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.
Sunday, November 23, 2014
December 18th: Northern California BioPharmaceutical Project Management Breakfast Meeting
Animal, Vegetable, or Mineral: 20 Questions to a Winning CMC Strategy
Speaker: Stephen F. Tuck, Ph.D. – Co-Founder, Solutio Partners
Date/Time: Thursday, Dec. 18th, 8:00-10:00 AM, presentation begins at 8:30 sharp
Place: Genentech, 475 East Grand Ave, SSF, CA 94080, Building 42-1D
RSVP: http://NCBPPMDec2014Breakfast.eventzilla.net (Admission is free, but registration is required by 9:00 am 12/16)
Speaker Bio:
Stephen is a strategic drug development expert who cofounded Solutio Partners in 2007, a firm that provides drug development and regulatory consultation and contract services to emerging biopharma companies. He has extensive experience leading CMC, manufacturing, and product development programs and setting global CMC regulatory strategy for a range of novel medicinal products that includes Fluad? at Chiron and Heplisav?at Dynavax. He earned a Ph.D in chemistry from Imperial College London and completed post-doctoral training at Johns Hopkins University School of Medicine in Pharmacology and Therapeutics and at UCSF in Pharmaceutical Chemistry. Stephen’s career in biotech has spanned over 20 years in both public and private biopharmaceutical companies.
As a consultant, he has contributed to a diverse range of projects. Recently he has provided his CMC regulatory expertise to lead submissions to US and European authorities and has contributed to the design and execution of CMC programs for first-in-human as well as established molecules for cancer, asthma, and infectious diseases.
Stephen is unique among technical leaders. He brings not only strategic vision but also pragmatism and operational excellence to companies. This marriage of big-picture thinking and technical execution has earned him a reputation as an innovative problem solver who can streamline products through development while minimizing risk and expense.
Abstract:
Chemistry, Manufacturing, and Controls (CMC) is one leg of the development triangle that is critical to moving your drug into the clinic, keeping it there, and, if you are fortunate, submitting an NDA or BLA. In recent years, the second most common reason for FDA issuance of a complete response letter is a major deficiency in the CMC package. Building a robust CMC program requires the ability to adjust the CMC strategy to be appropriate for each successive stage of development from Discovery through NDA or BLA and navigating the inevitable speed bumps that arise. Thus, a thoughtful and nimble CMC approach paves a time- and cost-efficient route to the IND or marketing application. Using some examples of the challenges and opportunities that can occur, Stephen will discuss how to tailor CMC strategies and build a solid CMC regulatory package. The starting point is always good science. He will convince you that the process is the same as used in the parlor, radio and TV game known as “20 Questions” in which no more than 20 questions must be asked to distinguish between 220, or 1,048,576, objects.
*2 PDUs awarded for PMP re-certification
RSVP: http://NCBPPMDec2014Breakfast.eventzilla.net (Admission is free, but registration is required by 9:00 am 12/16)
Speaker Bio:
As a consultant, he has contributed to a diverse range of projects. Recently he has provided his CMC regulatory expertise to lead submissions to US and European authorities and has contributed to the design and execution of CMC programs for first-in-human as well as established molecules for cancer, asthma, and infectious diseases.
Stephen is unique among technical leaders. He brings not only strategic vision but also pragmatism and operational excellence to companies. This marriage of big-picture thinking and technical execution has earned him a reputation as an innovative problem solver who can streamline products through development while minimizing risk and expense.
Abstract:
Chemistry, Manufacturing, and Controls (CMC) is one leg of the development triangle that is critical to moving your drug into the clinic, keeping it there, and, if you are fortunate, submitting an NDA or BLA. In recent years, the second most common reason for FDA issuance of a complete response letter is a major deficiency in the CMC package. Building a robust CMC program requires the ability to adjust the CMC strategy to be appropriate for each successive stage of development from Discovery through NDA or BLA and navigating the inevitable speed bumps that arise. Thus, a thoughtful and nimble CMC approach paves a time- and cost-efficient route to the IND or marketing application. Using some examples of the challenges and opportunities that can occur, Stephen will discuss how to tailor CMC strategies and build a solid CMC regulatory package. The starting point is always good science. He will convince you that the process is the same as used in the parlor, radio and TV game known as “20 Questions” in which no more than 20 questions must be asked to distinguish between 220, or 1,048,576, objects.*2 PDUs awarded for PMP re-certification
Monday, August 25, 2014
September 19th: Northern California BioPharmaceutical Project Management Breakfast Meeting
Antibacterial Drug Development and Commercialization:
Avoiding the pitfalls in pre-market AST device development for post-market success
Speaker: Kevin Krause, Associate Director - Clinical Microbiology, Cerexa, Inc
Time: 8:00-10:00 AM, presentation begins at 8:30 sharp
Place: Achaogen, 7000 Shoreline Ct, S San Francisco, CA 94080
RSVP: http://NCBPPMSeptember2014Breakfast.eventzilla.net (Admission is free, but registration is required by 11:45 pm 9/17)
Speaker Bio:
Kevin has spent more than 15 years in various R&D Infectious Diseases roles in the biopharmaceutical industry. For nearly 11.5 years, Kevin was on the team that led to the discovery of telavancin and brought this drug to both the US and EU markets as Vibativ™. In parallel, he worked on multiple additional programs that led to two other compounds now successfully in clinical development. For the last 4 years, Kevin has been working in the Clinical Microbiology group at Cerexa, Inc. (A subsidiary of Forest Laboratories, Inc., now Actavis) on the Advisory Committee, launch and product support of Teflaro™, the clinical development of ceftazidime-avibactam, ceftaroline-avibactam and Quinsair™ (Inhaled levofloxacin) and post-approval commitments for Colobreathe™(Inhaled colistin).
Abstract:
The infectious disease landscape has reached a pivot point in the history of antibacterial drug development. Healthcare providers are begging for new antibiotics and daily news reports remind us about a coming global pandemic of multi-drug resistant “Superbugs”. Government officials, the FDA and the Infectious Diseases Society of America have all made public statements about the need to promote the development of novel antibacterials to stave off a looming public health crisis. Despite these proclamations, very few new antimicrobials have made it to the marketplace in the last 20 years and even fewer have been commercially successful. Why is that? For many years, there were significant regulatory challenges in the US that prevented new drugs from reaching the market, but those times are changing. Recently, the FDA’s Center for Drug Evaluation and Research has begun to completely rethinking its approach to antibiotic development in ways that will help reduce costs and speed the delivery of new medicines to the marketplace.
Despite this improving regulatory landscape, there are other significant barriers to market that most companies and few regulators understand that will continue to stand in the way of wide spread adoption of new antibacterials. Among these barriers, a major contributor is the development of antimicrobial susceptibility testing (AST) devices.
AST devices are used by hospitals to make formulary decisions and to guide patient care. Without a robust set of FDA approved AST devices, hospitals can’t test a drug against their patient’s bugs to know if they are susceptible. For this reason, a new drug will never be used by a hospital without the widespread availability of AST devices. Unfortunately, many companies don’t realize this until it is too late and their initial sales do not meet expectations.
While there are financial, scientific and regulatory challenges in proper AST device development, there are several critical steps that can be taken to mitigate the risk of leaving healthcare professionals with a new drug that they desperately need but that they can’t routinely use. During this presentation, Mr. Krause will share his strategic expertise and tactical knowledge on successful approaches in AST device development, particularly in collaborating with and overseeing AST device manufacturers to maximize the potential for new antibacterials across the entire product lifecycle.
*2 PDUs awarded for PMP re-certification
See slides from the presentation here.
Antibacterial Drug Development and Commercialization:
Avoiding the pitfalls in pre-market AST device development for post-market success
Speaker: Kevin Krause, Associate Director - Clinical Microbiology, Cerexa, Inc
Time: 8:00-10:00 AM, presentation begins at 8:30 sharp
Place: Achaogen, 7000 Shoreline Ct, S San Francisco, CA 94080
RSVP: http://NCBPPMSeptember2014Breakfast.eventzilla.net (Admission is free, but registration is required by 11:45 pm 9/17)
RSVP: http://NCBPPMSeptember2014Breakfast.eventzilla.net (Admission is free, but registration is required by 11:45 pm 9/17)
Speaker Bio:
Abstract:
The infectious disease landscape has reached a pivot point in the history of antibacterial drug development. Healthcare providers are begging for new antibiotics and daily news reports remind us about a coming global pandemic of multi-drug resistant “Superbugs”. Government officials, the FDA and the Infectious Diseases Society of America have all made public statements about the need to promote the development of novel antibacterials to stave off a looming public health crisis. Despite these proclamations, very few new antimicrobials have made it to the marketplace in the last 20 years and even fewer have been commercially successful. Why is that? For many years, there were significant regulatory challenges in the US that prevented new drugs from reaching the market, but those times are changing. Recently, the FDA’s Center for Drug Evaluation and Research has begun to completely rethinking its approach to antibiotic development in ways that will help reduce costs and speed the delivery of new medicines to the marketplace.Despite this improving regulatory landscape, there are other significant barriers to market that most companies and few regulators understand that will continue to stand in the way of wide spread adoption of new antibacterials. Among these barriers, a major contributor is the development of antimicrobial susceptibility testing (AST) devices.
AST devices are used by hospitals to make formulary decisions and to guide patient care. Without a robust set of FDA approved AST devices, hospitals can’t test a drug against their patient’s bugs to know if they are susceptible. For this reason, a new drug will never be used by a hospital without the widespread availability of AST devices. Unfortunately, many companies don’t realize this until it is too late and their initial sales do not meet expectations.
While there are financial, scientific and regulatory challenges in proper AST device development, there are several critical steps that can be taken to mitigate the risk of leaving healthcare professionals with a new drug that they desperately need but that they can’t routinely use. During this presentation, Mr. Krause will share his strategic expertise and tactical knowledge on successful approaches in AST device development, particularly in collaborating with and overseeing AST device manufacturers to maximize the potential for new antibacterials across the entire product lifecycle.
*2 PDUs awarded for PMP re-certification
See slides from the presentation here.
Monday, June 9, 2014
June 26th: Northern California BioPharmaceutical Project Management Networking Social
Join us for the Summer 2014 happy hour mixer!
Kick-off your summer by expanding your biotech and pharma network in the Bay! Project Management and all disciplines welcome.
When: June 26, 2014
6:00-8:30 PM
Where: Porterhouse Restaurant
60 E. Third Ave.
San Mateo, CA, 94401
Pricing: $20 pre-registration by June 19
$30 walk-in (cash only)
Registration: http://ncbppmjunenmixer.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.
*Please note, appetizers are pre-ordered based on the number of registered attendees. As a result, we are unable to offer refunds for cancellations after June 19.
Thursday, March 6, 2014
March 21st: Northern California BioPharmaceutical Project Management Breakfast Meeting
Learn to do more than others do and to think more than others do: the human side of project management
Speaker: Richard Hemingway, President, Hemingway Associates
Time: 8:00-10:00 AM, presentation begins at 8:30 sharp
Place: Genentech, 475 East Grand Ave, SSF, CA 94080, Building 42-1C
Abstract:
In this presentation, meeting attendees will learn a systematic step-by-step approach to developing cohesive teams and improving effectiveness.
Equally important to having the skills and tools to run projects effectively, project managers need to acquire skills that enable their teams to become and remain cohesive. To enable a team to work effectively, project managers need to recognize the importance of diversity and that every team member has a valuable and unique perspective. These factors are integral to the way in which a team operates.
Richard will outline simple methods he has used to improve individual, team, and company effectiveness by focusing on “the human side” of project management. It is critical for project managers to develop the skills to facilitate effective meetings which enable the team to align and agree on project objectives.
He will provide real-world examples that demonstrate the importance of developing and using a systematic approach to gain alignment within the team. Richard will present means of developing cohesive teams which is pivotal to driving successful tasks and projects forward.
Equally important to having the skills and tools to run projects effectively, project managers need to acquire skills that enable their teams to become and remain cohesive. To enable a team to work effectively, project managers need to recognize the importance of diversity and that every team member has a valuable and unique perspective. These factors are integral to the way in which a team operates.
Richard will outline simple methods he has used to improve individual, team, and company effectiveness by focusing on “the human side” of project management. It is critical for project managers to develop the skills to facilitate effective meetings which enable the team to align and agree on project objectives.
He will provide real-world examples that demonstrate the importance of developing and using a systematic approach to gain alignment within the team. Richard will present means of developing cohesive teams which is pivotal to driving successful tasks and projects forward.
Speaker Bio:
Prior to founding Hemingway Associates, Richard was a senior science manager in the UK and in California for Zeneca Agrochemicals. He also ran the staff development program at the Zeneca Western Research Center mainly using Coverdale programs. He left Zeneca in 1999 to establish his own company working closely with Coverdale, an international consulting company.
His vision for Hemingway Associates is to help a range of companies become more effective by developing powerful teamwork and encouraging clearer planning and faster completion of tasks and projects. He has worked with companies in a range of industries including many bioscience companies. Companies that have used the approach have become more effective working as multifunctional teams and faster at completing projects to meet stakeholder needs. Individuals develop a range of valuable skills.
Hemingway’s bioscience clients include Roche, Bayer Healthcare, Life Technologies, Lundbeck Research, Syntech Research. We have also used our approach with Nextel, Oakland Housing Authority, Claremont Insurance, Montblanc, Carl Zeiss and Cricket Communications. All have gained many benefits in planning more effectively and running projects faster, frequently improving effectiveness by 20- 30%.
Additional Information:
- Genentech requires valid photo ID upon checking
- Due to strict Genentech policies, registration closes at midnight March 18th - no exceptions, no walk-ins
- 2 PDUs for PMP re-certification may be claimed for attendance
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