Biotech 2050 Podcast

James Mackay, PhD, 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 PhD in Medical Genetics from Aberdeen University, Scotland.

A physician-scientist, her groundbreaking work in vascular and lung engineering has made Dr. Niklason a world leader in regenerative medicine. She is a member of the National Academies of Engineering and Medicine. Dr. Niklason is the founder of Humacyte and has served as President and Chief Executive Officer since November 2020 and as a member of the Humacyte Board since 2004. Dr. Niklason holds a Ph.D. in Biophysics from the University of Chicago and an M.D. from the University of Michigan.

Dr. Fordyce brings more than 15 years’ experience leading teams in drug discovery, development, clinical translation, and commercialization of new treatments. Before founding Vera, Fordyce was the founder and CEO of gene-editing company Trucode Gene Repair, Inc., having previously served as an entrepreneur in residence at Kleiner Perkins Caufield and Byers. Earlier in his career, Fordyce served as Senior Director of clinical research at Gilead Sciences, Inc., where he contributed to seven new drug approvals and served as project lead for Gilead’s TAF/GENVOYA development program. With subspecialty training in infectious disease from Columbia University Vagelos College of Physicians and Surgeons, Fordyce was previously Chief Resident at NYU Bellevue and spent two years as a translational research fellow at Rockefeller University. Fordyce currently serves on the Board of Directors of the Albert and Mary Lasker Foundation. He received his BA from Harvard University and his MD from Harvard Medical School.

Dr. Schneider is the Chief Operating Officer for Solid Biosciences, responsible for overseeing corporate and technical operations, quality, patient advocacy, communications, corporate strategy, and human resources. As Solid’s first employee in 2014, Dr. Schneider was instrumental in discovering and executing proof-of-concept studies for SGT-001, as well as building the company’s unique disease-focused business model. In his role as Chief Operating Officer, Dr. Schneider oversees corporate and technical operations, quality, patient advocacy, communications, corporate strategy, and human resources. Dr. Schneider previously completed a postdoctoral fellowship at Harvard University in the Department of Stem Cell and Regenerative Biology, characterizing and developing small molecules that enhance skeletal muscle regeneration. He holds a Ph.D. from Rutgers University and an undergraduate degree from Brandeis University. Dr. Schneider is the author of numerous peer-reviewed articles related to Duchenne and stem cell biology.

Patricia (Trish) Hurter, Dr. Patricia Hurter is CEO of Lyndra Therapeutics. Prior to Lyndra, Dr. Hurter was Senior Vice President of Pharmaceutical and Preclinical Sciences at Vertex Pharmaceuticals, Inc. She also served as Interim Head of Global Regulatory Affairs from 2013-2014 and oversaw several label expansions for Kalydeco® and the submission of the new drug application for Orkambi®. She played a leadership role in the development and commercialization of 5 transformative therapies for Vertex: Incivek®, Kalydeco®, Orkambi® and Symdeko® and Trikafta®. Prior to joining Vertex, Dr. Hurter was Director, Formulation Design and Characterization for Merck where she was a key member of the early development team for Januvia®, a treatment for type II diabetes. A respected thought leader in the pharmaceutical industry, Dr. Hurter is a frequent contributor to many scientific publications. At Vertex, she founded and was the executive sponsor of “IWILL,” a Vertex employee network devoted to the advancement of women leaders. As a member of the Advisory Board for Women in the Enterprise of Science & Technology (WEST), she mentors Boston-area women who are early or in the midst of their careers in STEM. She also champions the Posse Foundation, an organization that recruits high school students from diverse backgrounds and supports them as they pursue college degrees and beyond. She is a mentor to alumnae from the program. Dr. Hurter earned her Ph.D. in chemical engineering from the Massachusetts Institute of Technology, as well as an M.S. in mechanical engineering from West Virginia University and a B.Sc. in chemical engineering, cum laude, from the University of KwaZulu-Natal in Durban, South Africa. Jessica Ballinger Mrs. Ballinger is President and Chief Operations Officer of Lyndra Therapeutics. In her 25+ year career, she has contributed to the development and commercialization of more than 15 leading-edge patient therapies. Prior to joining Lyndra, she was a Senior Director at Biogen responsible for redesigning and transforming the patient-centered technical development organization. While at Biogen, she contributed to developing products in critical therapeutic areas such as hemophilia, Alzheimer’s Disease, spinal muscular atrophy and multiple sclerosis, delivering high-quality, highly-innovative, globally approved products with three products filed and approved in just three years. Prior to Biogen, she was the Senior Director Injectable Product and Device Strategy and Business Unit Interface driving technology development and lifecycle management innovation priorities for injectable products and devices in partnership with Pfizer Business Units and R&D. While in this role, Ballinger delivered ~50% capital investment savings and 25% cost-of-goods reduction through an innovative injectable device platform. She led the technical development and manufacturing scale-up of critical therapies in diabetes, endocrinology, neurology, ophthalmology, cardiovascular, women’s health and men’s sexual health. Ballinger is a respected leader in diversity and inclusion, co-creating the inaugural Biogen Alzheimer’s Patient and Caregiver Employee Resource Network (ERN), co-leading the inaugural Biogen Women’s Innovation Network, and co-leading the inaugural Pfizer European Women’s ERN. She was appointed to the inaugural Chief of Staff position supporting the Pfizer European R&D and Site Leader during her time at Pfizer Sandwich. She received the honorable Pfizer R&D Achievement Award twice in her tenure at Pfizer, recognizing her strong leadership and business impact. Ballinger is an active volunteer in fundraising and leadership roles, working with the Oasis Domestic Abuse Service and the Melanoma Education Foundation. She holds a Bachelor’s degree in Biochemistry from the University of Illinois – Champaign/Urbana.

Shawn M. Leland is the Founder and Chief Executive Officer of Elevation Oncology overseeing all day-to-day operations. Shawn brings over a decade of experience in medical affairs and business development for the pharmaceutical/biotech industry, with a focus on building collaborations to realize the full potential of targeted and personalized therapeutics. Shawn has been involved in global transactions totaling more than $450 million in upfront payments and milestone payments at Eli Lilly, ARIAD Pharmaceuticals, Argos Therapeutics and Verastem Oncology. Shawn has also served as an expert strategic consultant for Catenion providing guidance on portfolio management for pharmaceutical/biotech companies. Shawn resides in Denver, Colorado and enjoys snowboarding, hiking and cycling.

Paul Biondi, Executive Partner, Flagship Pioneering and President, Pioneering Medicines Paul joined Flagship Pioneering in 2019 as Executive Partner, Flagship Pioneering and President, Pioneering Medicines. In his role at Flagship, Paul works with growth company CEOs and their teams to achieve the best attainable value for each company and serves on the boards of selected Flagship companies including Seres Therapeutics, Valo Health. As a member of Flagship’s senior leadership team, Paul is involved in strategic and operational aspects of Flagship, including leading Pioneering Medicines. Pioneering Medicines is an initiative of Flagship dedicated to conceiving and developing an innovative pipeline of life-changing treatments for patients. By harnessing the power of Flagship’s scientific platforms, Pioneering Medicines will create novel medicines that deliver benefits to more patients, sooner. Pioneering Medicines also enters into strategic partnerships to jointly conceive new products by combining partners' R&D priorities with Flagship's unique platform capabilities, providing partners access to the full spectrum of innovation across Flagship as well as the R&D expertise that Pioneering Medicines offers. Paul joined Flagship Pioneering following a seventeen-year tenure at Bristol-Myers Squibb (BMS). Most recently, Paul served as the Senior Vice President of Strategy and Business Development where he had enterprise-wide responsibility for establishing and evolving BMS’s strategy, and for pursuing strategic transactions to access external innovation, enhance BMS’s capabilities and strengthen the company’s portfolio. Prior to this role, Paul held a series of leadership roles within BMS’ R&D organization overseeing strategy, portfolio and project management, and clinical and business operations. Prior to BMS, Paul spent nine years at Mercer Management Consulting. He received his M.B.A. from the J.L. Kellogg School of Management at Northwestern University and his B.A. from Dartmouth College.

Thank you for your support for Season 2! We reflect and look forward to Season 3 on this episode! Learn more about our co-hosts below! Alok Tayi, PhD is the Co-founder and CEO of Vibe Bio. Vibe is a therapeutics company that partners with patient communities to develop new medicines. Previously, Alok spent 10 years as an entrepreneur and life sciences software executive. He started and built the Life Sciences business unit at Egnyte, was a YCombinator-backed founder and started two SaaaS companies. Prior to his career in software, Alok spent over 15 years as a scientist, including postdoctoral work at Harvard University with George Whitesides. Alok holds a PhD from Northwestern University and BS from Cornell University. Rahul Chaturvedi is the Founder and CEO of Clora, the leading marketplace where people go to discover, build, and manage on-demand life science teams. Prior to founding Clora in 2017, Rahul was the head of clinical development at several biopharma companies, such as Kaleido Biosciences (NSDQ: KLDO) and Avedro (acquired by Glaukos). Rahul has successfully led the development activities for 20+ Phase II/III programs that have resulted in 6 product approvals to date. Rahul holds a bachelor of science degree from Brandeis University.

As Chief Medical Officer Dr. Ticho is responsible for Stoke’s efforts to develop first-in-class RNA based disease-modifying medicines to treat severe genetic diseases. He is also co-founder and former CEO of Verve Therapeutics which is developing therapies to edit the genome and confer protection from cardiovascular disease. Prior to joining Stoke Barry was Head of R&D for Cardiovascular and Metabolic Diseases at Moderna Therapeutics. He was previously Head of External R&D Innovation for Cardiovascular and Metabolic Diseases at Pfizer. Prior to that he was Vice President of Clinical Development at Biogen where he led clinical development for the Tysabri program for MS and led the aducanumab program for Alzheimer’s Disease. Barry obtained his M.D. and Ph.D. degrees from the University of Chicago and completed Pediatrics training at Northwestern University and a Cardiology fellowship at Children’s Hospital in Boston. He was on clinical staff at Harvard Medical School and Massachusetts General Hospital.

Gregory J. Divis serves as Avadel’s Chief Executive Officer and a member of Avadel’s Board of Directors. Greg was appointed CEO in June of 2019, after previously serving in several leadership roles within the company, including Chief Operating Officer, Executive Vice President, and Chief Commercial Officer. Greg brings over 30 years of experience in building and leading business and financial operations within the pharmaceutical industry. Prior to joining Avadel, Greg served as an Executive in Residence at Linden Capital Partners, a healthcare-focused private equity firm. He also served as President and Chief Executive Officer of Lumara Health, a specialty branded pharmaceutical company focused on women's health. Prior to Lumara, Greg held general management, sales, marketing, and business development roles at Schering-Plough, which was acquired by Merck & Co., Inc., and Sanofi-Aventis. Greg earned his bachelor's degree from the University of Iowa.