How To… Set a Regulatory Roadmap

Jun 10 2015https://www.eventbrite.com/e/how-to-set-a-regulatory-roadmap-tickets-15871823050

JLABS BAY AREA EVENT MAXIMUM CAPACITY HAS BEEN REACHED FOR THIS EVENT; THERE WILL BE NO ONSITE REGISTRATION.

Program Overview:
Second to funding, navigating the regulatory process can be the most challenging aspect of running your start-up. This session will help you pinpoint the information you need to develop a regulatory roadmap, and then hit the ground running. You will learn what healthcare startups need to know about regulatory affairs and how to locate the information. This "how to" workshop is geared towards pharmaceutical, biotech, and medical device start-ups.

Key topics will include:
    - Common regulatory questions and challenges in early development
    - Publicly available info
    - Evaluating consultants
    - Hiring your first Regulatory FTE

The "How to... Workshop" series is dedicated to giving you the keys to a successful business, from creation to exit. As with all our events, the "How to... Workshop" is interactive and informal so bring your questions with you!

Agenda:
11:30am | Registration, Networking and Lunch
12:00pm | Presentation
12:30pm | Q&A
1:00pm | Close

Speakers:
Ramon Polo | Vice President and Head, Infectious Diseases and Global Public Health Regulatory Affairs, GRA (Global Regulatory Affairs), Janssen Research & Development, LLC read bio»
Els Van Beirendonck | Director, Infectious Diseases & Vaccines (ID&V) Regulatory Affairs, GRA (Global Regulatory Affairs), Janssen Research & Development, LLC read bio»

Fees:
$35 General Public
$20 Student/Academic
MAXIMUM CAPACITY HAS BEEN REACHED FOR THIS EVENT; THERE WILL BE NO ONSITE REGISTRATION.

Location:
Johnson & Johnson Innovation, JLABS
329 Oyster Point Blvd – 3rd Floor
South San Francisco, CA

Speakers' Biographies:
Ramon Polo Ramon Polo | Vice President and Head, Infectious Diseases and Global Public Health Regulatory Affairs, GRA (Global Regulatory Affairs), Janssen Research & Development, LLC
Ramon recently became a member of the Global Regulatory Affairs Senior Leadership Team and of the Leadership Team for the ID Therapeutic Area. In his new role, Ramon is responsible for leading the Infectious Diseases (ID) and Global Public Health (GPH) Regulatory Affairs team, which is comprised of 45+ colleagues across seven global sites. Ramon and his team drive the regulatory strategy for all projects within this therapeutic area and GPH and ensure that regulatory support is provided and that regulatory submissions and approvals are delivered at all stages of development.
Ramon is also currently the Integration Leader for the ALIOS transition into Janssen as well as the Compound Development Team Leader (CDTL) for VX-787 (Influenza A specific Direct Acting Antiviral).
During 2014, Ramon was also the Early Compound Development Team Leader (eCDTL) for JNJ-678 (RSV specific Fusion Inhibitor).
From 2013 to January 2015, Ramon was the R&D Co-Leader of the Respiratory Infections (RI) Disease Area Stronghold (DAS) focused primarily in identifying the key therapeutic solutions for influenza and RSV that has led to the current therapeutic portfolio of the RI DAS. Since 2011, Ramon was the late-stage CDTL for the influenza-specific monoclonal antibody (FlumAbs) program within Crucell/Janssen.
Previously, Ramon led as CDTL, the global development (in Partnership with Vertex Pharmaceuticals) and the NDA and EMEA filings and approvals of INCIVO (Telaprevir) for hepatitis C patients (HCV) as the first in class Direct Acting Antiviral. Before his key position related to Telaprevir development, he significantly contributed to the global development, NDA/MAA filings, and FDA and EMA approvals, of several products in other therapeutic areas (Ortho EVRA, Ortho Tricyclen LO and Ortho Prefest).
Ramon worked in new business development (Alliance Management) and strategic marketing (Late-stage lifecycle) roles with Johnson & Johnson from 2003-2006 in the US before he returned to R&D as a CDTL in the ID&V TA in 2006.
From 1998 – 2003, Ramon worked for Global Regulatory Affairs for the J&JPRD organization and was responsible for a global team that provided regulatory and drug development support to global product teams in the area of hormone replacement therapy, contraception and urology.
Before joining Janssen in October, 1990, Ramon was a Part-time research fellow at University Complutense of Madrid, Spain.
Ramon received his Pharm.D / Ph.D. (Clinical Biochemistry) degree from the University Complutense of Madrid, Spain, and obtained his MBA from the IESE and Harvard Business School.
Connect with Ramon: Connect on LinkedIn


Els Van Beirendonck Els Van Beirendonck | Director, Infectious Diseases & Vaccines (ID&V) Regulatory Affairs, GRA (Global Regulatory Affairs), Janssen Research & Development, LLC
Els currently is the Regulatory Disease Area Lead for Respiratory projects within Janssen Infectious Diseases. In this role Els is responsible for overall strategic Global Regulatory Affairs input into Disease Area Stronghold strategies and alignment with individual project strategies. Els is also a Global Regulatory Leader of several projects and as a leader of Global Regulatory Teams she has a key role in developing regulatory strategies and ensuring regulatory submissions and approvals are delivered at all stages of development.
Els joined the Global Regulatory Affairs department of J&J in 1996 and as a member of multiple compound development teams she significantly contributed to the successful development and global registrations of CNS and infectious disease products. In 2001 Els became the head of the regulatory & CMC group at Janssen Animal Health (currently Elanco - Ely Lilly) and successfully managed global regulatory projects for life stock and companion animal products. In 2005, Els joined Tibotec (Janssen Infectious Diseases). As Global Regulatory Leader she worked on several HCV and HIV early development projects. From 2010 until 2013 she was also the Global Regulatory Leader for Sirturo and significantly contributed to submissions in the EU/US/other regions and FDA/EMA approvals. From 20007 until 2014 Els represented global regulatory in the J&J First in Human Committee.
Before joining Janssen, Els held regulatory positions at NeXstar Pharmaceuticals (currently Gilead) and at Pharmacia (currently Pfizer).
Els obtained a Master Degree in Pharmacy and in Industrial Pharmacy at the University of Antwerp, Belgium. She also obtained a Postgraduate Diploma in Regulatory Affairs organized by TOPRA, validated by the University of Wales, United Kingdom.
Connect with Els: Connect on LinkedIn

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