Dear Northern California BPPM subscribers and friends:
Many of you are aware that our Northern California BPPM network has changed to The Biopharma Consortium (BPC), based on 1) the growing interest of our supporters outside of the project management discipline and 2) the strategic direction that our board of directors is rapidly moving.
This change is rooted, in particular, in the depth and breadth of the biotech and pharmaceutical industry programming we have been providing over the past 2-1/2 years, spanning research & development (from bench science to regulatory strategy), strategic alliances, marketing & corporate development, and resulting in more diverse networking opportunities.
Over the past few years, we have progressively have gained new members from diverse disciplines in the life sciences enabling us to more than double the volume of our subscribers in less than 2 years.
To better reflect who we are as a biopharma industry group, and in order to serve the needs of this growing and diverse life science community, we have shifted our core focus from “PM exclusivity” to create an entity that reflects the needs and the interests of this community which is “PM inclusive”. As a consortium, we employ a collaborations model to bring and endorse selected programming from our network "sister" organizations within the consortium.
Our Mission Statement:
The Biopharma Consortium (BPC) is a life science consortium that engages, serves and partners with biotech, pharma, medical device, academia, research institutes and special interest or service groups within the life science industry to provide access to a broad and deep network of professionals and career opportunities fueled by leading edge science, medicine and business.
BPC will continue the essential legacy commitment to career development, training, and leading-edge industry trends.
BPC’s core focus is the leading edge of the biotech and pharmaceutical industry and affiliates – we strive to keep pace with the rapidly changing landscape that will continue to drive our programming and networking opportunities that follow.
We look ahead with you to this exciting new chapter. Stay tuned for new developments. We welcome your questions, ideas, and contributions.
Sincerely,
The BPC Board
Lisa Hagerty-McMahon, Deborah Ovadia, Julia Larson, Matthew Busse, Neeraj Sharma
Note: We officially launched BPC on March 27, 2015 as announced at our most recent breakfast meeting at Genentech. To review the information and slides / FAQs that accompany this transition, please visit our former (transitioning) website: http://norcalbppm.blogspot.com. Announcements for our new website will follow soon. For Project Management Professionals (PMPs), in most cases you will be able to claim PDUs for attendance at our programs. Please view the 3/27/15 slides for detail.
Monday, May 11, 2015
Monday, March 9, 2015
March 27th: Northern California BioPharmaceutical Project Management Breakfast Meeting
Ways to Accelerate Drug Development: Fast-Track, Breakthrough Designation, Accelerated Approval, Priority Review
Speaker: Michele Bronson, Ph.D. – Vice President, Program Management, Portola Pharmaceuticals
Date/Time: Friday, March. 27th, 8:00-10:00 AM, presentation begins at 8:30 sharp
Place: Genentech, 475 East Grand Ave, SSF, CA 94080, Building 42-1C
RSVP: http://NCBPPMMar2015Breakfast.eventzilla.net (Admission is free, but registration is required by 9:00 am 03/25)
Speaker Bio:
Michele is a drug development professional, who has built and led Regulatory, Quality and Project Management organizations. Michele joined Portola in November 2014, with over 15 years of experience at start-up to medium-size biotech companies. She was most recently Vice President of regulatory and quality at Labrys Biologics developing an anti-CGRP monoclonal antibody for the prevention of migraine. Labrys was acquired by Teva Pharmaceuticals for $825 million in July 2014. Prior to Labrys, Michele was Vice President of Regulatory, Quality and Project Management at Medivation, Inc., where she oversaw the development of their prostate cancer compound (enzalutamide) from pre-IND stage through FDA approval. Michele served in roles of increasing responsibility in regulatory affairs at Chiron Corporation, until its acquisition by Novartis in 2006. Michele received her Ph.D. in molecular biology from UT Southwestern Medical School.
Abstract:
Whether one is working a start-up or an established company, the sooner a product can be brought to market the better—better for patients and better for the company. Over the last few years, the FDA has created numerous pathways to accelerate drug development. In addition to the long-standing Accelerated Approval process and Priority Review status, the FDA has also created both Fast Track and Breakthrough Therapy Designation. The differences and advantages of each program will be presented, along with experience to date in the industry, as well as general considerations that impact drug development programs considering these pathways must examine.
*2 PDUs awarded for PMP re-certification
RSVP: http://NCBPPMMar2015Breakfast.eventzilla.net (Admission is free, but registration is required by 9:00 am 03/25)
Speaker Bio:
Abstract:
Whether one is working a start-up or an established company, the sooner a product can be brought to market the better—better for patients and better for the company. Over the last few years, the FDA has created numerous pathways to accelerate drug development. In addition to the long-standing Accelerated Approval process and Priority Review status, the FDA has also created both Fast Track and Breakthrough Therapy Designation. The differences and advantages of each program will be presented, along with experience to date in the industry, as well as general considerations that impact drug development programs considering these pathways must examine.*2 PDUs awarded for PMP re-certification
Friday, January 9, 2015
January 28th: NorCal BioPharma PM 2015 New Year Mixer
Resolve to expand your network in 2015! Kick-off the new year by making new professional connections and deepening existing ones.
When: January 28, 2015
6:00-8:30 PM
Where: Porterhouse Restaurant
60 E. Third Ave.
San Mateo, CA, 94401
Pricing: $20 pre-registration by January 22
$25 on-line by January 27
$25 on-line by January 27
$30 walk-in (cash only)
Registration: http://ncbppmjan2015mixer.eventzilla.net
Join us in the bar and lounge for an evening of delicious appetizers and free-flowing networking. Cash bar.
Enjoy a relaxed evening out socializing and catching up on the latest industry buzz with your fellow professionals in biotech.
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