Venue: Tokyo American Club, Brooklyn room
Speakers: Frank Nogueira, CEO, and Khushboo Sharma, chief regulatory innovation officer, Accumulus Synergy
Hosting Committee: Healthcare
Meal: American breakfast buffet
Member Fee: ¥3,600
Guest Fee: ¥7,000
Registration/Cancellation Deadline: Wednesday, February 21 (12:00)
The Covid-19 pandemic raised a critical question: How can our regulatory ecosystem work better and faster to evaluate and deliver therapies across the globe?
By shifting from a document-centric mindset to a more data-driven approach, and by leveraging cross-border reliance practices that enable real-time data exchange and discussion among regulators and companies, we can ensure that new drugs reach patients more quickly and efficiently.
Accumulus Synergy, a non-profit industry association focused on global digital transformation, is uniquely positioned to assist in this effort. Accumulus is building a first-of-its-kind cloud solution to optimize data exchange, insight sharing, and collaboration among all stakeholders, thus enabling improved interactions that lead to shortened review times and earlier delivery of critical therapies to all nations.
Join us for this event at which Accumulus CEO Frank Nogueira and Chief Regulatory Innovation Officer Khushboo Sharma will share the company’s vision and progress to date, and discuss Japan’s role in this global movement.
About the Speakers
Frank Nogueira
Chief Executive Officer Frank Nogueira joined Accumulus Synergy from Genentech, where he served as vice president and leveraged his 20 years of regulatory strategy, asset development, and commercialization experience to deliver enterprise value and bring medicines to patients. There he headed multiple global teams, most recently overseeing the development and delivery of an oncology-medicines portfolio to China, as well as lifecycle management of an Alzheimer’s molecule. Nogueira holds an executive MBA degree from Rutgers University and a bachelor of arts degree in earth science from Kean University.
Khushboo Sharma
Before joining Accumulus as chief regulatory innovation officer, Khushboo Sharma served as chief of staff and senior vice president at BIO, where she led the science and regulatory team on major initiatives, from pre-clinical to post-market policy. Before that, she spent 11 years at the US Food and Drug Administration, where she oversaw business, regulatory, and programmatic operations as deputy director of operations in the Office of New Drugs. She also supported regulatory review for the New Drugs Regulatory Program and served as a negotiator for the Prescription Drugs User Fee Act. Sharma began her career managing oncology and therapeutic monoclonal antibody products at Janssen. She earned a bachelor of science degree in biotechnology and microbiology and an MBA in healthcare and biotechnology industry management from Pennsylvania State University. In 2021, she was named one of InVivo’s Rising 30 Leaders in healthcare and science.
ACCJ Healthcare Committee
Makoto (Mark) Kawai, chair
Harunobu Amagase, Katsunori Fujita, Eiji Sasahara, Anne Smith, and Daisuke Yasumizu, vice-chairs
NOTE 1: This event is OFF THE RECORD.
NOTE 2: Please note that, as with all guest presentations, the content and comments of the speakers reflect their own opinions and do not necessarily represent the opinions or policies of the ACCJ.
NOTE 3: To ensure the safety of our members, guests, and staff, we ask that you review the registration guidelines and safety measures and complete the consent form before registering.
NOTE 4: If you cancel after the stated deadline, the full meeting fee will be charged to your account. All guests must be accompanied by a member of the ACCJ. No substitutions or walk-ins.
NOTE 5: If you are driving to Tokyo American Club, please inform the ACCJ of the make, model, color, and plate of the vehicle, by the registration deadline, as arrangements must be made. A ¥2,200 parking fee will apply.