Date(s) - 7 May 2020 until 7 May 2020
12:00 PM - 1:00 PM
Cracking the Commercialization Code
4 defining steps that could unlock your life science technology’s commercialization potential
May 7, 2020
12:00 pm–1:30 pm PDT/AZ
You believe in your science and that it will generate a safe and effective product; unfortunately, that alone might not ensure it reaches patients. From understanding your market and regulatory needs to payor reimbursement and clinical adoption, we aim to provide an aerial view to help define your pathway through the commercialization maze. In this session, we take you through the nuances of the 4 key steps on the path to commercialization:
- Global markets
- Regulatory agencies
- Payor reimbursement
- Clinician adoption
Join us for practical steps to help maneuver the maze. Like most things for life science entrepreneurs, starting early can help smooth the road.
Co-Founder, President, Telos Partners LLC
Joel is a medical device industry veteran, with 20 years of leadership experience developing scientific and regulatory strategies for start-ups to large cap companies. He has delivered >$100 million return on investment by delivering FDA approvals for Class II and Class III devices in the musculoskeletal and wound care spaces. He has published and presented the results of pre-clinical and clinical science in journals such as American Journal of Sports Medicine, American Journal of Orthopaedics, and venues such as the American College of Foot and Ankle Surgeons.
In 2010, he led a business development team in the application of a novel biologic material to osteoporotic patients for reducing the incidence of hip fractures. After conducting early-phase trials and developing the scientific and regulatory strategy, the team sold the technology for $30 million. He has also overseen key areas of investment and integration for four major acquisitions. Joel’s interests include the transformation of healthcare in developing countries of Africa, in partnership with the vision of LifeNet International.
Joel earned a BS in exercise science from the University of Florida and an MA in bioethics and health policy from Loyola University Chicago Stritch School of Medicine.
PETER T. BIGELOW
President, xCell Strategic Consulting LLC
Peter is the President of xCell Strategic Consulting, a consulting firm to the Pharmaceutical Industry. xCell provides consulting services in the areas of Drug Development, Outsourcing, and Supply Chain. In addition, xCell Provides advice and support for M&A in the Pharmaceutical Services Industry. Prior to founding xCell, Peter served as Division President of Qualitest, Endo Pharmaceutical’s Generic Drug Division. He also served as the President of North America Commercial Operations and CEO at Patheon Pharmaceuticals. Patheon is a leading Contract Manufacturing and Contract Research Organization which at the time was Publicly Traded and had $700 million in revenues and 5000 employees.
Prior to joining Patheon, Peter spent 14 years with Wyeth Pharmaceuticals. While at Wyeth, he oversaw a significant portion of the Manufacturing and Supply Chain organization including Consumer Products such as Advil and Centrum Vitamins, Branded Drug Products and Vaccines such as Prevnar. He also oversaw Global Engineering and expansion programs to support drug manufacturing and Research and Development.
Peter also spent 14 years at SmithKline Beecham (now GlaxoSmithKline) before joining Wyeth. His assignments included significant international project work in Europe and the Far East and operations experience with injectable product manufacturing.
Peter is a member of the Global Pharmaceutical Manufacturing Leadership Forum of the ISPE and is a frequent speaker at Industry events. He serves as the Chairman of the Board of Trustees of the Pharma, Biopharma Outsourcing Association (PBOA); a non-profit trade association that represents the needs and interests of Pharmaceutical Contract Development & Manufacturing Organizations (CDMOs). Peter is on the Board of Frontida Laboratories and on the Board of CASA Youth Services – a non profit organization serving the needs of Children in the Foster Care environment. He has a BS in Mechanical Engineering from Villanova University and an MBA from Philadelphia University. Peter and his wife Lynn reside in Valley Forge, Pennsylvania.
LUCIA MOKRES, DVM
CEO and Principal, Araneae Biotech Consulting LLC
Dr. Lucia Mokres coaches current and aspiring life science founders through Stakeholder Ecosystem DiscoverySM, a robust and intensive model for establishing product-market fit and understanding the needs of the complex landscape of decision makers that will determine their path to market. Using an evidence-based approach to their product development plan enables founders to gain traction and develop an investable technology and business model. The skills learned in her training can be used again and again to start new companies, develop new pipeline products, and rapidly adapt to changing economic, regulatory, and competitive landscapes.
Prior to establishing her consultancy, Dr. Mokres was the Chief Medical Officer of EpiBiome, Inc., where she led EpiBiome through the NSF Innovation Corps and several other incubators and accelerators. Dr. Mokres is an invited speaker nationally and internationally on the challenges faced by early stage companies seeking regulatory approval.
In her spare time, Dr. Mokres mentors life science company founders through the Springboard Enterprises and California Life Sciences Institute advisory programs, and mentors women completing their PhD and postdoctoral studies on behalf of the Association for Women in Science.
MICHAEL K. O’BRIEN, PhD
CEO, NGT BioPharma Consultants; President and CEO of NGT BioPharma
Consultants, Dr. O’Brien is recognized as a forward-thinking innovator in the biopharmaceutical industry. As the VP Pharmaceutical Sciences Technology & Innovation at Pfizer Pharmaceuticals, he conceived and collaborated on the design, fabrication and implementation of a portable, continuous, miniature and modular (PCMM) oral solid dose manufacturing facility that was built off-site and assembled in a warehouse, with the capability to transfer and reassemble the facility at other sites. The PCMM facility won the 2016 ISPE Facility of The Year Award. Dr. O’Brien previously served as the acting head of a large biopharma chemical development organization, where he oversaw and managed cGMP Kg-laboratories, pilot plants, API external supply groups, environmental, health and safety (EHS) teams, as well as the Synthesis R&D group.
An agent of change who strategically aligns stakeholders to ensure executive support for status quo transformation, Dr. O’Brien’s expertise extends to development of digital, analytical, drug substance and drug product platform technologies, which, when implemented, automate critical industry processes, operations and oversight. He was named an Industry Influencer on The Medicine Maker 2019 Power List and has more than 55 publications, presentations and patents.
AVERY SONNEBERG, PhD
Principal, Two Bear Capital
As a Principal at Two Bear Capital, Avery focuses on the technology, science, and business case behind investment decisions. With a PhD in Bioengineering from UC San Diego, Avery joins the firm after a senior engineering role in the Life Science Innovation group at Becton Dickinson. Avery’s expertise, through both academic and industry experience, is in anticipating, understanding, and solving the roadblocks between transformational technologies and life-changing products. Avery enjoys hiking, biking, climbing, and camping, especially with his wife and three young sons.
12:00 pm – 12:45 pm – Presentation
12:45 pm – 1:30 pm – Panel Discussion and Audience Q & A