SABPA Newsletter February 2011
Table of Contents
SABPA Events
1. SABPA Science & Technology Forum IX: New Trend in Drug Development:
Companion Diagnostics (March 19th, 2011)
2. The 9th SABPA Entrepreneur Symposium (April 16th, 2011)
SABPA Reports
3. 2011 Chinese New Year Party (February 5th, 2011)
4. Beijing Investment Promotion Bureau Visiting San Diego Event (February 20th,
2011)
Community Events
5. Is Your Automated Liquid Handler Working For Your Assays? (March 2nd, 2011)
6. 2011 Wilbur K. Woo Greater China Business Conference (March 4th, 2011)
7. SDEE Roundtable - Global Climate Change and Entrepreneurial Opportunities in
The New Decade (March 9th, 2011)
8. Device Alliance Professional Business Mixer (March 16th, 2011)
9. Asia Pharma R&D Leaders 2011—the largest and premier pharma R&D summit
in China (March 24th and 25th, 2011)
10. IBC conference (The 6th China Pharmaceutical R&D Summit) (April 11th-13th,
2011)
11. San Diego Regional EDC and CleanTECH San Diego celebrate Earth Day (April
20th, 2011)
12. San Diego Bioprocess Forum Event (April 26th, 2011)
13. The Biotechnology of Oenology (April 27th, 2011)
Job Postings
14. Skingenix Job Postings (Ontario, California)
15. Simcere of America Job Posting
16. Ab-Mart posting
17. A-bio/Luye posting
SABPA Events
1. SABPA Science & Technology Forum IX: New Trend in Drug Development:
Companion Diagnostics
When: March 19, 2011 (Saturday) 8:30 am – 12:30 pm
Where: Institute of Americas, UCSD
Organizer: SABPA
Registration: https://www.123signup.com/register?id=vcycz
$20 for online registration, $10 for students and post-docs
$40 for on-site registration, online registration ends March 16, 2011
Event Website: http://www.sabpa.org
Companion diagnostics, which identifies and detects genetic, protein, or gene expression
markers to predict whether a drug works or causes adverse effect in patients, has emerged
as an exciting new field over the last few years. With the cost and hurdle for new drug
approval getting increasingly higher, pharmaceutical companies begin to explore
companion tests in order to develop safer and more effective drugs. The value of
companion diagnostic tests has already been demonstrated by a number of marketed
products, such as HercepTest for Herceptin and K-RAS mutation tests for Erbitux and
Vectibix. Despite these proven successes and ever-increasing awareness of companion
diagnostics, pharmaceutical companies still move slowly to adopt the new paradigm of
co-developing companion tests along with the clinical trial of new drugs. The regulatory
hurdles, physician and patient acceptance, insurance coverage, IP strategies, and other
barriers remain unsettled for this young filed. At the coming SABPA Science &
Technology Forum IX, we invite opinion leaders representing pharmaceutical companies,
diagnostic companies and other interest groups to share their insights and visions on this
rapidly growing field.
Speakers
Kenneth J. Bloom, M.D., F.C.A.P. Chief Medical Officer, Clarient, Inc.
François Ferré, Ph.D President and CEO of AltheaDx
Laura K. Shawver, Ph.D. Executive in Residence at 5AM Ventures, Founder and CEO
of The Clearity Foundation
James Christensen, Ph.D. Director, Oncology Translational Research, Pfizer
Chen Peng, J.D., Ph.D. Partner, Morrison & Foerster LLP
Lyle Arnold, Ph.D. President and Founder at Aegea Biotechnologies
David Nelson, Ph.D. President and CEO of Epic Sciences
Erik Holmlin, Ph.D. EIR of Domain Associates
Jian-Bing Fan, Ph.D. Senior Director, Scientific Research, Illumina
Reception: To Be Sponsored by Luye Pharma Group
In 2010, Luye Pharma Group, a Singapore-listed, China-based pharmaceutical company
became the major shareholder of A-Bio, enabling A-Bio to serve as the R&D center for
their biologics pipeline, aiming at China’s rapidly growing biopharmaceutical market and
unmet medical needs. Luye will be hosting a reception immediately after the S&T forum,
and will give a presentation to introduce Aegea Biotechnologies as well as their strategies
for the biologics business in China. Company members will then be available for a
short Q&A session and to network with the audience afterwards. Below are the Aegea
Biotechnologies team members who are visiting San Diego:
Dr. Steven LEE, CEO of Aegea Biotechnologies Pharma Pte Ltd, (subsidiary in
Singapore)
Dr. Dongxiao FENG, Director of Biotechnology Development,
Dr. Gang CHENG, Manager of International Technology Transfer and Collaboration
2. The 9th SABPA Entrepreneur Symposium
When: 5:00 pm to 8:00 pm, Saturday, April 16th, 2011
Where: Institute of Americas, UCSD (Parking is free at Pangea)
Registration: http://sabpa.org/web/news_details.php?ID=322
Lecture Title: ―Bringing Novel Therapeutics from Concept to Market--A Case Study in
Regenerative Medicine‖
Lecture Summary:
In this lecture, Dr. Gail Naughton will discuss the following topics:
- Why biomedical discovery
- Hurdle to market
- Tissue engineering
- Road to commercialization
- Financial reality: Many issues
- Biotech product development & external funding
Speaker: Gail K. Naughton, Ph.D., CEO and Chairman, Histogen, Inc.
In addition to being the Dean of the College of Business Administration at San Diego
State University since 2002, Dr. Naughton founded Histogen, Inc. in 2007, and currently
serves as CEO and Chairman of the Board for the Company. She oversaw the
development of four tissue engineered products through to market launch and was pivotal
in raising over $350 Million US dollars from both public markets and corporate
partnership. Dr. Naughton has spent more than 15 years extensively researching the
process of tissue engineering, holds over 95 U.S. and foreign patents and has been
extensively published in the field.
Schedule:
5:00 to 5:30 pm: Reception and Networking
5:30 to 5:40 pm: Welcome and Announcement
5:40 to 6:40 pm: Presentation and Q&A
6:40 to 7:30 pm: Networking
SABPA Reports
3. 2011 SABPA Chinese New Year Party
This past February 5th , 2011, many of the SABPA volunteers and their families gathered
together at the clubhouse of the beautiful Fairbanks Ranch in Rancho Santa Fe for our
annual Chinese New Year party. This was also a time for us to share volunteering spirits
among team members from different committees representing both San Diego and
Orange County/Los Angeles (OC/LA) Chapters, and to recognize the contributions of
many of our dedicated volunteers.
SABPA’s past president Drs. Xiangming Fang and Hengchu Cao expressed their deepest
appreciation to all of the volunteers who helped make so many exciting SABPA events
possible over the last year. They then presented this year’s SABPA awards to the
following team members:
Leadership award: Yinghong Gao and Wen Luo
Achievement award: Jiangli Yan, Bhawan Brar, Allan Pan, and Jiayi Yang
Team award: Yiwen Tao, Kevin Chang, Chih-Cheng Yang, Chia-Yu Ku, and Isaac
Mehl
OC/LA award: Tony Chen, Yan-bo Yang, Zhen Zhu, and Bin Tian.
Outstanding service and leadership award: Hui Cai, Xiangming Fang, and Hengchu
Cao
Dr. Hui Li, the chair of SABPA board then presented the Outstanding Service and
Leadership Award to Drs. Hui Cai, Xiangming Fang, and Hengchu Cao. These great
leaders were recognized for being the inspiration for many of us. Their vision, devotion
and leadership have been instrumental to SABPA’s success.
Congratulations to all of award winners for winning the SABPA awards and for keeping
up the good work!
The next announcement was for the new presidents of both chapters. The new president
Peter Zhu of San Diego chapter and Fred Ouyang of OC/LA chapter were introduced
by Dr. Hui Li to give their impromptu speeches at the party. In addition, Dr. Mingzhu
Zhang was nominated to be the Executive Vice President of the San Diego Chapter.
Last but not least, we want to thank our support teams to make this event truly enjoyable
for all. It was a great opportunity to catch up with old friends, and to make new ones, to
enjoy very good Chinese food and to socialize with SABPA members and their families.
Happy Chinese New Year to you all!
4. Beijing Delegation Event Report
On Sunday February 20th 2011, SABPA successfully organized another event for a
delegation from China – Beijing Investment Promotion Bureau. Near 150 people from
San Diego, Irvine, Los Angeles and San Francisco attended the event. Mr. Weimin Zhou,
Director General of Beijing Investment Promotion Bureau and Mr. Xu Zhou, Deputy
Director of Beijing Investment Promotion Bureau gave very informative talks on
―Economic development, key industries, government policies, and advantages and
resources available in Beijing‖. J. Christopher Mizer, Managing Director and Co-founder
of ChinaBio® Capital Partners talked about the China biotech from a venture capitalist
point of view. Three consuls (Consul Xiangdong Ye, Consul Jian Zhang and Consul
Cheng Wu) from the Science and Technology Office, the Consulate General of the
People’s Republic of China in Los Angeles, joined the award ceremony and gave very
encouraging speeches.
In addition to presentation and general discussion, delegation from Beijing Investement
Promotion Bureau also had successful discussion with nearly 20 companies and
individuals on potential collaborations. This specific exchange has been very well
received from both sides and all time slots were booked prior to the event.
For the presentation slides, please visit:
http://www.sabpa.org/web/news_details.php?ID=317
For report in Chinese, please visit: http://www.sandiegochinesepress.com/press/?p=3759
Community Events
5. Is Your Automated Liquid Handler Working For Your Assays? Uncovering
Errors, Understanding Device Behavior, and Optimizing Methods
When: Wednesday March 2nd, 6 pm
Where: Johnson & Johnson, Pharmaceutical Research and Development, 3210
Merryfield Row, San Diego, 92121
Organizer: Jointly San Diego LEADS and San Diego LRIG
Registration: Free
Details: Kevin Khovananth, West Coast Laboratory Applications Specialist, ARTEL
The focus of this presentation is to highlight the need of ensuring quality in important
assays performed with automated liquid handlers. Nearly all assays performed within a
laboratory are volume-dependent. In turn, all concentrations of biological and chemical
components in these assays, as well as the associated dilution protocols, are volume-
dependent. Because analyte concentration is volume-dependent, an assay’s results might
be falsely interpreted if liquid handler variability and inaccuracies are unknown or if the
system(s) go unchecked for a long period. Measuring and knowing the exact volumes
transferred, for specific and/or routine methods, will inherently lead to confidence in the
experiment, i.e., the results can be trusted
This presentation focuses on the importance of understanding liquid handler behavior for
many types of assays. To understand and assess liquid handler performance in each case,
a standardized volume verification method was employed (MVS® Multichannel
Verification System). For instance, it will be presented how liquid handling steps were
measured, understood, and/or optimized: (1) on-board mixing efficiency; (2) finding a
bad ―tip-in-the-box‖ in a newly opened tip box; (3) highlighting the differences between
accuracy and precision; (4) comparing individual volume transfers over multi-sequential
dispenses; (6) optimizing an automated method for a specific target volume; and (7)
directly comparing performance between liquid handlers from multiple locations.
Refreshments are sponsored by Artel
6. 2011 Wilbur K. Woo Greater China Business Conference
Topic: A Race for Growth: Leveraging Cross Border Opportunities
When: March 4th, 2011 (Friday) 8:30am – 4:30 pm
Where: Anderson School of Management, UCLA
Organizer: GCBA-Anderson
Registration: http://www.anderson.ucla.edu/x34444.xml, $100 for Regular online
registration, $50 for academic registration before 28th, 2011
The Wilbur K. Woo Greater China Business Conference aims to bring business leaders,
professionals, academics, and students together to discuss business trends, challenges,
and impacts of the increasing role of Greater China in the global economy. It also aims to
provide a collaborative platform for participants to build networks, exchange ideas, and
share knowledge. Keynote speeches and an Executive Exchange will highlight Greater
China's Cross Border Opportunities. Panel discussions featuring experts who share their
experiences and ideas on industry trends will explore growth strategies for firms in China
and the United States
Panelists:
Healthcare Medical Reform Benefits and Challenges
Media New Media for a New Era
Finance U.S. and Asian Financial Systems Post-Credit Crisis
Clean Tech Rapid Developments Across Global Markets
Speakers:
Joshua Berlin | Executive Editor & Director of Business Development, Elsevier Business
Intelligence
Joy Chen '98 | Executive Recruiter and former Deputy Mayor of Los Angeles
Pete Cooper | Director of Global Development, Better Place
Ira Kalish | Director of Global Economics, Deloitte Research
David Liu | Managing Director & COO, Key West Financial Services
Jerry Nickelsburg | Senior Economist, UCLA Anderson Forecast
Michael J. Reilly | Co-Founder & CEO, Western States Biopharmaceutical
Sofia Qiao | Co-founder and CEO, LINQ Pharmaceuticals, Inc.
Maria Sendra | Partner, Baker & McKenzie
Peter Shiao | CEO, Orb Media Group
Ian Toner | Head of Commission Management & Currency Implementation, Russell
Investment Group
Veena Wu | Business Development Manager, BYD and more...
Schedule
8:30 am Registration & continental breakfast
9:15 am Welcoming remarks and keynotes
11:15 am Executive exchange
12:30 pm Lunch
1:00 pm Networking reception
1:45 pm Concurrent panel discussions
3:15 pm Concurrent panel discussions
4:30 pm Conference close
7. SDEE Roundtable - Global Climate Change and Entrepreneurial Opportunities
in the New Decade
When: Wednesday, March 09, 2011 from 5:00 PM - 8:30 PM (PT)
Where: Johnson & Johnson Auditorium, 3210 Merryfield Row, San Diego, CA
92121
Organizer: San Diego Entrepreneurs Exchange
Registration: Free, RSVP is appreciated at http://sdee-03-09-2011-
greentech.eventbrite.com
Roundtable & Discussion:
Steve Mayfield, Director of the San Diego Center for Algae Biotechnology, UCSD
Ron Pitt, CEO of EcoDog
Barry Toyonaga, CBO of Kent BioEnergy
Sandy Madigan, CEO of Strategic Enzyme Applications
Moderator: David Schwarz, President and CSO of Advanced Cellular Dynamics
8. Device Alliance Professional Business Mixer
When: Wednesday, March 16th, 2011. 5:30-7:30pm
Where: Please go to http://www.devicealliance.org/
Register: Please join us for an enjoyable evening of networking and socializing.
This is an opportunity to learn what other folks working in the Medical Device industry
in southern California are seeing in terms of their markets, new and interesting
technologies, opportunities, and industry trends. $10 non-member RSVP, $15 non-
member at the door, Free for members with paid membership through 2011.
Questions? Please contact Kevin McNerney at kevinmcnerney@devicealliance.org
9. Asia Pharma R&D Leaders 2011—the largest and premier pharma R&D summit
in China
When: March 24th and 25th, 2011
Where: Sofitel Jinjiang Oriental Pudong Shanghai
Organizer: Global Leaders Institute
Website: http://www.aprdl.com/about.asp?id=322
Registration: SABPA members receive special discount. Please contact Daniel Chen at
86-21-32516046 or send email to daniel.chen@globaleaders.com
Featured Speakers:
Steve Q.Yang, Vice President, Head of Asia R&D, Pfizer
RuiPing Dong, MD&Ph.D. Vice President, Head of R&D Japan & China, Bristol-Myers
Squibb
Gerd Maass, Global Head of Biomarker and Pathway Analysis, Roche Pharma Research
and Early Development
Peter Hongaard Anderson, Executive Vice President,Head of Research, H. Lundbeck A/S
Samantha Du, President, Hutchison Medipharm
Davinder Gill, PhD VP/Head Global Biotherapeutics Technologies, Pfizer
Xiaolin Zhang, Vice President and the Head of the Innovation Center China (ICC),
AstraZeneca
Xin Ma, Head of Global Drug Discovery - Innovation Center China, Bayer Schering
Pharma
and more from top 20 big pharmaceutical companies and China local big pharmaceutical
and biotechnology companies
Drug discovery and research activities have traditionally focused on diseases common in
the U.S. and Europe. That is, after all, where the money is. China is grabbing an
increasing share of the global R&D budget, with investigators launching a slew of new
studies to help understand how to treat the country's huge population and tap into one of
the fastest growing pharmaceutical markets on the planet. As the premier pharmaceutical
R&D conference in China, Asia Pharma R&D Leaders 2011 is organized under this
background and supported by SABPA. We welcome you to join this important meeting to
meet the heads of R&D from the top 20 big pharmaceutical companies, leading
pharmaceutical, biotechnology companies from China, global Contract research
organizations and the top research institutes. All will meet to explore opportunities in
R&D partnering, external research, licensing opportunities in China.
10. IBC conference (The 6th China Pharmaceutical R&D Summit)
When: April 11th-13th, 2011
Where: Shanghai
Why you should attend: SABPA members will enjoy a 20% discount on registration
The 6th China Pharmaceutical R&D Summit will be held in Shanghai from April 11th-
13th. (www.ibclifesciences.com) A never-before line-up of over 80 Speakers from
international pharmaceutical companies, multi-national corporations in China, and
domestic Chinese pharmaceutical and biotechnology companies will be sharing their
expert opinions and experiences on transformation & innovation in China, clinical
challenges, regulatory updates, New Chemical Entity discovery efforts, preclinical
partnerships, biosimilar development and more!
11. San Diego Regional EDC and CleanTECH San Diego celebrate Earth Day
When: Wednesday, April 20, 2011, 8:00 – 9:30 am
Where: Cricket Communications, Inc., 1st Floor Training Rooms, 5887 Copley
Drive, San Diego, CA 92111
Organizer: San Diego Regional EDC and CleanTECH San Diego
Registration: http://2011earthday.eventbrite.com
Join us to learn more about one of San Diego’s most exciting emerging industries! More
than 400 people in our region work in the sector, which has an economic impact of over
$120 million per year – and it’s growing! Learn more about the region’s biofuels sector.
A consortium of San Diego organizations – BIOCOM, CleanTECH San Diego, San
Diego Regional EDC, and the San Diego Center for Algae Biotechnology won a $4
million grant last year to develop workforce training programs for the biofuels industry –
putting our mega region at the forefront of this exciting industry.
Meet our partners–
Dr. Barry Toyonaga, Chief Business Officer, Kent Bioenergy Corporation – Innovating
commercially viable microalgae-based technologies for liquid fuel production, water
pollution remediation,
CO2 capture, landfill management, and production of livestock feed additives - Dr.
Toyonaga will tell us more about the front line in the algae business and what’s on the
horizon for this promising new industry.
Professor Stephen Mayfield, Director at San Diego Center for Algae Biotechnology, will
tell us more about the innovative new algae training curriculum at UCSD – who is taking
these courses, career paths and how San Diego is growing its own workforce to
supporting this promising 21stCentury industry.
Jason Anderson, Vice President, CleanTECH San Diego, will share the sector specific
strategies and key regional assets used to position San Diego as one of the top cleantech
economies world-wide.
12. San Diego Bioprocess Forum Event
When: Tuesday, April 26th, 5:30 to 7:30 Pm
Where: Sheppard Mullin LLP, 12275 El Camino Real, Suite 200, San Diego,
92130
Organizer: San Diego Bioprocess Forum
Registration: www.sdbioprocessforum.org
The San Diego BioProcess Forum is a recently founded networking group dedicated to
providing local biotechnology professionals an opportunity to network and discuss topics
focused on bioprocess technologies and trends. Our first event will be held on April 26th,
2011. Our featured speaker is Dr. Wolfgang Noe, Senior consultant at BPTC, and
previously Vice President of Strategic Alliance and Technical Development at Biogen
IDEC. The topic of his speech is ―Considerations for Qualifying a CMO to Manufacture
your [Biologic] Product for FIH‖
13. The Biotechnology of Oenology
When: Thursday, April 27, 2011, 5:30-8:30 pm
Where: Knobbe Martens, 12790 El Camino Real, San Diego, CA 92130
Organizer: PGC200
Registration: http://pgc200.org/events/43-oenology
Details: Presenter is Kerith Overstreet, Co-Founder, Chief Scientist, Bruliam Wines
Winemaking is both an art and a science. The unique flourish and complexity of great
wine is enabled by a winemaker who fully integrates the scientific foundation with her art.
Kerith will showcase of emerging technology in the craft of wine production. Beginning
in the vineyard with an overview of root stock selection and scion material, Kerith then
delves into the contentious debate on genetically engineered root stock and how genetic
instability proffers an infinite number of pinot noir clones. The primary grapevine viruses
that threaten the Vitis vinifera crop will also be mentioned, followed by the science of
fermentation. Genetic sequencing had transformed the taxonomy of fermentation yeast
from mildly confusing to mind-numbingly bewildering! Native yeast and bacteria interact
dynamically in the context of bacteriocins and bacteriophages. The biochemistry of
malolactic fermentation and how winemakers manipulate the citric acid cycle create
extraordinary buttery flavors. Finally we will briefly discuss the science of aging wine
with a focus on oxidation chemistry and our emerging understanding of superoxides. The
role of tannin elongation in organoleptic development will be reviewed in conjunction
with the basic biochemistry of oak barrel aging. At last, for those participants not already
deep in stage 3 REM slumber, we will drink more wine.
Kerith Overstreet is a physician who has turned her research and investigative talents to
winemaking. Kerith’s MD is from the University of Rochester School of Medicine and
Dentistry and her BA in English Literature from Cornell. With clinical and laboratory
experience, a dozen papers and several awards for best research, Kerith is well-equipped
to bring the best of science and technology to the marvellous art of oenology. Bruliam
wines will be served with a light dinner catered by Bibi Kasrai of Harvard Cookie Girl.
Job Postings
14. Skingenix Job Postings (Ontario, California)
Skingenix, a start up pharmaceutical company specialized in regenerative medical
research and organ in situ regenerative product development, has two immediate
positions open:
1). Executive Assistant (Scientific/Administrative)
Job Description
• Prepare scientific presentation materials and other reports, proposals in
English/Chinese.
• Perform translation and other general office duties for CEO.
• Requesting/providing needed business information to outside clients and follow-
up on the
resolution.
• Maintain CEO's calendars, coordinate meetings, travels and special events.
Job Requirements
• Bilingual in English/Mandarin.
• Bachelor degree in life sciences, biology or chemistry or equivalent.
• Medical/pharmaceutical/biotech background.
• Excellent written, verbal communication and PC application skills.
2). Manufacturing Manager
Job Description
• oversee manufacturing of soft gel capsule, liquid and ointment products.
• Lead and develop multiple groups, with up to 5 direct reports in three areas,
including
formulation, fill finish and packaging.
• Provide leadership and managerial development to these groups, and oversee
production
scheduling in a challenging and technically sophisticated environment.
Job Requirements
• Bachelor degree in pharmaceutical science/chemistry/biology/engineering or
equivalent.
• 10+ years experience in pharmaceutical manufacturing
• 5+ years management experience in pharmaceutical manufacturing
• Strong management skills and a proven track record of employee development
• Bilingual (English and Chinese) strongly preferred.
Compensation:
Salary will be commensurate with experience. We provide dynamic trainings, continuing
educations and opportunities for career growth. Please email resume to hr@skingenix.us
or fax to 1-(626) 446-7186.
15. Simcere of America Job Posting
1) DIRECTOR, BUSINESS DEVELOPMENT
Simcere of America (―SOA‖) is a wholly owned subsidiary of Simcere Pharmaceutical, a
leading Chinese pharmaceutical company (NYSE: SCR). With an annual revenue of
$300M and a growth rate approaching 30%, Simcere is on a fast growth trajectory in one
of the largest pharmaceutical markets in the world. Innovation is one of our key growth
drivers. As we continue to build a world-class innovative pipeline with externalization
efforts, we are seeking a capable seasoned business development professional to join our
newly established Simcere of America team to lead search and evaluation efforts for
potential in-licensing and co-development opportunities. This position will report to
President of Simcere of America. He/she can be based at the San Francisco Bay Area or
Princeton, New Jersey. Extensive travel is expected for this position.
ESSENTIAL RESPONSIBILITIES INCLUDE:
• Identify and evaluate potential in-licensing and co-development opportunities
worldwide
• Drive deal flow process, from search and evaluation to due diligence and
execution of
a deal
• Work with the internal team based in China to develop sound business case to
support
licensing and co-development proposals and gain senior management buy-in
• Build external network of potential partners to establish credibility and identify
sourcing
opportunities in key markets
• Contribute to the overall growth of Simcere of America, coach junior members of
the
team and help build a healthy business culture at SOA
QUALIFICATIONS:
• Ph.D. or MD required
• Deep scientific expertise and understanding of biology in at least one of the
following
disease areas: oncology, cardiovascular, diabetes, and neurology
• Minimum 10 years of experience in the pharmaceutical industry, with a
combination of
research and business development experience
• Previous search and evaluation experience desired
• Transaction experience with a variety of deal structures desired but not required
• Fluent in Mandarin and English
PERSONAL CHARACTERISTICS:
Certain fundamentals will be critical:
• A strategic thinker who can generate ideas/opportunities and turn them into
successful
results.
• Effective interpersonal skills – persuasive; generates enthusiasm; credible, etc.
• Pro-active – results-oriented/sustained energy with a demonstrated ability to close
transactions.
• Flexible about implementation while being inflexible about the quality and
timeliness of
results.
• Recognizes and executes critical details; designs/implements visionary strategic
plans.
• Appreciate and sensitive to cultural differences.
HOW TO APPLY:
Applicants should email his/her resume to Dr. Jie Liu D’Elia, President of SOA, at
jdelia@simcere.com. Please also attach a deal sheet if available.
16. Ab-Mart job postings
Please also see the job postings on SABPA website: http://sabpa.org/web/job-info.htm
• Are you wondering about biotech startup opportunities in China?
• Do you know what it takes to build a biotech business in China?
• Are you struggling with whom to talk to and where the funding is coming from?
Please attend the recruiting event of a biotech startup on Sunday March 27th in
San Diego. Contact abmart10@ab-mart.com for seminar location and time.
Abmart is the biggest mAb company in China. Our long-term goal is building Abmart
into a world-leading antibody company. Our short-term goal is putting Abmart on IPO in
2014. For Abmart company details please go to www.ab-mart.com.
Open Positions:
R&D Director of antigen/antibody/assay technology
Business Director of international sales & marketing
Engineering Director of bioinformatics.
You can find more positions and position details in www.abmart10.com
17. A-bio/Luye posting
JOB DESCRIPTION
PROCESS DEVELOPMENT & OPERATIONS DEPARTMENT
A-Bio Pharma Pte Ltd is one of Asia's pioneering biologics contract manufacturers since
2003. Based in Singapore, we leverage on the excellent business and manufacturing
infrastructure, as well as the rapidly growing Biomedical Sciences cluster in the island
state. In 2010, Luye Pharma Group, a Singapore-listed, China-based pharmaceutical
company became the major shareholder of A-Bio, enabling A-Bio to serve as the R&D
center for their biologics pipeline, aiming at China’s rapidly growing biopharmaceutical
market and unmet medical needs. Our aim remains to be the preferred development and
manufacturing partner for pharmaceutical and biotechnology companies worldwide
seeking to bring their products to the market in a timely and cost-effective manner.
Title : Head, Upstream Process Development
Reports to : VP or Senior Director, Bioprocess Development & Operations
Functional Description:
Lead, build and develop a high performance Upstream Process Development group
engaged in mammalian cell culture development for commercial therapeutic proteins,
including subclone/clone selection, basal/feed media optimization, cell line stability study,
cell culture manufacturing process development and scale up. Manage the day to day
functions of the Upstream Process Development group while working hands on with the
projects as necessary. The successful candidate will play a key role in developing,
characterizing, and implementing monoclonal antibody cell culture processes from
laboratory to pilot scale. The successful candidate will apply engineering and biological
expertise to collaboratively develop and optimize cell culture processes suitable for
cGMP manufacturing, and will interact with the teams within Bioprocess Development
and Operations, as well as collaborate with members from Manufacturing, Quality
Control and Quality Assurance. Also interact with third party venders which provide
essential and enabling services worldwide. The successful candidate will also be
responsible for new technology development and process optimization as it benefits A-
Bio’s current and future cell culture platforms.
General Duties and Responsibilities:
1. Plan day-to-day activities within the Upstream Process Development in
developing upstream processes suitable for large-scale commercial production for
multiple biologics from inoculum and seed preparations, bioreactor operations and
product recovery steps.
2. Lead and direct the Upstream Process Development group to perform and deliver
project milestones and objectives, including cell line stability, cell line screening/cloning,
cell culture process development, material supply for Research & Development activities,
and technical support for Manufacturing and Quality.
3. Design, develop and implement cell culture processes for recombinant protein
production from laboratory to pilot scale using mammalian cells.
4. Serve as a technical expert in cell culture process development within the
organization and provide support to Manufacturing and development laboratory.
5. Work with Operations closely and assist in technology transfer to cGMP
manufacturing sites, provide technical support and support troubleshooting of existing
processes.
6. Work closely with internal groups to ensure that business objectives are met,
especially cell line development group.
7. Serve as author/reviewer as required for relevant CMC sections for regulatory
submissions.
8. Ensure that development reports are completed in a timely fashion for any
development work that serves as the basis of manufacturing processes cited in regulatory
submissions and/or transferred to partners/licensees.
9. Introduce novel technologies to improve process performance.
10. Interact with research institutes and experts in relevant fields to continuously
improve group performance.
11. Lead IND (CMC Section) filing process.
Qualifications:
The ideal candidate will have a Ph.D. degree in relevant biological sciences and/or
engineering, such as molecular biology, analytical and biochemistry, protein chemistry or
biological engineering, biochemical engineering with minimum of 5 years industry
experience in the pharmaceutical and/or biotechnology industries, or MS with at least 7
years of experience or BS/BA in life sciences with at least 10 years of laboratory
experience in an industry setting.
Applicants are expected to exhibit strong leadership skills and have a proven ability in the
cell line development in the biopharmaceutical industry. The candidate must have:
1. Knowledge and experience of the design, optimization and scale-up of cell culture
processes is a necessity.
2. Knowledge of cell culture process development equipment and systems, and their
maintenance.
3. Direct experience with mammalian cell culture process development and process
transfer for clinical or commercial manufacturing of biopharmaceutical product(s) highly
preferred.
4. Knowledge in the use of DOE to conduct experiments for media optimization,
selection of process parameters and scale up conditions.
5. Hands-on experience with unit operations such as lab and pilot-scale bioreactor
operation, centrifugation, clarification and filtration.
6. Process validation and cGMP experience is desirable.
7. Must be highly motivated, have excellent organizational and communication
skills, and must be able to work independently and as part of a multi-disciplinary team.
8. Demonstrated accomplishments of successful mammalian cell culture process
development and scale up for commercial protein therapeutics.
Title : Head, CMO Business Development & Global Project Management
Reports to : CEO
Functional Description:
Plan, execute and finalize projects of global nature according to deadlines and within
budget including acquiring resources, coordinating the efforts of team members and
third-party contractors or consultants in order to deliver projects according to plan.
Manage third parties global services providers through designing and negotiating contract
terms and conditions, providing project planning, scheduling & monitoring. Also
through global networking develop, evaluate and manage strategic business opportunities
in biopharmaceutical industries: partnerships, alliances and/or joint ventures. Monitor
competitive activities in global biopharmaceutical industry, and identify potential
customers. Provide leadership in the planning, designing, due diligence, and
implementing of strategic business objectives. Build global CMO customer base to
sustain and ensure full utilization of GMP facility capacities and resources.
General Duties and Responsibilities:
1. Generate new business leads from potential clients worldwide. In particular,
global biopharmaceutical companies.
2. Proactively seek out and independently propose new business development
opportunities.
3. Define project scope, goals and deliverables that support business goals in
collaboration with senior management and stakeholders.
4. Effectively communicate project expectations to team members and stakeholders
in a timely and clear fashion.
5. Liaise with project stakeholders on an ongoing basis.
6. Draft and submit budget proposals, and recommend subsequent budget changes
where necessary.
7. Determine and assess need for additional staff and/or consultants and make the
appropriate recruitments if necessary during project cycle.
8. Plan and schedule project timelines and milestones using appropriate tools.
9. Track and monitor project milestones and deliverables.
10. Develop and deliver progress reports, proposals, requirements documentation and
presentations.
11. Define project success criteria and disseminate them to involved parties
throughout project life cycle.
12. Coach, mentor, motivate and supervise project team members and contractors,
and influence them to take positive action and accountability for their assigned work.
13. Build, develop and grow any business relationships vital to the success of the
project.
14. Develop best practices and tools for project execution and management.
15. Negotiate various types of agreements with clients to meet business development
goals.
16. Provide financial (costing) analysis to support negotiations and assess financial
attractiveness of different deal structures. Work closely with other functional groups to
ensure scope of work and costing structure translating into agreement drafts.
17. Manage and coordinate due diligence process to evaluate potential projects.
Provide recommendations to CEO on whether or not to undertake the potential projects.
18. Assist CEO in developing/revising A-Bio strategic plan to achieve Company’s
objectives.
19. Lead in developing financing strategy to meet the requirements of A-Bio strategic
plan.
20. Develop annual marketing plans for all contract services including pricing,
advertising and promotion planning, conference and convention planning, business
alliance strategy and tactics, and internal/external corporate and marketing
communications.
21. Represent A-Bio in road shows/conferences including preparation of conference
materials and presentations.
22. Responsible for expanding and developing strategic account relationships to
foster future revenue opportunities.
Qualifications:
1. A minimum of a Bachelors degree in Business or a related discipline is required.
An MBA and/or Ph.D. /M.D. in a life science discipline is preferred. Equivalent
experience may be accepted.
2. A strong technical background in the biopharmaceutical industry and a minimum
of 6-10 years of industry experience in any of the following areas: business development,
licensing, product/project management, marketing research, and sales; Individuals must
understand critical investment and returns practices such as ROI and NPV criteria. A
thorough understanding of the drug development and regulatory process is necessary.
3. Experience in developing and negotiating various kinds of collaborations,
including licenses, acquisitions, and/or co-promotions. A proven track record of project
management, financing, partnerships, alliances and/or joint ventures is required.
4. Must be able to demonstrate an ability to lead business and technical discussions
internally and externally.
5. Excellent communication skills both oral and written are required.
6. Must have excellent interpersonal skills with a proven ability to work across
multiple functions, disciplines and people.
7. Experience in managing global service providers including CROs and CMOs.
8. Extensive knowledge of the development and manufacturing of biological
products including recombinant proteins and monoclonal antibodies.
9. Knowledge and experience in contract drafting, designing and face-to-face
negotiation.
10. Proven experience in risk and change management.
VP or SENIOR DIRECTOR, BIOPROCESS DEVELOPMENT & OPERATIONS
Title : VP/Senior Director, Bioprocess Development & Operations
Reports to: CEO
Functional Description:
Our company is currently seeking a well recognized, highly motivated and experienced
senior leader in biopharmaceutical industry to lead, build and manage a high performance
bioprocess development and biotech operations group to engage in early stage biologics
development of recombinant protein therapeutics and monoclonal antibodies, from cell
line to IND filing. This group is composed of Cell Line, Upstream Process (cell culture
and recovery), Downstream (protein purification) and Analytical Development. Multiple
projects begin with cell line design and construction for target proteins, followed by cell
culture process development, media optimization via DOE, product recovery and
purification, scale-up, non-GMP production of toxicology study material, tech transfer
the bioprocess technology to commercial-scale production facilities. Additionally, this
leader will support design and planning of biologics manufacturing plant for clinical
study material and large scale commercial manufacturing, select qualified suppliers and
service providers worldwide, support CMO projects, and manage cross-functional teams
in a global business environment. Will collaborate with members from Manufacturing,
Quality Control and Quality Assurance.
General Duties and Responsibilities:
1. Recruit talents globally in bioprocess development and biologics manufacturing
to establish a high performance team to conduct early stage protein therapeutics,
especially monoclonal antibodies, development from product selection, cell line
construction to per-clinical material production, tech transfer and IND filing.
2. Develop and direct staff by active coaching and training while cultivating
collaborative team culture, creative problem-solving and result-driven operations.
3. Lead the high performance team by setting clearly defined objectives and
business goals, execute flawlessly to accomplish critical deliverables including cell line
development, selection of process technologies, cell culture process design and
optimization, protein recovery and purification and in-process monitoring and analysis,
large scale production issues, tech transfers and so on.
4. Communicate regularly to senior management, executives and board on progress
of projects, business opportunities and related business matter via presentations and
reports.
5. Manage and plan budget, projects, personnel and schedules to perform specific
projects according to clinical timing and deliverables and overall business priorities.
6. Support strategic planning of product and process development to meet the
organization’s strategic goals and long term growth.
7. Lead technology transfer internally and externally, technical support of large scale
non-GMP and support cGMP production and plant operations.
8. Interact regularly and communicate proactively with internal and external
customers, to resolve process and operations issues promptly.
9. Build and establish appropriate processes and systems to effective improve
operating productivity and manage continuous improvement programs.
10. Support business development in project evaluation, contract negotiation and
provide leadership and technical inputs to potential projects.
11. Introduce and develop novel process technologies to advance process productivity
and biologics manufacturing efficiency.
12. Apply innovative technical ability and knowledge to critically analyze the
experimental results and literature findings.
13. Maintain well-organized, clear and complete records of collected data and process
in a highly secure and confidentiality-protected work environment.
14. Contribute in preparing materials and sustaining data security that protect the
intellectual property portfolio of the company and clients.
15. Interact with research institutions and academic scholars to collaborate on various
advanced technical projects and aspects of scientific studies focusing on process and
productivity improvement.
Qualifications:
The ideal candidate will have a Ph.D. degree in relevant biological sciences and/or
engineering, such as molecular biology, analytical and biochemistry, protein chemistry or
biological engineering, biochemical engineering with minimum of 15 years industry
experience in the pharmaceutical and/or biotechnology industries. Applicants are
expected to exhibit strong leadership skills and have a proven ability in the process
development and production in the biopharmaceutical industry. The candidate must have:
1. Excellent project team management and matrix system management skills.
2. Excellent communication, documentation and technical writing skills.
3. Experience in cell line development, cell culture, purification and analytical
sciences for producing clinical and commercial biopharmaceuticals.
4. Proven records and demonstrated ability in process development and productivity
improvement.
5. Significant successful experience in leading technical departments involved in
process development and scale up activities from laboratory to pilot and commercial
scale manufacturing.
6. Familiarity of regulatory issues pertaining to the manufacture of biologics, large
scale biopharmaceutical unit operations and process validation.
7. Appreciation and understanding of cGMP and practices.
8. Demonstrated innovative problem-solving skills under resource constraints and
time pressure.
9. Ability to make decisions that require in depth evaluation of extremely complex
factors, anticipation of unknowns, and interactions with multiple stakeholders.
10. Proficient in computer and IT concerning application of process modeling and
numerical analysis software such as Excel, Matlab, and/or SuperPro.
11. Strong capital cost and operating cost knowledge and management in biologics
development.
12. Hands-on experience of monoclonal antibody development is highly desirable.
HEAD, BIOLOGICS OPERATIONS
Title : Head, Biologics Operations
Reports to: CEO
Functional Description:
Our company is currently seeking a well recognized, highly motivated and experienced
senior leader in biopharmaceutical industry to lead, build and manage a high performance
biotech operations group to engage in early stage biologics development of recombinant
protein therapeutics and monoclonal antibodies, from cell line to IND filing. This group
is composed of Upstream Process (seed, cell culture and recovery), Downstream (protein
purification) and Facility & Engineering. Multiple projects begin with tech transfer
internally and/or externally, from cell banking and storage, cell culture process, media
preparation, product recovery and purification, scale-up, non-GMP production of
toxicology study material, tech transfer the bioprocess technology to commercial-scale
production facilities, and so on. Additionally, this leader will support design and
planning of biologics manufacturing plant for clinical study material and large scale
commercial manufacturing, select qualified suppliers and service providers worldwide,
support CMO projects, and manage cross-functional teams in a global business
environment. Will collaborate with members from Process Development, Quality Control
and Quality Assurance, Corporate Support functions.
General Duties and Responsibilities:
16. Recruit talents globally in biologics manufacturing to establish a high
performance team to conduct process scale up and production of pre-clinical and clinical
study material for multiple protein therapeutics, especially monoclonal antibodies,
working closely with development from product selection, cell line construction to pre-
clinical material production, tech transfer and IND filing.
17. Responsible for the entire cGMP production facility including daily operations,
maintenance and repairs, schedule planning and execution, document management, utility
system operations, warehouse operations, and so on.
18. Develop facility improvement and/or renovation plant and design, prepare capital
requirement schedule and obtain approval of project proposal and execute plan flawlessly.
19. Develop and direct staff by active coaching and training while cultivating
collaborative team culture, creative problem-solving and result-driven operations.
20. Lead the high performance team by setting clearly defined objectives and
business goals, execute flawlessly to accomplish critical deliverables including upstream
process and protein purification operations, selection of process and manufacturing
technologies, in-process monitoring and analysis, large scale production, tech transfers
and so on.
21. Communicate regularly to senior management, executives and board on progress
of projects, business opportunities and related business matter via presentations and
reports.
22. Manage and plan budget, projects, personnel and schedules to perform specific
projects according to clinical timing and deliverables and overall business priorities.
23. Support strategic planning of product and process development to meet the
organization’s strategic goals and long term growth.
24. Lead technology transfer internally and externally, technical support of large scale
non-GMP and support cGMP production and plant operations.
25. Interact regularly and communicate proactively with internal and external
customers, to resolve process and operations issues promptly.
26. Build and establish appropriate processes and systems to effective improve
operating productivity and manage continuous improvement programs.
27. Support business development in project evaluation, contract negotiation and
provide leadership and technical inputs to potential projects.
28. Introduce and develop novel process technologies to advance process productivity
and biologics manufacturing efficiency.
29. Apply innovative technical ability and knowledge to critically analyze the
experimental results and literature findings.
30. Maintain well-organized, clear and complete records of collected data and process
in a highly secure and confidentiality-protected work environment.
31. Contribute in preparing materials and sustaining data security that protect the
intellectual property portfolio of the company and clients.
Qualifications:
The ideal candidate will have a B.S./M.S./Ph.D. degree in relevant biological sciences
and/or engineering, such as biology, analytical and biochemistry, protein chemistry or
biological engineering, biochemical engineering, mechanical engineering with minimum
of 10 years relevant industry experience in the pharmaceutical and/or biotechnology
industries. Applicants are expected to exhibit strong leadership skills and have a proven
ability in the process development and production in the biopharmaceutical industry. The
candidate must have:
13. Excellent project team and matrix system management skills.
14. Excellent communication, documentation and technical writing skills.
15. Experience in biologics manufacturing, plant engineering and design, facility
maintenance and repairs, productivity and efficiency improvement, production systems
improvement for producing clinical and commercial biopharmaceuticals.
16. Proven records and demonstrated ability in biologics manufacturing, process scale
up, and productivity improvement.
17. Significant successful experience in leading technical and operations departments
involved in process scale up activities from laboratory to pilot and commercial scale
manufacturing.
18. Familiarity of regulatory issues pertaining to the manufacture of biologics, large
scale biopharmaceutical unit operations and process validation.
19. Appreciation and understanding of cGMP and practices.
20. Demonstrated innovative problem-solving skills under resource constraints and
time pressure.
21. Ability to make decisions that require in depth evaluation of extremely complex
factors, anticipation of unknowns, and interactions with multiple stakeholders.
22. Proficient in computer and IT concerning application of process modeling and
numerical analysis software such as Excel, Matlab, and/or SuperPro.
23. Strong capital cost and operating cost knowledge and management in biologics
production.
24. Hands-on experience of monoclonal antibody development is highly desirable.
Title : Senior Scientist and Project Manager, Cell Line Development
Reports to : VP or Senior Director, Bioprocess Development & Operations
Functional Description:
Lead, build and develop a high performance Cell Line Development group engaged in
mammalian cell line development for commercial therapeutic proteins, including gene
and vector construction, subclone/clone selection, third party vendor’s support and novel
cell line platforms development. Manage the day to day functions of the Cell Line
Development Group while working hands on with the projects as necessary. Responsible
for directing staff on the timing, implementation and execution of project goals; training
and developing staff, in all procedures and required documentation; providing strategic
insights on novel cell line platforms; initiating the continuous improvement of the group's
operations to improve efficiencies; reporting directly to senior management on progress
of projects and issues; serving as the key leader interfacing with third party service
providers; participating in evaluating business opportunities in a global business
environment.
General Duties and Responsibilities:
1. Oversee all aspects of the Cell Line Development Group including scheduling,
staffing and project management, as well as executing tasks.
2. Generation and characterization of stably transfected cell lines for the expression
of multiple product candidates.
3. Apply high-throughput methods to streamline cell line screening and cloning.
4. Perform full genetic characterization of cell lines and target products generated by
new cell lines.
5. Lead and direct novel expression vector design and construction for commercial
products.
6. Prepare and review of technical reports and publications, including Cell Line
Development project reports.
7. Responsible for development and execution of procedures to enhance productivity
and reduce timelines.
8. Responsible for the reporting of Project progress to senior management and
project management in a complex matrix environment.
9. Oversee and execute the cell culture production of products made by created cell
lines/clones.
10. Oversee the identification, sourcing, installation and operation of new equipment
to enhance productivities.
11. Oversees non-GMP Cell line inventory including the storage and tracking of
parental, packaging and production cell lines.
12. Recruit talents globally to strengthen staffing the Cell Line Development Group.
13. Support IND (CMC Section) filing.
Qualifications:
The ideal candidate will have a Ph.D. degree in relevant biological sciences and/or
engineering, such as molecular biology, analytical and biochemistry, protein chemistry or
biological engineering, biochemical engineering with minimum of 5 years industry
experience in the pharmaceutical and/or biotechnology industries, or MS with at least 7
years of experience or BS/BA in life sciences with at least 10 years of laboratory
experience in an industry setting.
Applicants are expected to exhibit strong leadership skills and have a proven ability in the
cell line development in the biopharmaceutical industry. The candidate must have:
1. Practical experience with mammalian cell culture techniques including sterile
technique, passaging cells and transfecting cells.
2. Practical experience and knowledge with molecular biology techniques including
qPCR, plasmid construction and preparation.
3. Relevant experience on the optimization of transfection, growth and selection
conditions for a variety of mammalian cell lines, mainly CHO.
4. Design strategy for multiple cell line platforms for advanced, novel therapeutic
proteins including human cell lines (e.g. PER.C6, HEK293)
5. Demonstrated leadership in managing teams and projects in a complex matrix
environment.
6. Must be organized, self-motivated and result-oriented.
7. Has proven track records of delivering milestones under time pressure and limited
resources.
8. Demonstrated creative complex problem solving, involving in-depth evaluation
and analysis of variables.
9. Independently develops methods, techniques and evaluation criteria to achieve
results.
10. Monoclonal antibody cell line development experience is a must.
Besides the specific positions advertised above, we are also looking for talents
specialized in bioanalyitcal development, protein purification and cell line
development. In general, we welcome inquiries from all who have background in
the bio-pharmaceutical industry and are interested in a career at A-Bio/Luye. Please
send your inquiries and CVs to career@a-bio.com.