Biotech 2050 Podcast

Synopsis: Mahesh Karande is the President and CEO of Omega Therapeutics, a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines for unprecedented control of gene regulation and cellular function. Through its OMEGA platform, the company engineers mRNA therapeutics called Omega Epigenomic Controllers™ (OECs), with the goal of treating or curing a broad range of diseases. Mahesh discusses his early years in engineering and consulting before moving into the pharmaceutical industry. He talks about the transition from big pharma to biotech and the lessons he learned from his days in pharma. He discusses being a CEO and how he approaches the role differently the second time around. He talks about company culture and leadership at Omega and how he motivates team members in such a fast paced environment. Finally, he dives into programmable approaches to biology, what it really means, and the intersection of biology and technology. Biography: Mahesh Karande joined Omega Therapeutics as President and Chief Executive Officer and brings deep experience in running biopharma businesses across discovery, preclinical development, clinical development, commercialization and product life cycle management stages. His breadth of therapeutic experience spans cardiovascular and metabolic, oncology, neurosciences, ophthalmology, antibiotics, pain, respiratory and rare and genetic diseases, as well as drug and device combinations. Mr. Karande has been involved with more than 10 product launches in the U.S. and across global markets. He has strong leadership, operational and business-building experiences combined with a global work history spanning the U.S., Europe, Asia and Africa. Prior to taking the helm at Omega, Mr. Karande was President and Chief Executive Officer of Macrolide Pharmaceuticals, a company he took from discovery into early development. Earlier, Mr. Karande spent several years at Novartis in senior leadership roles: Vice President and Head of U.S. Oncology for solid tumors, President of Novartis Africa and President of Novartis Egypt. He worked for McKinsey & Company prior to joining the bio-pharmaceutical industry. Currently, Mr. Karande serves on the Board of Directors of KSQ Therapeutics and Ashvattha Therapeutics. Mr. Karande has an MBA from the Wharton School of the University of Pennsylvania. He is also a graduate of the Georgia Institute of Technology where he completed his M.S. in Engineering, and the University of Bombay where he completed undergraduate studies in engineering.

Synopsis: Joseph Payne is the Founder, President and CEO of Arcturus Therapeutics, a global late-stage clinical messenger RNA medicines and vaccines company focused on the discovery, development and commercialization of therapeutics for rare diseases and vaccines. Joseph discusses the founding story behind Arcturus and the impetus behind starting his own company. He talks about fundraising and what he would do differently now, and shares his perspective on the dynamic between entrepreneurs and VCs. He shares his thoughts on the evolution of messenger RNA over the last decade, the challenges the modality has faced and how we've overcome some of those challenges. Finally, he dives into the work Arcturus is pursuing now, where they are from a development perspective, and recent partnerships. Biography: Joseph E. Payne, is the President and Chief Executive Officer of Arcturus Therapeutics. He serves on Arcturus’s Board since March 2013. He brings with him an exceptional track record of ushering novel therapeutics to the clinic including targeted RNA medicines utilizing lipid-mediated delivery technologies. Joseph’s background includes over 20 years of successful drug discovery experience at Merck Research Labs, DuPont Pharmaceuticals, Bristol-Myers Squibb, Kalypsys, and Nitto as evidenced by over 40 publications and patents, and several investigational new drug (IND) clinical candidates. His academic training includes a Bachelor's Degree in Chemistry, magna cum laude from Brigham Young University, a Master of Science in Synthetic Organic Chemistry from the University of Calgary and Executive Training Certification from MIT Sloan School of Management.

Synopsis: Robert Blum and Fady Malik are the President & CEO and EVP, Research and Development, respectively, of Cytokinetics, ​​a late-stage biopharmaceutical company committed to developing potential medicines that impact the mechanics of muscle and may improve the lives of people living with debilitating diseases. Robert and Fady discuss how they have developed a company culture that embraces some of the learnings that come along with failure and the advice they would provide other leaders. They talk about how the current capital market environment shapes the way the company is operating. They also discuss the cardiovascular market and overall landscape, where Cytokinetics is from a development perspective, and some upcoming milestones. Finally, they each share a piece of advice they wish they could provide to their younger selves knowing what they now know. Biography: Robert Blum has served as President and Chief Executive Officer of Cytokinetics and a member of our Board of Directors since 2007. Previously, he served as Cytokinetics’ President and held other senior-level positions at the Company overseeing research and development, finance, corporate development, legal, commercial operations, and business development at various times since participating in the launch of Company operations in 1998. Prior to Cytokinetics, Robert held senior positions in business development and marketing at COR Therapeutics from 1991 to 1998. He also performed roles of increasing responsibility in sales, marketing, and other pharmaceutical business functions at Marion Laboratories and Syntex Corporation beginning in 1981. Robert previously served on the faculty at the Center for BioEntrepreneurship at University of California, San Francisco, where he taught a corporate finance course to graduate students. He co-chaired the BIO Business Development Committee and is a frequent lecturer on matters of business development and finance in the biopharmaceutical industry. Mr. Blum received B.A. degrees in Human Biology and Economics from Stanford University and an M.B.A. from Harvard Business School. Fady Malik has led Research and Development since 2014 and been with Cytokinetics since its inception in 1998 when he joined its founders to participate in the launch of the company. Early on, Fady recognized the potential therapeutic utility of modulating the sarcomere of cardiac and skeletal muscle and led discovery and development efforts giving rise to Cytokinetics’ current portfolio of early- to late-stage development programs targeting muscle contractility for the treatment of cardiovascular and neuromuscular diseases. Fady is an internationally recognized cardiovascular physician-scientist, an inventor on more than 20 issued patents, and has authored or co-authored over 60 publications appearing in prominent journals such as Science, Nature Medicine, the Lancet, and the New England Journal of Medicine. He currently holds an appointment in the Cardiology Division of the University of California, San Francisco, as a Clinical Professor of Medicine and until 2019 was an Attending Interventional Cardiologist at the San Francisco Veterans Administration and UCSF Medical Centers. Fady serves on the Board of Directors for Rocket Pharmaceuticals, Inc. (NASDAQ:RCKT). Fady received a B.S. in bioengineering from the University of California at Berkeley, and a M.D./Ph.D. from the University of California at San Francisco where he also completed an internal medicine residency and fellowship in cardiology.

James McArthur, CEO of PepGen, discusses his venture capital experience and how it influences his management style. He explores drug development in rare diseases, particularly neuromuscular diseases. He highlights the importance of multiple treatment options and patient organizations. He also talks about adapting to a changing environment during the pandemic and the value of surrounding oneself with good people.

Synopsis: Paul Lammers, M.D., is the CEO of Triumvira Immunologics, a clinical-stage immuno-oncology company developing unique, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat a broad range of patients with cancer. A Dutch-trained biologist and physician, Paul talks about starting his career in pharma and some of the commonalities between operating in pharma and biotech. He talks about being a CEO and how his approach to running a company has evolved over the years. He discusses the uncertainty in the market and how that’s informing how the company is approaching development activities. He dives into the fundamental challenges and opportunities within cell therapy and the work Triumvira is doing to treat cancer. Biography: Paul Lammers, MD, MSc, joined Triumvira Immunologics as President and CEO in January 2018. Before Triumvira, Dr. Lammers served as President & CEO at Mirna Therapeutics, for which company he raised $160 million through venture capital and Federal and State government funding, as well as a public listing on NASDAQ. Previously, he served as Chief Medical Officer and Head of US Product Development for EMD Serono. During his early industry tenure, Dr. Lammers also held various executive/senior management positions in clinical development, medical and regulatory affairs, at different pharmaceutical companies, as well as at small public and privately held biotech companies. Dr. Lammers serves as Lead Independent Director for publicly-traded Salarius Pharmaceuticals, and as Director for a private biotech company, Immunomet.

Andrew Scharenberg, CEO of Umoja Biopharma, discusses next-gen immunotherapies for cancer, including in vivo CAR T-cell therapy. He talks about indication selection, team building during the pandemic, and the importance of wearing different hats in biotech. The podcast also explores the challenges in manufacturing CAR-T cells, the future of stem cell-derived cell therapies, and managing complexity in drug development.

Synopsis: Theresa Heah, M.D., is the CEO of Intergalactic Therapeutics. Intergalactic is overcoming the limitations of viral-based gene therapy and developing a best-in-class non-viral alternative. Intergalactic uses synthetic biology and engineered gene circuits to make covalently closed and circular DNA (“C3DNA”) molecules designed to provide a potentially safer and more effective solution for patients. Theresa has over two decades of global drug development and commercial experience. She talks about her choice to focus on ophthalmology, where ophthalmology as a therapeutic area is from a drug development perspective, and some of the opportunities she sees ahead for this space. She discusses the importance of having mentors and the emotional aspects of being a CEO. Finally, she dives into the work Intergalactic is doing, where they are from a company building perspective, and how she thinks about driving more access and scale for gene therapies, given the high cost of development and scalability. Since this podcast was recorded, in July 2023, new data from IG-002, Intergalactic’s lead program, demonstrated persistent ABCA4 expression in non-human primate retinas over six months after a single administration.This data support plans to advance IG-002 into Phase 1 trials in 2024. Biography: Dr. Heah is an accomplished executive who brings over two decades of drug development and commercial experience, focused primarily in gene therapy and ophthalmology. She most recently served as President and Chief Medical Officer at Kriya Therapeutics, where she launched the ophthalmology division, Kriya Ophthalmology, and was responsible for building its AAV gene therapy portfolio strategy and supporting the company’s Series C financing. Prior to joining Kriya, Dr. Heah served as Executive Vice President of Operations and Chief Medical Officer at AsclepiX Therapeutics, where she led the company’s Series A financing and advancement of its pipeline products into the clinic. Dr. Heah also previously served as Chief Medical Officer at Applied Genetic Technologies Corporation (AGTC), working to develop gene therapies in ophthalmology and rare diseases. In addition, she has held several leadership positions with increasing responsibility in early-stage private companies (Fovea Pharmaceuticals) and publicly traded companies (Aerie Pharmaceuticals, Allergan, Bayer Healthcare, Sanofi). Dr. Heah earned her M.D. from Guy’s, King’s and St. Thomas’ School of Medicine, King’s College, University of London, and her Executive Master’s in Business Administration from the European School of Management & Technology (ESMT), Berlin.

Synopsis: Volker Herrmann is the President and CEO of Sonata Therapeutics, a Flagship Pioneering company revolutionizing the world’s understanding of the cellular microenvironment and its importance to human biology and disease. Sonata’s product-platform creates drugs based on a systematic, comprehensive characterization of the microenvironment in diseases with high unmet medical need. Volker discusses the arc of his career, starting with attending medical school in Germany, then training as a cardiologist and clinical pharmacologist before working at Pfizer. He talks about his transition from big pharma to biotech and how his approach to running a biotech has evolved. He discusses the importance of patient impact and how that drives him in this industry. He talks about their work at Sonata to develop therapeutics for cancer and other diseases, and how he thinks about indication selection. Biography: Volker Herrmann is Chief Executive Officer of Sonata Therapeutics and a Flagship Pioneering CEO-Partner. A veteran pharmaceutical and biotech leader, Volker brings more than 20 years of experience in management, commercial development, business development, marketing and strategy to Sonata. Volker was previously the Chief Executive Officer of Inzen Therapeutics, a predecessor to Sonata, after serving as President and Chief Operating Officer at SQZ Biotechnologies. Prior to SQZ, he held various leadership roles at Pfizer, including European Lead CNS/Pain franchise, Global Lead Pain franchise and Head of Global Strategy, Marketing and Commercial Development within Pfizer’s Vaccine Business Unit. Subsequently, he served as the Chief Commercial Officer for Viamet Pharmaceuticals, where he was responsible for preparing the organization for the launch of its first commercial product as well as streamlining the company’s pipeline. Volker also served as the Chief Operating Officer of Selenity Therapeutics. Volker received his M.D. from Albert-Ludwigs University Freiburg in Germany and an MBA from the University of San Diego.

Synopsis: Greg Flesher is the President and CEO of Reneo Pharmaceuticals, a clinical-stage pharmaceutical company focused on the development of therapies for patients with rare genetic mitochondrial diseases with significant unmet medical needs. Greg discusses beginning his career at Eli Lilly in the mid 1990s and how he approaches being a CEO differently the second time around. He talks about the rare mitochondrial disease landscape and the opportunities and challenges within it. He also dives into patient access for rare diseases and the difficulties around accessing the right patients for late-stage pivotal trials. Finally, he shares how the current environment impacts how he approaches execution against clinical programs and his advice to other leaders navigating the current times. Biography: Greg is the President and Chief Executive Officer of Reneo Pharmaceuticals and serves as a member of the company’s Board of Directors. Greg brings to Reneo more than 25 years of biopharmaceutical industry experience in executive management, corporate and business development, operations, sales and marketing, and clinical development. He has been closely involved with several novel development programs resulting in multiple product approvals and successful commercial launches in the U.S. and Europe. Prior to joining Reneo, Greg was Chief Executive Officer and a member of the Board of Directors of Novus Therapeutics (Nasdaq: NVUS), a clinical-stage pharmaceutical company he took public in 2017 and led through the transformational acquisition of Anelixis Therapeutics in 2020. Prior to Novus, Greg was Chief Business Officer of publicly traded Avanir Pharmaceuticals (AVNR), a commercial-stage pharmaceutical company, where he led corporate and business development as well as corporate operations through the $3.5 billion acquisition of the company by Otsuka Pharmaceuticals in 2015. From 1995 to 2006, Greg held multiple leadership roles at Intermune (acquired by Roche), Amgen, and Eli Lilly and Company. Greg received his B.S. in biology from Purdue University and studied biochemistry and molecular biology at Indiana University School of Medicine.

Synopsis: Adrian Gottschalk is the president and CEO of Foghorn Therapeutics, a clinical-stage biotechnology company pioneering a new class of medicines that treat cancers and other serious diseases by correcting abnormal gene expression. Adrian discusses his early beginnings at Biogen before joining Foghorn. He talks about the evolution of his role as CEO at Foghorn, particularly as the company has grown tremendously from a small biotech to a clinical- stage company. He discusses the work his team is pursuing at Foghorn, the overall landscape for therapeutic options in oncology, and what’s changed with our ability to modulate gene expression. He also dives into Foghorn’s pipeline of over 15 different programs and its two major collaborations with Merck and Loxo Lilly Oncology. This interview was recorded in February 2023. Biography: Adrian Gottschalk is president and chief executive officer of Foghorn Therapeutics. An experienced leader in biotech, Adrian is interested in solving complex issues at the intersection of science, medicine, and business on a global scale to help people and families dealing with diseases. Prior to joining Foghorn, Adrian spent 13 years at Biogen, where he was most recently a senior vice president and the neurodegeneration therapeutic area head. In this role, he was responsible for the late-stage development and commercialization of medicines for Alzheimer’s disease, Parkinson’s disease, and amyotrophic lateral sclerosis (ALS). During his time at Biogen, Adrian held additional roles of increasing responsibility ranging from head of corporate strategy, head of global commercial strategy, head of Japan, and head of the Japan, Australia and Emerging Markets geographies. He has also worked as a consultant for Price Waterhouse in Dallas, Texas. He holds a BS in biochemistry from Texas A&M University and received his MBA from the Sloan School of Management at MIT. He also holds an ScM degree from the joint Harvard Medical School / MIT Biomedical Enterprise Program, where his graduate work was focused on evaluating the costs and benefits of the Prescription Drug User Fee Acts and improving the efficiency of the drug development process.