Dr. Jennifer Doudna. Nabiha is also a TED speaker and co-creator of I Am A Scientist, an educational program running in 50 states that inspires children to explore science.

Synopsis: Andrew Allen is the Co-Founder, President and CEO of Gritstone bio, a clinical-stage biotech company developing groundbreaking immunotherapies for cancers and infectious diseases such as COVID-19 and HIV. Gristone seeks to generate a therapeutic immune response by leveraging insights into the immune system’s ability to recognize and destroy diseased cells by targeting select antigens. Andrew joins host Rahul Chaturvedi for a conversation about his entrepreneurial journey founding a biotech, the state of biotech right now and how he manages his team during times of volatility. He also discusses the exciting science they’re pursuing at Gritstone and the role T cells play in engaging the immune system against cancer and infectious diseases. Biography: Andrew Allen, M.D., Ph.D. co-founded Gritstone bio, Inc. and has served as President, CEO and a board member since 2015. In 2009, Dr. Allen co-founded Clovis Oncology and served as Chief Medical Officer until 2015, driving development of Rucaparib, a PARP inhibitor. Prior he was Chief Medical Officer at Pharmion Corporation, developing Vidaza, the first approved DNA methylation inhibitor, until acquisition by Celgene in 2008. Dr. Allen also served in clinical development leadership roles at Chiron Corporation and Abbott Laboratories, and worked at McKinsey & Company. He currently serves on the board of directors of TCR2 Therapeutics and Sierra Oncology (both public biopharma companies) and Revitope Oncology and Verge Genomics (both private biopharma companies). He previously served on the board of directors of Epizyme (developers of the first approved histone methylation transferase inhibitor) and Cell Design Labs (acquired by Gilead Sciences in 2017). Dr. Allen qualified in medicine at Oxford University and received a Ph.D. in immunology from Imperial College of Science, Technology and Medicine in London.

Synopsis: Nicki Thompson is the CEO of Amphista Therapeutics, a company identifying and advancing novel approaches in targeted protein degradation to develop a new generation of innovative therapies. Nicki spent the first 20 years of her career in big pharma at GSK before joining the biotech industry. She shares her thoughts on how the interaction points between biotech and pharma have changed over the last 10 years. She also talks about target protein degradation as a treatment modality and the opportunities and challenges it brings, as well as Amphista’s novel approach to targeted protein degradation to treat diseases with high unmet need in oncology, immunology and CNS disorders. Biography: Nicki has over 25 years’ experience in pharmaceutical and biotechnology R&D in a variety of senior scientific and leadership roles. She was previously VP and Global Head of External Drug Discovery at F. Hoffmann-La Roche Ltd and prior to that, Senior Director, Business Development for GSK’s Centre of Excellence for External Drug Discovery (CEEDD). Nicki’s Biotech experience includes her role as Chair of the Board for Nanna Therapeutics Ltd, founding CEO of VirionHealth and Head of Drug Discovery at Syntaxin Ltd. She holds a PhD in Cell Biology from University College London.

Disclaimer: Anything that is express in the following conversation are Michael's views and not necessarily those of Roche / Genentech. Synopsis: Michael Rosenblatt is the Vice President of Clinical Operations at Roche, leading their organization to reduce hierarchy, embrace agility, and increase engagement. Michael has spent the last 11 years between regulatory and clinical operations in late stage development at Roche/Genentech and is currently leading its GI indications from an operational standpoint. He provides his perspective on the clinical operations landscape now and what’s changed over the last five-seven years. He shares the technology he’s excited by that has the potential to transform R&D and clinical operations. He discusses his role at Roche and some of the transformation underway bringing more treatments and better outcomes to patients everywhere! Biography: Michael Rosenblatt is a Vice President in Roche’s late stage clinical operations group (PDG). In this role he is responsible for registrational clinical trials for Roche’s Gastroenterology and Hepatology portfolio. He also acts as a mentor and coach for the countries in Roche’s Asian operational footprint. In this role he helps to ensure that Roche is taking full advantage of the talent and capabilities in that region. Michael is also part of the team leading the transformation of Roche’s Clinical Operations function, moving from a siloed hierarchical structure to a flatter, more agile organization. In this transformation Roche has helped rethink Clinical Operations, enabling talent flow across disease areas and cross-functional projects and empowering teams to make decisions closest to the work and takes. This work is unleashing significant efficiencies and helping Roche reach its goal of bringing new medicines to patients faster. In earlier roles at Roche, Michael oversaw key infrastructure for both the Clinical Operations and Regulatory groups at Roche and helped pioneer early eTMF processes and technology. Prior to joining Roche, Michael was a consultant in IBM’s life sciences consulting and business process management practices working with multiple pharmaceutical companies to introduce processes and technology designed to streamline and simplify work across finance, commercial, regulatory and other business units. He has also held numerous consulting, sales, marketing, and operational roles for several other US-based enterprises. Michael is an avid runner and swimmer. He resides near San Francisco, CA with his wife and two boys.

Synopsis: Josh Mandel-Brehm is the President and CEO of CAMP4 Therapeutics, a company pioneering mRNA amplification by using programmable ASO therapeutics to control gene expression. He joins host Rahul Chaturverdi to discuss the arc of his career and his interest in the intersection of business and science. They dive into the origins of CAMP4 and the inspiration behind the company’s name. He also talks about where CAMP4 is from a pipeline development perspective and how he approaches fundraising. Biography: Josh Mandel-Brehm is President & Chief Executive Officer of CAMP4 Therapeutics. Mr. Mandel-Brehm previously held roles as an entrepreneur partner with Polaris Partners and key business development and operations leadership roles at leading biotech companies. Most recently he served as part of the Business Development group at Biogen, where he led multiple strategic activities and corresponding transactions, which included expanding Biogen’s non-malignant hematology franchise and overseeing seminal investments to enter in gene therapy and the ophthalmology field. Prior to Biogen, Mr. Mandel-Brehm held several roles of increasing responsibility at Genzyme as part of the business development group for the company’s rare disease business unit. Mr. Mandel-Brehm earned a BA in Biology from Washington University in St. Louis and holds an MBA from the University of Michigan.

Synopsis: This special episode features a panel discussion with three biotech leaders about drug development for rare diseases. James Mackay, Ph.D., is the Founder, President and CEO of Aristea Therapeutics, an immunology-focused clinical stage biotech that is focused on inflammatory diseases. Arthur T. Suckow, Ph.D., is the Co-Founder and CEO of DTx Pharma, which is focused on developing novel technology for delivery of RNA medicines. Eslie Dennis is the SVP and CMO of Kyowa Kirin North America, a Japan-based global specialty pharmaceutical company. Our guests discuss the patient journey for those living with rare diseases, the importance of driving awareness for this patient population, important points to consider when partnering with big pharma, clinical trial design for patients with rare diseases, and best practices for driving awareness and inclusion of people of color in rare disease trials. Biography: James Mackay, Ph.D., Founder, President and Chief Executive Officer, has over 25 years of development and commercialization expertise in the pharmaceutical industry, including 6 drug product approvals across multiple therapeutic areas. Prior to founding Aristea, he was President and Chief Executive Officer of Ardea Biosciences, Inc., following the company’s acquisition by AstraZeneca in 2012. James was instrumental to setting up an innovative model for Ardea Biosciences that retained the biotech’s independence and accountability for the development of the gout franchise while also developing a synergistic and collaborative relationship with the parent company, AstraZeneca. Prior to Ardea, James held senior executive positions at AstraZeneca where he led the development and commercialization of drugs across a range of therapy areas. and managed significant global functional departments. James plays a pivotal role in the San Diego Ecosystem and currently sits on the Board and Executive Committee of CONNECT and sits on the Board of BIOCOM. He is a former Board member of the San Diego Economic Development Corporation (EDC). James holds a BS in Genetics and Ph.D. in Medical Genetics from Aberdeen University, Scotland. Dr. Arthur Suckow founded DTx Pharma in 2017. An innovative leader in drug discovery, he previously worked on the ophthalmology, diabetes, and NASH programs at Regulus Therapeutics, at the MedImmune arm of AstraZeneca, and in the Diabetes Drug Discovery program at Johnson & Johnson. Dr. Suckow received his BS from the University of Delaware and his PhD from University of California, San Diego. He has received numerous awards including a Beckman Fellowship, a NSF graduate research fellowship, and a BIOCOM catalyst award. Dr. Eslie Dennis joined Kyowa Kirin in May 2021 as SVP, Chief Medical Officer for Kyowa Kirin North America. Prior to joining this organization, she was Vice President and Head Global Medical Affairs at Ventana/Roche Tissue Diagnostics. She is a physician with 10 years experience in clinical practice (internal medicine and hematology/oncology) and research, and over 20 years international biopharma experience holding positions of increasing responsibility in pharmaceutical and diagnostic organizations at MSD, Novartis and Roche, including leadership of public-private consortia at the Critical Path Institute. Throughout her career, Dr. Dennis has championed innovative science and solutions to address unmet needs for patients and society, particularly addressing healthcare disparities. Dr. Dennis received her MBChB from the Godfrey Huggins School of Medicine in Harare, Zimbabwe, and was the recipient of the Winston Churchill, Margaret Low, and Prankard-Jones Scholarships, as well as the Guy Elliot Bursary. She is a Fellow of the College of Physicians of South Africa and received her internal medicine and hematology/oncology training at Groote Schuur Hospital in Cape Town, South Africa.

Synopsis: Mike Cloonan is the President and CEO of Sionna Therapeutics, a life sciences company dedicated to developing therapies for people living with cystic fibrosis. They are developing first-in-class small molecules that are focused on a unique target with the potential to fully normalize CFTR function for the first time for the vast majority of people living with CF. Mike has over 20 years of experience in biotech and healthcare, 14 of which were spent working at Biogen where he was focused on the business and commercial side of the company. In this episode, he provides his perspective on the right time for a company to build out a commercial team and hire a commercial leader, his learnings stepping into a CEO role for the first time, and the current landscape of cystic fibrosis and what drew him to work on such an important patient population. Biography: Mike is President and Chief Executive Officer of Sionna. He is a respected biotech leader with over 20 years of biopharma experience across global organizations. Most recently he served as Chief Operating Officer at Sage Therapeutics leading all the business functions (commercial, medical affairs, government affairs, business development, technical operations, strategy and program management) and G&A functions. During his four years with Sage, he helped lead the growth of the organization through multiple capital raises, the launch of the company’s first product, and execution of a transformational, multi-billion dollar collaboration. Prior to Sage, he had a 14-year tenure at Biogen in various business and commercial roles. His most recent role at Biogen was as Senior Vice President, U.S. Commercial, where he was the general manager of the multi-billion dollar MS, hemophilia, and SMA franchises. Prior to Biogen, Mike worked at Bain & Company as a consultant specializing in healthcare. Mike earned his MBA from the Darden Graduate School of Business Administration at the University of Virginia and a B.A. from College of the Holy Cross.