An Introduction to JLABS: Who We Are, What We Do | 11:05 AM – 11:35 AM, Thursday, October 1

Stephen Pitt, Ph.D. is the Head of Johnson & Johnson Innovation, JLABS US North East which includes the JLABS @ NYC, JPOD @ Boston, JLABS @ LabCentral, JLABS @ M2D2 and JPOD @ Philadelphia. He is responsible for external engagement, innovation sourcing, company onboarding, portfolio management, operational excellence, educational programming and P&L. He catalyzes and supports the translation of science and technology into valuable solutions for patients and consumers across the pharmaceutical, medical device, consumer and healthtech sectors.

Steve joined JLABS from GlaxoSmithKline, where he was Senior Director of Emerging Science Innovation and Head of the Digital Innovation Hub R&D Team. At GSK, Steve led externally focused R&D teams that shifted pipeline strategies from basic symptom relief to holistic disease management to transform self-care. He also created partnerships with academic institutions, start-ups, corporate partners, hospital systems, and other novel outsourcing collaborators with the aim to build breakthrough technology platforms and products.

Prior to GSK, he continually increased his responsibility as an R&D leader over 15 years in drug discovery, pharmaceutical development and consumer healthcare at Johnson & Johnson, Pfizer, Bayer, and in biotech. His experiences include drug discovery and advancing compounds to clinical trials, pharmaceutical development and commercialization of novel Rx Drugs, and consumer health product development in upstream innovation groups to shape and launch new external technologies.

Steve earned his Ph.D. in Molecular Pharmacology from Cornell Medical School and Memorial Sloan Kettering Cancer Center in New York City. At Cornell, Steve pioneered computational molecular dynamic drug discovery approaches. He also holds several patents and has published in top scientific journals.

COVID-19 Testing: What You Need to Know Now | 10:15 AM – 10:45 AM, Friday, October 2

Susan Van Meter is executive director of AdvaMedDx. AdvaMedDx represents manufacturers of in vitro diagnostic (IVD) tests and technologies. AdvaMedDx member company innovations allow early detection of disease, facilitate evidence-based medicine, improve patient health and health care, and enable personalized medicine, while often lowering overall health care costs. AdvaMedDx is the only advocacy organization exclusively addressing policy issues facing diagnostics manufacturers in the U.S. and around the world.

AdvaMedDx operates as a division of AdvaMed, the Advanced Medical Technology Association. AdvaMed is the world’s largest medical technology association, with over 400 member companies that develop medical devices, diagnostic tools, and health information systems.

Prior to joining AdvaMedDx in 2018, Ms. Van Meter served as senior vice president at the Healthcare Association of New York State (HANYS), focused on hospital and health system policy, payment, quality and health information technology priorities. Ms. Van Meter has an undergraduate degree in Political Science and French from Villanova University and a MA in Political Science from Boston University.

Can CRISPR-based technologies lessen disparities in access to equitable healthcare? | 9:30 AM – 10:00 AM, Friday, October 2

Eric B. Kmiec, Ph.D., is the Founder and Director of the Gene Editing Institute (GEI) at the Helen F. Graham Cancer Center & Research Institute at Christiana Care Health System. The Gene Editing Institute has recently been endowed by the Ammon Foundation. His research centers on understanding the process of gene repair and gene editing with a focus on CRISPR-directed genome engineering in human cells. He is widely recognized for his pioneering work in the fields of molecular medicine and gene editing having discovered many of the molecular activities that regulate the efficiency of human gene editing. Throughout his professional career, Dr. Kmiec has led research teams in developing gene editing technologies and genetic therapies for inherited disorders such as Sickle Cell Disease. Research efforts in GEI now centers on the mechanism of action, the genotoxicity and the regulation of gene editing based and how best to translate these discoveries into novel therapeutics for Sickle Cell Disease, Non-Small Cell Lung Carcinoma and Melanoma using a patient-centered approach.

Dr. Kmiec received his BA in Microbiology from Rutgers University, MS in Cell Biology from Southern Illinois University and his Ph.D. in Molecular Biology and Microbiology from the University of Florida School of Medicine. His Post-doctoral training was done at University of Rochester. Dr. Kmiec holds faculty appointments at the University of Delaware and the Wistar Institute. He has also held faculty appointments at Thomas Jefferson University, University of California at Davis and Georgetown University School of Medicine.

Dr. Kmiec has served as the Principal Investigator for research projects supported by the National Institute of Health (R01, COBRE and R21 grants), the National Science Foundation, the NIST-BIRD Foundation, the March of Dimes, the State of Delaware and the American Cancer Society for over 35 years. He serves on numerous editorial boards, has authored 165 peer-reviewed publications as primary or senior author, numerous reviews and has edited several books and journals in gene therapy.

Dr. Kmiec has been the primary thesis mentor for 18 Ph.D. students, 4 MS students and numerous postdoctoral fellows and residents. He has held or holds major administrative posts on various NIH regional and State biomedical research grants, including IDeA Network of Biomedical Research (INBRE) and Centers of Biomedical Research Excellence (COBRE) as well as NIH study sections. Dr. Kmiec was also honored as the Eminent Scholar in residence at Marshall University (Huntington, West Virginia) in 2009-2011 and was elected as an Honorary Medical Commander of the 436th Air Wing at Dover Air Force Base in Dover, Delaware for in 2013 and again in 2014. Dr. Kmiec has 15 issued patents, has founded two biotechnology companies and has received numerous service medals and awards, including the Genome Canada Lectureship, the Proudford Research Award in Sickle Cell Disease, multiple Delaware Bio Science Innovation Awards, and the Philadelphia- Israeli Chamber of Commerce Life Science Innovator Award.

SEED and SBIR Programs – Latest Updates | 12:25 PM – 12:55 PM, Thursday, October 1

Dr. Sasiela has over a decade of experience providing support and consultation to academic innovators and small businesses engaged in therapeutic, device, and diagnostic development programs. As the Innovator Support Team Lead in SEED (Small business Education and Entrepreneurial Development) in the Office of Extramural Research at the National Institutes of Health, Chris coordinates the activities of a team of seasoned professionals with experience in product and business strategy, business development, fundraising, partnerships, reimbursement, and regulatory affairs. Chris is passionate about enabling NIH’s innovator community to progress their discoveries as far as science and human biology permit. Starting her career as a researcher, Chris worked in basic research at the University of Southern California and the University of Maryland, and in drug discovery, development, and improvement groups at Baxter, the Department of the Army, and the National Cancer Institute. Chris transitioned from a research to a regulatory career path via an Interagency Oncology Taskforce Fellowship at the US Food and Drug Administration. Continuing her regulatory career path at Social & Scientific Systems, the National Institute of Allergy and Infectious Diseases, and the National Heart, Lung, and Blood Institute, Chris deepened her experience working with product development researchers understand, develop, and execute regulatory plans to get their innovative technologies from ideas to first-in-human and beyond. She regularly conducts project-focused consultations, delivers educational seminars, and develops regulatory resources for internal and external audiences. Dr. Sasiela earned a bachelor’s degree in chemistry from Whittier College, a Ph.D. in Pharmaceutical Sciences from the University of Maryland, School of Pharmacy, and has maintained Regulatory Affairs Certification status from the Regulatory Affairs Professional Society since 2011.

Update On Plasma Therapies | 8:55 AM – 9:25 AM, Friday, October 2

Mittie Doyle, MD, FACR joined CSL Behring in 2017 and currently serves as Vice President and Clinical Co-Lead overseeing Immunology Clinical and Therapeutic Strategy. Mittie earned her M.D. at Yale School of Medicine, completed her Internal Medicine training at Massachusetts General Hospital and her Rheumatology fellowship at Brigham and Women’s Hospital. She is a board-certified rheumatologist with over 25 years of experience in both academic medicine and the pharmaceutical industry. She previously served on the faculties of Harvard and Tulane Medical School and the adjunct faculty at the University of Pennsylvania Medical School.

Her clinical development expertise spans first in human clinical trials and proof of concept through successful BLA submission. She began her industry career at Centocor/Janssen supporting numerous large molecule programs including Remicade® and Simponi®. She also led the Stelara® psoriatic arthritis program. Following her tenure at Janssen, she gained experience at two smaller biotech companies; first in the Early Development / Translational Medicine group at Alexion as a Senior Medical Director in complement biology and then as Vice President of Clinical Research and Development at Flexion Therapeutics for the Zilretta® program. Prior to joining CSL Behring she served as Vice President, Global Development Team Leader in Immunology at Shire.

In addition to her strong background in Immunology, Mittie brings extensive experience in orphan drug development, indication selection, corporate strategy and business development to her role at CSL Behring.

Driving Win-Win Investment Collaborations with Entrepreneurs and Scientific Founders | 11:45 AM – 12:15 PM, Wednesday, September 30

 Chris Garabedian founded Xontogeny in June of 2016 to support multiple promising technologies from early development through clinical proof of concept. In 2017, Chris joined Perceptive Advisors to develop their Venture Fund strategy and launched the Perceptive Xontogeny Venture Fund in 2018 to support early stage companies seeded and incubated at Xontogeny and other ventures.

Chris has a broad base of experience and a track record of success over his decades long experience in the biopharma industry. Chris served as the President and CEO of Sarepta Therapeutics from 2011 to 2015, overseeing the turnaround of a company that is now a commercial stage leader in the genetic technology space after leading the development of the company’s Duchenne Muscular Dystrophy program. Prior to Sarepta, Chris led Corporate Strategy for Celgene from 2007 to 2010. Prior to Celgene, Chris served in a number of global commercial and corporate development leadership roles at Gilead from 1997 to 2005.

Chris serves on a number of Boards of life sciences companies and speaks at industry conferences on a wide range of important issues. Chris is also on the Board of Directors of MassBio and serves as a Senior Advisor for the Boston Consulting Group.

COVID-19 Impacts on Supply Chain | 12:25 pm – 12:55 am Thursday, October 1

Marla founded Xavier Health in 2008 at Xavier University, where she advances the industry with FDA officials and Pharmaceutical and Medical Device professionals. Marla began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in the position of Head of Quality Operations at the Merck North Carolina facility. Additionally, Marla is the Founder, CEO and President of Pathway for Patient Health, leading the implementation of a Quality Science Education program that is free for undergraduate and graduate students around the world, and is working with Chief Quality and Operations Officers to Mobilize Enterprise-wide Effectiveness. Marla holds a B.S. in Chemistry from Xavier University, and a Ph.D. in Organic Chemistry from the University of North Carolina – Chapel Hill.

Supply Chain Virtual Audits: Temporary Change or Permanent Impact? | 10:15 am – 10:45 am, Wednesday, September 30 

Jim Fries is a success based executive with over 25 years of experience building medical device and diagnostic companies. He became CEO of Rx-360 in February of 2018. Jim’s dedication to healthcare supply chain security and patient safety has always been his personal mission. In 2020 Rx-360 also founded the Rx-360 Education and Research Foundation (501c3) that is dedicated to bringing awareness of patient safety to everyone worldwide through educational programs and research. His personal vision coupled with the Rx-360 mission brings a wealth of awareness and success to all Rx-360 members and the industry as a whole.

Clinical Trials: How to Move Forward During COVID-19 | 10:50 am – 11:20 am, Friday, October 2

COVID-19 Mutation: What the Scientists Are Seeing | 10:15 AM – 10:45 AM, Wednesday, September 30 

Ben Doranz co-founded Integral Molecular in 2001 and has led all aspects of the company’s growth since its inception, bringing five different technologies from research to market and growing the company into a profitable commercial entity. He is an inventor on six of the company’s patents, the principal investigator on over 30 NIH grants, and an author on over 90 publications, including articles published in Cell, Science, and Nature.

Dr. Doranz is an established life science entrepreneur previously responsible for directing the biotechnology program at the Port of Technology business incubator and helping create startups at the University of Pennsylvania. Dr. Doranz earned a Ph.D. in Cellular and Molecular Biology from the University of Pennsylvania where he led the discovery of the coreceptor for HIV (CCR5), an MBA at Wharton where he co-founded the Penn Biotech Group, and a BA at Cornell University.

Leading from Within: How Meditation Can Make You a More Effective Leader | 12:20 PM – 12:50 PM, Wednesday, September 30 

Lisa Gonzalez has been teaching in a variety of roles for over 15 years. As a former school teacher, Lisa understands the importance and relevance of yoga, meditation and mindfulness. She serves as Meditation4Leadership’s Chief Meditation Officer training leaders in the corporate world how to effectively use meditation as a tool to develop a deeper awareness, enhance their connections, broaden their perspective and achieve their greatest potential both professionally and personally. She has studied yoga and meditation from world renowned yoga teacher Jonny Kest. Lisa is also a “teacher of teachers” as she leads some of the most successful Yoga Teacher Trainings in the nation for LifeTime Fitness.  Recently completing her first 10 Day silent Vipassana Meditation, she considers the late S.N. Goenka one of her greatest teachers.

Supply Chain Globalization or Localization in a Post-Pandemic Era? | 11:05 AM – 11:35 AM, Thursday, October 1

Mr. Albert DeRitis is an Assistant Clinical Professor at Drexel LeBow College of Business. He brings over thirty-five years of unique & diversified experience in accounting, finance, and supply chain in the healthcare industry. He has an in-depth understanding of domestic and international marketplace dynamics across Supply Chain, Commercial Sales & Marketing, and R&D organizations.

Most recently, he served as Worldwide Supply Chain Product Management Director for Johnson & Johnson, where he was responsible for all aspects of Life Cycle Management and End-to-End (E2E) supply chain for J&J’s top selling pharmaceutical product across 111 markets, impacting 2.7 million patients worldwide.

Mr. DeRitis previously served as Worldwide Financial Controller for a French Pharmaceutical company. He possesses knowledge in both Chemical (small molecule) and Biologic (large molecule) API business models, and has manufacturing plant experience in both environments.

• Executive Faculty Member for LeBow College of Business
• MBA from St. Joseph’s University Haub School of Management
• Certified Public Accountant (CPA), Certified Supply Chain Professional (CSCP), and Chartered Global Management Accountant (CGMA).
• Courses include: Essentials of Financial Reporting for MBA/EMBA, Operations & Supply Chain Management, Cost Accounting, Advanced Cost Accounting, Strategic Cost Management, Integrating Supply Chain with Financial Management, and Strategy & the Master Budgeting Process

From the Heart of Cellicon Valley: An Update | 11:40 am – 12:10 pm, Thursday, October 1

Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, is the Founding Director of the Clinical Cell and Vaccine Production Facility (CVPF) in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. He received a B.A. (Biology) from Penn and a Ph.D. in Immunology and Infectious Diseases from Johns Hopkins. First-in-human adoptive immunotherapy trials include the first use of a lentiviral vector, the first infusions of gene edited cells, and the first use of lentivirally-modified cells to treat cancer. Dr. Levine has overseen the production, testing and release of 3,000 cellular products administered to >1,200 patients in clinical trials since 1996. He is co-inventor of the first FDA approved gene therapy (Kymriah), chimeric antigen receptor T cells for leukemia and lymphoma, licensed to Novartis. Dr. Levine is co-inventor on 27 issued US patents and co-author of >180 manuscripts and book chapters with a Google Scholar citation h-index of 87. He is a Co-Founder of Tmunity Therapeutics, a spinout of the University of Pennsylvania. Dr. Levine is a recipient of the William Osler Patient Oriented Research Award, the Wallace H. Coulter Award for Healthcare Innovation, serves as President of the International Society for Cell and Gene Therapy, and serves on the Board of Directors of the Alliance for Regenerative Medicine. He has written for Scientific American and Wired and has been interviewed by the NY Times, Wall Street Journal, Washington Post, NPR, Time Magazine, National Geographic, Bloomberg, Forbes, BBC, and other international media outlets.