Other Advisors
The CAP engages a number
of management, investment, legal, and industry advisors, too many to be listed
separately. Advisors listed below are a representative sample for your information,
and you also may want to visit Lartas web site www.larta.org regularly.
Rahul Ballal, Ph.D.
Industry Advisor
Business Development-Broad Institute of MIT/Harvard
ballal@broadinstitute.org
With more than seven years
of experience in high-technology and biotech financing, Rahul is practiced in
raising capital for startup companies. Rahul was most recently a Senior Associate
at ASMR, a $30MM biotech venture capital fund located in Washington DC. Previous
to joining ASMR, Rahul was the CEO and founder of Redmind, Inc., a venture backed
software start-up that raised $12MM and was acquired by real-time applications
vendor Ikimbo Inc. Rahul received a B.S. in biology from Brown University and
a M.S. in Bioinformatics from The Johns Hopkins University. He left ASMR to
complete his PhD at Georgetown University School of Medicine. He currently works
in Business Development at the Broad Institute of MIT/Harvard.
Tien T. Bui
Industry Advisor
Biozen Consulting
tien@biozenconsulting.com
Tien T. Bui is the Principal
of Biozen Consulting, a healthcare strategic consulting firm. Ms. Bui is also
on the Leadership Team of the Institute for Drug Resistance which was created
to serve as a vehicle for enabling, supporting, and promoting novel, multidisciplinary
approaches to tackle the challenges of drug resistance for the research and
clinical communities. She has 18 years of experience in the Pharmaceutical and
Biotechnology Industry having been extensively involved in all aspects of drug
and technology commercialization. For seven years she was VP of Sales &
Marketing and VP of Medical Affairs and Education for Virology and Oncology,
at Monogram Biosciences (formerly Virologic). During that time she started Monogram's
first specialty sales force and was in charge of all commercial functions including
payer relations, client services, medical marketing, clinical affairs &
education and launched 4 new state-of-the-art technologies. Before joining Monogram,
Ms. Bui served in various commercial, health policy and strategic product development
roles at DuPont and DuPont-Merck Pharmaceuticals from 1990 to 2000. Ms. Bui
is a board member of Asian Pacific Islander Wellness Center and chairs the Development
Committee.
Karen J.
Cha
Regulatory Affairs and Quality Assurance Advisor
Sapience Regulatory Consulting Services
SapienceReg@gmail.com
Karen Cha is a Regulatory
Affairs and Quality Assurance professional with 12 years of experience working
with pharmaceutical and biotechnology organizations from early development through
Phase 3 clinical trials. Most recently, she was Sr. Director of Regulatory Affairs
and Quality Assurance (QA) and a founding member of Catalyst Pharmaceutical
Research, LLC, a full service contract research organization in Pasadena, California.
She has worked with companies ranging from virtual start-ups to multi-national
organizations developing a broad range of therapeutic products.
In the area of Regulatory
Affairs, Karen specializes in filing original Investigational New Drug Applications
(IND) to FDA to allow the initiation of clinical studies. She has written and
submitted numerous original INDs for chemical drugs as well as protein biologics
to various Divisions within FDA, including providing assistance with the completion
of IND-enabling studies and helping to address compliance around the outsourcing
needs of smaller companies such as contract manufacturing. She has also routinely
provided assistance with FDA meeting requests, preparation of the meeting briefing
package, authoring or technical writing support of IND documents (protocols,
Investigator Brochure, Study Reports, etc.), and on-going maintenance of INDs
which have been both paper and electronic in the new Common Technical Document
format accepted in the ICH regions (US, EU and Japan).
She also has extensive Quality
Assurance experience complementing the needs of early development projects including
conduct of vendor audits (GMP, GLP, 21 CFR Part 11 compliance), clinical site
GCP audits, SOP writing, GCP training, document management initiatives, etc.
In addition to her experience
in pharmaceutical and biologic drug products, Karen has experience in regulatory
affairs for cosmetics and over-the-counter drug products from an industry leader
in consumer products.
Karen received her Bachelor
of Arts in Biology, a Masters degree in Biomedical Science and a Master
of Business Administration all from Boston University. She is an active member
of the Regulatory Affairs Professional Society and the Drug Information Association.
Alan Donald
Regulatory Advisor
Matrix Medical Consulting Corporation
adonald@matrixmedcorp.com
Alan Donald is currently
President, CEO, and Founder of Matrix, a consulting firm specializing in domestic,
Food and Drug Administration (FDA), and international regulations related to
medical devices, biologics, and pharmaceuticals. Prior to Matrix, Donald was
president, CEO, and founder of Pacific Regulatory Services, Inc. (PRSI), a consulting
firm specializing in FDA regulation of devices, biologics and drugs; product
development, and quality assurance.
As Director of Regulatory
Affairs for ABA, Donald worked on regulatory affairs including domestic and
international projects in technologies and products ranging from breast implants
to AIDS therapies. Donald was the Senior Manager of Regulatory Affairs and Quality
Assurance specializing in human skin grown synthetically for human transplants.
There he directed corporate-wide regulatory and quality assurance programs in
compliance with FDA regulations. As V.P. of Operations, Donald was responsible
for production, quality control, and regulatory affairs at Tri-Stage, a manufacturer
and marketer of dental implants and associated instruments. The company was
acquired by Collagen Corporation in November, 1989 for cash and royalty payments.
Donald was retained by Collagen to facilitate the transfer for products and
technology. While at Windsor Medical he managed eight departments, significantly
reducing operational/manufacturing costs while increasing product quality and
reliability. The company specialized in portable, programmable insulin infusion
pumps and other diabetic therapy-related products. The company was sold to C.R.
Bard. Donald held various management positions at IMED, a manufacturer of intravenous
therapy products.
Alan Donald received his
MA in Biochemistry from San Diego State University and performed specialty studies
at Harvard University. He received his Executive MBA from University of California.
Donalds additional
contributions include: Member, Tech Coast Angels; Member, ASTM Standards Group
for Tissue-Engineered Medical Products; Regulatory Affairs Professional Society;
The Honorable Mark Wyland Biologics Advisory Committee; Professor, Regulatory
Affairs, Masters Program, Center for Bio / Pharmaceutical and Biodevice
Development, San Diego State University; Lead Auditor, Registrars Accreditation
Board; National Institutes of Health (NIH); Small Business Innovation Research
(SBIR) Grant Review Committee; National Institute on Drugs of Abuse (NIDA);
Member, BIOCOM; Medical Device and Diagnostic Industry (MD&DI) Technical
Advisory Board.
Farida Fotouhi
Marketing Advisor
Reality2
farida@reality2.com
Farida Fotouhi is President
and founder of Reality2 LLC, a marketing and advertising company. She has spent
30 years working with clients ranging from major national brands to start-ups,
in just about every business category.
Reality2 helps companies
define what they stand for (branding) and what they should say to whom (positioning
strategy). Then, the firm executes unified programs based on the strategy. Program
elements can be a new website, logo, sales literature, presentations, trade
show displays and ad campaigns in all media. The Reality2 package for
startups includes positioning strategy, corporate image, website, brochure
and PowerPoint.
The company is named after
its reality-based approach, which starts by analyzing three key realities: what
customers care about, the competitive environment, and the clients true
strengths. Instead of overlooking the truth or hiding it, as marketing is sometimes
accused of doing, Reality2 uses core truths to drive results.
One of Faridas noteworthy
traits is the ability to distill highly complex concepts into simple and compelling
messages, whether the client is in technology, higher education or financial
services. She thinks this capability comes from her and her teams multi-cultural
background.
She spent her childhood
overseas as the daughter of an American diplomat, and consequently speaks Japanese,
Portuguese, some French, Hausa, and casual Spanish. Her ability to build bridges
between different cultures has been an asset in todays fragmented marketing
environment. Reality2 is in effect a translator, helping clients
talk to each target audience in its own language.
For 25 years she and her
creative partner Jorge Alonso headed up one of LAs top mid-sized advertising
agencies, Fotouhi Alonso. Her current company, reinvented as Reality2, is the
result of a desire to work more closely with clients one-on-one.
Farida was graduated cum
laude from Middlebury College in Vermont. She lives in Mandeville Canyon with
her husband Mike Freehling and their Rhodesian Ridgeback Shaka Zulu. She is
an avid equestrian and competes in show jumping events.
Albrecht W. Frauendorf, Ph.D.
Industry Advisor
CODA Genomics, Inc.
afrauendorf@codagenomics.com
Albrecht is currently Senior
Vice President of Operations and Finance for CODA Genomics, Inc., a company
that provides protein expression solutions to the pharmaceutical and biotech
industry. He is responsible for operational excellence and strategy execution.
With over ten years experience
in project and quality systems management, he has helped the commercialization
process of several start-up companies. He is currently also coaching entrepreneurs
to become more successful by dealing with their personal shadow. Albrecht has
an interdisciplinary background that includes chemistry, neurophysiology, systems
theory, and analytical psychology.
Albrecht came to the U.S.
for post-doctoral work in the laboratory of R. Letsinger at Northwestern University.
Starting a business career in 1996, Albrecht joined Protogene Laboratories,
Inc., and had increasing levels of responsibility leading to the title of Directory
of DNA micro-array Manufacturing. He facilitated growth of the operations group
from 8 to over 30 employees through project management training and team building.
Albrecht then joined Nimblegen Systems, Inc. as Vice President of Manufacturing
and Quality Systems where he was responsible for growing global production during
commercialization and setting up the company's manufacturing facilities in Madison,
WI and Reykjavik, Iceland.
Albrecht earned his Ph.D.
in Biophysical Chemistry in the laboratory of Professor J. Engels at the University
of Frankfurt, Germany.
Paul M. Grand
Investment Advisor
RCT BioVentures
pgrand@rctech.com
Paul M. Grand is Director,
Pacific Coast for RCT BioVentures, a technology venture investment firm and
management company that provides early-stage venture funding for promising biomedical
companies and technologies. RCT has assets of more than $300 million to advance
technology and product development. Prior to joining RCT, Grand was co-founder
and VP of Operations of Imagine Pharmaceuticals. Imagine is developing a platform
to selectively deliver therapeutics and other compounds across the blood brain
barrier. He was also co-founder and CEO of MicroSurgeon in Los Angeles. MicroSurgeon
is developing a microwave thermal ablation device for the treatment of solid
tumors.
Grand has extensive experience
in new company formation and fund raising. Since 1990, he has built, operated,
recruited management and raised financing for eight high technology, medical
device and biotechnology companies. He has employed more than 300 people in
the Los Angeles area and served as CEO in companies with up to 150 employees.
Grand also was a managing director for Fruition Ventures, a group of private
equity investors focused primarily on early-stage information technology companies.
Grand is a frequent panelist
at biomedical conferences, and he is a member of the Los Angeles Life Science
Roundtable. Grand has lectured on entrepreneurship and venture funding to faculty,
students and scientists at the University of California in Los Angeles, and
he serves as an investment advisor to the LARTA NIH Commercialization Assistance
Program for National Institute of Health Phase II Small Business Innovation
Research (SBIR) program awardees. Grand has spoken at more than 100 conferences,
been featured in hundreds of articles in publications including Forbes, New
York Times and Wall Street Journal and appeared as an expert on Bloomberg Television,
CNN, and CNN/FN.
James K. Hu
Industry Advisor
Martek Biosciences Corp.
j77hu@yahoo.com
James K. Hu currently serves
as Associate General Counsel at Martek Biosciences Corp. At Martek, James focuses
on technology and licensing transactions, corporate collaborations, IP matters,
regulatory, and merger and acquisitions. Prior to joining Martek, James was
the Director of Legal Affairs of Focus Diagnostics, where he was the chief legal
officer of the company and guided the company through three successful acquisitions
and ultimate sale of the company to Quest Diagnostics. Prior to joining Focus,
James was a partner of Helios Concepts, where he provided strategic consulting
and management services to early-stage biotechnology and information technology
companies. Prior to Helios, James co-founded and served as Executive Vice President
and General Counsel of AegiSoft Corp. James was instrumental in growing Aegisoft
from a start-up to a multi-million dollar company and was the company's chief
strategist and negotiator in several rounds of private venture financing, international
licensing and strategic partnerships and eventually in the sale of the company
to RealNetworks, Inc. Prior to Aegisoft, James was one of the founding employees
and served as the Director of Corporate Development for Stem Cell Therapeutics,
Inc. Prior to Stem Cell, James was the Associate Director of Technology Transfer
for Temple University focused in life sciences technology and medical devices.
James also held various corporate development and legal positions with Cytogen
Corp. and the Cornell Research Foundation. James earned a J.D. from Syracuse
University and a B.S. in Microbiology, Molecular Genetics, and Economics from
UCLA. James currently sits on the Board of the Chinese Biopharmaceutical Association.
Zeynep Ilgaz
Industry Advisor
Confirm BioSciences
zilgaz@confirmbiosciences.com
Zeynep Ilgaz is the co-founder
and President of Confirm BioSciences. As the global leader in the field of lab
testing for drugs of abuse, Confirm BioSciences is committed to being on the
cutting edge of offering new, service-oriented drug testing technologies. The
company was recently named as one of the fastest growing companies in San Diego
(#3) by the San Diego Business Journal.
Ilgaz is an advisor to the
National Institutes of Health commercialization assistance program and is a
dedicated participant in the educational and entrepreneurial programs of San
Diego State University, UCSD,High Tech High and the San Diego Unified School
District. She has initiated a corporate giving program whose beneficiaries include
The Alpha Project for the Homeless, The McAlister Institute, San DiegoYouth
and Community Services, Teen Challenge International and Volunteers of Americas
Alcohol and Drug Services Center.
Ilgaz received her MBA from
San Diego State University in 2000. She earned her bachelors degree in
Economics and Finance from Bosphorus University, Istanbul, Turkey.
Ilgaz was a recipient of
the 2008 YWCA TWIN (Tribute to Women in Industry) awards and a recipient of
40 under 40 in from San Diego Metropolitan Magazine in September 2008. In 2009,
SDSU presented her with the Charles Lamden Rising Star in Business award.
Lisa Kattan
Intellectual Property Advisor
Venable LLP
LMKattan@Venable.com
Lisa Kattan is an intellectual
property litigator and focuses her practice on complex patent litigation. Ms.
Kattan concentrates on patent litigation regarding pharmaceuticals (including
Hatch-Waxman litigation), biotechnology, medical devices, optical equipment,
polymers, catalysts and consumer products.
Ms. Kattan has experience
with all phases of patent litigation, including developing litigation strategies,
participating in bench and jury trials, motions practice, and Markman hearings,
as well as primary responsibility for developing expert testimony and taking
and defending fact and expert witness depositions. Ms. Kattan has litigated
in federal district courts throughout the U.S., the Court of Federal Claims,
and the International Trade Commission. Ms. Kattan also has been involved with
appeals before the Federal Circuit. She has experience with matters before the
U.S. Patent and Trademark office, including preparing patent applications, responses
to office actions, and requests for reexamination. Ms. Kattan is registered
to practice before the U.S. Patent and Trademark Office.
Ms. Kattan is a member of
the American Intellectual Property Law Association, the American Bar Association
(Intellectual Property section), the Federal Circuit Bar Association (Pro Bono
committee), the Women's Bar Association of the District of Columbia and the
American Chemical Society. She earned a B.A. in Chemistry from the University
of South Dakota, M.S. in Scientific and Technical Communication from the University
of Minnesota, and J.D. from Northwestern University.
Roger Kitterman
Investment Advisor
Partners Healthcare
rkitterman@partners.org
Roger is an experienced
venture capital investor with more than 15 years in the industry and has guided
multiple venture-backed companies through the earliest stages of development
through IPO. He has also been the startup CEO for three venture-backed companies.
He is currently a Partner in the Innovation Fund of Partners Healthcare, an
integrated healthcare delivery system founded in 1994 by Massachusetts General
Hospital and Brigham and Women's Hospital, two of the main teaching hospitals
of Harvard Medical School. Previously, he was a general partner at Mi3 Venture
Partners, an early stage, bioengineering focused fund. Prior to joining Mi3,
he was a managing director at Lee Munder Venture Partners, the venture capital
arm of Lee Munder Capital Group. He joined Lee Munder from Boston University's
Technology Fund, where he made venture capital investments in the life sciences
and developed and managed spinouts from the university and Boston Medical Center.
Roger began his venture capital career in Eastern Europe with the Bulgarian-
American Enterprise Fund, a $55 million venture capital fund. Roger holds an
MBA in Finance and Business Development from the Columbia Business School and
an AB from Harvard College. He is a Member of the Board of Directors of a number
of private companies.
Scott Leese
Industry Advisor
Dynamic Coaching Strategies
dynamiccoaching@verizon.net
Scott Leese founder Dynamic
Coaching Strategies a consulting and coaching firm specializing in advisory
support of entrepreneurs inventors and start-up teams.
Responsibilities include:
Evaluation and alignment
of market viability
Commercialization strategic planning and process.
Alignment of decision making strategies that accelerate market entry, position
and time-to-market.
Generating linkages between inventors, research institutions, investors and
industry leaders.
Advisory rolls in technology transference, adaptation and facilitation.
Management and team innovation consulting and coaching.
Scott was invited to join the Larta Institute as an advisor for the National
Institutes of Health program back in October of 2007. Scott has recently been
involved in the Keiretsu So-cal forum as well as the So.Cal Tech forum.
Furthermore Scotts
expertise falls in the areas of Executive development, Presentation preparation
and the amplification of innovation process through the fields of TRIZ, NLP,
and Six Sigma. Scott has worked with current and former executives from Unocal,
Gartner Group, and Nexxan Technologies.
Scott and his family live
in Thousand Oaks California. He holds a Masters in Educational Technology from
Pepperdine University and spent 9 years as a volunteer for the Malibu Mountain
Search and Rescue Team.
Steve Maylish
Industry Advisor
Aubrey Group, Inc.
smaylish@aubreygroup.com
Mr. Steve Maylish has been
in the medical device industry for 20+ years. Prior to Source Scientific and
Aubrey Group, he was associated with several well-known medical companies, including
Johnson & Johnson, Shiley, Sorin Biomedical, Baxter Healthcare, and Edwards
Lifesciences. His past management experience includes serving as Director, Cardiopulmonary
Marketing, at Edwards Lifesciences, and as Director, Hardware Division, at Jostra
Bentley.
Mr. Maylish has mostly been
involved in marketing medical devices related to cardiac surgery and has coordinated
product launches both in the U.S. and abroad. In 1999, he was instrumental in
the integration of both Cobe Cardiovascular and Avacor perfusion businesses
into Baxter Healthcare. As Baxter Healthcare spun-off Edwards Lifesciences,
he assumed responsibility for Cardiopulmonary Marketing. With the subsequent
purchase of the Bentley division from Edwards Lifesciences by Jostra Bentley,
he became responsible for the strategic direction and implementation of the
company's hardware division.
At Source Scientific, Mr.
Maylish is responsible for sales and marketing efforts related to the company's
medical device design and manufacturing services. His prior management experience
also includes serving as an International Service Manager and Product Manager
for Sorin Biomedical, and Senior Product Manager for Baxter Healthcare. Mr.
Maylish has an A.S. degree in Electronics from RETS Electronics Institute, Broomall,
PA, a B.S. in Business from the University of La Verne, La Verne, CA and an
MBA from the University of California, in Irvine.
Andrew McAleavey
Intellectual Property Advisor
PatentBest
andrew@patentbest.com
Andrew McAleavey is a registered
patent agent with over six years of experience. He focuses his practice on procuring
patents for companies and individuals in the United States and throughout the
world.
Andrew holds a B.S. in Biomedical
Engineering from The Johns Hopkins University, which included work in a number
of disciplines. Consequently, his practice spans a wide range of technologies,
including medical devices, bioinformatics, applied chemistry, computer science,
business methods, mechanical engineering, and electrical engineering. He specializes
in multidisciplinary technologies that require a good grounding in basic science
and broad knowledge of engineering.
Andrew began his career
as a patent agent with Pillsbury Winthrop LLP, a global law firm, where he prepared
and prosecuted patent applications for a number of well-known companies and
also acted as a technical advisor to a litigation team in a case involving machine
vision and programming language theory. After leaving Pillsbury Winthrop, Andrew
joined a smaller, Washington, D.C.-area firm with a growing patent practice,
handled patent cases, and advised on infrastructure and procedural issues.
In addition to work in private
practice, Andrew also served as a patent examiner at the U.S. Patent and Trademark
Office, where he examined patent applications directed to cleaning technologies,
including dishwashers, washing machines, and semiconductor wafer cleaning apparatus.
Barrett McGrath
Industry Advisor
Larta Institute
barrett.mcgrath@sbcglobal.net
Barrett McGrath is an executive
with more than 24 years of commercial and business development experience in
the biopharmaceutical industry. He has worked with mid-size companies as well
start-up and emerging Life Sciences concerns. Most recently, Barrett served
as Executive Director, Alliance and Portfolio Management with Novaquest (formerly
PharmaBio Development), the strategic investment unit of Quintiles Transnational.
In this capacity, he was responsible for oversight of new and established product
development and commercialization partnerships with early stage and emerging
biotechnology companies.
Barrett has also served
as a consultant to the Life Sciences industry, providing both commercial and
business development services to privately held companies, and helping guide
them through several levels of financing, including IPOs. Notable among these
is Tercica Inc., founded in 2001 and having an IPO in 2003. During this engagement,
Barrett had an instrumental role in Tercicas successful migration from
New Zealand to the United States, the raising of a Series A financing, and closing
the in-licensing of their lead compound, IGF-I, from Genentech.
Barretts career began
in 1982 with American Critical Care, a pharmaceutical division of American Hospital
Supply Corporation (ACC was subsequently acquired by Du Pont Pharmaceuticals).
During his tenure at ACC/Du Pont, he held positions of increasing responsibility
in sales and marketing/brand management. Barrett then joined Genentech in 1989,
where he remained for 11 years, and again held positions of increasing responsibility
in sales management and marketing management.
Barrett received his Bachelor
of Science Degree in Business Administration/Marketing from the University of
Tennessee in 1982. He is married, with three children, and resides in Los Altos,
California.
Nader Mousavi
Legal Advisor
Technology Transactions and Licensing Practice Group
nader.mousavi@wilmerhale.com
Nader Mousavi is a partner in the Technology Transactions and Licensing Practice
Group. He joined the firm in 2001. After working in the Boston office, he returned
to his native California in 2005 as a founding member of the firm's Palo Alto
office.
Mr. Mousavi concentrates his practice on business transactions involving technology
and intellectual property. He has represented emerging and established clients
in hundreds of transactions involving the licensing, development, manufacturing,
supply, marketing and commercialization of products, technology and intellectual
property. He also has extensive experience advising clients in collaborations,
alliances, joint ventures, spinouts, mergers and acquisitions, cross-licenses
and settlements.
Mr. Mousavi has substantial in-house legal experience. After the establishment
of the Palo Alto office, he served on special assignment to Cisco Systems' technology
licensing group, where he advised Cisco's voice and wireless business units.
Prior to joining the firm, he served as the general counsel of TCS, a telecommunications
software and services company. At TCS, Mr. Mousavi was responsible for all legal
affairs from TCS' startup phase in 1997 through its substantial growth and then
acquisition by Convergent Networks in 2000 for over $100 million. Following
the acquisition of TCS, Mr. Mousavi served as senior counsel of Convergent Networks,
a broadband infrastructure company, until joining the firm in 2001.
While in Boston, Mr. Mousavi was one of 10 attorneys selected to participate
in the Boston Bar Association's Public Interest Leadership Program, an intensive,
year-long leadership development initiative focusing on public service. He also
served as a member of the Grants Committee for the Boston Bar Foundation and
a member of the Development Advisory Board of the Philips Brooks House Association,
a student-led public service organization at Harvard University.
Richard P. Ormond
Legal Advisor
Buchalter Nemer
rormond@buchalter.com
Richard Ormond is an Associate
in the firm's Los Angeles office, with expertise in intellectual property, e-discovery,
remedies and litigation, including bankruptcy litigation. Representative of
his clients are national lending and financial institutions, popular international
clothing companies, a national upscale restaurant chain, state and federal receivers
and international technology companies.
Bilingual and biliterate
in Spanish, Mr. Ormond was twice chosen as a Southern California Super Lawyers
Rising Star (2005 and 2006). He represents both institutional and entrepreneurial
clients in litigation, dispute resolution, intellectual property matters including
copyright, trademark, trade secret and trade dress claims e-commerce and e-discovery
matters, domain name litigation and enforcement of meta-tag rights. Mr. Ormond
has tried cases before the Los Angeles Superior Court, as lead trial counsel,
the United States District Court, Central District of California and the Bankruptcy
Court of the United States District Court Central District of California and
has arbitrated before JAMS, Alternative Dispute Resolution and the American
Arbitration Association.
Mr. Ormond chairs the Buchalter
Nemer Pro Bono committee, co-chairs the firm's Diversity Committee, founded
its Hispanic Attorneys Committee and co-chairs the firm's litigation MCLE committee.
He is the author of numerous articles and teaches Continuing Legal Education
courses on New Developments in e-Discovery, Considerations for Complex Litigation,
Basics of Receivership Law and Practice, and Lender Security in Intellectual
Property.
In addition to his practice,
Mr. Ormond is actively engaged in civic and professional organizations, among
them, Uncommon Good, a nonprofit organization of which he is a board member,
and Bet Tzedek House of Justice, which provides free legal services to Los Angelenos
who need them. Professionally, he is an active member of the National Hispanic
Bar Association, the Los Angeles County Bar Association, of which he is a member
of the Remedies Section Executive Committee and co-chair of the Remedies Section
Recruitment/Membership sub-committee, and the California Receivers Forum.
Mr. Ormond earned his bachelor's degree at the University of California, Los
Angeles and his J.D. at the University of San Diego School of Law. He also studied
international law and business law at the University of Buenos Aires, Argentina.
He is admitted to the bars
of California, U.S. District Court Central District of California, and the U.S.
Court of Appeals 9th Circuit.
Robert D. Patti
Industry Advisor
California Manufacturing Technology Consulting
rpatti@cmtc.com
Robert D. Patti is a quality
professional with diverse industry experience in the design, manufacture and
quality of high technology products for worldwide consumer, aerospace, telecommunication,
electronics, medical and industrial markets.
Mr. Patti has over 30 years
experience in the medical device and pharmaceutical industry. He has held executive
level positions with: Baxter, G.D. Searle, Medtronic, Technicon and Siemens
Pacesetter Systems. In addition, he has consulted domestically and internationally
for such companies as: Eli Lilly, Siemens Medical, National Medical Care, and
many other firms including the FDA. He has performed over 60 quality systems
audits in 14 countries to QSR, GMP, and ISO requirements.
His experience includes
assisting companies in recovering from FDA: 483s, Warning Letters, Consent Decrees
and Import Embargos. His product experience includes: IVDs, Drugs, OTCs, and
a broad variety of all three classes of Medical Devices. He is versed in quality
systems implementation, sterilization processes, bioburden control, the MDR,
customer complaint evaluations, clinical evaluations, regulatory approvals,
metrology, recalls, field notifications, product test and inspection, vendor
control, corrective and preventive actions.
He holds a BS in Electronic
Engineering from California Polytechnic State University in San Luis Obispo,
CA and is a Professional Quality Engineer in the State of California. He has
served as an Examiner for the California Governor's Golden State Quality Awards
and is a Senior Member of the American Society of Quality, Society of Manufacturing
Engineers and the Instrument Society of America. He is also a member of the
Southern California Biomedical Council.
Patti has ten years experience
with California Manufacturing Technology Consulting.
Karol Pessin, JD
Intellectual Property Advisor
Foley & Lardner
kpessin@kpessin.com
Karol Pessin is an intellectual
property lawyer and advisor with about 20 years experience in the biotechnology
field.
She worked at Amgen for
over 10 years with primary responsibility for IP of the Neupogen/Neulasta franchise.
Prior to Amgen, Ms. Pessin was in private practice at Lyon & Lyon, where
her major responsibility was patent litigation on behalf of Genentech. She is
currently with the law firm Foley & Lardner.
As a Larta advisor under
the CAP program, Ms. Pessin has advised start-up management on patent and licensing
business and research strategies, including market exclusivity and market entry.
This involves not only patent properties, but may involve regulatory requirements,
manufacturing strategies or licenses. Ms. Pessin has advised on managing outside
counsel, and how or when to use outside counsel effectively, and on setting
up an in-house law department. Currently, Ms. Pessin is an intellectual property
lawyer with Foley & Lardner, in the life sciences and chemical/pharmaceutical
area.
Ms. Pessin received her
JD from UC Berkeley, Boalt Hall.
David Pyrce
Senior Industry Advisor
Jaguar Investment Group
davidpyrce@verizon.net
David J. Pyrce is a skilled
executive with more than 25 years of diverse senior management experience. Mr.
Pyrce's background includes investment banking, venture capital, asset management,
business development, product development, marketing and sales.
David Pyrce is the Founder
and the Managing General Partner of the Jaguar Investment Group, LLC, an investment
management firm focused on opportunistic investments. Prior to forming Jaguar,
Mr. Pyrce was President of Bear Creek Capital Management, LLC, an investment
management firm and Managing General Partner of Bear Creek Capital Partners,
LP, a limited partnership investing in public and private equity as well as
direct investments. Previously, Mr. Pyrce worked at First Security Van Kasper,
a San Francisco investment banking firm, as Managing Director of Investment
Banking and General Partner of their venture capital fund. Mr. Pyrce joined
the Company as a Vice President and Senior Analyst.
Mr. Pyrce began his professional
investment activities while part of the venture capital group of SmithKline
Beecham Pharmaceuticals. While at SmithKline, Mr. Pyrce managed the roll-up
strategy for the Company's clinical laboratory group, acquiring a portfolio
of regional clinical labs across the country. Mr. Pyrce soon learned that owning,
repositioning and ultimately disposing of these medical office properties was
a highly profitable business.
Mr. Pyrce was Chief Business
officer of Inovio AS, an Oslo, Norway-based biopharmaceutical firm developing
monoclonal antibodies, protein therapeutics and vaccines. Mr. Pyrce negotiated
the sale of Inovio to Genetronics Biomedical, a San Diego-based firm with similar
product development programs, with the company renamed, Inovio Biomedical Corporation.
Earlier in his career, Mr.
Pyrce was Vice President of Corporate Development of Vical Inc., a biopharmaceutical
company, and was Vice President of Sales and Marketing for Baxter Healthcare.
A graduate of Northern Illinois
University, where he earned a Bachelor of Science degree in Chemistry and Biology,
Mr. Pyrce holds a Master of Business Administration in Financial Management
from the Stuart School of Business at the Illinois Institute of Technology.
He is also an alumnus of the Advanced Executive Program at the Kellogg School
of Business at Northwestern University.
David Roth
Industry Advisor
CODA Genomics, Inc.
droth@codagenomics.com
Dr. Roth is presently the
Senior Vice President of Research and Development at CODA Genomics, Inc., in
Laguna Hills, CA, a privately held biotechnology company spun out of technologies
invented at, licensed from, and developed in close collaboration with scientists
at UC-Irvine beginning in 2005. CODA applies its proprietary technologies using
computational and synthetic biology to design and build genes for optimal protein
expression and function. CODAs business model is to drive revenues via
synthetic gene programs for optimized protein production for clients and partnering
to solve customers' demanding protein challenges. David is responsible for creating,
developing, and executing CODAs product and technologies pipeline, developing
and managing the intellectual property portfolio, and creating business and
academic alliances for grants and contracts (including the NIH and DOE), collaborations,
and strategic relationships. He works closely with CODAs Market Development,
Business Development, Operations, and Sales and Marketing teams to conceive,
propose and manage corporate- and USG- funded partnerships.
Prior to his work at CODA
David spent 3 years as the VP-R&D at Gene Therapy Systems, Inc., a startup
biotech company in San Diego specializing in molecular tools aimed at the DNA,
RNA and protein delivery markets, and the development of proprietary platform
technologies for antigen discovery used for vaccine and diagnostic product development.
At GTS David identified new funding opportunities, spearheaded and wrote successful
collaborative grant and contract applications, and worked as the business development
and lead scientist to promote and raise money for the company by identifying
and negotiating contracted services, strategic alliances and partnerships with
vaccine and diagnostic companies, US government (including NIH and the NMRC)
and international agencies, and non-profit organizations. He designed and oversaw
the development of new catalog-driven products and wrote new patent applications
for novel products invented in-house. David also created and directed collaborations
between GTS and biotechnology, pharmaceutical, vaccine and diagnostics partners
(strategic alliances, joint ventures, grant- and contract-based collaborations
and partnerships), academic and institutional collaborations, and scientific
consultants.
David began his industry
career at Collateral Therapeutics, Inc. in San Diego, where he was the Director
of Research and Technology for over 4.5 years where he planned and managed R&D
projects in these integrated fields: cell and molecular biology, biochemistry,
rodent physiology (rats, mice, transgenics), large animal physiology and pharmacology
(pigs, rabbits), and process development. David directed and coordinated internal
interactions between these departments: research program planning and management,
quality assurance, regulatory affairs (including FDA interactions), legal/in-house
counsel (patents, licensing, intellectual property), process development and
manufacturing (GLP, GMP, QC), pre-clinical and clinical development, product
development, human resources, financial planning and budgets. He also provided
leadership during evaluation and prioritization of programs and projects during
acquisition/transition phases of Collateral Therapeutics with Schering AG-Germany,
and its wholly owned US subsidiary, Berlex Biosciences.
Prior to working in the
biotech industry, David was an Assistant Professor and Director of the Molecular
Physiology Laboratory in the Department of Integrative Physiology at the University
of Colorado in Boulder. Along with running successful research programs, he
was also the recipient of the Universitys Teaching Excellence Award given
by the Student Organization for Alumni Relations (SOAR) for tenure track faculty
for the 30-75 undergraduate student class size.
David received his BS, MS
and PhD degrees at UC-Berkeley in the laboratory of Prof. George Brooks, PhD,
and completed a postdoctoral fellowship at UC-San Diego School of Medicine with
Prof. H. Kirk Hammond, MD, in Molecular Cardiology.
Steve Runnels
Senior Industry Advisor
ProteoTech, Inc.
srunnels13@cox.net
Mr. Steve Runnels has more
than twenty-six years of successful and proven international business management
experience in the healthcare industry. He is the Chief Executive Officer of
ProteoTech, Inc., a drug development company with therapeutic programs in Alzheimers
and Parkinsons disease.
He has held the position
of President and CEO of several start-up biopharmaceutical companies, executive
vice president and Board member of publicly traded NeoTherapeutics, Inc. (NEOT:
NASDAQ) and Vice President of Marketing and Business Development at Sigma-Aldrich,
a Fortune 500 company. He has extensive business experience covering strategic
planning, development of domestic and international sales and marketing teams
and development of an international distributor network.
He has led drug discovery
and in vitro diagnostic product development activities in the therapeutic areas
of Central Nervous System, Oncology, Clinical Cytogenetics, Assisted Reproductive
Technologies, Immunohematology and Diseases of Bone and Cartilage.
Mr. Runnels is a Senior
Industry Advisor for the National Institutes of Health Commercialization Assistance
Program (NIH-CAP), managed by the Los Angeles Regional Technology Association
(LARTA). He is on the Advisory Board for Extension Courses in Medical Product
Development, at the University of California Irvine. Mr. Runnels holds
a B.S. in Cell Biology and certification from the American Society of Clinical
Pathology as a specialist in Immunohematology. He has an MBA in International
Business and is a Ph.D. candidate in Management.
Ronald Schoengold
Senior Industry Advisor
E Gold Solutions
ron@egoldsolutions.com
Ronald Schoengold has been
an active contributor to the biomedical environment for over 40 years. As a
consultant to both large and small companies in the biotechnology industry,
he offers expert advice to companies that must comply with regulatory and quality
system requirements. Schoengold is certified in regulatory affairs and has a
proven track record for integrating quality and regulatory requirements with
technical, organizational and business development needs. He offers advice on
the effective commercialization and maintenance of medical products and services.
Schoengold has specialized training and hands-on experience in developing screening
and diagnostic products in gastroenterology (e.g., Hemoccult® colorectal
cancer screening tests), infectious disease and point-of-care devices, reagents
and test systems. He is currently listed as a senior advisor to the Larta Institute
(National Institutes of Health, Commercialization Assistance Program). Schoengold
has published, presented or contributed to more than 16 scientific publications
including a book chapter on point-of-care testing. He holds 8 patents related
to point-of-care diagnostics.
Joanna Schulman
Senior Industry Advisor
Thallo Bioscience Advisors, LLC
joanna@thallobiosciences.com
Joanna Schulman is founder
and managing partner of Thallo Bioscience Advisors, LLC a financial and strategic
advisory firm serving clients globally in the life sciences sector. She has
extensive experience working with organizations ranging from startups to multinational
enterprises providing advisory services in the areas of corporate financing
& growth strategies, asset acquisition & divestiture, M&A, partnering
and alliances, licensing opportunities, company/product positioning and capital
raising.
Prior to establishing Thallo,
Joanna worked with Deloitte to build their national/international life sciences
practice and has held various executive positions in industry including Vice
President of a pharmaceutical commodities trading company and Consulting Director
to Pathways Cancer Center.
Joanna is and active participant,
committee member and speaker for industry organizations including BIO, BayBio,
Larta & CHI. She has served on the board and steering committees for a wide
range of non-profit and patient advocacy groups.
Greg Scott
Investment Advisor
Life Science Angels
gscott@centient.com
Mr. Scott is President and co-founder of Life Science Angels, a private equity
investment group that has invested in ten early stage biotechnology and medical
device companies since its launch in 2005. He is also founder and CEO of Centient
Consulting, a consulting firm providing business and investment strategy services
to emerging and established life science companies. Mr. Scott has helped launch
more than twenty startups as founder, angel investor, board member and advisor.
He is also the Executive Editor of The Centient Biotech Investor and the
Managing Editor of The Golden State BioBusiness News. Mr. Scott previously
held senior management positions with MCI, PricewaterhouseCoopers and Capgemini.
Michael A. Shimokaji
Intellectual Property Advisor
Shimokaji & Associates, P.C.
mshimokaji@shimokaji.com
Mr. Shimokaji is a shareholder
in the law firm of Shimokaji & Associates, P.C., located in Irvine, California.
The firm is engaged in intellectual property litigation and the procurement
of patent rights domestically and abroad.
For more than 20 years, Mr. Shimokaji has supported clients in industries as
diverse as aerospace, apparel, household products, medical devices, software,
telecommunications, photo imaging, and semiconductors. He is the author of articles
that include Inducement and Contributory Infringement Theories to Regulate
Pre-Patent Issuance Activity 37 IDEA 571 (1997); Type of Use Determines
Whether Use of Web Content Will Be Infringing L.A. Daily Journal, August
22, 2002; and Cease and Desist Letters May Contain Some Hidden Perils
L.A. Daily Journal, February 27, 2003; Contingency Defense in Patent Lawsuits
L.A. Daily Journal, August 1, 2006; Putting Designs to the Test
L.A. Daily Journal, October 30, 2008; Mind Over Matter Los Angeles
Lawyer, April 2009; Taking Orders L.A. Daily Journal, August 19,
2009.
During the past seven years, Mr. Shimokaji has been a member of the Steering
Committee for the California Minority Counsel Program. He was a founding director
of the Orange County Japanese-American Lawyers Association and has served as
an instructor in the paralegal program at the University of California, Irvine.
Mr. Shimokaji is a past president of the Orange Coast Optimist Club. He served
for three years on the Executive Committee for the California State Bar Intellectual
Property Section. He is currently serving a three year term on the California
State Bar Federal Courts Committee. Mr. Shimokaji is also a member of the editorial
board for The Journal of the Association of University Technology Managers.
Following graduation from the University of California, Irvine with a bachelors
degree in chemistry, Mr. Shimokaji received his Juris Doctorate degree from
Southwestern University School of Law. In law school, Mr. Shimokaji was an executive
editor for the schools law review. He has served as a judicial extern
for the Honorable Robert M. Takasugi, Judge, United States District Court. Mr.
Shimokaji is admitted to the California Bar. He is also admitted to practice
before the United States Patent and Trademark Office.
Robin Tucker
Legal Advisor
Wilson Sonsini Goodrich & Rosati
rtucker@wsgr.com
Robin Tucker is an associate
in the Palo Alto office of Wilson Sonsini Goodrich & Rosati. She specializes
in corporate and securities law and advises private and public companies in
various technology industries, including life sciences.
Robin returns to legal practice
after a career in management consulting, with expertise in strategic planning,
market assessment, financial analysis, and training design. Robin also has management
experience in a start-up environment and spent over 12 years in the healthcare
industry.
Robin earned her B.S. in
Management and MBA from Arizona State University. She received her law degree
from University of California, Berkeley. Ms. Tucker is admitted to the California
bar.
Monica Alfaro Welling
Industry Advisor
Strategic Links
MWelling@StrategicLinks3.com
Ms. Welling has over 18
years of experience in strategic planning and marketing in pharmaceuticals,
biotechnology, and medical devices. Her unique career in the life science industry
has allowed her to touch every aspect of the development and commercialization
process of early and late stage development products and new therapeutic applications.
In addition Ms. Welling has experience launching products, medical devices,
and new product indications, both domestically and internationally.
Prior to co-founding Strategic
Links, which provides business solutions for life science companies, Ms. Welling
served as Senior Vice President for Hythiam, an early stage company focusing
on the medical treatment of addiction. She was a corporate officer and member
of the Executive Leadership Team, overseeing all of the companys marketing,
planning, and strategic operations. While there, Ms. Welling supported several
rounds of fund raising, and developed and implemented the commercial platform
for the company. This resulted in the roll-out of a robust data package plan,
an innovative strategy to create initial awareness and early adoption, and an
infrastructure to support company growth. Largely as a result of her initiatives
and management, the company grew to a market cap of $350M in the 3 years she
was there.
In addition to her experience
at Hythiam, Ms. Welling held senior level positions at Novo Nordisk and Allergan.
She was the first commercial person to manage a drug and device development
program during her tenure with Novo Nordisk, and she created several best practices
to manage project risks and ensure cross-functional management buy-in, which
was implemented throughout the company. At Allergan, she led the commercial
development of new medical therapeutic areas for BOTOX, one of the most successful
pharmaceutical brands ever to be marketed in the USA. These strategies and initiatives
resulted in significant expansion of its use in the medical community.
Ms Welling has a Masters
in Business Administration from Odense University in Denmark as well as a Bachelor
of Science in Biology and a Bachelor of Arts in Economics from the University
of California, Irvine.
Mark Wittman
Industry Advisor
mwittman3@roadrunner.com
Mark Wittman, MD, MBA is
an entrepreneur, consultant, and physician, with significant experience in both
clinical and management positions. In 2004, he was a cofounder of Alba Therapeutics,
a Baltimore based biotechnology company devoted to the inflammation, autoimmune
space. He assisted in company formation, capital raise efforts, and business
development initiatives. The lead candidate is currently in phase II human
clinical trials.
Dr. Wittman was a managing
director of COLDWATER ASSOCIATES, LLC, a capital advisory and strategic management
consulting company that was initially formed as Coldwater Financial, LLC in
June 2001. The partnership had two additional directors. Dr. Wittman's focus
was on the life sciences space, dealing with clients and investors in all sectors
of life sciences investments.
Dr. Wittman was a co-founder
and Senior Vice President of Business Development for My Life.com, an Idealab!
Company, an internet healthcare company devoted to improving the quality of
life through a portfolio of web-enabled medical devices that allowed users to
automatically send their health data to a secure, personalized life record.
Dr. Wittman served as a
strategic business development consultant to Edwards Lifescience, critical care
division, where he assisted in the launch of a minimally invasive hemodynamic
monitoring system, performed clinical sales support for the product, and assisted
on several product development initiatives.
Dr. Wittman was the principal
of MW Consulting, Inc., a consulting firm dedicated to areas of strategic development,
and product and market analysis. Examples of clients included Viso Health, a
start-up a telemedicine company that was focused on remotely diagnosing and
treating patients, thereby maintaining the health of its patients and significantly
decreasing medical costs.
Dr. Wittman has served clinical
and management roles in Emergency Medicine, Anesthesia, and Critical Care Medicine.
He has served as the Associate Director of Surgical Critical Care at Cedar-Sinai
Medical Center as well as the Co-Chairman of the Department of Anesthesia at
Midway Hospital Medical. He has had significant
experience in liver transplant anesthesia and critical care. He has also been
quite involved with the development and testing of new anesthesia and critical
care products.
Dr. Wittman holds a Doctor
of Medicine from Northwestern University, a Masters in Business Administration
from the University of Southern California, a Masters in Public Health from
University of California Los Angeles, and a Bachelors of Arts in Biology and
Psychology from Washington University. He is board certified in Emergency Medicine,
Anesthesia, and Critical Care Medicine, having obtained postgraduate training
at Harvard Medical School.
Allison Young
Legal Advisor
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
AYoung@mintz.com
Allison is an associate
in the firm's Palo Alto office, practicing in the Business and Finance and Intellectual
Property sections with technology and life science clients. She represents companies
at various stages of development from early start-up through venture funding
and entry into the public marketplace. She advises clients in a broad range
of industries, including biotechnology, pharmaceutical, medical device, internet
and computer hardware and software, on a variety of business and legal issues,
with an emphasis on structuring and negotiating complex technology transactions,
including international and domestic strategic alliances, joint ventures, collaborations,
licensing arrangements and other transactions involving intellectual property.
She also advises investors and companies on intellectual property matters arising
in M&A transactions, venture capital and public equity financings. Her practice
includes licensing and collaboration agreements, including joint R&D and
sponsored research agreements; counseling (including procurement and regulatory
approval); corporate organization, formation and management; antitrust considerations;
patent and trademark litigation and related risk assessment counseling; and
freedom to operate for high-technology, biotechnology, pharmaceutical and medical
device companies.
Prior to joining Mintz Levin,
Allison practiced in the Intellectual Property and Litigation groups of an international
law firm. Her practice was focused on the management of IP/patent licensing
deals as well as patent litigations for high technology and life science companies,
including medical device, pharmaceutical, diagnostic and instrumentation companies.
Prior to entering private practice, Allison worked for the Attorneys Generals'
Antitrust Divisions' Pharmaceutical Working Group Task Force, investigating
ANDA Paragraph IV patent infringement litigation settlements between brand name
and generic pharmaceutical companies. She was also the Assistant Director of
the Maryland IP Law Center, a non-profit center providing fee-free counseling
and representation to start-up technology companies in the greater D.C. Metropolitan
area.
Allison serves on a variety
of committees including CHI, BayBio, ABA; She is Executive Producer for BioTech
Nation on National Public Radio (NPR); Officer and Board Member of the Sima
Faris Young M.D. Foundation, a non-profit organization supporting medical research
targeting women's oncology; and authors articles and speaks at conferences,
including drafting the IP Section of the American Bar Association (ABA)'s resolution
on compulsory licensing, and co-authored Pharmaceutical Pricing: The Right Prescription,
published in the Journal of Generics Medicine.
Allison is admitted to practice law in California, the District of Columbia
and before the United States Court of Appeals for the Federal Circuit. She was
awarded her A.B. from the University of California at Davis (1999), and her
J.D. from The University of Maryland School of Law (2002), cum laude, where
she served as a Moot Court Board Member & Competition Judge.